FDA Pulls Emergency Authorization Of Antibody Treatment For COVID-19


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The Food and Drug Administration has pulled the emergency use authorization for a monoclonal antibody treatment that was used to provide additional protection against COVID-19 for people who are immunocompromised.

The FDA said that Evusheld, which is made by AstraZeneca, does not provide protection against the XBB.1.5. BQ.1, BQ.1.1, and XBB subvariants.

“Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product,” the FDA said in a statement.

The Department of Health and Human Services said that around one million doses of Evusheld have been distributed, and 720,000 patients have received the treatment, which consists of two injections every six months.

Despite pulling the authorization for Evusheld, the FDA said the providers do not need to dispose of the medication.

“The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future,” the agency said.

Last month, the FDA withdrew authorization for the antibody treatment bebtelovimab because it was ineffective against the BQ.1 and BQ.1.1 subvariants of the coronavirus.

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