FDA gives full approval of Moderna COVID-19 vaccine

January 2022

U.S. health regulators has given the official green light to Moderna’s version of the COVID-19 vaccine. To be marketed as Spikevax, full approval of the shot has been granted for ages 18 and older, and will continue to be administered as a series of two doses.

Moderna and the U.S. Food and Drug Administration (FDA) announced the approval on Monday.

The action by the FDA 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 data 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 notable increase in vaccinations after the Pfizer approval.