POST 269. August 31, 2022. “Everyone Has a Plan Until They Get Punched in the Mouth.” (Mike Tyson). Are we in a slow retreat to herd immunity?

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JONATHAN M. Metsch on Facebook

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“At the very moment a better coronavirus vaccine is expected to finally become available, America’s vaccination program is feeling the effects of a long period of retreat.

Local programs to bring shots to the places where Americans gather and the institutions they trust have folded, a consequence in some cases of congressional resistance to more pandemic response spending…

With the virus killing far fewer people than it once did and many Americans reverting to their prepandemic ways, the country’s no-expenses-spared attitude to saving lives has evolved into a response that has put a greater onus on individuals to protect themselves. In keeping with that approach, many health officials believe the vaccine machinery is in place to meet what they expect, lamentably, to be tepid demand this fall.

But others are worried that the country is surrendering a decisive opportunity to stoke that demand and restore the more robust vaccination efforts that lifted last year’s initial rollout.

“We are watching the dismantling of the hyperlocal infrastructure that actually brought needles to arms in the most vulnerable communities in the country,” said Stephen Thomas, the director of the Center for Health Equity at the University of Maryland. “To this day, vaccine uptake in the United States is embarrassing.”…

The United States is leaning ever more heavily on vaccines to defend against the virus at a time when health officials are pulling back on other preventive measures, like masking, distancing and quarantining…

But, at the same time, the vaccination campaign is lagging. While two-thirds of Americans have completed the primary vaccine series, only about one-third have received boosters. The country’s per capita booster coverage trails that of some 70 other nations, according to Our World in Data.

Some are worried that the country is surrendering a decisive opportunity to stoke demand for and restore the more robust vaccination efforts that lifted last year’s initial rollout.

Partly as a result, scientists said, Americans this year have died from Covid at a rate 80 percent higher than Canadians and 30 percent higher than residents of the European Union.” (A)

“AIDS. SARS. H1N1 influenza. Ebola. Covid-19. Monkeypox. Infectious disease outbreaks often come and go, though some persist over the long haul, much like the man who has occupied the campus of the National Institutes of Health in Bethesda, Md., as director of the National Institute of Allergy and Infectious Diseases since 1984: Dr. Anthony Stephen Fauci…

As Dr. Fauci prepares to retire at the end of this year, one has to wonder if this is the end of an era as well. Don’t get me wrong: No one I know thinks that our gains on AIDS and the progress we’ve made in other areas of infectious disease control — particularly on vaccine-preventable diseases — are trivial accomplishments.

But with Covid-19, something has changed. It tested a fundamental equilibrium among science, public health and politics in America. Most administrations, I argue, simply don’t care much about science and public health; it’s not a priority for them. On AIDS, Mr. Reagan ignored it, and Bill Clinton paid lip service to it. George W. Bush came the closest to making it a priority, with the establishment of the President’s Emergency Plan for AIDS Relief, but by the time of Barack Obama, activists were protesting again about an administration’s neglect.

But Covid-19 caught the attention of politicians, and not in a good way. For decades, Dr. Fauci and other scientists could advise presidents, even sway them for good on occasion, because so little was at stake politically for these leaders. But with Mr. Trump and President Biden, too much was riding on their short-term political fortunes to indulge scientific and public health evidence and advice too much or for too long.” (B)

“But however much truth there is to the story that Dr. Fauci was a victim of our polarized era and broken media environment, it is also partial and simplistic. It amounts to insisting that skepticism of the good doctor must have been everyone’s fault but his own…

Dr. Fauci became the face of American public health’s incoherent response to the pandemic. He urged the country to shut down weeks after dismissing early Covid worries as a baseless fear of “going to a Chinese restaurant”; he encouraged masking weeks after counseling against it; he aggressively cast the lab leak theory as fringe (though possible) despite many scientists wanting more to be done on lab safety. Just this April, Dr. Fauci said one day that we were “out of the pandemic phase” and the next day that we were “still experiencing a pandemic.”..

This is a bad place for us to be. While Dr. Fauci has unfairly borne the burden of a failure that belongs to the entire public health system, he has also embraced his role as its figurehead, and is still held up by it as an idol. And while public health leaders are now gingerly attempting to confront their mistakes, what we have seen in, say, the C.D.C.’s new internal report are halfhearted, proceduralist ideas. The public health establishment will not be able to do better than this without real soul-searching. And that will require swallowing a bitter pill: labeling Dr. Fauci’s Covid legacy and the approach it embodied a failure. His retirement is an opportune moment to move on from the view of science he stood for throughout the pandemic to something new.” (C)

“The pandemic itself is another impediment. The agency’s massive complex outside Atlanta sits mostly empty, while employees, including Dr. Walensky, work remotely.

“The actions that are being taken all strike me as actions that make sense and would make C.D.C. a more effective public health agency,” said Dr. Besser, the former C.D.C. acting director.

But he said it was hard to see how Dr. Walensky could execute wholesale changes when she only sees most of her staff at a distance. “I don’t know how you motivate and inspire culture change when people aren’t together,” he said.” (D)

“The Biden administration has been planning for how to get past the crisis phase of the Covid-19 pandemic and will stop buying vaccines, treatments and tests as early as this fall, White House Covid-19 Response Coordinator Dr. Ashish Jha said on Tuesday.

One of the things we’ve spent a lot of time thinking about in the last many months — and we’re going to continue this work, and you’ll hear more from the administration on this — is getting us out of that acute emergency phase where the US government is buying the vaccines, buying the treatments, buying the diagnostic tests,” Jha said at an event sponsored by the US Chamber of Commerce Foundation…

“I would like to get to a point where every adult in America who wants a vaccine can get one. I’m hopeful we will be there. We’re not quite there yet in terms of how many vaccine doses we’ve been able to buy,” he said.

Jha said the transition to commercialization is complicated. It involves regulatory issues, market dynamic issues and equity issues, but the administration is working carefully and thoughtfully to get it right.

“Right now, everybody can walk into a CVS and get a vaccine. I want to make sure that when we make this transition, we don’t end up at a point where nobody can get a vaccine because we didn’t get the transition right,” he said.

Jha said some of the commercialization would start in the fall, but most would be visible in 2023.

He said it would be important for the government to continue to make investments in the development of the next generation of vaccines and in pandemic preparedness.

“But this business of day-to-day running of a pandemic, that needs to transition, and we’re working very hard to make sure that transition is in a very orderly and transparent way so everybody sees it coming,” he said.” (E)

“The government will end its giveaway of Covid-19 at-home tests Friday because of insufficient congressional funding, a senior Biden administration official said Sunday.

A stockpile of the tests is being depleted, and officials want to have enough on hand in the event of a fall surge, the source said.

The giveaway, which includes tests mailed at no cost to recipients who request them at, will end Friday, according to an announcement on the site — unless there’s a surprise round of funding from Congress, the source said.

“If Congress provides funding, we will expeditiously resume distribution of free tests through,” the source said. “Until then, we believe reserving the remaining tests for distribution later this year is the best course.”

“The administration has been clear about our urgent Covid-19 response funding needs,” the source said. “We have warned that congressional inaction would force unacceptable tradeoffs and harm our overall Covid-19 preparedness and response — and that the consequences would likely worsen over time.”

Fewer people are testing for the coronavirus, and many are believed to have had it without knowing conclusively. In fact, experts believe many Americans have been reinfected at this point in the pandemic.

With the halting of distribution Friday, the vast majority of people in the U.S. would still have the option of free testing or getting reimbursed through private insurance, Medicare or Medicaid.

The federal government has distributed an estimated 600 million tests through its Covid-19 test website. It first started shipping the free tests in January, when the omicron variant was peaking.

It was not immediately clear how many are currently left in the stockpile.

In March, the White House asked Congress for an additional $22.5 billion in funding for Covid relief efforts, warning that it would be unable to sustain testing capacity without it.

But an impasse resulted in the funding, which the Biden administration also intended to use for research and treatments, not being granted. “ (F)

“The updated Covid vaccine boosters, a reformulated version targeting the BA.5 omicron subvariant, could be available around Labor Day. They’ll be the first Covid shots distributed without results from human trials. Does that matter?

Because the Biden administration has pushed for a fall booster campaign to begin in September, the mRNA vaccine-makers Pfizer-BioNTech and Moderna have only had time to test the reformulated shots in mice, not people. That means the Food and Drug Administration is relying on the mice trial data — plus human trial results from a similar vaccine that targets the original omicron strain, called BA.1 — to evaluate the new shots, according to a recent tweet from the FDA commissioner, Dr. Robert Califf.

Federal health officials hope that the new vaccines will provide stronger protection over the existing booster shots, which still target the original coronavirus strain. But the lack of data in humans means officials likely won’t know how much better the new shots are — if at all — until the fall booster campaign is well underway.

The FDA’s decision to move forward without data from human trials is a gamble, experts say, threatening to further lower public trust in the vaccines should the new boosters not work as intended…

The FDA’s decision to consider Covid boosters without human data is in line with how it evaluates modified vaccines for influenza each year. Clinical studies in humans aren’t required for the approval of seasonal influenza vaccines, even when they’re reformulated for strain changes, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.

Still, the flu vaccine isn’t a fair comparison, said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.

The FDA’s policy on influenza shots is based on decades of experiences with strain changes where the flu vaccines behaved generally in the same way. The U.S. is still on its first iteration of the Covid vaccines, and the mRNA technology has only been in widespread use since late 2020.

The agency is making “huge assumptions” in its consideration of the new Covid boosters, Offit said, adding that it’s possible the new shots may not be any more effective than the existing vaccines.

Not all experts see it the same way.” (G)

“The Food and Drug Administration on Wednesday authorized updated versions of Pfizer-BioNTech’s and Moderna’s Covid booster shots that target the highly contagious BA.5 omicron subvariant…

“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent Covid-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” Dr. Peter Marks, the agency’s top vaccine regulator, said in a statement.

The FDA’s signoff isn’t the last step: The decision will now go to the Centers for Disease Control and Prevention and its advisory committee to issue their own recommendation on how the shots should be used. The agency’s Advisory Committee on Immunization Practices is scheduled to vote Thursday. CDC Director Dr. Rochelle Walensky could sign off on the doses shortly after Thursday’s meeting, and vaccinations could begin widely after Labor Day….

The FDA convened its outside advisory committee in June to review data on a different version of a booster — one that combined the original strain with an earlier version of omicron, called BA.1. At the time, the committee voted in favor of updating the shot to target omicron, but it did not specify which particular subvariant.

The FDA did not consult its advisory committee again before Wednesday’s authorizations”. (K)

“After the game-changing COVID-19 antiviral Paxlovid began to be used in late 2021, researchers noticed a perplexing trend. In some people taking the drug, symptoms and detectable virus vanish, only to mysteriously return days later.

After months of grasping at straws, scientists are beginning to make some headway in understanding ‘Paxlovid rebound’. Two recent studies suggest that it is surprisingly common for SARS-CoV-2 to return in untreated cases of COVID-191, while hinting that the virus’s comeback is fiercer and more common in people who take Paxlovid2.

“We’re all seeing people who are taking Paxlovid doing really well and then suddenly they’re getting sick again,” says Michael Charness, a physician-scientist at VA Boston Healthcare in Massachusetts, who published an early description of Paxlovid rebound3. “There are so many unanswered questions.”…

The study, led by infectious-disease physician and vaccine scientist Kathryn Stephenson at Beth Israel Deaconess Medical Center in Boston, closely followed 11 people who took Paxlovid for COVID-19 and 25 who did not. More than one-quarter of the Paxlovid recipients rebounded, based on levels of SARS-CoV-2, compared with just one of the 25 untreated people. Moreover, people with Paxlovid rebound had high levels of virus for several days, as if they had new acute infections. “The single case of viral rebound without treatment was more like a viral ‘blip’,” Stephenson wrote on Twitter.

Charness says that Paxlovid rebound does seem to be qualitatively different from rebound in untreated people, whose viral levels rarely reached the peaks of their initial infection.

But the cause of Paxlovid rebound remains unclear. Studies have suggested that it’s unlikely to be due to viral drug resistance or feeble immune responses in rebounders. Researchers are testing whether viral replication, having been suppressed by Paxlovid, can bounce back when the drug vanishes from the body, leading to high viral levels and potent immune responses that can cause symptoms to reappear.

Physicians also need a better guide as to how to treat, and ultimately prevent, Paxlovid rebound. Mark Siedner, a clinical epidemiologist at Massachusetts General Hospital in Boston who is studying Paxlovid rebound, says the phenomenon reminds him of what occurs when other diseases are treated for too short a time. “This smells like treatment duration is not long enough for the subgroup of people who have rebound.”

The drug is currently given for five days, but Charness says it’s worth looking at longer treatment periods — as long as this doesn’t promote drug resistance. “There is still a lot to learn.”” (H)

“Starting Sept. 6, employees of Goldman Sachs will be allowed to enter the office regardless of vaccination status and will no longer be required to test for COVID-19 or wear masks.

“With many tools including vaccination, improved treatments, and testing now available, there is significantly less risk of severe illness,” Goldman said in the memo sent out to all employees.

The company cited the Centers for Disease Control and Prevention, which recently relaxed many restrictions including quarantine rules and social distancing requirements.

Goldman Sachs has been a big advocate of bringing people back into the office, setting it apart from other companies in finance and tech that are leaning more toward a hybrid work style.

In a push to prove the world has returned to normal, the company is also reducing the number of COVID tests available around the office.

“With antigen test kits widely available in the community, we will begin ramping down the provision of test kits on our campuses, with the current expectation of ending the program by year end,” the memo stated.

The memo comes just days before the bank expects all employees to return to its offices five days a week.” (I)

“When White House Chief Medical Advisor Dr. Anthony Fauci warned in 2020 that living with the coronavirus was going to be our new normal, he meant it.

“We’re not going to eradicate the virus from the face of the Earth,” Fauci told Yahoo Finance in an interview on Tuesday. “I don’t believe we’re even going to eliminate it from this country to the tune of getting zero cases.”

Despite earlier estimates pointing to a possible end to the pandemic by 2024, along with assumptions that all countries would be fully vaccinated by then, poor adherence to vaccinations and public health mitigation measures has resulted in an ongoing pandemic that is nowhere near under control…

Instead, Fauci, who also serves as the director of the National Institute of Allergy and Infectious Diseases (NIAID), hopes that at least by 2024, the circulation of the virus is low enough “that it does not disrupt … the economy, our ability to interact socially with each other, schools, and things like that.”” (J)

“The 7-day average for new daily cases has dipped slightly to the 120,000 range over the past 3 days, according to an analysis by the Washington Post. Today the 7-day average is 121,739 cases.

Meanwhile, the 7-day average for new daily deaths is rising, today reaching 496. Deaths, often a lagging indicator, have shown a slow rise since the middle of July.

According the Centers for Disease Control and Prevention (CDC), 41.7% of US counties have high COVID community levels, and 38.9% are at the medium level. Its community transmission map shows that 94% are classified as having high transmission, a level for which CDC recommends masking while indoors and using public transportation.” (L)

“When COVID-19 vaccines first became available, public officials, community organizations and policymakers mobilized to get shots into arms. These efforts included significant investments in making vaccines accessible to Black, Hispanic, American Indian and Alaska Native populations. These groups experienced exceptionally high COVID-19 death rates early in the pandemic and had low initial vaccine rates.

The efforts worked. As of August 2022, vaccination rates for the primary series – or required initial doses of COVID-19 vaccines – for Black and Hispanic people exceeded those of white Americans.

But boosters are a different story. Comparable booster vaccine promotion efforts have been lacking. Confusion in the public health messaging surrounding boosters and limited federal funding for rolling out vaccination campaigns have resulted in slow booster uptake across the country.

As a result, divides have once again emerged. A recent study of COVID-19 booster rates found that 45% of white adults and 52% of Asian American adults had received boosters by January 2022. But only 29% of Black adults and 31% of adults who reported another racial or ethnic identity, such as American Indian, Alaska Native, Native Hawaiian, Pacific Islander or multiracial, were boosted.” (M)


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