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FDA staff declines to take stance, citing unverified 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.

Reuters On Wednesday, the Food and Drug Administration declined to issue a position on whether booster shots for’s Covid-19 vaccine should be approved. The agency stated that U.S. regulators hadn’t reviewed all available data.| 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 verified all the available data.

In a 23-page report published by the FDA, they stated that there are several relevant studies. However FDA hasn’t independently verified or reviewed the data and their conclusions. The September 17th, 2021 VRBPAC meeting will include a summary of some of the studies and data from Israel’s vaccination program.

Some observational studies suggested that the Pfizer vaccine’s effectiveness against symptoms and against the Delta variant has declined over time. Others have not.

The staff wrote, “Overall data suggest that US-licensed and authorized COVID-19 vaccinations still provide protection against severe COVID-19 illness and death in America.”

The data the FDA is looking at includes efficacy numbers out of Israel, where researchers there have released observational studies showing the effectiveness of the Pfizer vaccine against infection waned over time.

Pfizer claimed that a third dose (Covid) of vaccine after the second dose restores 95% protection. Separate documents were released Wednesday.

FDA staff seemed skeptical of the data due to observational studies not following the same guidelines as formal clinical trials.

Agency staff stated that observational studies are useful in understanding real-world effectiveness. However, they can also be susceptible to biases. The US-based study of BNT162b2’s post-authorization effectiveness may be the most accurate way to measure vaccine effectiveness in the US.

This staff report was prepared to inform the FDA’s Vaccines and Related Biological Products Advisory Committee. It meets Friday to discuss Pfizer’s request for approval of Covid booster doses. The agency offers a glimpse into its view of third shots in the documents that were published.

Biden’s administration stated that it would like to start offering booster shots to everyone as soon as possible, subject to FDA authorization. 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 and characterizing the administration’s push for boosters as premature.

According to Dan Barouch (an immunologist from Harvard Medical School), there is not yet a consensus within the biomedical field on boosters for general public.

He stated that senior experts are on opposing sides. It’ll be fascinating to watch the discussion unfold, although it is clear that the Biden administration believes boosters are necessary.

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 people to get a third dose eight months after they got their second shot of either the Pfizer or Moderna vaccine. Biden stated that scientists are evaluating whether the third dose should be moved up by three more months.

Senior health officials expressed concern that protection from severe diseases, hospitalizations, and death could decrease in the coming months after the announcement of the plan by the Obama administration in August. This was especially true for those at greater risk who were not vaccinated in the early phases.

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. The scientists stated that while Covid vaccine effectiveness may diminish over time for mild disease, severe diseases protection appears to be intact.

On Tuesday, WHO officials called again for wealthy nations to stop distributing Covid vaccine booster doses in hopes of making more shots available for poorer countries with lagging immunization rates.

Tedros Adhanom Ghebreyesus Director of the WHO stated at a press conference that “there are some countries with less then 2% vaccination coverage. Most of these are in Africa.” And starting with boosters is not the right thing, particularly when it comes to giving it to people who are healthy.