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PEMGARDA has been authorized by FDA for the emergency use described on this site. It is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.

PEMGARDA is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PEMGARDA under Section 564(b)(1) of the FD&C Act, 21 U.S.C. § 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner.