Moderna granted full FDA approval for COVID-19 vaccine
Maddie Meyer/Getty Images News


Moderna (MRNA
+2.7%) shares are trading higher after announcing that the FDA approved its Biologics License Application (BLA) for its COVID-19 vaccine. With full approval, the messenger-RNA-based shot is allowed for use under the brand name SPIKEVAX for COVID-19 prevention in those aged 18 years and above.

In December 2020, the federal agency granted the Emergency Use Authorization (EUA) for the vaccine at the 100-Âµg dose level. Last year, the FDA greenlighted a booster dose at the 50-Âµg dose level for adults aged 18 years and older.
âThis is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," remarked Moderna (NASDAQ:MRNA) CEO StÃ©phane Bancel.
"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,â he added. 
The decision comes more than five months after Modernaâs (MRNA) rivals, Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX), won the full FDA approval for their COVID-19 shot.