The U.S. is halting distribution of sotrovimab, a COVID-19 antibody made by GlaxoSmithKline and Vir Biotechnology, in regions where the omicron subvariant BA.2 has become dominant in response to data suggesting the treatment is ineffective against the strain.
In a March 25 update, HHS said sotrovimab shipments to HHS Region 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont) and Region 2 (New Jersey, New York, Puerto Rico and the Virgin Islands) will be paused immediately. HHS cited alternative treatments — including bebtelovimab, a monoclonal antibody, and COVID-19 antivirals Paxlovid and molnupiravir — that current data has shown to be effective against BA.2.
The FDA said new data "shows that the authorized dose of sotrovimab is unlikely to be effective against the BA.2 subvariant."
"We will continue to monitor BA.2 in all U.S. regions and may revise the authorization further to ensure that patients with COVID-19 have effective treatments available. Healthcare providers should also monitor the frequency of BA.2 in their region as they choose appropriate treatment options for patients."
The CDC estimates the omicron subvariant accounted for about 35 percent of U.S. cases for the week ending March 25.