Moderna COVID-19 vaccine gets full FDA approval

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The Moderna Covid-19 vaccine received full approval from the U.S. Food and Drug administration Monday, 11 months after the shot was given an emergency use authorization.

The Food and Drug Administration announced it has granted Moderna’s COVID-19 vaccine full approval for use in adults on Monday.

“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 said in a statement. “We are grateful to the U.S. FDA for their thorough review of our application,” she said. “We are humbled by the role that Spikevax is playing to help end this pandemic.”

In its announcement Monday, the FDA said it had seen a rare risk of heart inflammation within 7 days of a second Moderna dose, specifically in men ages 18 to 24.ANGELA WEISS/AFP via Getty ImagesANGELA WEISS/AFP via Getty Images

 

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