Moderna said Monday that U.S. health regulators from the Food and Drug Administration have granted full approval to the company's COVID-19 vaccine.
"This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," Moderna CEO Stéphane Bancel said in a statement. "We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic."Moderna's vaccine has been available in the U.S. under an emergency use authorization since December 2020.
"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 added.
An employee shows the Moderna COVID-19 vaccine at Northwell Health's Long Island Jewish Valley Stream hospital in New York, Dec. 21, 2020. Reuters/Eduardo Munoz In the U.S., Moderna is used only by adults for initial vaccination and as a half-dose booster. The company said last fall that the FDA had delayed deciding whether to clear the shots for 12- to 17-year-olds as it examined the heart inflammation risk.
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