Distribution of Sotrovimab Paused to Certain States
March 30, 2022
COVID-19 Therapeutics Update
The following statement is an update to our announcement on March 25, 2022. An updated edition of this announcement was published on April 5, 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 March 29, 2022, the
Centers for Disease Control and Prevention (CDC) Nowcast data estimated the proportion of COVID-19 cases caused by the Omicron BA.2 variant to be above 50% in three additional Health and Human Services (HHS) regions (5, 9, and 10). Due to these data,
FDA has added these regions to the list of states and territories where sotrovimab is not authorized at this time.
Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that sotrovimab is not fully active against the BA.2 variant. The FDA
Fact Sheet for sotrovimab was updated on March 25, 2022, to reflect new data using authentic live BA.2 virus.
Accordingly,
ASPR has paused distribution of sotrovimab to all states in
HHS Region 5 (Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin), Region 9 (American Samoa, Arizona, California, Commonwealth of the Northern Mariana, Guam, Hawaii, Nevada, Republic of Palau, Republic of the Marshall Islands), and Region 10 (Alaska, Idaho, Oregon, Washington). This is in addition to Region 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont) and Region 2 (New Jersey, New York, Puerto Rico, and the Virgin Islands) that exceeded 50% prevalence of BA.2 last week. ASPR paused distribution of sotrovimab to Regions 1 and 2 on March 25.
Currently authorized alternative treatments are available for distribution. These include, Paxlovid (an oral antiviral treatment) and molnupiravir (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, bebtelovimab, and molnupiravir from the authorized distributer by following the existing ordering and reporting procedures. The FDA recommends that health care providers in all states in Regions 1 and 2 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 CDC website (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html) 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.
