Tag Archives: Pandemic

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.

U.S. Hits Highest 1-Day Toll from Coronavirus With 3,054 Deaths, Hospitalizations and Answers to the Questions About the Vaccines

I have rewritten this post about 15 times but finally decided with the approval of the Pfizer vaccine for emergency use that I needed to answer a number of questions. So, here we go.

Vanessa Romo reported on the Covid Tracking Project and found that the coronavirus pandemic has pushed the U.S. past another dire milestone Wednesday, the highest daily death toll to date, even while the mortality rate has decreased as health experts learn more about the disease.

The Covid Tracking Project, which tracks state-level coronavirus data, reported 3,054 COVID-19 related deaths — a significant jump from the previous single-day record of 2,769 on May 7.

The spread of the disease has shattered another record with 106,688 COVID-19 patients in U.S. hospitals. And overall, states reported 1.8 million tests and 210,000 cases. According to the group, the spike represents more than a 10% increase in cases over the last 7 days.

Additionally, California nearly topped its single-day case record at 30,851. It is the second highest case count since December 6, the organization reported.

The staggering spike in fatalities and infections has overwhelmed hospitals and intensive care units across the nation, an increase attributed by many experts to people relaxing their precautions at Thanksgiving.

New Data Reveal Which Hospitals Are Dangerously Full. Is Yours?

Audrey Carlsen reported that Health care workers at United Memorial Medical Center in Houston face another full-throttle workday last week.

The federal government on Monday released detailed hospital-level data showing the toll COVID-19 is taking on health care facilities, including how many inpatient and ICU beds are available on a weekly basis.

Using an analysis from the University of Minnesota’s COVID-19 Hospitalization Tracking Project, NPR has created a tool that allows you to see how your local hospital and your county overall are faring. 

It focuses on one important metric — how many beds are filled with COVID-19 patients — and shows this for each hospital and on average for each county.

The ratio of COVID-19 hospitalizations to total beds gives a picture of how much strain a hospital is under. Though there’s not a clear threshold, it’s concerning when that rate rises above 10%, hospital capacity experts told NPR.

Anything above 20% represents “extreme stress” for the hospital, according to a framework developed by the Institute for Health Metrics and Evaluation at the University of Washington.

If that figure gets to near 50% or above, the stress on staff is immense. “It means the hospital is overloaded. It means other services in that hospital are being delayed. The hospital becomes a nightmare,” IHME’s Ali Mokdad told NPR.

At Hospitals, A Race to Save ‘Hundreds of Thousands’ Of Lives with New Vaccine

Sarah McCammon noted that lately, Jon Horton has been dreaming about freezers.

“I was opening the freezer and I was taking something out of the freezer and putting it in something else,” Horton said. “And it was just like — whew!”

And not just an ordinary freezer. Horton is pharmacy operations director at Sentara — a health care network based in Norfolk, Va.

Sentara officials are working out every detail of the logistics involved in rolling out the coronavirus vaccine from Pfizer, which has to be kept at nearly minus 100 degrees Fahrenheit or risk losing effectiveness.

“At a certain point, you’re just trying to figure out what needs to be done next,” Horton said during an interview with NPR at Sentara Norfolk General Hospital. “So, you’re focusing on this process, and as you open up that door, you learn a little more.”

As federal regulators prepare to meet Thursday to consider whether they’ll approve Pfizer’s brand-new coronavirus vaccine, employees like Horton are preparing to receive the vaccine at hospitals around the United States.

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The Sentara health system has four of the ultracold freezers that the vaccine requires, including one obtained through collaboration with a local medical school.

“We usually just deal with freezing temperatures, you know, a typical freezer,” said Tim Jennings, Sentara’s chief pharmacy officer. “That’s why we had to actually go out and acquire a special freezer for this.”

For sites that don’t, there’s dry ice. Jennings opens a big blue bin full of it, which resembles white “cheese doodles,” he notes.

There’s little room for error here: The vaccines must be monitored to make sure the temperature is stable each step of the way. And they’re in short supply right now; the first shipment from Pfizer is expected to include only about 72,000 doses for all of Virginia, a state of more than 8 million people.

Michelle Hood, chief operating officer at the American Hospital Association, said health care administrators across the country are gearing up for a major logistical undertaking.

“We’ve never done anything like this as a country or in the world, as significant as this exercise is,” Hood said. “And everything is new.”

The first vaccines will go mostly to front-line health care workers at the highest risk of exposure.

That’s where Mary Morin, a vice president in charge of employee vaccination at Sentara, comes in. She has a lot to think about as well.

“I did wake up last night and I’m going, ‘Oh, my God,’ ” Morin said.

Morin, whose background is as a registered nurse, has to turn Centers for Disease Control and Prevention guidelines about who should be first in line for the coronavirus vaccine into a real-life plan for her hospital workers.

“A front door to the hospital is the emergency department. You may have a security guard there. They’re patient facing. They’re forward facing,” she said. “So, it’s the staff — it isn’t just the nurses and the physicians.”

Unlike the flu shot, Sentara officials say, the coronavirus vaccine will be optional for staff. Large studies indicate the Pfizer vaccine is about 95% effective with few side effects. But it’s brand-new, and convincing people to take it may be a challenge.

The challenge ahead for hospital staff members like Jennings is making sure the vaccine is properly stored and administered to those who are willing and able to take the first doses. If the vaccine receives federal approval, officials say it could start being given to health care workers within days.

“We realize if we do this right, we could save thousands of lives,” Jennings said, “if not hundreds of thousands.”

The Covid-19 Vaccine: When Will It Be Available for You?

I was included in the set of clinical trials for the COVID-19 vaccine. But I was just notified that I was being “kicked out” due to the fact that the Committee wanted to make sure that I was vaccinated and not having the possibility of being given the placebo as per the trials due to the fact as a physician I am seeing cancer patients daily.

Vaccines, especially as one is already approved by the FDA and the other should be approved for emergency use this coming week.

I thought that I would review a number of questions that many have regarding the new vaccines.

First U.S. rollouts of doses could start in December, with health-care workers, older Americans likely to take priority

Peter Loftus and Betsy McKay reported that Pfizer Inc.  and its partner, BioNTech SE, have asked the U.S. Food and Drug Administration to authorize use of their coronavirus vaccine, and an FDA decision could come as soon as this weekend. Moderna Inc.  has made a similar request for its shot, and other vaccines could follow. The first rollouts could begin within days.

Here is what we know and don’t know about how, and when, the vaccine will get to you.

How will the Covid-19 vaccines be approved, and who decides who will get them?

The FDA will determine whether to authorize Covid-19 vaccines for use. An FDA advisory committee of outside experts voted Thursday in favor of Pfizer’s request for authorization of its vaccine. The FDA is expected to decide imminently.

The FDA has scheduled a Dec. 17 advisory committee meeting to consider Moderna’s request for authorization. A separate advisory committee to the U.S. Centers for Disease Control and Prevention has voted to recommend that health workers and residents of nursing homes and other long-term care facilities be first in line for the limited number of doses. The same committee will hold additional votes on which groups should be next in line. But governors can make the final call within their states.

How will the vaccines be distributed?

The federal government has a contract with McKesson Corp. to be a centralized distributor of Covid-19 vaccines, with the exception of Pfizer’s. Pfizer has set up its own distribution network. Federal health officials say initial doses would be shipped within 24 hours of any FDA authorization, and immunizations could begin within about 48 hours. The federal government also has partnerships with national pharmacy chains CVS and Walgreens to vaccinate residents and staff at long-term care facilities.

Some experts say it could take more than 48 hours for dosing to begin, as hospital workers and others get used to procedures for opening specialized, temperature-controlled boxes of vaccine vials and learn the risks and benefits of the shots.

“Many providers are going to need a few days to get it up and running, if not a week,” said Claire Hannan, executive director of the Association of Immunization Managers, whose members run state, territorial and local vaccination programs.

What logistics are in place to deliver the vaccines?

McKesson, the centralized distributor for vaccines other than Pfizer’s, also will receive and package kits of medical supplies needed to administer the Covid-19 vaccine, such as needles and syringes and alcohol prep pads. It will send the kits and vials of the vaccine out to pharmacies, doctors’ offices and other facilities, at a minimum of 100 doses per order, based on order information supplied by the CDC.

Pfizer plans to use its own distribution centers and ship its vaccine in specially designed reusable containers that can keep thousands of doses at the ultracold temperatures required for it.

How many doses will be available at first?

The initial expected supply of Pfizer’s vaccine after authorization is about 6.4 million doses, according to Gen. Gustave Perna, chief operating officer of the U.S. government’s Operation Warp Speed initiative.

Of this, about 2.9 million doses will be shipped within 24 hours. A federal official said Wednesday that an additional 2.9 million doses would be held back and shipped about three weeks later for those initial vaccine recipients to get the second of the two-dose regimen. Another 500,000 doses from the initial supply would be held in reserve in case any problems arise, the official said. If Moderna’s vaccine is authorized, officials estimate the initial allocation will be about 12.5 million, which may also be sent in separate shipments to accommodate the second injection.

Including that initial supply, federal officials have estimated there would be enough doses to vaccinate 20 million Americans in December.

How many doses will be available next year?

Federal officials have estimated there could be enough to vaccinate about 30 million people in the U.S. in January and then about 50 million in February, with more in the months following. Globally, Pfizer expects to produce up to 1.3 billion doses in 2021 and Moderna expects up to 1 billion.

Who will get the first doses?

The first doses will likely go to health-care workers and residents of nursing homes and other long-term care facilities, which together number about 24 million. After that, the CDC vaccine advisory committee is considering recommending that essential workers such as teachers, police and food workers get vaccinated, followed by adults with underlying conditions that put the at high risk, and seniors age 65 and older.

The committee hasn’t completed its recommendation beyond the first phase, and decisions on which groups get vaccinated when could depend in part on the particular vaccine and what its data show about effectiveness among different age groups or health conditions.

Is there any debate about who should get vaccinated first?

Yes. Some health officials and experts believe health-care workers should be vaccinated first, while others are advocating for the most vulnerable—older Americans—to be first in line. And some state governors have singled out occupations such as teachers that should be at or near the top of the list. There is a similar debate about whether non-health-care essential workers such as teachers and police should be ahead of adults with high-risk medical conditions and people age 65 and over who aren’t in congregate settings.

When can the general public expect to have access?

Secretary of Health and Human Services Alex Azar said he expects there to be enough vaccine doses starting in the second quarter of 2021 so that anyone who wants a vaccine can get it. Other federal health officials have said in the spring or summer. The timeline could change if manufacturing doesn’t go as planned.

How will vaccine doses be allocated to U.S. states?

For the initial supplies, the federal government plans to allocate doses to states proportionally based on the size of their adult populations. It is unclear how long the federal government would stick with population-based proportions and how it would allocate supplies later.

How do states decide to distribute doses?

State, territorial and some local immunization programs, working with the CDC, have drawn up plans to distribute doses within their jurisdictions and to conduct vaccination campaigns. These plans include identifying facilities where vaccination campaigns can be conducted, enrolling them and ensuring the necessary equipment is in place to conduct them. States also have estimated their populations of high-priority groups like health-care workers.

Does the vaccine work the same way in all population groups?

Pfizer and Moderna haven’t yet provided full breakdowns of vaccine efficacy by age and race or ethnicity, but the companies have said efficacy was consistent across these groups.

Does everyone get the same dose regardless of age or other demographic?

Yes.

Coronavirus Daily Briefing and Health Weekly

How many people need to get vaccinated to stop the pandemic in the U.S.?

Moncef Slaoui, chief adviser to Operation Warp Speed, has said if 70% of the population were immunized, that level would achieve herd immunity, based on the approximately 95% effectiveness of both the Pfizer and Moderna vaccines.

A vaccine would need to be at least 80% effective, with about 75% of a population receiving it, to extinguish an epidemic without any other public-health measures, according to a study published in October in the American Journal of Preventive Medicine.

Reaching those levels of immunization would require educating millions of Americans about the safety and effectiveness of vaccines and confronting a strong antivaccine movement, said Peter Hotez, a vaccine scientist at the Baylor College of Medicine and an author of the paper. Those are steps the government hasn’t taken yet, he said. “To use a vaccine to eliminate this virus—it is a really high bar,” he said.

One open question is how effective the vaccines are at preventing people from transmitting the virus to others, Dr. Hotez said. Both vaccines were tested primarily for their effectiveness at preventing people from becoming ill. They are expected to be evaluated for effectiveness at preventing infection regardless of symptoms, but those data haven’t been released yet.

What is herd immunity?

Epidemiologists estimate that between 60% and 70% of a population needs to develop an immune response to the virus to reach “herd immunity,” a state in which enough people have either been infected or vaccinated to stop transmission of the virus. Some epidemiologists say herd immunity to Covid-19 might be achieved at a lower threshold of 50%.

When the vaccines are widely available, how will I get the shot?

Federal officials say they want to make getting a Covid-19 vaccine as easy as going to a pharmacy to get a flu shot. The government has formed partnerships with about 60% of U.S. pharmacies to administer Covid-19 vaccines to the broader population after high-priority groups are vaccinated. Manufacturers would ship doses to distributors to get them to hospitals, pharmacies, nursing homes and other administration sites, as determined by state and federal plans. Pfizer’s vaccine requires ultracold shipping and storage, while Moderna’s can be shipped at higher—though still freezing—temperatures. After thawing, doses can be kept in refrigerators for certain periods.

How many doses will I need?

Vaccines from Pfizer, Moderna and AstraZeneca PLC are given in two doses, three or four weeks apart. Federal and state officials are planning to issue reminders to people to come back for their second doses. A Johnson & Johnson vaccine is being tested as a single dose, but the company hasn’t yet reported how well that works.

How much does it cost? Will insurance cover it?

Both the Trump administration and President-elect Joe Biden have said the vaccine would be free of charge to all Americans, with administration fees billed to private or government insurance plans or to a special government relief fund for the uninsured.

Does it have to be a needle?

The vaccines closest to authorization are given as injections. Merck & Co. is exploring an oral formulation of a Covid-19 vaccine, but it isn’t expected to be available in the near term.

Should I get a vaccine if I’ve already been infected?

You can still benefit from the vaccine, the CDC says. Scientists don’t yet know how long someone is protected from getting sick again once they have had Covid-19. There is some evidence that natural immunity doesn’t last long.

How long does immunity last after vaccination?

The median follow-up period in the large clinical trials was only about two months after vaccination, so it isn’t yet known how long protection will last beyond that.

Will my child be able to get vaccinated? Has it been tested in children?

Children likely won’t get vaccinated until later because they are much less likely to have severe Covid-19 than adults. Pfizer has requested U.S. authorization of use of the vaccine in people 16 and older. Pfizer and Moderna have started to test the vaccine in children as young as 12, and other companies also plan to test their Covid-19 vaccines in children.

Can I stop wearing a mask after getting a COVID-19 vaccine?

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the US could reach herd immunity by May, based on the effectiveness of the Pfizer and Moderna vaccines if enough people are vaccinated

Can I stop wearing a mask after getting a COVID-19 vaccine?

No. For a couple reasons, masks and social distancing will still be recommended for some time after people are vaccinated.

To start, the first coronavirus vaccines require two shots; Pfizer’s second dose comes three weeks after the first and Moderna’s comes after four weeks. And the effect of vaccinations generally isn’t immediate.

People are expected to get some level of protection within a couple of weeks after the first shot. But full protection may not happen until a couple weeks after the second shot.

It’s also not yet known whether the Pfizer and Moderna vaccines protect people from infection entirely, or just from symptoms. That means vaccinated people might still be able to get infected and pass the virus on, although it would likely be at a much lower rate, said Deborah Fuller, a vaccine expert at the University of Washington.

And even once vaccine supplies start ramping up, getting hundreds of millions of shots into people’s arms is expected to take months.

Fuller also noted vaccine testing is just starting in children, who won’t be able to get shots until study data indicates they’re safe and effective for them as well.

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the country could reach herd immunity as early as May, based on the effectiveness of the Pfizer and Moderna vaccines. That’s assuming there are no problems meeting manufacturers’ supply estimates, and enough people step forward to be vaccinated.

FDA panel endorses Pfizer coronavirus vaccine for emergency use.

Thomas Barrabi reported that the U.S. Food and Drug Administration advisory panel voted Thursday to endorse the Pfizer-BioNTech coronavirus vaccine, clearing the way for FDA leaders to authorize emergency mass distribution amid an ongoing surge of COVID-19 cases across the country. And Friday it was official that the Pfizer vaccine is approved for emergency use.

Vaccine shipments would begin within hours of the FDA’s decision, which could come by as early as Friday, with the first vaccinations to follow soon afterward. Pfizer’s vaccine will be available in limited quantities, with initial doses earmarked for frontline health care workers and high-risk patients.

In November, Pfizer announced that its coronavirus vaccine was 95 percent effective and has not displayed any major side effects.

The advisory panel, comprised of outside experts, based its decision on data from clinical trials. Members were asked to vote on “whether the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older” based on the totality of available evidence.

Some committee members raised concerns about the wording of the question and whether trials have provided enough information regarding the vaccine’s effects on people aged 16 and 17 years old. The committee opted to vote on the question as it was originally worded.

Of the committee’s 23 members, 17 voted to recommend the vaccine and four voted against the recommendation. One member abstained in its endorse

Pfizer is one of several companies in the final stages of development. The FDA is expected to decide whether to approve a vaccine developed by Moderna for mass use later this month. Johnson & Johnson and AstraZeneca also have vaccines in the works.

More than 290,000 Americans have died from COVID-19 since the pandemic began. More than 15.4 million cases have been reported.

Convincing people to get COVID vaccine is vital — here’s how to do it

Dr. Austin Baldwin and Jasmin from Fox News makes us aware that the decision by the Food and Drug Administration Friday night to issue an emergency use authorization for Pfizer’s COVID-19 vaccine is a critical breakthrough in the battle against the disease that has infected more than 15.7 million Americans and killed nearly 300,000.

The FDA ruling that the Pfizer vaccine is safe and effective is just a first step in a massive rollout of the vaccine. Now the enormous task of distributing the vaccine around the nation begins.

But a crucial obstacle to widespread vaccinations will be public hesitancy to take the vaccine, driven by doubts, fears, and misinformation spreading throughout the nation and the world.

The same challenge will face other vaccines now awaiting approval in the U.S. and vaccines distributed globally. Gaining public acceptance for the Pfizer vaccine and other vaccines is vital, because we won’t end the worst global health crisis in a century until the majority of the world’s 7.7 billion people are vaccinated against COVID-19. The disease has infected more than 70 million people around the world and killed nearly 1.6 million.

Behavioral science will be as important to vaccine acceptance as basic science was to vaccine development. If government and health care leaders take the right approach to educating the public about the vaccines, we can create a pathway for the public to assess options and choose to get vaccinated. Given the accelerated development of the Pfizer vaccine and other vaccines not yet approved, convincing people that the vaccines are safe and effective is critical.

The World Health Organization identified vaccine hesitancy as a top global health threat in 2019 — just months before the COVID-19 outbreak. An Axios-Ipsos survey found that only half of Americans say they are likely to get a COVID-19 vaccine as soon as it is available. These numbers are even lower among African Americans, at just more than a quarter. Why?

Historically, minority communities have been suspicious of new health technologies and biomedical research due to past unethical experimentation on African Americans and Native Americans.

Given that African Americans are hardest hit by COVID-19, public health officials must respond to these concerns. Beliefs in vaccine conspiracies and rumors that the government is cutting corners in testing and development must also be addressed if we are to achieve herd immunity, the threshold of 70 percent of the population needed in order for person-to-person transmission to be largely eliminated.

As plans are developed to roll out the Pfizer vaccine and later other COVID-19 vaccines throughout the nation, public health officials and other health care leaders should consider three steps.

Transparency to build trust

Leaders at all levels of government and the health care community must be upfront that science is always evolving and that knowledge about the vaccines will continue to accumulate.

Communications should stress that the Pfizer vaccine and the Moderna vaccine (not yet approved) are 90 to 95% percent effective. It’s also important to emphasize that while the development, testing, and approval processes for vaccines have been accelerated, no steps were skipped.

When people are asked if they’re willing to get a vaccine that is “more than 90% effective” or one that has been “proven safe and effective,” willingness to be vaccinated increases to 65 to 70%.

Transparency also means being upfront about potential side effects of vaccines. These include possible arm soreness (as with most vaccines) and possible fatigue a day or two after vaccination. If people expect knowledge to evolve and believe public health leaders will be upfront, reports of new side effects are less likely to undermine confidence and trust.

 Active engagement with vaccine information

Communications about the vaccines should pose questions such as: “How will my family and I benefit from the vaccine?” or “If I don’t get a vaccine and then later get COVID-19, to what extent would I regret that decision?”

Such questions lead people to more actively engage with the information rather than simply being told that the vaccine is safe.

We took this approach when we developed an app and website to address parental hesitancy about the HPV vaccine among diverse populations. We are now working to adapt this approach to provide information on COVID-19 vaccines.

Interactive technology makes it more likely that people will become engaged in the decision to be vaccinated and be motivated to follow through to get the required second dose. 

Meeting different informational needs and styles of decision-making among people 

Some people will want detailed information to weigh the scientific evidence before being vaccinated against COVID-19. Others will want information mediated through a trusted source, like health care providers, faith-based leaders and public figures.

To accommodate different needs and maintain transparency, educational materials should provide information in a stepped manner. Basic information from trusted sources is presented first. This is followed by more detailed information using different media such as print, video and formats such as personal stories and graphics to explain numbers and risk.

Websites and apps that enable people to navigate to their level of desired information provide another level of empowerment. We found our app’s stepped approach led previously hesitant parents to be 2.5 times more likely to decide in favor of the HPV vaccine.

Our major investments in vaccine development and testing will fall short of achieving their potential impact unless the public takes the COVID-19 vaccines. We must work proactively to communicate better than ever before.

So, as I have said before about the flu vaccine, if it is offered to you, get the COVID-19 vaccine and be part of the solution to ending this Pandemic.

And wear the Damn MASKS, as Governor Hogan keeps telling us!

Time to prepare for an even more deadly pandemic and Trump’s Healthcare Plan

What a confusing time and how disappointed can one be when one candidate running for President convinces a group of physicians to complain about Trump’s response to the Pandemic. I am embarrassed to say that they are in the same profession that I have been so proud to call my own. Can you blame the President for the pandemic as all the other countries that are experiencing the increased wave of COVID? Can you blame Trump for the lack of PPE’s when former President Obama and yes, Vice President Biden refused to restock the PPE’s used for the other SAR’s viruses?  What a pathetic situation where the average American is so hateful and, yes, the word is stupid, and with no agreement in our Congress except to make us all hate them. Where is the additional financial support, the stimulus package promised, for the poor Americans without jobs and huge debts? This is a difficult situation when we have such poor choices for the most important political office and can’t see through the media bias.

I just had to get all that off my chest as I am like many very frustrated. How did we get here and who do we believe as we hear more about Biden’s connection with his son’s foreign dealings?

Thomas J. Bollyky and Stewart M. Patrick reported that the winner of the presidential election, whether that is Donald Trump or Joe Biden, will need to overcome the COVID-19 pandemic — the worst international health emergency since the 1918 influenza outbreak — and also begin preparing the United States and the world for the next pandemic.

Think it is too soon to worry about another pandemic? World leaders have called the coronavirus outbreak a “once-in-100-year” crisis, but there is no reason to expect that to be true. A new outbreak could easily evolve into the next epidemic or a pandemic that spreads worldwide. As lethal as this coronavirus has been, a novel influenza could be worse, transmitting even more easily and killing millions more people.

Better preparation must begin with an unvarnished assessment of what has gone wrong in the U.S. and in the global response to the current pandemic and what can be done to prepare for the next one when it strikes, as it inevitably will.

Preparedness needs to start with investment. Despite multiple recent threats, from SARS (2003) to H5N1 (2007) to H1N1 (2009) to Ebola (2013-2016); many blue ribbon reports and numerous national intelligence assessments; international assistance for pandemic preparedness has never amounted to more than 1% of overall international aid for health.

The United States devoted an even smaller share of its foreign aid budget in 2019 — $374 million out of $39.2 billion — to prepare for a pandemic that has now cost the country trillions of dollars. Meanwhile, funding for the Centers for Disease Control and Prevention’s support to states and territories has fallen by more than a quarter since 2002. Over the last decade, local public health departments have cut 56,360 staff positions because of lack of resources.

Preparation isn’t only about investing more money. It is also about embracing the public health fundamentals that allowed some nations to move rapidly and aggressively against the coronavirus. The United States has been hard hit by this pandemic, but all countries were dealt this hand.

But we can do better. Here are four measures, outlined in a new report from the Council on Foreign Relations, that would make Americans and the rest of the world safer.

First, the United States must remain a member of the World Health Organization, while working to reform it from within. The agency is hardly perfect, but it prompted China to notify the world of the coronavirus and it has coordinated the better-than-expected response to the pandemic in developing nations. Yet, the agency has no authority to make member states comply with their obligations and less than half of the annual budget of New York-Presbyterian Hospital. The WHO needs more dedicated funding for its Health Emergencies Program and should be required to report when governments fail to live up to their treaty commitments.

Second, we need a new global surveillance system to identify pandemic threats, one that is less reliant on self-reporting by early affected nations. An international sentinel surveillance network, founded on healthcare facilities rather than governments, could regularly share hospitalization data, using anonymized patient information. Public health agencies in nations participating in this network, including the CDC, can assess that data, identify unusual trends and more quickly respond to emerging health threats.

The U.S. should take the lead in forming a coalition to work alongside the WHO to develop this surveillance network. We should also work with like-minded G-20 partners, as well as private organizations, in this coalition to reduce unnecessary trade and border restrictions; increase the sharing of vaccines, therapeutics and diagnostics; and work with international financial institutions to provide foreign aid and debt relief packages to hard-hit nations.

Third, responding to a deadly contagion requires a coordinated national approach. Too often in this pandemic, in the absence of federal leadership, states and cities competed for test kits and scarce medical supplies and adopted divergent policies on reopening their economies. The next administration needs to clarify the responsibilities of the federal government, states and 2,634 local and tribal public health departments in pandemic preparedness and response. Elected leaders, starting with the president, must also put public health officials at the forefront of communicating science-based guidance and defend those officials from political attacks.

Finally, the U.S. must do better by its most exposed and vulnerable citizens. More than 35% of deaths in the U.S. from COVID-19 have been nursing home residents. Many others have been essential workers, who are disproportionately Black and Latinx and from low-income communities. Federal, state and local governments should direct public health investments to these groups as a matter of social justice and preparedness for future threats.

All of this will require leadership and marshaling support at home and abroad. The next president need not be doomed to replay this current catastrophe — provided he acts on the tragic lessons learned from the COVID-19 pandemic.

In search of President Trump’s mysterious health care plan

Hunter Walker responded to questions about President Trump’s healthcare plan noting that President Trump’s health care plan has become one of the most highly anticipated, hotly debated documents in Washington. And depending on whom you ask, it might not exist at all. 

The contents — and the whereabouts — of the health plan have been a growing mystery since 2017, when efforts to pass a White House-backed replacement for Obamacare stalled in the Senate. Since then, Trump has repeatedly vowed to unveil a new health plan. In July, it was said to be two weeks away. On Aug. 3, Trump said the plan would be revealed at the end of that month. Last month, White House press secretary Kayleigh McEnany said it would be released within two weeks. At other points, Trump has suggested the plan is already complete. That shifting schedule has lent Trump’s health plan an almost mythical status.

Let me state here that if President Trump doesn’t win this election his lack of a healthcare plan as well as the blame for the pandemic will be the deciding reason that even previous GOP supporters will vote for Biden. Hard to believe, right? In fact, weeks to months ago I related the need for the President to release his healthcare plan to further prove to the voters that he is fulfilling his promises.

The mystery surrounding the president’s vision for health care has added urgency because the Supreme Court is currently scheduled to hear oral arguments in a case that could decide the future of former President Barack Obama’s signature health care law on Nov. 10, exactly one week after the election. That case was brought by Republican attorneys general and joined by the Trump administration. The argument that Obamacare is unconstitutional could lead to the current health care framework being struck down, but Trump has yet to present an alternative. 

With both the election and the court date looming, questions about Trump’s health care plan have intensified on the campaign trail. And the White House’s answers have only added to the uncertainty. 

During the first presidential debate last month, Trump was pressed by Fox News moderator Chris Wallace about the fact he has “never in these four years come up with a plan, a comprehensive plan, to replace Obamacare.”

“Yes, I have,” Trump replied. “Of course, I have.”

He was apparently referring to the Republican tax bill passed in 2017 that eliminated the tax penalty for individuals who did not purchase health insurance, or obtain it through their jobs or government assistance. That so-called individual mandate was a critical part of the Affordable Care Act, more commonly known as Obamacare, meant to ensure that even healthy people would buy health insurance and spread the costs out across the population. Other parts of the Affordable Care Act remain in place, but the Republican lawsuit argues that without the mandate the entire program should be overturned. 

That could end the most popular feature of Obamacare: the requirement that insurance companies provide affordable coverage for preexisting conditions. While Trump has repeatedly insisted, he wants to maintain that protection, any details of his plan or evidence of how he would do it have remained elusive.  

During the final debate last week, Democratic nominee Joe Biden argued that the administration “has no plan for health care.”

“He’s been promising a health care plan since he got elected. He has none,” Biden said of Trump. “Like almost everything else he talks about, he does not have a plan. He doesn’t have a plan. And the fact is, this man doesn’t know what he’s talking about.” 

The issue also came up during the vice-presidential debate on Oct. 7, when Vice President Mike Pence said, “President Trump and I have a plan to improve health care and protect preexisting conditions for every American.” 

“Obamacare was a disaster, and the American people remember it well,” Pence said.

But Trump seemed to admit during last week’s debate that his plan is more of a dream than a concrete proposal. 

“What I would like to do is a much better health care, much better,” he said, adding, “I’d like to terminate Obamacare, come up with a brand-new, beautiful health care.”

However, by the end of last weekend, the idea of a written, completed Trump health plan was back on the table — literally. 

During the president’s contentious “60 Minutes” interview that aired on Sunday, host Lesley Stahl asked Trump about his repeated promises of a health plan coming imminently.

“Why didn’t you develop a health plan?” Stahl asked.  

“It is developed,” Trump responded. “It is fully developed. It’s going to be announced very soon.”

And after Trump ended the interview and walked out on Stahl, McEnany, the White House press secretary, came in and handed the “60 Minutes” correspondent a massive binder.

“Lesley, the president wanted me to deliver his health care plan,” McEnany said. “It’s a little heavy.” 

Indeed, Stahl struggled with the huge book. The situation seemed reminiscent of other instances where Trump tried to dissuade debate by presenting massive piles of paper that didn’t stand up to scrutiny, and it sparked speculation that the contents of the massive binder were blank. However, the conservative Washington Examiner newspaper subsequently reported it contained more than 500 pages comprising “13 executive orders and 11 other pieces of healthcare legislation enacted under Trump.”

Stahl was unimpressed. After perusing the gigantic tome, she declared, “It was heavy, filled with executive orders, congressional initiatives, but no comprehensive health plan.”

McEnany took issue with that assessment and shot back with a tweet that declared, “@60Minutes is misleading you!!”

“Notice they don’t mention that I gave Leslie 2 documents: a book of all President @realDonaldTrump has done & a plan of all he is going to do on healthcare — the America First Healthcare Plan which will deliver lower costs, more choice, better care,” the press secretary wrote.

McEnany had implied one of Washington’s most wanted documents was printed, bound and ready for review. It even had a name! Were we really this close to seeing the Trump health plan?

Not exactly. 

After Yahoo News requested a copy of the “health care plan” that she presented to Stahl, McEnany provided a statement detailing the contents of the enormous binder.

“The book contains all of the executive orders and legislation President Trump has signed,” McEnany said.

She credited those actions with “lowering health care premiums and drug costs” compared with where they were under Obama and Vice President Biden. Trump has previously claimed premiums and costs have gone down during his administration, but these assertions aren’t entirely backed up by the data. And many of Trump’s executive orders on health care have been largely symbolic. 

McEnany also provided us with a copy of the second document that she described on Twitter and Stahl had supposedly ignored. It was a 10-page report (including front and back covers) with a large-print, bullet-pointed list of highlights from Trump’s previous actions on health care and slogans making promises for the future. 

“The America First Healthcare Plan lays out President Trump’s second term vision animated by the principles that have brought us lower cost, more choice and better care,” McEnany said. 

The White House’s immense binder clearly didn’t contain Trump’s “health care plan” as McEnany declared during the dramatic on-camera delivery. But it did hold a fragment of the president’s policy vision. 

Perhaps more pieces of the puzzle could be found on Capitol Hill. After all, in April 2019, Trump proclaimed on Twitter that “the Republicans … are developing a really great HealthCare Plan.” That comment followed reports that a group of Republican senators including Mitt Romney of Utah, John Barrasso of Wyoming, Rick Scott of Florida and Bill Cassidy of Louisiana were working on drafting a proposal. Trump said this plan would “be far less expensive & much more usable than ObamaCare.” The president further suggested it would be complete and ready to be voted on “right after the election.”

So, is there a finished plan floating around Capitol Hill ready to make its debut in a matter of weeks? No.

A Republican Senate source who has been privy to the talks told Yahoo News that a group of GOP senators including Romney, Barrasso, Lindsey Graham of South Carolina and Senate Health Committee Chairman Lamar Alexander of Tennessee have been “exploring” an alternative to Obamacare “over the course of the past year and a half.” However, with the coronavirus pandemic and a Supreme Court confirmation dominating the agenda, the source, who requested anonymity to discuss the deliberations, suggested the planning had stalled.

“I don’t think they’ve talked about this stuff for months now due to other pressing issues,” the source said of the health care planning.

The source predicted that activity on health care would not resume until the outcome of the election and the Supreme Court’s Obamacare case are clear. 

“Depending on how things in November shake out and … what the Supreme Court does with the ACA, maybe those discussions will be revived,” the source said. “But there really has not been much going on of late.”

Nevertheless, the source contended that, even though there is no finished plan, Trump and his Republican allies on the Hill have made some real progress toward “a potential plan that would preserve private insurance but also seek to lower costs.” They suggested Senate efforts to lower drug prices and end surprise medical billing are part of the “frameworks,” as are some of the executive orders issued by Trump.

“There have been sort of piecemeal efforts in this area. … The executive branch has done what they can do within their authority to try to lower costs,” the source said. “There just hasn’t been … a wholesale piece of legislation or framework that everyone has coalesced around. That’s just something that has not come together.”

In the end, perhaps the truest answer to the ongoing mystery of Trump’s proposed Obamacare replacement came from the president himself during the “60 Minutes” interview. In the conversation, Trump suggested that his health plan exists in a realm beyond the bounds of space and time.

“A new plan will happen,” he said. “Will and is.” 

As you can tell from the lead in to this post, that many of us who can really think and put enough words together to make a understandable sentence our choices are not good but it is really important for us all to go and turn out to vote, either in person, with masks in place and socially distancing or by mail in or drop off ballots.

Also, make sure you all get your new flu shots!!

Election 2020: What Exactly Is Joe Biden’s Healthcare Plan? And Really, Telehealth to Care for Our Patients?

So, first I wanted to relate an experience, which exemplifies the failure of telehealth, or maybe the failure of healthcare workers who are taking advantage of the “new” health care system of patient care.

Consider the case a two weeks ago. As I was about to operate on a cancer surgery patient, I was asked to evaluate a patient healthcare conundrum. One of our nurse teammate’s husband was sick and no one knew what was the problem. He had lost 23 pounds over 3 ½ weeks, was dehydrated, appetite, sore throat, weak and needed to go to the emergency room multiple times for intravenous fluids. Each time he was told that they were very sorry but they had no idea what the problem was.

His Primary care physician would not see him in person, and he had another telehealth visit, which he was charged for and was prescribed an antibiotic with no improvement.

I asked if he had a COVID test which he did and it was negative.

I then asked if I could examine him or if she had any pictures. She had pictures, with no skin rashes except I noticed something interesting on the intraoral pictures, which showed left sided ulcers on his cheeks, left lateral posterior tongue and palate, again-only on the left side.

I asked if this was true in that the ulcers were only on one side of his mouth? When his wife responded with a yes to the question I then responded that he had intraoral shingles involving the nerve to the tongue, cheek, palate ( glossophyngeal nerve ) and sometimes also affected additional nearby cranial nerve, which is probably why he was having some of his stomach problem. She thought that was interesting and wanted to know what to do since he was about to have some gallbladder studies.

I outlined a treatment plan and low and behold he is getting better. My question is why didn’t anyone in the doc’s office or ER never complete a thorough physical exam? Oh, wait- how does one do a complete physical exam through the telehealth system? What about heart or lung disease patients, how does a nurse or physician listen to their heart or lungs, etc?? Are we physicians forgetting our teachings and training regarding the proper approach to physical diagnosis?

And now what about Biden’s proposal for health care?

Leigh Page pointed out that physicians — like all Americans — are trying to size up Joe Biden’s healthcare agenda, which the Democratic presidential nominee has outlined in speeches and on his official website.

Many healthcare professionals, patients, and voters of all political stripes think our current healthcare system is broken and in need of change, but they don’t agree on how it should change. In Part I of this article, we take a look at Biden’s proposals for changing the US healthcare system. Then, we include comments and analysis from physicians on both sides of the fence regarding the pros and cons of these proposed healthcare measures.

Part 1: An Overview of Biden’s Proposed Healthcare Plan

Biden’s proposed healthcare plan has many features. The main thrust is to expand access to healthcare and increase federal subsidies for health coverage.

If elected, “I’ll put your family first,” he said in a speech in June. “That will begin the dramatic expansion of health coverage and bold steps to lower healthcare costs.” He said he favored a plan that “lowers healthcare costs, gets us universal coverage quickly, when Americans desperately need it now.”

Below are Biden’s major proposals. They are followed by Part 2, which assesses the proposals on the basis of comments by doctors from across the political spectrum.

Biden Says We Should Restore the ACA

At a debate of the Democrat presidential candidates in June 2019, Biden argued that the best way to expand coverage is “to build on what we did during the Obama administration,” rather than create a whole new healthcare system, as many other Democratic candidates for president were proposing.

“I’m proud of the Affordable Care Act,” he said a year later in his June 2020 speech. “In addition to helping people with preexisting conditions, this is the law that delivered vital coverage for 20 million Americans who did not have health insurance.”

At the heart of the ACA are the health insurance marketplaces, where people can buy individual insurance that is often federally subsidized. Buyers select coverage at different levels ― Gold, Silver, and Bronze. Those willing to pay higher premiums for a Gold plan don’t have high deductibles, as they would with the Silver and Bronze plans.

Currently, federal subsidies are based on premiums on the Silver level, where premiums are lower but deductibles are higher than with the Gold plan. Biden would shift the subsidies to the Gold plan, where they would be more generous, because subsidies are pegged to the premiums.

In addition, Biden would remove the current limit on subsidies, under which only people with incomes less than 400% of the federal poverty level qualify for them. “Many families making more than 400% of the federal poverty level (about $50,000 for a single person and $100,000 for a family of four), and thus not qualifying for financial assistance, still struggle to afford health insurance,” the Biden for President website states.

Under the Biden plan, there would still be a limit on insurance payments as a percentage of income, but that percentage would drop, meaning that more people would qualify. Currently, the level is 9.86% or more of a person’s income; Biden would lower that level to 8.5%.

“We’re going to lower premiums for people buying coverage on their own by guaranteeing that no American ever has to spend more than 8.5% of their income on health insurance, and that number would be lower for lower-income people,” Biden said in the June speech.

Add a Public Option, but Not Medicare for All

In the primary, Biden parted company from rivals who backed Medicare for All, a single-payer health system that would make the government pay for everyone’s healthcare. “I understand the appeal of Medicare for All,” he said in a video released by his campaign. “But folks supporting it should be clear that it means getting rid of Obamacare, and I’m not for that.” But he nor anyone else who supported Obamacare has come up with a way to finance this type of healthcare system.

However, Biden embraced a “public option” that would allow people to buy into or be subsidized into “a Medicare-like” plan. It is unclear how similar the public option would be to regular Medicare coverage, but the Biden campaign has made it clear that it would not take funds from the Medicare trust fund, which is expected to start losing funds by 2026.

The more than 150 million Americans who have employer-sponsored insurance could keep it, but they could still buy into the public option if they wanted to. In addition, the public option would automatically enroll ― at no cost to them ― some 4.8 million low-income Americans who were excluded from the ACA’s Medicaid expansion when many states chose to opt out of the Medicaid expansion.

In addition, the 37 states that participate in expanded Medicaid could switch coverage to the new public option, provided that they continue to pay their current share of the costs. (In June, Oklahoma became the 37th state to allow the expansion, following the results of a ballot measure.)

“We need a public option now more than ever, especially when more than 20 million people are unemployed,” Biden said in the June speech. “That public option will allow every American, regardless of their employment status, the choice to get a Medicare-like plan.”

Lower the Medicare Age

In spring 2020, Biden proposed lowering the age to qualify for Medicare from 65 to 60. This provision is not included among the official policies listed on the Biden for President website, but it has been cited by many, including the Biden-Sanders Unity Task Force.

This provision would bring almost 23 million people into Medicare, including 13.4 million from employer-sponsored coverage, according to one analysis. It’s not clear whether these people would buy into Medicare or simply be covered. Their care would not be paid for by the Medicare Trust Fund but would use tax dollars instead. Oh, finally, we find out that our taxes would go up. How much is the problem as we consider all the other programs that Biden and Harris have promoted.

Provide Relief in the Covid-19 Pandemic

Biden would cover the cost of COVID-19 testing and the cost of health coverage for people laid off during the pandemic.

“Testing unequivocally saves lives, and widespread testing is the key to opening our economy again,” Biden said in his June speech. “To fix the economy, we have to get control over the virus.”

Prescription Drug Reform

Biden would repeal a Bush-era exception that bars the Medicare program from negotiating prescription drug prices for the Part D prescription drug benefit. “There’s no justification for this except the power of prescription drug lobbying,” the Biden for President website states.

In addition, Biden’s prescription drug reform plan would do the following:

• Limit launch prices for drugs. The administration would establish an independent review board that would assess the value of new drugs and would have the power to set limits on their prices. Such drugs are “being abusively priced by manufacturers,” the Biden for President site says.

• Limit price increases to inflation. As a condition of participation in government programs, drug prices could not rise more than the general inflation rate. Biden would impose a tax penalty on drug makers whose prices surpassed inflation.

• Allow consumers to buy prescription drugs from other countries. Biden would allow consumers to import prescription drugs from other countries, provided the US Department of Health and Human Services certifies that those drugs are safe.

• Stop tax breaks for pharma ads: Biden would drop drug makers’ tax breaks for advertising, which amounted to $6 billion in 2016.

Stop Surprise Billing

Biden proposes to stop surprise billing, which occurs when patients receive care from a doctor or hospital that is not in their insurer’s network. In these situations, patients can be surprised with very high bills because no payment limit has been negotiated by the insurer.

Twenty-eight states have enacted consumer protections to address surprise medical billing, but Congress has not passed such a measure. One proposed solution is to require payers to pay for out-of-network services on the basis of a benchmark, such as the average Medicare rate for that service in a specific geographic area.

Closely Monitor Healthcare Mergers

Biden would take a more active stance in enforcing antitrust laws against mergers in the healthcare industry.

“The concentration of market power in the hands of a few corporations is occurring throughout our health care system, and this lack of competition is driving up prices for consumers,” the Biden for President website states.

Overhaul Long-term Care

Biden’s latest plan calls for a $775 billion overhaul of the nation’s caregiving infrastructure. Biden says he would help create new jobs, improve working conditions, and invest in new models of long-term care outside of traditional nursing homes.

Restore Funding for Planned Parenthood

Biden would reissue guidance barring states from refusing Medicaid funding for Planned Parenthood and other providers that refer for abortions or that provide related information, according to the Biden for President website. This action would reverse a Trump administration rule.

Boost Community Health Centers

Biden promises to double federal funding for community health centers, such as federally qualified health centers, that provide care to underserved populations.

Support Mental Health Parity

Biden says he supports mental health parity and would enforce the federal mental health parity law and expand funding for mental health services.

Part 2: Physicians’ Opinions on Biden’s Healthcare Plans: Pro and Con

Biden’s plans to expand coverage are at the heart of his healthcare platform, and many see these as the most controversial part of his legislative agenda.

Biden’s Medicare expansion is not Medicare for All, but it can be seen as “Medicare for all who want it.” Potentially, millions of people could enter Medicare or something like Medicare. If the Medicare eligibility age is dropped to 60, people could switch from their employer-sponsored plans, many of which have high deductibles. In addition, poor people who have no coverage because their states opted out of the Medicaid expansion would be included.

The possibility of such a mass movement to government-run healthcare alarms many people. “Biden’s proposals look moderate, but it is basically Medicare for All in sheep’s clothing,” said Cesar De Leon, DO, a family physician in Naples, Florida, and past president of the county’s medical society.

Reimbursements for Doctors Could Fall- No, Will Fall!

A shift of millions of people into Medicare would likely mean lower reimbursements for doctors. For example, the 13.4 million people aged 60 to 65 who would switch from employer-sponsored coverage to Medicare would be leaving some of the best-paying insurance plans, and their physicians would then be reimbursed at Medicare rates.

“Biden’s plan would lower payments to already cash-strapped doctors and hospitals, who have already seen a significant decrease in reimbursement over the past decade,” De Leon said. “He is trying to win the support of low-income voters by giving them lower healthcare prices, which doctors and hospitals would have to absorb.

“Yes, the US healthcare system is dysfunctional,” De Leon added, “but the basic system needs to be fixed before it is expanded to new groups of people.”

The American Association of Neurological Surgeons/Congress of Neurological Surgeons warns against Biden’s proposed government-run system. “We support expanding health insurance coverage, but the expansion should build on the existing employer-based system,” said Katie O. Orrico, director of the group’s Washington office. “We have consistently opposed a public option or Medicare for All.

“Shifting more Americans into government-sponsored healthcare will inevitably result in lower payments for physicians’ services,” Orrico added. “Reimbursement rates from Medicare, Medicaid, and many ACA exchange plans already do not adequately cover the costs of running a medical practice.”

Prospect of Higher Taxes- Absolutely, grab your wallets and your retirement funds!!

Paying for ambitious reforms means raising taxes. Biden’s plan would not make the Medicare trust fund pay for the expansions and would to some extent rely on payments from new beneficiaries. However, many new beneficiaries, such as people older than 60 and the poor, would be covered by tax dollars.

Altogether, Biden’s plan is expected to cost the federal government $800 billion over the next 10 years. To pay for it, Biden proposes reversing President Trump’s tax cuts, which disproportionately helped high earners, and eliminating capital gains tax loopholes for the wealthy.

“Rather than tax the average American, the Democrats will try to redistribute wealth,” De Leon said.

“The elephant in the room is that taxes would have to be raised to pay for all these programs,” said Gary Price, MD, president of the Physicians Foundation. Because no one likes higher taxes, he says, architects of the Biden plan would try to find ways to save money, such as tamping down reimbursements for physicians, to try to avoid a public backlash against the reforms.

“Physicians’ great fear is that efforts to keep taxes from getting too high will result in cutting physician reimbursement,” he said.

Impact of COVID-19

Perhaps an even larger barrier to Biden’s health reforms comes from the COVID-19 crisis, which didn’t exist last year, when health reform was the central issue in the presidential primary that pitted Biden against Vermont Senator Bernie Sanders, the chief proponent of Medicare for All.

“The top two issues on voters’ minds right now are the pandemic and the economy,” said Daniel Derksen, MD, a family physician who is professor of public health policy at the University of Arizona in Tucson. “Any other concerns are pushed down the list.”

The COVID-19 crisis is forcing the federal government to spend trillions of dollars to help businesses and individuals who have lost income because of the crisis. Will there be enough money left over to fund an ambitious set of health reforms?

“It’s not a good time to start reforms,” warned Kevin Campbell, MD, a cardiologist in Raleigh, North Carolina. “Given the current pressures that COVID-19 has placed on physicians, healthcare systems, and hospitals, I don’t believe that we can achieve meaningful change in the near term.”

However, supporters of Biden’s reforms think that now, during the COVID-19 crisis, is precisely the right time to enact healthcare reform. When millions of Americans lost their jobs because of the pandemic, they also lost their insurance coverage.

“COVID-19 has made Biden’s healthcare agenda all the more relevant and necessary,” said Don Berwick, MD, who led the Center for Medicare & Medicaid Services (CMS) under President Obama. “The COVID-19 recession has made people more aware of how vulnerable their coverage is.”

Orrico at the neurosurgeons group acknowledges this point. “The COVID-19 pandemic has exposed some cracks in the US healthcare system,” she said. “Whether this will lead to new reforms is hard to say, but policymakers will likely take a closer look at issues related to unemployment, health insurance coverage, and healthcare costs due to the COVID-19 emergency.”

Many Physicians Want Major Reform

Although many doctors are skeptical of reform, others are impatient for reform to come and support Biden’s agenda ― especially its goal to expand coverage.

“Joe Biden’s goal is to get everyone covered,” said Alice Chen, MD, an internist who is a leader of Doctors for Biden, an independent group that is not part of the Biden campaign. “What brings Democrats together is that they are united in the belief that healthcare is a right.”

In January, the American College of Physicians (ACP) endorsed both Medicare for All and the public option. The US healthcare system “is ill and needs a bold new prescription,” the ACP stated.

The medical profession, once mostly Republican, now has more Democrats. In 2016, 35% of physicians identified themselves as Democrats, 27% as Republicans, and 36% as independents.

Many of the doctors behind reform appear to be younger physicians who are employed by large organizations. They are passionate about reforming the healthcare system, and as employees of large organizations, they would not be directly affected if reimbursements fell to Medicare levels ― although their institutions might subsequently have to adjust their salaries downward.

Chen, for example, is a young physician who says she has taken leave from her work as adjunct assistant clinical professor of medicine at the University of California, Los Angeles, to raise her young children.

She is the former executive director of Doctors for America, a movement of thousands of physicians and medical students “to bring their patients’ experiences to policymakers.”

“Doctors feel that they are unseen and unheard, that they often feel frankly used by large health systems and by insurance companies,” Chen said. “Biden wants to hear from them.”

Many idealistic young physicians look to health system leaders like Berwick. “I believe this nation needs to get universal coverage as fast as we can, and Biden’s policies present a path to get there,” the former CMS director said. “This would be done chiefly through Biden’s public option and his plans to expand coverage in states that have not adopted the ACA Medicaid expansion.”

But what about the potential effect of lowering reimbursement rates for doctors? “The exact rates will have to be worked out,” Berwick said, “but it’s not just about who pays physicians, it’s about how physicians get paid.” He thinks the current fee-for-service system needs to be replaced by a value-based payment system such as capitation, shared savings, and bundled payments.

The Biden-Sanders Task Force

Berwick was a member of the Biden-Sanders Unity Task Force, which brings together supporters of Biden and Sanders to create a shared platform for the Biden campaign.

The task force issued a report in early July that recommended a variety of healthcare reforms in addition to expanding access to care. One of them was to find ways to address the social determinants of health, such as housing, hunger, transportation, and pollution, which can harm health outcomes.

Chen specifically cites this provision. “We need to focus on the social determinants of heath and try to encourage better health,” she said. “I remember as a doctor advising a patient who was a young mother with several small children that she needed to exercise more. She asked me, ‘When am I supposed to exercise, and who will watch my kids?’ I realized the predicament that she was in.”

Price is also glad to see the provision in Biden’s plan. “Social determinants of health has been a key focus of the Physicians Foundation,” he said. “To my knowledge, this is the first time that a political candidate’s healthcare policy has included this point.

“Physicians are not in control of the social determinants of health, even though they affect their reimbursements,” he said. Under Medicare’s Merit-based Incentive Payment System, for example, doctors are penalized when their patients don’t meet certain health standards, such as when diabetes patients can’t get their A1C levels under control, he says.

However, Price fears that Biden, in his efforts to make peace with Sanders supporters, may have to some degree abandoned his moderate stance on health reform.

Is the Nation Ready for Another Health Reform Battle?

Clearly, many Democrats are ready to reform the system, but is the nation ready? “Are American voters ready for another major, Democratic-led health reform initiative?” asked Patricia Salber, MD, an internist and healthcare consultant who runs a blog called The Doctor Weighs In.

“I’ve been around long enough to remember the fight over President Clinton’s health plan and then President Obama’s plan,” she said. Each time, she says, there seemed to be a great deal of momentum, and then there was a backlash. “If Biden is elected, I hope we don’t have to go through the same thing all over again,” Salber said.

Derksen believes Biden’s proposed healthcare reforms could come close to rivaling President Obama’s Affordable Care Act in ambition, cost, and controversy.

He shares Biden’s goal of extending coverage to all ― including paying the cost of covering low-income people. But the result is that “Biden’s agenda is going to be a ‘heavy lift,’ as they say in Washington,” he said. “He has some very ambitious plans to expand access to care.”

Derksen speaks from experience. He helped draft part of the ACA as a health policy fellow in Capitol Hill in 2009. Then in 2011, he was in charge of setting up the ACA’s insurance marketplace for the state of New Mexico.

Now Biden wants to begin a second wave of health reform. But Derksen thinks this second wave of reform could encounter opposition as formidable as those Obama faced.

“Assuming that Biden is elected, it would be tough to get this agenda passed ― even if he had solid Democratic majorities in both the House and Senate,” said Derksen,

According to polls by the Kaiser Family Foundation (KFF), 53% of Americans like the ACA, while 37% dislike it ― a split that has been relatively stable for the past 2 years, since the failed GOP effort to repeal the law.

In that KFF poll, the public option fared better ― 68% of Americans support the public option, including 42% of Republicans. These numbers help explain why the Biden campaign moved beyond its support of the ACA to embrace the public option as well.

Even when Democrats gain control of all the levers of power, as they did in 2009, they still have a very difficult time passing an ambitious healthcare reform bill. Derksen remembers how tough it was to get that massive bill through Congress.

The House bill’s public option might have prevailed in a reconciliation process between the two bills, but that process was cut short when Sen. Ted Kennedy died and Senate Democrats lost their filibuster-proof majority. The bill squeaked through as the Senate version, without the public option.

The ACA Has Survived-But at What Cost?

The ACA is much more complex piece of legislation than the public option.

“The ACA has survived for a decade, despite all efforts to dismantle it,” Salber said. “Biden wants to restore a law that the Republicans have been chipping away at. The Republicans eliminated the penalty for not having coverage. Think about it, a penalty of zero is not much of a deterrent.”

It was the loss of the ACA penalty in tax year 2019 that, paradoxically, formed the legal basis for the latest challenge of the ACA before the Supreme Court, in a suit brought by the Trump administration and 18 Republican state attorneys general.

The Supreme Court will make its ruling after the election, but Salber thinks the suit itself will boost both Biden and the ACA in the campaign. “I think most people are tired of all the attempts to repeal the ACA,” she said.

“The public now thinks of the US healthcare system as pathetically broken,” she added. “It used to be that Americans would say we have the best healthcare system in the world. I don’t hear that much anymore.”

Physicians who oppose the ACA hold exactly the opposite view. “Our healthcare system is in shambles after the Obamacare fiasco,” Campbell said. “Even if Biden has a Democrat-controlled House and Senate, I still don’t think that there would be enough votes to pass sweeping changes to healthcare.”

Biden Could Choose Issues Other Than Expanding Access

There are plenty of proposals in the Biden healthcare plan that don’t involve remaking the healthcare system.

These include making COVID-19 testing free, providing extra funding for community health centers, and stopping surprise billing. Proposals such as stepping up antitrust enforcement against mergers would involve administrative rather than Congressional action.

Some of these other proposals could be quite expensive, such as overhauling long-term care and paying for health insurance for laid-off workers. And another proposal ― limiting the prices of pharmaceuticals ― could be almost as contentious as expanding coverage.

“This proposal has been talked about for many years, but it has always met with strong resistance from drug makers,” said Robert Pearl, MD, former CEO of the Permanente Medical Group and now a faculty member at Stanford School of Medicine and Graduate School of Business.

Pearl thinks the first item in Biden’s drug plan ― to repeal a ban against Medicare negotiating drug prices with drug makers ― would meet with Congressional resistance, owing to heavy lobbying and campaign contributions by the drug companies.

In addition, Pearl thinks Biden’s plans to limit drug prices ― barring drug makers from raising their prices above the general inflation rate and limiting the launch prices for many drugs ― enter uncharted legal waters and could end up in the courts.

Even Without Reform, Expect Lower Reimbursements

Although many doctors are concerned that Biden’s healthcare reforms would reduce reimbursements, Pearl thinks reimbursements will decline even without reforms, owing in part to the COVID-19 pandemic.

Employer-based health insurance has been the bedrock of the US healthcare system, but Pearl says many employers have long wanted to get rid of this obligation. Increasingly, they are pushing costs onto the employee by raising deductibles and through premium sharing.

Now, with the pandemic, employers are struggling just to stay in business, and health insurance has truly become a financial burden, he says. In addition, states will be unable to balance their budgets and will try to reduce their Medicaid obligations.

“Before COVID-19 hit, healthcare spending was supposed to grow by 5% a year, but that won’t happen for some time into the future,” Pearl said. “The COVID economic crisis is likely to continue for quite some time, forcing physicians to either accept much lower payments or find better ways to provide care.”

Like Berwick, Pearl believes healthcare will have to move to value-based payments. “Instead of producing more services, doctors will have to preserve resources, which is value-based healthcare,” he said. The primary form of value-based reimbursement, Pearl thinks, will be capitation, in which physicians agree to quality and service guarantees.

Even steadfast opponents of many of Biden’s reforms foresee value-based payments taking off. “Certainly, there are ways to improve the current healthcare system, such as moving to value-based care,” said Orrico at the neurosurgeons’ group.

In short, a wide swath of observers agree that doctors are facing major changes in the payment and delivery of healthcare, regardless of whether Biden is elected and succeeds with his health agenda.

Notice that no one has mentioned tort reform in healthcare. Why Not???????

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

It is truly amazing how out of touch the GOP and, I believe President Trump is, on health care, especially “after” or during this COVID pandemic. Consider the amount of monies spent on caring for the millions of patients diagnosed with COVID-19. One must remember that due to the EMTALA Act, which ensures public access to emergency services regardless of ability to pay. Think of all the COVID testing and ICU care that has been provided for all that needed it. This experience, etc. should convince, even the clueless that we need a type of universal health care policy.

They, the GOP and the President, promised us all that they would create, provide a wonderful healthcare for all, better than Obamacare. But have they? No!

And now is the time to produce a well-designed alternative, or consider Obamacare as a well thought out program, except for the lack of financial sustainability. And guess what happened after I had a phone call with a member of the Trump administration. He asked me what I thought Trump’s chances of winning re-election. I responded that I thought he had about a 20% chance of getting re-elected. He pressed me as what I thought that would increase his chances. My response was to finally reveal their, the GOP/Trump’s

, plan and I suggested that they should adopt the Affordable Care Act but outline a plan to sustainably finance the healthcare plan.

My suggestion- embrace the Affordable Care Act as a good starting point and use a federal sales tax to finance it instead of putting the onus on the young healthy workers.

 At a hearing on the coronavirus response, Senator Dick Durbin asked the Trump administration’s top health officials about the president’s comments touting a plan to replace the Affordable Care Act, also known as Obamacare. They said they did not know about such a plan.

And a Republican victory in Supreme Court battle could mean millions lose health insurance in the middle of a pandemic.

John T. Bennett noted that Ruth Bader Ginsburg, Barack Obama, Donald Trump and Mitch McConnell could soon be forever linked if the late Supreme Court justice’s death leads to the termination of the 44th president’s signature domestic policy achievement: the Affordable Care Act

All sides in the coming battle royal over how to proceed with filling the high court seat she left behind are posturing and pressuring, floating strategic possibilities and offering creative versions of history and precedent. Most Republicans in the Senate want to hold a simple-majority floor vote on a nominee Mr. Trump says he will announce as soon as this week before the end of the calendar year. Democrats say they are hypocrites because the blocked a Barack Obama high court pick during his final year.

It appears Democrats have only extreme options as viable tactics from preventing confirmation hearings and a floor vote before this unprecedented year is up. Speaker Nancy Pelosi on Sunday refused to rule bringing articles of impeachment against the president or even William Barr, his attorney general whom the Democrats say has improperly used his office to help Mr. Trump’s friends and use federal law enforcement unjustly against US citizens.

Unless Ms Pelosi pulls that politically dangerous lever, the maneuvering of the next few weeks most likely will end after Congress returns after the 3 November election with a high court with a 6-3 conservative bend. Analysts already are warning that conservatives appear months away from being able to partially criminalize abortion and also take down the 2011 Affordable Care Act, also known as Obama care.

Democrats have sounded off since Ms. Ginsburg’s death to warn that millions of Americans could soon lose their health insurance, especially those with pre-existing conditions. Last year, 8.5m people signed up for coverage using the Affordable Care Act, according to the Congressional Budget Office.

“Healthcare in this country hangs in the balance,” Joe Biden, who is the Democratic nominee for president and was vice president when Mr. Obama signed the health plan now linked to his name into law, said on Sunday.

Mr. Biden accused Republicans of playing a “game” by rushing the process to replace Ms. Ginsburg on the court because they are “trying to strip healthcare away from tens of millions of families.”

Doing so, he warned, would “strip away their peace of mind” because insurance providers would no longer be required to give some Americans policies. Should a 6-3 court decide to uphold a lower court’s ruling that the 2011 health law be taken down, those companies would “drop coverage completely for folks with pre-existing conditions,” Mr. Biden warned in remarks from Philadelphia.

“If Donald Trump has his way, the complications from Covid-19 … would become the next deniable pre-existing condition for millions of Americans.” That means they would lose their health insurance and be forced to either pay for care out of their pocket or use credit lines. Both could force millions into medical bankruptcy or otherwise create dire financial hardships.

Mr. Trump about a month ago promised to release a new healthcare plan that, if ever passed by both chambers of Congress and signed into law, would replace Obamacare.

So far, however, he has yet to unveil that alleged plan.

Trump Press Secretary Kayleigh McEnany told reporters last week that the White House’s Domestic Policy Council is leading the work on the plan. But when pressed for more details, she chose to pick a fight with a CNN reporter.

“I’m not going to give you a readout of what our healthcare plan looks like and who’s working on it,” Ms. McEnany said. “If you want to know, if you want to know, come work here at the White House.”

When pressed, Ms. McEnany said “stakeholders here in the White House” are working on a plan the president has promised for several years. “And, as I told you, our Domestic Policy Council and others in the White House are working on a healthcare plan,” she insisted, describing it as “the president’s vision for the next five years.”

The president frequently mentions healthcare during his rowdy campaign rallies, but only in general terms. He promises a sweeping plan that will bring costs down across the board and also protect those with pre-existing conditions. But he mostly brings it up to hammer Mr. Obama and Mr. Biden for pushing a flawed law that he has been forced to tinker with to make it function better for consumers.

Broad brush

His top spokeswoman echoed those broad strokes during a briefing on Wednesday. “In aggregate, it’s going to be a very comprehensive strategy, one where we’re saving healthcare while Democrats are trying to take healthcare away,” she told reporters. “We’re making healthcare better and cheaper, guaranteeing protections for people with preexisting conditions, stopping surprise medical billing, increasing transparency, defending the right to keep your doctor and your plan, fighting lobbyists and special interests, and making healthier and making, finding cures to diseases.”

If there is a substantive plan that would protect millions with pre-existing conditions and others affected by Covid-19, it would have made a fine backbone of Mr. Trump’s August Republican National Committee address in which he accepted his party’s presidential nomination for a second time. But healthcare was not the major focus, even though it ranks in the top two issues – along with the economy – in just about every poll that asks voters to rank their priorities in deciding between Mr. Trump and Mr. Biden.

If there is a coming White House healthcare plan that would protect those with pre-existing conditions and prevent millions from losing coverage as the coronavirus pandemic is ongoing, the president is not using his campaign rallies at regional airport hangars to describe or promote it.

“We will strongly protect Medicare and Social Security and we will always protect patients with pre-existing conditions,” said at a campaign stop Saturday evening in Fayetteville, North Carolina, before pivoting to a completely unrelated topic: “America will land the first woman on the moon, and the United States will be the first nation to land an astronaut on Mars.”

The push to install a conservative to replace the liberal Ms. Ginsburg and the lack of any expectation Mr. Trump has a tangible plan has given Democrats a new election-year talking point less than two months before all votes must be cast.

“Whoever President Trump nominates will strike down the Affordable Care Act,” Hawaii Democratic Senator Mazie Hirono told MSNBC on Sunday. “It will throw millions of people off of healthcare, won’t protect people with pre-existing conditions. It will be disastrous. That’s why they want to rush this.”

 About 1 In 5 Households in U.S. Cities Miss Needed Medical Care During Pandemic

Patti Neighmond noted that when 28-year-old Katie Kinsey moved from Washington, D.C., to Los Angeles in early March, she didn’t expect the pandemic would affect her directly, at least not right away. But that’s exactly what happened.

She was still settling in and didn’t have a primary care doctor when she got sick with symptoms of what she feared was COVID-19.

“I had a sore throat and a debilitating cough,” she says, “and when I say debilitating, I mean I couldn’t talk without coughing.” She couldn’t lie down at night without coughing. She just wasn’t getting enough air into her lungs, she says.

Kinsey, who works as a federal consultant in nuclear defense technology, found herself coughing through phone meetings. And then things got worse. Her energy took a dive, and she felt achy all over, “so I was taking naps during the day.” She never got a fever but worried about the coronavirus and accelerated her effort to find a doctor.

No luck.

She called nearly a dozen doctors listed on her insurance card, but all were booked. “Some said they were flooded with patients and couldn’t take new patients. Others gave no explanation, and just said they were sorry and could put me on a waiting list.” All the waiting lists were two to three months’ long.

Eventually Kinsey went to an urgent care clinic, got an X-ray and a diagnosis of severe bronchitis — not COVID-19. Antibiotics helped her get better. But she says she might have avoided “months of illness and lost days of work” had she been able to see a doctor sooner. She was sick for three months.

Kinsey’s experience is just one way the pandemic has delayed medical care for Americans in the last several months. A poll of households in the four largest U.S. cities by NPR, the Robert Wood Johnson Foundation and Harvard’s T.H. Chan School of Public Health finds roughly one in every five have had at least one member who was unable to get medical care or who has had to delay care for a serious medical problem during the pandemic (ranging from 19% of households in New York City to 27% in Houston).

We had people come in with heart attacks after having chest pain for three or four days, or stroke patients who had significant loss of function for several days, if not a week.

There were multiple reasons given. Many people reported, like Kinsey, that they could not find a doctor to see them as hospitals around the U.S. delayed or canceled certain medical procedures to focus resources on treating COVID-19.

Other patients avoided critically important medical care because of fears they would catch the coronavirus while in a hospital or medical office.

“One thing we didn’t expect from COVID was that we were going to drop 60% of our volume,” says Ryan Stanton, an emergency physician in Lexington, Ky., and member of the board of directors of the American College of Emergency Physicians.

“We had people come in with heart attacks after having chest pain for three or four days,” Stanton says, “or stroke patients who had significant loss of function for several days, if not a week. And I’d ask them why they hadn’t come in, and they would say almost universally they were afraid of COVID.”

Stanton found that to be particularly frustrating, because his hospital had made a big effort to communicate with the community to “absolutely come to the hospital for true emergencies.”

He describes one patient who had suffered at home for weeks with what ended up being appendicitis. When the patient finally came to the emergency room, Stanton says, a procedure that normally would have been done on an outpatient basis “ended up being a very much more involved surgery with increased risk of complications because of that delay.”

The poll finds a majority of households in leading U.S. cities who delayed medical care for serious problems say they had negative health consequences as a result (ranging from 55% in Chicago to 75% in Houston and 63% in Los Angeles).

Dr. Anish Mahajan, chief medical officer of the large public hospital Harbor-UCLA Medical Center in Los Angeles, says the number of emergencies showing up in his hospital have been down during the pandemic, too, because patients have been fearful of catching the coronavirus there. One case that sticks in his mind was a middle aged woman with diabetes who fainted at home.

“Her blood sugar was really high, and she didn’t feel well — she was sweating,” the doctor recalls. “The family called the ambulance, and the ambulance came, and she said, ‘No, no, I don’t want to go to the hospital. I’ll be fine.’ “

By the next day the woman was even sicker. Her family took her to the hospital, where she was rushed to the catheterization lab. There doctors discovered and dissolved a clot in her heart. This was ultimately a successful ending for the patient, Mahajan says, “but you can see how this is very dangerous — to avoid going to the hospital if you have significant symptoms.”

He says worrisome reports from the Los Angeles County coroner’s office show the number of people who have died at home in the last few months is much higher than the average number of people who died in their homes before the pandemic.

“That’s yet another signal that something is going on where patients are not coming in for care,” Mahajan says. “And those folks who died at home may have died from COVID, but they may also have died from other conditions that they did not come in to get cared for.”

Like most hospitals nationwide, Harbor-UCLA canceled elective surgeries to make room for coronavirus patients — at least during the earliest months of the pandemic, and when cases surged.

In NPR’s survey of cities, about one-third of households in Chicago and Los Angeles and more than half in Houston and New York with a household member who couldn’t get surgeries or elective procedures said it resulted in negative health consequences for that person.

“Back in March and April the estimates were 80[%] to 90% of normal [in terms of screenings for cancer]” at Memorial Sloan Kettering Cancer Center in New York, says Dr. Jeffrey Drebin, who heads surgical oncology there.

“Things like mammograms, colonoscopies, PSA tests were not being done,” he says. At the height of the pandemic’s spring surge in New York City, Drebin says, he was seeing many more patients than usual who had advanced disease.

“Patients weren’t being found at routine colonoscopy,” he says. “They were coming in because they had a bleeding tumor or an obstructing tumor and needed to have something done right away.”

In June, during patients’ information sessions with the hospital, Drebin says patients typically asked if they could wait a few months before getting a cancer screening test.

“In some cases, you can, but there are certainly types of cancer that cannot have surgery delayed for a number of months,” he explains. With pancreatic or bladder cancer, for example, delaying even a month can dramatically reduce the opportunity for the best treatment or even a cure.

Reductions in cancer screening, Drebin says, are likely to translate to more illness and death down the road. “The estimate,” he says, “is that simply the reduction this year in mammography and colonoscopy [procedures] will create 10,000 additional deaths over the next few years.”

And even delays in treatment that aren’t a matter of life and death can make a big difference in the quality of a life.

For 12-year-old Nicolas Noblitt, who lives in Northridge, Calif., with his parents and two siblings, delays in treatment this year have dramatically reduced his mobility.

Nicolas has cerebral palsy and has relied on a wheelchair most of his life. The muscles in his thighs, hips, calves and even his feet and toes get extremely tight, and that “makes it hard for him to walk even a short distance with a walker,” says his mother, Natalie Noblitt. “So, keeping the spasticity under control has been a major project his whole life to keep him comfortable and try to help him gain the most mobility he can have.”

Before the pandemic, Nicolas was helped by regular Botox injections, which relaxed his tight muscles and enabled him to wear shoes.

As Nicolas says, “I do have these really cool shoes that have a zipper … and they really help me — because, one, they’re really easy to get on, and two, they’re cool shoes.” Best of all, he says they stabilize him enough so he can walk with a walker.

“I love those shoes and I think they sort of love me, too, when you think about it,” he tells NPR.

Nicolas was due to get a round of Botox injections in early March. But the doctors deemed it an elective procedure and canceled the appointment. That left him to go months without a treatment.

His muscles got so tight that his feet would uncontrollably curl.

“And when it happens and I’m trying to walk … it just makes everything worse,” Nicolas says, “from trying to get on the shoes to trying to walk in the walker.”

Today he is finally back on his Botox regimen and feeling more comfortable — happy to walk with a walker. Even so, says his mom, the lapse in treatment caused setbacks. Nicolas has to work harder now, both in day-to-day activities and in physical therapy.

‘Warp Speed’ Officials Debut Plan for Distributing Free Vaccines

Despite the president’s statements about military involvement in the vaccine rollout, officials said that for most people, “there will be no federal official who touches any of this vaccine.”

Katie Thomas reported that Federal officials outlined details Wednesday of their preparations to administer a future coronavirus vaccine to Americans, saying they would begin distribution within 24 hours of any approval or emergency authorization, and that their goal was that no American “has to pay a single dime” out of their own pocket.

The officials, who are part of the federal government’s Operation Warp Speed — the multiagency effort to quickly make a coronavirus vaccine available to Americans — also said the timing of a vaccine was still unclear, despite repeated statements by President Trump that one could be ready before the election on Nov. 3.

“We’re dealing in a world of great uncertainty. We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services. “This is a really quite extraordinary, logistically complex undertaking, and a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those uncertainties.”

The officials said they were planning for initial distribution of a vaccine — perhaps on an emergency basis, and to a limited group of high-priority people such as health care workers — in the final three months of this year and into next year. The Department of Defense is providing logistical support to plan how the vaccines will be shipped and stored, as well as how to keep track of who has gotten the vaccine and whether they have gotten one or two doses.

However, Mr. Mango said that there had been “a lot of confusion” about what the role of the Department of Defense would be, and that “for the overwhelming majority of Americans, there will be no federal official who touches any of this vaccine before it’s injected into Americans.”

Army Lt. Gen. Paul Ostrowski said Operation Warp Speed was working to link up existing databases so that, for example, a patient who received a vaccine at a public health center in January could go to a CVS pharmacy 28 days later in another state and be assured of getting the second dose of the right vaccine.

Three drug makers are testing vaccine candidates in late-stage trials in the United States. One of those companies, Pfizer, has said that it could apply for emergency authorization as early as October, while the other two, Moderna and AstraZeneca, have said they hope to have something before the end of the year.

Coronavirus vaccine study by Pfizer shows mild-to-moderate side effects

Pfizer Inc said on Tuesday participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.

The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo. Kathrin Jansen, Pfizer’s head of vaccine research and development, stressed that the independent data monitoring committee “has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date.”

The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech. Over 12,000 study participants had received a second dose of the vaccine, Pfizer executives said on an investor conference call.

The comments follow rival AstraZeneca’s COVID-19 vaccine trials being put on hold worldwide on Sept. 6 after a serious side effect was reported in a volunteer in Britain.

AstraZeneca’s trials resumed in Britain and Brazil on Monday following the green light from British regulators, but remain on hold in the United States.

Pfizer expects it will likely have results on whether the vaccine works in October. “We do believe – given the very robust immune profile and also the preclinical profile … that vaccine efficacy is likely to be 60% or more,” Pfizer’s Chief Scientific Officer Mikael Dolsten said.

Rushing the COVID-19 Vaccine Could Have Serious and Fatal Side Effects

Jason Silverstein noted that States have been told by the Centers for Disease Control and Prevention they should prepare for a coronavirus vaccine by “late October or early November,” according to reports last Wednesday. But an untested coronavirus vaccine may have serious and fatal side effects, could even make the disease worse, and may very well have an effect on the election.

What’s the worst that could happen if we give an untested vaccine to millions of people?

We received a reminder today, when one of the leading large coronavirus vaccine trials by AstraZeneca and Oxford University was paused due to a “suspected serious adverse reaction.” There are eight other potential coronavirus vaccines that have reached Phase 3, which is the phase that enrolls tens of thousands of people and compares how they do with the vaccine against people who only get a placebo. Those eight include China’s CanSino Biologics product that was approved for military use without proper testing back in July, and Russia’s coronavirus vaccine that has been tested in only 76 people.

If the CDC distributes an untested coronavirus vaccine this Fall, it would be the largest drug trial in history—with all of the risks and none of the safeguards.

“Approving a vaccine without testing would be like climbing into a plane that has never been tested,” said Tony Moody, MD, director of the Duke Collaborative Influenza Vaccine Innovation Centers. “It might work, but failure could be catastrophic.”

One concern about this vaccine is that it’s tracking to be an “October surprise.” From Henry Kissinger’s “peace is at hand” speech regarding a ceasefire in Vietnam less than two weeks before the 1972 election to former FBI Director James Comey’s letter that he would reopen the investigation into Hillary Clinton’s emails, October surprises have always had the potential to shift elections. But never before have they had the potential to catastrophically shift the health of an already fragile nation.

If there is an October surprise in the form of an untested coronavirus vaccine, it won’t be the first time that a vaccine was rushed out as a political stunt to increase an incumbent president’s election chances.

What happened with the last vaccine rush?

On March 24, 1976, in response to a swine flu outbreak, President Gerald Ford asked Congress for $135 million for “each and every American to receive an inoculation.”

How badly did the Swine Flu campaign of 1976 go? Well, one of the drug companies made two million doses of the wrong Swine Flu vaccine, vaccines weren’t exactly effective for people under 24, and insurance companies said, no way, they didn’t want to be liable for the science experiment of putting this vaccine into 120 million bodies.

By December, the Swine Flu vaccination program was suspended when people started to develop Guillain-Barré Syndrome, a rare neurological condition whose risk was seven times higher in people who got the vaccine and which paralyzed more than 500 people and killed at least 25.

What else can go wrong when vaccines are rushed

“Vaccines are some of the safest medical products in the world, but there can be serious side effects in some instances that are often only revealed by very large trials,” said Kate Langwig, Ph.D., an infectious disease ecologist at Virginia Tech.

One of the other possible side effects is known as vaccine enhancement, the very rare case when the body makes antibodies in response to a vaccine but the antibodies help a second infection get into cells, something that has been seen in dengue fever. “The vaccine, far from preventing Covid-19, might turn out to make a patient’s disease worse,” said Nir Eyal, D.Phil., a bioethics professor at Rutgers University.

We do not know whether a coronavirus vaccine might cause vaccine enhancement, but we need to. In 1966, a vaccine trial against respiratory syncytial virus, a disease that many infants get, caused more than 80 percent of infants and children who received the vaccine to be hospitalized and killed two.

All of these risks can be prevented, but safety takes patience, something that an American public which has had to bury more than 186,000 is understandably short on and Trump seems to be allergic to.

“To put this into perspective, the typical length of making a vaccine is fifteen to twenty years,” said Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Offit’s laboratory developed a vaccine for rotavirus, a disease that kills infants. That process began in the 1980s and wasn’t completed until 2006. The first scientific papers behind the HPV vaccine, for example, were published in the early 1990’s, but the vaccine wasn’t licensed until 2006.

An untested vaccine may also prove a deadly distraction. “An ineffective vaccine could create a false sense of security and perhaps reduce the emphasis on social distancing, mask wearing, hand hygiene,” said Atul Malhotra, MD, a pulmonologist at the UC San Diego School of Medicine.

Other issues with inadequately tested vaccines

Even worse, an untested vaccine may have consequences far beyond the present pandemic. Even today, one poll shows that only 57% of people would take a coronavirus vaccine. (Some experts argue that we need 55 to 82% to develop herd immunity.)

If we don’t get the vaccine right the first time, there may not be enough public trust for a next time. “Vaccines are a lot like social distancing. They are most effective if we work cooperatively and get a lot of people to take them,” said Langwig. “If we erode the public’s trust through the use of unsafe or ineffective vaccines, we may be less likely to convince people to be vaccinated in the future.”

“You don’t want to scare people off, because vaccines are our way out of this,” said Dr. Offit.

So, how will you be able to see through the fog of the vaccine war and know when a vaccine is safe to take? “Data,” said Dr. Moody, “to see if the vaccine did not cause serious side effects in those who got it, and that those who got the vaccine had a lower rate of disease, hospitalization, death, or any other metric that means it worked. And we really, really want to see that people who got the vaccine did not do worse than those who did not.

And finally, don’t forget to get your Flu vaccine, now!

Pandemic fears are boosting demand for trustworthy news; And What Have We Learned from Sweden’s Experience?

During these last few months of the pandemic one of my concerns is the lack consistent reliable data with which the media pundits of all sorts deliver their predictions and many times with false knowledge and predictions. Question, what is the correct social distancing length? Studies keep on changing! One of the key features of the web is its ability to turn regular people into citizen journalists. The cost of publishing text on the web is almost nil. The barriers to entry in the media industry are low, too. And many readers are not picky about where their news comes from: the stories that go viral can come from amateur scribes or veteran ones, media startups or established outfits. But this is not always the case. New research suggests that when a crisis hits, readers turn to reliable sources.

In 2018 Paul Resnick and James Park, two researchers at the University of Michigan, devised a pair of tools for measuring the popularity of English-language news stories on Facebook and Twitter. The first, dubbed the “Mainstream Quotient”, measured the proportion of highly-shared links that came from mainstream news sources, such as the New York Times, the BBC and, yes, The Economist. The second, the “Iffy Quotient”, measured the share originating from less trustworthy sources, based on ratings provided by NewsGuard, a company that tracks misinformation published online.

Both indices have shifted significantly during the pandemic. Beginning in February, when the coronavirus started to spread outside China, traffic to traditional media outlets and news sites surged, whereas dodgier sites attracted fewer readers. The Mainstream Quotient rose steadily during this period, a phenomenon Messrs Resnick and Park call a “flight to quality”. The Iffy Quotient, meanwhile, tumbled. The drop was particularly steep during March, when many countries instituted lockdown measures (see chart).

The researchers argue that consumers seek out reliable news sources during times of uncertainty, in the same way that fearful investors turn to gold. Whether these patterns will last remain unclear. The Iffy Quotient has already started to creep back up, for both Facebook and Twitter. And recent efforts by social-media platforms to crack down on fake news may prove only temporary. Once the pandemic subsides, demand for unreliable news may return to pre-covid levels. For now, at least, the flight to quality has taken off.

Pandemic Spike in Telehealth Levels Off

Crystal Phend of MedPage pointed out that Telehealth’s early bonanza during the pandemic has given way to persistently elevated use in primary care, a Department of Health and Human Services (HHS) report showed.

Analysis of Medicare fee-for-service (FFS) data showed an increase in Medicare primary care visits from 0.1% of all primary care in February to 43.5% in April, representing an increase from about 2,000 to 1.28 million telehealth visits per week.

Meanwhile, there was a “precipitous” drop in in-person visits for primary care in mid-March as COVID-19 took hold in the U.S., then a rise from mid-April through May, according to the report from the Office of the Assistant Secretary for Planning and Evaluation.

Use of telehealth in primary care “declined somewhat but appears to have leveled off at a persistent and significant level by the beginning of June,” the report noted. It still accounted for 22.7% of Medicare beneficiaries’ primary care visits as of June 3rd.

Overall, weekly primary care visit rates have not yet returned to pre-pandemic levels.

“Based on early experience with Medicare primary care telehealth at the start of the COVID-19 public health emergency, there is evidence that Medicare’s new telehealth flexibilities played a critical role in helping to maintain access to primary health care services — when many beneficiaries and providers were concerned with transmission of COVID-19,” the authors noted. “The stable and sustained use of telehealth after in-person primary care visits started to resume in mid-April suggests there may be continued demand for telehealth in Medicare, even after the pandemic ends.”

The findings overall match those from healthcare provider databases suggesting a 60% to 70% drop in health care office visits, partially offset by telehealth visits, with the start of the pandemic. Drug market research firm IQVIA has reported from physician surveys that about 9% of patient interactions were via telehealth prior to the pandemic but 51% during the shutdown, with expectation of a 21% rate after the pandemic, the HHS report noted.

There have been calls for Medicare to make the loosened rules around telemedicine permanent, and some legislative movement in that direction, but private insurers have signaled the opposite.

Fred Pelzman, MD, an internal medicine physician at Weill Cornell Medicine in New York City (and MedPage Today columnist), said an informal survey of his patients indicated they would be willing to do up to 50% of their care via video tools.

“We went from a handful of video visits in our practice to several thousand over the course of the months,” he said. “It’s a great way to take care of people, kept a lot of people safe, we think. What has happened is that as we started to open our practice back up again and offer appointments, the floodgates have opened and patients are declining video visits.”

Those patients opting for in-person visits tend to be older, braving what feels like a quiet time in the pandemic for the state to take care of necessary visits, he noted. “I think ultimately that we’ll plateau. It will probably come down a little more.”

The study included Medicare FFS Part B claims from January through May 2020 for primary care services along with preliminary Medicare Part B primary care claims data up to June 3. Primary care services included evaluation and management, preventive services, and advance care planning.

Telehealth usage increased most in urban counties early in the pandemic and saw smaller declines in May compared with rural counties across the country. Among cities, Boston had the greatest proportion of primary care visits by telehealth (73.1%) and Phoenix the lowest (37%).

Notably, the rate “was not strongly associated with differences in COVID-19 severity across cities as measured by rate of hospitalizations per thousand Medicare FFS beneficiaries,” the report pointed out.

I read an article predicting that telehealth visits are the future of medicine. This is truly worrisome due to the many incorrect diagnoses as well as poor control of chronic diseases that I have seen coming through my office alone. Physical diagnosis is made by looking at the patient, listening to the patient, hearing what the patient is really saying, touching the patient and using the different diagnostic tools such stethoscopes, ophthalmoscopes, otoscopes, percussion hammers, etc. to make the correct diagnoses and to follow our patients. How is that done virtually? The only ones benefitting the most from these virtually visits are the practices and the electronic medical record companies selling the practices additional software to utilize telehealth. And patients are finding that not all telehealth “visits” are paid for by their insurance companies.

How Did Sweden Flatten Its Curve Without a Lockdown?

One expert credits a “good-enough strategy”; others worry that it won’t last. Who is correct?

Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage reported that

Despite never implementing a full-scale lockdown, Sweden has managed to flatten its curve, prompting its health leadership to claim victory — but others question the cost of the strategy, as the country has a far higher death toll than its Scandinavian neighbors.

In late July, Sweden’s 7-day moving average of new cases was about 200, down from a peak of around 1,140 in mid-June. Its daily death totals have been in the single digits for two weeks, well below its mid-April peak of 115 deaths in a single day.

However, on a per-capita basis, Sweden far outpaces its Scandinavian neighbors in COVID deaths, with 567 deaths per million people compared with Denmark’s 106 deaths per million, Finland’s 59 deaths per million, and Norway’s 47 deaths per million. The Swedish figure is closer to Italy’s 581 deaths per million.

While the positive trends have led Anders Tegnell, PhD, chief epidemiologist at the Swedish Public Health Agency and architect of Sweden’s coronavirus strategy, to state that the “Swedish strategy is working,” others have criticized the approach, including two dozen Swedish academics who published a recent USA Today editorial.

“In Sweden, the strategy has led to death, grief, and suffering,” they wrote. “On top of that, there are no indications that the Swedish economy has fared better than in many other countries. At the moment, we have set an example for the rest of the world on how not to deal with a deadly infectious disease.”

The Swedish Public Health Agency has not openly stated that herd immunity was its goal, though many suspect that this was the intention. Tegnell told reporters last week he thought the recent trends indicated that immunity was now widespread in the country. But with rates of antibody positivity around 10%, that seems impossible. (Officials at the agency did not respond to MedPage Today‘s request for comment.)

So how has Sweden managed to get its outbreak under control?

Behavior Change

While Sweden didn’t officially lock down, many in the country have described a locked-down “feeling” that has eased in the summer months.

At the start of the outbreak, only high schools and universities closed; daycare and elementary schools have been open. Businesses have also remained open, but typically at reduced hours, and restaurants have functioned at reduced capacity.

Swedes have been asked to keep their distance in public, refrain from non-essential travel, and work from home when possible. Gatherings of more than 50 people are also banned. People age 70 and over are advised to stay away from others as much as possible.

Masks were never required and aren’t commonly worn.

This response hasn’t changed over time, through the June surge and into today’s decline, so there’s no definitive explanation for the flattening, though, and experts have several theories.

“Swedes in general have changed their behavior to a great extent during the pandemic and the practice of social distancing as well as physical distancing in public places and at work has been widespread,” said Maria Furberg, MD, PhD, an infectious diseases expert at Umea University Hospital in northeastern Sweden.

“During the months of March to early June, all shops were practically empty, people stopped dining with friends, and families stopped seeing even their closest relatives,” Furberg told MedPage Today. “A lock-down could not have been more effective. Handwashing, excessive use of hand sanitizers, and staying home at the first sign of a cold became the new normal very quickly.”

Mozhu Ding, PhD, an epidemiologist at the famed Karolinska Institute, said the decline is “likely to be a combination of measures taken by individuals, businesses and a widespread information campaign launched by the government.”

“Even without a strict lockdown order, many businesses allowed employees to work from home, and universities are offering distance courses to the students,” Ding told MedPage Today. “Individuals are also taking personal hygiene more seriously, as items like hand sanitizers and single-use gloves are often sold out in pharmacies and grocery stores.”

Immunity

Experts told MedPage Today there weren’t clear data to prove Tegnell’s assertion of widespread immunity in Sweden.

Furberg said there is likely “some sort of unspecific immunity that protects parts of the population from contracting COVID-19” but it’s not necessarily secondary to SARS-CoV-2 exposure.

For instance, a study by the Karolinska Institute and Karolinska University Hospital recently found that about 30% of people with mild or asymptomatic COVID showed T-cell-mediated immunity to the virus, even though they tested negative for antibodies.

“This figure is [more than] twice as high as the previous antibody tests, meaning that the public immunity to COVID-19 is probably much higher than what antibody studies have suggested,” Ding told MedPage Today. “This is of course very good news from a public health perspective, as it shows that people with negative antibody test results could still be immune to the virus at a cellular level.”

Indeed, T-cell immunity is coming into focus as a potentially important factor in COVID infection. A paper published in Nature in mid-July found that among 37 healthy people who had no history of either the first or current SARS virus, more than half had T cells that recognized one or more of the SARS-CoV-2 proteins.

Another 36 people who had mild-to-severe COVID-19 were all found to have T-cell responses to several SARS-CoV-2 proteins, and another 23 people who had SARS-CoV-1 (the virus responsible for the SARS outbreak in 2003) all had lasting memory T cells — even 17 years later — that also recognized parts of SARS-CoV-2.

It could be that T cell immunity is the result of a previous infection with common cold coronaviruses, but this hasn’t yet been established; nor is it certain that T cell immunity is driving Sweden’s decline in COVID cases.

Path Forward

Summertime is another factor that may account for the decline, which began around late June — not directly because of the weather, but social factors related to it.

Swedes are “outdoors more, and students are not at school,” said Anne Spurkland, MD, a professor of immunology at the University of Oslo in Norway.

Also, “perhaps Sweden has finally gotten better control over the disastrous spread of the virus in nursing homes which to some extent can explain their relatively high death rates,” Spurkland told MedPage Today. About half of Sweden’s 5,730 deaths occurred among those in elder care homes.

Norway is still requiring that Swedes quarantine for 10 days when coming into Norway, and Denmark has not fully reopened its borders to its neighbor yet either.

That doesn’t bode well for the Swedish economy. If the goal of avoiding a lockdown was to spare economic woe, its success has been limited.

According to Business Insider, “international tourism and trade are decimated. … Sweden’s National Institute of Economic Research predicts Sweden’s GDP will fall 5.4% in 2020, after predicting a 1% rise [in] December 2019. It also expects unemployment to rise around three percentage points, to 9.6%, between the end of 2019 and the end of 2021.”

Spurkland said it’s still “too early yet to conclude whether the Swedish approach was the wisest over all,” as it remains to be seen whether Norway and other countries that did lock down will avoid a second wave of infections in the fall.

Yet she cautions that choosing to take on a higher case load may have health consequences far beyond the immediate infection.

“What we have learned these months is that COVID-19 is not only about death, it is also about ill health,” Spurkland said. “Quite a number of people going through the infection have long-term symptoms, that may be stopping them from resuming their daily life. We do not know yet how large a proportion of those who get the virus will fall into this category, but it is certainly a concern.”

“So, when deciding on taking a herd immunity approach to handle a totally new virus we do not know anything about,” she said, “the Swedish government has also unknowingly put the general population at risk for much long-term ill-health caused by the virus.”

Furberg doesn’t see it that way: “I am very proud of the way Swedes have adapted to the restrictions and regulations and I believe the Public Health Agency of Sweden has picked a good-enough strategy for our country.”

What Americans Need to Understand About the Swedish Coronavirus Experiment

Sweden made headlines for never shutting down. Here’s what’s really happening there.

Matthew Zeitlin pointed out that Tooutsiders, life in Stockholm, Sweden, appears perfectly normal: Walk down a cobblestone street, and you may see two friends sitting at a cafe enjoying the spring air or a group of kids kicking a soccer ball in the park. Cars and bicyclists may zip by; a family may walk past you on their afternoon stroll.

Whereas most of the Western world has been in lockdown for weeks, Sweden has opted to forgo any sort of shelter-in-place policy in response to the coronavirus and instead allow businesses and parks to stay open and groups of under 50 to gather.

That’s not to say the country hasn’t been proactive at all. The policy in effect in Sweden is similar to what had been implemented in much of the United States before shelter-in-place orders were issued — and the one that will soon be in place in states that reopen. The Swedish government has recommended that people wash their hands frequently, maintain social distance, work from home if they can, and those who are elderly or more susceptible to Covid-19 stay home. The government recommended that universities switch to online teaching; they quickly followed course. Social distance is required by law in restaurants, and bar service is banned. The government changed its sick leave rules to encourage anyone who is feeling symptoms to stay home. “Instead of saying ‘close down all of society,’ we have looked at society and closed down… aspects of society,” where the disease is most likely to spread, Anders Tegnell, the epidemiologist at Sweden’s Public Health Agency in charge of recommending policy to the government, told The Daily Show. “I think that’s had a great effect.”

Sweden may not be so much an alternative, as a glimpse of the future.

Sweden’s approach has been hailed by critics of American and European pandemic policies as a less restrictive — and less economically devastating — alternative to state or national shutdowns, but it’s also been lambasted by others as an unnecessarily risky strategy that has led Sweden to have the highest Covid-19 death toll among the Nordic nations. As more and more areas of the United States reopen, Sweden may not be so much an alternative as a glimpse of the future.

As of Sunday afternoon, the country had 25,921 confirmed cases and3,220deaths, according to the Johns Hopkins Coronavirus Resource Center. These are much higher figures than those of the country’s neighbors, but lower than those in some other wealthy Western European countries on both an overall and population-adjusted basis. Sweden also has suffered problems familiar to residents of countries that have had more severe outbreaks and stricter policies. Nursing homes have been hard hit, and Tegnell described Sweden’s failure to protect nursing home residents as its greatest shortcoming so far. Immigrant and ethnic minority communities also have suffered, due in part to their larger households. Just over half of all households in Sweden in 2016 consisted of only one person, while immigrants were substantially more likely than native-born residents to live in overcrowded conditions or multigenerational household.

Even with the less aggressive containment measures, the economic effects of the virus have been severe for the country. Sweden’s National Institute for Economic Research projected that gross domestic product would contract by 7% in 2020 and the unemployment rate would rise to just over 10%. The large fall in consumer and business confidence, the institute said in a release, point “to a rapid and severe downturn, not least in large parts of the service sector.”

“The economy will shrink both due to a drop in exports and is already contracting due to lower consumption. But the underlying causes differ: The export sector is mostly affected by the international situation, whereas the drop in consumption is directly related to the government’s recommendation of social distancing,” said Lina Maria Ellegård, an economist at Lund University.

In the first three months of the year, the Swedish economy contracted by less than 1% — less than the United States’ fall — but the production of both goods and services declined in March. The car industry — one of Sweden’s major export sectors — along with real estate, hospitality, and restaurants led the way.

That’s because even without lockdowns or orders, the behavior of Swedes still changed — to an extent. According to data collected by Google and Apple, Swedes have cut back on their travel to places like stores and restaurants and decreased their use of transit-like buses substantially, though not as dramatically as their Nordic neighbors in Denmark. Still, travel over the Easter holiday fell by 90%, Tegnell said on The Daily Show.

Multiple experts in Sweden I spoke to agreed that because a recommendation made by Swedish leadership is culturally viewed as more of a demand, the freedoms allowed have not resulted in free-for-alls. “There’s a basic misconception that there’s one big huge after-ski party,” said Lars Trägårdh, a Swedish historian. “That’s not true.”

Sweden’s voluntary restrictions policy is made possible by the high levels of trust throughout Swedish society. “We have a lot of social trust and a lot of trust in the institutions, and the institutions have confidence in the citizens,” said Trägårdh. “That’s why we decided to have this voluntary approach as opposed to one that’s more hardcore.”

The photos circulating online don’t fully represent the broader reality on the ground either. “I’ve seen pictures in the newspapers and news media of what looks to be crowded restaurants in Stockholm. What I’ve seen is mostly pretty sparse restaurants. Every other table is empty, and there’s very little business,” said Bo Becker, an economist at the Stockholm School of Economics. “Life doesn’t go on as usual, but maybe the lockdown is less severe than in other countries.”

But even if Sweden’s policy of allowing businesses to open and people to move out and about is not that different from some policies American states have or will soon implement, there’s been one major difference: the schools. Schools for children up to age 15 have remained open, all the way down to daycares and preschool. “That makes a world of difference,” Trägårdh told me. “It’s a gender issue.”

Sweden has one of the highest rates of female participation in the labor force for rich countries. Forcing young children to stay home would put many mothers in a bind or even knock them out of the workforce entirely.

“Closing down schools works well if you are in a well-to-do, middle-class family that has a house and a garden and can afford to have one person staying at home,” Trägårdh said. “That may not look like a doable proposition if you are a single parent or do not make a lot of money.”

Shutting down daycare and schools could increase risk as well, Erik Angner, a philosopher and economist at Stockholm University, explained, by leading working parents to turn to their own parents for help. “If you close daycares, then either one parent has to stop working or grandma or grandpa shows up,” he said. But since the elderly are most at risk, it was even more important to keep schools and daycares open

As other countries work through their peak infections, they will have to figure out how to reach a new status quo where the disease’s spread is still slow but restrictions can be lightened. “Now that everybody else is starting to shift toward opening up, people are talking about Sweden,” said Trägårdh. “Other Nordics are realizing you can’t keep schools closed forever. We’re in the long run here. It’s not a 60-meter race, it’s more like a marathon.”

While Sweden has a higher death rate than its Nordic neighbors and other wealthy European nations like Germany, it has been lower than rates in the Netherlands, France, and the United Kingdom. According to the Financial Times’ figures, Sweden has seen an 18% jump in excess deaths since the start of the outbreak, while Denmark has seen a 5% rise. Excess deaths in England and Wales are up 37%.

“The data out of Finland, Norway, and Denmark looks much better,” said Angner. “But everything will hinge on what will happen next.”

There’s some evidence that Sweden has managed to take the heaviest blow from the virus already — about a fourth or fifth of the population of Stockholm may have been infected, which would put the infection rate at a level similar to that found in New York City, which has had many more deaths and been under a near-total lockdown for almost two months. On Tuesday, health officials in Stockholm said the number of new deaths linked to Covid-19 was slowly decreasing from one week to the next.

The Swedish example carries both optimistic and pessimistic tidings for the United States as it embraces a partial, scattered reopening cheered on by the White House. It suggests that, even without punitive mandates, people can and will take measures to keep themselves safe from the disease. But even though people are protecting themselves without formal orders, the economy will be only slightly better off than it was under lockdown. Meanwhile, the American push to reopen is being driven by distrust of the government combined with the absence of robust safety-net programs to stem the economic bleeding. In the American context, Sweden’s example may be no example at all.

As a paper that was just accepted for publication, written by this author and two coauthors, we need reliable data to evaluate our progress as well as our failures to predict, based on appropriate statistical models and in order to lead us all in the correct path for future strategies for this pandemic and future crises.

3 States See Record High in Daily Coronavirus Infections After Reopening; and What About the Rest of the World?

Many were waiting whether lockdowns were the answer to this pandemic, especially when we learned that Sweden didn’t mandate lockdowns or self-quarantines. But low and behold we learn of the spike in infections and deaths at the end of last week. In the article by Meghan Roos, 6/12/2020, In Sweden, Where No Lockdown was Ever Implemented, there was an increase one day spike of 1,474 on Thursday, 6/11/2020. Swedish health officials reported 49,684 infections and 4,854 deaths by Friday 6/12/2020. This country now has one of the highest per capita fatality rates in the world with an estimate 10 per cent of all COVID-19 cases resulting in death, accounting to date from John Hopkins University.

Now, as Nick Visser reported that Texas, Arizona and Florida all reported their highest daily increases in new coronavirus cases on Tuesday, even after all three states implemented and later lifted stay-at-home orders meant to stop the spread of infections.

State officials in Florida reported 2,783 new cases, in Texas, 2,622, and in Arizona, 2,392. All three states have seen social distancing regulations relaxed for weeks, and most businesses have been allowed to reopen in some capacity.

The figures come amid ongoing efforts by President Donald Trump and other Republican leaders to downplay the ongoing spread of the virus. At least 21 states have seen rates of new cases increase over the last two weeks as a majority of the country reopens.

At the same time, Trump has been pushing misleading claims that infections are only increasing because there’s more testing, going so far as to claim Monday, without evidence, that “if we stop testing right now, we’d have very few cases, if any.”

The president is also preparing to hold a massive rally in Oklahoma this weekend with 20,000 attendees at an indoor arena, despite pleas from local officials and health professionals that the event could quickly lead to a renewed outbreak in the state. Infection rates in Oklahoma rose 68% in the second week of June. 

“I’m extremely concerned,” Bruce Dart, the executive director of the Tulsa health department, told the Tulsa World. “I think we have the responsibility to stand up when things are happening that I think are going to be dangerous for our community, which it will be. It hurts my heart to think about the aftermath of what’s going to happen.”

Other state leaders have pushed back their own reopening efforts as cases have surged, including the governors of Utah and Oregon.

But in Florida, Gov. Ron DeSantis (R) said he was not considering another shutdown despite the surge in cases. He also rolled out the White House’s misleading talking point that cases were rising only because of increased testing.

“We’re not rolling back,” DeSantis said during a press briefing, according to the Miami Herald. “The reason we did the mitigation was to protect the hospital system.”

“You have to have society function,” he added. “To suppress a lot of working-age people at this point I don’t think would be very effective.”

In Arizona, some health officials were already reporting a strain on hospitals’ intensive care capacity due to a spike in coronavirus cases, even as Gov. Doug Ducey (R) said any concern was “misinformation” and said the facilities were prepared to handle an influx in patients.

And in Texas, Gov. Greg Abbott (R) said that, despite his own state’s figures, hospital capacity remained “abundant.”

“The more Texans protect their own health, the safer our state will be and the more we will be able to open up for business,” he said Tuesday.

Dr. Anthony Fauci, the country’s top infectious disease expert, said that, despite the attempts to alleviate any concern, some states jumped the gun on reopening before meeting White House criteria on case levels.

“There certainly were states that did not strictly follow the guidelines that we put out about opening America again,” Fauci said in an interview with NPR. “Clearly there were states that ― left to their own decision about that ― went ahead and opened to a varying degree … certainly before they got to the benchmarks that they needed to get.”

Recent news report is that multiple Florida hospitals have run out of ICU beds as the Coronavirus cases continue to spike.

In This State, the Virus Is ‘Spreading Like Wildfire’

Jenn Gidman noted that as states start to reopen, as well as the recent ongoing protests, amid the pandemic, there’s a red flag rising out of the Southwest. Business Insider reports the coronavirus outbreak “is going very badly” in Arizona, with more than 4,400 new cases over the weekend, bringing the total number of cases in the state to more than 37,500 as of Sunday, with nearly 1,200 deaths. Per Healthline, there’s been a 300% increase in reported cases since May 1. Tucson.com reports that in just one week (from May 31 to June 6), the state saw its biggest week-to-week increase yet: 7,121 new coronavirus patients, or about a 54% increase from the previous week. Meanwhile, the Arizona Republic reports that hospitalizations are on the rise as well, with two straight weeks of statewide hospitalizations surpassing 1,000 daily—the highest number since state reporting began in the beginning of April. Will Humble, a former director of the state’s Department of Health Services, says the spike is “definitely related” to the state’s stay-at-home order being dropped on May 15, per Newsweek. More on the Grand Canyon State:

Eyewitness to tragedy: CBS 5 talked to one doctor who works at two Phoenix hospitals, and he described what he’s been seeing in ERs and ICUs. “He asked if he could make a call in the hospital,” he says of one elderly patient. “It was very tragic to hear him say goodbye to his godkids and grandchildren, who you could really tell loved him.”

Texas Governor Says ‘No Reason Today to Be Alarmed’ As Coronavirus Cases Set Record

One question that I have is if states or cities declare a lockdown whether people will adhere to the lockdown?  Laurel Wamsley reported that Texas has seen a recent uptick in the number of COVID-19 cases, with a record level of new cases and hospitalizations announced Tuesday. People are seen here Monday along the San Antonio River Walk.

Texas Gov. Greg Abbott announced on Tuesday the state’s highest-ever number of new COVID-19 cases: 2,622.

He also reported a second record high: 2,518 people hospitalized with the virus in Texas, up from 2,326 a day earlier.

Despite the concerning uptick in people sick with the virus, Abbott said that the reason for his news conference was to let Texans know about the “abundant” hospital capacity for treating people with COVID-19. He and other officials spent much of the briefing touting the state’s hospital bed availability.

Disclosing the new record high number of hospitalizations related to COVID-19, Abbott emphasized that figure is “really a very small percentage of all the beds that are available.” Texas has so far been spared the high case numbers in other populous states. While it’s the second-largest state by population, Texas currently ranks sixth in terms of cumulative case numbers.

Before releasing the number of new cases, Abbott delved into what he said accounted for the previous daily high on June 10, which had 2,504 new cases. The governor said that spike could be largely attributed to 520 positive tests of inmates in Texas prisons being reported at once as well as a data error in a rural county.

He said there are also reasons for why Tuesday’s new case count was so high: tests results coming from an assisted living facility near Plano; a county south of Austin where positive cases seemed to be reported in batches; and 104 cases in one East Texas county that appear to be primarily from tests at a prison.

But he also pointed to uncareful behavior as a possible driver in some of the new cases. Abbott said there were a number of counties where a majority of those who tested positive for the coronavirus were under the age of 30, which he attributed to people going to “bar-type” settings or Memorial Day celebrations and not taking health precautions.

Abbott said that measures such as wearing masks, hand sanitizing and social distancing are what make it possible to reopen the state’s economy and Dr. John Hellerstedt, commissioner of the Texas Department of State Health Services, struck the same note.

“The message is we are seeing some increase in the number of COVID patients in the state. We expected this,” he said. “But we are seeing it occurring at a manageable level. I really want to stress that the continued success is up to the people of the state of Texas.”

Despite Abbott’s emphasis on the importance of masks, he has barred Texas cities from implementing any rules that would require face coverings. Abbott signed an executive order on April 27 that says while individuals are encouraged to wear face masks, “no jurisdiction can impose a civil or criminal penalty for failure to wear a face covering.”

On Tuesday, the mayors of nine Texas cities — including Houston, Dallas, San Antonio, Austin, Fort Worth and El Paso — sent a letter to the governor asking for the authority to set the rules and regulations on the use of face coverings.

“A one-size-fits-all approach is not the best option. We should trust local officials to make informed choices about health policy. And if mayors are given the opportunity to require face coverings, we believe our cities will be ready to help reduce the spread of this disease,” they wrote. “If you do not have plans to mandate face coverings statewide, we ask that you restore the ability for local authorities to enforce the wearing of face coverings in public venues where physical distancing cannot be practiced.”

Abbott said Tuesday that judges and local officials have other tools available for enforcement such as issuing fines for gatherings that don’t follow state protocols.

Austin Mayor Steve Adler extended a stay-at-home warning on Monday amid the news of rising cases – but that warning could only be advice to residents and not an order due to the state’s preemption.

“People are confused,” Adler told NPR’s Steve Inskeep on Tuesday. “They just don’t know at this point if it’s really important to wear face coverings or not, because I think they’re feeling like they’re getting mixed messaging — not only from state leadership but from national leadership. So, we’re just not getting the vigilance that we need on these efforts.”

And the Surges In COVID-19 Cases Cause Friction Between Local Leaders, Governors

In Austin, Adler said, you’ll see most everyone wearing a mask in grocery stores but not in restaurants or music clubs: “When we started opening up the economy and when the governor took away from cities the ability to make it mandatory, more and more people stopped wearing them.”

Adler said he agreed with Abbott that face coverings are key to reopening parts of the economy, even if they’re unpleasant for wearers.

“I know it’s inconvenient. I know it’s hot. I know it’s a nuisance,” Adler said. “And it’s hard to do, and people don’t like it. But at the same time, our community has to decide just how much we value the lives of folks in our community that are over 65 and older. We have to decide how much we value the lives of the communities of color that are suffering disproportionately because of this virus.”

Florida Officials Spar Over Rising COVID-19 Cases

Greg Allen reported that in Florida, where there’s a surge of new COVID-19 cases, officials are divided over what to do about it. The state saw 2,783 new cases Tuesday. It was the third time in the past seven days that Florida set a new daily record.

Florida Gov. Ron DeSantis and other Republican officials, including President Trump, say the rising number of new cases was expected and is mostly the result of increased testing. Florida is now testing more than 200,000 people a week, more than double the number tested weekly in mid-May.

But local officials and public health experts are concerned about other statistics that show that the coronavirus is still spreading in Florida. The state’s Department of Health reports that the number of people showing up in hospital emergency rooms with symptoms of the flu and COVID-19 is rising. Also, worrisome — the percentage of people who are testing positive for the virus is going up, total positive residents are 63,374 with 11,008 hospitalizations and 2,712 deaths.

In Palm Beach County, health director Alina Alonso says the rising positivity rate is a clear sign that the new cases can’t just be attributed to increased testing. Since Palm Beach County began allowing businesses to reopen, Alonso says, the percentage of people testing positive has jumped from 4.9% to 8.9%. “The fact that these are going up means there’s more community spread,” she says. “The virus now has food out there. It has people that are out there without masks, without maintaining distancing. So, it’s infecting more people.”

Alonso say the number of people hospitalized for the coronavirus has also gone up in Palm Beach County. “The numbers are very concerning to the hospitals,” she says. So far, the number of deaths from COVID-19 has remained low. But Alonso says deaths lag behind new recorded cases by about six weeks. She thinks the number of deaths will also rise. “We need to be cautious at this time. Wait a little bit until we see whether or not that happens,” she says. “If we go forward without waiting to see what is going on … by the time we get those deaths, it will be too late.”

Palm Beach County currently isn’t requiring residents to wear face coverings when in public places. County commissioners are now considering following the lead of Broward and Miami-Dade counties and making face masks mandatory.

In Tallahassee, DeSantis held a news conference where he responded to concerns about the rising positivity rate. Much of it, he said, is related to outbreaks among farmworkers and people in prison. Among the incidents he highlighted — a watermelon farm near Gainesville where, out of 100 workers tested, 90 were positive. DeSantis said, “When you have 90 out of 100 that test positive, what that does to positivity — that’s huge numbers.” Some of the other localized outbreaks among farmworkers, he noted, were in Palm Beach County.

DeSantis said there’s no reason to consider rolling back the rules allowing businesses to reopen at the moment. He has encouraged the resumption of sports events and attended a NASCAR race in Homestead, Fla., on Sunday with a few hundred other spectators. And he successfully lobbied for Florida to host President Trump’s acceptance speech at a Republican National Convention event in Jacksonville. That gathering is expected to draw thousands.

Democrats have become increasingly critical, saying DeSantis is ignoring important data that favor a more cautious response. Florida’s top elected Democrat, Agriculture Commissioner Nikki Fried, said, “Refusing to acknowledge the alarming patterns in cases, hospitalizations and positivity is not only arrogant but will cost lives, public health and our economy.”

Asymptomatic coronavirus transmission appears worse than SARS or influenza — a runner can leave a ‘slipstream’ of 30 feet

Quentin Fottrell reported that the WHO currently estimates that 16% of people are asymptomatic and can transmit the novel coronavirus, while other data show that 40% of coronavirus transmission is due to carriers not displaying symptoms of the illness. One study says that asymptomatic transmission “is the Achilles” heel of COVID-19 pandemic control. How worried should you be about asymptomatic transmission of COVID-19?

 hours earlier that transmission of the novel coronavirus in carriers who don’t show apparent symptoms happened in “very rare” cases.

Maria Van Kerkhove said it was a “misunderstanding to state that asymptomatic transmission globally is very rare,” and that her comments during a WHO news briefing had been based on “a very small subset of studies.” “I was just responding to a question; I wasn’t stating a policy of WHO,” she said.

The WHO currently estimates that 16% of people with COVID-19 are asymptomatic and can transmit the coronavirus, while other data show that 40% of coronavirus transmission is due to carriers not displaying symptoms of the illness.

Public-health officials have advised people to keep a distance of six feet from one another. Face masks are designed to prevent the wearer, who may be infected with COVID-19 but have very mild or no symptoms, from spreading invisible droplets to another person and thereby infecting them too. But “there’s nothing magic about six feet,” said Gregory Poland, who studies the immunogenetics of vaccine response in adults and children at the Mayo Clinic in Rochester, Minn., and is an expert with the Infectious Diseases Society of America.

“The virus can’t measure,” he told MarketWatch. “For example, the viral cloud while speaking will extend 27 feet and linger in the air for about 30 minutes. This is more like influenza in the sense that people transmit the virus prior to experiencing any symptoms and some people, of course, will not get sick.”

Asymptomatic transmission “is the Achilles’ heel of COVID-19 pandemic control through the public-health strategies we have currently deployed,” according to a study by researchers at the University of California, San Francisco published May 28 in the New England Journal of Medicine.

“Symptom-based screening has utility, but epidemiologic evaluations of COVID-19 outbreaks within skilled nursing facilities … strongly demonstrate that our current approaches are inadequate,” researchers Monica Gandhi, Deborah Yokoe and Diane Havlir wrote.

Brazil is on track to lead the world in coronavirus cases and deaths, and it still doesn’t have a plan for tackling the outbreak

Amanda Perobelli reported that Brazil could surpass the US in coronavirus cases and deaths by the end of July, according to estimates from the University of Washington.

The country recorded a daily record of 34,918 new coronavirus cases on Tuesday, according to Reuters. And despite the growing number of cases, the country has not created a plan to tackle the outbreak. Brazil could surpass the US in both coronavirus infections and deaths by the end of July, according to the main coronavirus tracking model from the University of Washington.

The country, which has yet to impose a national coronavirus lockdown, is on its way to registering more than 4,000 daily deaths, The Washington Post reported, citing the university. As of Tuesday, Brazil had more than 923,000 coronavirus infections and more than 45,000 deaths. Experts told Reuters the true number of cases was most likely higher.

As The Post noted, the country doesn’t have the same infrastructure to help it handle such a large outbreak as the US. But that hasn’t stopped President Jair Bolsonaro from largely dismissing the crisis the novel coronavirus is causing. In fact, he’s even attacked governors who chose to impose restrictions and threatened to host large barbecues in spite of public-health advice, The Post reported.

Brazil has not initiated a national testing campaign, has not implemented a national lockdown, and is dealing with insufficient healthcare expansion. Reuters reported that that country counted 34,918 new daily coronavirus cases on Tuesday.

In a report in early May, Carlos Machado, a senior scientist with Brazil’s Oswaldo Cruz Foundation, and his team warned that without a lockdown in Rio de Janeiro, the outcome would be “in a human catastrophe of unimaginable proportions.” He now says had his warnings been taken seriously, the outcome would not have been so bleak.

“From the point of view of public health, it’s incomprehensible that more-rigorous measures weren’t adopted,” Machado told The Post. “We could have avoided many of the deaths and cases and everything else that is happening in Rio de Janeiro. It was an opportunity lost.”

Scientists in the country told The Post that the country was veering into unknown territory. “We are doing something that no one else has done,” Pedro Hallal, an epidemiologist at the Federal University of Pelotas, told The Post. “We’re getting near the curve’s peak, and it’s like we are almost challenging the virus. ‘Let’s see how many people you can infect. We want to see how strong you are.’ Like this is a game of poker, and we’re all in.”

Bolsonaro’s approach has been to ignore the problem and sideline health experts

Reuters reported that senior officials leading Brazil’s coronavirus response had claimed the outbreak was under control.

“There is a crisis, we sympathize with bereaved families, but it is managed,” said Braga Netto, who spoke during a webinar held by the Commercial Association of Rio de Janeiro.

The World Health Organization’s regional director Carissa Etienne said Brazil was a major concern, Reuters reported. “We are not seeing transmission slowing down” in Brazil, Etienne said. Etienne said the country accounted for about 4 million coronavirus cases in the Americas and about 25% of the deaths.

The Post described Bolsonaro’s approach as being to ignore and sideline health experts. The Brazilian president fired Luiz Henrique Mandetta, his first health minister, after disagreements on social distancing, and then he fired his replacement, Nelson Teich, because he disagreed with the use of chloroquine as a treatment for coronavirus.

Similar to US President Donald Trump, Bolsonaro has boosted the use of hydroxychloroquine in the past. On Monday, the US Food and Drug Administration revoked the emergency-use authorization issued for the antimalarial drug.

One expert said even the public in Brazil did not heed public-health advice to limit the spread of the virus and continued to congregate without any safety measures implemented.

“It was a failure,” Ligia Bahia, a professor of public health at the Federal University of Rio de Janeiro, told The Post. “We didn’t have enough political force to impose another way. The scientists alone, we couldn’t do it. There’s a sense of profound sadness that this wasn’t realized.”

Presently there is only one country that has declared it COVID-19 cleared, that is Montenegro. New Zealand has declared their country COVID-19 free and then two cases turned up as two people from Europe who traveled to New Zealand tested positive and are now quarantined.

Look at the recent world numbers where the total cases are 8,174,327 with 443,500 deaths. Way too many!

When will it all be over?

Mood darkens in Sweden as high death rate raises tough questions over lack of lockdown, and Now A Second Wave and a Possible Kids’ Epidemic!

Richard Orange noted that Sweden, in deference to the rest of the countries believing in the strategy to lockdown their populace, decided not to use stay-at-home or lockdowns except for the elderly.  Sweden’s opposition has attacked the government for its handling of the coronavirus pandemic, with the stubbornly high death rate fueling questions over the decision not to impose a lockdown. 

Jimmie Akesson, the leader of the populist Sweden Democrats, first called for Anders Tegnell, the architect of Sweden’s less restrictive coronavirus strategy, to resign. The attacks continued in heated televised leaders’ debate on Sunday night.  

“The strategy in Sweden was not to try to hold back the infection, but instead to try to limit it at the same time as protecting risk groups,” Mr Akesson wrote in a debate article in the Dagens Nyheter newspaper.

“By that measure, it has failed miserably. Anders Tegnell should therefore resign. Only then will he show the Swedish people that he takes responsibility for the mistakes FHM [Public Health Agency of Sweden] has made.”

During a party leaders’ debate on Sunday evening, Ebba Busch-Thor, leader of the Christian Democrat party, blamed Sweden’s strategy – and by extension the government that allowed it – for some of the 4,659 deaths due to the virus. 

“What we can say about Sweden is that many of those who are mourning over those they have lost this spring are doing so because Sweden knowingly and deliberately allowed a large spread of the infection,” she said.  

Ulf Kristersson, the leader of the Moderate Party, the biggest party on the Centre-Right, held back from joining Mrs. Busch-Thor’s attack on the strategy, instead attacking the implementation of it.

“I had no problem with the strategy. It was a bit slow but, when it was in place, I had nothing against it,” he said. “But the government didn’t put any power behind the words.”

The Prime Minister, Stefan Lofven, continued to back Sweden’s strategic decision not to impose a lockdown, instead laying the blame for the death rate on failures within elderly care. 

“I think the strategy is the right one,” he said. “But it has transpired that that very many people, in certain areas, have died in elderly care. There’s no doubt that elderly care needs to be improved.” 

Mr Akesson faced an immediate counter-attack from Johan Carlsson, the director of FHM, who dismissed his call as “almost pathetic”. 

Dagens Nyheter’s political commentator Ewa Stenberg wrote on Sunday that the debate marked an end to the “borgsfred”, or “castle truce”, in Sweden.

“The tone was harsh and quite contrary to how it was when the virus hit the country. Then all the parties backed the government’s decision to let the Public Health Authority take the lead,” she wrote.

However, the return of political opposition does not yet seem to reflect a loss of support for the government among the public.

Kids During Lockdown: Is Another Epidemic About to be Revealed?

Ingrid Walker-Descartes noted that even in non-pandemic years, the summertime “back-to-school” rush of appointments in many pediatric practices can be a logistical challenge. This year could be even more hectic after many families delayed routine appointments during quarantine. Hoping to return to their routines, children and teens will need vaccines, physical exams for sports clearances and school forms, and all the regular developmental and emotional surveillance that is so important to keep them healthy.

As pediatricians, we should be adding another layer to our checklists in these visits this year. For many children, this visit may be the first time in weeks or months that someone outside their immediate family has had eyes on them.

We must be careful to listen, very carefully, to what the children and parents tell us, both in their words and in other signs. How has the family coped with the stress of being stuck at home? Are there financial struggles? Food insecurity? Other stresses? As a child abuse pediatrician, I know all of these things can put tremendous stress on a family, and ultimately can lead to a child being maltreated or abused. We have a real opportunity right now to intervene and provide critical support to families, and to protect children.

Sadly, we know from previous disasters that during these times of intense emotional and economic stress, rates of child abuse and neglect increase. Injuries and deaths among infants due to abusive head trauma increase during times of economic stress, and scattered reports among physicians at children’s hospitals in various states are reporting that is happening now, too. For example, a hospital in Fort Worth, Texas, and a hospital in Philadelphia, are reporting an increase in the number of severe physical abuse cases. Many times, this abuse occurs when a parent or caregiver is frustrated or at the “end of their rope,” and in a moment of anger, makes a devastating choice that injures a child.

For the past few months, during sheltering in place, children have lacked many of the people who often step forward as protectors — the aunt they may confide in, a teacher who sees a bruise, or a physician who notices an injury where there reasonably should be none. Reports to child abuse hotlines and child protective services have declined during the pandemic, but this is not necessarily because fewer children are being injured. We know that teachers and school counselors are the most frequent reporters of suspected abuse, and for months children have not had access to these trusted protectors. Many of them have not seen their pediatrician, either. These combined realities have left some of our most vulnerable children without several much-needed layers of protection.

As a pediatrician who specializes in diagnosing abuse and protecting children from further abuse, I am well versed in talking with children to understand what happened to cause their injuries. Some may convey lessons learned from their choices made due to curiosity or naivete. Others struggle to elaborate on marks or scars made in anger by a caregiver. Post COVID-19, it will be important for all pediatricians to have a careful approach as they are talking with families, listening and observing to understand what children experienced during the pandemic, and how we can help them and their families be safe and healthy.

Some families may benefit from a referral to a nutrition program, caregiver support program, parental counseling, or other resources. In other cases, a pediatrician may notice a sign of potential abuse that should be reported to the relevant child protection agencies. This is always difficult, but it can be the first step to making sure a child is safe and protected while a family gets the support they need.

The American Academy of Pediatrics (AAP) recently provided a webinar guide on how to identify child abuse during the pandemic, and additional resources are provided on the AAP website, including a list of child abuse programs across the country to help support you in this difficult role.

The stress on families and children will not end when the stay-at-home orders lift. Let’s be prepared to help all our children emerge healthy and strong, and ready to learn.

CDC wants states to count ‘probable’ coronavirus cases and deaths, but most aren’t doing it

Reinhard, Emma Brown Reis Thebault and Lena H. Sun reported that fewer than half the states are following federal recommendations to report probable novel coronavirus cases and deaths, marking what experts say is an unusual break with public health practices that leads to inconsistent data collection and undercounts of the disease’s impact.

A Washington Post review found that the states not disclosing probable cases and deaths include some of the largest: California, Florida, North Carolina and New York. That is one reason government officials and public health experts say the virus’s true toll is above the U.S. tally as of Sunday of about 1.9 million coronavirus cases and 109,000 deaths — benchmarks that shape policymaking and public opinion on the pandemic.

The U.S. Centers for Disease Control and Prevention works closely with a group of health officials called the Council of State and Territorial Epidemiologists to issue guidelines for tracking certain illnesses. The guidelines are voluntary, though states generally comply. The goal: solid comparisons between states and accurate national statistics that inform public health decision-making.

In April, as coronavirus infections multiplied and laboratory testing was limited, the CSTE and the CDC advised states to count both probable cases and deaths — where symptoms and exposure pointed to infection — along with those confirmed by tests.

Yet weeks after the guidance was handed down to standardize coronavirus reporting, a Post review found states as of early June counting cases and deaths in all sorts of ways.

At least 24 states are not heeding the national guidelines on reporting probable cases and deaths, despite previously identifying probable cases in other national outbreaks, including H1N1 flu during the country’s last pandemic in 2009.

The failure of many states to document probable coronavirus cases and deaths is “historic in many ways because there are lots of probable case classifications and probables are regularly and normally reported on,” said Janet Hamilton, the CSTE executive director. “We are definitely concerned about the undercounting of covid-19 deaths and cases.”

New Jersey says it began reporting probable cases and deaths to the CDC on May 15 but does not disclose them publicly on its website. Georgia says it tracks the information internally but is not reporting those numbers on its website or to the CDC.

“We do have intentions of sharing them but not yet,” said Nancy Nydam, a spokeswoman for the Georgia Department of Public Health, who said as of late May the department had tracked 1,658 probable cases and potentially dozens of probable deaths.

Officials in Montana, Rhode Island and the District of Columbia say they haven’t reported any probable cases or deaths because they have not had any, citing low numbers or the wide availability of testing.

Seven states did not respond to The Post’s requests for a breakdown of cases and death counts. Five of those are not reporting probable cases or deaths, according to data the CDC began publishing June 2. South Dakota reports probable deaths but not cases.

Officials in the remaining 17 states say they are reporting probable and confirmed coronavirus cases and deaths on their websites and to the CDC. Some states distinguish between probable and confirmed while others group them.

In some states not reporting probable cases, officials cite the demands of an unprecedented crisis in which Americans press for daily updates from public health data systems that are chronically underfunded and outdated.

In Washington state, where many of the nation’s first deaths occurred, health department spokeswoman Lisa Stromme Warren said documenting probable cases and deaths “is one of many urgent priorities.” The state has identified about 100 people whose death certificates list covid-19 but were never tested, so they are not included in the public death count or reported to the CDC.

“We suspect that we are actually more likely to be undercounting deaths than overcounting them,” Katie Hutchinson, the health department’s health statistics manager, said during a recent briefing.

CDC spokeswoman Kristen Nordlund said that the agency is working with health departments to improve the flow of data. “In pandemic circumstances, such as with covid-19, collecting complete information on each case is challenging,” Nordlund said. “The current case and deaths counts reported to CDC are likely an undercount.”

During the H1N1 flu pandemic, states initially counted probable and confirmed cases individually. But about three months into the outbreak, the CDC said those individual counts represented “only a fraction of the true burden” of the disease. The agency stopped collecting individual case reports and instead began publishing estimates based on hospitalizations, symptoms and other data.

The CDC is planning to come up with similar estimates for the coronavirus but has no immediate plans to stop counting individual cases. “CDC is actively working on a model to address and assess the true burden of covid-19 in the U.S.,” Nordlund said.

All eyes on numbers

For government officials assessing how quickly to reopen the economy and individuals deciding what risks to take, their daily judgment calls are based, in part, on the case and death counts publicized on television and computer screens.

That has propelled the pandemic counts into the contentious political arena, where some allies of President Trump and conservative voices on social media have claimed that the covid-19 death toll is inflated. The debate over whether counts of probables are crucial or misleading extends beyond the nation’s capital.

In Illinois, two Republican lawmakers and three businesses have sued the Democratic governor over coronavirus disaster orders. A spokeswoman for the health department, Melaney Arnold, said the state is not divulging probable deaths on its website “because there is concern from the public that the number of deaths is being inflated. . . . We need the public to have confidence in the data and therefore are reporting only those deaths that are laboratory confirmed.”

The state website lists about 5,700 deaths as of June 5, excluding the approximately 185 probable deaths tracked internally as of that day and reported to the CDC.

But a resident looking at a state chart and then turning to the CDC might not find the same numbers. The newly posted CDC table does not reflect the probables that officials in some states said they have reported. Officials say that’s because the reports sent to the CDC include those with confirmed cases in one figure and because the national update can run slightly behind state websites.

Since the 1950s, CSTE has recommended which diseases states should track and what those reports to the federal government should look like. The CDC works closely with the epidemiologists’ council and adopts its guidelines to “enable public health officials to classify and count cases consistently across reporting jurisdictions,” according to the CDC website.

States usually follow these recommendations and report the incidence of dozens of different diseases to the CDC, with some exceptions. A state may not report cases of a disease that does not occur within its borders, yet may track another illness found only in its part of the country.

Hawaii, for example, does not report Lyme disease, as every other state does, but it does report hallucinogenic fish poisoning.

“It’s more of a handshake agreement between the states and CDC that we will send you the data in this way so that you can then aggregate it,” said Kathy Turner, Idaho’s deputy epidemiologist. “In general, there’s no argument. We all do it because we realize the importance of being able to look at a disease on a national level.”

Some reportable diseases rarely result in deaths, so CSTE directives have typically focused on how to count cases, not fatalities. Then came the coronavirus and a mushrooming death toll. The CDC acknowledged in early April that the death count was an “underestimation” because it included only fatalities in which the virus was laboratory confirmed. Testing shortages, people dying at home or in nursing homes, and spotty postmortem testing meant victims were overlooked.

“When the outbreak first started and we were all just counting lab-confirmed cases by default, it became clear that we were not going to be able to describe the burden of the pandemic because so many people were not being tested,” said Turner, lead author of the CSTE statement on covid-19.

“We usually don’t approach a death separately from a case, but in this situation, we decided it was needed,” she said.

The CSTE recommended reporting probable and confirmed cases and deaths on April 5. The CDC’s written response to the recommendations, which was shared with The Post, said the agency “concurs” and that adoption by states is “very important” for covid-19 record-keeping. On April 14, the CDC noted on its website that the national tally includes probables, although the agency did not at that time provide a state-by state breakdown. The CDC also modified the form states use for coronavirus reports, adding boxes that can be checked to indicate a “lab-confirmed” case or “probable” case.

Probable cases were defined as showing symptoms and having contact with an infected person, or meeting one of those criteria and testing positive for coronavirus antibodies, rather than for the virus itself. Probable deaths meant those who were never tested for the virus but whose death certificates listed covid-19 as the cause of death or a significant condition contributing to death.

The CSTE statement also says that confirmed and probable counts should be included in the tallies “released outside the public health agency,” which could mean a state website or written report, according to the organization.

“When states are using different approaches, it always begs the question: ‘Why does one state choose one over another? Why a more conservative approach over a more sensitive one?’’’ asked Lorna Thorpe, director of the division of epidemiology at NYU Grossman School of Medicine. “That’s the reason we have standards and guidance that are technically sound.”

Information varies

The erratic reporting of coronavirus cases and deaths means that what residents can learn about the extent of the pandemic in their community varies widely.

Ohio was one the first states to begin disclosing probable cases and deaths in early April. “It usually is a given when CSTE makes a recommendation like that,” said Brian Fowler, chief data officer for the Ohio Department of Health. “When they made that recommendation, we looked at it and said, okay, well this is what we need to use.”

As of June 5, Ohio’s website showed 2,117 confirmed deaths and 222 probables. By breaking out the numbers separately, Fowler said, “you can’t be accused of hiding information and you can’t be accused of inflating numbers — it’s all out there.”

The transition to counting probables was not “a huge lift,” Fowler said. Epidemiologists at the health department were already reviewing all suspected coronavirus cases.

Some health officials were candid about how adding probable deaths would boost the overall tally. “I want to make sure that everyone understands that these are not new deaths,” Indiana Health Commissioner Kristina Box said at an April 20 news conference. “Rather, we are capturing the deaths that have occurred really since this pandemic began.” Box suggested other states would do the same: “Indiana — like every other state — will include these deaths in our reporting in order to better capture the toll that covid-19 has truly taken.”

One week earlier, Michigan officials had said they intended to begin disclosing probable cases and deaths. When the state finally began doing that on June 5, more than 5,000 cases and 200 deaths were added to coronavirus totals.

California’s state health department is reviewing the process to track probable deaths and “working to provide as much data as possible about COVID 19 while ensuring that the data are valid and useful for understanding the pandemic,” according to a May 20 email to The Post.

Hilda Solis, a supervisor in Los Angeles County who represents a heavily Hispanic and impoverished district, said she was surprised that the state is not following national recommendations on counting coronavirus deaths. She has called for more post-mortem testing by the medical examiner. “A lot of people are dying at home. Poor people are dying at home. Homeless people are dying,” said Solis, a former U.S. labor secretary under President Barack Obama. “I do believe covid-19 is being underreported and that we need to take more responsibility.”

The scale of undercounting that results from reporting only confirmed cases became clear when New York City on April 14 added more than 3,700 probable deaths to its numbers, sending the city’s tally over 10,000.

The city that sits at the epicenter of the pandemic in the United States still is not counting probable cases, however. New York Gov. Andrew M. Cuomo, a Democrat praised for his command of daily news briefings during the pandemic, has indicated skepticism about recording probable cases. “Probable is different than confirmed,” he said at a news conference in late May. “Probable is ‘probable, but I have to check, I don’t know, I have to do further testing.’ We’ve had many cases that were probable coronavirus and turned out not to be coronavirus and that’s why they call them probable.” Covid-19 websites for New York and New Jersey include probable deaths at nursing homes, but those numbers are not included in the states’ overall death totals. A spokesperson for North Carolina’s health department said the state is not reporting probables because of wariness about the reliability of antibody tests, and because of concerns that the CSTE’s definition of a probable case is overly broad. Officials in Florida did not respond to repeated requests for comment about why the state isn’t following federal guidelines.

People behind ‘probables’

Behind each probable death is a person. Barnes O’Neal, 83, checked into the Brightmoor Nursing Center in Georgia in March to recover from a 10-day hospitalization. Less than a month into his stay at the facility about 40 miles south of Atlanta, a coronavirus outbreak forced a lockdown. O’Neal developed a fever and pneumonia. His daughter, Natalie Turner, pleaded with her father’s caretakers and the state health department for a coronavirus test. She said she wanted his illness on the record.

On April 20, just hours after Turner had spoken with him by phone, O’Neal died. He was never tested, but Turner said his doctor told her there was “zero doubt” it was covid-19 and wrote it on her father’s death certificate.

Still, her father, a frequent volunteer at the local soup kitchen, would not be included in the death toll on the state website because he was never tested. “It’s just important to me because my dad’s life counted,” Turner said. “I feel like there’s a face behind every statistic, and that’s forgotten many times.”

And now the pandemic’s overall death toll in U.S. has exceeded 100,000, but what are the real numbers?

Second U.S. Virus Wave Emerges as Cases Top 2 Million

Emma Court and David Baker noted that a second wave of coronavirus cases is emerging in the U.S., raising alarms as new infections push the overall count past 2 million Americans. Texas on Wednesday reported 2,504 new coronavirus cases, the highest one-day total since the pandemic emerged. A month into its reopening, Florida this week reported 8,553 new cases — the most of any seven-day period. California’s hospitalizations are at their highest since May 13 and have risen in nine of the past 10 days.

A fresh onslaught of the novel coronavirus is bringing challenges for residents and the economy in pockets across the U.S. The localized surges have raised concerns among experts even as the nation’s overall case count early this week rose just under 1%, the smallest increase since March.

“There is a new wave coming in parts of the country,” said Eric Toner, a senior scholar at the Johns Hopkins Center for Health Security. “It’s small and it’s distant so far, but it’s coming.”

Though the outbreaks come weeks into state reopenings, it’s not clear that they’re linked to increased economic activity. And health experts say it’s still too soon to tell whether the massive protests against police brutality that have erupted in the past two weeks have led to more infections.

In Georgia, where hair salons, tattoo parlors and gyms have been operating for a month and a half, case numbers have plateaued, flummoxing experts.

Puzzling differences show up even within states. In California, which imposed a stay-at-home order in late March, San Francisco saw zero cases for three consecutive days this week, while Los Angeles County reported well over half of the state’s new cases. The White House Coronavirus Task Force has yet to see any relationship between reopening and increased cases of Covid-19, Food and Drug Administration Commissioner Stephen Hahn said on a podcast.

But in some states, rising numbers outpace increases in testing, raising concerns about whether the virus can be controlled. It will take a couple of weeks to know, Toner said, but by then “it’s going to be pretty late” to respond.

Since the pandemic initially swept the U.S. starting early this year, 2 million people have been infected and more than 112,000 have died.

After a national shutdown that arrested the spread, rising illness had been expected as restrictions loosened. The trend has been observed across 22 states in recent weeks, though many increases are steady but slow.

In New York, the state hardest hit by Covid-19, Governor Andrew Cuomo only recently started reopening by region. New York City, the epicenter, began the first of four phases Monday.

“We know as a fact that reopening other states, we’re seeing significant problems,” Cuomo said Tuesday. “Just because you reopen does not mean you will have a spike, but if you are not smart, you can have a spike.”

Experts see evidence of a second wave building in Arizona, Texas, Florida and California. Arizona “sticks out like a sore thumb in terms of a major problem,” said Jeffrey Morris, director of the division of biostatistics at University of Pennsylvania’s Perelman School of Medicine.

Arizona Spike

Arizona’s daily tally of new cases has abruptly spiked in the last two weeks, hitting an all-time high of 1,187 on June 2.

This week, its Department of Health Services urged hospitals to activate emergency plans. Director Cara Christ, told a Phoenix television station that she was concerned about the rising case count and percentage of people tested who are found to be positive.

Valleywise Health, the public hospital system in Phoenix, has seen an increase in Covid-19 cases during the past two weeks. It’s expanded its intensive-care capacity and those beds are 87% full, about half with Covid patients, according to Michael White, the chief medical officer.

White said Valleywise has adequate protective gear for staff, but hospitals aren’t getting their entire orders. A surge in Covid cases could put that supply under stress, he said.

The increase in transmission follows steps to resume business and public life as well as the riots and protests.

“Within Phoenix, we’ve been more relaxed than I’ve seen in some of the other parts of the country,” White said, with some people disregarding advice to wear masks and maintain six feet of distance from others. “People are coming together in environments where social distancing is challenging.”

Texas on Wednesday reported a 4.7% jump in hospitalizations to 2,153, the fourth consecutive daily increase. The latest figures showing an escalation came as Governor Greg Abbott tweeted a public service announcement featuring baseball legend Nolan Ryan urging Texans to wash their hands and to not be “a knucklehead.”

Abbott was criticized for an aggressive reopening last month. Mobile-phone data show activity by residents is rebounding toward pre-Covid levels, according to the Children’s Hospital of Philadelphia’s PolicyLab.

That could reflect a perception that the virus wasn’t “ever a big threat,” said Morris, who recently moved to Philadelphia after 20 years in Houston.

Florida’s health department said in a statement that it attributes the increase in cases to “greatly expanded efforts in testing,” and noted that overall positivity rates remain low, at about 5.5%.

Bucking the trend is Georgia, which was the first U.S. state to reopen. Covid cases there have plateaued. Despite local outbreaks in the state, “their sea levels did not rise,” said David Rubin, director of the PolicyLab, which has been modeling the virus’ spread. “They’ve kind of held this fragile equilibrium.”

Creeping In

California was the earliest state to shut down its economy over the coronavirus, after one of the nation’s first outbreaks in the San Francisco Bay Area. It has been slower than most to reopen.

Even so, the state has also seen the number of people hospitalized with Covid-19 rebound in the past two weeks, as commerce accelerates. Case counts are climbing too, although officials attribute that to increased testing and say it’s a sign of preparation.

In part, rising numbers represent the virus spreading into places that largely avoided the first round of infections, including rural Imperial County in California’s southeastern desert. Yet the contagion remains present in places that bore the brunt of the first wave, including Los Angeles County. Hospitalizations there are lower than at the start of May, but deaths remain stubbornly high, with 500 in the past week alone.

Barbara Ferrer, Los Angeles County public health director, said the region has likely not seen the end of the first wave. And despite concerns about infections coming out of mass demonstrations in the sprawling city, she thinks the reopening of the economy will have a bigger impact.

“We’re not at the tail end of anything,” Ferrer said. “We never had a huge peak. We’ve kind of been within this band. We’re not in decline, we’re kind of holding our own in ways that protect the health-care system.” But, she added, “go to Venice and see the crowds, and you’ll understand why I have concerns.”

Another Onslaught

The U.S. has long been bracing for another wave, but future outbreaks are likely to take a different shape. Social distancing and mask-wearing, as well as careful behavior by individuals, are likely to have staying power even as economies reopen.

Experts are steeling for autumn, when changes in weather and back-to-school plans could have damaging repercussions.

“The second wave isn’t going to mirror the first wave exactly,” said Lance Waller, a professor at Emory University’s Rollins School of Public Health in Atlanta. “It’s not snapping back to exactly the same thing as before, because we’re not exactly the way we were before.”

Daniel Lucey, a fellow at the Infectious Diseases Society of America, compared the virus’ new paradigm with a day at the beach: The U.S. has been bracing for another “high tide” like the one that engulfed New York City. Today is a low tide, but “the waves are always coming in.”