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

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

David de Delgado | Reuters

Food and Drug Administration staff on Wednesday declined to take a stand on whether to subsidize booster shots PfizerA Covid-19 vaccine, saying US regulators have not yet reviewed all available data.

“There are several potentially relevant studies, but the FDA has not independently reviewed or verified the baseline data or their conclusions,” they wrote in a 23-page document posted 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 that some observational studies suggested the effectiveness of the Pfizer vaccine declines over time against symptomatic infections or against the delta variant, while others have not.

“Overall, the data indicates that currently licensed or licensed COVID-19 vaccines in the United States continue to provide protection against severe COVID-19 illness and death in the United States,” they wrote.

The data the FDA is looking for includes Event numbers outside IsraelThere, researchers released observational studies that show the efficacy of the Pfizer vaccine against infection wanes over time.

In separate documents released on Wednesday, Pfizer argued that a third dose of the Covid vaccine six months after the second shot restores protection against infection to 95%.

FDA personnel seem to be taking a skeptical tone about the data because the observational study does not adhere to the same standards as formal clinical trials.

“It must be recognized that while observational studies can enable an understanding of real-world efficacy, there are known and unknown biases that can affect their reliability,” the agency staff said. “Furthermore, studies conducted in the United States on the post-licensing efficacy of BNT162b2 may more accurately represent the efficacy of the vaccine in the US population.”

The task force’s report is intended to brief the Food and Drug Administration’s Advisory Committee on Vaccines and Related Biological Products, which is meeting Friday to review Pfizer’s request for approval of COVID-boosting doses for the general public. The published documents provide a glimpse into the agency’s point of view in the third shot.

The Biden administration said it wants to start offering booster shots to the general public as early as next week, pending authorization from the Food and Drug Administration. This move is part of President Joe Biden wider plan To counter a greater number of Covid cases fueled by the fast-spreading delta variable.

Scientists and other health experts have criticize repeatedly The plan, which says data cited by federal health officials has not been convincing, calling the administration’s push for reinforcements premature.

There is currently no consensus in the biomedical community on boosters for the general public, said Dan Baruch, an immunologist at Harvard Medical School.

“There are top experts who are caught in different sides of the debate,” he said. “For now, it will be interesting to see where the discussion goes, but it is clear that the Biden administration has suggested that reinforcements are needed.”

The Biden administration cited three studies, released by the Centers for Disease Control and Prevention, that showed vaccines protect against Corona virus disease diminished over a period of several months. management plan, the summary By top health officials, it calls for a third dose eight months after people have had a second shot of either Pfizer or modern Serum. Biden said scientists are studying whether the third shot should be moved by three months.

A group of scientists, including two senior officials of the Food and Drug Administration and the World Health Organization, published a paper Monday in The Lancet which argued that booster shots are not necessary at this time for the general public. The scientists said that while the effectiveness of the Covid vaccine against mild disease may wane over time, protection against severe disease appears to be continuing.

On Tuesday, WHO officials Called back to the rich countries Stop distributing booster doses of the Covid vaccine in the hope of providing more doses to poor countries with late immunization rates.

“There are countries with less than 2% vaccination coverage, mostly in Africa, who haven’t even had their first and second doses,” Director-General Tedros Adhanom Ghebreyesus said at a press conference. healthy population, it’s not really true.”


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