Based on recent data, the U.S. FDA has revised emergency use authorization (EUA) for

AstraZeneca’s Evuseld™ (tixagevimab co-packaged with cilgavimab).

• According to the FDA, data suggests that Evusheld retains activity for six months, when given at a dose of 300mg tixagevimab and 300mg cilgavimab, against the current prevalent Omicron subvariants of SARS-CoV-2, the virus that causes COVID-19. Therefore, the FDA now recommends repeating this dose once every six months in eligible individuals.
• Evusheld is authorized to prevent COVID-19 in adults and pediatric individuals (at least 12 years old and weighing at least 40kg, or 88 pounds) who are not currently infected with SARS-CoV-2, who have not had a known recent exposure to an individual infected with SARSCoV-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 COVID-19 vaccine component(s).
• Evusheld first received EUA to prevent COVID-19 in 2021.