FDA Updates Sotrovimab Emergency Use Authorization
Photo Credit: FDA Photo Sourced From: PCRM.org
The U.S. Food and Drug Administration is continually monitoring how authorized and approved treatments for COVID-19 are affected by changing variants—currently Omicron and the Omicron sub-variants, such as BA.2. Today, considering the most recent data available, FDA is announcing that sotrovimab is no longer authorized for use at this time in the following states and territories:
- Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont (Health and Human Services [HHS] Region 1)
- New Jersey, New York, Puerto Rico, and the Virgin Islands (HHS Region 2)
New data included in the health care provider fact sheet shows that the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Based on Centers for Disease Control and Prevention Nowcast data, the BA.2 sub-variant is estimated to account for more than 50% of cases in the states and territories in Regions 1 and 2 listed above as of March 19, 2022.
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