A health worker administers a Pfizer-BioNTech Covid-19 vaccine to a child at a testing and vaccination site in San Francisco, California, U.S., on Monday, January 10, 2022.
David Pablo Morris | Mayor Bloomberg | fake images
The Food and Drug Administration has authorized the fourth Pfizer and modern Covid vaccine dose for everyone over 50, amid uncertainty over whether an even more contagious version of omicron will cause another wave of infection in the US as it has in Europe and China.
The FDA also said it has authorized a second Pfizer booster injection for people 12 and older who have compromised immune systems, and a second Moderna booster for adults 18 and older with compromised immune systems. New boosters are given at least four months after the last injection.
The FDA made the decision without a meeting of its vaccine advisory committee, a rare move the agency has taken with increasing frequency over the course of the pandemic to expand the uses of already approved Covid vaccines. Drug regulator authorization comes just two weeks after Pfizer and modern asked the FDA to allow a second booster vaccine based on data from Israel. The Centers for Disease Control and Prevention is expected to quickly sign off on the decision.
The FDA’s decision bypasses its vaccine advisory committee, which is scheduled to meet on April 6 to discuss the future of booster shots in the US.
Committee member Dr. Paul Offit criticized the drug regulator for going ahead without holding an open meeting where the American public could hear experts weigh the data and make a recommendation to the FDA on the best way forward. . Vaccine advisory committee recommendations are not binding, but help provide transparency to the public.
“It’s kind of a fait accompli,” Offit said of the FDA clearance. “So is that how it works? We talk endlessly about how we follow the science; it doesn’t seem to work that way.”
The FDA has not asked committee members to make a recommendation on booster shots since last fall when voted for a third dose of Pfizer or Moderna for people 65 and older and younger people at risk of severe Covid.
Health experts disagree on whether a fourth dose of vaccine is needed at this time, though the debate is nuanced. There is broader agreement that the elderly or immunocompromised may benefit from additional protection. Another booster shot for healthy young adults is more controversial, as they are less susceptible to serious illness from covid.
Dr. Peter Hotez, a vaccine expert at Baylor College of Medicine in Houston, said some scientists believe the sole purpose of the shots is to keep people out of the hospital. However, Hotez said that vaccine policy must also seek to prevent infection and prolonged covid. The effectiveness of the third dose against hospitalization of omicron has also decreased over time, he said.
the CDC published a study in February which showed that the effectiveness of the third dose against emergency room visits decreased from 87% to 66% against emergency room visits and from 91% to 78% against hospitalization four months after receiving the injection.
“That gives me pause for concern that boosters aren’t necessarily working as well as we’d like,” said Hotez, who strongly supports a fourth dose based on Israeli data showing another booster boosts protection for older people. 60 years.
israeli Scientists, in a study published last weekk, found that the death rate of omicron was 78% lower in people aged 60 to 100 years who received a fourth Pfizer dose compared to those who received only three injections. The study, which has not undergone peer review, examined the medical records of more than 500,000 people from January through February at Clalit Health Services, Israel’s largest health care provider.
The FDA’s decision to authorize fourth doses for people over 50 was broader than Pfizer’s request and narrower than Moderna’s. Pfizer had asked the FDA to approve the fourth dose for people over 65, while Moderna asked the drug regulator to allow it for all adults over 18. Stephane Bancel, CEO of Moderna he told CNBC last week that the biotech company filed a broader application to give the FDA flexibility in deciding which age group needs a fourth dose right now.
John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, criticized Moderna’s request for a fourth dose for all adults as an aggressive and pervasive application that fails to distinguish between the different needs older and younger people have. .
“The frail elderly person is much more in need of an additional dose of vaccine than a young, healthy athlete,” Moore said.
The authorization of the fourth injections comes as a more contagious omicron sub-variant, BA.2, has sparked new waves of infection in major European nations and in China, which is battling its worst outbreak since 2020. BA.2 has gained ground in the US since February. and it is expected to become the dominant variant here in the coming weeks. White House chief medical adviser Dr. Anthony Fauci has said infections could rise in the US due to BA.2, though don’t wait for another wave.
BA.2 generally doesn’t make people sicker than omicron’s earlier version, BA.1, and the vaccines are equally effective against both types of the variant, according to studies from South Africa and Qatar, among others. None of the studies have undergone peer review.
It’s unclear if the FDA will also approve fourth doses for younger adults at some point, as there is less data to support such a decision at this time. A February Israeli Study among healthcare workers aged 18 and older indicated that a fourth dose does not boost immunity, but rather restores it to the full strength of the third dose. Many people in the study who received a fourth dose still became infected, even though they were asymptomatic or had mild symptoms.
“A fourth vaccination of young, healthy health care workers may have only marginal benefits,” Dr. Gili Regev-Yochay and a team of scientists from Sheba Medical Center and the Israeli Ministry of Health wrote in a letter to New England. they conducted the study. Journal of Medicine this month.
The FDA’s advisory committee voted overwhelmingly against a third dose for everyone over 16 in September last year because experts felt there wasn’t enough data to support such a decision. Two months later, the FDA authorized enhancers from Moderna and Pfizer for all adults without having an advisory committee meeting, and then reduced eligibility to December and January to include everyone 12 and older.