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FDA staff refuses to take a stance, quoting unconfirmed data

On August 18, 2021, I was vaccinated with the Pfizer-BioNTech Vaccine (COVID-19) for coronavirus disease at a mobile vaccination site in Bronx, New York.

David’Dee’Dergado | Reuters

Wednesday Food and Drug Administration staff refused to take a position on whether to support booster shots PfizerCovid-19 vaccine states that US regulators have not validated all available data.

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

Staff said some observational studies have suggested reduced efficacy of the Pfizer vaccine against symptomatic infections or delta variants, but some have not.

“Overall, the data show that the COVID-19 vaccine currently licensed or licensed in the United States still provides protection against severe COVID-19 disease and death in the United States,” they write. increase.

The data examined by the FDA includes: Validity figures from IsraelResearchers there have published observational studies showing that the effectiveness of the Pfizer vaccine against infection has diminished over time.

In another document released Wednesday, Pfizer claimed a third dose of the Covid vaccine six months after the second dose restored protection from infection to 95%.

FDA staff appeared to be skeptical of the data, as observational studies did not comply with the same standards as formal clinical trials.

“Observational studies allow us to understand the effectiveness of the real world, but we should be aware that there are known and unknown biases that can affect their credibility,” government officials said. Stated. “In addition, US-based studies of post-approval efficacy of BNT162b2 may most accurately represent the efficacy of vaccines in the US population.”

The staff report is intended to outline the FDA’s Vaccine and Related Biopharmaceutical Advisory Board. The committee will meet on Friday to review Pfizer’s request for approval of the Covid booster dose for the general public. The published document gives a glimpse of the agency’s view of the third shot.

The Biden administration says it wants to wait for FDA approval and start offering booster shots as early as next week.This move is from President Joe Biden Broader plan Confront more Covid cases, supported by a rapidly expanding delta variant.

Scientists and other health professionals Repeated criticism The plan said the data quoted by federal health officials were unconvincing and did not characterize the government’s promotion of boosters prematurely.

Dan Barouch, an immunologist at Harvard Medical School, said there is currently no consensus in the biomedical community regarding boosters for the general public.

“There are senior experts who fall into various aspects of the debate,” he said. “For now, it’s interesting to see where the debate goes, but it’s clear that the Biden administration has suggested that boosters are needed.”

The Biden administration cited three studies showing vaccine prevention published by the Centers for Disease Control and Prevention. COVID It decreased in a few months. Administration plan, Overview Senior health authorities are asking people to take a third dose eight months after taking one of the following second shots: Pfizer Also Modana vaccination. Biden said scientists are considering moving the third shot up three months.

When the government announced its plans in August, senior health officials said that there would be more protection against severe illness, hospitalization and death among those who were vaccinated, especially at high risk or in the early stages of vaccination. Rolled out said he was concerned that it could decrease in months.

A group of two FDA officials and scientists including the World Health Organization Published a treatise The lancet that claimed booster shots on Monday in the journal is not needed by the general public at this time. Scientists say that the effectiveness of the Covid vaccine against mild illness may decline over time, but protection against severe illness seems to be persistent.

WHO staff on Tuesday Called back to wealthy nations Stop distributing Covid vaccine booster doses in the hope of making more injections available to poorer countries with delayed immunization rates.

“Some countries have less than 2% vaccination rates, most of them in Africa, and haven’t even received the first and second vaccinations,” Tedros Adhanom Gebreez, Executive Secretary, said in a press conference. “And starting with a booster, especially giving it to healthy people, is really wrong.”

FDA staff refuses to take a stance, quoting unconfirmed data

Source link FDA staff refuses to take a stance, quoting unconfirmed data

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