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​Sotrovimab

Important Information About Sotrovimab

On April 5, 2022, CDC estimated that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is greater than 50% in all HHS regions. Due to these data, use of sotrovimab is not authorized in any U.S. state or territory at this time, as indicated in the FDA Fact Sheet for Healthcare Providers. The Administration for Strategic Preparedness and Response (ASPR) paused distribution of sotrovimab to all U.S. states and territories on April 5, 2020.

Emergency Use Authorization (EUA) of Sotrovimab

The Centers for Disease Control and Prevention Nowcast data from April 5, 2022, estimates that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is above 50% in all U.S. Department of Health and Human Services (HHS) U.S. regions. Data included in the U.S. Food and Drug Administration’s (FDA) health care provider fact sheet show the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Due to these data, sotrovimab is not authorized in any U.S. state or territory at this time.

Allocation and Distribution of Sotrovimab

On April 5, 2022, ASPR paused distribution of sotrovimab to all U.S. states and territories. Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients.

Sotrovimab FDA EUA Resources

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