Ralph Ellis reminded us that more than 100,000 people in the United States were hospitalized with COVID-19 this past few weeks — a figure not reported since late January, when vaccines were not widely available.
Statistics from the U.S. Department of Health and Human Services showed 100,317 COVID hospital patients on Wednesday, a figure that grew to 101,050 on Thursday.
That’s about six times the number of COVID hospitalizations from about nine weeks ago, CNN says.
The HHS data shows COVID hospitalizations are highest across the Southeast, with more than 16,800 patients in Florida, 14,000 in Texas, 6,200 in Georgia, 3,000 in Alabama, and 2,300 in Missouri.
In comparison, California, the most populous state, has about 8,700 people hospitalized with COVID, the HHS said.
Alarmingly, many of these COVID patients are severely ill. About 30% of the nation’s intensive care unit beds are now occupied by COVID patients, HHS data shows.
Infections, deaths, and hospitalizations have increased since early summer as the Delta variant spread across the nation, especially in places with low vaccination rates.
Health experts have said the majority of the hospitalized people are unvaccinated. Research shows that vaccinated people who become infected with the Delta variant generally don’t become as sick as unvaccinated people.
Paul Offit, MD, an FDA vaccine advisory committee member, said the current availability of the vaccine makes the high number of hospitalizations especially tragic.
“The numbers now…are actually in many ways worse than last August,” Offit said on CNN. “Last August, we had a fully susceptible population, (and) we didn’t have a vaccine. Now, we have half the country vaccinated…but nonetheless the numbers are worse. The Delta variant is one big game changer.”
Sources:
U.S. Department of Health and Human Services: “Hospital Utilization.”
CNN: “With more than 100,000 people in the hospital with Covid-19 in the US, this August is worse than last, expert says.”
From Cancer to COVID: Is There a Fix for Willful Medical Ignorance?
Dr. H. Jack West pointed out something very interesting as he relayed an observation. He patient saw a patient for a second opinion after developing metastatic disease, but he’d initially been diagnosed with locally advanced non–small cell lung cancer (NSCLC). His oncologist had appropriately proposed treatment with concurrent chemoradiation followed by durvalumab. He listened to the rationale and the evidence, but he refused to pursue it, favoring alternative medicine instead.
A repeat scan several months later showed obvious progression. Even though it was potentially treatable — including with curative intent — he demurred again.
Several months down the line, he developed back pain heralding a new spinal metastasis. Only then did he accept that perhaps conventional, evidence-based anticancer therapy was worth pursuing. Of course, by that time the window of opportunity to treat with the hope of cure had closed.
But in other ways, it isn’t too late for him. He can at least benefit from subsequent treatments for advanced NSCLC. Too many other patients I’ve seen have eschewed conventional medicine so long that their poor performance status precludes standard therapies that would have been effective had they pursued them as something other than a final act of desperation.
Corollaries to Coronavirus Though this dynamic has existed for decades in oncology, the current rejection of the coronavirus vaccine, on a massive scale involving a significant minority of the US population, is a reflection of this same willful ignorance.
In 2008, I started a nonprofit organization — the Global Resource for Advancing Cancer Education — dedicated to providing free, timely, and credible information to cancer patients and caregivers around the world.
It was based on the premise that if the lay public had access to the best information — in other words, the same content that informs experts and defines optimal patient management — patients would then be able to pursue these treatments to the extent that they were broadly available. And although this service and a growing number of similar efforts have since generated a virtual army of sophisticated patients (who have since become an important force in and of themselves), it has been humbling to recognize that this approach can’t help the many people who denigrate the very pursuit of evidence-based medicine.
The widespread rejection of COVID vaccines brings this into high relief for a couple of reasons. First, the selfishness of those who reject the vaccine affects not only the individual who makes that choice but the broader public. Their decision not only puts them at risk but also the unwitting person exposed to them later. At least with cancer, poor choices only affect those making them.
Another reason that COVID vaccination is such a flashpoint: everyone, including every public figure, now makes a public declaration of their support or suspicion of science and evidence-based medicine. And we are seeing an alarming fraction of people with access to very good information rejecting the evidence and our best opportunity to control the pandemic.
I am particularly disheartened that those who reject the science aren’t prone to change their views with better educational efforts. I recognize that there is a spectrum of resistance and that some of our colleagues have convinced family members and patients to reverse their prior anti-vaccine stance; but I wish it wasn’t so hard to overcome people’s biases against the establishment — biases that lead not only to self-harm but danger to the broader public.
We need to do more to understand what leads people to reject science, because it’s clearly not just ignorance and lack of better information. We have to recognize that this phenomenon is now a leading bottleneck in the progress of modern medicine, both in oncology and other settings.
I would love to learn what others think, including successes and more optimistic views — or to simply vent your frustrations with these issues.
Helping Patients Understand Breakthrough COVID Benefits Us All –Here’s how to approach the conversation.
I have been asked these questions multiple times about breakthrough infections from Covid by my patients and I thought that this would be a good time to review, especially recently with infection numbers and the discussion regarding booster shots. Dr. Gary C. Steben pointed out that the recent change in masking guidance from the CDC and reinstated public health measures from local and state governments have been met with frustration and defiance, with people understandably questioning why they got vaccinated if they have to go back to masking and distancing anyway. The answer is in the degree of exposure to SARS-CoV-2, and the explanation lies in the way vaccines work. We can help our patients understand this with three talking points:
1. The antibody levels in the bloodstream are completely helpless at preventing infection (saying it that way seems to get everybody’s attention!)
Neutralizing virus particles from the environment is the sole responsibility of the vaccine-induced antibodies in our respiratory, GI, and ocular secretions — our “frontline” defensive antibodies in our saliva, tears, nasal secretions, and pulmonary mucus. When exposed to airborne virus particles, these antibodies attach to the spike protein of SARS-CoV-2, physically preventing it from latching on to the ACE2 receptor on the surface of our respiratory epithelium and gaining entry to those cells to cause an infection. But that’s all we’ve got — if we are exposed to so many virus particles that all the antibodies in these secretions have attached themselves to virus particles, yet we continue to expose ourselves to new particles faster than we transport more antibodies into these secretions, our antibody defense gets overwhelmed, we inhale or come in contact with more virus particles than we are able to neutralize, and we get infected.
2. Circulating antibodies help to contain the infection
Once infected, the virus takes over the machinery of our cells to make more virus particles and release them, and that’s where our circulating vaccine-induced antibodies come in. They latch on to these newly minted particles to prevent them from infecting adjacent cells and from being exhaled. Therein, unfortunately, lies one of the Delta variant’s strong suits — it can reproduce itself so rapidly that our antibodies don’t slow it down much, and we see that when infected, vaccinated people are shedding virus similarly to unvaccinated folks.
The third element of the response to the vaccine that you don’t hear as much about is the T-cell immunity that is induced. This arm of the immune system kills off our own infected cells — they’re a lost cause anyway, and will need to be replaced — and thereby limits the extent of disease. That’s why the vaccines remain effective at limiting the severity of disease, and the reason why we don’t see many vaccinated people among the hospitalized even as the number of vaccinated people infected with the Delta variant increases. That’s also why it’s so critical to get vaccinated — the vaccines are extremely effective at preventing severe illness and death from COVID-19. But it is not in the T-cell job description to go after viruses themselves. Vaccine-induced T-cells do not provide protection against getting infected; they only mitigate severity once infected.
So, the CDC revised its masking guidance because, as we’re seeing in places like Provincetown and Milwaukee’s Deer District, vaccinated people can both get and spread SARS-CoV-2. More and more vaccinated people are getting infected because they’re interpreting vaccination as carte blanche to return to pre-pandemic life without restriction and are exposing themselves to massive viral loads that overwhelm their immunity. Every single vaccinated person I spoke with during a telemedicine visit in July who got themselves infected at a Bucks championship game told me they would have taken more precautions had the meaning of vaccination been explained to them as I have above.
These principles add to the arguments surrounding whether to administer a third dose, as recently discussed. Many studies have shown that neutralizing antibody titers decline only slowly over months, while we continue to see blunted disease severity in those vaccinated individuals who get infected. Moreover, breakthrough infections are not only occurring in older people who are far out from their second dose. This suggests breakthrough infections may occur not so much because of waning immunity, but because of people’s behavior that exposes them to overwhelming viral loads, especially in the face of the new variants. If that’s the case, a third dose without behavior modification may not be enough to promote sufficient disease containment. We need data from our contact tracers on the circumstances under which breakthrough infections occurred to better inform the decision on a third dose.
I believe history will judge our response to the pandemic harshly for its reliance on mandates more than education. We physicians were not consulted appropriately early on in the pandemic for our expertise and community respect to help shape local and regional procedures tailored to maximize disease containment while mitigating economic impact. There remains no coordinated effort to promote local physician involvement in mitigation strategies, and we are seeing the fallout from that in the current surge. So we must take it upon ourselves to do everything we can to educate our patients by promoting evidence-based containment measures and offering common-sense explanations for COVID-19 and the vaccines.
This is the most important public health crisis of our careers and lifetimes, and the urgency of this situation will reach a whole new level if post-acute COVID syndrome (PACS) turns out to be a virus-triggered autoimmune response that intensifies with subsequent infections. I sure hope that will not be the case and there is no evidence for that yet, but we physicians don’t have the luxury of waiting to find out. We need to leverage the respect we’ve earned among our communities to do what we can to transcend the rhetoric and misinformation, and minimize the worsening catastrophe that we know COVID-19 can become. Now.
Anti-parasite drug for animals ivermectin flying off store shelves as COVID spikes- Ivermectin dispensing by retail pharmacies has increased’ the CDC says. After many hours of “discussions” with friends who have decided not to get vaccinated and instead an anti-parasitic drug used on horses, cows, sheep and dogs, I thought that it would be worth a discussion. Daniella Genovese reported that despite strict warnings from federal health officials, consumers around the country are still trying to get their hands on a drug commonly used to treat or prevent parasites in animals in order to protect themselves against the coronavirus.
The drug, ivermectin, has been reportedly flying off stores shelves in multiple states, including Texas and Oklahoma, even though it has not been approved for treating or preventing COVID-19 in humans. “Ivermectin dispensing by retail pharmacies has increased, as has use of veterinary formulations available over the counter but not intended for human use,” the Centers for Disease Control and Prevention said Thursday. “FDA has cautioned about the potential risks of use for prevention or treatment of COVID-19.
Earlier this month, the FDA said it has seen a “growing interest” in the drug and already received multiple reports of “patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.”
However, over a dozen stores in the Dallas and Fort Worth, Texas area have sold out of the medicine, The Dallas Morning News reported. Noah Krzykowski, who manages the Irving Feed Store in Irving, Texas, told the outlet that he is seeing droves of new customers in search of the product. “You can tell the difference between someone who has cattle and someone who doesn’t,” Krzykowski told the Morning News. “And we’re seeing a lot of people right now who don’t have cattle.” Meanwhile, Alex Gieger, who manages the Red Earth Feed and Tack in Oklahoma City, Kansas, told KOCO that the store has been flooded with requests for the drug.
Scott Schaeffer, managing director of the Oklahoma Center Poison and Drug Information, told FOX Business they have already received seven calls this month regarding ivermectin. This is up from three calls in July. “We’re more concerned that people are taking medication without the input of their physician/prescriber, and that there is no reliable evidence that ivermectin is effective for the treatment or prevention of COVID,” Schaeffer said.
Ivermectin tablets are only approved by the FDA “to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms,” the agency said. According to the FDA, some forms of ivermectin are also approved to treat parasites like head lice and for skin conditions like rosacea while other forms are “used in animals to prevent heartworm disease and certain internal and external parasites.”
The FDA said consumers should never use medications intended for animals. “It’s important to note that these products are different from the ones for people, and safe when used as prescribed for animals, only,” the FDA said.
US Plans COVID-19 Booster Shots at 6 Months Instead of 8: WSJ
The Reuters Staff reported that U.S. health regulators could approve a third COVID-19 shot for adults beginning at least six months after full vaccination, instead of the previously announced eight-month gap, the Wall Street Journal reported on Wednesday.
Approval of boosters for three COVID-19 shots being administered in the United States — those manufactured by Pfizer Inc and partner BioNTech SE, Moderna Inc and Johnson & Johnson — is expected in mid-September, the report said, citing a person familiar with the plans.
Pfizer and BioNTech have already started the application process for the approval of its booster shot in people 16 and older, saying it spurs a more than three-fold increase in antibodies against the coronavirus.
Earlier this week, U.S. regulators granted full approval to Pfizer’s two-dose vaccine. Moderna said on Wednesday it has completed the real-time review needed for a full approval for its jab in people 18 and above.
White House spokeswoman Jen Psaki said in her daily briefing that any such development would be under the purview of the Centers for Disease and Control and Prevention (CDC).
The CDC said the government’s plan to administer booster shot depends on pending action from the Food and Drug Administration and recommendation to it from the Advisory Committee on Immunization Practices.
The FDA, however, reiterated its joint statement from last week that said the government was gearing up to roll out the third shot from mid-September to Americans who had their initial course of two-dose vaccines made by Moderna and Pfizer more than eight months ago.
The rollout would start if the FDA and the CDC decide that boosters are needed, U.S. officials had said.
But the next question is:
Are We Jumping the Gun on COVID Boosters?- Efficacy, safety, and ethical questions linger
Dr. Vinay Prasad points out that over the last weeks, the topic of COVID-19 booster shots — a third dose of mRNA vaccine for healthy Americans — has been thrust into the spotlight. The surgeon general, CDC director, Anthony Fauci, MD, and President Biden have announced that they wish for boosters to be available by late September for healthy adults who are 8 months out from their original two-dose series. While this will be contingent on an FDA evaluation to determine the “safety and effectiveness of the third dose,” a clear path forward has already been set. And just like everything else throughout the course of the pandemic, the choice has been made with a dearth of data and an abundance of political pressure.
Diminishing vaccine effectiveness supposedly makes the case for boosters. But there are two big questions here: First, what is current vaccine effectiveness? And second, what justifies boosters? Let’s consider these in turn.
What Is Vaccine Effectiveness Now?
We have to be honest, many vaccine effectiveness studies are poorly done. All studies compare the rate of getting a breakthrough infection among vaccinated people against the rate of infection in unvaccinated people. But there are some issues with this approach. First, as time goes on, more unvaccinated people have had and recovered from COVID-19 (and these individuals may be less likely to go on to get a shot). This means that their risk of getting COVID-19 a second time is far less than the typical unvaccinated person who has never been sick. Even if vaccines “work” as well as before, this factor alone will result in the appearance of diminishing vaccine effectiveness.
Second, the order of vaccination in all nations is non-random. The folks who got vaccinated first are often the oldest and most vulnerable people with frailty and senescent immune systems. Vaccine effectiveness after 6 months, 8 months, and 12 months increasingly compares older, frailer people who got vaccinated first against unvaccinated people. These older people may always have a slightly higher risk of breakthrough infections. This bias will also give the false appearance of diminishing vaccine effectiveness.
A third consideration: We’re looking at vaccine effectiveness, but for what? People don’t want to get severely ill from SARS-CoV-2 and don’t want to die, but it might be too much to ask that vaccines prevent the nucleotide sequence of SARS-CoV-2 from ever being in your nose. In other words, vaccine effectiveness against severe disease may be much higher than vaccine effectiveness against asymptomatic or mild infection. This matters a great deal — if the vaccines continue to be highly effective against risk of severe illness and death, is it really worth boosting people in the U.S. right now?
And putting this all together, the best estimates of vaccine effectiveness do, in fact, still show high protection against severe disease and death.
What Justifies Boosters?
No matter what vaccine effectiveness is against preventing COVID-19 illness generally, the important question for boosters is whether they further lower the risk of severe disease or death. The only way to show this is through randomized controlled trials of the size and duration to measure that outcome. It is entirely possible that vaccine effectiveness is not perfect over time, or slightly lower than initial trials, but it’s also possible that boosters do not further reduce the risk of SARS-CoV-2. Only trials can answer this.
While emerging data from Israel suggest boosters may diminish the risk for COVID-19 infection and severe illness in people 60 and older, the data are not based on the types of studies we need. Pfizer has only submitted early trial results to the FDA to support their boosters, with phase III trial data forthcoming. But again, the data may be insufficient if severe outcomes are not captured.
Moreover, we have to consider the risk of new, compounding, and worse toxicity. Randomized trials and close observation will be needed to exclude worse safety signals, particularly increases in myocarditis and pericarditis. These rare adverse events are more common after the second mRNA dose — will they be even more common after dose three?
In short, diminished vaccine effectiveness does not make the case for boosters. A reduction in severe outcomes makes the case for boosters, but we have no such data to date.
Global Equity
There’s also the ethical question of how a wealthy nation can give its inhabitants a third dose when there are literally billions of vulnerable older people around the world who have not gotten any doses. The World Health Organization has begged nations not to do this, and history will judge us poorly if we pursue this. It is a human rights violation to direct limited mRNA supply and capabilities to third doses in the U.S. when the world remains vulnerable. Moreover, it is self-defeating. We are not safe from global variants.
Take a Step Back
Decisions about boosters have to be based in science and made by vaccine regulators. They should not be subject to the pressure of manufacturers, politicians, or political appointees. They should not be rushed. On Sunday television, Surgeon General Vivek Murthy, MD, was specifically asked if the third shot was safe. His response: “the plan is contingent on that…”
Excuse me? We don’t know that to be true, and yet, our top medical and public health experts are pushing for boosters? Drug safety expert Walid Gellad, MD, MPH, tweeted: “It was irresponsible to push for boosters in healthy people before safety review.”
Two days after the White House’s announcement, two people with knowledge of the FDA’s deliberation told The Washington Post that the agency was investigating myocarditis signal with the Moderna vaccination. Canadian data suggest the risk may be 2.5 times that of Pfizer’s vaccine. The timing of this internal information leaking to reporters naturally leads me to wonder if reviewers in the agency are attempting to counteract political pressure, and create space to conduct a thorough review of booster data.
Boosters are an important medical question. Their approval must have a favorable safety and efficacy profile. Only randomized trials measuring severe disease can show that. Still, recently the FDA that boosters for Pfizer is only recommended for people over 65 and those compromised.
Let’s wait for the next set of data from the Moderna post vaccination studies, which is expected by the end of November.
203 Doctors Told Us What They Actually Think Of COVID Vaccines, And Everyone Should Hear Their Answers
A growing refrain among vaccine skeptics is that they won’t get vaccinated against COVID-19 because a handful of health scientists have told them they don’t have to.
Robert Malone, the self-proclaimed inventor of mRNA technology back in the 1980s, has been among those celebrated by the far right for voicing unproven concerns about COVID-19 vaccines to his 280,000-plus Twitter followers. While it’s easy to explain away an embittered, bruised-ego scientist, it’s much harder to dismiss the significant majority of healthcare professionals who support the vaccines and the preponderance of evidence backing them up.
Enter the anti-vaxxer’s latest unfounded claim: that most public health officials secretly don’t support vaccines. In fact, a friend of mine recently made a stunning declaration that she wholeheartedly believes: “Most experts are too afraid to speak up, but I suspect 9 out of 10 doctors would advise against COVID vaccines if you asked them privately.”
Though I could have readily dismissed such a callous and unsubstantiated statement, the journalist in me began to wonder whether I should.
After all, if a meaningful percentage of individuals with legitimate infectious disease and vaccination expertise were concerned, that would be worth reporting. Besides, I’d asked her to question her convictions, so shouldn’t I be willing to do the same?
With that in mind, I began researching epidemiologists, virologists, health department directors, pediatricians, infectious disease experts, and public health officials. I deemed it important to find such people in all 50 states and in counties that leaned both left and right in case politics had tainted anyone’s objectivity.
No one directed me where I should look nor which experts I could turn to; and I steered clear of anyone I’d seen making regular cable news appearances to ensure I was getting fresh perspectives from experts who may not have already spoken up.
In my research, I identified more than 200 such individuals, and, in the interest of taking up as little of their limited time as possible, decided to ask them all the same two yes or no questions with an invitation to elaborate if they chose to.
I also wanted them to know they could answer freely, so I offered anonymity — a condition that some appreciated and others waived.
My two questions were simply whether they believed the benefits of COVID-19 vaccinations outweigh any potential harms, and whether they’d recommended the shots to their own children if they had any in the 12–18-year-old age groups. Responses began pouring in almost immediately.
Over the next few days, I heard back from 203 of the doctors I’d reached out to. If my friend’s unfounded suspicions were correct, 183 of them should have recommended against vaccination.
Turns out the actual number against COVID vaccines was zero. And the number of vaccine experts who recommended the shots to me in our private, one-on-one interactions was a whopping 203.
None of the 203 responders raised a single concern about COVID vaccines for adults or for children. “The benefits outweigh the extremely rare harms by many miles,” one biostatistics researcher told me.
What’s more, many of the responders had a lot to say about the type of public health official who would use their academic credibility to steer people away from COVID-19 vaccines.
Abner told me she doesn’t actually know of any public health officials who have advocated against the vaccines; rather, the handful of fringe persons who have gained notoriety doing so are actually “lab scientists without any public health or epidemiological expertise. Being an expert in one area of science or medicine does not confer expertise in others.”
One health department director in Idaho put it even more bluntly: “Any public health official who discourages vaccination isn’t concerned about public health at all.”
CORRECTED-COVID SCIENCE-mRNA vaccines trigger backup immune response; some cancer drugs may help
Nancy Lapid summarized of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.
Antibodies wane but other immune defenses remain alert.
A new study may help explain why mRNA vaccines by Pfizer/BioNTech and Moderna are more effective at preventing hospitalizations and deaths than they are at preventing infection. Test-tube experiments on blood samples from 61 fully vaccinated adults showed that by six months, vaccine-induced antibodies that can immediately neutralize the virus had declined. But so-called memory B cells, which produce new antibodies if they encounter the virus later on, had increased and become better at recognizing viral variants, according to a report posted on Monday on bioRxiv https://bit.ly/3zoCSAY ahead of peer review. “Your immune system has a backup,” said study leader John Wherry of the University of Pennsylvania Perelman School of Medicine. B-cell production of antibodies might take a few days to get underway, but then these memory B cells “kick into action and prevent severe disease,” Wherry added.
Early data favors certain cancer treatments during pandemic
Certain cancer drugs may help protect patients with malignancies from being infected with the new coronavirus, preliminary data suggests. The drugs, known as mTOR/PI3K inhibitors and antimetabolites, target the parts of cells that the virus uses to enter and make copies of itself, including a “gateway” protein on cell surfaces called angiotensin-converting enzyme 2 (ACE2). The study of 1,701 cancer patients found that after taking underlying risk factors into account, patients treated with mTOR/PI3K inhibitors or ACE2-lowering antimetabolites were 47% less likely to test positive for the virus than patients who received other drug therapies. Gemzar (gemcitabine) from Eli Lilly appeared to be particularly promising, according to the report in JAMA Oncology https://bit.ly/38icqN6 on Thursday. The study does not prove that the drugs lowered infection rates, however, and much more research is needed to confirm their potential for protecting cancer patients from the coronavirus.
One in four infected LA residents had been vaccinated
From May through July 2021, as the Delta variant spread, 43,127 residents of Los Angeles County in California were diagnosed with SARS-CoV-2 infections. One in four had been fully vaccinated, though these patients had lower rates of hospitalization (3.2% versus 7.6%), intensive care (0.5% versus 1.5%) and need for machines to help with breathing (0.2% versus 0.5%) than unvaccinated patients, public health officials reported on Tuesday in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report https://bit.ly/2XWWZIx. During the study period, the prevalence of the Delta variant rose from less than 9% to at least 87%, the authors note. As of July 25, hospitalization rates were 29 times higher for unvaccinated patients, they estimated, “indicating that COVID-19 vaccination protects against severe COVID-19 in areas with increasing prevalence of the SARS-CoV-2 Delta variant.”
Infectious disease expert: Americans must ‘recalibrate’ vaccine expectations
Tim O’Donnell reiterated what I have been trying to educate my patients and friends that COVID-19 vaccines won’t eliminate the coronavirus, “no matter how many booster shots the United States gives,” Céline R. Gounder writes for The Atlantic. But that’s no reason to panic or lose confidence in them.
Grounder, an infectious disease specialist and epidemiologist at New York University’s Grossman School of Medicine and Bellevue Hospital in New York City, thinks public health messaging got out of hand early on during the vaccine drive, especially when the Centers for Disease Control and Prevention published real-world evidence that showed that two doses of the Pfizer and Moderna vaccines were 90 percent effective at preventing infections, as opposed to just disease. After that, folks got excited, believing that full vaccination status meant you could only very rarely get infected or transmit the disease. But now that the efficacy appears to be lower, there’s a lot of anxiety.
Grounder tried to ease that, explaining that vaccines are typically more effective at protecting against infection outright when battling viruses that have longer incubation periods, like measles and smallpox. In those cases, the body is trained to kick the virus out before it can really establish itself. But the coronavirus and influenza, for example, don’t take as long to start replicating and can do so before a vaccinated defense system revs up. Once it does, though, the virus doesn’t have much room to operate and is usually blocked from progressing in the lungs and causing serious damage.
With that in mind, Grounder says Americans simply need to “recalibrate our expectations about what makes a vaccine successful.” While “the public discussion of the pandemic has become distorted by a presumption that vaccination can and should eliminate COVID-19 entirely,” that’s not an attainable standard, she argues. And it’s one that makes “each breakthrough infection” look “like evidence that the vaccines are not working,” even though they’re performing “extremely well” and reducing what may have been serious infections to either mild or asymptomatic ones. Read Grounder’s full piece at The Atlantic.
Let us take a few moments of silence for the service men and women and the other civilians who lost their lives last week to the horror of the ISIS bomber.
Carolyn Crist reported that the nation’s top health officials said Tuesday that the Delta variant of the coronavirus is racing through the country and now is responsible for 83% of all U.S. cases.
That’s a massive increase from a week ago, when Delta was seen as responsible for just more than half of new cases, CDC Director Rochelle Walensky, MD, told a Senate committee.
And listen to her carefully…is she actually suggesting a Federal Mandate to vaccinate everyone???
“The best way to prevent the spread of COVID-19 variants is to prevent the spread of disease, and vaccination is the most powerful tool we have,” she said.
Meanwhile, several states in the South are reporting a large increase in COVID-19 cases, particularly in areas with low vaccination rates, according to The Atlanta Journal-Constitution.
Arkansas, Florida, and Missouri are reporting full-fledged outbreaks, and neighboring states such as Alabama, Georgia, Louisiana, Mississippi, Tennessee, and Texas are following behind.
“4th wave is here,” Thomas Dobbs, MD, the state health officer for Mississippi, wrote on Twitter on Monday.
Dobbs posted a graph of hospitalizations in Mississippi, which showed numbers climbing dramatically in July after hitting a low in May and June.
“Very sad indeed,” he wrote. “Didn’t have to be this way.”
Mississippi reported more than 2,300 new COVID-19 cases over the weekend, which is the state’s largest 3-day increase in cases since February, according to The Associated Press. Mississippi has one of the lowest COVID-19 vaccination rates in the country.
Florida has become one of the country’s biggest COVID-19 hot spots, now accounting for a fifth of new infections in the U.S., according to NBC News.
In Jacksonville, UF Health broke its record for hospitalized COVID-19 patients, jumping from 86 patients on Sunday to 126 on Monday.
“We’re gaining cases at such a rapid rate, we don’t really know where it’s going to stop,” Chad Neilsen, the director of infection prevention at UF Health, told NBC News.
“We aren’t even thinking a couple of months,” he said. “We’re thinking what’s going to immediately happen in the next week.”
Hospitals in Arkansas and Missouri are also preparing for a surge of patients that could strain staff and resources again, according to NBC News. If hospitalizations triple in the next 2 weeks, as projected by the University of Arkansas for Medical Sciences (UAMS), it could feel like the chaotic period at the end of 2020.
“Right now, we’re managing OK, but we’re in surge mode,” Steppe Mette, MD, the CEO of the UAMS Medical Center, told NBC News.
“We’re putting patients in physical locations where we weren’t putting them normally because of that demand,” he said.
At Houston Methodist Hospital in Texas, COIVD-19 hospitalizations have increased by 70% during the last week, according to the Houston Chronicle. On Monday, the hospital had 184 COVID-19 patients, which is double the number it had on July 1.
The Delta variant accounts for about 85% of the cases, and the hospital recorded its first hospitalization with the Lambda variant, the Chronicle reported. The Lambda variant, which was first identified in Peru, has been spreading throughout South America and is now reaching the U.S.
The Delta variant has been “running rampant” among unvaccinated people in Texas, Marc Boom, MD, the CEO of Houston Methodist, wrote in an email to hospital staff. The variant will account for nearly all COVID-19 cases in the area within the coming weeks, he said.
“It is the variant of concern in Houston,” he said. “What we’re seeing now is that Delta is far more infectious.”
Public health officials are grappling with the best way to move forward as cases and hospitalizations continue to rise. Increasing vaccinations is key, but mandating or guilting people into getting a shot would likely backfire, NBC News reported.
“People have heard our messages ad nauseam, but to see patients struggling to breathe and wishing they got vaccinated, that may make a difference,” Mette told the news outlet.
“Those are real people who are getting real sick,” he said.
What Evidence Do We Need to Move Forward With COVID Boosters?
Dr. Vinay Prasad noted that a few weeks ago, on Monday, employees of Pfizer met with high level executives in the Biden administration to discuss the role of boosters — a.k.a. a third vaccination with an mRNA vaccine for SARS-CoV-2. Some have speculated that, as with the first two doses, the emergency use authorization pathway will again be used to market boosters. With the rise of the Delta variant and others, enthusiasm in the media and the Twitter commentariat for boosters is growing. However, there are certain criteria that must be met before we jump on the booster bandwagon. Some of these criteria apply at home, and others apply abroad. What does stand out is that more data, real data, and an evaluation of several factors at home and abroad will be key in moving forward.
Abroad
As a general rule, if your goal is to avoid variants — or mutated versions of a virus — you want the virus to replicate less. When it comes to variants, it doesn’t matter where the virus does the replicating. In a globally connected world, it is only a matter of time before an advantageous mutation finds its way to all parts of the world. As such, we in the U.S., are only as safe as the least safe place in the world.
What this means is that before we shift our manufacturing capacity to develop boosters for the current variants, we must make a real effort to ensure that the vaccines we do have get distributed to the greatest number of global citizens who will take them. I argued in April that, practically, this means that children in high income nations should be vaccinated after older citizens globally – this same logic extends to boosters.
Before we shift our manufacturing to booster production, we should make sure that we have manufactured adequate supplies of the original vaccine for all global citizens. Moreover, we need to put effort toward solving the last mile problem: how to deliver very cold mRNA vaccines to places in the world where it is difficult to deliver and keep things very cold. This is a technological problem well within our scope.
Efforts to manufacture and deliver vaccine boosters to already vaccinated individuals in high-income nations cannot take priority and must not interfere with efforts to vaccinate at-risk individuals around the world. In fact, it is in our best interest to vaccinate those at-risk first. If we pursue boosters in the U.S. without helping the rest of the world, then we might as well get ready for the fourth, fifth, and sixth boosters. We will watch rising death tolls around the world, while worrying that yet new variants may end up on our shores.
At Home
Here in the U.S., there are also metrics that need to be met before we contemplate widespread dosing of hundreds of millions of people with booster shots. Specifically: show me the data! I have no doubt that a third mRNA shot will lead to higher neutralizing antibody titers. For that matter, I would guess six shots would outperform three on that metric. But the burden of evidence to accept boosters is not simply a change in antibody titer — or even demonstration of improved titers for rare variants.
We must show that boosters improve clinical endpoints before we ask Americans to roll up their sleeves again. A large randomized trial of vaccinated individuals powered for reduction in symptomatic SARS-CoV-2 or (better yet) severe COVID-19 is needed to justify the harms and inconvenience of boosters. If such a trial simply cannot be powered, or takes a very long time, due to the sparsity of serious infection in the U.S., then the argument for emergency use authorization is inherently flawed. When there’s too little disease to run the definitive trial, you are, by definition, no longer in an emergency. One way to solve this problem might be to deliver boosters only in elderly individuals or those who are immunocompromised. Here, a trial measuring COVID-19 outcomes may be possible.
Alternatively, a case for boosters can be made if evidence shows that boosters alter the epidemic course for a nation or the globe. Here, too, antibody titers are insufficient. Moreover, ironically, clinical trials would have to be larger and more complex to demonstrate this. For these reasons, I think the burden is on vaccine manufacturers to show that severe COVID-19 outcomes are averted.
Finally, we need to consider the second order effects of boosters. Would we gain more if we took the effort that would go into boosters and instead used it to try to increase vaccination uptake by those who are reluctant to get their first and second dose? Is the mere fact that news outlets and companies report the possible need for boosters a disincentive to be vaccinated? A skeptical person may now no longer see SARS-CoV-2 vaccines as the path out of the pandemic, but a recurring, and possibly someday yearly obligation that they may prefer to avoid altogether. We can’t ignore the potential impact of discussing boosters on vaccine acceptance.
Boosters Without Data
If we accept boosters in the U.S. while the rest of the world remains unvaccinated, and if we authorize them based on inevitable improved laboratory titers without clinical outcomes, we run the risk of creating a medical industrial perpetual motion machine.
We will continue to breed new variants outside of our nation, which will lead to calls for yet more boosters, and we will continue to get new boosters without any evidence they are necessary (i.e., lower severe COVID-19 outcomes). Our arms will ache, our hearts will hurt, our wallets will be empty, and so too will our brains, as we will have abandoned all principles of evidence-based medicine.
Lambda variant of COVID-19 identified at Texas hospital. Is it worse than delta?
Ryan W. Miller reported that a Houston hospital has its first case of the lambda variant of the coronavirus, but public health experts say it remains too soon to tell whether the variant will rise to the same level of concern as the delta variant currently raging across unvaccinated communities in the U.S.
About 83% of COVID-19 cases in the U.S. are from the delta variant and the vast majority of hospitalizations are among unvaccinated people, according to the Centers for Disease Control and Prevention.
The lambda variant, on the other hand, has been identified in less than 700 cases in the U.S. However, the World Health Organization in June called lambda a “variant of interest,” meaning it has genetic changes that affect the virus’ characteristics and has caused significant community spread or clusters of COVID-19 in multiple countries.
Dr. S. Wesley Long, medical director of diagnostic biology at Houston Methodist, where the case was identified, said while lambda has some mutations that are similar to other variants that have raised concern, it does not appear to be nearly as transmissible as delta.
“I know there’s great interest in lambda, but I think people really need to be focused on delta,” Long said. “Most importantly, regardless of the variant, our best defense against all these variants is vaccination.
What is the lambda variant and how is it different from the delta variant?
The lambda variant is a specific strain of COVID-19 with specific mutations. It’s one of a handful of variants identified by the WHO as variants of concern or interest. Many other variants have arisen since the outbreak was first detected in late 2019 in central China.
“The natural trajectory of viruses is that they have a tendency to have mutations, and whenever we have a significant mutation that changes the virus … we get a new variant,” said Dr. Abhijit Duggal, a staff ICU physician and director for critical care research for the medical ICU at the Cleveland Clinic.
Some of the lambda mutations occur in its spike protein, which is the part of the virus that helps it penetrate cells in the human body and is also what the vaccines are targeting.
Mutations occurring there and in other parts of lambda are similar to those in variants of concern, like alpha and gamma, Long said. But even gamma, which never took hold in the U.S. to the same level as alpha or delta, has more concerning mutations than lambda, Long said.
Duggal said there hasn’t been anything specific with the lambda variant to spark concern about it becoming the dominant variant in the U.S., but “watchful waiting and being cautious is going to be the most important thing at this point.”
Where was the lambda variant first identified?
The lambda variant was first identified in Peru in December 2020. Since April, more than 80% of sequenced cases in the country have been identified as the lambda variant.
As of June, the WHO said it had identified the lambda variant in 29 countries. Argentina and Chile have also seen rising lambda cases, the WHO said.
However, the variant hasn’t spread nearly to the same level on a global scale as the delta variant. Lambda may have become so widespread in parts of South America largely because of a “founder effect,” Long said, wherein a few cases of the variant first took hold in a densely populated and geographically restricted area and slowly became the primary driver for the spread locally over time.
Long compared lambda to the gamma variant, which first was detected in Brazil and spread in similar ways.
Are COVID-19 vaccines effective against the lambda variant?
Studies have suggested the vaccines currently authorized for use in the U.S. are highly effective at preventing severe COVID-19 and death across multiple variants.
Duggal said while there is no reason to believe the vaccines will be ineffective against the lambda variant, more data is need to know exactly how effective it will be. The efficacy may lower some, but hospitalization may still be largely preventable in variant cases with vaccination, he said.
Remember ‘Nothing in this world is 100%’: Those fully vaccinated against COVID-19 can be infected, but serious illness is rare.
However, a new study posted online Tuesday found the Johnson & Johnson vaccine was not as effective at preventing symptomatic disease when faced with the delta and lambda variants. The study was not yet peer reviewed or published in a journal, but it aligned with studies of the AstraZeneca vaccine that conclude one dose of the vaccine is 33% effective against symptomatic disease of the delta variant.
Vaccines made by Pfizer-BioNTech and Moderna have shown to keep similar levels of effectiveness against several of the variants of concern. But, just announced, a new preprint study conducted by Pfizer-BioNTech found its vaccine efficacy could drop down to 84% within 6 months.
Getting vaccinated still remains the most important factor in stopping the virus’ deadly effects and slowing down new variants, Long said.
Mutations occur in the coronavirus as it spreads from person to person. Vaccination can help prevent symptomatic disease and decrease the spread in communities with high vaccinations rates, which can then prevent mutations from occurring and new variants from arising, Duggal added.
Delta’s threat: CDC reveals data on why masks are important for the vaccinated and unvaccinated
More on the Delta mutated variant, which is becoming a real problem for the un vaccinated portion of our population and why wearing masks are important for all. Adrianna Rodriquez reported that The Centers for Disease Control and Prevention has had a busy week.
Only a few days after announcing updated mask guidelines, the agency on Friday released new scientific data on the delta variant that gives a snapshot of how the highly contagious strain triggered a wave of coronavirus cases.
The much-anticipated report comes a day after a presentation compiled by a doctor with the agency was leaked to the media and detailed the dangers of the delta variant and how mask-wearing is essential to bring it under control.
In a briefing Tuesday, CDC director Dr. Rochelle Walensky said the new data spurred the agency to take immediate action by recommending fully vaccinated people to wear mask indoors in public settings where coronavirus transmission is high.
“The delta variant is showing every day its willingness to outsmart us and be an opportunist in areas where we have not shown a fortified response against it,” she said earlier this week. “This new science is worrisome and unfortunately warrants an update to our recommendations.”
Here’s everything to know about the delta variant and how it impacts fully vaccinated people.
‘Pivotal discovery’: What the new data says about delta variant, transmission
Fully vaccinated people made up nearly three-quarters of COVID-19 infections that occurred in a Massachusetts town during and after Fourth of July festivities, according to a CDC study published Friday in the agency’s Mortality and Morbidity Weekly Report.
Out of 469 cases that were identified in Barnstable County, Massachusetts, from July 3 to 17, the agency found 74% occurred in fully vaccinated people. The CDC sequenced samples taken from 133 patients and discovered 90% were caused by the delta variant.
“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with delta can transmit the virus,” Walensky said in a statement sent to USA TODAY on Friday. “This finding is concerning and was a pivotal discovery leading to the CDC’s mask recommendation.”
Health officials continue to reiterate the majority of COVID-19 transmission occurs among the unvaccinated, not fully vaccinated people.
“Vaccinated individuals continue to represent a very small amount of transmission occurring around the country,” Walensky said. “We continue to estimate that the risk of breakthrough infection with symptoms upon exposure to the delta variant is reduced by sevenfold. The reduction is twentyfold for hospitalizations and death.”
Four fully vaccinated people between the ages of 20 and 70 were hospitalized, two of whom had underlying medical conditions. No deaths were reported.
The study found 79% of patients with breakthrough infection reported symptoms including cough, headache, sore throat, muscle pain, and fever.
Remember also that: Breakthrough COVID-19 infections after vaccination can lead to long-haul symptoms, Israeli study shows.
Of the 346 breakthrough infections, 56% of people were vaccinated with the Pfizer-BioNTech vaccine, 38% with Moderna and 7% with Johnson & Johnson. As of Friday, over 190 million doses of the Pfizer vaccine has been administered in the U.S., nearly 140 million of Moderna and 13.3 million of Johnson & Johnson, according to the CDC.
Health experts say the reason why more breakthrough infections occurred in the mRNA vaccines compared to the Johnson & Johnson vaccine is because more people in the U.S. received the Pfizer-BioNTech and Moderna vaccines.
“When you look at the data, it may concern some people that there appears to be a higher rate of breakthrough COVID infections in people fully vaccinated with the Pfizer vaccine, however, as a percentage of people who are fully vaccinated, more people have been vaccinated with the Pfizer vaccine,” said Dr. Teresa Murray Amato, chair of emergency medicine at Long Island Jewish Forest Hills in Queens, New York.
“It still appears that all three of the current vaccines with emergency use administration authorization in the United States are safe and effective against the delta variant of the COVID-19 virus,” she added.
While study authors say evidence suggests fully vaccinated people exposed to the delta variant can contract and spread the virus, it is not sufficient to determine the vaccines’ effectiveness against the highly contagious strain.
Delta substantially more contagious than other variants
Although the study didn’t specify if fully vaccinated people can transmit the virus to other fully vaccinated people, health experts say they should wear a mask and socially distance largely to protect those who haven’t been vaccinated or who have a weakened immune system and can’t get full protection from the vaccine.
“The data makes a pretty compelling justification for why we need to go back to mask wearing and other public health measures,” said Dr. Charles Chiu, an infectious disease specialist at the University of California, San Francisco. “I do think it’s because of the delta variant.”
The delta variant is known to be substantially more contagious than other variants – as contagious though deadlier than chicken pox, according to the CDC presentation. Among common infectious diseases, only measles is more contagious.
People may also be infectious for longer with the delta variant, 18 days instead of 13, the presentation says.
Vaccines remain effective at preventing hospitalization and death from COVID-19, though they worked better against the original strain and the alpha variant than they do against delta, data finds.
What do the CDC mask guidelines say?
The CDC is urging fully vaccinated Americans to wear masks indoors in areas of high or substantial coronavirus transmission.
They’re also recommending universal indoor masking for all teachers, staff, students and visitors inside schools from kindergarten to 12th grade, regardless of vaccination status. That aligns closely with guidelines from the American Academy of Pediatrics, which recommended this month that anyone older than 2 be required to wear a mask in school.
The CDC and the AAP are still urging that children return to full-time in-person learning in the fall.
The goal behind the guidance may be to protect both the fully vaccinated and the unvaccinated, health experts say, especially vaccinated people who may be immunocompromised and children under 12 who aren’t yet eligible to get their shot.
But the reality is there’s hardly any transmission among fully vaccinated people to truly affect community spread, they say.
“It makes sense why they did it, but I don’t think it’s going to make a major difference in the large surge that we’re having,” said Dr. Ashish Jha, dean of the Brown University School of Public Health in Providence, Rhode Island. “The real issue still is unvaccinated people who are not going around masked up. I have no reason to think that this guidance will get unvaccinated, unmasked people putting on masks. And that’s what we really need.”
Is there a test for the delta variant?
A traditional PCR test alone cannot differentiate the delta variant from the original virus.
The delta variant has distinctive mutations that serve as biological markers that can only be detected through genome sequencing.
Many U.S. laboratories sequence a small – but nationally representative – number of positive samples for epidemiological purposes. According to the CDC, more than 175,000 sequences have been collected through the agency’s surveillance program since Dec. 20.
People who test positive for COVID-19 aren’t made aware if they were infected by the delta variant, even if their sample was sequenced.
“Our patients will not learn if they have a variant or not,” said Dr. Christina Wojewoda, chair of College of American Pathologists Microbiology Committee. “It is for epidemiology purposes only and currently, there is no medical use for that result.”
However, the CDC said more than 80% of sequenced samples have the delta variant, which means people sick with COVID-19 were most likely infected with the highly contagious strain.
“It is safe to assume in most places, if you are infected now, it is likely delta,” Wojewoda said.
‘A Few Mutations Away’: The Threat of a Vaccine-Proof Variant
Damian McNamara noted something that concerns me if we don’t get control of the virus using the best weapon that we have, vaccinations. The Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.
“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus…[becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Walensky told reporters on Tuesday.
A new, more elusive variant could be “just a few mutations away,” she said.
We are already reporting the lambda variant and I predict that next will be the gamma and then the kapa variant.
“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the Division of Medical Toxicology at Rutgers New Jersey Medical School in Newark, told Medscape Medical News.
“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”
“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta — that it is so infectious.”
He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”
“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Ray, vice-chair of medicine for data integrity and analytics and professor in the Division of Infectious Diseases at Johns Hopkins School of Medicine in Baltimore, Maryland.
“The problem is if the virus changes in such a way that the spike protein — which the antibodies from the vaccine are directed against — are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Nelson said.
If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
Technology to the Rescue?
The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.
“That’s absolutely reassuring,” Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.
“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.
“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”
Both Nelson and Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.
Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Ray said.
Mutations are not the only concern!
Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.
Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.
“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”
“The more diverse the strains that are circulating, the bigger a possibility this is,” Ray said.
Protected, for Now
Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.
On a positive note, Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”
Records have been set nearly every day lately in Tokyo, but not all of them have been by athletes competing in the Olympics.
Japan’s capital has exceeded 4,000 coronavirus infections for the first time — 4,058 cases, to be exact. That’s a record high and nearly four times as many cases were reported just a week ago.
Tokyo set new case records every day from Monday to Wednesday, experiencing just a slight dip on Thursday, when they totaled 3,300 — still one of the city’s highest daily counts on record.
So, those of you, your friends, associates who haven’t been vaccinated, your best protection is still getting vaccinated.
Damian McNamara reviewed some of the controversies regarding COVID-19 pandemic and our present status. Have we arrived at a much-anticipated tipping point in the COVID-19 pandemic in the United States? Or do we still have some time before we can return to some semblance of life as we knew it in 2019?
The CDC relaxation of masking and social distancing guidance for fully vaccinated Americans is one reason for optimism, some say, as is the recent milestone where we surpassed more than 50% of Americans vaccinated.
But it’s not all good news. “Right now, we are struggling with vaccine hesitancy,” Ali H. Mokdad, PhD, told Medscape Medical News.
“My concern now is people who don’t want the vaccine are looking around them and saying, ‘Oh we are in a very good position. Infections are down, more than 50% of Americans are vaccinated. Why do I need to get a vaccine?’ ” he said.
Another potential issue is waning immunity, added Mokdad, professor of health metrics sciences at the Institute for Health Metrics and Evaluation, University of Washington, Seattle. Companies are developing booster shots and Anthony Fauci, MD, the White House chief science advisor, said they may be required in the future.
Mokdad said this could add to vaccine hesitancy now. “Someone might think ‘Why should I take this vaccine when there is a new one coming up?’ If I wait for 2 months, I’ll get a new one.'”
“We can definitely be optimistic. Things are going in the right direction,” John Segreti, MD, told Medscape Medical News when asked to comment. “The vaccines seem to be working as well as advertised and are holding up in a real-world situation.”
However, “It’s too early to say it’s over,” he stressed.
“There is still moderate to substantial transmission in the community just about everywhere in the US. It might take a while until we see transmission rates declining to the point where the pandemic will be declared over,” added Segreti, hospital epidemiologist and medical director of infection control and prevention at Rush University Medical Center in Chicago, Illinois.
The global picture is another reason for pessimism, he said. “There is not enough vaccine for around the world. As long as there is uncontrolled transmission of coronavirus somewhere in the world, there is a greater chance for selecting out variants and variants that can escape the vaccine.”
“But overall I am much more optimistic than I was 6 months ago,” Segreti added.
Vaccines vs Variant
In a study evaluating two COVID-19 vaccines against the B.1.167.2 variant first reported in India, researchers evaluated data from Public Health England and reported reassuring news that the vaccines protected against this variant of concern. They studied the efficacy of the Pfizer/BioNTech and AstraZeneca/Oxford vaccines.
“After two doses of either vaccine there were only modest differences in vaccine effectiveness with the B.1.617.2 variant,” the researchers note. “Absolute differences in vaccine effectiveness were more marked with dose one. This would support maximizing vaccine uptake with two doses among vulnerable groups.”
The study was published online May 22 as a preprint on MedRxiv. It has not yet been peer reviewed.
The positive findings generated a lot of discussion on Twitter, with some still urging caution about celebrating the end of the pandemic. For example, a tweet from Aris Katzourakis, a paleo-virologist and researcher at the University of Oxford, United Kingdom, questioned how the results could be interpreted as good news “unless your priors were unreasonably catastrophic.”
“It depends on what happens to hospitalizations and deaths, as Andrew Pollard said this morning,” Charlotte Houldcroft, PhD, a post-doctoral research associate at Cambridge University in the UK, replied.
Houldcroft was referring to a comment this week from Andrew Pollard, MBBS, PhD, director of the Oxford Vaccine Group, who said if most people with COVID-19 are kept out of the hospital with the current vaccines “then the pandemic is over.”
Pollard also told The Guardian: “We can live with the virus; in fact, we are going to have to live with the virus in one way or another. We just need a little bit more time to have certainty around this.”
Seasonal Variation?
Others acknowledge that even though cases are dropping in the US, it could mean COVID-19 will transition to a seasonal illness like the flu. If that’s the case, they caution, a warm weather lull in COVID-19 cases could portend another surge come the winter.
But, Segreti said, it’s too early to tell.
“It’s reasonable to expect that at some point we will need a booster,” he added, but the timeline and frequency remain unknown.
Economic Indicators
The US economy is operating at 90% of where it was before the pandemic, according to the ‘Back to Normal Index’ calculated by CNN Business and Moody’s Analytics based on 37 national and seven state measures.
The index improved in 44 states in the week prior to May 26, which could also reflect an overall improvement in the COVID-19 pandemic.
State and federal unemployment numbers, job postings and hiring rates, and personal savings appear to be trending in a positive direction. In contrast, box office sales, hotel occupancy, and domestic air travel continue to struggle.
Explained: How to Talk to Anti-Vaxxers
Collectively, by turning around those who believe otherwise, we can save lives.
I am getting very tired of trying to convince people of the safety and need for vaccinations and then I reviewed this article. Erica Weintraub Austin and Porismita Borah helps us communicate with this population group. An estimated 24,000 to 62,000 people died from the flu in the United States during the 2019-20 flu season. And that was a relatively mild flu season, which typically starts in October and peaks between December and February.
The computer model predicted 300,000 deaths from COVID-19.
With the advent of flu season, and COVID-19 cases rising, a public health disaster even worse than what we’re now experiencing could occur this fall and winter. Two very dangerous respiratory diseases could be circulating at once.
This will put the general population at risk as well as the millions of people who have pre-existing conditions. Hospitals and health care workers would likely be overwhelmed again.
We are scholars from the Edward R. Murrow Center for Media & Health Promotion Research at Washington State University. As we see it, the only way out of the reopening and reclosing cycles is to convince people to get the flu vaccine in early fall – and then the COVID-19 vaccine when it’s available. Right now, up to 20 COVID-19 vaccine candidates are already in human trials. Chances seem good that at least one will be available for distribution in 2021.
But recent studies suggest that 35% might not want to get a COVID vaccine, and fewer than half received a flu vaccine for the 2019-2020 season.
Getting Coverage
To arrest the pandemic’s spread, perhaps 70% to 80% of the population must opt in and get the vaccine. They also need the flu shot to avoid co-infection which complicates diagnosis and treatment.
Achieving herd immunity is a steep climb. We conducted a national online survey, with 1,264 participants, between June 22 and July 18. We found that only 56% of adults said they were likely or extremely likely to get the COVID-19 vaccine. Westerners were most accepting (64%), followed by Midwesterners (58%), with Southerners (53%) and Northeasterners (50%) least likely.
Anti-vaxxers, promoting unlikely scenarios and outright falsehoods about vaccine risks, are not helping.
With all this in mind, we would like to share some myths and truths about how to increase rates of vaccinations.
Facts Don’t Convince People
People who support vaccination sometimes believe their own set of myths, which actually may stand in the way of getting people vaccinated. One such myth is that people respond to facts and that vaccine hesitancy can be overcome by facts.
That is not necessarily true. Actually, knowledge alone rarely convinces people to change behavior. Most decisions are informed – or misinformed – by emotions: confidence, threat, empathy and worry are four of them.
Another myth is that people can easily separate accurate information from the inaccurate. This is not always true, either. With so much misinformation and disinformation out there, people are often overconfident about their ability to discern good from bad. Our research during the H1N1 epidemic showed that overconfidence can lead to faulty conclusions that increase risk.
Also, it’s not always true that people are motivated to get accurate information to protect themselves and their loved ones. People are often too busy to parse information, especially on complicated subjects. They instead rely on shortcuts, often looking for consistency with their own attitudes, social media endorsements and accessibility.
And, to complicate matters, people will sometimes disregard additional fact checking that contradicts their political beliefs.
Assuming that people who get the flu vaccine will also get the COVID-19 vaccine is a mistake, too.
In our survey, 52% of respondents said they got a flu or other vaccine in the past year, but only 64% of those who got a vaccine in the past year said they were somewhat or extremely likely to get the COVID-19 vaccine. On the other hand, 47% who did not get a recent vaccine said they were somewhat or extremely likely to get the COVID-19 vaccine.
Ways that Do Help
Here are five things you can do to encourage your family, friends and neighbors to vaccinate and to seek out reliable information:
Help them discern trustworthy news outlets from the rest. Is the outlet clearly identified? Does it have a good reputation? Does it present verifiable evidence to back up claims? It is hard to know whether a site is advancing a political agenda but check the “about” or “sponsors” type of links in the menu on the homepage to gain a bit more information. People should be particularly suspicious if the source makes absolutist claims or evokes stereotypes. An anger-provoking headline on social media might be nothing more than manipulative clickbait, intended to sell a product or profit in some way from a reader’s attention.
Make trustworthy news sources accessible and consistent by putting them on your social media feeds. Community service centers are a good one. Partner with opinion leaders people already trust. Our survey respondents viewed local news and local health departments more useful than other outlets, although favorite sources vary with their age and political orientation.
Provide clear, consistent, relevant reasons to get the vaccines. Don’t forget the power of empathy. Our survey says only 49% thought a COVID-19 vaccine would help them, but 65% believed it would help protect other people. Avoid the temptation to use scare tactics and keep in mind that negatively framed messages sometimes backfire.
Remember that skepticism about vaccines did not happen overnight or entirely without cause. Research shows that mistrust of news media compromises confidence in vaccination. Many are also skeptical of Big Pharma for promoting drugs of questionable quality. The government must too overcome mistrust based on past questionable tactics, including “vaccine squads” targeting African Americans and immigrants. Honesty about past mistakes or current side effects is important. Some information about vaccines, widely disseminated in the past, were later revealed to be wrong. Although the evidence for the efficacy of vaccines is overwhelming, any missteps on this subject breed mistrust. One recent example: Two major studies about COVID-19 treatments were ultimately retracted.
Let them know that science is the answer, but it requires patience to get it right. Scientific progress is made gradually, with course corrections that are common until they build to consensus.
And emphasize the things we are certain of: The pandemic is not going away by itself. Not all news outlets are the same. Both flu and COVID-19 shots are necessary. And vaccines work. Collectively, by turning around those who believe otherwise, we can save lives.
How to Talk to Someone Who’s Hesitant to Get the COVID-19 Vaccine
I really like this set evaluation and set of suggestions put together by Elaine K. Howley, for Dr. Gabriel Lockhart, a pulmonologist and critical care intensivist at National Jewish Health in Denver, the question of how best to approach loved ones who are vaccine hesitant hit very close to home.
Lockhart, who is also the director of the ICU for National Jewish Health, has been on the front lines of the pandemic since the beginning, traveling to New York a few times to help out during the peak of its COVID crisis. “I had a lot of first-hand experience with the disastrous outcomes of COVID,” he says.
That, plus his background in pulmonary critical care medicine, has led to his working with Gov. Jared Polis of Colorado as part of the Governor’s Expert Emergency Epidemic Response Committee medical advisory group in collaboration with the Colorado Department of Public Health to address the pandemic in Colorado. “My specific focus was on vaccine distribution,” he says, which is a “very personal topic” for him because he’s African-American and Hispanic.
Communities of color have been hit disproportionately hard by the pandemic, and deploying vaccines to populations that are more vulnerable has been a key component of public health messaging.
But many people in these (and other) communities are hesitant to take the vaccine. And for good reason – there’s a long history of mistrust between communities of color and American health institutions.
For some people of color, there are deep-seated and legitimate concerns that this could be a repeat of Tuskegee, Lockhart says, referencing the infamous “ethically unjustified” Tuskegee study, which intended to study untreated syphilis in Black men and involved misinformation, lack of informed consent and outright manipulation of participants.
Fearing this situation might be similar, with communities of color being misled in the name of medical studies, some people expressed to Lockhart that they felt like “lab rats.” These responses caused the advisory committee in Colorado to take a step back and evaluate how they would encourage people in these communities to take the vaccine.
Lockhart says his own mother was initially resistant to getting the shot. “She finally just recently got her second dose, but that took six to eight months of me pestering her to finally get that to happen,” he says.
For his part, Lockhart was cautious too. “I wasn’t going to take the vaccine and promote it to my family and friends and patients unless I was completely confident in its safety and efficacy.”
When the clinical trials concluded, he reviewed the data and soon felt 100% comfortable about the safety and efficacy of the vaccine. He got his shots in December, among the earliest wave of health care personnel who were able to access the protective inoculation.
Making the Case for Vaccination
Since then, Lockhart has gone on to spread the message that the vaccines are safe, effective and everyone who’s able should get inoculated. He’s also learned that there’s a distinction between people who can be swayed and those who can’t be.
“When I approach people, who are hesitant about the vaccine, I think it’s first important to distinguish between those who are vaccine hesitant and those who are anti-vaxxers. Because those are two different things, in my opinion,” he explains.
“Vaccine hesitancy means they’re open to hearing information and making an educated decision based on good quality information they receive. They may not be wanting to go blindfolded into taking the vaccine. But if they’re willing to hear that information, then they can make an educated decision from that point.”
On the other hand, he says “anti-vaxxers are going to be dead set, no matter what information you tell them. They’re always going to be coming up with a firehose of misinformation and leading you down a rabbit hole of tangential information that isn’t really useful, accurate or helpful when it comes to vaccines. I don’t typically engage that much with purely anti-vaxxers because there’s really not going to be a lot of gain from that population.”
However, educational efforts can go a long way toward convincing those who are hesitant but open to learning more to take the vaccine to protect themselves and their communities, Lockhart says.
Dr. Julita Mir, a practicing internist and infectious disease physician and chief medical officer of Community Care Cooperative (C3) in Boston, urges patience and compassion when talking with others about taking the vaccine. “For most people, it’s a matter of time. We all move at different paces and accepting others’ pace is key.”
Find Out Their Concerns
Because there can be so many different, highly personal reasons why someone might be hesitant to take the vaccine, “it’s best to approach people in a supportive and respectful manner, and make it clear that your goal is to understand what their concerns are,” says Dr. Richard Seidman, chief medical officer of L.A. Care Health Plan – the largest publicly operated health plan in the country.
“We can’t assume what others are thinking or feeling, so it’s best to ask. Once we understand others’ concerns more clearly, we’re better able to engage in a meaningful discussion to explore how to best address their concerns.”
Dr. Lisa Doggett, senior medical director for HGS AxisPoint Health, a care management services company based in Westminster, Colorado, and a newly appointed fellow with American Academy of Family Physicians’ Vaccine Science Fellowship, recommends asking “if there’s anything that might change their mind. If they say, ‘absolutely not,’ it’s probably a good idea to stop and agree to disagree. By continuing you’ll often force them to dig into their beliefs with even greater conviction.”
But, she adds, that if they show some glimmer that they might be willing to consider an alternate view point, “offer to provide one,” but first, “ask for permission. If they agree, proceed with care, stay calm and offer information that’s likely to be meaningful to that particular person.”
Dr. Charles Bailey, medical director for infection prevention at Providence St Joseph Hospital and Providence Mission Hospital in Orange County, California, agrees that coming from a “place of love” often is more fruitful when trying to convince someone to get vaccinated.
He recommends saying something along the lines of: “‘I’m concerned about your reluctance to get a COVID vaccination because I care about your health and safety.’ And before going directly to examples of who you know who’s gotten the vaccine and had no or minimal problems, try to ascertain from where the reluctance originates.”
Ask questions like: “‘What in particular makes you hesitant to get vaccinated at this time?’ Phrasing it in this way provides room for a subsequent change in their decision later as more information comes to light and/or more consideration has occurred,” he explains.
Lockhart recommends “really making sure it’s a two-way conversation” that involves specific reasons. With a full explanation of where that hesitancy comes from, he says it’s possible to provide the accurate and correct information that can help move people toward getting the vaccine.
Mir also recommends “leading by example” and getting vaccinated yourself. “People tend to trust and be influenced more so by those in their close circles.”
Doggett adds, “at all costs, avoid insults and demeaning language, which would be counterproductive. And have realistic expectations. Not everyone
Countering Common Vaccine Concerns
There are a wide variety of legitimate reasons why some people may be hesitant to take the COVID-19 vaccine. These may include:
Speed that the vaccine was developed.
Safety.
Misinformation or misunderstanding the science.
Side effects.
Distrust of science, the government or medical authorities.
Underlying conditions that they believe might make them more vulnerable.
Speed of Development For some people, the concern is the speed with which the vaccine was developed and how “new” the mRNA technology being used in two of the three shots currently available in the U.S. seems. But Lockhart notes, this approach to developing vaccines “isn’t that new. We’ve had experience with mRNA technology for the last two decades.”
Primarily, it was studied for use in cancer treatment and has also been investigated for use in vaccines against influenza, rabies and Zika. With all this scrutiny, scientists have developed “a good sense of the side effect profile when it comes to mRNA technology.”
The speed with which these vaccines were made available stems from that past experience with mRNA technology and the all-hands-on-deck approach that global health authorities took early on to bring this burgeoning crisis under control.
Lockhart uses an analogy to explain how it all came together so quickly. “It’s like having six different construction companies that were all employed to build separate skyscrapers. They’re told a skyscraper typically takes two years to build. But then they’re all told, ‘Hey, we need all of you to focus on the same skyscraper and expedite the production. Pivot your focus all on the same skyscraper.’ So, yeah. It’s gonna happen a lot faster when you already have infrastructure in place that all comes together for a common cause.”
Despite this fast-tracking, Bailey notes that the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have been clear from the beginning that “no short cuts in safety were taken” in bringing these vaccines into use this quickly. “The rapid development was facilitated primarily by massive governmental investment in private-sector pharma companies as well as liability protections.”
All the normal safety steps were taken in developing these vaccines, and because this was such an urgent need and highly scrutinized, all the trials were conducted to the most stringent standards. All three currently available vaccines in the U.S. have been found to be safe and highly effective.
The numbers may paint a clearer picture. The Pfizer-BioNTech vaccine trial included more than 43,000 participants. Of the group that received the vaccine (rather than a placebo) only eight individuals developed COVID-19. That’s compared to 162 in the placebo group. Of those infections, 10 were severe, but only one of those occurred in the vaccinated group, and the other nine were in the placebo group.
The Moderna vaccine trial included more than 30,000 people, and only five cases of COVID-19 were reported in the group that received the vaccine versus 90 in the placebo group. Of those 90 cases, 30 were severe. There were no severe cases of COVID-19 reported in the vaccine group.
The Johnson & Johnson one-dose adenovirus vector vaccine was trialed in nearly 44,000 people in eight countries. There were 116 cases of COVID-19 in the vaccine group and 348 in the placebo group at least 14 days after vaccination. Of those, only two were severe among the vaccine group, compared to 29 in the placebo group. Seven people in the placebo group died of COVID-19, while none died in the vaccine group.
For all three vaccines, the Food and Drug Administration granted emergency use authorization because they were “at least 50% more effective than placebo in preventing COVID-19,” which is consistent with the organization’s guidelines for granting authorization. “A vaccine with at least 50% efficacy would have a significant impact on disease, both at the individual and societal level,” the FDA reports.
Some of the testing steps happened in tandem, which is part of how these companies were able to condense the timeline. There was also unprecedented collaboration across pharmaceutical companies. This helped move everything along faster.
“Just because they happened faster doesn’t mean it’s not a quality product,” Lockhart adds.
Safety Concerns about safety are also common, Seidman says. For example, concerns about very rare blood clots caused the FDA to pause distribution of the Johnson & Johnson vaccine for 11 days in April to reevaluate the data. Putting a pause on a new vaccine or medication is not unusual, and it’s an example of the system working exactly as it should.
In this case, there were six reported cases of blood clots and one death related to the J&J vaccine. More than 6.8 million doses had been administered when the pause was initiated in mid-April. In other words, the chances of developing a blood clot from the J&J vaccine were observed to be quite literally less than one in a million. However, in an abundance of caution, the FDA paused use of the vaccine to reevaluate the data and found that “it’s a very, very small concern, and compared to the risk of blood clots with contracting COVID, it’s extremely small,” Lockhart says.
A November 2020 study conducted at UC San Diego Health and involving more than 8,000 patients diagnosed with COVID-19 noted that 20% of people hospitalized with severe COVID-19 will develop blood clots. For patients in the intensive care unit, the rate was 31%. The study also noted that blood clots led to an increased risk of death by 74%. So the risk of getting a blood clot from the vaccine is miniscule in comparison to the risk of getting a blood clot from COVID-19 itself.
Doggett notes that “nearly everything we do in medicine, and in life, carries some inherent risk. Medications have side effects; treatments and procedures can have unintended consequences. Sometimes the risks and benefits are nearly equal, and choosing the right path is difficult. However, with the COVID-19 vaccine, the risks of vaccine refusal are clear and are substantially greater, for almost everyone, than the very small risk of the vaccine.”
Physicians are constantly weighing the risk versus benefit of any intervention, and the COVID vaccines have been found to be very beneficial with exceedingly small risks.
Plus, there’s reassurance in numbers, Seidman says. “The fact is that nearly 150 million people have been vaccinated in the United States alone with very few serious side effects.” This is excellent evidence that the vaccines really are very safe.
“All approved vaccines have an excellent safety profile, which is regularly tested,” says Dr. Eyal Leshem, director of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center and a clinical associate professor in Tel Aviv University School of Medicine in Israel. This means safety testing isn’t just a one-and-done situation. These vaccines are constantly being monitored and evaluated. Any adverse effects are being carefully recorded, and if a safety concern does arise, as did with the J&J vaccine, use will be halted until further investigation can be conducted.
“Medicine in general and vaccine safety assessment specifically are scientific disciplines,” Leshem adds, and the science is showing these vaccines to be extremely safe and effective.
Misinformation or Misunderstanding the Science “If misinformation is fueling the reluctance, simply supplying accurate information may dispel the nonacceptance,” Bailey says. To dispel some of these myths:
These vaccines can’t give you COVID-19. The vaccines do not include any live virus and thus cannot give you COVID-19. The vaccine triggers the immune system to manufacture antibodies against the disease.
They can’t affect your fertility. The CDC reports that there’s currently “no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems.”
They don’t contain other substances or materials that are harmful or controlling. Several bizarre conspiracy theories floating around the internet have suggested that the vaccines contain microchips or other nefarious ingredients that could be used to control people. These ideas are completely false and not based in science or reality.
You should get vaccinated even if you had COVID-19. That’s because while having had the disease offers some protection against future infection, there’s not enough data about that level of protection to know when it tapers off or how protective it is. If you’ve recently had COVID-19, you can receive the first dose of the vaccine four weeks after the onset of symptoms. The second dose can be administered after you’ve completed your isolation period (about 10 days). If you received certain treatments for COVID, including convalescent plasma or antibody infusions, you’ll need to wait 90 days before you can take the vaccine.
These vaccines can’t change your DNA. Some people have misunderstood what mRNA is and how it works and believe that this approach can alter your DNA. But that’s not true. “There’s no interference of your DNA. The vaccine doesn’t affect your DNA at all,” Lockhart says.
The Moderna and Pfizer-BioNTech vaccines both use mRNA to stimulate the body to create the antibodies it needs to fight off infection from the coronavirus. mRNA is messenger RNA, and in this context, it refers to a piece of the virus’ spike protein. This molecule contains a a piece of genetic code that instructs your cells to create antibodies against the coronavirus. To do this, the mRNA doesn’t even enter the nucleus of the cell – the cell breaks it down and removes it after it’s finished using the instructions.
Side Effects For some people, it’s a prior negative experience that’s driving their reluctance. In this case, whether the concern is a bad reaction to another vaccine or concerns about side effects that someone else has experienced, Bailey says discussing the facts around the statistics can help dispel some of that hesitation. He notes that the risk of severe side effects from the COVID vaccines is very low and much lower than the risk of getting COVID if you don’t get vaccinated.
Many people experience no side effects from any of these vaccines. But for others, after having one or both shots, they have reported experiencing:
Soreness, redness or swelling at the injection site.
Mild, flu-like symptoms, including a headache and body aches.
Tiredness.
Low-grade fevers.
Most of these side effects are mild and resolve quickly – within a day or two for most people. They’re also normal and signs that the vaccine is working to get your immune system ramped up to better meet the challenge if you’re exposed to the coronavirus in the future.
The most common side effects are also likely to be far less intense than if you were to get infected with COVID, so it’s worth it to feel a little lousy for a few hours – or even a couple days – after your shot if it means protecting yourself – and others – from a potentially far worse outcome if you caught the disease.
In very rare cases, some people have experienced more intense side effects including:
Severe allergic reactions including anaphylaxis. This has been observed in approximately two to five patients per million people vaccinated. This reaction also almost always occurred within 30 minutes after vaccination, which is why recipients are instructed to wait 15 to 30 minutes after each shot for observation.
Thrombosis with thrombocytopenia syndrome. Also called TTS, this condition involves blood clots with low platelets. This very rare syndrome has occurred almost exclusively in adult women younger than age 50 who received the J&J/Janssen vaccine. According to the CDC’s Vaccine Adverse Event Reporting System, as of May 11, 2021, more than 9 million doses of the J&J/Janssen vaccine had been given and 28 reports of TTS had been confirmed.
It’s important to underscore that these effects have been observed in a very small proportion of patients.
In addition, the CDC reports that there’s currently no evidence that there’s a causal link between the vaccine and any deaths apart from a “plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious event – blood clots with low platelets – which has caused deaths.” The CDC and the FDA are continuing to monitor all adverse events and deaths and are reporting such to the VAERS.
Distrust of Science, the Government or Medical Authorities Seidman also notes that “many people just don’t like being told what to do, especially if the message is coming from the government.” This is where community-based initiatives to educate and provide vaccines to people where they are can be especially useful.
“I’ve been working on talking to several community groups and leaders so they can answer questions and disseminate this information to their communities,” Lockhart says. Talking with a trusted adviser, such as a church elder or a barber, may offer more reassurance to hesitant people than speaking with a doctor, he adds. “If I can get buy-in from those folks, I think that’s the best efficacy. We can get people to accept the true information about these vaccines” because it’s coming from a trusted community leader.
Doggett adds that “for those who are concerned about personal liberties, a message that will sometimes resonate is that vaccinating more people will help encourage the government to lift restrictions and increase freedom in the long run.”
Leshem notes that this has already happened in Israel, where as of May 10, 2021, nearly 63% of the population has been vaccinated against COVID-19. “As we’re now experiencing in Israel, when most of the population are vaccinated disease spread declines and it is possible to go back to living a normal life.”
Barriers to vaccination such as the long history of racism and, as Seidman explains, “government-sanctioned experimentation on low-income people of color that has eroded trust” may be more difficult to combat. Lockhart says that while these are very legitimate concerns, avoiding the vaccine is only going to worsen the disparity in outcomes between white communities and communities of color.
Again, community-based, grassroots outreach efforts may be better for convincing people who have this as their primary concern. There needs to be a re-establishment of trust with agencies and entities that purvey medical information and care. “My advice is to get the facts from a trusted source of truth, like your doctor or from your faith-based leaders. And be careful not to accept what you might hear or read in biased media sources,” Seidman says.
“Many people tend to trust their primary care doctors, and building on that trust to overcome vaccine hesitancy is important,” Doggett says. And across the board, she adds that “the medical community needs to communicate effectively and consistently about the safety of the vaccine to help improve vaccine acceptance.”
Underlying Conditions For some people who are pregnant or have medical conditions, such as cancer, there’s been a lot of fear and confusion surrounding whether it’s safe to take a COVID-19 vaccine.
Cancer. The American Cancer Society reports that for most people with cancer or a history of cancer, the vaccine is safe and should be accepted, but individual cases may have other factors to consider, so talk with your oncologist.
Pregnancy. Though there has been some hesitation among pregnant people in taking the vaccine, studies have found that it’s safe and could actually protect your baby from contracting the virus after birth. The CDC’s V-safe COVID-19 Vaccine Pregnancy Registry is monitoring deployment of the vaccine in pregnant people. As of May 10, 2021, more than 110,000 pregnant people have been vaccinated. Talk with your obstetrician for advice tailored to your specific situation.
Immune disorders. If you have a chronic immune disorder or are taking medications that suppress the function of the immune system, you are eligible to get the vaccine. But you should talk with your health care provider about your situation.
Negative previous reactions to vaccines. If you’ve had a previous severe allergic reaction (anaphylaxis) you should not take the vaccine. If you have severe allergies to certain medications, latex, pets, foods or other environmental triggers, talk with your health care provider about whether it’s safe for you to take the vaccine.
“Referral to a family physician, nurse specialist or an infectious disease doctor can further help in more complicated cases, such as immune compromise, severe allergy or pregnancy,” Leshem says.
Why Vaccination Matters
The sooner everyone gets vaccinated, the better our chances of putting the pandemic completely behind us. “The COVID-19 vaccines are the best tool we have to get the pandemic under control, allowing us to get back to doing all of the things we need and want to do as individuals, families, business owners and as a community,” Seidman says. “Every additional person who gets vaccinated gets us one step closer to getting the virus under control.”
Still, as Doggett notes, “over a quarter of U.S. adults say they won’t get vaccinated. Their refusal makes it harder to stop the spread of the coronavirus, increasing infection rates and health care costs, and raising the risk of new, more dangerous variants. It also makes it more difficult for us to achieve herd immunity and effectively end the pandemic.”
This ongoing hesitancy to get vaccinated will drag out the pandemic and make it more difficult to resume life as usual, she says, because “the pandemic is far from over.”
In countries where vaccination rates are high, such as the UK, Israel and some parts of the U.S., cases are declining. “But rates of COVID-19 remain dangerously high in many parts of the world,” Doggett says. The higher these rates of infection, the more likely the virus will mutate into more dangerous strains that can undermine all the efforts over the past year to stamp out the pandemic.
“Even in the U.S., we’re still seeing tens of thousands of new cases every day and hundreds of deaths. The faster people get vaccinated, the faster we can stop the virus from spreading, and the sooner we can safely resume activities that many of us have given up during the pandemic, like travel, indoor dining and visiting family.”
The bottom line, she says, “getting vaccinated is the safest way to protect yourself and everyone around you from getting sick. It’s also an important way to stop the creation of new variants of the virus, that may be more virulent, more resistant to the vaccine and could extend the pandemic.”
Vaccine refusal, on the other hand, “will lead to higher health care costs, damage to the economy, and more people living with long-term COVID-19 complications, such as damage to the heart, lungs and brain that we’ve started to see in as many as a third of COVID-19 survivors.”
“Getting vaccinated is a personal decision,” Seidman notes. But choosing “not to get vaccinated is a decision that impacts everyone.”
Estimates of the number of people who need to be vaccinated to achieve herd immunity have typically ranged from 60% to 80% or so, but there are still many open questions about how durable immunity is and when we’ll have reached the threshold of protection.
In the meanwhile, getting vaccinated and convincing your friends and loved ones to do the same is our best means of moving out of this crisis. For his part, Seidman says “the COVID-19 vaccines are really a miracle of modern science. These vaccines are very safe and effective in preventing infection, hospitalizations and deaths from the worst pandemic in 100 years.”
And now with the Delta variant, Some areas of the U.S. could see “very dense outbreaks” of the Delta coronavirus variant throughout the summer and fall, particularly in states with low vaccination rates, according to CBS News.
The Delta variant, which was first identified in India, now makes up about 20% of new cases across the country. The variant has led to surges in parts of Missouri and Arkansas where people haven’t yet received a COVID-19 vaccine.
“It’s going to be hyper-regionalized, where there are certain pockets of the country where we can have very dense outbreaks,” Scott Gottlieb, MD, former commissioner of the FDA, said Sunday on CBS News’ “Face the Nation.”
“As you look across the United States, if you’re a community that has low vaccination rates and … low immunity from prior infection, the virus really hasn’t coursed through the local population,” he added. “I think governors need to be thinking about how they can build out health care resources in areas of the country where you still have a lot of vulnerability.”
Arkansas Gov. Asa Hutchinson, who spoke on “Face the Nation” before Gottlieb, also expressed concerns about the Delta variant. Arkansas has one of the lowest vaccination rates in the country, which Hutchinson attributed to vaccine hesitancy and conspiracy theories about the COVID-19 vaccines.
“The Delta variant is a great concern to us,” he said. “We see that impacting our increasing cases and hospitalizations.”
Hospital admissions increased 30% during the last week, and the University of Arkansas Medical Center reopened its COVID-19 ward. The state is offering incentives for people to get vaccinated, but they haven’t been successful, Hutchinson said. About 50% of adults are vaccinated, and public health officials want to move the needle higher.
“If incentives don’t work, reality will,” he said. “As you see the hospitalizations go up, the cases go up, I think you’ll see the vaccination rate increase as well.”
The Delta variant has been detected in 49 states and the District of Columbia, CBS News reported. The strain is more transmissible and can cause more severe COVID-19. The U.S. and other countries have marked the Delta variant as a “variant of concern” to monitor as the pandemic continues worldwide.
The Delta variant has become the dominant strain in the U.K. and now accounts for 95% of cases that are sequenced, according to the latest update from Public Health England. On Sunday, Gottlieb said the U.S. is about a month or two behind the U.K. with local surges in cases due to the variant.
“They’re seeing cases grow,” he said. “The vast majority are in people who are unvaccinated … the experience in the U.S. is likely to be similar.”
My friend and cartoonist just succumbed to his long battle with cancer. He will be missed by us all and I thank him for being my friend, patient and cartoonist.
Damian McNamara reviewed some of the controversies regarding COVID-19 pandemic and our present status. Have we arrived at a much-anticipated tipping point in the COVID-19 pandemic in the United States? Or do we still have some time before we can return to some semblance of life as we knew it in 2019?
The CDC relaxation of masking and social distancing guidance for fully vaccinated Americans is one reason for optimism, some say, as is the recent milestone where we surpassed more than 50% of Americans vaccinated.
But it’s not all good news. “Right now, we are struggling with vaccine hesitancy,” Ali H. Mokdad, PhD, told Medscape Medical News.
“My concern now is people who don’t want the vaccine are looking around them and saying, ‘Oh we are in a very good position. Infections are down, more than 50% of Americans are vaccinated. Why do I need to get a vaccine?’ ” he said.
Another potential issue is waning immunity, added Mokdad, professor of health metrics sciences at the Institute for Health Metrics and Evaluation, University of Washington, Seattle. Companies are developing booster shots and Anthony Fauci, MD, the White House chief science advisor, said they may be required in the future.
Mokdad said this could add to vaccine hesitancy now. “Someone might think ‘Why should I take this vaccine when there is a new one coming up?’ If I wait for 2 months, I’ll get a new one.'”
“We can definitely be optimistic. Things are going in the right direction,” John Segreti, MD, told Medscape Medical News when asked to comment. “The vaccines seem to be working as well as advertised and are holding up in a real-world situation.”
However, “It’s too early to say it’s over,” he stressed.
“There is still moderate to substantial transmission in the community just about everywhere in the US. It might take a while until we see transmission rates declining to the point where the pandemic will be declared over,” added Segreti, hospital epidemiologist and medical director of infection control and prevention at Rush University Medical Center in Chicago, Illinois.
The global picture is another reason for pessimism, he said. “There is not enough vaccine for around the world. As long as there is uncontrolled transmission of coronavirus somewhere in the world, there is a greater chance for selecting out variants and variants that can escape the vaccine.”
“But overall I am much more optimistic than I was 6 months ago,” Segreti added.
Vaccines vs Variant
In a study evaluating two COVID-19 vaccines against the B.1.167.2 variant first reported in India, researchers evaluated data from Public Health England and reported reassuring news that the vaccines protected against this variant of concern. They studied the efficacy of the Pfizer/BioNTech and AstraZeneca/Oxford vaccines.
“After two doses of either vaccine there were only modest differences in vaccine effectiveness with the B.1.617.2 variant,” the researchers note. “Absolute differences in vaccine effectiveness were more marked with dose one. This would support maximizing vaccine uptake with two doses among vulnerable groups.”
The study was published online May 22 as a preprint on MedRxiv. It has not yet been peer reviewed.
The positive findings generated a lot of discussion on Twitter, with some still urging caution about celebrating the end of the pandemic. For example, a tweet from Aris Katzourakis, a paleo-virologist and researcher at the University of Oxford, United Kingdom, questioned how the results could be interpreted as good news “unless your priors were unreasonably catastrophic.”
“It depends on what happens to hospitalizations and deaths, as Andrew Pollard said this morning,” Charlotte Houldcroft, PhD, a post-doctoral research associate at Cambridge University in the UK, replied.
Houldcroft was referring to a comment this week from Andrew Pollard, MBBS, PhD, director of the Oxford Vaccine Group, who said if most people with COVID-19 are kept out of the hospital with the current vaccines “then the pandemic is over.”
Pollard also told The Guardian: “We can live with the virus; in fact, we are going to have to live with the virus in one way or another. We just need a little bit more time to have certainty around this.”
Seasonal Variation?
Others acknowledge that even though cases are dropping in the US, it could mean COVID-19 will transition to a seasonal illness like the flu. If that’s the case, they caution, a warm weather lull in COVID-19 cases could portend another surge come the winter.
But, Segreti said, it’s too early to tell.
“It’s reasonable to expect that at some point we will need a booster,” he added, but the timeline and frequency remain unknown.
Economic Indicators
The US economy is operating at 90% of where it was before the pandemic, according to the ‘Back to Normal Index’ calculated by CNN Business and Moody’s Analytics based on 37 national and seven state measures.
The index improved in 44 states in the week prior to May 26, which could also reflect an overall improvement in the COVID-19 pandemic.
State and federal unemployment numbers, job postings and hiring rates, and personal savings appear to be trending in a positive direction. In contrast, box office sales, hotel occupancy, and domestic air travel continue to struggle.
Explained: How to Talk to Anti-Vaxxers
Collectively, by turning around those who believe otherwise, we can save lives.
I am getting very tired of trying to convince people of the safety and need for vaccinations and then I reviewed this article. Erica Weintraub Austin and Porismita Borah helps us communicate with this population group. An estimated 24,000 to 62,000 people died from the flu in the United States during the 2019-20 flu season. And that was a relatively mild flu season, which typically starts in October and peaks between December and February.
The computer model predicted 300,000 deaths from COVID-19.
With the advent of flu season, and COVID-19 cases rising, a public health disaster even worse than what we’re now experiencing could occur this fall and winter. Two very dangerous respiratory diseases could be circulating at once.
This will put the general population at risk as well as the millions of people who have pre-existing conditions. Hospitals and health care workers would likely be overwhelmed again.
We are scholars from the Edward R. Murrow Center for Media & Health Promotion Research at Washington State University. As we see it, the only way out of the reopening and reclosing cycles is to convince people to get the flu vaccine in early fall – and then the COVID-19 vaccine when it’s available. Right now, up to 20 COVID-19 vaccine candidates are already in human trials. Chances seem good that at least one will be available for distribution in 2021.
But recent studies suggest that 35% might not want to get a COVID vaccine, and fewer than half received a flu vaccine for the 2019-2020 season.
Getting Coverage
To arrest the pandemic’s spread, perhaps 70% to 80% of the population must opt in and get the vaccine. They also need the flu shot to avoid co-infection which complicates diagnosis and treatment.
Achieving herd immunity is a steep climb. We conducted a national online survey, with 1,264 participants, between June 22 and July 18. We found that only 56% of adults said they were likely or extremely likely to get the COVID-19 vaccine. Westerners were most accepting (64%), followed by Midwesterners (58%), with Southerners (53%) and Northeasterners (50%) least likely.
Anti-vaxxers, promoting unlikely scenarios and outright falsehoods about vaccine risks, are not helping.
With all this in mind, we would like to share some myths and truths about how to increase rates of vaccinations.
Facts Don’t Convince People
People who support vaccination sometimes believe their own set of myths, which actually may stand in the way of getting people vaccinated. One such myth is that people respond to facts and that vaccine hesitancy can be overcome by facts.
That is not necessarily true. Actually, knowledge alone rarely convinces people to change behavior. Most decisions are informed – or misinformed – by emotions: confidence, threat, empathy and worry are four of them.
Another myth is that people can easily separate accurate information from the inaccurate. This is not always true, either. With so much misinformation and disinformation out there, people are often overconfident about their ability to discern good from bad. Our research during the H1N1 epidemic showed that overconfidence can lead to faulty conclusions that increase risk.
Also, it’s not always true that people are motivated to get accurate information to protect themselves and their loved ones. People are often too busy to parse information, especially on complicated subjects. They instead rely on shortcuts, often looking for consistency with their own attitudes, social media endorsements and accessibility.
And, to complicate matters, people will sometimes disregard additional fact checking that contradicts their political beliefs.
Assuming that people who get the flu vaccine will also get the COVID-19 vaccine is a mistake, too.
In our survey, 52% of respondents said they got a flu or other vaccine in the past year, but only 64% of those who got a vaccine in the past year said they were somewhat or extremely likely to get the COVID-19 vaccine. On the other hand, 47% who did not get a recent vaccine said they were somewhat or extremely likely to get the COVID-19 vaccine.
Ways that Do Help
Here are five things you can do to encourage your family, friends and neighbors to vaccinate and to seek out reliable information:
Help them discern trustworthy news outlets from the rest. Is the outlet clearly identified? Does it have a good reputation? Does it present verifiable evidence to back up claims? It is hard to know whether a site is advancing a political agenda but check the “about” or “sponsors” type of links in the menu on the homepage to gain a bit more information. People should be particularly suspicious if the source makes absolutist claims or evokes stereotypes. An anger-provoking headline on social media might be nothing more than manipulative clickbait, intended to sell a product or profit in some way from a reader’s attention.
Make trustworthy news sources accessible and consistent by putting them on your social media feeds. Community service centers are a good one. Partner with opinion leaders people already trust. Our survey respondents viewed local news and local health departments more useful than other outlets, although favorite sources vary with their age and political orientation.
Provide clear, consistent, relevant reasons to get the vaccines. Don’t forget the power of empathy. Our survey says only 49% thought a COVID-19 vaccine would help them, but 65% believed it would help protect other people. Avoid the temptation to use scare tactics and keep in mind that negatively framed messages sometimes backfire.
Remember that skepticism about vaccines did not happen overnight or entirely without cause. Research shows that mistrust of news media compromises confidence in vaccination. Many are also skeptical of Big Pharma for promoting drugs of questionable quality. The government must too overcome mistrust based on past questionable tactics, including “vaccine squads” targeting African Americans and immigrants. Honesty about past mistakes or current side effects is important. Some information about vaccines, widely disseminated in the past, were later revealed to be wrong. Although the evidence for the efficacy of vaccines is overwhelming, any missteps on this subject breed mistrust. One recent example: Two major studies about COVID-19 treatments were ultimately retracted.
Let them know that science is the answer, but it requires patience to get it right. Scientific progress is made gradually, with course corrections that are common until they build to consensus.
And emphasize the things we are certain of: The pandemic is not going away by itself. Not all news outlets are the same. Both flu and COVID-19 shots are necessary. And vaccines work. Collectively, by turning around those who believe otherwise, we can save lives.
How to Talk to Someone Who’s Hesitant to Get the COVID-19 Vaccine
I really like this set evaluation and set of suggestions put together by Elaine K. Howley, for Dr. Gabriel Lockhart, a pulmonologist and critical care intensivist at National Jewish Health in Denver, the question of how best to approach loved ones who are vaccine hesitant hit very close to home.
Lockhart, who is also the director of the ICU for National Jewish Health, has been on the front lines of the pandemic since the beginning, traveling to New York a few times to help out during the peak of its COVID crisis. “I had a lot of first-hand experience with the disastrous outcomes of COVID,” he says.
That, plus his background in pulmonary critical care medicine, has led to his working with Gov. Jared Polis of Colorado as part of the Governor’s Expert Emergency Epidemic Response Committee medical advisory group in collaboration with the Colorado Department of Public Health to address the pandemic in Colorado. “My specific focus was on vaccine distribution,” he says, which is a “very personal topic” for him because he’s African-American and Hispanic.
Communities of color have been hit disproportionately hard by the pandemic, and deploying vaccines to populations that are more vulnerable has been a key component of public health messaging.
But many people in these (and other) communities are hesitant to take the vaccine. And for good reason – there’s a long history of mistrust between communities of color and American health institutions.
For some people of color, there are deep-seated and legitimate concerns that this could be a repeat of Tuskegee, Lockhart says, referencing the infamous “ethically unjustified” Tuskegee study, which intended to study untreated syphilis in Black men and involved misinformation, lack of informed consent and outright manipulation of participants.
Fearing this situation might be similar, with communities of color being misled in the name of medical studies, some people expressed to Lockhart that they felt like “lab rats.” These responses caused the advisory committee in Colorado to take a step back and evaluate how they would encourage people in these communities to take the vaccine.
Lockhart says his own mother was initially resistant to getting the shot. “She finally just recently got her second dose, but that took six to eight months of me pestering her to finally get that to happen,” he says.
For his part, Lockhart was cautious too. “I wasn’t going to take the vaccine and promote it to my family and friends and patients unless I was completely confident in its safety and efficacy.”
When the clinical trials concluded, he reviewed the data and soon felt 100% comfortable about the safety and efficacy of the vaccine. He got his shots in December, among the earliest wave of health care personnel who were able to access the protective inoculation.
Making the Case for Vaccination
Since then, Lockhart has gone on to spread the message that the vaccines are safe, effective and everyone who’s able should get inoculated. He’s also learned that there’s a distinction between people who can be swayed and those who can’t be.
“When I approach people, who are hesitant about the vaccine, I think it’s first important to distinguish between those who are vaccine hesitant and those who are anti-vaxxers. Because those are two different things, in my opinion,” he explains.
“Vaccine hesitancy means they’re open to hearing information and making an educated decision based on good quality information they receive. They may not be wanting to go blindfolded into taking the vaccine. But if they’re willing to hear that information, then they can make an educated decision from that point.”
On the other hand, he says “anti-vaxxers are going to be dead set, no matter what information you tell them. They’re always going to be coming up with a firehose of misinformation and leading you down a rabbit hole of tangential information that isn’t really useful, accurate or helpful when it comes to vaccines. I don’t typically engage that much with purely anti-vaxxers because there’s really not going to be a lot of gain from that population.”
However, educational efforts can go a long way toward convincing those who are hesitant but open to learning more to take the vaccine to protect themselves and their communities, Lockhart says.
Dr. Julita Mir, a practicing internist and infectious disease physician and chief medical officer of Community Care Cooperative (C3) in Boston, urges patience and compassion when talking with others about taking the vaccine. “For most people, it’s a matter of time. We all move at different paces and accepting others’ pace is key.”
Find Out Their Concerns
Because there can be so many different, highly personal reasons why someone might be hesitant to take the vaccine, “it’s best to approach people in a supportive and respectful manner, and make it clear that your goal is to understand what their concerns are,” says Dr. Richard Seidman, chief medical officer of L.A. Care Health Plan – the largest publicly operated health plan in the country.
“We can’t assume what others are thinking or feeling, so it’s best to ask. Once we understand others’ concerns more clearly, we’re better able to engage in a meaningful discussion to explore how to best address their concerns.”
Dr. Lisa Doggett, senior medical director for HGS AxisPoint Health, a care management services company based in Westminster, Colorado, and a newly appointed fellow with American Academy of Family Physicians’ Vaccine Science Fellowship, recommends asking “if there’s anything that might change their mind. If they say, ‘absolutely not,’ it’s probably a good idea to stop and agree to disagree. By continuing you’ll often force them to dig into their beliefs with even greater conviction.”
But, she adds, that if they show some glimmer that they might be willing to consider an alternate view point, “offer to provide one,” but first, “ask for permission. If they agree, proceed with care, stay calm and offer information that’s likely to be meaningful to that particular person.”
Dr. Charles Bailey, medical director for infection prevention at Providence St Joseph Hospital and Providence Mission Hospital in Orange County, California, agrees that coming from a “place of love” often is more fruitful when trying to convince someone to get vaccinated.
He recommends saying something along the lines of: “‘I’m concerned about your reluctance to get a COVID vaccination because I care about your health and safety.’ And before going directly to examples of who you know who’s gotten the vaccine and had no or minimal problems, try to ascertain from where the reluctance originates.”
Ask questions like: “‘What in particular makes you hesitant to get vaccinated at this time?’ Phrasing it in this way provides room for a subsequent change in their decision later as more information comes to light and/or more consideration has occurred,” he explains.
Lockhart recommends “really making sure it’s a two-way conversation” that involves specific reasons. With a full explanation of where that hesitancy comes from, he says it’s possible to provide the accurate and correct information that can help move people toward getting the vaccine.
Mir also recommends “leading by example” and getting vaccinated yourself. “People tend to trust and be influenced more so by those in their close circles.”
Doggett adds, “at all costs, avoid insults and demeaning language, which would be counterproductive. And have realistic expectations. Not everyone
Countering Common Vaccine Concerns
There are a wide variety of legitimate reasons why some people may be hesitant to take the COVID-19 vaccine. These may include:
Speed that the vaccine was developed.
Safety.
Misinformation or misunderstanding the science.
Side effects.
Distrust of science, the government or medical authorities.
Underlying conditions that they believe might make them more vulnerable.
Speed of Development For some people, the concern is the speed with which the vaccine was developed and how “new” the mRNA technology being used in two of the three shots currently available in the U.S. seems. But Lockhart notes, this approach to developing vaccines “isn’t that new. We’ve had experience with mRNA technology for the last two decades.”
Primarily, it was studied for use in cancer treatment and has also been investigated for use in vaccines against influenza, rabies and Zika. With all this scrutiny, scientists have developed “a good sense of the side effect profile when it comes to mRNA technology.”
The speed with which these vaccines were made available stems from that past experience with mRNA technology and the all-hands-on-deck approach that global health authorities took early on to bring this burgeoning crisis under control.
Lockhart uses an analogy to explain how it all came together so quickly. “It’s like having six different construction companies that were all employed to build separate skyscrapers. They’re told a skyscraper typically takes two years to build. But then they’re all told, ‘Hey, we need all of you to focus on the same skyscraper and expedite the production. Pivot your focus all on the same skyscraper.’ So, yeah. It’s gonna happen a lot faster when you already have infrastructure in place that all comes together for a common cause.”
Despite this fast-tracking, Bailey notes that the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have been clear from the beginning that “no short cuts in safety were taken” in bringing these vaccines into use this quickly. “The rapid development was facilitated primarily by massive governmental investment in private-sector pharma companies as well as liability protections.”
All the normal safety steps were taken in developing these vaccines, and because this was such an urgent need and highly scrutinized, all the trials were conducted to the most stringent standards. All three currently available vaccines in the U.S. have been found to be safe and highly effective.
The numbers may paint a clearer picture. The Pfizer-BioNTech vaccine trial included more than 43,000 participants. Of the group that received the vaccine (rather than a placebo) only eight individuals developed COVID-19. That’s compared to 162 in the placebo group. Of those infections, 10 were severe, but only one of those occurred in the vaccinated group, and the other nine were in the placebo group.
The Moderna vaccine trial included more than 30,000 people, and only five cases of COVID-19 were reported in the group that received the vaccine versus 90 in the placebo group. Of those 90 cases, 30 were severe. There were no severe cases of COVID-19 reported in the vaccine group.
The Johnson & Johnson one-dose adenovirus vector vaccine was trialed in nearly 44,000 people in eight countries. There were 116 cases of COVID-19 in the vaccine group and 348 in the placebo group at least 14 days after vaccination. Of those, only two were severe among the vaccine group, compared to 29 in the placebo group. Seven people in the placebo group died of COVID-19, while none died in the vaccine group.
For all three vaccines, the Food and Drug Administration granted emergency use authorization because they were “at least 50% more effective than placebo in preventing COVID-19,” which is consistent with the organization’s guidelines for granting authorization. “A vaccine with at least 50% efficacy would have a significant impact on disease, both at the individual and societal level,” the FDA reports.
Some of the testing steps happened in tandem, which is part of how these companies were able to condense the timeline. There was also unprecedented collaboration across pharmaceutical companies. This helped move everything along faster.
“Just because they happened faster doesn’t mean it’s not a quality product,” Lockhart adds.
Safety Concerns about safety are also common, Seidman says. For example, concerns about very rare blood clots caused the FDA to pause distribution of the Johnson & Johnson vaccine for 11 days in April to reevaluate the data. Putting a pause on a new vaccine or medication is not unusual, and it’s an example of the system working exactly as it should.
In this case, there were six reported cases of blood clots and one death related to the J&J vaccine. More than 6.8 million doses had been administered when the pause was initiated in mid-April. In other words, the chances of developing a blood clot from the J&J vaccine were observed to be quite literally less than one in a million. However, in an abundance of caution, the FDA paused use of the vaccine to reevaluate the data and found that “it’s a very, very small concern, and compared to the risk of blood clots with contracting COVID, it’s extremely small,” Lockhart says.
A November 2020 study conducted at UC San Diego Health and involving more than 8,000 patients diagnosed with COVID-19 noted that 20% of people hospitalized with severe COVID-19 will develop blood clots. For patients in the intensive care unit, the rate was 31%. The study also noted that blood clots led to an increased risk of death by 74%. So the risk of getting a blood clot from the vaccine is miniscule in comparison to the risk of getting a blood clot from COVID-19 itself.
Doggett notes that “nearly everything we do in medicine, and in life, carries some inherent risk. Medications have side effects; treatments and procedures can have unintended consequences. Sometimes the risks and benefits are nearly equal, and choosing the right path is difficult. However, with the COVID-19 vaccine, the risks of vaccine refusal are clear and are substantially greater, for almost everyone, than the very small risk of the vaccine.”
Physicians are constantly weighing the risk versus benefit of any intervention, and the COVID vaccines have been found to be very beneficial with exceedingly small risks.
Plus, there’s reassurance in numbers, Seidman says. “The fact is that nearly 150 million people have been vaccinated in the United States alone with very few serious side effects.” This is excellent evidence that the vaccines really are very safe.
“All approved vaccines have an excellent safety profile, which is regularly tested,” says Dr. Eyal Leshem, director of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center and a clinical associate professor in Tel Aviv University School of Medicine in Israel. This means safety testing isn’t just a one-and-done situation. These vaccines are constantly being monitored and evaluated. Any adverse effects are being carefully recorded, and if a safety concern does arise, as did with the J&J vaccine, use will be halted until further investigation can be conducted.
“Medicine in general and vaccine safety assessment specifically are scientific disciplines,” Leshem adds, and the science is showing these vaccines to be extremely safe and effective.
Misinformation or Misunderstanding the Science “If misinformation is fueling the reluctance, simply supplying accurate information may dispel the nonacceptance,” Bailey says. To dispel some of these myths:
These vaccines can’t give you COVID-19. The vaccines do not include any live virus and thus cannot give you COVID-19. The vaccine triggers the immune system to manufacture antibodies against the disease.
They can’t affect your fertility. The CDC reports that there’s currently “no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems.”
They don’t contain other substances or materials that are harmful or controlling. Several bizarre conspiracy theories floating around the internet have suggested that the vaccines contain microchips or other nefarious ingredients that could be used to control people. These ideas are completely false and not based in science or reality.
You should get vaccinated even if you had COVID-19. That’s because while having had the disease offers some protection against future infection, there’s not enough data about that level of protection to know when it tapers off or how protective it is. If you’ve recently had COVID-19, you can receive the first dose of the vaccine four weeks after the onset of symptoms. The second dose can be administered after you’ve completed your isolation period (about 10 days). If you received certain treatments for COVID, including convalescent plasma or antibody infusions, you’ll need to wait 90 days before you can take the vaccine.
These vaccines can’t change your DNA. Some people have misunderstood what mRNA is and how it works and believe that this approach can alter your DNA. But that’s not true. “There’s no interference of your DNA. The vaccine doesn’t affect your DNA at all,” Lockhart says.
The Moderna and Pfizer-BioNTech vaccines both use mRNA to stimulate the body to create the antibodies it needs to fight off infection from the coronavirus. mRNA is messenger RNA, and in this context, it refers to a piece of the virus’ spike protein. This molecule contains a a piece of genetic code that instructs your cells to create antibodies against the coronavirus. To do this, the mRNA doesn’t even enter the nucleus of the cell – the cell breaks it down and removes it after it’s finished using the instructions.
Side Effects For some people, it’s a prior negative experience that’s driving their reluctance. In this case, whether the concern is a bad reaction to another vaccine or concerns about side effects that someone else has experienced, Bailey says discussing the facts around the statistics can help dispel some of that hesitation. He notes that the risk of severe side effects from the COVID vaccines is very low and much lower than the risk of getting COVID if you don’t get vaccinated.
Many people experience no side effects from any of these vaccines. But for others, after having one or both shots, they have reported experiencing:
Soreness, redness or swelling at the injection site.
Mild, flu-like symptoms, including a headache and body aches.
Tiredness.
Low-grade fevers.
Most of these side effects are mild and resolve quickly – within a day or two for most people. They’re also normal and signs that the vaccine is working to get your immune system ramped up to better meet the challenge if you’re exposed to the coronavirus in the future.
The most common side effects are also likely to be far less intense than if you were to get infected with COVID, so it’s worth it to feel a little lousy for a few hours – or even a couple days – after your shot if it means protecting yourself – and others – from a potentially far worse outcome if you caught the disease.
In very rare cases, some people have experienced more intense side effects including:
Severe allergic reactions including anaphylaxis. This has been observed in approximately two to five patients per million people vaccinated. This reaction also almost always occurred within 30 minutes after vaccination, which is why recipients are instructed to wait 15 to 30 minutes after each shot for observation.
Thrombosis with thrombocytopenia syndrome. Also called TTS, this condition involves blood clots with low platelets. This very rare syndrome has occurred almost exclusively in adult women younger than age 50 who received the J&J/Janssen vaccine. According to the CDC’s Vaccine Adverse Event Reporting System, as of May 11, 2021, more than 9 million doses of the J&J/Janssen vaccine had been given and 28 reports of TTS had been confirmed.
It’s important to underscore that these effects have been observed in a very small proportion of patients.
In addition, the CDC reports that there’s currently no evidence that there’s a causal link between the vaccine and any deaths apart from a “plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious event – blood clots with low platelets – which has caused deaths.” The CDC and the FDA are continuing to monitor all adverse events and deaths and are reporting such to the VAERS.
Distrust of Science, the Government or Medical Authorities Seidman also notes that “many people just don’t like being told what to do, especially if the message is coming from the government.” This is where community-based initiatives to educate and provide vaccines to people where they are can be especially useful.
“I’ve been working on talking to several community groups and leaders so they can answer questions and disseminate this information to their communities,” Lockhart says. Talking with a trusted adviser, such as a church elder or a barber, may offer more reassurance to hesitant people than speaking with a doctor, he adds. “If I can get buy-in from those folks, I think that’s the best efficacy. We can get people to accept the true information about these vaccines” because it’s coming from a trusted community leader.
Doggett adds that “for those who are concerned about personal liberties, a message that will sometimes resonate is that vaccinating more people will help encourage the government to lift restrictions and increase freedom in the long run.”
Leshem notes that this has already happened in Israel, where as of May 10, 2021, nearly 63% of the population has been vaccinated against COVID-19. “As we’re now experiencing in Israel, when most of the population are vaccinated disease spread declines and it is possible to go back to living a normal life.”
Barriers to vaccination such as the long history of racism and, as Seidman explains, “government-sanctioned experimentation on low-income people of color that has eroded trust” may be more difficult to combat. Lockhart says that while these are very legitimate concerns, avoiding the vaccine is only going to worsen the disparity in outcomes between white communities and communities of color.
Again, community-based, grassroots outreach efforts may be better for convincing people who have this as their primary concern. There needs to be a re-establishment of trust with agencies and entities that purvey medical information and care. “My advice is to get the facts from a trusted source of truth, like your doctor or from your faith-based leaders. And be careful not to accept what you might hear or read in biased media sources,” Seidman says.
“Many people tend to trust their primary care doctors, and building on that trust to overcome vaccine hesitancy is important,” Doggett says. And across the board, she adds that “the medical community needs to communicate effectively and consistently about the safety of the vaccine to help improve vaccine acceptance.”
Underlying Conditions For some people who are pregnant or have medical conditions, such as cancer, there’s been a lot of fear and confusion surrounding whether it’s safe to take a COVID-19 vaccine.
Cancer. The American Cancer Society reports that for most people with cancer or a history of cancer, the vaccine is safe and should be accepted, but individual cases may have other factors to consider, so talk with your oncologist.
Pregnancy. Though there has been some hesitation among pregnant people in taking the vaccine, studies have found that it’s safe and could actually protect your baby from contracting the virus after birth. The CDC’s V-safe COVID-19 Vaccine Pregnancy Registry is monitoring deployment of the vaccine in pregnant people. As of May 10, 2021, more than 110,000 pregnant people have been vaccinated. Talk with your obstetrician for advice tailored to your specific situation.
Immune disorders. If you have a chronic immune disorder or are taking medications that suppress the function of the immune system, you are eligible to get the vaccine. But you should talk with your health care provider about your situation.
Negative previous reactions to vaccines. If you’ve had a previous severe allergic reaction (anaphylaxis) you should not take the vaccine. If you have severe allergies to certain medications, latex, pets, foods or other environmental triggers, talk with your health care provider about whether it’s safe for you to take the vaccine.
“Referral to a family physician, nurse specialist or an infectious disease doctor can further help in more complicated cases, such as immune compromise, severe allergy or pregnancy,” Leshem says.
Why Vaccination Matters
The sooner everyone gets vaccinated, the better our chances of putting the pandemic completely behind us. “The COVID-19 vaccines are the best tool we have to get the pandemic under control, allowing us to get back to doing all of the things we need and want to do as individuals, families, business owners and as a community,” Seidman says. “Every additional person who gets vaccinated gets us one step closer to getting the virus under control.”
Still, as Doggett notes, “over a quarter of U.S. adults say they won’t get vaccinated. Their refusal makes it harder to stop the spread of the coronavirus, increasing infection rates and health care costs, and raising the risk of new, more dangerous variants. It also makes it more difficult for us to achieve herd immunity and effectively end the pandemic.”
This ongoing hesitancy to get vaccinated will drag out the pandemic and make it more difficult to resume life as usual, she says, because “the pandemic is far from over.”
In countries where vaccination rates are high, such as the UK, Israel and some parts of the U.S., cases are declining. “But rates of COVID-19 remain dangerously high in many parts of the world,” Doggett says. The higher these rates of infection, the more likely the virus will mutate into more dangerous strains that can undermine all the efforts over the past year to stamp out the pandemic.
“Even in the U.S., we’re still seeing tens of thousands of new cases every day and hundreds of deaths. The faster people get vaccinated, the faster we can stop the virus from spreading, and the sooner we can safely resume activities that many of us have given up during the pandemic, like travel, indoor dining and visiting family.”
The bottom line, she says, “getting vaccinated is the safest way to protect yourself and everyone around you from getting sick. It’s also an important way to stop the creation of new variants of the virus, that may be more virulent, more resistant to the vaccine and could extend the pandemic.”
Vaccine refusal, on the other hand, “will lead to higher health care costs, damage to the economy, and more people living with long-term COVID-19 complications, such as damage to the heart, lungs and brain that we’ve started to see in as many as a third of COVID-19 survivors.”
“Getting vaccinated is a personal decision,” Seidman notes. But choosing “not to get vaccinated is a decision that impacts everyone.”
Estimates of the number of people who need to be vaccinated to achieve herd immunity have typically ranged from 60% to 80% or so, but there are still many open questions about how durable immunity is and when we’ll have reached the threshold of protection.
In the meanwhile, getting vaccinated and convincing your friends and loved ones to do the same is our best means of moving out of this crisis. For his part, Seidman says “the COVID-19 vaccines are really a miracle of modern science. These vaccines are very safe and effective in preventing infection, hospitalizations and deaths from the worst pandemic in 100 years.”
And now with the Delta variant, Some areas of the U.S. could see “very dense outbreaks” of the Delta coronavirus variant throughout the summer and fall, particularly in states with low vaccination rates, according to CBS News.
The Delta variant, which was first identified in India, now makes up about 20% of new cases across the country. The variant has led to surges in parts of Missouri and Arkansas where people haven’t yet received a COVID-19 vaccine.
“It’s going to be hyper-regionalized, where there are certain pockets of the country where we can have very dense outbreaks,” Scott Gottlieb, MD, former commissioner of the FDA, said Sunday on CBS News’ “Face the Nation.”
“As you look across the United States, if you’re a community that has low vaccination rates and … low immunity from prior infection, the virus really hasn’t coursed through the local population,” he added. “I think governors need to be thinking about how they can build out health care resources in areas of the country where you still have a lot of vulnerability.”
Arkansas Gov. Asa Hutchinson, who spoke on “Face the Nation” before Gottlieb, also expressed concerns about the Delta variant. Arkansas has one of the lowest vaccination rates in the country, which Hutchinson attributed to vaccine hesitancy and conspiracy theories about the COVID-19 vaccines.
“The Delta variant is a great concern to us,” he said. “We see that impacting our increasing cases and hospitalizations.”
Hospital admissions increased 30% during the last week, and the University of Arkansas Medical Center reopened its COVID-19 ward. The state is offering incentives for people to get vaccinated, but they haven’t been successful, Hutchinson said. About 50% of adults are vaccinated, and public health officials want to move the needle higher.
“If incentives don’t work, reality will,” he said. “As you see the hospitalizations go up, the cases go up, I think you’ll see the vaccination rate increase as well.”
The Delta variant has been detected in 49 states and the District of Columbia, CBS News reported. The strain is more transmissible and can cause more severe COVID-19. The U.S. and other countries have marked the Delta variant as a “variant of concern” to monitor as the pandemic continues worldwide.
The Delta variant has become the dominant strain in the U.K. and now accounts for 95% of cases that are sequenced, according to the latest update from Public Health England. On Sunday, Gottlieb said the U.S. is about a month or two behind the U.K. with local surges in cases due to the variant.
“They’re seeing cases grow,” he said. “The vast majority are in people who are unvaccinated … the experience in the U.S. is likely to be similar.”
My friend, former patient and cartoonist, Rick Kollinger, succumbed to his long battle with cancer picture him at the Golden Gates with a sketchpad in hand waiting to draw all of those that he surely will meet, possible insult, and entertain. I and many others will miss you.
Happy Fourth of July to ALL! Let us reflect on the history and the future of our great country. Take a moment to consider what we all have achieved this past year and focus on what we can accomplish in our future.
As our national mortality statistics reach over 500,000 and a third vaccine has been approved by the FDA I thought that we should examine the use of masks, etc. after vaccinations. This is an important question especially considering the increasing findings of more viral mutants.
Recently, a spirited discussion was sparked on social media: is it acceptable to relax masking 14 days after the second COVID-19 vaccine dose? Doctor Vinay Prasad and Doctor David Aronoff, in this post will discuss the advice as to whether to continue wearing masks as well as social distancing, etc. after one completes their vaccination.
Doctor Prasad starts off by noting that having spent some time thinking about the topic, and discussing with colleagues, I have reached two conclusions. First, it is a tradeoff with residual uncertainties, and reasonable people can disagree. But also, I favor the view that generally, 14 days after vaccination, we can relax some restrictions.
The caveats
It is important to be upfront with the caveats. Everything I say applies to average people in the community — I am not speaking about enhanced precautions in high-risk settings like nursing homes or medical centers. My argument is contingent on there being no “vaccine escape,” that is, no mutation in the coronavirus that markedly reduces vaccine efficacy. If that happens, may God help us. I am not sure we will make it.
Finally, my argument is appropriate for most places and most times, but if health systems are overwhelmed, e.g., as we saw in places like southern California or New York City, it might be reasonable to temporarily increase precautions. Additionally, my guiding principle does not apply to businesses, such as grocery stores or pharmacies, which can and will enforce their own policies.
Now, having said that: for most people, once you get 14 days out of your second dose of vaccine, I believe you can ease up on masking or another restriction, such as visiting a loved one for lunch or having more than one person visit a nursing home at the same time, or a small gathering of vaccinated people for dinner without masks.
The data
There are three lines of evidence that I wish to offer for my claim. First, consider the efficacy of the vaccine. The efficacy of the two mRNA vaccines is superb, offering 95% reduction in the rate of acquisition of symptomatic COVID-19 in randomized trials. That is a remarkable result. But the key statistic here is one step beyond the vaccine efficacy. If you get two doses of the vaccine, and if you remain asymptomatic 14 days after the second dose, what is the probability you will develop COVID-19? For Moderna, the answer is there is a 99.92% chance that you won’t. Only 12 cases occurred after this time in 14,550 actively vaccinated people in the trial, while the control arm experienced nearly 3.5% cumulative incidence. For Pfizer, only eight cases occurred amongst people who had completed a second dose and went 7 days without symptoms, again a 99.95% chance of not getting COVID if one remained asymptomatic a week after the second dose. In other words, if you get 14 days past the second dose, and feel fine, the likelihood you will get COVID-19 in these studies is very low. Some argue that in the real world — where folks are not as motivated as trial participants — the rate of SARS-CoV-2 acquisition might be higher, and thus relaxing rules riskier. But this logic cuts both ways: if people in the real world are less compliant, then the rules might be relaxed no matter what we say.
Next, consider the risk of spreading SARS-CoV-2 to others. That risk is in part driven by symptomatic infections which are exceedingly rare after second doses. Risk of spreading is diminished by the brisk immune response that occurs after symptomatic infection once someone is vaccinated. In the Moderna study, there were 30 cases of severe COVID overall and zero in the vaccination arm. Less symptomatic and less severe COVID will result in a lower propensity to propagate SARS-CoV-2. Moreover, studies of both recombinant antibody products speed viral clearance from airways. If the body is primed to manufacture anti-spike antibodies through vaccination, there is likely a similar rapid clearance and subsequent reduction in infectiousness occurs.
What about asymptomatic infection and so-called silent spread? In the Moderna trial, swabs taken from asymptomatic participants as they were receiving dose 2 showed a roughly 60% reduction in PCR positivity. It is likely that a second dose and longer asymptomatic period will result in greater reduction in PCR positivity. Preliminary data from AstraZeneca’s ChAdOx1 vaccine also showed reduced in asymptomatic PCR detection. In short, it is highly likely that receipt of vaccination and a 14-day asymptomatic period afterward results in both personal protection and reduced likelihood of ongoing viral propagation.
Third, what is the effect size of masks? More correctly — what is the effect size of masks 14 days after a vaccine with 95% efficacy? What is the effect of masks if PCR positivity is only 1 in 1,000 amongst asymptomatic people? I think we must confront a forgotten truth. Masks make sense not because we have perfect randomized controlled trial data showing they protect the wearer, or others, but based on bio-plausibility, and the precautionary principle, they were a reasonable public health measure to incorporate.
Authors of a 2020 update to the Cochrane review wrote, “Compared to no masks there was no reduction of influenza-like illness (ILI) cases (risk ratio 0.93, 95% CI 0.83-1.05) or influenza (risk ratio 0.84, 95% CI 0.61-1.17) for masks in the general population, nor in healthcare workers (risk ratio 0.37, 95% CI 0.05-2.50).” But the truth is none of these trials perfectly fits the moment. And we never did a cluster RCT of cloth masks — as they are used in the politically torn U.S. — to clarify the effect size with SARS-CoV-2.
The truth is I wear a cloth mask and I quite like it. But I have seen no data that can tell me the added benefit of masks 14 days after vaccination with 95% efficacy. It’s the biological equivalent of asking what happened before the Big Bang. If you ask, what is the evidence that it’s safe to stop wearing a mask, I say, what is the evidence that it’s still beneficial?
This same line of thinking applies to other restrictions that could be eased instead. What evidence supports restricting nursing home visitors, if all parties are vaccinated and masked? What evidence supports banning a small dinner, if everyone has had the vaccine? There is no evidence that supports these continued prohibitions.
Knowing these three facts allows us to put it all together. Is it reasonable to tell someone that, if they are asymptomatic 14 days after the second vaccine, they are highly unlikely to get COVID-19, and also less likely to spread the virus — both by having less severe disease, less asymptomatic carriage, clearing virus faster, stronger antibody responses, and fewer symptomatic cases? Absolutely, is my view.
It is then reasonable to say that the theoretical benefit of the mask may be so small that easing up on its use is fine. Alternatively, you might keep the mask, but ease up on something else, and, to be honest, most people might actually prefer a different concession. You might choose to see family instead, or have a gathering with your vaccinated friends. Getting vaccinated is like getting a stack of tickets at Chuck E. Cheese — you get to decide what to trade them in for!
The politics/sociology
Some contend my stance will undermine efforts to normalize masks, send mixed messages to the public. That’s possible, but it is also possible that my message empowers and excites people to get vaccinated, which is the only viable path out of the nightmare we find ourselves in. I think the less scientists manipulate their statements while trying to guess the response the better. I have tried to be fully transparent in my thinking on this topic. None of us knows the second or third order effects. If we distort the facts and bang on harder about prolonged mask use or other restrictions, will the world actually be better? Or will we provoke a deep backlash that has been brewing for some time? Do we risk losing some folks who might otherwise get vaccinated? I am not an incarnation of God, so I don’t know. I worry that the likes and retweets on social media encourage the fearful message rather than the correct one.
Public health experts have reminded me to talk about despair. We are all facing it, and when you clamp down on a society with restrictions, a free society can only bear it for so long. There must be a path out of it, and easing restrictions — particularly when the burden may outweigh the unproven, theoretical, and at best highly marginal benefit — is a great way to renew optimism. Folks who spend time doing boots on the ground public health share their view with me that this is a great place to start.
The last objection I want to discuss is that my policy is not the safest policy. It is not absolute safety. Indeed, I acknowledge this is true. But I disagree that wearing a mask is absolute safety. I disagree that only one nursing home visitor is the safest policy, and only having a picnic outside is safest. Only truly becoming a hermit is absolute safety. Lock yourself in home, and get all foodstuffs delivered. When you go out, always wear an N95, and do this even a year or two after vaccination. After all, who knows if the vaccine will wear off? None of us really wants absolute safety. We seek reasonable safety, and I will defend the proposition that is achieved merely by a prolonged asymptomatic period after second vaccination and after that something can be relaxed — and there are several options.
The end of COVID
COVID-19 will someday no longer be the topic of daily and breathless news coverage. The virus may always circulate, and some people may always get sick, but the real end will be when we stop thinking about it every moment of every day. That’s how this pandemic will end. Not with a bang, but a whimper.
People need to know that there is light at the end of the tunnel because there is.
Vaccination in the absence of viral escape is the way out of this. Once a person is a sufficient time and distance away from the second shot, and if they are feeling well, we can start to view them differently. They are less a vector for the transmission of a plague, and more a real person — with hopes and wants and desires and seeking connection. In such a moment, if they remove their mask to share a smile with me, I can promise you, I will lower my mask, and smile back.
And Opposing View-Now Is Not the Time to Relax COVID Restrictions
Doctor David Aronoff counters the argument with the facts that the COVID-19 pandemic has now raged on for more than a year. In the U.S., we have documented more than 24.5 million cases and 400,000 COVID-19-related deaths, with between 3,000 and 4,000 people dying each day. The CDC projects we will reach nearly 500,000 total deaths within the next month. COVID-19-related hospitalizations remain at an all-time high. America continues to suffer through a third wave of disease activity that has dwarfed the peaks of the Spring and Summer of 2020.
And, while COVID-19 is beating down on us, it could be worse, believe it or not. We have learned much about how the SARS-CoV-2 virus spreads, easily, through our breath from one person to another. Most nefarious has been the extent to which transmission occurs silently, moving from infected individuals who feel well, look well, and have no idea that they are infected. However, we know that maintaining our distance from others protects against transmission, as does the use of cloth face-coverings. It has been through social distancing and mask use that we have, in the absence of vaccination and herd immunity, been able to limit the damage done by this horrible infectious disease.
Clearly, vaccines against SARS-CoV-2 are the light at the end of the tunnel, assuming that viral mutations do not escape our vaccines sooner than we can put out the fire. With estimates that more than 60% of the population will need to have immune protection against SARS-CoV-2 to benefit from herd immunity, we have a long way to go. While less than 10% of the U.S. population has been formally diagnosed with COVID-19, a recent estimate suggested that by November of 2020 we were at about 15% of the U.S. population immune to the virus. And while that figure may now exceed 20%, this leaves more than 250 million Americans without immune protection, and falls short of the roughly 200 million people who might need to be immune for herd immunity to take hold.
Vinay Prasad, MD, MPH, has authored a thoughtful, evidence-based commentary, making a strong case for why we can relax some restrictions following successful immunization against SARS-CoV-2. He succinctly lays out an argument about why and how immunization, in the absence of vaccine-escaping virus mutants, will confer strong enough protection to render tight adherence to wearing masks and other restrictions unnecessary. And, while I think he has the right idea (I would love to see more people’s faces right now and share a meal with my friends), it is premature to suggest that now is that time. It is OK for us to hold differing opinions (that’s what we do). Two well-intentioned scientists can both look at the same data and reach different policy conclusions. So, let me focus on the case for keeping our masks on, even as we roll our sleeves up. The same logic holds for other restrictions.
First, given how active COVID-19 is right now we need to be doing everything in our power to slow its spread. Lives hang in the balance. I really like the Swiss Cheese model of pandemic defense, popularized by Australian virologist Ian Mackay, PhD, which demonstrates the concept that each measure we implement to interrupt the SARS-CoV-2 pandemic is imperfect yet when layered together they cooperatively reduce transmission risk.
Even immunization is not a perfect defense. Thus far, SARS-CoV-2 vaccination has not been shown to eliminate the risk that someone will get infected or pass the virus on to others. Studies published to date on the Moderna and Pfizer-BioNTech mRNA vaccines show clear protection against developing symptomatic COVID-19. But they also show that some vaccinated people still develop symptomatic disease. And, given what we know about the disease in non-immune people, symptomatic infections represent a fraction of total infections. This predicts that despite immunization some people will develop asymptomatic infection. Do I think that SARS-CoV-2 immunization will significantly protect people against both asymptomatic and symptomatic COVID-19? Yes. Do I think the risk to an individual will be zero following successful immunization? No. Stated differently, removing masks from vaccinated people (or relaxing social distancing) is likely to increase the risk for propagating COVID-19 compared to maintaining these restrictions. And, even if that incremental risk is small, why take it, given where we are with the disease now?
There will be a time when immune people can let their guards down, allowing even non-immune people to do the same (a benefit of herd immunity). But that time is not now.
The issue of wearing masks has been a contentious one, not helped by mixed messaging from leaders in the federal and state government. This has translated into story after story of difficulty convincing people of the public health benefit of wearing face-coverings. What we do not need are more people out and about in public spaces without masks, which sends the wrong message at the wrong time. We cannot know if an unmasked person is unvaccinated or simply an anti-masker. Why provide fuel for people to skirt mask policies based on stating they have been vaccinated, when they might not have been? And the same holds for hosting dinner parties or participating in other gatherings.
To safely advise people that once they are immunized, they can leave their masks at home and relax other infection control measures we need to record sustained decreases in disease activity, hospitalizations, and deaths, to the point where leading infectious disease and public health experts are comfortable recommending that we can de-escalate these interventions. We also need to ensure widespread vaccine uptake, particularly among Black, indigenous, and people of color, who have been disproportionately harmed by COVID-19. Recent data show that Black Americans, for example, are getting vaccinated at lower rates than white Americans.
We remain in the thick fog of a true healthcare emergency and need to be doing all we can, especially the simple things, to shut it down. Now is not the time to let up on masking, even for the relatively few who have been immunized. Abandoning mask-wearing and social distancing, even in immunized persons, is not the right thing to recommend, yet. We need masks on and sleeves up.
COVID-19 Variants: ‘The Virus Still Has Tricks Up Its Sleeve’
Now more on the counterpoint reported by Molly Walker who interviewed Dr. Warner Greene as followed: We are honored to be joined once again by Dr. Warner Greene. He’s senior investigator at Gladstone Institutes and a professor at University of California San Francisco. As we’ve discussed, COVID-19 variants are very much in the news. Can we go over what is the latest news about the variants, even today? What do we know about them and what’s the latest that’s been happening?
Variants are very much in the news. What we’re seeing is the slow but steady evolution of the coronavirus. There are now four major variants that are of concern. And, in fact, they call them variants of concern. The first recognized was the U.K. variant, recognized in the south of the United Kingdom. It has an increased transmission efficiency. And there are some reports that it may be somewhat more virulent, particularly in men over the age of 60.
Of even greater concern is the South African variant, which contains mutations that confer resistance to certain monoclonal antibodies, like one of the two monoclonal antibodies developed by Regeneron. The Eli Lily monoclonal antibody doesn’t seem to work against the South African variant and vaccine efficiency is also reduced with the South African variant.
Similarly, the Brazilian variant has basically the same set of mutations that are conferring antibody resistance, causing real concern. What it means for the vaccines, etc.: I think that both the South African and the Brazilian variants are a major concern. And it is possible that those variants as they spread, and they are in the United States now, we may need to revise the vaccines to account for these types of variants. That’s not clear yet, but better to be prepared, in case we do need to revise the vaccine.
And then there’s a fourth type of variant, which is just kind of emerging, less well-studied at this point, but out of California. So clearly there, the virus is searching for a lock and key mechanism trying to search for ways to allow itself to replicate better. We’re applying immune pressure. So, it’s mutating away from some of that immune pressure, and that’s why this antibody resistance is emerging.
So, what types of mutations does the SARS-CoV-2 virus have to go through to make it a variant?
Well, for example, the South African variant has 27 mutations, nine of which occur in the spike protein. The spike is the protein on the surface that binds to the ACE2 receptor and allows entry and fusion into the host cell. And, of course, that’s where most of the vaccines are focused, is on the spike. That’s where the monoclonal antibody therapeutics are focused, on the spike. And so the virus is looking for ways to avoid these types of immune pressures and it’s making mutations in its receptor binding domain and the internal domain that confer resistance to certain types of neutralizing antibodies.
Given that recent studies from Novavax and Johnson & Johnson last week found somewhat reduced clinical efficacy of vaccines against these variants, what type of booster modification is required for vaccines in order to better combat them with the mRNA and the viral vector vaccines? Is it different, is it the same?
I think the booster that, for example, Moderna and Pfizer are now working on is to take the genetic sequence of the variant and use that as the immunogen. So, there is a mutation at position 484 that is absolutely key for this loss of antibody protection. You would introduce an RNA that now has that same mutation at position 484 into the vaccine to create a vaccine that is really tailored to take that particular type of virus out. And that mutation is shared between the South African and the Brazilian variants.
And so it wouldn’t require a different type, depending on the type of vaccine, it would just be the same type of reformulation. It wouldn’t be mRNA, different than a viral vector, it would just be a different formula. It’s not anything to do with the type of vaccine. It still would be an mRNA-based vaccine. It would just contain a different RNA or more likely it will be a multi-valent vaccine that would be original virus, as well as a new virus.
It’s not clear exactly how that would be administered. It may be that we want to boost immunity against the old virus, as well as the new virus, so we would use a multi-valent approach in that case. But the mRNA vaccine platform is quite amenable to this type of updating. That’s a real advantage, much more so than the adenoviral vectors, the virus-delivered vaccines. It’s a more complicated process there.
If we could just look at the vaccines as we have them now against this wild-type strain, if for some reason we didn’t have any boosters, what type of progress could we make against the pandemic? Can we vaccinate our way out of the pandemic, even if we don’t have these boosters? Have these variants prevented that?
To be clear, these variants, the Brazilian and the South African variants, are only compromising the neutralizing antibody response against the coronavirus. The T-cell immune response presumably is fully intact and remains unevaluated. So it’s quite possible that these vaccines will stand up better than we expect or predict. Clearly the U.K. variant does not appear to be a threat, although the recent acquisition of the neutralizing mutation at 484 causes concern that the virus is evolving. Even the U.K. variant is evolving.
I would say that the one thing that is disturbing to me, or that causes me pause is the story in Manaus, Brazil. Manaus is in the Amazon basin, they had a huge outbreak in the spring. It was thought, as reported, that there would probably be herd immunity within the community up to about 75%. Then this variant comes in to the community and it’s just sweeping through, causing re-infection or what appears to be re-infection.
Now did the original immunity wane and these people were all sensitive? Is it just that the variant is able to avoid both the T-cell and the antibody response that was present in the herd in Manaus? That kind of real-time experiment is concerning in terms of the spread of this virus. And I think data like that and what’s going on in South Africa is what’s really prompting the vaccine companies to get prepared now. We don’t know the full dimensions of the problem, but better to overprepare at this point in time.
So, given what happened in Brazil, do you think that’s evidence of viral escape?
Certainly, the South African and Brazilian variants, the mutations they are acquiring in their spike protein are examples of escape from the antibody neutralization. These are mutating principal antibody-binding sites that are responsible for neutralization, so that these variants are emerging under the influence of immune pressure. It’s harder to get around the T-cell immunity though, because T-cell immunity differs from person to person based on the composition of our HLA genes and our immune response. And T-cells are really the major defense mechanism against viruses, so let’s hope that our T-cells fill in for any gaps that the antibodies might come up a little short on.
I’m not sure exactly what has happened in Manaus, whether there was really ever herd immunity, whether it’s waned, but I do know that the variant there is hitting hard. So, that’s a big question mark. I think Brazil holds the answers to a lot of the future of this pandemic. We need to understand precisely what is going on there.
What do we need to be studying in Brazil specifically? And what type of data would we need to be looking at and tracking, what types of real-world studies and epidemiological studies would you like to see out of what’s happening in Brazil to help us going forward?
I would like to know whether or not there was real herd immunity. Before this new variant began to spread, was there clear evidence of a good antibody response and retention of durable antibody responses against the original strain of “wild-type” virus. So, if, in fact, there was an intact immune response, and this virus was able to overwhelm that response, well that’s not good news, but if the response had waned or had never really developed fully, then that’s a less daunting problem.
Now on the positive side, you look at the Johnson & Johnson vaccine, it’s not the world’s best at preventing you from becoming infected with or developing minor respiratory symptoms. But even with the South African variant, this vaccine protects you from severe disease, having to go to hospital and dying. And frankly, that’s what we want from a vaccine. That is fantastic. You may have a runny nose or a mild upper respiratory tract infection, but you’re not going to develop life-threatening pneumonia and require hospitalization, intubation, etc. And I’d sign up for that type of vaccine any day.
All we have from the mRNA vaccines from Pfizer and Moderna are these kinds of in vitro and in lab studies that if you expose them to these variants, this is what they’ll do, but do we need some type of clinical efficacy? Would you say at this point that we don’t have evidence of clinical efficacy against the variants with these two vaccines that are currently being distributed?
Exactly. The mRNA vaccines are not being tested extensively in areas where the variants are prospering, but one of the trial sites for Johnson & Johnson was in South Africa. So, they were able to see how their vaccines stood up against that variant and it fared very well in terms of prevention of serious disease.
When do you think that we are going to get these types of studies? Is that something that we’re going to see as the vaccine trials kind of evolve, and are we going to be able to get that from the mRNA vaccines? Are we just going to not know what their clinical efficacy is until we get a booster, we’re just going to only have the lab evidence?
It’s likely that the virus is probably replicating at higher levels or more virus is replicating in terms of country here in the United States than almost anywhere else in the world, in terms of the breadth of cases that we’ve had, etc. We just simply do not have the genomic surveillance types of apparatus to necessarily detect these variants. For example, we’re just now detecting the California variants. There may be many variants in the United States. We do know that the Brazilian, as well as the South African, variants are in the United States, and it’s possible that there is community spread of these variants. So, we just have to really ramp up our sequencing efforts to really track what’s happening within our pandemic within the country and what types of viruses that we’re dealing with.
And it’s in that kind of setting as variants begin to hold sway. For example, it’s suggested that the U.K. variant will become dominant in the United States by March. So, our prediction is that the current vaccines will do very well against that variant. Now, if that variant is replaced by, for example, a South African variant, which is more immunologically daunting, well then, we’re going to have to see how the mRNA vaccines hold up against that. And it’s that kind of real-world information that’s going to inform whether or not we need to boost the immune system with a third shot.
Are the variants occurring in regions due to the similarities in the genome of the regional population, causing the viral RNA to mutate in a specific direction, and do antigen tests pick up variants?
No, the antigen tests will not pick up the variants. You really have to do the sequencing to find these mutations. So, it’s clear that the virus has a set of mutations and it’s trying different combinations. All the virus wants to do is to replicate better. The U.K. variant has one mutation in the receptor binding domain, which confers tighter binding to the ACE2 receptor and a higher level of transmission by 40% to 70%. And that’s the variant that may become dominant here in the United States by March. In contrast, the South African and the Brazilian variants, they not only have the same mutation that the U.K. variant does, they’ve added to it. They’ve added at least two additional mutations that really take out these neutralizing antibodies.
Now, did these two variants arise independently? Some would say yes. I don’t think that we know precisely because one person coming from South Africa carrying the virus could seed the virus in Brazil. So, we don’t know, but there are subtle differences. The virus is working toward a solution here for avoiding the antibodies.
Now, another question is, is the virus throwing everything at us right now that it’s got? Is this it and can we expect a pretty much static situation from here on out? And, you know, I don’t think so. I think the virus still has tricks up its sleeve, and will continue to evolve as we put additional immune pressures on it. So, that would be my guess, but we’re right at the cusp of the evolving science. And to think that where we were a year ago with no defense, no innate or no intrinsic immunity to this virus, and nothing really therapeutic or preventive. And now we’re in a situation where we have multiple, highly effective vaccines. It’s a true triumph of science.
Can you go into how else the virus could mutate? Is there any way that it could mutate that T-cell immunity that we have that would be compromised? Is that possible or is it just not that complex a virus?
Yeah, there may be the emergence of escape mutations that escape a cytotoxic T-cell, CD8 T-cell responses, or CD4 helper T-cell responses. We could certainly see that and it’s much harder to monitor for those types of immune reactions. So, certainly, like you get immune escape against antibodies, you can have immune escape against T-cell immunity as well.
California man tests positive for COVID-19 weeks after second jab: report
Edmund DeMarche reported that a California man said he was diagnosed with COVID-19 three weeks after he received his second dose of the vaccine, reports said.
CBS Los Angeles reported that Gary Micheal, who lives in Orange County’s Lake Forest, found out he had the virus after being tested for an unrelated health concern. His symptoms are relatively minor, the report said.
He received the Pfizer vaccine, the report said. Patch.com reported that he got his first dose on Dec. 28 and his second jab on Jan. 18.
Dr. Anthony Fauci, the country’s leading infectious-disease scientist, said the latest evidence indicates that the two vaccines being used in the U.S. — Pfizer’s and Moderna’s — are effective even against the new variants.
A doctor interviewed in the CBS report said that he was not surprised to hear about Michael’s diagnosis.
“I think I’ve heard of six or seven independent cases over the last three weeks of individuals that have been vaccinated with different timelines that have tested positive, and I think we’re going to continue to see that more and more,” Dr. Tirso del Junco Jr., chief medical officer of KPC Health, told the station.
Fauci has estimated that somewhere between 70% and 85% of the U.S. population needs to get inoculated to stop the pandemic that has killed close to 470,000 Americans.
And Now Four people in Oregon who received both doses of vaccine test positive for coronavirus
Minyvonne Burke reported that four people in Oregon have tested positive for the coronavirus after receiving both doses of the Covid-19 vaccine, health officials said.
There are two cases each in Yamhill and Lane counties, the state’s Health Authority said in a series of tweets on Friday. The cases are either mild or asymptomatic.
“We are working with our local and federal public health partners to investigate and determine case origin,” the agency said. “Genome sequencing is underway, and we expect results next week.”
The agency referred to the individuals who tested positive as “breakthrough cases,” meaning that they got sick with the virus at least 14 days after receiving both doses.
The Health Authority said more breakthrough cases could pop up.
“Clinical trials of both vaccines presently in use included breakthrough cases. In those cases, even though the participants got Covid, the vaccines reduced the severity of illness,” the agency said in a tweet.
“Based on what we know about vaccines for other diseases and early data from clinical trials, experts believe that getting a Covid-19 vaccine may also help keep you from getting seriously ill even if you do get the virus. … Getting as many Oregonians as possible vaccinated remains a critical objective to ending the pandemic.”
The agency’s announcement came the same day its health officer said there has been a decline of daily Covid-19 cases over the past several weeks. As of Friday, there were 149,576 cases in the state, according to the department’s count.
“These decreases are a testament to the actions all Oregonians are taking to slow the spread of Covid-19 and the sacrifices made – thank you,” health officer Dean Sidelinger said at a news conference Friday.
Another breakthrough case was reported in North Carolina, according to NBC affiliate WCNC-TV in Charlotte. The state’s Department of Health and Human Services told the outlet that the person had mild symptoms and did not need to be hospitalized.
The Centers for Disease Control and Prevention has said that quarantining is not necessary for fully vaccinated people within three months of having received their last doses as long as they do not develop any symptoms.
They do, however, still need to practice certain safety measures such as wearing face masks, social distancing, and avoiding crowds or poorly ventilated spaces.
“Fully vaccinated” means at least two weeks have passed since a person has completed their vaccination series and now we have the addition of the Johnson and Johnson vaccine, which is a single dose with less effectivity but about the same activity of our yearly flu vaccine.
So, as I have said before, continue to wear your masks, whether one, two, three or whatever the number of masks that we are going to be advised with future “scientific” evidence.
This has been an interesting few week and almost led me to close my office and retire. We had a patient come in the office and complete the questionnaire and “by-pass” our screening procedures, lying to us about his exposure to the COVID-19 virus. He just visited his brother the two days before the days office visit and lied to us, saying that he had no recent exposure, etc. However, a week later he called our office to allow notification that his COVID test was positive.
The thing that angered me and my staff more was that the patient waited a number of days to notify, besides lying to us about his exposure. This led us to close the office, cancel all patients until we could have a complete cleaning of the office and all get COVID tested.
Luckily, we all tested negative and all my staff and I had at least had our first vaccine doses. If we had tested positive, we would have to notify all the patients that were seen in the office between his visit and the day that we closed the office.
What an irresponsible set of actions and my fear is that this goes on in many situations because many of our patients, etc. are selfish and irresponsible and don’t care about anyone else except themselves…and they think the virus is all a lie, util one of their family members or close friends dies. How totally stupid and disgusting!!
John Johnson wrote that the virus continues to mutate quickly. Anyone tracking the news is familiar with the new UK strain that is moving around the globe and threatens to become the dominant strain in the US soon. Now, health authorities in California have identified yet another strain that has popped up in about a dozen counties, reports the Los Angeles Times. Coverage on that and more:
California strain: The variant has been linked to large outbreaks in Santa Clara County and smaller outbreaks elsewhere. It’s still too early to say whether the new strain is more contagious or more lethal than the first forms of COVID that emerged, but studies on that are being prioritized. Bottom line: “This virus continues to mutate and adapt, and we cannot let down our guard,” says Dr. Sara Cody, Santa Clara County health officer.
A lament: In a New York Times op-ed, Ezra Klein runs through the coming COVID changes under the Biden administration. They include plans to get vaccinations organized on a mass scale, along with expanded testing and contract tracing. It’s all pretty basic stuff, he writes, which has him astonished that the Trump administration hasn’t done these things yet. “That it is possible for Joe Biden and his team to release a plan this straightforward is the most damning indictment of the Trump administration’s coronavirus response imaginable.”
Hopeful trend: US deaths are about to pass 400,000, but one medical expert spies a positive trend in the new data as well. “Over the last four days for the first time in months, we’ve seen a steady decline … a thousand per day fewer hospitalizations in the United States,” Dr. Jonathan Reiner of George Washington University tells CNN. “We’ve seen the same trend in new cases.” The next two months will likely be brutal, he adds, “but there is a ray of sunshine” as vaccinations continue.
Hopeful, II: In “The Morning” newsletter at the Times, David Leonhardt is tired of the “they’re only 95% effective” drumbeat, and he’s not alone. “It’s driving me a little bit crazy,” Dr. Ashish Jha of the Brown School of Public Health tells Leonhardt. Dr. Aaron Richterman of the University of Pennsylvania adds, “We’re underselling the vaccine.” As Leonhardt explains and doctors emphasize, the vaccine will save your life, even if you’re in that other 5%. To wit, of 32,000 people who got the Pfizer and Moderna vaccines in trials, only one person suffered a severe COVID case.
Migrant caravan demands Biden administration ‘honors its commitments’
Now, a real challenge for the new Biden administration. Adam Shaw noted that a migrant caravan moving from Honduras toward the U.S. border is calling on the incoming Biden administration to honor what it says are “commitments” to the migrants moving north, amid fears of a surge at the border when President-elect Joe Biden enters office.
More than 1,000 Honduran migrants moved into Guatemala on Friday without registering, The Associated Press reported. That is part of a larger caravan that left a Honduran city earlier in the day.
The outlet reported that they are hoping for a warmer reception when they reach the U.S. border, and a statement issued by migrant rights group Pueblo Sin Fronteras, on behalf of the caravan, said it expects the Biden administration to take action.
“We recognize the importance of the incoming Government of the United States having shown a strong commitment to migrants and asylum seekers, which presents an opportunity for the governments of Mexico and Central America to develop policies and a migration management that respect and promote the human rights of the population in mobility,” the statement said. ” We will advocate that the Biden government honors its commitments.”
Biden has promised to reverse many of Trump’s policies on border security and immigration. He has promised to end the Migrant Protection Protocols (MPP), which keeps migrants in Mexico as they await their hearings. The Trump administration has said the program has helped end the pull factors that bring migrants north, but critics say it is cruel and puts migrants at risk.
Biden has also promised a pathway to citizenship for those in the country illegally and a moratorium on deportations by Immigration and Customs Enforcement (ICE). The migrants’ group also pointed to promises to end the asylum cooperative agreements the administration made with Northern Triangle countries.
“A new United States Government is an opportunity to work with the Mexican Government to develop a cooperation plan with Central America to address the causes of migration, together with civil society organizations, as well as an opportunity to increase regional cooperation regarding the persons in need of protection, and to dismantle illegal and inhuman programs such as Remain in Mexico, the United States’ Asylum Cooperation Agreements with El Salvador, Guatemala and Honduras, as well as the Title 42 expulsions by the United States authorities,” it said, referring to the Centers for Disease Control (CDC) order that allows the U.S. to quickly remove migrants on public health grounds.
Biden officials, however, have been keen to send the message to migrants that it will not mean open borders overnight.
“Processing capacity at the border is not like a light that you can just switch on and off,” incoming Biden domestic policy adviser Susan Rice told Spanish wire service EFE. “Migrants and asylum seekers absolutely should not believe those in the region peddling the idea that the border will suddenly be fully open to process everyone on Day 1. It will not.”
“Our priority is to reopen asylum processing at the border consistent with the capacity to do so safely and to protect public health, especially in the context of COVID-19,” she said. “This effort will begin immediately but it will take months to develop the capacity that we will need to reopen fully.”
It is unclear how far the migrants will get, and Guatemalan and Mexican governments have indicated they intend to turn them back. But the caravan comes amid fears that the new outlook on immigration and asylum from the Biden administration will fuel a surge at the border.
Acting Customs and Border Protection (CBP) Commissioner Mark Morgan said on “America’s News HQ” on Saturday that the caravan could include more than 5,000 migrants and blamed the tone from the incoming administration.
“We’re looking at two groups that are well over five thousand. And one of those groups have already gotten through the Guatemala border. And they’re on their way to El Rancho, which is about the located centrally in Guatemala,” he said. “It’s coming. It’s already started, just as we promised and anticipated it would with this rhetoric from the new administration on the border.”
President Trump warned this week that ending his policies and increasing incentives would lead to “a tidal wave of illegal immigration, a wave like you’ve never seen before” and that there were already signs of increased flows.
“They’re coming because they think that it’s a gravy train at the end,” he said. “It’s going to be a gravy train. Change the name from the caravans, which I think we came up with, to the gravy train because that’s what they’re looking for — looking for the gravy.”
Biden transition official tells migrant caravans: ‘Now is not the time’ to come to US
Yael Halon reported further on the migration noting that a migrant caravan moving from Honduras toward the U.S. border called on the incoming Biden administration to honor their “commitments” to the migrants moving north, citing the incoming administration’s vow to ease Trump’s restrictions on asylum.
But on Sunday, an unnamed Biden transition official said that migrants hoping to claim asylum in the U.S. during the first few weeks of the new administration “need to understand they’re not going to be able to come into the United States immediately,” NBC News reports.
More than 1,000 Honduran migrants moved into Guatemala on Friday without registering as part of a larger caravan that left a Honduran city earlier in the day.
The Associated Press reported that they are hoping for a warmer reception when they reach the U.S. border, and a statement issued by migrant rights group Pueblo Sin Fronteras, on behalf of the caravan, said it expects the Biden administration to take action.
The Biden transition official, however, warned migrants against coming to the U.S. during the early days of the new administration, telling NBC that while “there’s help on the way,” now “is not the time to make the journey.”
“The situation at the border isn’t going to be transformed overnight,” the official told the outlet.
“We have to provide a message that health and hope is on the way, but coming right now does not make sense for their own safety…while we put into place processes that they may be able to access in the future,” the official said.
President-elect Joe Biden has promised to reverse many of Trump’s policies on border security and immigration. He has promised to end the Migrant Protection Protocols (MPP), which keeps migrants in Mexico as they await their political asylum hearings. The Trump administration has said the program has helped end the pull factors that bring migrants north, but critics say it is cruel and puts them at risk.
Biden has also promised a pathway to legal permanent residency for those in the country illegally and a moratorium on deportations by Immigration and Customs Enforcement (ICE). The migrants’ group also pointed to promises to end the asylum cooperative agreements the administration made with Northern Triangle countries.
President Trump warned last week that ending his policies and increasing incentives would lead to “a tidal wave of illegal immigration, a wave like you’ve never seen before,” claiming that there were already signs of increased flows.
AMA President: Biden Team Must Create National Pandemic Strategy
Ken Terry stated that now that the campaign is over, that the incoming Biden administration must formulate an effective national strategy for the COVID-19 pandemic, said Susan R. Bailey, MD, president of the American Medical Association (AMA), in a speech delivered today at the National Press Club in Washington, DC.
Bailey noted that America’s fight against the pandemic is in a critical phase, as evidenced by the escalation in cases, hospitalizations, and deaths in recent weeks. Emergency departments and ICUs are overwhelmed; many frontline clinicians are burned out; and the state- and local-level mechanisms for vaccine distribution have been slow and inconsistent, she said.
“The most important lesson for this moment, and for the year ahead, is that leaving state and local officials to shoulder this burden alone without adequate support from the federal government is not going to work,” Bailey emphasized.
She called on the Biden administration, which takes over next week, to “provide states and local jurisdictions with additional resources, guidance, and support to enable rapid distribution and administration of vaccines.”
In addition, she said, the incoming administration needs to develop a more robust, national strategy for continued COVID-19 testing and PPE production “by tapping into the full powers of the Defense Production Act.”
Biden Vaccine Distribution Policy
In a question-and-answer period following her speech, however, Bailey said she opposed the president-elect’s decision to release nearly all available vaccine supplies immediately, rather than hold back some doses for the second shots that the Pfizer and Moderna vaccines require. On Tuesday, the Trump administration announced that it plans to do the same thing.
“We’re a little bit concerned about the announcement that [the Department of Health & Human Services] will not hold back vaccine doses to make sure that everyone who’s gotten their first dose will have a second dose in reserve,” Bailey said. “We don’t have adequate data to tell us that one dose is sufficient — we don’t think it is — and how long you can wait for the second dose without losing the benefits of the first dose.”
She added that it’s not recommended that people mix the two vaccines in the first and second doses. “Since the Pfizer vaccine has such rigid storage requirements, I want to make sure there’s plenty of vaccine for frontline healthcare workers who got the Pfizer vaccine because it was the first one to come out in December. I want to make sure they get their second dose on time and [do] not have to wait.”
Bailey said she hoped there will be plenty of vaccine supply. But she suggested that state and local health authorities be in communication with the federal government about whether there will be enough vaccine to guarantee people can get both doses.
Bolstering Public Health
In her speech, Bailey outlined five areas in which steps should be taken to improve the health system so that it isn’t overwhelmed the next time the US has a public health crisis:
Restore trust in science and science-based decision making. Make sure that scientific institutions like the Centers for Disease Control and Prevention and the Food and Drug Administration are “free from political pressure, and that their actions are guided by the best available scientific evidence.”
Ensure that the health system provides all Americans with affordable access to comprehensive healthcare. Bailey wasn’t talking about Medicare for All; she suggested that perhaps there be a second enrollment period for the Affordable Care Act’s individual insurance exchanges.
Work to remove healthcare inequities that have hurt communities of color, who have been disproportionately impacted by the pandemic. She referred to a recent AMA policy statement that recognized racism as a public health threat.
Improve public health domestically and globally. Among other things, she noted, the public health infrastructure needs to be revitalized after “decades of disinvestment and neglect,” which has contributed to the slow vaccine rollout.
Recognize the global health community and restore America’s leadership in global efforts to combat disease, which are critical to preventing future threats. She praised Biden for his promise that the US will rejoin the World Health Organization.
At several points in her presentation, Bailey rejected political interference with science and healthcare. Among other things, she said public health could be improved by protecting the doctor-patient relationship from political interference.
Answering a question about how to separate politics from the pandemic, she replied, “The key is in sticking to the science and listening to our public health authorities. They all have to deliver the same message. Also, leaders at all levels, including in our communities, our schools, churches and college campuses, should wear masks and socially distance. This isn’t about anything other than the desire to get out of the pandemic and get our country on the right track again. Masks shouldn’t be political. Going back to school shouldn’t be political. Taking a certain medication or not shouldn’t be political. We need to stick to the science and listen to our public health authorities. That’s the quickest way out.”
Asked when she thought that life might get back to normal again in the US, Bailey said a lot depends on the extent of vaccine uptake and how much self-discipline people exhibit in following public health advice. “I think we’re looking at the end of this year. I’m hopeful that by fall, things will have opened up quite a bit as the Venn diagrams of those who’ve gotten vaccines grow larger.”
Merck Ends Development of Two Potential COVID-19 Vaccines
Tom Murphy, AP Health Writer, pointed out that the drug maker, Merck, said Monday that it will focus instead on studying two possible treatments for the virus that also have yet to be approved by regulators. The company said its potential vaccines were well tolerated by patients, but they generated an inferior immune system response compared with other vaccines.
Merck was developing one of the potential vaccines with France’s Pasteur Institute based on an existing measles vaccine. The French institute said it will keep working on two other vaccine projects using different methods.
Merck entered the race to fight COVID-19 later than other top drug makers.
It said last fall that it had started early-stage research in volunteers on potential vaccines that require only one dose. Vaccines developed by Pfizer and Moderna were already in late-stage research at that point.
The Food and Drug Administration allowed emergency use of both the Pfizer and Moderna vaccines late last year. Each requires two shots.
Five potential vaccines have reached late-stage testing in the United States, the final phase before a drug maker seeks approval from regulators. Results from a single-dose candidate developed by Johnson & Johnson are expected soon.
Since vaccinations began in December, nearly 22 million doses have been delivered to people nationwide, according to the Centers for Disease Control and Prevention. Nearly 6% of the population has received at least one dose.
A total of 3.2 million people, or 1% of the population, have received both doses required for those vaccines.
More than 419,000 people in the United States and 2 million globally have died due to the coronavirus, according to Johns Hopkins University.
The government is paying Merck & Co. about $356 million to fast-track production of one of its potential treatments under Operation Warp Speed, a push to develop COVID-19 vaccines and treatments. The money will allow the Kenilworth, New Jersey, company to deliver up to 100,000 doses by June 30, if the FDA clears the treatment for emergency use.
The treatment, known as MK-7110, has the potential to minimize the damaging effects of an overactive immune response to COVID-19. This immune response can complicate the life-saving efforts of doctors and nurses.
Merck said early results from a late-stage study of that drug showed a more than 50% reduction in the risk of death or respiratory failure in patients hospitalized with moderate or severe COVID-19. The company expects full results from that study in the first quarter.
Merck’s other potential treatment is an oral antiviral drug.
Merck said it will focus COVID-19 research and manufacturing efforts on two investigational medicines: MK-7110 and MK-4482, which it now calls molnupiravir. Molnupiravir, which is being developed in collaboration with Ridgeback Bio, is an oral antiviral being studied in both hospital and outpatient settings. If these oral antiviral drugs are effective this will be a real advancement in the treatment of COVID-19. Merck said a phase 2/3 trial of the drug is set to finish in May, but initial efficacy results are due in the first quarter and will be made public if clinically meaningful.
Merck said results from a phase 3 study of MK-7110, an immune modulator being studied as a treatment for patients hospitalized with severe COVID-19, are expected in the first quarter. In December, the company announced a deal to supply MK-7110 to the U.S. government for up to about $356 million. (Reporting by Deena Beasley Editing by Shri Navaratnam)
Moderna Study: Vaccine Effective vs COVID Variants
With the weekly announcement of new mutant strains of the COVID virus we are all wondering whether the vaccine that are being administered will be effective against the new strains. Carolyn Crist noted that as mutated strains of the coronavirus represent new threats in the pandemic, vaccine makers are racing to respond.
Moderna, whose two-dose vaccine has been authorized for use in the U.S. since Dec. 18, said Monday that it is now investigating whether a third dose of the vaccine will work to prevent the spread of a variant first seen in South Africa, while it also tests a new vaccine formula for the same purpose.
“Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective … against this and potentially future variants,” Moderna CEO Stephane Bancel said in a statement.
Moderna on Monday also said its COVID-19 vaccine could protect against the U.K. strain but that it is less effective against the strain identified in South Africa.
Pfizer and BioNTech, whose vaccine were also authorized in December, announced last week that their COVID-19 vaccine creates antibodies that could protect vaccine recipients from the coronavirus variant first identified in the United Kingdom.
“This is not a problem yet,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNBC.
“Prepare for it. Sequence these viruses,” he said. “Get ready just in case a variant emerges, which is resistant.”
There were at least 195 confirmed cases of patients infected with the U.K. variant in the U.S. as of Friday, according to the CDC. No cases from the South African variant have been confirmed in the U.S. To try and prevent the variant from entering the country, President Joe Biden plans to ban travel from South Africa, except for American citizens and permanent residents.
The U.S. has reported more than 25 million total COVID-19 cases, according to data from Johns Hopkins University, marking another major milestone during the pandemic.
That means about 1 in 13 people in the U.S. have contracted the virus, or about 7.6% of the population.
“Twenty-five million cases is an incredible scale of tragedy,” Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told The New York Times. She called the pandemic one of the worst public health crises in history.
After the first U.S. case was reported in January 2020, it took more than 9 months to reach 10 million cases in early November. Numbers rose during the holidays, and 10 million more cases were reported by the end of the year. Following a major surge throughout January, with a peak of more than 300,000 daily cases on some days, the U.S. reached 25 million in about 3 weeks.
Hospitalizations also peaked in early January, with more than 132,000 COVID-19 patients in hospitals across the country, according to the COVID Tracking Project. On Sunday, about 111,000 patients were hospitalized, which is the lowest since mid-December.
The U.S. has also reported nearly 420,000 deaths. As recently as last week, more than 4,400 deaths were reported in a single day, according to the COVID Tracking Project. Deaths are beginning to drop but still remain above 3,000 daily deaths.
The University of Washington’s Institute for Health Metrics and Evaluation released a new projection last week that said new cases would decline steadily in coming weeks. New COVID-19 cases have fallen about 21% in the last 2 weeks, according to an analysis by The New York Times.
“We’ve been saying since summer that we thought we’d see a peak in January, and I think that, at the national level, we’re around the peak,” Christopher J.L. Murray, MD, director of the institute, told the newspaper.
At the same time, public health officials are concerned that new coronavirus variants could lead to an increase again. Murray said the variants could “totally change the story.” If the more transmissible strains spread quickly, cases and deaths will surge once more.
“We’re definitely on a downward slope, but I’m worried that the new variants will throw us a curveball in late February or March,” Rivers told the newspaper.
So, next, when we get vaccinated do we need to wear masks and continue social distancing?
Now we are finding out that this new Coronavirus variant is being found in many states as well as in England. Wow! What does all this mean and the larger question- are the vaccines already being given active against this variant? This after I just received my first dose of the Mederna vaccine.
MEDPage’s Molly Walker reported that the new SARS-CoV-2 variant first appearing in southern England has a transmission advantage of 0.4 to 0.7 points higher in reproduction number, also known as R0, compared to the initial strain, British researchers found.
This variant, called 202012/01, has a “substantial transmission advantage,” meaning its reproduction numbers could vary from 1.4 to 1.8, according to a multi-disciplinary team based at Imperial College London (ICL), who published their findings on the school’s website.
Led by ICL’s Erik Volz, PhD, the team found a “large and statistically significant imbalance” in regions where incidence of the variant increased and incidence of the non-variant decreased, and vice versa, which would indicate a change in R0.
Volz and colleagues also noted a larger share of individuals under age 20 among reported cases of the variant versus non-variant cases, dubbing this “a shift in age composition.” They estimated that the variant’s R0 is 40%-80% higher than for the wild-type virus.
For context in the U.S., prior research found seasonal influenza had a median reproduction number of 1.28, while the median reproduction number for the 1918 flu pandemic was 1.80.
This variant already traveled across the pond, with a Colorado man as the first documented case in the U.S. last week, though reports of the variant cropped up in other states over the holiday, including California and Florida.
CDC officials briefed reporters about the variant on Wednesday, noting it appears unlikely to impact COVID-19 vaccine effectiveness, though it may render certain treatments less effective, such as convalescent plasma. The agency says it expects more data on the variant soon.
A preliminary report from the U.K.’s Centre for Mathematical Modelling of Infectious Diseases on Dec. 23 originally estimated transmission may be at least 56% and up to 70% higher. They updated their findings on Dec. 31, noting the frequency of the variant “has grown substantially in all regions of England,” with a 50% or greater frequency in all National Health System regions.
The Imperial College group examined both epidemiological and genetic data, including 1,904 whole genomes from October and December 5 with a genetic background of 48,128 genomes collected over the same period. Notably, they found a “high correlation” between S-gene target failure (SGTF) during COVID-19 PCR testing and frequency of the variant, meaning S-gene target failure could act as a biomarker to detect the variant in the community.
“We see a very clear visual association between SGTF frequency and epidemic growth in nearly all areas … which is reinforced by empirical assessment of area-specific week on week growth factors of [variant] and non-[variant] case numbers,” Volz and colleagues wrote.
They noted a “small, but significant” shift towards individuals under age 20 being more affected by the variant, even after adjusting for several confounders. Any number of factors could account for this: an overall increase in transmissibility of the variant, younger people being more susceptible, or greater symptomatology with the variant.
The group warned that while further research is needed, a variant with increased transmissibility indicates increased public health measures may be needed to contain the virus.
“Social distancing measures will need to be more stringent than they would have otherwise. A particular concern is whether it will be possible to maintain control over transmission while allowing schools to reopen,” the group wrote.
But there continues to be no indication that the variant will resist vaccine-mediated immunity, or that it’s more lethal, except to the extent that hospitals become more overburdened with cases and thus less able to provide high-level care to every patient.
Dr. Marc Siegel: COVID vaccinations will increase rapidly — greatest accomplishment in vaccine history
I think that most of us thinking correctly that all of our most vulnerable populations, beginning with the elderly (who account for over 80% of COVID deaths) should be immunized as soon as possible
Dr. Mark Siegel noted that for the past several months I have counted on my personal protective equipment to create a necessary barrier between me and my patients. Several patients have tested positive for COVID-19, even though they had no clear symptoms at the time of the visit.
But although I will continue to wear PPE, the risk to me and my patients will diminish. This is not because COVID-19 is going away (the opposite is true), but because I have received the Pfizer-BioNTech vaccine.
Ten days after being vaccinated, I am starting to gain some immunity, which probably means that if I do acquire COVID from one of my patients or elsewhere it will be a milder case, although this has yet to be proven.
What has been shown in clinical trials is that the first shot may offer me just over 50% protection against COVID-19 in advance of my taking the second shot. This is a statistical calculation and by no means a certainty. This means that in the clinical trials those who tested positive for COVID-19 were over 50% less likely to have received the actual vaccine versus a placebo (more than twice the number of COVID cases occurred in the placebo group
With there being a slow rollout of the new COVID-19 vaccines both in the U.S. and around the world, I understand the impulse to give only one dose of the Pfizer-BioNTech, the Moderna, or the Oxford-AstraZeneca vaccine in Britain, in order to vaccinate millions more people in the legitimate hope that this decreases the risk of severe illness and hospitalization at a time when hospitals are overwhelmed with COVID-19 cases.
But this hope is not purely science. I believe we should keep to the two-dose schedule as studied. Keep in mind that the clinical trials were all conducted with careful dosing regimens and the conclusions drawn are based entirely on these two-dose protocols.
The Food and Drug Administration’s emergency use authorization for vaccinations is conditional. The United Kingdom and its National Health Service are taking a risk in three ways by delaying the second vaccine dose for three months so more people can get the first dose.
First, the degree of immunity may well diminish over the three-month period. Second, there is no direct proof yet that the initial dose alone will decrease hospitalizations. And third, there is no guarantee that the second dose will even be available in three months. Once there is an expectation on the part of the general public that their first dose is in the offing, this demand may get in the way of the second dose for others for several months.
With over 14 million doses of the Pfizer and Moderna vaccines having been distributed in the U.S and just over 3 million doses having been administered here, it is clear that a good part of the delay is occurring at the state level.
It is crucial that all of our most vulnerable populations, beginning with the elderly (who account for over 80% of COVID deaths) be immunized as soon as possible.
I expect the numbers vaccinated in the U.S. to increase exponentially in January, as over 40,000 pharmacy sites (Walgreens, CVS, Costco) receive their doses and begin vaccinating.
Keep in mind that by one measure the rollout (albeit much slower than expected) has been a big success. As we have gone from thousands vaccinated in clinical trials to millions vaccinated under the emergency use authorization, the number of significant side effects (mostly allergies) has been extremely small. This bodes well for the future of both vaccine compliance as well as usefulness.
Whereas more than 1 million Israelis have already received a COVID-19 vaccine (11% of the population, well above the global average of 0.13% according to data from Oxford University), we in the U.S. still lag far behind.
But if we think of this as a race, we are losing it will be far too easy NOT to see it for what it really is: the greatest accomplishment in vaccine science in history.
I will never forget the moment of awe and raw emotion when I received my first COVID-19 shot. I intend to receive my second shot on schedule. It will be happening for you soon too.
Dr. Marty Makary decries people ‘cutting in line’ to get coronavirus vaccine
Fox News medical contributor, Dr. Marty Malkary has pledged not to accept vaccine ‘until every high-risk American has had the opportunity to have it’
Angelica Stabile reported that “There’s a lot of cutting in line” to get the coronavirus vaccine in the early weeks of nationwide distribution, Fox News medical contributor Dr. Marty Makary told “America’s News HQ” Friday.
“Ironically, after all the conversation about Black Lives Matter, here we are with people inserting themselves – people with access, people with wealth, people with connections to the local facilities, and they’re basically saying their life matters more and I think it’s entirely inappropriate,” said Makary, who went on to accuse the Centers for Disease Control and Prevention of being “way too slow” to clarify who should receive priority access to the vaccine.
“It should go to the highest-risk individuals after it goes to nursing homes and front-line health care workers, not all health care workers,” he said. “I’ve taken a pledge not to take the vaccine, along with many health care workers, until every high-risk American has had the opportunity to have it first.”
However, according to Makary, the CDC’s recommendation that “health care personnel” receive priority access to the vaccine has led to the likes of cosmetic surgeons, hospital board members and spouses of health care workers getting the shot “inappropriately.”
I think his assumption is incorrect as evidenced by the next report. We all physicians continue to see patients continuously and are exposed to patients who lie to us because they all believe that their lives are more important then, the physicians, the nurses and our staff. These physicians, nurses and staff then go home with the possibility of exposing their friends and family.
The Fox News medical contributor also questioned the decision by some states to “hold back 50% of the vaccine supply so people could be sure to get a second dose.”
“That was a mistake, in my opinion,” he said. “The strategy should have been give it out to as many people as possible.”
Makary noted that nearly 5% of the U.K. population has already been vaccinated, while not even 1% of the U.S. population has been dosed.
Should Docs’ Spouses Be Higher Up on COVID Vaccine Priority List?
Yes, says ICU physician whose wife got the virus from him and nearly died. Another reporter from MedPage, Cheryl Clark, noted that as frontline healthcare workers around the country line up for the first COVID-19 vaccines, some providers treating the sickest patients, including emergency and critical care physicians, are asking a vexing question: Shouldn’t their spouses also be prioritized?
If they’re not at least 75, or they don’t have serious medical issues, physician spouses aren’t in phase 1a or 1b of the Advisory Committee on Immunization Practices’ recommendations for vaccination priority. They might be considered under 1c, but that may be weeks if not months away.
Denny Amundson, DO, a 70-year-old pulmonary intensivist in California, thinks spouses probably should be moved up the priority list — and the sad ordeal he and his wife have endured makes his case.
Denny Amundson, DO, critical care medicine specialist at Scripps Mercy Chula Vista Hospital. (Photo courtesy of Denny Amundson)
Amundson has been pulling long shifts since March, trying to save the lives of hundreds of patients sick enough to be in the 28-bed ICU at Scripps Mercy Hospital in Chula Vista, California, 10 miles north of the Mexican border. He is the hospital’s ICU medical director.
Amundson’s 71-year-old wife, Stephanie Brodine, MD, a non-practicing infectious diseases physician who heads the division of epidemiology and biostatistics at San Diego State University and runs its school of public health, understood the risks. They took every precaution but continued to live together and “take our chances,” isolating themselves from their six children and nine grandchildren, he said.
He bought an ultraviolet light to sterilize the hospital closets and rooms where he and his colleagues stored their clothing and equipment.
“We thought we’d be safe, following all the personal protection guidelines,” he said, “and we were. For the first eight months.”
On Oct. 18, Amundson started a five-day run at the hospital. The next day, he saw a 74-year-old patient on high-flow oxygen who was going to die if he wasn’t put on mechanical ventilation. The patient was refusing because of all the terrible things he’d heard, that going on a vent meant certain death.
“I probably spent an hour and a half trying to talk him into it,” Amundson recalled. He went into the man’s room three times that day. Though he was properly geared with PPE, the noisy equipment of the man’s high-flow oxygen made it hard for Amundson to hear him.
On several occasions, Amundson recalled, he got very close to the man’s face, “nose to nose with him, except for an N95 and a face plate in between.”
“He had a better than even chance,” Amundson said, citing hospital rates of 60% survival for ventilated patients. “I guess partly because we were close in age, it made me spend an inordinate amount of time with him.”
Still, the man refused. He died later that day.
On Oct. 23, Amundson and Brodine left town. They drove 400 miles north to Yosemite, where they have a second home, a physically-isolated escape in the national forest that’s a mile from their nearest neighbors.
But the day after they arrived, Amundson sensed the sudden loss of his smell and taste. He was congested and started coughing. Two days later, Brodine developed a persistent cough so bad she couldn’t talk.
Amundson remembers no breach in his PPE, but thinking back, he’s nearly certain the time he spent in that man’s room was the cause. The virus somehow got into his nasal pharynx, down into his respiratory tract, and on to infect his wife.
They drove back to San Diego that day and got tested at a commercial lab, which called them that night. “We were both positive,” he said.
Amundson has been off work ever since, saying extreme fatigue cuts his days short by noon, but is gaining more strength every day.
Wife Hit Harder
Not so for his wife, a previously healthy hiker and yoga and Pilates enthusiast with no underlying conditions.
Brodine was so sick, she spent 27 days at Scripps Mercy Hospital in Hillcrest, 11 of them in the intensive care unit, with complications of severe COVID pneumonia. “There was a period of time when all the physicians there — obviously we have friends at the hospital — were concerned for her life,” and some recommended she go on mechanical ventilation, Amundson said.
There was more bad news. Brodine also developed methicillin-resistant Staphylococcus aureus pneumonia. She was treated aggressively with dexamethasone, which can cause bowel disorders. A perforated bowel and diverticular abscess followed, Amundson said.
She’s now been home for the last week, and can move from her bed to the couch with assistance and a four-post walker. Her voice remains raspy and gives out, making it difficult for her to talk. “She’s probably looking at months, if not six months of significant rehabilitation with physical and occupational therapy,” Amundson said.
‘I Brought This Home’
Amundson feels terrible. “The elephant in the room is, I brought this home. I did this to my wife of 40 years. There were lots of periods of time when the tears flowed and we weren’t sure – we weren’t sure she was going to live.”
He wonders if he should have moved out of the house, which they had once considered. “Several colleagues rented trailers and parked them in their driveways,” he said.
Of course, for Amundson and his wife, the question of her access to the vaccine is moot. No vaccine was available in October 2020. But the life-changing experience has left Amundson wondering about other healthcare workers — especially those working like him in the maw of COVID, and who are older, but who think they’re properly protected, only to have this virus sneak up on their families at home.
“We ought to look at maybe prioritizing these people because if you bring it home and give it to a family member who doesn’t know it for the first five days … now, you’ve caused an outbreak of the disease,” Amundson said.
According to the American Medical Association, as of two years ago more than 120,000 practicing U.S. physicians were age 65 or older, an indication that a good portion of their spouses are probably older — and more vulnerable to serious COVID illness — as well, but not old enough to fit into a current vaccine priority tier.
Amundson spent time in Iraq during the war, and has done many things that, in his words, “put you in harm’s way. But to see someone who is really innocent and is only there because of what I do for a living, it doesn’t seem right,” Amundson said.
Chris Van Gorder, CEO of the five-hospital Scripps Health system, sympathized with the issue but noted that vaccines are in short supply. “Being a spouse is not called out right now and I doubt it will be – it’s all individual based,” he said in an email.
Arthur Caplan, PhD, director of the division of medical ethics at NYU Langone Medical Center, suggested that perhaps spouses of providers who work with COVID patients and are older should be ranked higher to get the vaccine. “I would treat them as high-risk elderly,” he said in an email.
Amundson is still trying to regain his full strength, but plans to return to the ICU next week because healthcare workers trained and willing to treat COVID patients are in short supply.
The 116-bed facility was 100% full as of last week, 80% of it filled with COVID-19 patients. In the basement is the hospital’s 28-bed ICU, and 24 of those patients have COVID, all of them on ventilators. Over the last two weeks, the county has averaged more than 2,700 new cases a day. On Dec. 26, numbers in San Diego County of both hospitalized patients and those in the ICU because of COVID broke new records.
Their experience has led Amundson to decide to retire, which he had no plans to do before they both got sick. He’ll return to help with the surge, and train new people to take over when he leaves in September.
Some positive changes amid the COVID-19 crisis
With all the negative reports I wanted to high light some of the positive changes from this pandemic. Dawn Boubds and Wrenetha Julion reported that if COVID-19 is the war, then front-line healthcare workers are our hero soldiers. Sadly, the list of healthcare providers lost to COVID-19 worldwide grows longer and longer. How is it that the country that spends the most per person on healthcare ended up sending soldiers to the battlefield without proper protection (too few masks and caregivers resorting to garbage bags as gowns).
As mental health and public health nurses with over 50 years of combined experience, we are left with the sentiment that we cannot go back to the way things were. Yes, when we signed up to be nurses, we knew what we were getting into. We knew that we would miss family events, such as parties, baptisms and weddings. We were prepared to miss out on spending time with our families. We also knew that we would work long shifts, spending hours on our feet, sometimes without so much as a bathroom break or an opportunity to sit down and eat a meal.
We knew all of this and we did it anyway because caring for patients, families and communities is what we do. But what we couldn’t possibly know is that the COVID-19 global pandemic would strike the U.S. in 2020 and that we could die from it as a result our work. U.S. healthcare will not and should not ever be the same.
Still, despite the tragic losses and seismic industry shifts, there have been some positive developments during this crisis that could shepherd major change. Among them:
Valuing the contribution of healthcare providers, first responders and researchers.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has been one of the most prominent and trusted scientific voices in this crisis. He’s kept the country informed on the evidence-based public health efforts to prevent the spread of COVID-19 and handle the surge of people who are already sick. Fauci and all of our medical experts and researchers—true public servants— deserve support and respect. Healthcare workers and first responders risking their lives for the well-being of others is not unique. What is new today is that their work and dedication are being heralded as heroic amid this pandemic. As a result, healthcare providers and first responders are receiving support in the form of nightly neighborhood serenades in their communities, video messages from celebrities, as well as countless perks from corporations and local businesses—to name just a few gestures of public support.
Probably the biggest thank you would be in the form of student loan forgiveness for front-line healthcare providers. That’s an objective of the movement calling for a Student Debt Forgiveness for Frontline Health Care Workers Act.
COVID-19 offers the public a small window into the daily lives of our healthcare providers and first responders.
Providing insurance reimbursements for telehealth visits without regard to location.
Healthcare visits across the country have quickly shifted online or by phone to patients who do not require an in-person visit. The number of telehealth visits have rapidly increased due to the need to prevent unnecessary exposure to COVID-19. As a result, insurance companies have agreed to reimburse for these visits without regard to the location of the provider or patient (e.g., at home). This was virtually unheard of prior to COVID-19. Before the outbreak, one of the only ways for providers to be reimbursed for telehealth visits was from clinic to clinic—when the provider and the patient were situated in separate clinics.Telehealth visits have increased access to medical and mental healthcare, helped us prioritize and improve workflow and harnessed our triage skills.
Surely, after we have rapidly implemented protocols for these visits—processes that can take years to implement—these efforts must not be lost after COVID-19. Instead let’s keep reimbursing for these visits, offering them from providers’ homes and in patients’ homes whenever possible. All temporary waivers and regulatory changes should be made permanent.
Removing barriers to APRNs practicing at the top of their license.
As the need for more healthcare providers has risen during this pandemic, the pressure to remove barriers to practice for advanced practice registered nurses has become even more apparent. APRNs have been fighting for the removal of these barriers—which vary from state to state—for years. Our scope of practice includes ordering tests, diagnosing, treating and prescribing medications for a variety of health concerns. We have a solid reputation of offering quality healthcare to patients, especially in under-resourced areas. APRNs are often the providers of choice for patients. Despite improving access and offering quality care, barriers to practice such as state requirements for supervisory (restrictive practice) or collaborative (reduced practice) relationships with physicians persist. Some states have already removed barriers to full practice authority and these states are called full-practice states. Other states that have removed some barriers to practice are considered reduced-practice states. Recently, Florida joined 28 other states in granting nurse practitioners full practice authority. California, currently a restricted practice state, is looking to join the ranks of states granting full practice authority.
Since APRNs do not train as long as physicians, many opponents of full-practice authority voice concerns about the safety of patients cared for by APRNs. The data suggests otherwise, because research indicates that APRNs can and do provide care comparable to that provided by other medical providers.
During these dark days of the COVID-19 pandemic it’s crystal clear that APRNs are not competitors of physicians but instead partners in healthcare. Once this crisis has passed, we should continue to expand full-practice authority nationwide for the common goal of access to quality healthcare.
So, the most important thing that we all should take from our discussion is that all continue to practice social distancing, wear our masks and when notified, get vaccinated.
Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?
It is truly amazing how out of touch the GOP and, I believe President Trump is, on health care, especially “after” or during this COVID pandemic. Consider the amount of monies spent on caring for the millions of patients diagnosed with COVID-19. One must remember that due to the EMTALA Act, which ensures public access to emergency services regardless of ability to pay. Think of all the COVID testing and ICU care that has been provided for all that needed it. This experience, etc. should convince, even the clueless that we need a type of universal health care policy.
They, the GOP and the President, promised us all that they would create, provide a wonderful healthcare for all, better than Obamacare. But have they? No!
And now is the time to produce a well-designed alternative, or consider Obamacare as a well thought out program, except for the lack of financial sustainability. And guess what happened after I had a phone call with a member of the Trump administration. He asked me what I thought Trump’s chances of winning re-election. I responded that I thought he had about a 20% chance of getting re-elected. He pressed me as what I thought that would increase his chances. My response was to finally reveal their, the GOP/Trump’s
, plan and I suggested that they should adopt the Affordable Care Act but outline a plan to sustainably finance the healthcare plan.
My suggestion- embrace the Affordable Care Act as a good starting point and use a federal sales tax to finance it instead of putting the onus on the young healthy workers.
At a hearing on the coronavirus response, Senator Dick Durbin asked the Trump administration’s top health officials about the president’s comments touting a plan to replace the Affordable Care Act, also known as Obamacare. They said they did not know about such a plan.
And a Republican victory in Supreme Court battle could mean millions lose health insurance in the middle of a pandemic.
John T. Bennett noted that Ruth Bader Ginsburg, Barack Obama, Donald Trump and Mitch McConnell could soon be forever linked if the late Supreme Court justice’s death leads to the termination of the 44th president’s signature domestic policy achievement: the Affordable Care Act
All sides in the coming battle royal over how to proceed with filling the high court seat she left behind are posturing and pressuring, floating strategic possibilities and offering creative versions of history and precedent. Most Republicans in the Senate want to hold a simple-majority floor vote on a nominee Mr. Trump says he will announce as soon as this week before the end of the calendar year. Democrats say they are hypocrites because the blocked a Barack Obama high court pick during his final year.
It appears Democrats have only extreme options as viable tactics from preventing confirmation hearings and a floor vote before this unprecedented year is up. Speaker Nancy Pelosi on Sunday refused to rule bringing articles of impeachment against the president or even William Barr, his attorney general whom the Democrats say has improperly used his office to help Mr. Trump’s friends and use federal law enforcement unjustly against US citizens.
Unless Ms Pelosi pulls that politically dangerous lever, the maneuvering of the next few weeks most likely will end after Congress returns after the 3 November election with a high court with a 6-3 conservative bend. Analysts already are warning that conservatives appear months away from being able to partially criminalize abortion and also take down the 2011 Affordable Care Act, also known as Obama care.
Democrats have sounded off since Ms. Ginsburg’s death to warn that millions of Americans could soon lose their health insurance, especially those with pre-existing conditions. Last year, 8.5m people signed up for coverage using the Affordable Care Act, according to the Congressional Budget Office.
“Healthcare in this country hangs in the balance,” Joe Biden, who is the Democratic nominee for president and was vice president when Mr. Obama signed the health plan now linked to his name into law, said on Sunday.
Mr. Biden accused Republicans of playing a “game” by rushing the process to replace Ms. Ginsburg on the court because they are “trying to strip healthcare away from tens of millions of families.”
Doing so, he warned, would “strip away their peace of mind” because insurance providers would no longer be required to give some Americans policies. Should a 6-3 court decide to uphold a lower court’s ruling that the 2011 health law be taken down, those companies would “drop coverage completely for folks with pre-existing conditions,” Mr. Biden warned in remarks from Philadelphia.
“If Donald Trump has his way, the complications from Covid-19 … would become the next deniable pre-existing condition for millions of Americans.” That means they would lose their health insurance and be forced to either pay for care out of their pocket or use credit lines. Both could force millions into medical bankruptcy or otherwise create dire financial hardships.
Mr. Trump about a month ago promised to release a new healthcare plan that, if ever passed by both chambers of Congress and signed into law, would replace Obamacare.
So far, however, he has yet to unveil that alleged plan.
Trump Press Secretary Kayleigh McEnany told reporters last week that the White House’s Domestic Policy Council is leading the work on the plan. But when pressed for more details, she chose to pick a fight with a CNN reporter.
“I’m not going to give you a readout of what our healthcare plan looks like and who’s working on it,” Ms. McEnany said. “If you want to know, if you want to know, come work here at the White House.”
When pressed, Ms. McEnany said “stakeholders here in the White House” are working on a plan the president has promised for several years. “And, as I told you, our Domestic Policy Council and others in the White House are working on a healthcare plan,” she insisted, describing it as “the president’s vision for the next five years.”
The president frequently mentions healthcare during his rowdy campaign rallies, but only in general terms. He promises a sweeping plan that will bring costs down across the board and also protect those with pre-existing conditions. But he mostly brings it up to hammer Mr. Obama and Mr. Biden for pushing a flawed law that he has been forced to tinker with to make it function better for consumers.
Broad brush
His top spokeswoman echoed those broad strokes during a briefing on Wednesday. “In aggregate, it’s going to be a very comprehensive strategy, one where we’re saving healthcare while Democrats are trying to take healthcare away,” she told reporters. “We’re making healthcare better and cheaper, guaranteeing protections for people with preexisting conditions, stopping surprise medical billing, increasing transparency, defending the right to keep your doctor and your plan, fighting lobbyists and special interests, and making healthier and making, finding cures to diseases.”
If there is a substantive plan that would protect millions with pre-existing conditions and others affected by Covid-19, it would have made a fine backbone of Mr. Trump’s August Republican National Committee address in which he accepted his party’s presidential nomination for a second time. But healthcare was not the major focus, even though it ranks in the top two issues – along with the economy – in just about every poll that asks voters to rank their priorities in deciding between Mr. Trump and Mr. Biden.
If there is a coming White House healthcare plan that would protect those with pre-existing conditions and prevent millions from losing coverage as the coronavirus pandemic is ongoing, the president is not using his campaign rallies at regional airport hangars to describe or promote it.
“We will strongly protect Medicare and Social Security and we will always protect patients with pre-existing conditions,” said at a campaign stop Saturday evening in Fayetteville, North Carolina, before pivoting to a completely unrelated topic: “America will land the first woman on the moon, and the United States will be the first nation to land an astronaut on Mars.”
The push to install a conservative to replace the liberal Ms. Ginsburg and the lack of any expectation Mr. Trump has a tangible plan has given Democrats a new election-year talking point less than two months before all votes must be cast.
“Whoever President Trump nominates will strike down the Affordable Care Act,” Hawaii Democratic Senator Mazie Hirono told MSNBC on Sunday. “It will throw millions of people off of healthcare, won’t protect people with pre-existing conditions. It will be disastrous. That’s why they want to rush this.”
About 1 In 5 Households in U.S. Cities Miss Needed Medical Care During Pandemic
Patti Neighmond noted that when 28-year-old Katie Kinsey moved from Washington, D.C., to Los Angeles in early March, she didn’t expect the pandemic would affect her directly, at least not right away. But that’s exactly what happened.
She was still settling in and didn’t have a primary care doctor when she got sick with symptoms of what she feared was COVID-19.
“I had a sore throat and a debilitating cough,” she says, “and when I say debilitating, I mean I couldn’t talk without coughing.” She couldn’t lie down at night without coughing. She just wasn’t getting enough air into her lungs, she says.
Kinsey, who works as a federal consultant in nuclear defense technology, found herself coughing through phone meetings. And then things got worse. Her energy took a dive, and she felt achy all over, “so I was taking naps during the day.” She never got a fever but worried about the coronavirus and accelerated her effort to find a doctor.
No luck.
She called nearly a dozen doctors listed on her insurance card, but all were booked. “Some said they were flooded with patients and couldn’t take new patients. Others gave no explanation, and just said they were sorry and could put me on a waiting list.” All the waiting lists were two to three months’ long.
Eventually Kinsey went to an urgent care clinic, got an X-ray and a diagnosis of severe bronchitis — not COVID-19. Antibiotics helped her get better. But she says she might have avoided “months of illness and lost days of work” had she been able to see a doctor sooner. She was sick for three months.
Kinsey’s experience is just one way the pandemic has delayed medical care for Americans in the last several months. A poll of households in the four largest U.S. cities by NPR, the Robert Wood Johnson Foundation and Harvard’s T.H. Chan School of Public Health finds roughly one in every five have had at least one member who was unable to get medical care or who has had to delay care for a serious medical problem during the pandemic (ranging from 19% of households in New York City to 27% in Houston).
We had people come in with heart attacks after having chest pain for three or four days, or stroke patients who had significant loss of function for several days, if not a week.
There were multiple reasons given. Many people reported, like Kinsey, that they could not find a doctor to see them as hospitals around the U.S. delayed or canceled certain medical procedures to focus resources on treating COVID-19.
Other patients avoided critically important medical care because of fears they would catch the coronavirus while in a hospital or medical office.
“One thing we didn’t expect from COVID was that we were going to drop 60% of our volume,” says Ryan Stanton, an emergency physician in Lexington, Ky., and member of the board of directors of the American College of Emergency Physicians.
“We had people come in with heart attacks after having chest pain for three or four days,” Stanton says, “or stroke patients who had significant loss of function for several days, if not a week. And I’d ask them why they hadn’t come in, and they would say almost universally they were afraid of COVID.”
Stanton found that to be particularly frustrating, because his hospital had made a big effort to communicate with the community to “absolutely come to the hospital for true emergencies.”
He describes one patient who had suffered at home for weeks with what ended up being appendicitis. When the patient finally came to the emergency room, Stanton says, a procedure that normally would have been done on an outpatient basis “ended up being a very much more involved surgery with increased risk of complications because of that delay.”
The poll finds a majority of households in leading U.S. cities who delayed medical care for serious problems say they had negative health consequences as a result (ranging from 55% in Chicago to 75% in Houston and 63% in Los Angeles).
Dr. Anish Mahajan, chief medical officer of the large public hospital Harbor-UCLA Medical Center in Los Angeles, says the number of emergencies showing up in his hospital have been down during the pandemic, too, because patients have been fearful of catching the coronavirus there. One case that sticks in his mind was a middle aged woman with diabetes who fainted at home.
“Her blood sugar was really high, and she didn’t feel well — she was sweating,” the doctor recalls. “The family called the ambulance, and the ambulance came, and she said, ‘No, no, I don’t want to go to the hospital. I’ll be fine.’ “
By the next day the woman was even sicker. Her family took her to the hospital, where she was rushed to the catheterization lab. There doctors discovered and dissolved a clot in her heart. This was ultimately a successful ending for the patient, Mahajan says, “but you can see how this is very dangerous — to avoid going to the hospital if you have significant symptoms.”
He says worrisome reports from the Los Angeles County coroner’s office show the number of people who have died at home in the last few months is much higher than the average number of people who died in their homes before the pandemic.
“That’s yet another signal that something is going on where patients are not coming in for care,” Mahajan says. “And those folks who died at home may have died from COVID, but they may also have died from other conditions that they did not come in to get cared for.”
Like most hospitals nationwide, Harbor-UCLA canceled elective surgeries to make room for coronavirus patients — at least during the earliest months of the pandemic, and when cases surged.
In NPR’s survey of cities, about one-third of households in Chicago and Los Angeles and more than half in Houston and New York with a household member who couldn’t get surgeries or elective procedures said it resulted in negative health consequences for that person.
“Back in March and April the estimates were 80[%] to 90% of normal [in terms of screenings for cancer]” at Memorial Sloan Kettering Cancer Center in New York, says Dr. Jeffrey Drebin, who heads surgical oncology there.
“Things like mammograms, colonoscopies, PSA tests were not being done,” he says. At the height of the pandemic’s spring surge in New York City, Drebin says, he was seeing many more patients than usual who had advanced disease.
“Patients weren’t being found at routine colonoscopy,” he says. “They were coming in because they had a bleeding tumor or an obstructing tumor and needed to have something done right away.”
In June, during patients’ information sessions with the hospital, Drebin says patients typically asked if they could wait a few months before getting a cancer screening test.
“In some cases, you can, but there are certainly types of cancer that cannot have surgery delayed for a number of months,” he explains. With pancreatic or bladder cancer, for example, delaying even a month can dramatically reduce the opportunity for the best treatment or even a cure.
Reductions in cancer screening, Drebin says, are likely to translate to more illness and death down the road. “The estimate,” he says, “is that simply the reduction this year in mammography and colonoscopy [procedures] will create 10,000 additional deaths over the next few years.”
And even delays in treatment that aren’t a matter of life and death can make a big difference in the quality of a life.
For 12-year-old Nicolas Noblitt, who lives in Northridge, Calif., with his parents and two siblings, delays in treatment this year have dramatically reduced his mobility.
Nicolas has cerebral palsy and has relied on a wheelchair most of his life. The muscles in his thighs, hips, calves and even his feet and toes get extremely tight, and that “makes it hard for him to walk even a short distance with a walker,” says his mother, Natalie Noblitt. “So, keeping the spasticity under control has been a major project his whole life to keep him comfortable and try to help him gain the most mobility he can have.”
Before the pandemic, Nicolas was helped by regular Botox injections, which relaxed his tight muscles and enabled him to wear shoes.
As Nicolas says, “I do have these really cool shoes that have a zipper … and they really help me — because, one, they’re really easy to get on, and two, they’re cool shoes.” Best of all, he says they stabilize him enough so he can walk with a walker.
“I love those shoes and I think they sort of love me, too, when you think about it,” he tells NPR.
Nicolas was due to get a round of Botox injections in early March. But the doctors deemed it an elective procedure and canceled the appointment. That left him to go months without a treatment.
His muscles got so tight that his feet would uncontrollably curl.
“And when it happens and I’m trying to walk … it just makes everything worse,” Nicolas says, “from trying to get on the shoes to trying to walk in the walker.”
Today he is finally back on his Botox regimen and feeling more comfortable — happy to walk with a walker. Even so, says his mom, the lapse in treatment caused setbacks. Nicolas has to work harder now, both in day-to-day activities and in physical therapy.
‘Warp Speed’ Officials Debut Plan for Distributing Free Vaccines
Despite the president’s statements about military involvement in the vaccine rollout, officials said that for most people, “there will be no federal official who touches any of this vaccine.”
Katie Thomas reported that Federal officials outlined details Wednesday of their preparations to administer a future coronavirus vaccine to Americans, saying they would begin distribution within 24 hours of any approval or emergency authorization, and that their goal was that no American “has to pay a single dime” out of their own pocket.
The officials, who are part of the federal government’s Operation Warp Speed — the multiagency effort to quickly make a coronavirus vaccine available to Americans — also said the timing of a vaccine was still unclear, despite repeated statements by President Trump that one could be ready before the election on Nov. 3.
“We’re dealing in a world of great uncertainty. We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services. “This is a really quite extraordinary, logistically complex undertaking, and a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those uncertainties.”
The officials said they were planning for initial distribution of a vaccine — perhaps on an emergency basis, and to a limited group of high-priority people such as health care workers — in the final three months of this year and into next year. The Department of Defense is providing logistical support to plan how the vaccines will be shipped and stored, as well as how to keep track of who has gotten the vaccine and whether they have gotten one or two doses.
However, Mr. Mango said that there had been “a lot of confusion” about what the role of the Department of Defense would be, and that “for the overwhelming majority of Americans, there will be no federal official who touches any of this vaccine before it’s injected into Americans.”
Army Lt. Gen. Paul Ostrowski said Operation Warp Speed was working to link up existing databases so that, for example, a patient who received a vaccine at a public health center in January could go to a CVS pharmacy 28 days later in another state and be assured of getting the second dose of the right vaccine.
Three drug makers are testing vaccine candidates in late-stage trials in the United States. One of those companies, Pfizer, has said that it could apply for emergency authorization as early as October, while the other two, Moderna and AstraZeneca, have said they hope to have something before the end of the year.
Coronavirus vaccine study by Pfizer shows mild-to-moderate side effects
Pfizer Inc said on Tuesday participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.
The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo. Kathrin Jansen, Pfizer’s head of vaccine research and development, stressed that the independent data monitoring committee “has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date.”
The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech. Over 12,000 study participants had received a second dose of the vaccine, Pfizer executives said on an investor conference call.
The comments follow rival AstraZeneca’s COVID-19 vaccine trials being put on hold worldwide on Sept. 6 after a serious side effect was reported in a volunteer in Britain.
AstraZeneca’s trials resumed in Britain and Brazil on Monday following the green light from British regulators, but remain on hold in the United States.
Pfizer expects it will likely have results on whether the vaccine works in October. “We do believe – given the very robust immune profile and also the preclinical profile … that vaccine efficacy is likely to be 60% or more,” Pfizer’s Chief Scientific Officer Mikael Dolsten said.
Rushing the COVID-19 Vaccine Could Have Serious and Fatal Side Effects
Jason Silverstein noted that States have been told by the Centers for Disease Control and Prevention they should prepare for a coronavirus vaccine by “late October or early November,” according to reports last Wednesday. But an untested coronavirus vaccine may have serious and fatal side effects, could even make the disease worse, and may very well have an effect on the election.
What’s the worst that could happen if we give an untested vaccine to millions of people?
We received a reminder today, when one of the leading large coronavirus vaccine trials by AstraZeneca and Oxford University was paused due to a “suspected serious adverse reaction.” There are eight other potential coronavirus vaccines that have reached Phase 3, which is the phase that enrolls tens of thousands of people and compares how they do with the vaccine against people who only get a placebo. Those eight include China’s CanSino Biologics product that was approved for military use without proper testing back in July, and Russia’s coronavirus vaccine that has been tested in only 76 people.
If the CDC distributes an untested coronavirus vaccine this Fall, it would be the largest drug trial in history—with all of the risks and none of the safeguards.
“Approving a vaccine without testing would be like climbing into a plane that has never been tested,” said Tony Moody, MD, director of the Duke Collaborative Influenza Vaccine Innovation Centers. “It might work, but failure could be catastrophic.”
One concern about this vaccine is that it’s tracking to be an “October surprise.” From Henry Kissinger’s “peace is at hand” speech regarding a ceasefire in Vietnam less than two weeks before the 1972 election to former FBI Director James Comey’s letter that he would reopen the investigation into Hillary Clinton’s emails, October surprises have always had the potential to shift elections. But never before have they had the potential to catastrophically shift the health of an already fragile nation.
If there is an October surprise in the form of an untested coronavirus vaccine, it won’t be the first time that a vaccine was rushed out as a political stunt to increase an incumbent president’s election chances.
What happened with the last vaccine rush?
On March 24, 1976, in response to a swine flu outbreak, President Gerald Ford asked Congress for $135 million for “each and every American to receive an inoculation.”
How badly did the Swine Flu campaign of 1976 go? Well, one of the drug companies made two million doses of the wrong Swine Flu vaccine, vaccines weren’t exactly effective for people under 24, and insurance companies said, no way, they didn’t want to be liable for the science experiment of putting this vaccine into 120 million bodies.
By December, the Swine Flu vaccination program was suspended when people started to develop Guillain-Barré Syndrome, a rare neurological condition whose risk was seven times higher in people who got the vaccine and which paralyzed more than 500 people and killed at least 25.
What else can go wrong when vaccines are rushed
“Vaccines are some of the safest medical products in the world, but there can be serious side effects in some instances that are often only revealed by very large trials,” said Kate Langwig, Ph.D., an infectious disease ecologist at Virginia Tech.
One of the other possible side effects is known as vaccine enhancement, the very rare case when the body makes antibodies in response to a vaccine but the antibodies help a second infection get into cells, something that has been seen in dengue fever. “The vaccine, far from preventing Covid-19, might turn out to make a patient’s disease worse,” said Nir Eyal, D.Phil., a bioethics professor at Rutgers University.
We do not know whether a coronavirus vaccine might cause vaccine enhancement, but we need to. In 1966, a vaccine trial against respiratory syncytial virus, a disease that many infants get, caused more than 80 percent of infants and children who received the vaccine to be hospitalized and killed two.
All of these risks can be prevented, but safety takes patience, something that an American public which has had to bury more than 186,000 is understandably short on and Trump seems to be allergic to.
“To put this into perspective, the typical length of making a vaccine is fifteen to twenty years,” said Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Offit’s laboratory developed a vaccine for rotavirus, a disease that kills infants. That process began in the 1980s and wasn’t completed until 2006. The first scientific papers behind the HPV vaccine, for example, were published in the early 1990’s, but the vaccine wasn’t licensed until 2006.
An untested vaccine may also prove a deadly distraction. “An ineffective vaccine could create a false sense of security and perhaps reduce the emphasis on social distancing, mask wearing, hand hygiene,” said Atul Malhotra, MD, a pulmonologist at the UC San Diego School of Medicine.
Other issues with inadequately tested vaccines
Even worse, an untested vaccine may have consequences far beyond the present pandemic. Even today, one poll shows that only 57% of people would take a coronavirus vaccine. (Some experts argue that we need 55 to 82% to develop herd immunity.)
If we don’t get the vaccine right the first time, there may not be enough public trust for a next time. “Vaccines are a lot like social distancing. They are most effective if we work cooperatively and get a lot of people to take them,” said Langwig. “If we erode the public’s trust through the use of unsafe or ineffective vaccines, we may be less likely to convince people to be vaccinated in the future.”
“You don’t want to scare people off, because vaccines are our way out of this,” said Dr. Offit.
So, how will you be able to see through the fog of the vaccine war and know when a vaccine is safe to take? “Data,” said Dr. Moody, “to see if the vaccine did not cause serious side effects in those who got it, and that those who got the vaccine had a lower rate of disease, hospitalization, death, or any other metric that means it worked. And we really, really want to see that people who got the vaccine did not do worse than those who did not.
And finally, don’t forget to get your Flu vaccine, now!
As the terrible fires continue to burn and Nancy Pelosi says that Mother Nature is angry with us and the political atmosphere is all about hate, I sometimes don’t know who to believe, especially when it comes to the media. Andrew Romano reported that earlier this week, Iowa Republican Sen. Joni Ernst became the first member of “the world’s greatest deliberative body” to embrace a false online conspiracy theory that seeks to minimize the danger of COVID-19 by claiming only a few thousand Americans have died from the virus — not the 185,000 reported by state and local health agencies and hospitals.
Ernst, who described herself as “so skeptical” of the official death toll, even went so far as to echo the nonsense argument spread by QAnon and other right-wing conspiracy-mongers that medical providers who have risked their own lives and health to treat COVID-19 patients have been attributing non-COVID deaths to the virus to rake in extra cash from the federal government.
“These health-care providers and others are reimbursed at a higher rate if COVID is tied to it, so what do you think they’re doing?” Ernst, who is facing a tight reelection race, said Monday at a campaign stop near Waterloo, Iowa, according to a report by the Waterloo-Cedar Falls Courier.
“They’re thinking there may be 10,000 or less deaths that were actually singularly COVID-19,” Ernst added in an interview with the paper. “I’m just really curious. It would be interesting to know that.”
Since Ernst is “really curious,” here are the facts.
Yes, Medicare pays hospitals more for treating COVID-19 patients — 20 percent more than its designated rate, to be exact. Incidentally, this additional payment was approved 96-0 in the U.S. Senate — including by Joni Ernst. The reason Ernst (and all of her Senate colleagues) voted for it is simple: It helped keep U.S. hospitals open and operating during a worldwide emergency.
“This is no scandal,” Joseph Antos, a scholar in health care at the conservative American Enterprise Institute, explained in a recent PolitiFact fact-check. “The 20 percent was added by Congress because hospitals have lost revenue from routine care and elective surgeries that they can’t provide during this crisis, and because the cost of providing even routine services to COVID patients has jumped.”
In other words, no one is getting rich by misclassifying COVID-19 deaths.
It’s also fair to say that fewer than 185,000 Americans have died “singularly,” as Ernst put it, from COVID-19. According to a recent update by the Centers for Disease Control and Prevention, 94 percent of patients whose primary cause of death was listed as COVID-19 were also judged to have comorbidities — secondary conditions like diabetes that often exacerbate the virus’s effects. For the remaining 6 percent, COVID-19 was the only cause listed in conjunction with their deaths.
On Sunday, President Trump retweeted a QAnon backer who falsely claimed this meant that only 6 percent of reported COVID-19 deaths — that is, 10,000 or so — were actually caused by the virus. Perhaps this “report” is what Ernst was referring to when she agreed Monday with an audience member who theorized that COVID-19 deaths had been overcounted. “I heard the same thing on the news,” she said.
Yet Twitter quickly removed the tweet for spreading false information, and for good reason.
Despite all the innuendo, there’s nothing unusual about the way the government is counting coronavirus deaths, as we have previously explained. In any crisis — whether it’s a pandemic or a hurricane — people with preexisting conditions will die. The standard for attributing such deaths to the pandemic is to determine whether those people would have died when they did if the current crisis had never happened.
When it comes to the coronavirus, the data is clear: COVID-19 is much more likely to kill you if your system has already been compromised by some other ailment, such as asthma, HIV, diabetes mellitus, chronic lung disease or cardiovascular disease. But that doesn’t mean patients with those health problems would have died this week (or last week, or next month) no matter what. The vast majority of them probably wouldn’t have. COVID-19 was the cause of death — the disease that killed them now, and not later.
A closer look at the CDC data, meanwhile, reveals that many of the comorbidities listed by medical providers are complications caused by COVID-19 rather than chronic conditions that predated infection: heart failure, renal failure, respiratory failure, sepsis and so on.
Feverishly creating a baseless fiction from two threads of unrelated information — the additional Medicare payments and the CDC update about comorbidities — is a classic conspiracy-theorist move. But that doesn’t make it true.
“Let there not be any confusion,” Dr. Anthony Fauci, the nation’s top infectious disease expert, said Tuesday. “It’s not 9,000 deaths from COVID-19. It’s 180,000-plus deaths.”
“The point that the CDC was trying to make was that a certain percentage of [deaths] had nothing else but COVID,” Fauci continued. “That does not mean that someone who has hypertension or diabetes who dies of COVID didn’t die of COVID-19. They did.”
In reality, it’s more likely that the U.S. is undercounting rather than overcounting COVID-19 deaths. According to a recent New York Times analysis of CDC estimates, at least 200,000 more people than usual died in the U.S. between March and early August — meaning that the official COVID-19 death count, which hit 140,000 over the same period, is probably too low.
In the Hawkeye State, COVID-19 had killed at least 1,125 as of Wednesday afternoon. Over the past week, the state has reported an average of 1,177 cases per day, an increase of 124 percent from the average two weeks earlier. Its positive testing rate has risen from 10 percent to 18.5 percent since then.
So while Republican lawmakers such as Ernst seek to downplay the lethality of the virus, Theresa Greenfield, Iowa’s Democratic Senate candidate, seized on her opponent’s baseless claim to underscore the gravity of the situation in one of the only states in America where the pandemic is getting worse.
“It’s appalling for you to say you’re ‘so skeptical’ of the toll this pandemic has on our families and communities across Iowa,” Greenfield tweeted Tuesday, addressing the senator. “We need leaders who will take this seriously.”
Why a herd immunity approach to COVID-19 could be a deadly disaster
Reporter Rebecca Corey noted that since the coronavirus pandemic began, herd immunity has been floated by some experts as a possible solution to the deadly virus that has so far killed over 865,000 people worldwide.
Herd immunity is possible when enough people have contracted and become immune to a virus, providing community-wide protection by limiting the number of people who can spread it. And while the strategy is considered controversial and even downright dangerous by many public health experts, it is also reportedly gaining momentum in the White House.
According to a report by the Washington Post, herd immunity is a strategy being pushed by Dr. Scott Atlas — a neuroradiologist with no background in infectious diseases or epidemiology who recently joined the White House as a pandemic adviser.
Atlas denied that he had encouraged the White House to adopt a herd immunity strategy, and on Wednesday White House coronavirus task force coordinator Dr. Deborah Birx and top infectious disease expert Dr. Anthony Fauci dismissed the idea that herd immunity was under consideration. An administration official, however, told CNN that the policies being promoted by Atlas are indeed akin to a herd immunity approach.
Ordinarily, herd immunity would be acquired through a majority of the population being vaccinated — not through immunity acquired by natural infection.
“Normally, when we talk about herd immunity, we talk about how much of the population needs to be vaccinated,” World Health Organization (WHO) COVID-19 technical lead Dr. Maria Van Kerkhove said on Aug. 27. “If we think about herd immunity in a natural sense of just letting a virus run, it’s very dangerous because you would need a lot of people to be infected.”
It’s still uncertain what percentage of a population would need to be immune to the virus in order to attain herd immunity. According to Johns Hopkins University, in general, the answer is 70 to 90 percent of a population, depending on how contagious the infection is. But a model published last month in the magazine Science found that the threshold needed for coronavirus herd immunity could be as low as 43 percent.
Proponents of herd immunity have looked to emulate Sweden’s more hands-off approach; unlike most countries in Europe, the Nordic country opted out of a nationwide lockdown and kept most businesses open.
But Sweden’s strategy didn’t entail a total return to normalcy. The Swedish government implemented a ban on gatherings of 50 people or more, and many Swedes voluntarily followed social distancing guidelines.
Former FDA Commissioner Scott Gottlieb noted in an op-ed published on Aug. 30 that in addition to being much larger than Sweden (a country with a population the same size as North Carolina’s), the U.S. has a high rate of citizens with preexisting conditions, which can lead to a higher rate of COVID-19 complications; about 10 percent of Americans have diabetes, and 40 percent are considered obese.
Moreover, Sweden’s pursuit of natural herd immunity doesn’t appear to be working. A study released in June by the country’s Health Agency showed that only 6 percent of Swedes had developed antibodies to the coronavirus — though a recent study from Sweden’s Karolinska Institute and Karolinska University Hospital suggests that immunity in Sweden may be higher than antibody tests indicate.
The role of antibodies and how much of an impact they have on long-term immunity is still questionable. A U.K. study, which had not yet been peer-reviewed, found that antibodies may start to decline 20 to 30 days after the onset of COVID-19 symptoms. And a Chinese study found that antibody levels in patients who had recovered from COVID-19 fell sharply within two to three months after infection.
Falling antibody counts may not necessarily mean waning immunity; other immune responses such as T-cells could also affect how long immunity lasts. But the case for natural herd immunity is made even more improbable by reports of coronavirus reinfections in Hong Kong, Europe and the U.S. If natural immunity is as short-lived as a few months, that wouldn’t be stable enough to provide community or nationwide protection.
Yahoo News Medical Correspondent Dr. Dara Kass says waiting to reach the minimal number of infections needed for natural herd immunity to work would not only take longer than waiting for a vaccine (which could come before the end of the year, according to the CDC) but would also likely cost more lives. Even if only 40 percent of the U.S. population needed to contract and recover from COVID-19 to reach natural herd immunity, Kass argues, that would mean another 126 million more Americans would still need to be infected.
“It’s taken us six months to get to 6 million infections,” Kass says. “What if we just said, let’s live life like normal? Let’s not wear masks, let’s not socially distance, let’s ride the subways and go to work. How fast could we get to 126 million infections? One year? Two years? Three years? We don’t know. But what we know is, the faster we infect people, the more people will die.”
“We’ve seen so far 185,000 Americans die of this coronavirus with 6 million people infected,” Kass continues. “If we want to intentionally infect another 126 million Americans, that means that over 1 million more Americans would die of this virus before we infected enough people to get to any possible natural herd immunity.”
According to a Gallup poll conducted in late July, 35 percent of Americans said they would not get a coronavirus vaccine even if it were FDA-approved and available to them at no cost. But Kass says a vaccine will likely be the key to any workable herd immunity strategy.
“The bottom line is, will herd immunity be the answer to this coronavirus pandemic? And the answer will be yes — but not natural herd immunity. We will get to herd immunity hopefully with the development of a safe, effective vaccine,” Kass says.
“Until we have a safe and effective vaccine that is available to the hundreds of millions of Americans that still need to be exposed and recovered from this virus, we just need to continue to do the hard work, which means wear a mask, be socially distanced from people you don’t know, wash your hands multiple times a day and listen to the science.”
College Students Are Already Itching to Sue Frats Over COVID-19
So, is anyone surprised at the stupidity of college students returning to campus after this long imposed “lock-down?” Are you surprised at the number of positive COVID-19 tested students after all of their large parties?
Emily Shugerman reported that across the country, as college students return to campus with masks and hand sanitizer, fraternities and sororities are doing what they’ve always done: drinking and partying.
At the University of Washington this summer, 137 students living in frat houses tested positive for the coronavirus after hosting raucous parties that violated their own internal guidelines. At the University of Alabama, students completed an entirely virtual rush process that ended with new members showing up in person to sorority houses, packing themselves together to take photos and then crowding the neighboring bars. The next week, the university announced more than 500 cases on campus.
For responsible students and their families, who could fall ill or have their classes canceled due to their classmates’ Greek Life antics, it all seems ripe for a lawsuit, right?
Not necessarily.
Two attorneys who specialize in litigation against frats told The Daily Beast they have received multiple inquiries from concerned students or parents wondering what their legal rights are when it comes to potential super-spreader events on their campus.
Attorney Douglas Fierberg said filing a lawsuit is absolutely an option, arguing that violating public health rules around coronavirus is no different than violating other safety rules, like a speed limit.
“The violation of [safety rules] by someone with no excuse or justification renders them responsible for the harm that’s caused,” he told The Daily Beast. “That precedent has been around since the dawn of American jurisprudence.”
But David Bianchi, an attorney who helped draft Florida’s anti-hazing law, said it isn’t so simple. In order to win such a suit, the plaintiff would have to prove not only that the defendant acted negligently, but that the negligent behavior directly caused them harm. And in a pandemic—where the virus could be picked up anywhere from a frat house to a grocery store parking lot—that could be difficult to prove.
“The defense lawyer will have a field day asking questions of the plaintiff about every single place they went for the seven days before the fraternity party, the seven days after the fraternity party, and they’re going to come up with a list of 50 places,” he said. “How do you prove that that’s not where they got it from?”
Bianchi said half a dozen parents called his office asking about the possibility of filing a lawsuit, and he told them not to bother.
“I call ’em like I see ’em, and I just don’t see it here,” he said.
Lawsuits against Greek organizations, for everything from wrongful death to sexual assault, are big business for personal injury attorneys. (In 2018, the parents of a freshman at Northern Illinois University won a historic $14 million settlement after their son died at a fraternity party.)
And there’s no question that some are bracing for suits against fraternal organizations: Holmes Murphy, an independent insurance brokerage with a specialty in frats, wrote a blog post on how clients could avoid trouble.
“We’ve received many questions about whether or not a house corporation has a duty to do anything,” the post said. “This is a question that will ultimately be tested after a case and spread within a house occurs. There is certainly no shortage of lawsuits as a result of the pandemic. Ultimately, doing the right thing comes first. Start with the basics. That may be all you can do. But it is better than doing nothing.”
What’s hazier is the prospect for coronavirus lawsuits in general. Thousands of suits have been filed since the pandemic started—against schools, businesses, prisons, and pretty much anywhere else you can pick up a virus—but few have been decided. Some legislators have also pushed for laws giving businesses widespread legal immunity, in hopes of getting the economy back up and running.
On college campuses, Fierberg said, legal actions may not happen right away—classes have only just started, and it takes time for someone to get infected, suffer a grievous injury, and find a lawyer. He predicted a rash of such suits in the next six months to a year.
“The time period that this is incubating is now,” he said. “What’s gonna happen in that experiment is yet to entirely show itself. If it comes out as Frankenstein then that’s one thing. If it comes out as something nice… well that’s a different thing.”
Why a Vaccine Won’t Be a Quick Fix for COVID-19
Medscape’s Brenda Goodman noted that nine months into the COVID-19 pandemic, we are all exhausted, stressed out, and looking for the exit, so hopes for a vaccine are high. Not only are we all stressed out but with the election only weeks away there is pressure to have a vaccine so that President Trump sees a bump in his numbers for re-election possibilities.
Numerous efforts are underway around the world to test, manufacture, and distribute billions of doses. A table maintained by the World Health Organization (WHO) lists 33 vaccines against SARS-CoV-2, the virus that causes COVID-19, currently being tested in people, with another 143 candidates in preclinical testing and I just reviewed an article which noted that there were actually 210 vaccines being studied.
The effort is so critical, the U.S. government is spending billions to make doses of vaccine that may be wasted if clinical trials don’t show them to be safe and effective. The goal of this massive operation, dubbed Warp Speed, is to deliver 300 million doses of safe and effective vaccines by January 2021.
As important as a vaccine will be, some experts are already trying to temper expectations for how much it will be able to do.
“We all hope to have a number of effective vaccines that can help prevent people from infection,” Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, said at an Aug. 3 news briefing. “However, there is no silver bullet at the moment, and there might never be.”
Barry Bloom, PhD, an expert in infectious diseases and immunology at the Harvard T.H. Chan School of Public Health, is even more direct: The idea that a vaccine will end the pandemic just isn’t realistic.
“That’s not going to happen,” he says. First, not enough people will get the vaccine. Second, for those who do take it, the vaccine may only offer partial protection from the virus.
“I am worried about incomplete availability, incomplete protection, unwillingness of a portion of a country to be vaccinated,” Bloom says.
At least at first, not enough people will get the vaccine for the world to achieve herd immunity, or community protection. Community protection robs the virus of the chance to spread easily. It occurs when enough people become immune, either because they’ve recovered from the infection or been vaccinated against it. This high level of immunity in a population cuts the chances that someone without immunity ― say an infant or someone who can’t be vaccinated for medical reasons ― will be exposed to the virus and get sick.
Typically, the herd immunity threshold for an infection is somewhere between 70% and 90% of the population. We don’t yet know where the threshold is for COVID-19 because there are still big unanswered questions about how our bodies respond to the virus or a vaccine against it: Do most people respond in a way that protects them in the future? If so, how long does that protection typically last?
Even at the low end of the typical range for community protection ― 70% ― we’re still far short of that mark.
Recent studies checking blood samples submitted to commercial labs suggest that 5% to 10% of the population has recovered from a COVID-19 infection in the U.S. That’s just an average. The real number varies widely across the U.S., ranging from a low of about 1% in San Francisco to a high of about 20% in New York City, according to CDC data. Most of the country is still in the 3%-5% range ― still a long way from community protection against the virus.
So, most of the immunity needed to reach a level that would provide community protection would have to come from a vaccine.
“It’s not just getting a vaccine. It’s using it and using it appropriately,” Bloom says. “Vaccines don’t prevent anything. Vaccination does.”
Getting enough doses to enough people will take a while, even after a vaccine becomes available, for several reasons.
When vaccines against COVID are first approved, supplies will be tight. Initially, there may be enough doses for 10 million to 15 million people in the U.S. The first shots will be reserved for the people who need them most.
Just this week, the National Academy of Sciences came up with a draft plan for how to fairly distribute the vaccine, which would unfold in four phases. Those phases will take time to execute.
The first phase recommends that the first doses go to health care workers and first responders, with the next batch going to people with health conditions that put them at highest risk of dying from COVID, and to seniors living in group homes. Those groups make up just 15% of the population, according to the report.
Phase two, which covers about 30% of the population, calls for vaccination of essential workers at “substantially high risk of exposure,” teachers, people with health conditions that put them at moderate risk from the disease, people living in close contact with others (like prisoners and those staying in homeless shelters), and seniors who weren’t covered in phase one.
The largest chunk of the population, including children, who can be infected but may show few signs of illness, aren’t a priority until phase three, which also includes other essential workers. Phase three accounts for about 40% of the population. The last phase, everyone else, makes up about 5%.
Among those who are eligible for vaccination, not everyone is likely to agree to get one.
A recent poll by Gallup found that 35% of Americans ― or about one in three ― don’t plan on getting a COVID-19 vaccine, even if it’s free. Among the two-thirds of Americans who say they will be immunized, a large number plan to wait. A recent survey by STAT found that 71% will wait at least 9 months to get their shots.
Those numbers align with a recent poll by WebMD, which found that 73% of readers said they would wait at least 3 months to get a vaccine when one becomes available.
“I don’t find that shocking. I would think for people who are rational, wouldn’t you want to see what the data are on safety and efficacy before you made a decision?” Bloom says. “I’m worried about the 25% who, no matter what happens, won’t take the vaccine. Those are the people who really worry me.”
Vaccine hesitancy ― fear of getting any vaccine ― is growing. The WHO recently listed it as one of the top threats to global health, pointing to the recent resurgence in measles. Many countries have recently seen large outbreaks of measles. These outbreaks have been caused by an increasing number of parents refusing to vaccinate their kids.
Experts are worried that vaccine hesitancy will play a large role in whether the U.S. and other countries reach herd immunity thresholds. The Gallup poll found Republicans are less likely to be vaccinated than Democrats, and nonwhite Americans ― the group being disproportionately affected by COVID-19 infections ― are less likely to be vaccinated than whites.
Bloom and others believe that right now, we should be working on a way to overcome vaccine hesitancy.
“Policymakers have to start focusing on this,” says Robert Litan, PhD, JD, a nonresident senior fellow at the Brookings Institute.
He thinks we shouldn’t try to overcome hesitancy by forcing people to take the vaccine. Instead, he wants the government to pay people to take it ― $1,000 each, or $4,000 for a family of four.
“That’s a lot of money,” especially now with the economy sagging and so many people out of work, Litan says. “I think a thousand dollars would get a lot of people to take the shot who would otherwise not take it.”
Litan ran the numbers, looking at various scenarios of how many people would take it and how effective the vaccine might be. He says he realized not enough people would be protected to fully reopen the country.
He says he’s not sure $1,000 is the right sum, but it should be generous because if people think the amount could go up, they will wait until it does, which would defeat the purpose of the incentive.
“I can’t think of anything else,” he says. “You either have carrots or sticks, and we can’t use sticks. It won’t work.” How Well Will It Work?
Getting enough people to take it is only one piece of the puzzle. We still don’t know how well any of the shots might work, or for how long that protection lasts.
Researchers have now confirmed at least four cases of COVID-19 reinfection, proving that the virus infected the same person twice.
We still don’t know how common reinfection is, but these cases suggest that some people may need a booster dose of vaccine before they’re fully protected against the virus, says Gregory Poland, MD, an expert in immunity and vaccine responses at the Mayo Clinic in Rochester, MN.
That’s similar to the way we dole out vaccines for seasonal flu, with people urged to get the shot every year, he says.
That’s another reason it could take a while to reach herd immunity.
It’s also not clear how effective a vaccine may be.
The FDA and WHO have said that a vaccine should be at least 50% more effective than a placebo to be approved. But that could mean that a shot merely decreases how bad an infection is but doesn’t stop it. That would be an important effect, Bloom says, but it could mean that even vaccinated people would continue to spread the infection.
“If it prevents disease, but doesn’t prevent growth in the upper respiratory tract, there is a possibility there will be a group of people who will be infected and not get sick because of the vaccine but still have the virus in their respiratory tract and be able to transit,” Bloom says. “That would not be the ideal for a vaccine, but it would protect against disease and death.”
He says the first studies will probably measure how sick vaccinated people get and whether or not they need to be hospitalized.
Longer studies will be required to see if vaccinated people are still able to pass the virus to others.
How effective any vaccine may be will also depend on age. In general, older adults ― the ones who most need protection against COVID-19 ― don’t respond as well to vaccines.
Our immune systems get weaker as we get older, a phenomenon called immunosenescence.
Seniors may need specially formulated vaccines ― with added ingredients, called adjuvants ― to get the same response to vaccines that a younger person might have.
Lastly, there’s the problem of reintroduction. As long as the virus continues to spread anywhere in the world, there’s a risk that it could reenter the U.S. and reignite infections here.
That’s what happens every year with measles. In most states, more than 90% of people are vaccinated against measles. The measles vaccine is one of the most effective ever made. It gives people substantial and long-lasting protection against a highly contagious virus that can stay in the air for long periods. You can catch it by walking through the same room an infected person was in hours before.
Every year, travelers come to the U.S. carrying measles. If they go to a crowded place, like a theme park, it increases the chances that initial infection will touch off many more. As vaccine hesitancy has increased in the U.S. and around the world, those imported cases have sparked outbreaks that have been harder and harder for public health officials to extinguish, raising the risk that the measles virus could become endemic again in countries like the U.S.
For the world to be rid of COVID-19, most of the world has to be vaccinated against it. There’s an effort underway ― called COVAX ― to pay for vaccinations for poorer countries. So far, 76 of the world’s wealthier countries have chipped in to fund the effort. The U.S. has not. The Trump administration says it won’t join because of the WHO’s involvement in the effort, a move that may place the plan in jeopardy.
For all these reasons, it will probably be necessary to continue to spread out, wear masks, and be vigilant with hand hygiene to protect yourself and others for the foreseeable future.
“For now, stopping outbreaks comes down to the basics of public health and disease control,” Tedros said.
We may get a vaccine, but we will still need to be able to test enough people for the virus, warn their contacts, and isolate those who are infectious to keep the epidemic under control, or, as Tedros has urged, “Do it all.”
During these last few months of the pandemic one of my concerns is the lack consistent reliable data with which the media pundits of all sorts deliver their predictions and many times with false knowledge and predictions. Question, what is the correct social distancing length? Studies keep on changing! One of the key features of the web is its ability to turn regular people into citizen journalists. The cost of publishing text on the web is almost nil. The barriers to entry in the media industry are low, too. And many readers are not picky about where their news comes from: the stories that go viral can come from amateur scribes or veteran ones, media startups or established outfits. But this is not always the case. New research suggests that when a crisis hits, readers turn to reliable sources.
In 2018 Paul Resnick and James Park, two researchers at the University of Michigan, devised a pair of tools for measuring the popularity of English-language news stories on Facebook and Twitter. The first, dubbed the “Mainstream Quotient”, measured the proportion of highly-shared links that came from mainstream news sources, such as the New York Times, the BBC and, yes, The Economist. The second, the “Iffy Quotient”, measured the share originating from less trustworthy sources, based on ratings provided by NewsGuard, a company that tracks misinformation published online.
Both indices have shifted significantly during the pandemic. Beginning in February, when the coronavirus started to spread outside China, traffic to traditional media outlets and news sites surged, whereas dodgier sites attracted fewer readers. The Mainstream Quotient rose steadily during this period, a phenomenon Messrs Resnick and Park call a “flight to quality”. The Iffy Quotient, meanwhile, tumbled. The drop was particularly steep during March, when many countries instituted lockdown measures (see chart).
The researchers argue that consumers seek out reliable news sources during times of uncertainty, in the same way that fearful investors turn to gold. Whether these patterns will last remain unclear. The Iffy Quotient has already started to creep back up, for both Facebook and Twitter. And recent efforts by social-media platforms to crack down on fake news may prove only temporary. Once the pandemic subsides, demand for unreliable news may return to pre-covid levels. For now, at least, the flight to quality has taken off.
Pandemic Spike in Telehealth Levels Off
Crystal Phend of MedPage pointed out that Telehealth’s early bonanza during the pandemic has given way to persistently elevated use in primary care, a Department of Health and Human Services (HHS) report showed.
Analysis of Medicare fee-for-service (FFS) data showed an increase in Medicare primary care visits from 0.1% of all primary care in February to 43.5% in April, representing an increase from about 2,000 to 1.28 million telehealth visits per week.
Meanwhile, there was a “precipitous” drop in in-person visits for primary care in mid-March as COVID-19 took hold in the U.S., then a rise from mid-April through May, according to the report from the Office of the Assistant Secretary for Planning and Evaluation.
Use of telehealth in primary care “declined somewhat but appears to have leveled off at a persistent and significant level by the beginning of June,” the report noted. It still accounted for 22.7% of Medicare beneficiaries’ primary care visits as of June 3rd.
Overall, weekly primary care visit rates have not yet returned to pre-pandemic levels.
“Based on early experience with Medicare primary care telehealth at the start of the COVID-19 public health emergency, there is evidence that Medicare’s new telehealth flexibilities played a critical role in helping to maintain access to primary health care services — when many beneficiaries and providers were concerned with transmission of COVID-19,” the authors noted. “The stable and sustained use of telehealth after in-person primary care visits started to resume in mid-April suggests there may be continued demand for telehealth in Medicare, even after the pandemic ends.”
The findings overall match those from healthcare provider databases suggesting a 60% to 70% drop in health care office visits, partially offset by telehealth visits, with the start of the pandemic. Drug market research firm IQVIA has reported from physician surveys that about 9% of patient interactions were via telehealth prior to the pandemic but 51% during the shutdown, with expectation of a 21% rate after the pandemic, the HHS report noted.
There have been calls for Medicare to make the loosened rules around telemedicine permanent, and some legislative movement in that direction, but private insurers have signaled the opposite.
Fred Pelzman, MD, an internal medicine physician at Weill Cornell Medicine in New York City (and MedPage Today columnist), said an informal survey of his patients indicated they would be willing to do up to 50% of their care via video tools.
“We went from a handful of video visits in our practice to several thousand over the course of the months,” he said. “It’s a great way to take care of people, kept a lot of people safe, we think. What has happened is that as we started to open our practice back up again and offer appointments, the floodgates have opened and patients are declining video visits.”
Those patients opting for in-person visits tend to be older, braving what feels like a quiet time in the pandemic for the state to take care of necessary visits, he noted. “I think ultimately that we’ll plateau. It will probably come down a little more.”
The study included Medicare FFS Part B claims from January through May 2020 for primary care services along with preliminary Medicare Part B primary care claims data up to June 3. Primary care services included evaluation and management, preventive services, and advance care planning.
Telehealth usage increased most in urban counties early in the pandemic and saw smaller declines in May compared with rural counties across the country. Among cities, Boston had the greatest proportion of primary care visits by telehealth (73.1%) and Phoenix the lowest (37%).
Notably, the rate “was not strongly associated with differences in COVID-19 severity across cities as measured by rate of hospitalizations per thousand Medicare FFS beneficiaries,” the report pointed out.
I read an article predicting that telehealth visits are the future of medicine. This is truly worrisome due to the many incorrect diagnoses as well as poor control of chronic diseases that I have seen coming through my office alone. Physical diagnosis is made by looking at the patient, listening to the patient, hearing what the patient is really saying, touching the patient and using the different diagnostic tools such stethoscopes, ophthalmoscopes, otoscopes, percussion hammers, etc. to make the correct diagnoses and to follow our patients. How is that done virtually? The only ones benefitting the most from these virtually visits are the practices and the electronic medical record companies selling the practices additional software to utilize telehealth. And patients are finding that not all telehealth “visits” are paid for by their insurance companies.
How Did Sweden Flatten Its Curve Without a Lockdown?
One expert credits a “good-enough strategy”; others worry that it won’t last. Who is correct?
Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage reported that
Despite never implementing a full-scale lockdown, Sweden has managed to flatten its curve, prompting its health leadership to claim victory — but others question the cost of the strategy, as the country has a far higher death toll than its Scandinavian neighbors.
In late July, Sweden’s 7-day moving average of new cases was about 200, down from a peak of around 1,140 in mid-June. Its daily death totals have been in the single digits for two weeks, well below its mid-April peak of 115 deaths in a single day.
However, on a per-capita basis, Sweden far outpaces its Scandinavian neighbors in COVID deaths, with 567 deaths per million people compared with Denmark’s 106 deaths per million, Finland’s 59 deaths per million, and Norway’s 47 deaths per million. The Swedish figure is closer to Italy’s 581 deaths per million.
While the positive trends have led Anders Tegnell, PhD, chief epidemiologist at the Swedish Public Health Agency and architect of Sweden’s coronavirus strategy, to state that the “Swedish strategy is working,” others have criticized the approach, including two dozen Swedish academics who published a recent USA Today editorial.
“In Sweden, the strategy has led to death, grief, and suffering,” they wrote. “On top of that, there are no indications that the Swedish economy has fared better than in many other countries. At the moment, we have set an example for the rest of the world on how not to deal with a deadly infectious disease.”
The Swedish Public Health Agency has not openly stated that herd immunity was its goal, though many suspect that this was the intention. Tegnell told reporters last week he thought the recent trends indicated that immunity was now widespread in the country. But with rates of antibody positivity around 10%, that seems impossible. (Officials at the agency did not respond to MedPage Today‘s request for comment.)
So how has Sweden managed to get its outbreak under control?
Behavior Change
While Sweden didn’t officially lock down, many in the country have described a locked-down “feeling” that has eased in the summer months.
At the start of the outbreak, only high schools and universities closed; daycare and elementary schools have been open. Businesses have also remained open, but typically at reduced hours, and restaurants have functioned at reduced capacity.
Swedes have been asked to keep their distance in public, refrain from non-essential travel, and work from home when possible. Gatherings of more than 50 people are also banned. People age 70 and over are advised to stay away from others as much as possible.
Masks were never required and aren’t commonly worn.
This response hasn’t changed over time, through the June surge and into today’s decline, so there’s no definitive explanation for the flattening, though, and experts have several theories.
“Swedes in general have changed their behavior to a great extent during the pandemic and the practice of social distancing as well as physical distancing in public places and at work has been widespread,” said Maria Furberg, MD, PhD, an infectious diseases expert at Umea University Hospital in northeastern Sweden.
“During the months of March to early June, all shops were practically empty, people stopped dining with friends, and families stopped seeing even their closest relatives,” Furberg told MedPage Today. “A lock-down could not have been more effective. Handwashing, excessive use of hand sanitizers, and staying home at the first sign of a cold became the new normal very quickly.”
Mozhu Ding, PhD, an epidemiologist at the famed Karolinska Institute, said the decline is “likely to be a combination of measures taken by individuals, businesses and a widespread information campaign launched by the government.”
“Even without a strict lockdown order, many businesses allowed employees to work from home, and universities are offering distance courses to the students,” Ding told MedPage Today. “Individuals are also taking personal hygiene more seriously, as items like hand sanitizers and single-use gloves are often sold out in pharmacies and grocery stores.”
Immunity
Experts told MedPage Today there weren’t clear data to prove Tegnell’s assertion of widespread immunity in Sweden.
Furberg said there is likely “some sort of unspecific immunity that protects parts of the population from contracting COVID-19” but it’s not necessarily secondary to SARS-CoV-2 exposure.
For instance, a study by the Karolinska Institute and Karolinska University Hospital recently found that about 30% of people with mild or asymptomatic COVID showed T-cell-mediated immunity to the virus, even though they tested negative for antibodies.
“This figure is [more than] twice as high as the previous antibody tests, meaning that the public immunity to COVID-19 is probably much higher than what antibody studies have suggested,” Ding told MedPage Today. “This is of course very good news from a public health perspective, as it shows that people with negative antibody test results could still be immune to the virus at a cellular level.”
Indeed, T-cell immunity is coming into focus as a potentially important factor in COVID infection. A paper published in Nature in mid-July found that among 37 healthy people who had no history of either the first or current SARS virus, more than half had T cells that recognized one or more of the SARS-CoV-2 proteins.
Another 36 people who had mild-to-severe COVID-19 were all found to have T-cell responses to several SARS-CoV-2 proteins, and another 23 people who had SARS-CoV-1 (the virus responsible for the SARS outbreak in 2003) all had lasting memory T cells — even 17 years later — that also recognized parts of SARS-CoV-2.
It could be that T cell immunity is the result of a previous infection with common cold coronaviruses, but this hasn’t yet been established; nor is it certain that T cell immunity is driving Sweden’s decline in COVID cases.
Path Forward
Summertime is another factor that may account for the decline, which began around late June — not directly because of the weather, but social factors related to it.
Swedes are “outdoors more, and students are not at school,” said Anne Spurkland, MD, a professor of immunology at the University of Oslo in Norway.
Also, “perhaps Sweden has finally gotten better control over the disastrous spread of the virus in nursing homes which to some extent can explain their relatively high death rates,” Spurkland told MedPage Today. About half of Sweden’s 5,730 deaths occurred among those in elder care homes.
Norway is still requiring that Swedes quarantine for 10 days when coming into Norway, and Denmark has not fully reopened its borders to its neighbor yet either.
That doesn’t bode well for the Swedish economy. If the goal of avoiding a lockdown was to spare economic woe, its success has been limited.
According to Business Insider, “international tourism and trade are decimated. … Sweden’s National Institute of Economic Research predicts Sweden’s GDP will fall 5.4% in 2020, after predicting a 1% rise [in] December 2019. It also expects unemployment to rise around three percentage points, to 9.6%, between the end of 2019 and the end of 2021.”
Spurkland said it’s still “too early yet to conclude whether the Swedish approach was the wisest over all,” as it remains to be seen whether Norway and other countries that did lock down will avoid a second wave of infections in the fall.
Yet she cautions that choosing to take on a higher case load may have health consequences far beyond the immediate infection.
“What we have learned these months is that COVID-19 is not only about death, it is also about ill health,” Spurkland said. “Quite a number of people going through the infection have long-term symptoms, that may be stopping them from resuming their daily life. We do not know yet how large a proportion of those who get the virus will fall into this category, but it is certainly a concern.”
“So, when deciding on taking a herd immunity approach to handle a totally new virus we do not know anything about,” she said, “the Swedish government has also unknowingly put the general population at risk for much long-term ill-health caused by the virus.”
Furberg doesn’t see it that way: “I am very proud of the way Swedes have adapted to the restrictions and regulations and I believe the Public Health Agency of Sweden has picked a good-enough strategy for our country.”
What Americans Need to Understand About the Swedish Coronavirus Experiment
Sweden made headlines for never shutting down. Here’s what’s really happening there.
Matthew Zeitlin pointed out that Tooutsiders, life in Stockholm, Sweden, appears perfectly normal: Walk down a cobblestone street, and you may see two friends sitting at a cafe enjoying the spring air or a group of kids kicking a soccer ball in the park. Cars and bicyclists may zip by; a family may walk past you on their afternoon stroll.
Whereas most of the Western world has been in lockdown for weeks, Sweden has opted to forgo any sort of shelter-in-place policy in response to the coronavirus and instead allow businesses and parks to stay open and groups of under 50 to gather.
That’s not to say the country hasn’t been proactive at all. The policy in effect in Sweden is similar to what had been implemented in much of the United States before shelter-in-place orders were issued — and the one that will soon be in place in states that reopen. The Swedish government has recommended that people wash their hands frequently, maintain social distance, work from home if they can, and those who are elderly or more susceptible to Covid-19 stay home. The government recommended that universities switch to online teaching; they quickly followed course. Social distance is required by law in restaurants, and bar service is banned. The government changed its sick leave rules to encourage anyone who is feeling symptoms to stay home. “Instead of saying ‘close down all of society,’ we have looked at society and closed down… aspects of society,” where the disease is most likely to spread, Anders Tegnell, the epidemiologist at Sweden’s Public Health Agency in charge of recommending policy to the government, told The Daily Show. “I think that’s had a great effect.”
Sweden may not be so much an alternative, as a glimpse of the future.
Sweden’s approach has been hailed by critics of American and European pandemic policies as a less restrictive — and less economically devastating — alternative to state or national shutdowns, but it’s also been lambasted by others as an unnecessarily risky strategy that has led Sweden to have the highest Covid-19 death toll among the Nordic nations. As more and more areas of the United States reopen, Sweden may not be so much an alternative as a glimpse of the future.
As of Sunday afternoon, the country had 25,921 confirmed cases and3,220deaths, according to the Johns Hopkins Coronavirus Resource Center. These are much higher figures than those of the country’s neighbors, but lower than those in some other wealthy Western European countries on both an overall and population-adjusted basis. Sweden also has suffered problems familiar to residents of countries that have had more severe outbreaks and stricter policies. Nursing homes have been hard hit, and Tegnell described Sweden’s failure to protect nursing home residents as its greatest shortcoming so far. Immigrant and ethnic minority communities also have suffered, due in part to their larger households. Just over half of all households in Sweden in 2016 consisted of only one person, while immigrants were substantially more likely than native-born residents to live in overcrowded conditions or multigenerational household.
Even with the less aggressive containment measures, the economic effects of the virus have been severe for the country. Sweden’s National Institute for Economic Research projected that gross domestic product would contract by 7% in 2020 and the unemployment rate would rise to just over 10%. The large fall in consumer and business confidence, the institute said in a release, point “to a rapid and severe downturn, not least in large parts of the service sector.”
“The economy will shrink both due to a drop in exports and is already contracting due to lower consumption. But the underlying causes differ: The export sector is mostly affected by the international situation, whereas the drop in consumption is directly related to the government’s recommendation of social distancing,” said Lina Maria Ellegård, an economist at Lund University.
In the first three months of the year, the Swedish economy contracted by less than 1% — less than the United States’ fall — but the production of both goods and services declined in March. The car industry — one of Sweden’s major export sectors — along with real estate, hospitality, and restaurants led the way.
That’s because even without lockdowns or orders, the behavior of Swedes still changed — to an extent. According to data collected by Google and Apple, Swedes have cut back on their travel to places like stores and restaurants and decreased their use of transit-like buses substantially, though not as dramatically as their Nordic neighbors in Denmark. Still, travel over the Easter holiday fell by 90%, Tegnell said on The Daily Show.
Multiple experts in Sweden I spoke to agreed that because a recommendation made by Swedish leadership is culturally viewed as more of a demand, the freedoms allowed have not resulted in free-for-alls. “There’s a basic misconception that there’s one big huge after-ski party,” said Lars Trägårdh, a Swedish historian. “That’s not true.”
Sweden’s voluntary restrictions policy is made possible by the high levels of trust throughout Swedish society. “We have a lot of social trust and a lot of trust in the institutions, and the institutions have confidence in the citizens,” said Trägårdh. “That’s why we decided to have this voluntary approach as opposed to one that’s more hardcore.”
The photos circulating online don’t fully represent the broader reality on the ground either. “I’ve seen pictures in the newspapers and news media of what looks to be crowded restaurants in Stockholm. What I’ve seen is mostly pretty sparse restaurants. Every other table is empty, and there’s very little business,” said Bo Becker, an economist at the Stockholm School of Economics. “Life doesn’t go on as usual, but maybe the lockdown is less severe than in other countries.”
But even if Sweden’s policy of allowing businesses to open and people to move out and about is not that different from some policies American states have or will soon implement, there’s been one major difference: the schools. Schools for children up to age 15 have remained open, all the way down to daycares and preschool. “That makes a world of difference,” Trägårdh told me. “It’s a gender issue.”
Sweden has one of the highest rates of female participation in the labor force for rich countries. Forcing young children to stay home would put many mothers in a bind or even knock them out of the workforce entirely.
“Closing down schools works well if you are in a well-to-do, middle-class family that has a house and a garden and can afford to have one person staying at home,” Trägårdh said. “That may not look like a doable proposition if you are a single parent or do not make a lot of money.”
Shutting down daycare and schools could increase risk as well, Erik Angner, a philosopher and economist at Stockholm University, explained, by leading working parents to turn to their own parents for help. “If you close daycares, then either one parent has to stop working or grandma or grandpa shows up,” he said. But since the elderly are most at risk, it was even more important to keep schools and daycares open
As other countries work through their peak infections, they will have to figure out how to reach a new status quo where the disease’s spread is still slow but restrictions can be lightened. “Now that everybody else is starting to shift toward opening up, people are talking about Sweden,” said Trägårdh. “Other Nordics are realizing you can’t keep schools closed forever. We’re in the long run here. It’s not a 60-meter race, it’s more like a marathon.”
While Sweden has a higher death rate than its Nordic neighbors and other wealthy European nations like Germany, it has been lower than rates in the Netherlands, France, and the United Kingdom. According to the Financial Times’ figures, Sweden has seen an 18% jump in excess deaths since the start of the outbreak, while Denmark has seen a 5% rise. Excess deaths in England and Wales are up 37%.
“The data out of Finland, Norway, and Denmark looks much better,” said Angner. “But everything will hinge on what will happen next.”
There’s some evidence that Sweden has managed to take the heaviest blow from the virus already — about a fourth or fifth of the population of Stockholm may have been infected, which would put the infection rate at a level similar to that found in New York City, which has had many more deaths and been under a near-total lockdown for almost two months. On Tuesday, health officials in Stockholm said the number of new deaths linked to Covid-19 was slowly decreasing from one week to the next.
The Swedish example carries both optimistic and pessimistic tidings for the United States as it embraces a partial, scattered reopening cheered on by the White House. It suggests that, even without punitive mandates, people can and will take measures to keep themselves safe from the disease. But even though people are protecting themselves without formal orders, the economy will be only slightly better off than it was under lockdown. Meanwhile, the American push to reopen is being driven by distrust of the government combined with the absence of robust safety-net programs to stem the economic bleeding. In the American context, Sweden’s example may be no example at all.
As a paper that was just accepted for publication, written by this author and two coauthors, we need reliable data to evaluate our progress as well as our failures to predict, based on appropriate statistical models and in order to lead us all in the correct path for future strategies for this pandemic and future crises.
I needed to let everyone know that telehealth is a scam and also that it is doing more harm than good. It doesn’t help care for many of our patients and is there to make money, first for the technology companies and also to bring in revenues for the physicians during this pandemic. They are taking advantage of our patient’s fears and the physicians who are in a bind not “allowed” to see their patients and therefore not able to bill the insurance companies. But as we have found out, both in our families needing care, our friends and our patients, that not all insurers are paying for these services and if paid the rate of payment is so poor and yes, it will end soon. Then what?
This week in fact, I had to see 3 patients whose cancers were very large and should have been evaluated and treated months ago, and yes, my office was open for those cancer patients. They also had medical conditions which should have been evaluated and treated which puts me in a bind knowing that I need to do surgery on these patients and now because of many conditions, I have to remove these large cancers in my office under local anesthesia. Yes, this has been a very depressing week.
Hallie Miller further discusses this problem. CareFirst BlueCross BlueShield, Maryland’s largest health insurer, is not reimbursing some medical and mental health providers for appointments held over the phone or via audio-only platforms to the dismay of those providers.
CareFirst, which serves over 3 million members, is only reimbursing primary care physicians, obstetricians and gynecologists, and behavioral health providers under specific conditions. They are paid a flat rate of $20 regardless of the length of the call.
Other specialists such as cardiologists, ophthalmologists and neurologists are not reimbursed by CareFirst for any phone or audio-only services.
With the coronavirus pandemic prompting doctors’ offices and hospitals to restrict in-person patient visits and elective surgeries, physicians and medical professionals have been forced to rapidly adjust to telehealth methods to provide routine care. Much of the daily grind has shifted to virtual channels, with video visits and phone calls replacing face-to-face interaction between doctors and patients as public health experts caution against gathering in close proximity indoors.
Most insurers, public and private, are now paying for telemedicine. But the lack of uniformity in policy and standards among insurers has caused frustration among Maryland’s physicians and mental health professionals, who have to navigate a new mode of care with differing guidelines and rates across the board.
“If we genuinely want to meet patients where they are, we need to have multiple flexible platforms, and if the payer isn’t flexible, that’s a challenge,” said Dr. George Ruiz, the chief of cardiology at MedStar Union Memorial Hospital, MedStar Good Samaritan Hospital and MedStar Harbor Hospital. “If payment structures come into place, we can overcome one of the major barriers to care that exist in medicine.”
Ruiz said insurers should not discount phone and audio-only sessions, which can serve vulnerable patient populations that may not have the technology or the ability to set up a video visit. Phone appointments also offer patients more convenience during time-sensitive situations and keep people out of hospitals and emergency rooms.
Gene Ransom, the CEO of MedChi, the state’s medical society, said his group has lobbied CareFirst to reconsider its audio and phone-only reimbursement policy.
“By not paying for audio-only services, you’re paying for much more expensive visits to emergency rooms later,” said Ransom, adding that some CareFirst-insured patients might not seek out care in the first place if they know their insurance will not cover it. “Carving out certain specialties could lead to a really bad outcome for the patient.”
In a statement, CareFirst said it only began reimbursing for phone and audio calls as a result of the coronavirus pandemic and then only for some doctors to allow check-ins to maintain continuity of care. It will continue such coverage after July 24 when a member cost share waiver put in place during the outbreak expires.
It also will continue to cover telemedicine, which it defines as a combination of interactive audio and video, as it did before the pandemic, CareFirst said.
“Visits that include both audio and visual components allow for provision of quality care for our members,” according to the statement.
CareFirst, in its statement, also noted that many doctors’ offices have reopened to provide on-site care.
Dr. Michael Silverman, managing physician at Cardiovascular Specialists of Central Maryland, a Johns Hopkins affiliate, believes video adds little to the substance of a telehealth visit. A phone call, he said, can deliver urgent care to patients with physical or technological limitations.
Silverman said a patient called him on June 10 for a 22-minute consultation about his spinal surgery the next day, which precipitated another 20 minutes of medical record review and note writing. CareFirst did not reimburse him for this effort, he said.
“There are physicians right now who are really suffering, financially,” said Silverman, adding that he came close to having to close his practice when the coronavirus pandemic reached Maryland in March.” A call to a cardiologist goes a long way, but if they can’t call, so be it.”
Ransom said insurers should follow the federal government’s lead, which has issued guidelines for Medicare and Medicaid — the services that cover older adults and people with low incomes — to cover audio and phone appointments and waive member cost shares until further notice. Other providers such as Aetna, Cigna and UnitedHealthcare also cover audio-only visits, though the guidelines differ from company to company.
Some providers said insurers should standardize telehealth so it can be utilized beyond the fall, as such services offer a number of benefits for both patients and doctors.
Paul Berman, a Towson-based psychologist and director of professional affairs for the Maryland Psychological Association, said telemedicine has proven especially effective for people with depression and severe phobias who struggle with leaving the home or driving. It also serves as a vital lifeline for people with substance use disorders or those suffering from acute crises.
Berman said CareFirst’s $20 flat fee for “phone consultations” for behavioral health providers covers only specific sessions that are initiated by the patient and are not related to matters discussed within seven days prior or 24 hours after the call. As a result, it does not provide for continuity of care.
“You have people who benefit from, and even need, ongoing treatment in order to stabilize their emotional state and physical health, and if they don’t have access to services, their functioning deteriorates,” Berman said. “Many psychologists … are not able to make paid contact with patients because of this exclusion.”
Berman said psychologists and counselors, in particular, will be put at risk if they are forced to return to their offices during the ongoing pandemic, as therapy requires face-to-face interaction for up to an hour. Public health experts have warned that such interaction, especially indoors, can lead to transmission of COVID-19 through aerosols.
To mitigate out-of-pocket costs for patients, Berman said some psychologists have decided to provide low-fee services, or have patients to scale back the number of sessions scheduled per month. But this can create gaps in care for patients that lead to regression in their mental health, he said.
“People have been locked out of the ability to make use of mental health services if insurance has not waived the telephone exclusion,” he said. “It makes no sense.”
U.S. COVID-19 deaths rise for second week in a row and it continues to rise
Reporter Lisa Shumaker noted that the U.S. deaths from COVID-19 rose for a second week in a row to more than 5,200 people in the week ended July 19, up 5% from the previous seven days, a Reuters analysis found.
The country reported over 460,000 new coronavirus cases last week, up nearly 15% from the prior week, according to the analysis of data from The COVID Tracking Project, a volunteer-run effort to track the outbreak.
Nineteen states have reported increases in deaths for at least two straight weeks, including, Arizona, Florida and Texas.
Testing for COVID-19 rose by 9% in the United States last week and set a new record high on Friday, with over 850,000 tests performed, the Reuters analysis found.
Nationally, 8.5% of tests came back positive for the novel coronavirus, down from 8.8% the prior week but still higher than the 5% level that the World Health Organization considers concerning because it suggests there are more cases in the community that have not yet been uncovered.
Thirty-one states had positivity test rates above 5%, according to the analysis, including Arizona at 24%, Florida and Nevada at 19%, and Idaho and Alabama at 18%.
Nationally, new COVID-19 cases have risen for seven straight weeks. Forty-three states reported more new cases of COVID-19 last week compared to the previous week, the analysis found.
For the first time since April, cases rose in New York State week over week, breaking a 13-week streak of declines. New Jersey now leads the nation with cases falling for two weeks in a row. The other six states have only seen cases decline for one week.
U.S. Coronavirus Deaths Could Be Cut 67 Percent With ‘Universal Mask Usage,’ Study Finds
Almost everyone is arguing about the use of masks and part of the problem is the changing opinions on mask wearing as well as the exhaustion of lockdowns and quarantines. Soo Kim reports that with novel coronavirus cases in the U.S. approaching nearly 3.9 million, several local authorities have issued orders requiring face coverings in public in a bid to reduce the spread of infection.
While many people have been opposed to mask mandates, the widespread use of masks could potentially help significantly reduce the country’s daily case count and daily death toll, according to data from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington.
The U.S. daily death toll is currently projected to be around 815 by November 1, according to projections from the IHME. . This daily death toll projected for November 1 could be reduced by over 66.4 percent if “universal masks” were applied across the country, the institute noted.
Universal mask usage refers to a 95 percent usage of masks in public in every location, with “mandates re-imposed for six weeks if daily deaths reach eight per million (0.8 per 100,000),” the institute explained.
Universal masks could also reduce the country’s projected daily case count for November 1 by more than half, according to the research. The daily case count in the U.S. is currently projected to reach around 124,929 by November 1, the IHME noted.
If universal masks were applied across the country, the projected daily case count could be reduced to about 46,495 by November 1, over 62.7 percent less than the current daily case count projected by the institute for the same date.
The daily case count and daily death toll in Arizona, which was found to be the most “anti-mask” state by a survey of over 150,000 Twitter posts using anti-mask-related hashtags, could also be reduced by around 70 percent if universal masks were applied across the state.
The state’s daily case count is projected to hit around 3,176 by November 1, which could be reduced to around 899 with universal mask usage, according to the IHME projection, a more than 71.6 percent reduction in daily new cases.
Arizona’s daily death toll is expected to reach nearly 20 by November 1. But the projected daily death toll could be reduced by over 68 percent if universal masks were applied, the IHME noted.
Statewide mask mandates have been issued in several parts of the country, including most recently in Texas, Kansas, Pennsylvania and Oregon.
Masks are currently not required in Iowa, Montana, South Dakota, and Wisconsin.
Face coverings are required in certain counties and cities within Alaska, Arizona, Florida, Georgia, Idaho, Kentucky, Minnesota, Mississippi, Missouri, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, Tennessee, West Virginia, and Wyoming.
This week, President Donald Trump appeared to have shifted from a reluctance to wearing face masks to suggesting they are patriotic, while sharing a photo of himself wearing one in a post Monday on his official Twitter account.
Telehealth could grow to a $250B revenue opportunity post-COVID-19: analysis
Heather Landi pointed out that during the COVID-19 pandemic, consumer adoption of telehealth has skyrocketed, from 11% of U.S. consumers using telehealth in 2019 to 46% of consumers now using telehealth to replace canceled healthcare visit, according to consulting firm McKinsey & Company’s COVID-19 consumer survey conducted in April.
McKinsey’s survey also found that about 76% of consumers say they are highly or moderately likely to use telehealth in the future. Seventy-four percent of people who had used telehealth reported high satisfaction.
Health systems, independent practices, behavioral health providers, and other healthcare organizations rapidly scaled telehealth offerings to fill the gap between need and canceled in-person care. Providers are ready for the shift to virtual care: 57% view telehealth more favorably than they did before COVID-19 and 64% are more comfortable using it, according to McKinsey’s recent provider surveys.
Pre-COVID-19, the total annual revenues of U.S. telehealth players were an estimated $3 billion, with the largest vendors focused on virtual urgent care.
Telehealth is now poised to take a bigger share of the healthcare market as McKinsey estimates that up to $250 billion, or 20% of all Medicare, Medicaid, and commercial outpatient, office, and home health spend could be done virtually.
The consulting firm looked at anonymized claims data representative of commercial, Medicare, and Medicaid utilization.
The company’s claims-based analysis suggests that approximately 20% of all emergency room visits could potentially be avoided via virtual urgent care offerings, 24% of healthcare office visits and outpatient volume could be delivered virtually, and an additional 9% “near-virtually.”
Up to 35% of regular home health attendant services could be virtualized, and 2% of all outpatient volume could be shifted to the home setting, with tech-enabled medication administration.
Many of the dynamics that have helped to expand telehealth adoption are likely to be in place for at least the next 12 to 18 months, as concerns about COVID-19 remain until a vaccine is widely available.
Going forward, telehealth can increase access to necessary care in areas with shortages, such as behavioral health, improve the patient experience, and improve health outcomes, McKinsey reported.
Providers and patients are concerned that recent federal and state policies expanding access to telehealth will be rolled back once the emergency period ends.
Industry groups, including the College of Healthcare Information Management Executives (CHIME), are calling on lawmakers to ensure the changes enacted by Congress and the administration become permanent.
McKinsey’s research indicates providers’ concerns about telehealth include security, workflow integration, effectiveness compared with in-person visits, and the future for reimbursement.
“We call on Medicare and all other insurers to continue to fund telehealth programs and work collaboratively on coverage and coding to lessen provider burden. We cannot go back to pre-COVID telehealth; instead, we must go forward. Patients will demand it and providers will expect it,” CHIME CEO and President Russell Branzell said in a recent statement.
Telehealth also is drawing bipartisan support. Senator Marsha Blackburn, R-Tenn., urged Congress to “continue to support this expansion and codify the administration’s changes to support the health needs of the American people,” in a recent news release.
Rep. Robin Kelly, D-Illinois, is introducing a bill directing HHS Secretary Alex Azar to oversee a telehealth study looking at the technology’s impact on health and costs, Politico reported in its newsletter today.
Taking advantage of the telehealth opportunity
Healthcare providers and payers will need to take action to ensure the full potential of telehealth is realized after the crisis has passed, according to McKinsey.
There continue to be challenges as providers cite concerns about telehealth include security, workflow integration, effectiveness compared with in-person visits, and the future for reimbursement. There also is a gap between consumers’ interest in telehealth (76%) and actual usage (46%). Factors such as lack of awareness of telehealth offerings and understanding of insurance coverage are some of the drivers of this gap.
“The current crisis has demonstrated the relevance of telehealth and created an opening to modernize the care delivery system,” McKinsey consultants wrote. “Healthcare systems that come out ahead will be those who act decisively, invest to build capabilities at scale, work hard to rewire the care delivery model, and deliver distinctive high-quality care to consumers.”
McKinsey outlined steps industry stakeholders should take to drive the growth of telehealth.
Payers: Health plans should look to optimize provider networks and accelerate value-based contracting to incentivize telehealth. Align incentives for using telehealth, particularly for chronic patients, with the shift to risk-based payment models.
Payers also should build virtual health into new product designs to meet changing consumer preferences, This new design may include virtual-first networks, digital front-door features (for example, e-triage), seamless “plug-and-play” capabilities to offer innovative digital solutions, and benefit coverage for at-home diagnostic kits.
Health systems: Hospitals and health systems should accelerate the development of an overall consumer-integrated “front door.” Consider what the integrated product will initially cover beyond what currently exists and integrate with what may have been put in place in response to COVID-19, for example, e-triage, scheduling, clinic visits, record access.
Providers also should build the capabilities and incentives of the provider workforce to support virtual care, including, workflow design, centralized scheduling, and continuing education. And, health systems need to take steps to measure the value of virtual care by quantifying clinical outcomes, access improvement, and patient/provider satisfaction. Include the potential value from telehealth when contracting with payers for risk models to manage chronic patients, McKinsey said.
Investors and health technology firms: These players also can support the new reality of expanded telehealth services. Technology firms should consider developing scenarios on how virtual health will evolve and when, including how usage evolved post-COVID-19, based on expected consumer preferences, reimbursement, CMS and other regulations.
Investors also should develop potential options and define investment strategies based on the expected virtual health future. For example, combinations of existing players/platforms, linkages between in-person and virtual care offerings and create sustainable value. Investors and technology companies also can identify the assets and capabilities to implement these options, including specific assets or capabilities to best enable the play, and business models that will deliver attractive returns.
And Now Payment Problems as Patients Lose Coverage due to COVID Leigh Page reviewed what many practices are seeing happen as the lockdowns ease up. Percy Erachshaw, DO, a general surgeon, was happy and encouraged when New York City started to open up a bit during the COVID outbreak and patients began coming back into doctors’ offices and having online visits.But Erachshaw, like many physicians nationwide, is quickly learning that the insurer payments he’s expecting may be a thing of the past.”The patient volume is back,” said Erachshaw, who manages four practice sites in Brooklyn and Queens, New York. Two of the sites that had been closed for 2 or 3 months recently reopened.However, “I have patients who don’t have insurance coverage anymore. They lost their jobs, but they are my long-term patients, so I can’t turn them away”. Many of these patients need help getting on Medicaid, but Erachshaw doesn’t have enough staff to help them. Much of his former staff left the practice and are not returning. With unemployment benefits temporarily enhanced by federal dollars, “They discovered they were making more money staying at home than working,” he said. Many Patients Lost Healthcare Coverage Because of layoffs during the COVID-19 crisis, an estimated 12.7 million Americans lost employer coverage from early March to May 1.Even some workers who have not been laid off may lose coverage. Although the Affordable Care Act requires large employers to provide health insurance, small businesses can cancel coverage.
“Depending on how long the high unemployment lasts, practices could have many more uninsured patients,” said Lori Foley, managing principal in Atlanta, Georgia, for PYA, a national healthcare consulting and accounting firm.
Patients who lose coverage have the option of buying their own insurance, but in many cases, Foley says, they can’t afford to do so. “Premiums for individual health insurance can be expensive, and laid-off workers may not have been saving for that, because they did not expect to be laid off,” she said.
Indeed, many people simply don’t have the funds to take out a new insurance policy. According to one analysis, 40% of Americans do not have $400 to cover unexpected expenses.
Don’t expect patients who have been laid off to turn up at your office with a new form of coverage, says Kathryn I. Moghadas, a healthcare consultant in Winter Springs, Florida. “They’re not going to run out and get new coverage,” she said. “If they come in, they’ll want to use their credit cards and negotiate a cheaper rate with the office.”
Many people who are still working are concerned about their finances or about getting the virus, so they’re limiting their medical care. Health insurers Humana and Aetna recently noted that use of medical services has plummeted by at least 30%.
High deductibles, which have become increasingly common, also incentivize people to cut back on care, particularly at the beginning of the year, before they have met their deductible. Among workers who have a health insurance deductible, the average deductible is $1655 this year.
Many patients are selecting health services on the basis of price. More hospitals are providing their prices online and even offer tools to calculate payment estimates. Patients also have begun to expect price quotes from practices.
“When these patients call a practice, they may not want to simply book an appointment,” Foley said. “They will want to hear about your prices. Many practices are still not used to this. They often don’t have the self-pay prices and payment plan information available.”
Payers Are Making It Tougher Some health insurers are taking longer to pay because, like many other businesses in the COVID-19 era, they have fewer staff, says Michael La Penna, a practice management consultant in Grand Rapids, Michigan.“Due to the lower staffing, it can take an insurer longer than the usual 30 to 45 days to process a payment,” he said. Low staffing has also made it hard to get prior authorizations, such as for primary care physicians’ (PCPs’) referrals to specialists in health maintenance organizations (HMOs). “We will call the HMO and we would be put on hold forever,” Erachshaw said. “It has been a mess and a half. If you don’t have an approval for a referral, you can’t refer the patient.” Some payers have temporarily waived the prior authorization process for certain services during the COVID-19 crisis, but they may not implement those changes. “Many payers claim to have relaxed authorizations for ‘most’ or ‘many’ services,” the report said, “but what ‘most’ or ‘many’ means is anyone’s guess.” Another area of confusion is the new or enhanced telehealth payments that Medicare and many private payers are temporarily allowing during the COVID crisis. “The typical PCP has six, seven, eight different payers, each with a different telehealth policy,” said Robert L. Phillips, MD, executive director Center for Professionalism and Value In Healthcare, a think tank in Washington, DC. “As a working clinician, I can’t manage all of those policy differences in my head.”“Each insurer has slightly different rules on telehealth, and they keep changing,” said Rebecca Etz, PhD, co-director of the Larry A. Green Center, another think tank in Washington, DC, which promotes primary care. “For example, some won’t pay for telephone-based care if the call lasts less than 10 minutes.” Insurance companies themselves may be confused about their own telehealth policies and thus underpay or deny payment to providers. Telehealth organizations say insurers have been slow to update their software and policies.Spotty payments for telemedicine and many other services mean many doctors are reimbursed only a fraction of what they are entitled. In an April survey of physicians and other clinicians in primary care, 57% said that fewer than half of their visits in the past week were reimbursable. Here are some ways practices can deal with patients who lose insurance and the insurance plans that represent them. Keep the bill low. Look for ways to keep costs in check. For example, “physicians could find less expensive form of meds for patients who are concerned about high costs,” Moghadas said. Know your prices. “Practices should be able to tell self-pay patients what they basically can expect to pay,” Foley said. At the least, a practice could state that a new visit would cost $150 for the visit, plus additional costs for labs and x-rays, and a visit for an established patient would cost $75, she says. Bring your patients back in. Many of your patients are not going to return to you without a little nudge. “You can’t sit back and wait. You need to remind them,” said Phil Boucher, MD, a pediatrician in Lincoln, Nebraska, who has been a speaker on the online Back to Busy Summit for physicians who want to revive their practices in the era of COVID-19. “Reach out to your patients by sending them an email, if not a text or a message on social media,” he advised. “Better yet, go on local news and talk about your practice opening. Give them a reason to come in, such as annual checkups and routine care.”For example, Moghadas notes that diabetes patients generally need to come in every 3 months, and women need to see their gynecologist more often than once a year. “You can set up your EHR system to determine when each patient needs to come in,” she said. Update insurance coverage information. “Asking every year about insurance coverage is not frequent enough right now because there are so many changes going on,” Foley said. “Ask about coverage on each visit.”adds that when employees are laid off, coverage often lasts for the rest of the month. If patients inform you of the change immediately, you might be able to get them in to see you before coverage ends, he says.Help patients get coverage. “Help to get patients signed up with Medicaid or COBRA,” Boucher said. “Your billing people can do this through a phone call.”
Small practices, however, may not have extra staff to do this work, Foley says. Also, many practices have staff shortages, such as Erachshaw’s practice. “I still have to find and train enough staff to get vital signs,” Erachshaw said. “I don’t have enough people to sign patients up for Medicaid.”
Effective Tactics to Collect from Patients Having many uninsured patients means you have to shift to getting more payments from patients, which is harder to do than getting paid by insurers, Moghadas says. “It really takes a lot of effort to collect this money,” she said. “Most practices are already experienced with patient collections, due to high deductibles,” Foley said. “Practices need to identify who is self-pay and what their discount approach is.“You have to collect at the time of service,” Foley adds. “If you wait until after the appointment, the chances of payment drop considerably.” If the bill is past due, “tell them about it when they come in for their next appointment,” she said. “It’s easier to collect a bill face to face.” When patients say they can’t pay the bill, ask about their financial hardship. “Find out their household income,” Foley said. “Set up a sliding scale in which payments are reduced depending on the patient’s income. Health systems do this all the time.”After sending a few bills, Foley says, the next letter to the patient ― the pre-collect letter ― should state that the bill will now go to a collection agency unless it is paid in full. “People worried about their credit rating, such as those buying a house, will pay, but others are willing to let their debt go to a collection agency,” she said.Creating payment plans requires setting a reasonable monthly amount to be paid. “If you set the amount too low, it could take years to pay off,” she said. If the amount owed is $500 or less, she recommends setting up three monthly payments, and if it’s over $1000, then six monthly payments. The Future The road ahead for doctors still seems very bumpy. The reopening of public places is coming in fits and starts, and when the number of COVID-19 cases rises again, patients stay away for a while, Phillips says. “Each temporary spike in COVID cases has a lasting effect on practices,” he said. “Patients will disappear for a while afterward. Philips predicts that because of the epidemic, primary care practices will lose almost $20 billion by the end of the year. If temporary telemedicine payments were removed, the losses could be double that, he says. When Medicare and other payers drop the current higher payments for telemedicine, as planned, many doctors will be forced to give up telemedicine, predicts La Penna. “At lower or nonexistent reimbursement rates for telemedicine, it would not be worth their while to use it,” he said. Some doctors, however, are doing surprisingly well now that the virus is abating and some restrictions have been lifted in some areas. When surgeries were temporarily banned because of COVID-19, George Waring IV, MD, an ophthalmologist in Mt. Pleasant, South Carolina, lost almost all his patients.When he reopened in May, he was not sure whether his previous volume of patients would return. Many of his patients undergo Lasik surgery to replace glasses or contact lenses, or they receive advanced lens implants after cataract surgery, both of which are usually not covered by health insurance. But as it turned out, he’s had more visits than at this time last year. Was this the result of pent-up demand for services, as many observers expected after bans on elective surgery are lifted? “No,” he said, “it’s much more than that.” He has several explanations for the high demand. “Having to wear masks against COVID makes people less comfortable wearing glasses, because they steam up,” he said. “Also, people need to avoid putting their hand on their face, which you have to do to insert contact lenses. So, they want Lasik.“Furthermore,” he added, “sheltering in place has made some people more contemplative, and they may get a new perspective on life and consider visual self-improvement.”
The question is what does the future look like and how do we prepare, which is what a paper that I wrote with two co-authors and was just accepted for publication considered (Science and Data Driven Choice: Shaping Empowerment During COVID-19 and Beyond)… Yeah!