Emergency Use Authorization for EVUSHELD

December 9, 2021

On Dec. 8, 2021, the Food and Drug Administration (FDA) granted Emergency Use Authorization to AstraZeneca’s monoclonal antibody, EVUSHELD, for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended.

Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2. Pre-exposure prophylaxis with EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

With this EUA, the federal government will be allocating approximately 1,000 doses to the Washington State Department of Health every two weeks beginning December 14, 2021. Sites that are interested in receiving an allocation must be enrolled in the Healthcare Partner Ordering Portal. Once enrolled, these sites will request the amount of patient courses they wish to receive, with a minimum order of 24 patient courses.

More information can be found on the EUA Fact Sheet for Healthcare Providers: Emergency Use Authorization for EVUSHELD.

Orientation for the Healthcare Partner Ordering Portal is hosted by the Dept of Health at 9 a.m. Tuesday Dec. 14 & Dec. 21. Please contact mcm@doh.wa.gov to register. (Washington State Department of Health)

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