The U.S. Food and Drug Administration today announced bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1., according to data included in the Health Care Provider Fact Sheet.

Nowcast data from the Centers for Disease Control and Prevention published last week estimates that the combined proportion of COVID-19 cases caused by the Omicron BQ.1 and BQ.1.1 subvariants to be above 57% nationally, and already above 50% in all individual regions but one, and data shows a sustained trend of increasing prevalence across all regions. Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time.

Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice by the Agency. Additionally, the Administration for Strategic Preparedness and Response (ASPR) has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative.

Please see attachment for further detail.

Navigation Menu

Search Bar

General Information:

Alert Detail

Alert Detail - HAN

Breadcrumb

Jump To:

HAN Alert Details Web

Asset Publisher

Related Alerts

Arboviral Surveillance Report for October 2, 2023

Youth Setting Needs Survey October 2, 2023

Chicago Respiratory Virus Weekly Surveillance Report - September 29, 2023

Chicago Long-Term Care Facility Survey Request for LTC PPE Kit Deployment

Bridge Access Program Enrollment for Pharmacies

Arboviral Surveillance Report for September 25, 2023

COVID-19

Footer Logo Content

City of Chicago

Footer Contact Health Alert Network(HAN)

Contact Health Alert Network (HAN)

Navigation Menu

Navigation Menu