The FDA granted full approval to Moderna's COVID-19 vaccine Jan. 31 for all adults 18 and up.
The vaccine will be marketed under the brand name Spikevax and is the second to gain full regulatory approval in the U.S. The FDA approved Pfizer's vaccine in August 2021.
The vaccine has been available under an emergency use authorization since December 2020. Since then, more than 204 million vaccine doses have been administered in the U.S., according to CDC data cited by The New York Times. Overall, 75 million people in the U.S. have been fully vaccinated with Moderna's shot.
"While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated," acting FDA Commissioner Janet Woodcock, MD, said in a Jan. 31 news release.
Prior to granting approval, the FDA verified Moderna's own analysis of the vaccine's efficacy, conducted a separate analysis of the data and completed a "detailed assessment" of manufacturing procedures, according to Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research.
The FDA said it also performed a "rigorous evaluation" of two heart-related side effects, myocarditis and pericarditis, that have been linked to the vaccine. These conditions are usually mild and can also stem from COVID-19, according to the Times. The FDA determined there was an increased risk of developing these side effects within a week after a second dose, with men ages 18-24 having the highest risk. However, the agency determined that the vaccine's benefits still outweigh the risks for all adults.