By Landon Gray
The FDA limited the emergency use authorization for sotrovimab in parts of the United States, because the authorized dose is unlikely to be effective against BA. 2, a new subvariant of omicron, which causes COVID-19.
The agency reversed the authorization for sotrovimab (GSK) in the following states and U.S. territories:
- Connecticut
- Maine
- Massachusetts
- New Hampshire
- New Jersey
- New York
- Puerto Rico
- Rhode Island
- Vermont
- Virgin Islands
Data from the CDC’s Nowcast show that the BA. 2 subvariant now accounts for an estimated 54.9% of cases in the states and territories listed above. Nationally, it constitutes 34.9% of cases.
However, the FDA reports several alternative therapies that are expected to be effective against the BA. 2 subvariant—nirmatrelvir, (Paxlovid, Pfizer); remdesivir (Veklury, Gilead), bebtelovimab (AbCellera/Eli Lilly) and molnupiravir (Lagevrio, Merck). These treatments have already been authorized or approved to treat certain patients with mild to moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.
The FDA recommends that health care providers assess whether these treatments are right for their patients.
—From FDA press materials
