U.S. FDA fully approves Moderna’s COVID-19 vaccine for adults

America’s Food and Drug Administration (FDA) gave full approval to Moderna’s COVID-19 vaccine for people aged 18 and above, making it only the second fully approved vaccine for the virus.

Moderna’s COVID-19 vaccine has been authorized for emergency use in the U.S. since December 2020 and will now be marketed and sold under the brand name Spikevax. BioNTech’s and Pfizer COVID-19 vaccine using similar technology received full approval in the United States in 2021 for people aged 16 and above after first receiving emergency authorization.

According to the U.S. Centers for Disease Control and Prevention data, almost 75 million people have already received Moderna’s two-dose COVID-19 shot in the United States.

The COVID-19 vaccine is Moderna’s first-ever FDA-approved product in the U.S.  Stéphane Bancel, chief executive officer of Moderna, in a statement, said this was a momentous milestone in Moderna’s history.

The full approval is centered on clinical trial data from nearly 30,000 test group participants, which showed the vaccine was an effective and safe protection against COVID-19. Moderna’s vaccine is cleared for use in more than 70 countries, including the European Union and Canada.

In June last year, the American biotechnology giant asked for its COVID-19 vaccine to be authorized for use in 12-17 year-olds, but the FDA is yet to respond to the request.