Category Archives: COVID-19 Variant

COVID Hospitalizations in the US Soar to More Than 100,000, Vaccines and The Idiocy regarding Ivermectin!

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.

3. Our vaccine-induced T-cell immunity limits disease severity

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.

Delta Variant Now Accounts for 83% of US Cases and Back to Mask Wearing, Even for Those Vaccinated!

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.

Just do it, get vaccinated!

Continue with COVID-19 Precautions or Declare Pandemic Under Control, Anti-vaxers and the Delta Variant?

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

The Pandemic Will Likely End In One Of These Four Ways; Social Media and More About Vaccines.

I am getting really frustrated having to try to convince friends and patients of the value of vaccinations for Covip-19. Vaccinations promise an end to the coronavirus pandemic in the US. What kind of ending, though, is up to us?

I “loved” the excuse that she knew that the GOVERNMENT was putting tracers in the vaccines to track our every move and racist thoughts.

And with the cases and deaths due to COVID increasing in such very high numbers, while Israel as a country is the only country that has reached herd immunity. Their vaccinations are over 80% of their population and their new cases are so very low.

Reporter Dan Vergano noted that if the White House’s vision goes according to plan, vaccinations will end the pandemic in the US in time for 4th of July fireworks. Or the pandemic won’t end, and these shots will be the first of many we’ll get for years. Or they’ll offer a brief summer respite — before a more severe version of the coronavirus catches fire.

A return to a life resembling normalcy looks closer than ever now that, as of Monday, vaccines are available to every adult in America. Around 80 million people are already fully vaccinated, and President Joe Biden said on Wednesday that the US has already reached his goal of 200 million shots in the first 100 days of his administration, eight days early.

But with half of the population still unvaccinated and COVID-19 cases once more rising, just how close are we to the pandemic ending, both in the US and across the world?

Whether the pandemic ends in the US by Independence Day — or much further in the future — will depend on the vaccines, the virus, and decisions people make, experts say. The big questions include how long the vaccines’ protection lasts, how well they fight off new coronavirus variants, and whether the entire globe can hold off these emerging threats. Then there’s the X factor of how many people will be willing to get shots.

The benchmark for a successful vaccination campaign has long been considered to be “herd immunity” — having enough people vaccinated to keep sick ones from sparking outbreaks. That might require 80% of US adults getting vaccinated, according to infectious disease researcher William Schaffner of the Vanderbilt University School of Medicine.

Other experts have urged Americans to not obsess over herd immunity. “I can’t say it’s going to be ‘this’ percent,” Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said this month, although he has previously floated percentages ranging from 70% to 85%. “We’ll know it when we see it. It’ll be obvious.”

Getting to that turning point could take very different routes, experts told BuzzFeed News. Although the summer everyone hopes for is within reach, worse outcomes are also possible. At this pivotal moment in the crisis, a lot depends on how willing people are to help themselves by continuing to wear masks and isolating until they are fully vaccinated — and to help people around the world get vaccinated too.

“It depends on decisions we make,” Lauren Ancel Meyers, a University of Texas epidemiologist, said this month at a Stanford University symposium about herd immunity.

Here are four ways that the pandemic could end in the US.

1. The Better Ending: Vaccination Returns Life Close to “Normal”

By June, most US adults get vaccinated. The shots halt the spread of SARS-CoV-2, even the more transmissible variants. And people feel safe shopping, traveling, and visiting each other, almost like they did before the pandemic.

This is the best outcome — and it isn’t completely far-fetched. Half of US adults have received at least one shot. Even with Johnson & Johnson’s vaccine paused, more than 3 million shots are being administered a day; at that rate, every adult American could receive one by late June.

Israel offers a glimpse of this future. There, a fast-paced campaign had immunized more than half of the population by mid-April. The results have been striking in the country of 9 million, with new cases falling to around 200 a day, 2% of the January peak. Starting this weekend, an outdoor mask mandate will be lifted.

White House / Via whitehouse.gov

White House COVID-19 briefing slide, showing case drop with 62% vaccination

Similarly, in the US, new cases among nursing home residents dropped by 96% and deaths by 91% between December, when vaccinations started, and March. After a slow start, more than 4.8 million people in nursing facilities have received at least one shot.

Although case numbers have increased in recent weeks, Deepta Bhattacharya, an immunologist at the University of Arizona College of Medicine, predicts “a smaller bump over the next couple months that should by the summer settle down to a pretty low level of cases.”

That doesn’t mean that masking would stop. It’s worth noting that the declines in both Israel and nursing homes happened while restrictions were maintained. Under current US plans, young teens won’t start getting shots until the fall and elementary school–age children in the winter of 2022, meaning that their schools will likely keep face coverings, some virtual classes, and other restrictions for the foreseeable future.

But most partial or full closures of shops, restaurants, universities, and bars could end this summer if US cases fall like they did in Israel.

The bottom line is that the Pfizer and Moderna vaccines, which make up the great majority of US shots, have proven 90% effective in real-world studies against COVID-19. Although some people have gotten infected despite vaccination, their numbers are small: about 6,000 cases out of 84 million fully vaccinated people, or .007%, according to CDC data.

“It is not unexpected — the vaccine is not 100% protective,” Scott Lindquist, a Washington state health department official, said in a recent press briefing about “breakthrough” infections there. “But what we saw were mostly very mild symptoms, if any at all.”

And existing vaccines appear to protect against new coronavirus variants, such as the B.1.1.7 strain, according to CDC data. “If you lose a little bit of protection to a variant, but the vaccine still keeps you safe, that’s still a good result,” Bhattacharya said. Vaccines aside, he noted that a sizable chunk of the population — more than 1 in 5 Americans by one recent estimate — also has some natural immunity from past infections, though studies suggest that this protection likely isn’t as long-lasting or robust as vaccination.

“I do think we’ll be OK by the summer,” said the immunologist, who is personally planning to travel to see his family in cities across the country. “Tickets booked for early July!”

In this future, the coronavirus cools down enough to be managed like the measles: a virus tamed by a vaccine that is added to childhood shot regimens, with occasional outbreaks in unvaccinated communities.

2. A Mixed Ending: Defanging, Not Defeating, the Virus

Mass vaccination delivers yet another future: the death rate from COVID-19 drops drastically, because the shots prevent severe and fatal illness, but outbreaks continue, largely among pockets of unvaccinated people, including younger people who are less targeted for vaccines or less worried about getting sick in the first place.

“A more realistic scenario is that older, more vulnerable individuals will receive a disproportionate number of doses,” said infectious disease modeler Jack Buckner of the University of California, Davis, by email. “Under these conditions additional outbreaks are more likely but the case fatality rate would be lower.”

Last month, CDC Director Rochelle Walensky was asked whether a sharp decline in death rates, with case numbers remaining high over the summer, might lessen the public’s urgency to get vaccinated. She called it a concern, but noted that children are dying of COVID-19, albeit very rarely, and that long-term complications from infections, also known as “long COVID,” plague even people with mild cases. A recent study from Sweden, for example, found 1 in 10 healthcare workers who had mild cases have felt effects, like loss of smell and taste, fatigue, and breathing problems, for months after.

“We’re going to defang the virus rather than defeat it.”

In this mixed scenario, we dodge a summer surge of deaths, but outbreaks occur in some counties or states. Herd immunity is also never quite reached in this future, because variants circle the globe every year like variations of the seasonal flu. Post–mass vaccination, the coronavirus would then enter a “mild endemic state,” where SARS-CoV-2 is reduced to a childhood cold, said Harvard epidemiologist Marc Lipsitch at the recent Stanford symposium about herd immunity. “We’re going to defang the virus rather than defeat it,” he said. “We’ll make it a nuisance that makes people a bit ill, rather than something that kills people in large numbers and causes the hospital system to groan under the weight.”

A related possibility is that vaccination only delivers immunity for a year or two and requires regular booster shots for older and younger people alike, which the heads of Pfizer and Moderna have told investors might be the case. (On Sunday, Fauci said on NBC’s Meet the Press that the FDA and CDC — not vaccine makers — will decide by fall about boosters.)

“Even if we reach the herd immunity threshold in the US or in rich countries, this virus is going to continue to circulate,” said Lipsitch.

Right now, doses are only promised on the order of hundreds of millions, and the planet is home to 7.8 billion people. The World Health Organization has warned that global under vaccination would be a catastrophic moral failure, prolonging coronavirus transmission around the world.

3. A Worse Ending: A Fourth Surge for the Summer

The better outcomes are far from inevitable. White House officials regularly say that the US is in a race between vaccination and more contagious coronavirus variants. In this scenario, we lose the race. The result: a fourth surge.

The reasons for worry are plain in case numbers that have stopped declining and are instead trending upward again, now averaging around 67,000 newly-reported infections a day. The more transmissible and dangerous B.1.1.7 coronavirus strain is quickly becoming the predominant one nationwide, now accounting for 26% of all new cases.

“We remain in a complicated stage,” the CDC’s Walensky said Monday. “On the one hand, more people in the United States are being vaccinated every single day and at an accelerated pace. On the other hand, cases and hospitalizations are increasing in some areas of the country, and cases among younger people who have not yet been vaccinated are also increasing.”

If the US falls behind on vaccinations, then a second lockdown period might result. Rising hospital admissions could lead governors and mayors to shutter bars, restaurants, and stores once again.

“We are in real risk of throwing away all the gains we have made, and losing another summer,” Debra Furr-Holden, a Michigan State University epidemiologist, told BuzzFeed News.

Her state, as well as the rest of the Upper Midwest and the Northeast, is in the thick of massive outbreaks right now. Some counties reopened bars, gyms, and restaurants too early, Furr-Holden believes, which in her view should serve as a warning to the rest of the country.

Although 74% of US adults say they want a shot, up from half in September, that’s still not enough to achieve herd immunity, some suggest. “We have to get about 80% of adults vaccinated,” said Schaffner, the infectious disease specialist at Vanderbilt. “We’ve never done that with any vaccine in the United States.”

Some areas of the country are also much more resistant to vaccination than others. In states like Tennessee, Kentucky, Alabama, and Mississippi, as many as 37% of people tell pollsters they don’t want a shot. Politics clearly plays a role. Older, rural conservatives express the most hesitation, and their fears are reinforced by misinformation and fearmongering on right-wing cable channels.

“We are running into people who have expressed some hesitancy, so we have to listen to them and address their concerns,” said Schaffner, who is based in Nashville. Walensky acknowledged this week that “the administration of vaccines across the country is not uniform.”

But Andy Slavitt, the senior White House COVID-19 adviser, said he was unwilling to entertain the idea of the federal vaccination campaign shifting doses to parts of the country clamoring for shots and sending less to ones in areas where they go unused. “We are not going to quote-unquote ‘punish’ less-ready areas,” Slavitt told BuzzFeed News during a briefing this week. The key, he said, is to convey to people that while vaccines were hard to get during the initial rollout, there are now more than 60,000 vaccination sites nationwide, and at least one of them is within 5 miles of where 95% of the population lives.

Whether enough Americans will take that message to heart remains to be seen. If not, we may only reach herd immunity after another painful surge.

4. The Bad Ending: After the Summer, Global Variants Revive the Pandemic

Then there’s the worst-case scenario. In a mostly unvaccinated world, a new and more deadly coronavirus variant — or variants — overpowers vaccines and restarts the global pandemic all over again. The US, along with everyone else, has to begin again with new vaccines.

“Coronavirus mutates a lot — they can do it in humans, they can do it in animals — and the question is how important are these mutants going to be,” Stanford University infectious disease expert Julie Parsonnet said at the herd immunity symposium held at her university. “We don’t live just in Palo Alto, or just in California, or just in the United States. We live in a world where there are a lot of unvaccinated people, and as long as we don’t focus on the world more globally, we’re going to have problems.”

For now, the available vaccines are effective against the variants circulating in the US. But experts are surprised at the speed at which more transmissible ones have arisen, said Bhattacharya of the University of Arizona. Their arrival reflects just how widely the coronavirus has spread from host to host, each acting as a lab for new mutations to emerge.

“The places where the variants are growing, they’re not growing because they are evading the immune system, they are going nuts because there aren’t enough people that are immune,” Bhattacharya said. “Obviously this isn’t the best situation, because the longer you let this go, the better the odds that you will get some weird thing that will eventually start to grow out because it can evade the immune system.”

Last week, the White House announced a $1.7 billion effort to detect such new strains. Pfizer, Moderna, and other vaccine makers are already testing prototype booster shots that are designed explicitly against variants, such as the B.1.1.7 strain.

In the face of this threat, a recent risk analysis led by George Ioannou, an expert on veteran care at the University of Washington, offers a framework for who should get prioritized for vaccines. To prevent deaths as much as possible, people with the most severe risk factors, such as diabetes, heart failure, or kidney failure, should be given shots first, this work suggests. At the same time, if there is enough supply, vaccines should be administered as quickly and widely as possible to combat the new variants.

“You really don’t want that threat just hanging around,” Bhattacharya said.

But even in this worst case, the silver lining is that the coronavirus has nevertheless proven amenable to vaccination, he and other experts noted, unlike HIV, which for decades has thwarted vaccines. A coronavirus strain that evades the current vaccines will almost certainly be susceptible to shots that have yet to be designed.

That means vaccines will at some point deliver an end to the pandemic, no matter how many changes in work, school, and daily life it leaves behind, said Yale sociologist Nicholas Christakis, author of Apollo’s Arrow: The Profound and Enduring Impact of Coronavirus on the Way We Live.

“Eventually it will return to normal,” Christakis told BuzzFeed News. “Plagues end — they just do.”

Social Media: A Parasite on Our Pandemic Mental Health

Doctor Vinay Prasad reported that recently, a physician colleague of mine, someone whom I’ve met in person and with whom I’ve shared a laugh, began to tweet increasingly hostile barbs about me. In a certain respect, it was a typical social media interaction — an uncharitable reading of one’s point of view and a scornful reply. But it was also unusual, as we have met in person, face to face.

In my experience, online anger like this is summoned only when the other person has been depersonalized — just a face dissociated from a person. I’d rarely experienced it from someone who I knew in real life. Just as I started to wonder what might be going on, a mutual friend called to say they had seen the out-of-character barbs. Apparently, this colleague has been suffering from a serious medical illness and was going through a hard time. By the end of the call, I was left feeling sympathetic.

Later that day, I noticed that a professor whose tweets I greatly enjoyed had shut down their account. Poof! They, and their astute comments, were gone entirely. I sent them a note, mostly to let them know that I had been affected by their sharp thinking over the years, and was sorry to see them go. The person wrote back that the growing hostility had driven them away. Every time they said anything, they felt mobbed by a sea of increasingly angry voices. They didn’t need the stress.

Finally, the same day, a colleague from another university called me to ask for some advice. She had been on Twitter, and was troubled by increasingly hostile and negative feedback. The specifics were ugly, and I could tell from the tone in her voice that my colleague was pained. I gave the few tips I know and went for a long run to think.

What Is Going On?

In the best of times, social media is a double-edged sword. It is a great way to get a message to many people, but it is de-personal, and driven by the economy of attention. Anger, disgust, and outrage are the emotions that engage and addict the users. People, good people, can become disinhibited and say things they don’t truly mean, or would never say in real life. Of course, this is during the best of times.

We are not in the best of times. People have been cut off from friends, family, and co-workers, and many are living in isolation. In fact, it is the loneliest year in human history. The largest number of people in history (billions) have deprived themselves of, at least some, social interactions. Mental health is suffering, and physicians, healthcare workers, researchers are suffering alongside everyone else. When we are tired and angry we are not our best selves, and paired with the algorithms of social media, it is a recipe for disaster.

Where Are We Now?

Every day people go online and the difficulties of the last year loom large in our minds — over 500,000 dead Americans, disjointed and often incoherent policy responses, the list goes on. Some are angry that we didn’t do more, sooner. Others are angry about interventions and restrictions that were broadly implemented that might not have helped, and even hurt. Both groups might be right: we were unwilling to do some things that might have helped, and simultaneously pursued other interventions that didn’t, and unfortunately hurt less-fortunate Americans. It will take years to tease these apart, as I have written. Regardless, we are angry. So, we go online looking to vent that anger. If we felt the bigger error was not enough restrictions, we get angry when someone is critical of restrictions. And if vice versa, we find a different scapegoat. A philosopher recently told me, we get most angry when other people don’t follow restrictions that we are able to follow.

The angry train goes off the rails when we invent motivations for others. Folks who share our point of view are always good people who want to save lives, and folks who disagree with us are people indifferent to human beings, grifters, ideologues, or attention-seekers. But, if one steps back, how can that possibly be? Surely people on all sides of an issue — whether that be school reopening or best vaccination practices — have varied reasons for holding their view. A tiny fraction may have some ulterior motive, but surely the vast majority hold their view for the same reason folks who disagree hold their view — an alternative interpretation of facts and values. I suspect a year from now the idea that the world is full of strictly good and bad people will look particularly ridiculous.

How Can We Make It Better?

I don’t know how we can improve the situation on social media, and more critically, reverse the anguish so many are facing in real life — but I do have some tips about how we might help ourselves.

1. Get offline. The professor who deleted their account had the right idea. Each of us has to decide if social media serves our purposes and makes us better informed or happier, but probably all of us should use it less. Read it less, and post less.

2. Mute all notifications. I did this a few years ago, and I quickly found more joy in my life. Say what you have to say, and let it go. No need to reply to anyone, and the easiest way is to set the accounts to never disturb you again.

3. Don’t reply to others. If you read a point of view you disagree with, what value is there in replying to the other person? Just state your point of view in your terms on your feed. No need to pick a fight. Just make your point on your terms.

4. If you are having a hard time at home or work, don’t use social media. It is hard enough to manage when you wake up in a good mood, but when you are feeling tired, scared, afraid or sick, it is too much. Corollary: If you love someone, and they are hurting, suggest they do the same.

5. Meet or call someone every day. Social media thrives from our loneliness — it’s a cheap way to feel less lonely in the loneliest year of human history. But it is a neon light to the sun. Call someone. Visit someone. Interact more in real life.

6. Tell someone you don’t know you appreciate their thoughts. Perhaps the best thing we can do to combat negative emotions is to give some positive feedback to folks we appreciate. I have sent some emails to people, but perhaps I am not thinking big enough. I plan to go on social media and talk openly about people whose thinking delighted me over this last year. It is the least I can do to combat the animosity.

Toward More Productive Dialogue

When we are feeling powerless, getting angry at someone is seductive. It is a way to channel and reorient your energy. Unfortunately, it leaves all involved worse off. Instead, consider using your energy to articulate or refine your perspective, to push for positive change. That doesn’t mean that there are not real errors — but jumping on a single tweet by a minor character in a drama is unlikely to be the change-maker. My tips are just suggestions, but all meant to re-orient the compass toward productive dialogue.

Scientists Reveal How the AstraZeneca Vaccine Causes Unusual Clots

Brenda Goodman reported that scientists in Germany say they’ve worked out the two-step mechanism by which the AstraZeneca vaccine causes rare but devastating blood clots that gobble up the body’s supply of platelets.

So far, European regulators have reported more than 220 cases of unusual blood clots and low levels of platelets in patients who received the vaccine, called Vaxzevria, which was developed with funding from Operation Warp Speed as part of the race to develop a suite of vaccines to protect people from COVID-19. Vaxzevria has not yet been authorized for use in the United States.

“This is, in my opinion, rock-solid evidence,” said Andreas Greinacher, MD, head of the Institute of Immunology and Transfusion Medicine, University Hospital Greifswald, Germany, who was among the first scientists in the world to link the rare clots to antibodies against the platelet factor 4 protein.

Greinacher said he found the same mechanism using three different technologies to gather evidence: dynamic light scattering, super-resolution microscopy, and electron microscopy.

“This is what scientists usually think is confirmatory evidence,” he said in a call with reporters hours after publishing his study as a preprint ahead of peer review on the Research Square server.

Greinacher said he felt an urgent need to get the information out as soon as possible. He said his team had worked around the clock for 5 weeks to get answers, “because we are in the middle of the vaccination campaign. This was the driving force for us and the big motivation to provide these data as fast as any other possible,” he told reporters on the call.

Greinacher said that he believes the mechanism linking the vaccine with the rare clotting reactions is likely to apply to other vaccines that also use adenoviruses to ferry instructions for making the virus’s spike protein into cells.

“My assumption is, and that’s a hypothesis, that this is a class effect of vaccines using adenovirus,” he said. He added that he could not be certain because he only studied reactions to the Vaxzevria vaccine. But previous studies have shown that adenoviruses can cause the type of platelet activation he saw in the reactions he studied.

Greinacher said that he had worked out an agreement with Johnson & Johnson about an hour before the call to collaborate on studying its COVID-19 vaccine. The company had previously been unwilling to share information, he said.

At least seven cases of the same pattern of unusual clots have been documented in people who received the one-dose Johnson & Johnson vaccine, which also uses an adenovirus as its delivery vehicle. Over 7 million Johnson & Johnson vaccines have been given in the United States so far.

While the reactions are extremely rare, they can be serious. One person, a 45-year-old woman in Virginia, has died. That led the US Centers for Disease Control and Prevention and the US Food and Drug Administration to call for a pause on administering the Johnson & Johnson vaccine last week. The company also announced that it would hold clinical trials to get more answers about the reactions.

In his new study, Greinacher and colleagues describe a cascade of events that has to happen in the body before the vaccines broker these large clots. He explained that while everyone has the basic immune machinery that leads to the unusual clots, it is almost always kept in balance. The body uses a series of checks to prevent any step in the process from getting out of control.

In some cases, however, there’s a perfect storm where each stage progresses to the next and the end result is very hard to control. That autoimmune attack, which causes the body to go into a hyper-clotting state, typically burns itself out after a few weeks. So if patients can get rapid treatment, the condition nearly always goes away.

He said he only knew of one case of an autoimmune syndrome like this lasting 10 years, but that was in a patient who had taken the blood thinner heparin, which can cause a nearly identical syndrome.

Two-Step Process Leads to Clots

In the first step, the adenovirus shell in the vaccine, along with proteins from the cells where the vaccine is grown, come into contact with platelets from the blood.

Platelets are best known as colorless cell fragments that rush to the site of an infection or injury, helping the blood congeal to stop bleeding; they also play a key role in the body’s immune response.

When activated, they surround invaders like bacteria and change shape to release chemical signals they store in granules.

When platelets are activated en masse, as can happen rarely after a person takes the blood thinner heparin or gets the Vaxzevria vaccine, they release a flood of these signals, Greinacher explained. These blaring signals recruit an ancient and hard-to-control branch of the immune response.

“Imagine this is like a dragon in the cave who was sleeping for a long time [but] which now got alerted by someone’s throwing a stone on it,” he said. The chemical signals awaken B-cells that then produce massive amounts of antibodies against the platelet factor 4 protein, which helps coordinate blood clotting.

The body erroneously thinks it is reacting to massive amounts of pathogens in the body, so the immune system overshoots. The antibodies bind the platelets, the platelets recruit white blood cells, and “then the whole thing is exploding,” he said.

The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the Vaxzevria vaccine.

EDTA is not listed as an ingredient in the Johnson & Johnson vaccine.

EDTA opens junctions between cells that form the walls of blood vessels, causing them to become leaky. This allows the giant complexes formed by proteins and platelets to enter the blood circulation, where they — on very rare occasions — trigger that bodywide alarm.

Asked if he thought there was anything that could be done to make the vaccine safer, Greinacher said his first thought would be to try to get rid of the EDTA, which causes the second step in the process. But he said he was not a vaccine developer and didn’t know how important it might be to its formulation.

Why might the Johnson & Johnson vaccine lead to similar types of clots, even though it doesn’t contain EDTA? Greinacher speculated that size might play a role.

When this reaction occurs in patients who have taken heparin, the size of the heparin molecule matters. With unfractionated heparin, the longest kind of molecule, the reaction is 10 times more common than when patients take smaller low-molecular weight heparins.

Other vaccines might form smaller antibody-protein complexes that generate smaller warning signals, making the reaction less likely.

As for why the reaction appeared to be more common in women, Greinacher said he was growing skeptical that there is a large gender bias. He pointed out that most of the first vaccine recipients in Europe had been healthcare workers, who are disproportionately women.

He noted that women might be slightly more susceptible because of hormones and because women are more likely to develop autoimmune diseases, but that the risk was probably more balanced between men and women than it first seemed.

“It’s not a disease of young women,” he said.

Several European countries have changed or abandoned their use of the AstraZeneca vaccine.

Last week, Denmark said it would no longer include Vaxzevria as part of its vaccination program. Italy has recommended that AstraZeneca vaccine only be used in people over age 60. UK officials said people under age 30 should be offered an alternative.

Meanwhile, the European Medicines Agency said a warning about the risk of blood clots and low platelets should be added to product information for the Johnson & Johnson vaccine.

ACIP Green-Lights J&J Vax for All Adults

Finally, Molly Walker reported that the pause is lifted, and Johnson & Johnson’s COVID-19 vaccine is once again recommended for adults, according to the CDC’s Advisory Committee on Immunization Practices (ACIP).

In a 10-4 vote, with one abstention, ACIP said in updated interim guidance that the Johnson & Johnson vaccine is recommended under FDA emergency use authorization (EUA) for all adults.

They ultimately decided that including a separate warning on the vaccine, as well as in an FDA EUA fact sheet and materials on the CDC website, was sufficient. One choice the committee chose not to vote on would have added language that women under age 50 should be aware of the increased risks of rare clotting events, and may opt for a different authorized COVID-19 vaccine. The committee agreed that any further qualifiers would be too cumbersome for local jurisdictions to implement and might contribute to vaccine hesitancy.

Johnson & Johnson researchers unveiled a proposed warning that the FDA agreed to add to the vaccine’s current EUA. It warns about the risks of thrombosis with thrombocytopenia syndrome (TTS), and recommends that clinicians consult with the published American Society of Hematology guidance for diagnosis and treatment of the condition.

ACIP member Grace Lee, MD, of Stanford University School of Medicine, said that putting a qualifier for any demographic group would be “extremely confusing,” because every ACIP recommendation “is a benefit/risk balance.”

The committee believed that the benefits of one-dose vaccination outweighed the risks, as it makes this vaccine available for vulnerable populations, including people experiencing homelessness, incarcerated populations, and home-bound populations.

The “no” votes came from members who felt that younger women would not be adequately informed about the risks of this rare adverse event by a warning label and EUA fact sheet.

“I did not object to the recommendation. I objected to the absence of any kind of guidance from us,” said ACIP member, Sarah Long, MD, of Drexel University College of Medicine in Philadelphia. “This is an age group that is most at risk and is getting the vaccine predominantly to save other people’s lives. I’m very sorry we haven’t chosen to put up front the knowledge we have that … there are options.”

ACIP chair, José Romero, MD, ultimately voted yes, but added that he thought there was a bit of a “selective interpretation” in terms of how much younger women would be informed. He urged vaccination sites to have a second vaccine available so that younger women are not forced to shop for vaccines.

“These events are rare, but they are serious,” Romero said.

The American Medical Association (AMA) reiterated their support for the Johnson & Johnson vaccine and pledged to help inform patients about the rare adverse events.

“The AMA will continue to work with the FDA and the [CDC] to ensure physicians and patients are aware of the rare, but increased risk of [TTS] in women under the age of 50, as well as the appropriate treatment, so they can act quickly,” said AMA president Susan Bailey, MD, in a statement.

On April 13, CDC and FDA agreed to a “pause” on use of Johnson & Johnson’s COVID-19 vaccine out of an abundance of caution. At that point, there were six cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, one fatal. ACIP met on April 14, but agreed to wait to vote until more data accrued on the available cases, including potential risk factors.

As of April 21, the number of cases rose to 15, with three deaths. Seven patients remain hospitalized, including four in the ICU, while five were discharged home.

Thirteen of these cases were in women ages 18-49, with two in women older than 50. Based on these data, Tom Shimabukuro, MD, of the CDC, estimated that the rate of TTS was 7.0 per million doses in younger women, and 0.9 per million in older women. Seven cases of 15 were among women ages 30-39.

While all cases were in women, Shimabukuro noted that some data were still under review, “including potentially male cases,” although as of now, there were no cases reported in men.

Median patient age was 37, with a median time to onset of 8 days following vaccination. While 12 cases were CVST, three were other forms of thrombosis. Seven patients had obesity, while two patients apiece reported oral contraceptive use, hypothyroidism, or hypertension. No patients had established coagulation disorders.

All patients had thrombocytopenia, with 10 patients having severe thrombocytopenia, or platelet levels under 50,000. Of the 11 patients where a platelet factor 4 heparin-induced thrombocytopenia ELISA antibody test was performed, all were positive. Four patients did not have available results. Seven patients with CVST experienced intracerebral hemorrhage.

Non-heparin anticoagulants were used to treat 12 patients and intravenous immunoglobulin to treat eight patients, while platelet transfusion was used for seven patients and heparin for six patients. Shimabukuro noted that the six patients received heparin prior to the CDC Health Alert about treating this condition.

Shimabukuro said that cases under investigation may increase, as researchers plan to broaden their case definition to harmonize with the draft Brighton Collaboration case definition for TTS. This could include other thrombotic events, including venous thromboembolism, deep vein thrombosis, pulmonary embolism, ischemic stroke, and acute myocardial infarction.

As I try to conquer my depression in my interaction with some of my patients who refuse to get vaccinated, I wonder if we, our country will ever reach herd immunity as Israel has accomplished. I am trying to figure out whether it is worth keeping these patients in my practice due to my concern for my staff, my other patients and our families.

Please get vaccinated!!

Throw Away Your Mask After COVID Vaccination or Not, What about the Mutations and Infection after Vaccination?

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.

Another New COVID Strain Is in the US; Will Present Vaccines Work with these New Strains, Pandemic Strategies Including New Migrants and What Happened to Merck’s Vaccine?

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?

We will explore that set of questions next.