Vaccines and Related Biological Products Advisory Committee- FDA
:: Vaccines and Related Biological Products Advisory Committee September 17, 2021
The committee met in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older.
YouTube recording: https://youtu.be/WFph7-6t34M
No FDA announcement on action proceeding from this meeting was identified at 18 Sep 2021 – 1600/New York. We include the Pfizer announcement and coverage from the New York Times below for context:
FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations
:: Committee reviewed clinical data showing a booster dose of COMIRNATY® elicits high neutralization titers against SARS-CoV-2 and all currently tested variants
:: Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series
:: Real-world data presented by Israel Ministry of Health show additional protection after receiving a booster translated to vaccine effectiveness comparable to levels seen early in the country’s vaccine rollout
:: FDA expected to make its decision in the coming days
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the FDA grant Emergency Use Authorization (EUA) for a booster dose of COMIRNATY® (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19. The committee recommended that the additional dose be administered at least six months after the two-dose series. The panel also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA…
An FDA panel’s vote deals the Biden administration’s push for universal booster shots a setback.
New York Times, 17 Sep 2021
The Biden administration’s push to make Covid-19 booster shots available to most fully vaccinated adults has been stymied for now by a Food and Drug Administration advisory panel’s recommendation that Pfizer boosters be made available only to those 65 and over and those at high risk of severe Covid.
However, the roiling debate over whether the shots are needed more broadly remains unsettled.
The panel of experts on Friday overwhelmingly voted not to recommend boosters for those over 16 after a tense, daylong debate that put divisions within the agency and the administration on public display.
The vote was a blow to President Biden, strengthening criticism of his effort to enhance the immunity of already vaccinated Americans at a time when most residents of poor nations have not even had first doses. The F.D.A. and the Centers for Disease Control and Prevention authorized third shots for some immunocompromised individuals more than a month ago, on the ground that the additional dose would simply lift their protection to the level other people achieve with two shots.
Some F.D.A. experts said that the data from Pfizer and elsewhere still seemed to show that two shots protected against severe disease or hospitalization for months afterward, and that there was not enough evidence that a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.
The panel’s final recommendations left some room for the White House to argue that the core of its booster strategy remained intact. Depending on how “at high risk” is defined, tens of millions of Americans could conceivably be deemed eligible for additional shots of the Pfizer vaccine. And a small but growing number of people have stopped waiting for federal authorization and are finding ways to receive booster shots…