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. 2022 Aug 1;5(8):e2228997.
doi: 10.1001/jamanetworkopen.2022.28997.

Administration of Anti-SARS-CoV-2 Monoclonal Antibodies After US Food and Drug Administration Deauthorization

Timothy S Anderson  1   2 , Ashley O'Donoghue  2 , Oren Mechanic  3   4 , Tenzin Dechen  2 , Jennifer Stevens  2   5
Affiliations

Administration of Anti-SARS-CoV-2 Monoclonal Antibodies After US Food and Drug Administration Deauthorization

Timothy S Anderson et al. JAMA Netw Open. .

Abstract

This cross-sectional study uses time-series data to evaluate the administration of bamlanivimab-etesevimab and casirivimab-imdevimab monoclonal antibody treatments for SARS-CoV-2 infection after the US Food and Drug Administration deauthorized their use in early 2022.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Anderson reported receiving grants from the National Institute on Aging, the American College of Cardiology, and the Boston Claude D. Pepper Older Americans Independence Center outside of the submitted work; and receiving honoraria from Alosa Health, a nonprofit educational organization with no relationship to any drug or device manufacturers. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Weekly Administration of Monoclonal Antibody (mAb) Doses, by Hospitals and Health Systems
A, Number administered, by mAb product. B, Number administered per 1000 COVID-19 cases. FDA indicates US Food and Drug Administration.
Figure 2.
Figure 2.. Monoclonal Antibody (mAb) Doses Administered After US Food and Drug Administration (FDA) Deauthorization, by State
A, Total number administered. B, Percentage of mAb supply administered.
See this image and copyright information in PMC

References

    1. US Food and Drug Administration . Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant. January 24, 2022. Accessed March 12, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19...
    1. Levin J, Wingrove J. DeSantis touts Covid treatments after FDA says they don’t work. Bloomberg. January 25, 2022. Accessed March 12, 2022. https://www.bloomberg.com/news/articles/2022-01-25/desantis-touts-covid-...
    1. US Department of Health and Human Services . COVID-19 reported patient impact and hospital capacity by state timeseries. 2022. Accessed March 12, 2022. https://healthdata.gov/Hospital/COVID-19-Reported-Patient-Impact-and-Hos...
    1. Centers for Disease Control and Prevention . Trends in number of COVID-19 cases and deaths in the US reported to CDC, by state/territory. 2022. Accessed March 12, 2022. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases
    1. Centers for Medicare and Medicaid Services . COVID-19 vaccines and monoclonal antibodies. Accessed March 12, 2022. https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/co...

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