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Back to Policy Updates

FDA Authorizes Monoclonal Antibodies to Prevent COVID-19

FDA Authorizes Monoclonal Antibodies to Prevent COVID-19

12/15/21 — FDA issued an EUA for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the prevention of COVID-19 in certain adults and children. Although vaccines have proven to be the best defense against COVID-19, some people may not have an adequate immune response or have a history of severe adverse reactions to the vaccine. This product is only authorized for individuals who are not currently infected or recently been exposed to someone infected with the SARS-CoV-2 virus who have either:

  • Moderately to severely compromised immune systems due to a medical condition or immunosuppressive medications; or
  • A history of severe adverse reactions to a COVID-19 vaccine or components of the vaccines, so vaccination with an available COVID-19 vaccine is not recommended.

Read the FDA announcement and fact sheets for healthcare providers and patients and caregivers.