October 15, 2022

FDA Warns That Certain COVID-19 Variants are Not Neutralized by Evusheld

The FDA issued a new warning regarding Evusheld (tixagevimab co-packaged with cilgavimab) –  the only available pre-exposure prophylactic for COVID-19 – which notes that the medication does neutralize certain variants of the virus.

Evusheld currently has an emergency use authorization (EUA) for the prevention of COVID-19 in individuals who are not currently infected, have not had recent exposure to the virus, and who:

  • Have moderate to severe immune compromise due to a medical condition and may not mount an adequate immune response to COVID-19 vaccination
  • Are receiving receipt of immunosuppressive medication treatments and may not mount an adequate immune response to COVID-19 vaccination
  • Are not able to receive COVID-19 vaccination due to severe adverse reaction to components of the vaccine

Evusheld is authorized to be administered every six months. Use of Evusheld is not a substitute for COVID-19 vaccination, and individuals for whom COVID-19 vaccination is recommended should get vaccinated.  Individuals who received Evusheld but who develop COVID-19 remain eligible for use of any of the available treatments for COVID-19 if the criteria for use are met. 

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