The Southern Medical Journal (SMJ) is the official, peer-reviewed journal of the Southern Medical Association. It has a multidisciplinary and inter-professional focus that covers a broad range of topics relevant to physicians and other healthcare specialists.

SMJ // Article

Letter to the Editor

Banning Monoclonal Antibody Therapies for COVID-19 Using In Vitro Data

Authors: Tony Zitek, MD, Brittney Pardinas, BS, David A. Farcy, MD

Abstract

To the Editor: On January 24, 2022 the US Food and Drug Administration (FDA) revoked the emergency use authorization for REGEN-COV (casirivimab/imdevimab) for coronavirus disease 2019 (COVID-19). The FDA’s press release stated that this treatment is “highly unlikely to be active against the Omicron variants” and expressed concerns about its adverse effects.1
Posted in: Infectious Disease156

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References

1. Cavazzoni P. Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron. Published January 24, 2022. Accessed January 25, 2022.
 
2. US Food and Drug Administration. FDA updates sotrovimab emergency use authorization.https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization?utm_medium=email&utm_source=govdelivery. Published April 5, 2022. Accessed April 6, 2022.
 
3. VanBlargan L, Errico J, Halfmann P, et al. An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies. Nat Med 2022;28:490–495.
 
4. Johnson AG, Amin AB, Ali AR, et al. COVID-19 incidence and death rates among unvaccinated and fully vaccinated adults with and without booster doses during periods of Delta and Omicron variant emergence—25 U.S. jurisdictions, April 4– December 25, 2021. MMWR Morb Mortal Wkly Rep 2022;71:132–138.
 
5. Weinreich DM, Sivapalasingam S, Norton T, et al. REGEN-COV antibody combination and outcomes in outpatients with Covid-19. N Engl J Med 2021;385:e81.