FDA Gives Moderna COVID-19 Vaccine Full Approval

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization, and death. This is a momentous milestone in Moderna’s history, as it is our first product to achieve licensure in the U.S.,” Moderna CEO Stéphane Bancel said in a company statement. “The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel, and other countries, where the adolescent indication is also approved.”

The EUA-approved Moderna vaccine remains available as a two-dose primary series for people 18 years and older, as a third primary series dose for certain immunocompromised people 18 years and older, and as a single booster dose for people 18 years and older at least five months after completing a primary series of the vaccine. It is also authorized for use as a “mix-and-match” single booster dose for people 18 years and older who have completed primary vaccination with a different COVID-19 vaccine.

“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax,” Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said in a statement. “This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods, and manufacturing facilities.”

Under the approval, Moderna must conduct postmarketing studies to further assess the risks of two heart conditions — myocarditis and pericarditis — following vaccination with Spikevax. And though there is no FDA requirement to do so, Moderna will also conduct other postmarketing safety studies, including one to evaluate pregnancy and infant outcomes after women receive Spikevax during pregnancy.