As FDA assesses another COVID recall, some experts question need

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The U.S. Food and Drug Administration (FDA) is convening a panel of experts to weigh the pros and cons of an additional COVID recall on April 6, and over the weekend the New York Times reported that the FDA is considering allowing an additional booster shot for Americans ages 50 and older as early as this week.

Either way, many infectious disease experts say most Americans shouldn’t need another vaccine anytime soon.

“The general consensus, certainly that of the CDC [Centers for Disease Control and Prevention] consensus, is that current vaccines are still very effective against Omicron and this new BA.2 variant in keeping people out of the hospital and preventing the development of serious illnesses,” said William Schaffner, MD, infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tennessee.

“Given this, there is no need at this time for the general population to receive a fourth vaccination,” Schaffner said. Medscape Medical News. “Our current focus should be to make sure as many people as possible get this [first] reminder who are eligible. »

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth vaccine (or a third, if they had initially received the Janssen vaccine) are those over the age of 65 or 70, Gandhi said.

“Older people need these antibodies at a high level because they are more susceptible to severe breakthroughs,” she said. Medscape Medical News.

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, Massachusetts, said the timing of a booster and who should be eligible depends on what the country is trying to achieve with its vaccination strategy.

“Is the goal to prevent symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent serious illness requiring hospitalization? ” asked Kuritzkes.

The current vaccine – with a booster – prevented serious illness, he said.

An Israeli study showed, for example, that a third dose of Pfizer was 93% effective against hospitalization, 92% against serious illness and 81% against death.

A randomized controlled study just published in the New England Journal of Medicine (NEJM) found that a Pfizer vaccine booster was 95% effective against COVID-19 infection and raised no new safety concerns.

A small Israeli study, also published in NEJM, of a fourth dose of Pfizer given to healthcare workers found that it prevented infections and symptomatic illnesses, but was much less effective than previous doses – perhaps 65% effective against symptomatic illnesses, write the authors.

Giving Americans another booster now – which has been shown to lose effectiveness after around 4 months – means it may not offer protection this fall and winter, when there could be a surge. seasonality of the virus, said Kuritzkes Medscape Medical News.

And, even if people get booster shots every few months, they’re still at risk of contracting a mild respiratory virus infection, he said.

“I’m pretty confident that we can’t get out of this pandemic,” Kuritzkes said. “We need to make sure there’s global vaccination first so that everyone who hasn’t been vaccinated at all gets vaccinated. That’s way more important than boosting people a fourth time.”

Extra confusion

The FDA’s April 6 meeting of the agency’s Vaccines and Related Biologics Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for a additional reminder.

Pfizer is seeking emergency use for a fourth vaccine in patients over 65, while Moderna wants a booster available for all Americans over 18.

The committee will review the evidence for the safety and effectiveness of additional vaccine doses and discuss how to put in place a process – similar to that used for the flu vaccine – to be able to flexibly determine the composition of COVID vaccines as new variants emerge. This could lay the groundwork for an annual COVID vaccine, if needed.

FDA advisers will not make recommendations or vote on whether — and which — Americans should receive a COVID booster. That’s the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, canceled the ACIP and recommended that all Americans — not just the elderly — get an additional COVID vaccine.

This past action worries Gandhi, who called it puzzling, and said it may have contributed to the fact that less than half of Americans have since chosen to get an encore.

Schaffner said he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think ACIP will recommend routine use.

The FDA will likely grant clearance for additional boosters, but the ACIP “could be more conservative or narrower in terms of recommending who should be boosted and when the boost is appropriate,” Kuritzkes agreed.

Gandhi said she was concerned that the FDA’s deliberations would be influenced by Moderna and Pfizer’s influence and that “pharmaceutical companies would have more say in the scientific process than they should.”

There are similar worries for Schaffner. He said he was “a bit grumpy” that vaccine makers used press releases to argue for recalls.

“Press releases are not a means of making vaccine recommendations,” Schaffner said, adding that he would “advise [vaccine makers] to sit back and shut up and let the FDA and CDC advisory board do their job.”

Supply problems?

Meanwhile, the UK has started offering booster shots to its population over 75, and Swedish health authorities have recommended a fourth vaccine for people over 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep pace, infectious disease experts said.

Indeed, the White House kept a fourth shot in the news, warning that it lacks the money to ensure all Americans would have access to it, if recommended.

On March 23, outgoing White House COVID-19 response coordinator Jeff Zients said the federal government has enough vaccines for the immunocompromised to receive a fourth dose “and, if allowed in the weeks ahead, enough supply for fourth doses for our most vulnerable, including the elderly.”

But he warned that without Congressional approval of a COVID-19 funding package, “we cannot secure the vaccine supply needed to support the fourth shots for all Americans.”

Zients also noted that other countries, including Japan, Vietnam and the Philippines, have already secured future booster doses and added, “We should secure additional supplies at this time.”

Schaffner said while it would be nice “to have a booster on the shelf,” the United States needs to work harder to create a globally coordinated process to ensure vaccines are matched to strains. in circulation and that they are produced in a timely manner.

He said he and others “remind the public that the COVID pandemic may indeed be waning and becoming endemic, but that doesn’t mean COVID is over, over, or gone.”

Schaffner said one would expect that “we might need a periodic boost to our immune system to stay protected. In other words, we might need to be boosted every year like we let’s do it with the flu”.

Alicia Ault is a freelance journalist based in Lutherville, Maryland, whose work has appeared in publications including JAMA, Smithsonian.com, The New York Times, and The Washington Post. You can find her on Twitter @aliciaault.

Kuritzkes disclosed consulting or speaking fees from GlaxoSmithKline, Janssen, Merck, Moderna and Pfizer. Gandhi did not disclose any relevant financial relationship.

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