FDA warns on risk of COVID-19 due to certain variants not neutralized by Evusheld

The US Food and Drug Administration (FDA) has added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving the drug of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld, which is marketed by UK pharma major AstraZeneca (LSE: AZN).

Detailed neutralization data can be found in the revised authorized  Fact Sheet for Healthcare Providers. Health care professionals should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive.

Evusheld is currently the only option for pre-exposure prophylaxis (PrEP) of COVID-19 and is approved under Emergency Use Authorization (EUA) for use in immunocompromised individuals who may not mount an adequate response to COVID-19 vaccination, and for individuals for whom COVID-19 vaccination is not recommended due to a history of a severe adverse reaction. It 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, the FDA pointed out.