Moderna's COVID-19 vaccine received full approval from the U.S. Food and Drug Administration, the company announced Monday, becoming the second coronavirus vaccine to receive full approval from federal health regulators.
On Friday, a panel of advisers to the Centers for Disease Control and Prevention voted unanimously to recommend the FDA's approval.
The question the advisers voted on was: "The Moderna COVID-19 BLA approved vaccine (Spikevax, 2-dose primary series) is recommended for persons 18 years of age and older." The vote was a unanimous 13-0.
The vaccine will now be marketed in the United States under the name Spikevax.
"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," Stéphane Bancel, Chief Executive Officer of Moderna, wrote in a statement. "The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S."
"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," Bancel added. "We are humbled by the role that Spikevax is playing to help end this pandemic."
The Pfizer-BioNTech COVID-19 vaccine received full FDA approval in August of last year, the first to receive such deisgnation from federal regulators.
According to data from the CDC, nearly 75 million people have been fully vaccinated with Moderna's vaccine, and more than 38 million people have been boosted with the two-dose regimen.
Nearly 250 million Americans have received at least one dose of a COVID-19 vaccine, accounting for 75% of the total U.S. population, with more than 211 million fully vaccinated, as of Sunday, Jan. 30. About 86 million Americans have received a booster dose of a COVID-19 vaccine.
Moderna's vaccine is approved for Americans 18 and older. The company said last year that it has delayed seeking authorization for Americans 12-17 as it investigates a rare risk of heart inflammation, largely in teen boys and young men.