Distribution of Sotrovimab Paused to All HHS Regions
April 5, 2022
COVID-19 Therapeutics Update
The following statement is an update to our announcements from March 25, 2022 and March 30, 2022.
The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPR’s updates related to COVID-19 monoclonal antibody therapeutics, please see our
full list of updates.
On April 5, 2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases caused by the Omicron BA.2 variant to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. Due to these data, use of sotrovimab is not authorized in any U.S. state or territory at this time. Accordingly and effective immediately, ASPR has paused sotrovimab distribution to all U.S. states and territories. The FDA has updated the Fact Sheet for sotrovimab to reflect product use restrictions.
Currently authorized alternative treatments are available for distribution. These include, Paxlovid (an oral antiviral treatment) and Lagevrio (an alternative oral antiviral for patients for which Paxlovid is not appropriate or accessible). Additionally, bebtelovimab is an alternative monoclonal antibody therapy that is currently authorized and available for distribution. Based on similar in vitro assay data currently available, these products are likely to retain activity against the BA.2 variant. All treatment delivery sites can continue ordering Paxlovid, Lagevrio, and bebtelovimab from the authorized distributer by following the existing ordering and reporting procedures. The FDA recommends that health care providers in all U.S. states and territories use alternative authorized therapy until further notice.
Health care providers should review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody and oral antiviral therapy available under an EUA for details regarding specific variants and resistance. Health care providers should also refer to the
Centers for Disease Control and Prevention (CDC) Nowcast data and information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.
COVID-19 therapies available under an EUA must be used in accordance with the terms and conditions for the respective authorization, including the authorized labeling. The
Letters of Authorization may be accessed at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.
ASPR and FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the therapies authorized for emergency use. We will provide further updates and consider additional action as new information becomes available.
Please contact
COVID19Therapeutics@hhs.gov with any questions.
