Health

FDA staff declines to take stance on Pfizer's Covid booster shots, citing lack of verified data


A person receives a dose of the Pfizer-BioNTech vaccine for the coronavirus disease (COVID-19), at a mobile inoculation site in the Bronx, New York, August 18, 2021.

David ‘Dee’ Delgado | Reuters

The staff of the Food and Drug Administration on Wednesday declined to take a stance on whether to back booster shots of Pfizer‘s Covid-19 vaccine, saying U.S. regulators haven’t reviewed all the available data yet.

“There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” they wrote in a 23-page document published on the agency’s website. “Some of these studies, including data from the vaccination program in Israel, will be summarized during the September 17, 2021 VRBPAC meeting.”

The staff said some observational studies have suggested declining efficacy of the Pfizer vaccine over time against symptomatic infection or against the delta variant, while others have not.

“Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” they wrote.

The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Friday to review Pfizer’s request to approve Covid booster doses for the general public. The documents published offer a glimpse of the agency’s view on third shots.

The Biden administration has said it wants to begin offering booster shots to the general public as early as next week, pending authorization from the FDA. The move is part of President Joe Biden’s broader plan to confront a higher number of Covid cases fueled by the fast-spreading delta variant.

Scientists and other health experts have repeatedly criticized the plan, saying data the federal health officials cited wasn’t compelling, characterizing the administration’s push for boosters as premature.

There is currently not a consensus in the biomedical community on boosters for the general public, said Dan Barouch, an immunologist at Harvard Medical School.

“There are senior experts who fall on different sides of the debate,” he said. “Right now, it’ll be interesting to see where the debate goes, but obviously it is known that the Biden administration has suggested that boosters are needed.”

The Biden administration has cited three studies, released by the Centers for Disease Control and Prevention, that showed the vaccines’ protection against Covid diminished over several months. The administration’s plan, outlined by senior health officials, calls for a third dose eight months after people get their second shot of either the Pfizer or Moderna vaccine. Biden has said scientists were reviewing whether to move the third shot up by three months.

A group of scientists, including two senior FDA officials and the World Health Organization, published a paper Monday in the journal The Lancet that argued booster shots are not needed at this time for the general public. While Covid vaccine effectiveness against mild disease may wane over time, protection against severe disease appears to persist, the scientists said.

This is a developing story. Please check back for updates.



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