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Evusheld

Important Information About Evusheld

Healthcare providers can administer Evusheld (AZD7442) for pre-exposure prophylaxis (PrEP) of symptomatic COVID-19, prior to exposure to the virus for prevention of COVID-19 in certain adults and pediatric patients (12 years of age and older weighing at least 40 kg). The drug can provide protection for those not expected to mount an adequate immune response following vaccination, including those who are immunocompromised due to a medical condition or immunosuppressive medications, as well as those individuals for whom COVID-19 vaccination is not recommended. Evusheld (AZD7442) is a combination of two long-acting antibodies (tixagevimab and cilgavimab) and is administered by intramuscular (IM) injection. Healthcare providers should only administer Evusheld to individuals who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to someone infected with SARS-CoV-2.

Emergency Use Authorization of Evusheld

AstraZeneca received initial Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational long-acting antibody (LAAB) combination therapy, Evusheld (tixagevimab co-packaged with cilgavimab) on December 8, 2021, and the EUA was updated on February 24, 2022. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose.

Allocation and Distribution of Evusheld

In alignment with the terms of the EUA for Evsheld (AZD7442), the U.S. Department of Health and Human Services (HHS) is overseeing the allocation and distribution of this product. Recurring allocations to state and territorial health departments are determined based on the total adult population within the jurisdiction (pro rata allocation).

Evusheld FDA EUA Resources


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