The U.S. Food and Drug Administration Monday gave full approval to U.S. pharmaceutical company Moderna’s COVID-19 vaccine, which will be marketed under the name Spikevax.
The vaccine has been widely distributed in the United States and around the world under the FDA’s emergency use authorization since December of 2020. It is the second COVID-19 vaccine the agency has fully approved, after Pfizer’s vaccine received the designation in August of 2021.
In a statement, acting FDA Commissioner Janet Woodcock said full authorization of the vaccine is an important step in the fight against COVID-19. She said that while hundreds of millions of doses of the Moderna shot have been administered under the emergency use authorization, she understands “for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”
Woodcock said the public can be assured that the Moderna vaccine “meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States.”
The Moderna vaccine has been approved for use in more than 70 countries including Britain, Canada, Japan and those in the European Union.
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