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Evusheld was an unapproved monoclonal antibody product containing tixagevimab co-packaged with cilgavimab. FDA formerly authorized it for emergency use as pre-exposure COVID-19 prophylaxis in selected adults and adolescents. FDA revoked the Emergency Use Authorization on December 13, 2024, and Evusheld is no longer authorized for emergency use in the United States.
read more about what was evusheld ...Tixagevimab and cilgavimab bound separate regions of the receptor-binding domain of the SARS-CoV-2 spike protein. This blocked interaction between the spike protein and human ACE2, which the virus uses for attachment to cells. Changes in circulating viral variants later reduced susceptibility to the antibody combination.
The former EUA covered adults and patients age 12 and older weighing at least 40 kg who were not infected or recently exposed and had moderate to severe immune compromise or a history of severe reactions that made COVID-19 vaccination unsuitable. Evusheld was not authorized for COVID-19 treatment or post-exposure prophylaxis.
The final EUA regimen used 300 mg of tixagevimab and 300 mg of cilgavimab as two separate consecutive intramuscular injections. Repeat dosing every six months was recommended when ongoing protection was needed. These instructions are historical and do not represent a current authorized U.S. regimen.
FDA revoked the EUA after the manufacturer requested revocation once distributed lots had expired and it no longer intended to market the product in the United States. Before revocation, Evusheld had already become unauthorized nationally due high frequencies of SARS-CoV-2 variants that were not susceptible to it. The former fact sheet also listed anaphylaxis and other hypersensitivity reactions and reported an imbalance in serious cardiac events in one prevention trial.
No. FDA revoked the Evusheld Emergency Use Authorization on December 13, 2024.
Evusheld contained the monoclonal antibodies tixagevimab and cilgavimab in separate co-packaged vials.
It was formerly authorized for pre-exposure COVID-19 prophylaxis in selected adults and adolescents at increased risk under specified criteria.
Circulating resistant variants made it unauthorized before the EUA was later revoked after distributed lots expired and U.S. marketing was discontinued.
CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products. U.S. Food and Drug Administration. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological. Date Accessed September 30, 2026.
Emergency Use Authorization - Archived Information. U.S. Food and Drug Administration. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information. Date Accessed September 30, 2026.
EVUSHELD Fact Sheet for Patients, Parents, and Caregivers. U.S. Food and Drug Administration. https://www.fda.gov/media/154702/download. Date Accessed September 30, 2026.
EVUSHELD Healthcare Providers Fact Sheet. U.S. Food and Drug Administration. https://www.fda.gov/media/154701/download. Date Accessed September 30, 2026.
FDA Revokes EUAs for Four Monoclonal Antibody Products. U.S. Food and Drug Administration. https://content.govdelivery.com/accounts/USFDA/bulletins/3c738bc. Date Accessed September 30, 2026.