Moderna Gets Full U.S. FDA Approval For Its Covid-19 Vaccine

By Will Feuer

Moderna Inc. said the U.S. Food and Drug Administration has fully approved the company's Covid-19 vaccine for use in people 18 and older.

The two-shot vaccine, also called Spikevax, was previously administered in the U.S. through an emergency use authorization. The FDA on Monday approved the company's application for a Biologics License Application, making it Moderna's first product to achieve licensure in the U.S., the company said.

"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," Chief Executive Stephane Bancel said. "The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus."

A booster shot of the vaccine is still available under an emergency use authorization, the company said.

Shares of Moderna traded 3% higher in morning trading. The stock has fallen 35% so far this year.

Write to Will Feuer at [e-mail]

(END) Dow Jones Newswires

01-31-22 1138ET