BREAKING NEWS: FDA Pulls Emergency Authorization on Evusheld

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The U.S. health authorities has revoked emergency-use permission for AstraZeneca’s (AZN.L) COVID-19 antibody cocktail Evusheld because the treatment is not anticipated to neutralize the XBB.1.5 subvariant of Omicron that is currently dominant.  

The Food and Drug Administration (FDA) had limited Evusheld’s usage earlier this month for the same reason, and the agency’s notification on Thursday caused U.S. shares of London-based AstraZeneca to fall by 1.31 percent to $65.  

According to official data, Omicron subvariant XBB.1.5 has swiftly expanded across the country since December and accounted for nearly half of all COVID-19 cases in the United States last week.  

Concerns voiced by the European health agency over the effectiveness of monoclonal antibodies such as Evusheld against newer strains are reflected in the FDA’s conclusion.  

As per Reuters, AstraZeneca was advised that the FDA will consider reinstating Evusheld’s approval if the proportion of resistant variants in the United States reduces to 90 percent or below and remains stable.  

In late 2021, the FDA authorized Evusheld to prevent COVID-19 infections in persons with compromised immune systems or a history of significant adverse reactions to coronavirus vaccinations. 

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