USA – FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization

Today, the U.S. Food and Drug Administration authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) for the treatment of COVID-19. FDA is providing this information to equip health care providers with the most current data so they can make informed decisions and provide appropriate care to patients with COVID-19. Health care providers should review the fact sheets for details regarding specific variants and potential resistance that may make the authorized mAb therapies less effective.   

The revised fact sheets are for:

The fact sheet revisions provide additional information to health care providers concerning how certain variants of SARS-CoV-2, known to be circulating within the United States, may impact the effectiveness of the authorized mAb therapies. The revisions include information on the following variants: B.1.1.7 (UK Origin), B.1.351 (South Africa Origin), P.1 (Brazil Origin), B.1.427/B.1.429 (California Origin), and B.1.526 (New York Origin)…