FDA Advisory Board Votes Against COVID Booster Vaccine Dose Except For High-Risk Groups
The Biden administration announced last month that it planned to begin offering a booster shot to the general population starting the week of September 20, but a Food and Drug Administration (FDA) advisory panel voted against a Covid-19 booster for the general population during a meeting on Friday morning, a decision that could put the agency at odds with administration officials who have been pushing to begin giving out booster shots to healthy adults as soon as next week.
The advisory committee was first asked to vote specifically on whether a booster dose of Pfizer-BioNTech’s Covid vaccine was safe and effective for people 16 and up. The panel voted overwhelmingly against that recommendation, citing concerns about the safety of the boosters in younger people. Following the advisory committee meeting, the booster question will go to a group of advisers to the CDC, which will take up the issue in a two-day meeting next week.
Despite several reports that supported the boosters, members of the FDA advisory committee struck a skeptical tone during the meeting, questioning Pfizer’s conclusions that immunity is waning to the point that vaccinated people of all ages need an additional dose to protect against hospitalization and death six months after they’ve received their second dose. The advisory committee followed the vote with a discussion about possible modifications to the booster question and voted again Friday afternoon to make the exception for those in high-risks groups, such as people with long-term conditions and those over 65.
NEW: After rejecting a full approval of a booster, the FDA is about to vote on the issuance of an EUA to approve a booster.
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— Andy Slavitt 🇺🇸💉 (@ASlavitt) September 17, 2021
Representatives from Pfizer said the need for a booster is based on data from Israel, which showed that severe cases increased tenfold from July to August, despite the fact that 60 percent of the population there was fully vaccinated. But data from the United States, presented by the CDC, found the vaccines continued to provide high protection against severe disease, hospitalization, and death.
WATCH LIVE: The VRBPAC meeting is underway. Today’s topic is the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in those 16 years and older. https://t.co/4l074Nm7Ic
— U.S. FDA (@US_FDA) September 17, 2021