The company is the second vaccine maker to get full FDA approval for a COVID-19 vaccine.
Moderna's COVID-19 vaccine has received full approval from the Food and Drug Administration, the US agency announced Monday. The company's vaccine has been available for adults age 18 and up since since December 2020 under emergency use authorization.
Moderna's vaccine, now marketed as Spikevax, is an mRNA vaccine administered in two doses one month apart. It's the second coronavirus vaccine to win full FDA approval. In August, the other mRNA vaccine available in the US, made by Pfizer and BioNTech, earned full FDA approval for those age 16 and up. (Pfizer's vaccine also has emergency use authorization for children age 5 through 15.)
While thorough safety and effectiveness data before a vaccine to receive emergency use authorization, full FDA approval is "based on the FDA's evaluation and analysis of follow-up safety and effectiveness data from the ongoing randomized, placebo-controlled, blinded clinical trial that supported the December 2020 EUA for the Moderna COVID-19 Vaccine," according to the FDA's release.
"The public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States," FDA Commissioner Dr. Janet Woodcock said in the release.
"While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated," Woodcock added.
A booster or third dose of Moderna's COVID-19 vaccine is still available under emergency use authorization. Johnson & Johnson, the only one-dose COVID-19 vaccine available in the US, still has emergency use authorization. Unlike the mRNA vaccines, J&J's product is based on traditional virus-based delivery tech. While two doses of a COVID-19 protect against severe disease and death from COVID-19, boosters are recommended as added protection against the highly contagious omicron variant.