Moderna Vaccine Granted Full Approval by F.D.A.


First American News LLC, Raleigh, NC: The Food and Drug Administration granted full approval on Monday to Moderna’s coronavirus vaccine, the second-most widely used in the United States and the second to receive full regulatory approval.

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The vaccine, which can be administered to adults and has been shown to be highly effective at preventing virus infections and severe cases of Covid-19, has been in use for more than a year under an emergency-use authorization. That rigorous standard lets federal regulators allow use of the shot in a public health emergency before they complete a longer and more detailed review. The vaccine received emergency-use authorization in December 2020.

The full approval of Moderna’s vaccine, which was widely expected, came roughly five months after the company said it had finalized its application for regulators, and after Pfizer and its partner BioNTech, the makers of a similar vaccine, won federal approval in August for use in people 16 and older. That approval set off a cascade of vaccination mandates from institutions that had eagerly awaited the more exhaustive review.

The Pfizer-BioNTech vaccine is cleared for use in people 5 and older, and could be authorized for even younger children in the next few months.

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