FDA Greenlights Pfizer Booster; Hurdles Remain Before Distribution Can Start
The Food and Drug Administration granted on Wednesday its emergency authorization to administer third doses of the Pfizer covid vaccine to Americans who are 65 or older or at high risk, like health care workers and teachers. Next steps before rollout starts include day two of a meeting of Centers for Disease Control and Prevention advisers.
Stat:
FDA Authorizes Pfizer's Covid-19 Booster For People Over 65 Or At High Risk
The Food and Drug Administration on Wednesday granted an emergency use authorization to Pfizer and BioNTech’s Covid-19 vaccine booster, though for now the FDA said use of the booster should be restricted to people over the age of 65, adults 18 and older at high risk of severe Covid, and those who, like health care workers, are at higher risk of infection because of their jobs. That list includes teachers. (Branswell, 9/22)
AP:
FDA Backs Pfizer COVID-19 Boosters For Seniors, High-Risk
However, more regulatory hurdles lie ahead before the dispensing of boosters can begin. Advisers to the Centers for Disease Control and Prevention opened a two-day meeting Wednesday to make their own, more specific recommendations about who should get the extra shots and when. And in their first day of discussions, some experts were so perplexed by the questions surrounding the rationale for boosters that they suggested putting off a decision for a month in hopes of more evidence. The uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month. (Perrone, Neergaard and Stobee, 9/23)
The New York Times:
F.D.A. Authorizes Pfizer Booster Shot For Higher-Risk People
Dr. Janet Woodcock, the acting F.D.A. commissioner, said that the authorization would allow for booster doses “in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.” Her statement suggested that agency leaders took a permissive view of the subgroups it deemed eligible for an extra injection. (Weiland and LaFraniere, 9/22)
Also —
The Wall Street Journal:
Pfizer Covid-19 Booster Shouldn’t Be For Moderna, J&J Vaccine Recipients, Health Official Says
A federal health official said Wednesday there isn’t enough data to support giving a Pfizer Inc.booster dose to people who have received other Covid-19 vaccines. Doran Fink, a deputy director in the Food and Drug Administration’s vaccines division, made the remarks at a meeting of a key vaccine advisory panel that would recommend who should get an additional dose of the vaccine from Pfizer and partner BioNTech SE. (Schwartz and Hopkins, 9/22)
Politico:
Covid-19 Boosters: 5 Takeaways From CDC's Big Vaccine Meeting
The CDC panel's role begins once the FDA authorizes the booster dose. The CDC's vaccine advisers will refine exactly who is eligible — in this case, that will likely involve defining "high risk." Those discussions are set to culminate on Thursday afternoon, but only if FDA authorizes the shot by that morning. Here are five key takeaways from the first day of the CDC vaccine meeting. (Gardner, 9/22)
