The Food and Drug Administration (FDA) has updated the authorized fact sheet for Evusheld (tixagevimab co-packaged with cilgavimab) to include information related to an increased risk of developing COVID-19 due to SARS-CoV-2 viral variants not neutralized by the product.

Evusheld is a combination of 2 long-acting monoclonal antibodies designed to bind to distinct sites on the SARS-CoV-2 spike protein. The product is authorized for emergency use for the pre-exposure prophylaxis of COVID-19 in patients 12 years of age and older, weighing at least 40kg who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2, and:

  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination; or
  • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s).

The Fact Sheet for Healthcare Providers now includes a warning advising health care providers to inform individuals of the increased risk for developing COVID-19 when exposed to SARS-CoV-2 viral variants not neutralized by Evusheld. The updated fact sheet includes a detailed table on the neutralization activity of Evusheld against SARS-CoV-2 variants by area.

Individuals who received Evusheld but who develop COVID-19 remain eligible for any of the available treatments for COVID-19 if the criteria for use are met. Evusheld is still recommended as an appropriate option for pre-exposure prophylaxis of COVID-19. The list of medical conditions or treatments that may result in moderate to severe immune compromise has also been updated in the fact sheet.

Additionally, the FDA recommends monitoring CDC regional variant frequency data to determine the neutralization activity of Evusheld against SARS-CoV-2 variants.

References

Latest information and updates about Evusheld for PrEP for COVID-19. News release. US Food and Drug Administration. Accessed October 3, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/latest-information-and-updates-about-evusheld-prep-covid-19