ASPR and FDA Statement on Shelf-Life Extension Evaluation of Sotrovimab

August 3, 2022

The Administration for Strategic Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services have issued joint communications regarding the availability of COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

On July 29, 2022, FDA and ASPR authorized an additional extension to the shelf life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. Due to the prevalence of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the Emergency Use Authorization (EUA). However, the U.S. Government recommends product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for sotrovimab.

Evaluation of future extensions of the shelf life for sotrovimab is ongoing. FDA will continue to evaluate the available data and provide updated information as soon as possible. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or previously provided extension dates, unless otherwise notified by FDA.

This recommendation applies to all unopened vials of sotrovimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers and Letter of Authorization for sotrovimab. Please contact COVID19Therapeutics@hhs.gov with any questions. The extended expiry date for each lot can be found in Table 1 below.

Table 1: Extended Expiry Dating for Sotrovimab Authorized under EUA 100