DOH Issues Advisory on Pause in Distribution of Sotrovimab

The New York State Department of Health (DOH) issued an Advisory on March 25, 2022 announcing the pause in distribution of sotrovimab to certain U.S. Department of Health and Human Services (HHS) Regions. The regions identified as being affected are Region 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont) and Region 2 (New Jersey, New York, Puerto Rico, and the Virgin Islands).

The Centers for Disease Control and Prevention (CDC) has identified that the BA.2 variant of COVID-19 is now circulating with a frequency exceeding 50 percent in HHS Regions 1 and 2. Per the DOH Advisory, "[r]esults from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that sotrovimab is not fully active against the BA.2 variant."

The Food and Drug Administration (FDA) Fact Sheet for sotrovimab was updated on March 25, 2022 to reflect new data using authentic live BA.2 virus.

Accordingly, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) has immediately paused distribution of sotrovimab to all states in Regions 1 and 2. All health care providers should monitor information from the CDC and state and local health authorities regarding the frequency of the BA.2 variant in their region.

Currently authorized alternative treatments are available for distribution, including Paxlovid, molnupiravir, and bebtelovimab.

Members are encouraged to reach out to Amy Nelson with any questions.

Contact: Amy Nelson, anelson@leadingageny.org, 518-867-8383 ext. 146