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FDA Warns Evusheld May Be Ineffective Against COVID-19 Subvariant XBB.1.5

• The FDA has cautioned that Evusheld, a preexposure prophylaxis for COVID-19, may not neutralize the XBB.1.5 subvariant, which accounts for nearly 30% of cases. • The agency is awaiting further data but suggests that Evusheld's effectiveness is compromised against XBB.1.5 compared to other variants. • Healthcare providers are advised to inform patients about the increased risk of COVID-19 infection due to the reduced efficacy of Evusheld against certain SARS-CoV-2 variants.

The FDA has issued a warning regarding the effectiveness of Evusheld, a monoclonal antibody treatment used for preexposure prophylaxis against COVID-19. The agency stated on January 6th that Evusheld may not be effective against the XBB.1.5 subvariant, which is responsible for approximately 3 in 10 COVID-19 cases. This raises concerns about the continued utility of Evusheld as a preventive measure against emerging strains of the virus.
While awaiting additional data, the FDA anticipates that Evusheld will not neutralize XBB.1.5. This announcement follows a similar statement in October concerning the BQ.1 and BQ.1.1 subvariants. Despite these concerns, the emergency use authorization for Evusheld remains in place, contrasting with the withdrawal of other COVID-19 treatments like Eli Lilly's bebtelovimab when faced with resistant variants.
Evusheld, developed by AstraZeneca, consists of two antibodies administered every six months as a preventive treatment, according to the CDC. The FDA and CDC have provided data on the reduction in susceptibility of Evusheld against several dominant Omicron subvariants. However, the susceptibility against BQ.1.1, XBB, BQ.1, BN.1, BF.7, and BA.2.75 subvariants have not been determined yet.
Given the uncertainty surrounding Evusheld's efficacy against XBB.1.5, the FDA advises healthcare providers to inform individuals about the increased risk of COVID-19 infection when exposed to SARS-CoV-2 variants that are not neutralized by Evusheld. This highlights the importance of ongoing surveillance and adaptation of treatment strategies in response to the evolving landscape of COVID-19 variants.
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Reference News

[1]
XBB.1.5 likely resistant to Evusheld, FDA says
beckershospitalreview.com · Jan 9, 2023

Evusheld, the only authorized COVID-19 preexposure prophylaxis, may not neutralize subvariant XBB.1.5, responsible for n...

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