FDA pulls EUA for AstraZeneca COVID PrEP

Jan. 27, 2023

The U.S. FDA announced this week that AstraZeneca’s Evusheld no longer has Emergency Use Authorization (EUA) for pre-exposure prophylaxis (PrEP) against COVID-19. 

Specifically, the FDA revised the EUA, limiting Evusheld's use to when the combined frequency of non-susceptible variants in the country is less than or equal to 90%. Because recent data has shown that the long-acting antibody cocktail is only likely to have an effect against less than 10% of circulating variants in the country, the risks no longer outweigh the benefits.

AstraZeneca first snagged EUA for Evusheld in December of 2021. At the time, the monoclonal antibody cocktail was the first treatment of its kind authorized for long-term prevention of COVID among people with weakened immune systems before they have been exposed to the coronavirus.

The original EUA was supported by pivotal phase 3 data from a large placebo-controlled clinical trial demonstrated that the cocktail is about 83% effective at preventing symptomatic disease.