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Tipsheet

FDA Fully Approves Moderna’s COVID-19 Vaccine

AP Photo/Rogelio V. Solis

On Monday, the U.S. Food and Drug Administration (FDA) granted its full approval to Moderna’s Wuhan coronavirus vaccine for adults ages 18 and older. The vaccine has been available under Emergency Use Authorization (EUA) since December 2020.

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The vaccine, which will now be marketed as Spikevax, is the second COVID-19 vaccine in the United States to receive full approval from the FDA. In August, the FDA approved the Pfizer-BioNTech coronavirus vaccine.

“The approval was based on a comprehensive submission package including efficacy and safety data approximately six months after the second dose,” Moderna wrote in a tweet.

"The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19.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. “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”

The Moderna Spikevax vaccine is a two-dose vaccine administered one month apart. Individuals who receive the initial primary doses are eligible for a booster shot six months after their second dose.

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“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax. This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.” 

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