Moderna's COVID-19 vaccine becomes 2nd to be fully approved by the FDA

A second COVID-19 vaccine has been fully approved in the United States.

The Food and Drug Administration on Monday fully approved the COVID-19 vaccine from Moderna for those over the age of 18. That makes the Moderna vaccine, which will be marketed as Spikevax, the second fully-approved coronavirus vaccine in the U.S. after the vaccine made by Pfizer and BioNTech was approved in August 2021.

"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," Acting FDA Commissioner Janet Woodcock said.

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Though the Moderna vaccine was already being administered under an emergency use authorization, even more data is required for a vaccine to earn full FDA approval. For that reason, Woodcock said the vaccine's approval "may instill additional confidence in making the decision to get vaccinated." Data has shown that Moderna's vaccine is safe and effective against COVID-19 and that a booster dose provides protection against the Omicron variant.

Moderna CEO Stéphane Bancel celebrated the FDA's step as a "a momentous milestone in Moderna's history," noting the vaccine is "our first product to achieve licensure in the U.S."