FDA Fully Approves Moderna’s COVID-19 Vaccine

The U.S. Food and Drug Administration has granted full approval to Moderna’s COVID-19 mRNA vaccine. The approval comes just over a year after the agency granted an emergency use authorization for the vaccine.

The FDA said the decision to grant the approval, which is for anybody over the age of 18, comes after follow-up data showed that the vaccine has a “high efficacy and favorable safety approximately six months after the second dose.”

“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. “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 agency continues to recommend a booster shot given five months after the two-dose regimen has been completed.

Moderna’s vaccine is the second to be granted full approval from the FDA. Pfizer’s COVID vaccine was fully approved last August for anybody over the age of 16. That vaccine is also available to adolescents between the ages of five and 15 under an emergency use authorization.

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