Moderna's 'Spikevax' COVID19 vaccine gets full approval by FDA
Feb 01, 2022
Washington [US], February 1 : Moderna's COVID-19 vaccine 'Spikevax' received full approval from the U.S. Food and Drug Administration (FDA), after more than a year of its "emergency use authorization", reported USA TODAY.
The announcement was made by Moderna on Monday.
"The totality of real-world data and the full (license) for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," Stephane Bancel, Moderna's CEO, said in a statement.
The full approval is for individuals 18 and older in the two-dose primary series for vaccination however, the booster dose is available under emergency use authorization only, reported the newspaper.
Acting FDA Commissioner Dr Janet Woodcock said that the full approval of Moderna's COVID vaccine "may instil additional confidence" for those who have not yet been vaccinated.
"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," Woodcock said.
Notably, about 204 million doses have since been administered in the U.S., according to data from the Centers for Disease Control and Prevention.
