An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.
Mike Segar | Reuters
A key monoclonal antibody used to treat people with weak immune systems who catch Covid is no longer authorized for use in the U.S. because it is not effective against emerging omicron subvariants.
The FDA, in a notice Wednesday, said bebtelovimab is not approved for use because it is not expected to neutralize the omicron BQ.1 and BQ.1.1 subvariants. They are causing 57% of new infections nationally and make up a majority of cases in every U.S. region except one.
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The Health and Human Services Department is putting on hold pending requests for bebtelovimab, and the manufacturer Eli Lilliy has also halted commercial distribution of the antibody treatment until further notice, according to the FDA notice.
But bebtelovimab stocks should be kept on hand in the event that Covid variants which the antibody can neutralize become dominant again in the future, according to FDA.
Bebtelovimab is a single-dose injection administered to people who catch Covid and are at high risk of developing severe disease, but cannot take any other FDA-approved treatments such as the oral antiviral Paxlovid. Many people with weak immune systems, such as organ transplant patients, cannot take Paxlovid with other medications they need.
U.S. health officials have warned that people with weak immune systems face a heightened risk from Covid this winter, because more immune evasive omicron subvariants threaten to knock out antibody treatments they rely on to stay safe from Covid.
Dr. Ashish Jha, the White House Covid coordinator, said in October that the failure of Congress to pass additional Covid funding means treatments will dwindle as new variants render them ineffective.
“We had hoped that over time as the pandemic went along, as our fight against this virus went along, we would be expanding our medicine cabinet,” Jha told reporters. “Because of lack of congressional funding that medicine cabinet has actually shrunk and that does put vulnerable people at risk.”
President Joe Biden has called on people with weak immune systems to consult with their physicians about what extra precautions they should take this winter to stay safe.