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FDA Updates Sotrovimab Emergency Use Authorization
The Centers for Disease Control and Prevention (CDC) 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 Health and Human Services (HHS) U.S. regions. Data included in the 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.
New Paxlovid Dose Pack Authorized by FDA
On April 14, 2022, the FDA revised the Emergency Use Authorization (EUA) for the COVID-19 oral antiviral therapeutic Paxlovid to authorize an additional dose pack presentation with appropriate dosing for patients with moderate renal impairment within the scope of the EUA. As a result, Paxlovid will soon be available in two package presentations.