U.S. FDA grants full approval to Moderna's COVID-19 vaccine
Moderna's COVID-19 vaccine is the second one in the United States to receive full approval from the FDA.
Moderna's COVID-19 vaccine received full approval from the U.S. Food and Drug Administration (FDA) on Monday.
The vaccine, named Spikevax, is approved for use in people ages 18 and older.
Spikevax meets the FDA's rigorous standards for safety, effectiveness and manufacturing quality required for approval, said the agency in a statement.
"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said Acting FDA Commissioner Janet Woodcock.
"Today's milestone puts us one step closer to altering the course of this pandemic in the U.S.," she said.
Moderna's COVID-19 vaccine is the second one in the United States to receive full approval from the FDA. Pfizer's COVID-19 vaccine, Comirnaty, was fully approved for use in people ages 16 and older in August 2021.
Moderna's COVID-19 vaccine has been available under the FDA's emergency use authorization for individuals 18 years of age and older since Dec. 18, 2020.