Shelf-Life Extension of Evusheld under Emergency Use Authorization

December 5, 2022

The Administration for Strategic Preparedness and Response and the Food and Drug Administration (FDA) announce the authorization of an additional extension to the shelf-life from 18 months to 30 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals.

As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below) and, as required by the emergency use authorization for Evusheld, unopened vials of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. FDA granted this extension following a thorough review of data submitted by AstraZeneca. This extension applies to all unopened vials of Evusheld that have been 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) 104 for Evusheld.

Evusheld has fixed expiration dates on the label of each vial and carton. The date identified on the vial and carton reflects the original shelf-life of 18 months and does not reflect the extended 30-month shelf-life. The table below provides a list of the updated expiry, by batch, for distributed Evusheld. Please reference the batch number on the carton to determine the new expiration date. If the batch number on the carton is not included in this listing, the product is labeled with the correct expiration date.

Table 1: Extended Expiry Dating for Evusheld (Tixagevimab Co-Packaged with Cilgavimab) Authorized under EUA 104