On Mar. 16, 2023, Pfizer announced that the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data supported the safety and effectiveness of PAXLOVID (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.

The AMDAC based its vote on the totality of scientific and real-world evidence shared by Pfizer, including safety and efficacy data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development program.

In addition, real-world evidence presented to the AMDAC showed that PAXLOVID’s clinical profile in the post-authorization setting is consistent with the safety and efficacy conclusions from the EPIC clinical program, including observations made when the Omicron variant and its lineages were the predominant forms of SARS-CoV-2 in circulation.