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The FDA withdraws the emergency use authorization of Evusheld, which was touted as a COVID prevention tool

  • February 1, 2023
The FDA withdraws the emergency use authorization of Evusheld, which was touted as a COVID prevention tool

The US Food and Drug Administration is withdrawing its emergency use authorization of a COVID antibody therapy because it’s unlikely to be effective against variants.

Evusheld, which is made by British Swedish pharmaceutical and biotechnology company, AstraZeneca, was first authorized in December 2021 as preexposure protective treatment against the virus for those who are immunocompromised and less likely to generate antibodies from vaccination.

However, the FDA said the medication does not neutralize several Omicron subvariants.

According to the centers for disease control and prevention, these subvariants make up at least an estimated 90 percent of cases in the us. Despite Evusheld losing emergency use authorization status, the FDA urged providers not to discard their doses of the drug. Evusheld currently remains authorized in other countries where it is approved for COVID preexposure treatment, including the EU and Japan.”

AstraZeneca has issued a statement saying it is aware of the decision and that it is cooperating with the FDA.

Watch the full report here

Tags: AstraZenecaCOVID Antibody TherapyEvusheldOmicron
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