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This page is currently under revision. Read this statement from the Panel's for the most recent information on the use of tixagevimab plus cilgavimab (Evusheld) as PrEP of COVID-19.

Anti-SARS-CoV-2 Monoclonal Antibodies

Last Updated: December 28, 2022

Monoclonal antibodies (mAbs) that target the SARS-CoV-2 spike protein have been shown to have clinical benefits in treating SARS-CoV-2 infection. However, laboratory studies have found that the activity of anti-SARS-CoV-2 mAbs against specific variants and subvariants can vary dramatically. Because of this, these products are not expected to be effective treatments for COVID-19 in areas where the circulating variants and subvariants are resistant to mAbs.

Recommendation

Anti-SARS-CoV-2 Monoclonal Antibodies That Have Received Emergency Use Authorizations

Four anti-SARS-CoV-2 mAb products (bamlanivimab plus etesevimab, casirivimab plus imdevimab, sotrovimab, and bebtelovimab) received Emergency Use Authorizations from the Food and Drug Administration for the treatment of outpatients with mild to moderate COVID-19. However, they are not currently authorized for use in the United States because the dominant circulating Omicron subvariants are not expected to be susceptible to these products. See the Centers for Disease Control and Prevention COVID Data Tracker for regular updates on the regional proportions of SARS-CoV-2 variants in the United States.

Tixagevimab plus cilgavimab (Evusheld) is the only anti-SARS-CoV-2 mAb product that is currently authorized for use as pre-exposure prophylaxis (PrEP). These recombinant human mAbs bind to nonoverlapping epitopes of the spike protein receptor-binding domain of SARS-CoV-2. Many Omicron subvariants, including the dominant Omicron subvariants in the United States, are expected to be less susceptible to tixagevimab plus cilgavimab. See Prevention of SARS-CoV-2 Infection for more information.

Table A. SARS-CoV-2 Variants Currently or Recently Circulating in the United States and Their Susceptibility to Anti-SARS-CoV-2 Monoclonal Antibodies
Table A. SARS-CoV-2 Variants Currently or Recently Circulating in the United States and Their Susceptibility to Anti-SARS-CoV-2 Monoclonal Antibodies

References

  1. Imai M, Ito M, Kiso M, et al. Efficacy of antiviral agents against Omicron subvariants BQ.1.1 and XBB. N Engl J Med. 2022. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36476720.
  2. Wang Q, Iketani S, Li Z, et al. Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants. Cell. 2022;Published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36580913.
  3. Food and Drug Administration. Fact sheet for health care providers: Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. 2022. Available at: https://www.fda.gov/media/145802/download.
  4. Food and Drug Administration. Fact sheet for health care providers: Emergency Use Authorization (EUA) of REGEN-COV (casirivimab and imdevimab). 2021. Available at: https://www.fda.gov/media/145611/download.
  5. Food and Drug Administration. Fact sheet for healthcare providers: Emergency Use Authorization (EUA) of sotrovimab. 2022. Available at: https://www.fda.gov/media/149534/download.
  6. Food and Drug Administration. Fact sheet for healthcare providers: Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab). 2022. Available at: https://www.fda.gov/media/154701/download.
  7. Food and Drug Administration. Fact sheet for healthcare providers: Emergency Use Authorization for bebtelovimab. 2022. Available at: https://www.fda.gov/media/156152/download.