Spikevax meets FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval, the agency said in a statement.
“While millions of people have been safely vaccinated against Covid-19, we’ve found that for some people, FDA approval of a vaccine can now give more confidence to get vaccinated. “, said Acting FDA Commissioner Janet Woodcock.
“Today’s milestone brings us one step closer to changing the course of this pandemic in the United States,” she said.
Moderna’s Covid-19 vaccine is the second in the US to receive full FDA approval. Pfizer’s Covid-19 vaccine, Comirnaty, was fully approved for use in people 16 years of age and older in August 2021.
Moderna’s Covid-19 vaccine has been made available under an FDA emergency use authorization to individuals 18 years of age and older as of December 18, 2020.