FDA To Weigh Allowing Pfizer Boosters For Anyone 18 Or Over
Pfizer and BioNTech asked Monday for authorization to start administering additional covid vaccine doses to any adult in the U.S. The companies submitted new study data on efficacy that was not available when a similar request was denied in September. The New York Times reports that the Food and Drug Administration is expected to grant the request.
NPR:
Pfizer And BioNTech Ask FDA To Authorize COVID Vaccine Booster For People 18+
Pfizer and BioNTech have asked the Food and Drug Administration to authorize their COVID-19 booster shot to all people 18 and older. The companies say the request is based on results from a study of more than 10,000 volunteers that show vaccine efficacy of 95% or greater for people receiving the booster. (Palca, 11/9)
The New York Times:
Pfizer Asks F.D.A. To Authorize Covid Booster Shots For All Adults
The Food and Drug Administration is expected to grant the request, perhaps before Thanksgiving and well ahead of Christmas travel and gatherings. The prospect of all 181 million fully vaccinated adults in the nation having access to extra shots is a turnaround from two months ago, when an expert advisory committee to the F.DA. overwhelmingly recommended against Pfizer-BioNTech’s request to authorize boosters for all adult recipients of that vaccine. (LaFraniere, 11/9)
CNBC:
Pfizer Asks FDA To Authorize Covid Booster Shots For All Adults
A third dose of the vaccine, which was developed with German partner BioNTech, has already been authorized by the FDA for elderly people and at-risk adults six months after they complete their primary series of shots. Booster shots of Moderna’s vaccine have also been cleared for the same groups as Pfizer’s while a second shot of Johnson & Johnson’s has already been cleared for all adults. More than 25 million Americans have received an additional dose of one of the three vaccines as of Monday, according to data compiled the Centers for Disease Control and Prevention. (Lovelace Jr., 11/9)
Canada, meanwhile, approved Pfizer's third covid jab for all adults —
The New York Times:
Canada Approves Pfizer-BioNTech Boosters For All Adults
Canada’s health agency authorized booster shots of the Pfizer-BioNTech vaccine nationwide on Tuesday, broadening eligibility to anyone over the age of 18, regardless of what vaccine they received initially. Health Canada, the federal department responsible for approving drugs, and the National Advisory Committee on Immunization had previously updated vaccine guidelines in September to recommend booster shots for seniors living in congregate settings and for people with compromised immune systems. (Isai, 11/9)