FDA says Evusheld is not currently authorized for emergency use in the USA

27 January 2023

The US Food and Drug Administration yesterday revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%.

Based on this revision, UK pharma major AstraZeneca’s (LSE: AZN) Evusheld is not currently authorized in the USA until further notice by the agency. The EUA was granted by the FDA I December 2021 for pre-exposure prophylaxis of COVID-19 in certain adults and children as young as 12 years.

Data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants. According to the most recent Centers for Disease Control and Prevention (CDC) Nowcast data, these variants are projected to be responsible for more than 90% of current infections in the USA. This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants.

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