FDA authorizes Omicron-specific boosters
The U.S. Food and Drug Administration on Wednesday authorized updated, Omicron-specific COVID-19 boosters from both Pfizer and Moderna, multiple outlets report.
The new shots are expected post-Labor Day, pending review from the Centers for Disease Control and Prevention later this week, notes The Washington Post. The boosters' bivalent formula targets both the BA.4 and BA.5 Omicron subvariant, as well as the original strain of the virus that circulated back in 2020.
The agency notably cleared the jabs without data from human trials, which it argued could detrimentally slow the process and perhaps render moot any data used in authorization, per The New York Times.
Pfizer's booster was cleared for use in individuals ages 12 and up, while the Moderna shot was authorized for those 18 and older. Prospective recipients must wait at least two months after finishing their primary series of vaccinations or after receiving their last booster dose to get the new shot.
"As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose," FDA Commissioner Robert Califf said Wednesday.
The Biden administration is preparing to distribute the shots as part of its fall booster campaign, NBC News adds.
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