FDA staff refuses to take a position on the third doses of Pfizer, citing the lack of verified data

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

David ‘Dee’ Delgado | Reuters

Food and Drug Administration staff on Wednesday declined to take a position on whether to support reinforcements to the Pfizer Covid-19 vaccine, saying U.S. regulators have not reviewed all available data.

“There are several potentially relevant studies, but the FDA has not independently reviewed or verified the underlying data or their findings,” 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 VRBPAC meeting on September 17, 2021.”

Staff said some observational studies have suggested a decrease in the effectiveness of the Pfizer vaccine over time against symptomatic infections or against the delta variant, while others have not.

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

The staff report is intended to inform the FDA’s Vaccine and Related Biological Products Advisory Council, which meets Friday to review Pfizer’s request to approve Covid booster doses for the general public. The published documents offer an overview of the agency’s vision on third photo.

The Biden administration has said it wants to begin offering a reinforcement shot to the general public by next week, pending authorization from the FDA. The move is part of President Joe Biden’s broader plan to address a higher number of Covid cases fueled by the rapidly spreading delta variant.

Scientists and other health experts have repeatedly criticized the plan, saying the data cited by federal health officials were unconvincing, characterizing the administration’s concern for boosters as premature.

There is currently no 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 for the various parts of the debate,” he said. “At this point, it will 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 cited three studies, published by the Centers for Disease Control and Prevention, that show that the protection of vaccines against Covid has been diminished for several months. The administration’s plan, explained by senior health officials, requires a third dose eight months after people receive their second shot of the Pfizer or Modern vaccine. Biden said scientists were reviewing whether to move the third shot in three months.

A group of scientists, including two senior officials from the FDA and the World Health Organization, published an article Monday in the journal The Lancet arguing that refreshment shots are not necessary at this time for the general public. While the effectiveness of Covid vaccination against minor diseases may decline over time, protection against serious diseases seems to persist, scientists say.

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

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