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

August 3, 2022

Therapeutics Update

View the COVID-19 Therapeutic Product Expiration Dates Database for the most recent shelf-life extension and product expiration information.

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.

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 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

Batch Number Labeled Expiry Date
Extended Expiry Date
658W 2022-02 2023-02
XV6W 2022-04 2023-04
Y74D 2022-04 2023-04
JP9Y 2022-04 2023-04
287F 2022-04 2023-04
287X 2022-05 2023-05
432U 2022-05 2023-05
433C 2022-05 2023-05
BX3T 2022-11 2023-05
9W8S 2023-03 2023-09
A39T 2023-03 2023-09
BD8F 2023-04 2023-10
BC9P 2023-04 2023-10
C86N 2023-04 2023-10
CC3D 2023-04 2023-10
CK9V 2023-04 2023-10
D74S 2023-04 2023-10
J23C 2023-06 2023-12
JJ7J 2023-06 2023-12
J67D 2023-06 2023-12
MJ8W 2023-07 2024-01
ME3Y 2023-07 2024-01
MJ8X 2023-07 2024-01