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# EUA Approved for AstraZeneca’s Evusheld
- URL: https://www.fdaweb.com/eua-approved-for-astrazenecas-evusheld/
- Published: 2021-12-08T12:00:00.000Z
- Updated: 2026-09-14T17:24:53.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150732

FDA has issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prevention of Covid-19 in certain adults and pediatric patients. An agency [notice](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure?ref=fdaweb.com) says the monoclonal antibody product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual with SARS-CoV-2\. The authorization also requires that individuals either have: 

- moderately to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and thus may not mount an adequate response to Covid-19 vaccination; or
- a history of severe adverse reactions to a Covid-19 vaccine and/or component(s) of those vaccines and thus vaccination with an available Covid-19 vaccine is not recommended.

The notice says that one dose of Evusheld may be effective for pre-exposure prevention for six months. It is not authorized for individuals for the treatment of Covid-19 or post-exposure prevention of Covid-19.

According to FDA, tixagevimab and cilgavimab are long-acting monoclonal antibodies that are specifically directed against the SARS-CoV-2 spike protein and designed to block the virus’ attachment and entry into human cells. The two proteins bind to different, non-overlapping sites on the virus spike protein.

Possible side effects include hypersensitivity reactions, bleeding at the injection site, headache, fatigue, and cough.