Moderna says U.S. health regulators have given full approval to its COVID-19 vaccine after reviewing additional data on its safety and effectiveness.
The decision Monday by the Food and Drug Administration comes after many tens of millions of Americans have already received the shot under its original emergency authorization.
Full approval means FDA has completed the same rigorous, time-consuming review for Moderna’s shot as dozens of other long-established vaccines.
Pfizer's COVID-19 vaccine received full approval last summer.
Public health advocates initially hoped the distinction would boost public confidence in the shots.
But there was no discernable bump in vaccinations after the Pfizer decision.
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BREAKING: The @FDA has approved the Biologics License Application (BLA) for SPIKEVAXâ„¢ (COVID-19 Vaccine, mRNA) to prevent #COVID19 in individuals 18 years of age and older. pic.twitter.com/Ska7SYBALr
— Moderna (@moderna_tx) January 31, 2022
