US- FDA Releases Information Regarding SARS-CoV-2 Omicron Subvariant, XBB.1.5 Not Neutralized by AstraZeneca’s Evusheld

FDA is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 Omicron variant that is currently estimated to account for 28% of circulating variants in the US. Due to its similarity to variants that are not neutralized by Evusheld (e.g., XBB), FDA does not anticipate that Evusheld will neutralize XBB.1.5. The FDA states that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, the FDA is awaiting additional data to verify that Evusheld is not active against XBB.1.5 and plans to provide further updates.

The FDA is advising health care providers to inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld.

Additional information : https://www.fda.gov/drugs/drug-safety-and-availability/fda-releases-important-information-about-risk-covid-19-due-certain-variants-not-neutralized-evusheld