Moderna announces full US approval for its COVID-19 vaccine

Moderna says U.S. health regulators have given full approval to its COVID-19 vaccine after reviewing additional data on its safety and effectiveness

WASHINGTON -- Moderna announced Monday that U.S. health regulators granted full approval to its COVID-19 vaccine, a shot that's been given to tens of millions of Americans since its emergency authorization over a year ago.

The action by the Food and Drug Administration means the agency has completed the same rigorous, time-consuming review of Moderna's shot as dozens of other long-established vaccines.

The decision was bolstered by real-world evidence from the more than 200 million doses administered in the U.S. since the FDA cleared the shot in December 2020. The FDA granted full approval of Pfizer’s vaccine last August.

Public health advocates initially hoped the regulatory distinction would boost public confidence in the shots. But there was no discernable bump in vaccinations after the Pfizer approval, which was heavily promoted by President Joe Biden and other federal officials.