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COVID-19: FDA Pauses Bebtelovimab EUA, CDC Updates Congregate Setting Guidance

The U.S. Food and Drug Administration has paused its emergency use authorization of bebtelovimab, a COVID-19 monoclonal antibody treatment, stating that the medication is not expected to neutralize the BQ.1 and BQ.1.1 omicron subvariants of the SARS-CoV-2 virus that causes COVID-19.

The pause is consistent with the terms and conditions of the letter of authorization, given that a current COVID-19 infection is likely to be caused by BQ.1 and BQ.1.1 omicron subvariants, which are not susceptible to the drug. As of Dec. 3, BQ.1 and BQ.1.1 collectively account for 62.8 percent of the nation’s COVID-19 cases.

Eli Lilly and its authorized distributors have halted commercial distribution of bebtelovimab until further notice, although the government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab become more prevalent in the future.

The Administration for Strategic Preparedness and Response also paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative.

Other treatment options for high-risk patients facing COVID-19, including Paxlovid, Veklury, and Lagevrio, are still available upon prescription.

Currently, Americans aged 65 and older make up 90 percent of deaths related to COVID-19, and the Biden administration is in the midst of a year-end campaign aimed at bolstering COVID-19 vaccinations among older adults to reduce hospitalizations and death.

Updated Guidance for Community Congregate Living Settings

The Centers for Disease Control and Prevention (CDC) updated guidance on managing COVID-19 in specific congregate communities, including sites serving people experiencing homelessness, correctional and detention facilities, and other congregate community living settings.

CDC updated this guidance to make it consistent with recommendations in its streamlined COVID-19 guidance and help protect people in these settings who are more likely to get very sick from COVID-19. Health care services delivered in these settings should be informed by CDC’s Infection Prevention and Control Recommendations.

The updated information also is consistent with CDC’s COVID-19 Community Levels recommendations.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Andrea Lugo is a communications associate at America's Essential Hospitals.

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