FDA Authorizes Shelf-Life Extension for Sotrovimab From 12 to 18 Months

May 12, 2022

The Assistant Secretary for 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 September 21, 2021, FDA and ASPR authorized an extension to the shelf-life from 12 months to 18 months for all lots of the refrigerated GSK monoclonal antibody, sotrovimab. Due to the high frequency of the Omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. Therefore, this drug may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. However, it is the recommendation of the U.S. Government that 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 Emergency Use Authorization (EUA) 100.

Evaluation of future extension of 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 the Agency.

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 or EUA 100. Please contact COVID19Therapeutics@hhs.gov with any questions.

Specific lots that may be stored for an additional six months from the labeled date of expiry can be found here. Sotrovimab lots not included in this list are already labeled with dates reflective of the 18-month expiry.

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