FDA Doubts Evusheld’s Efficacy Against New COVID-19 Variant

The FDA warned healthcare providers that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) might not be effective against the XBB.1.5 variant of the coronavirus that causes COVID-19, which currently accounts for 28 percent of circulating variants in the U.S. and 72 percent of new cases in the northeast region.

The agency said it is awaiting more data about Evusheld’s efficacy against the variant but “does not anticipate that Evusheld will neutralize XBB.1.5.”

Evusheld is currently authorized for emergency use in adults and children 12 years and older weighing at least 88 pounds who don’t have COVID-19, were not exposed to infected individuals and who are moderately to severely immunocompromised.