FDA Authorizes Revisions to Fact Sheets for SARS-CoV-2 Variants under EUA

The U.S. Food and Drug Administration (FDA) 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:

• Bamlanivimab

• Bamlanivimab and Etesevimab

• REGEN-COV (Casirivimab and Imdevimab)

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).

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. The mAb therapies are currently authorized by FDA to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains. Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19. Health care providers should review the authorized fact sheets for information on the use of the authorized mAb therapies against currently circulating viral variants. Providers should also refer to the Center for Disease Control and Prevention’s website on variant proportions in the U.S. Health care providers should consider the prevalence of mAb resistant variants in their area, where data are available, when considering treatment options. To guide treatment decisions, providers can also review information from state and local health authorities regarding reports of viral variants of significance in their region to guide treatment decisions.

FDA is required to regularly review the circumstances and appropriateness of an EUA, and the agency continues to review emerging scientific information associated with the emergency uses for the authorized mAb products, including information on viral variants. FDA is committed to providing updated information on variants and their potential impact on the authorized mAb therapies as new information becomes available.

FDA is working closely with the sponsors of the mAb EUAs to understand the potential impact of a variant on the effectiveness of the currently authorized mAb therapies. FDA is also working with the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, the CDC, and other government organizations to closely monitor the situation. The agency is committed to ensuring health care providers and health officials have the best information so patients may receive the most appropriate treatment available.