Moderna says the Food and Drug Administration has issued full approval for its COVID-19 vaccine for use in people aged 18 and older.
The company made the announcement in a press release on Monday morning.
Moderna says the vaccine will be marketed under the brand name "Spikevax."
"This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," Stéphane Bancel, Moderna's CEO, said in a statement. "The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic."
The Moderna vaccine was previously available for people under emergency use authorization. The Centers for Disease Control and Prevention has not yet authorized emergency use authorization for the Moderna vaccine for anyone younger than 18.
The Moderna vaccine is the second COVID-19 vaccine to receive full FDA approval. The agency previously issued full approval to the Pfizer vaccine last August.
This story is breaking and will be updated.
