February 8, 2023

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The FDA is recalling the bebtelovimab antibody because it is not effective against omicron BQ.1

The FDA is recalling the bebtelovimab antibody because it is not effective against omicron BQ.1

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Eli Lilly and Company’s pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.

Mike Cigar | Reuters

The monoclonal antibody used to treat people with compromised immune systems who develop Covid is no longer authorized for use in the United States because it is not effective against emerging sub-variants of Omicron.

Food and Drug Administration, On Wed’s noticeThe said bebtelovimab is not approved for use because it is not expected to inactivate the omicron BQ.1 and BQ.1.1 sub-variants. They cause 57% of new infections nationwide and make up the majority of cases in every US region but one.

The Department of Health and Human Services is suspending pending orders for bebtelovimab, and the manufacturer, Eli Lilliy, has halted commercial distribution of the antibody therapy until further notice, according to the FDA notice.

But stocks of bebtelovimab should be held in case Covid variants that the antibody can neutralize become dominant again in the future, according to the FDA.

Bebtelovimab is a single-dose injection given to people who develop Covid who are at high risk of severe disease, but who cannot take any other FDA-approved treatments such as the oral antiviral Paxlovid. Many people with weakened immune systems, such as transplant patients, cannot take Paxlofide with other medicines that they need.

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US health officials have warned that people with weakened immune systems face an increased risk of Covid this winter, as more immuno-evasive sub-variants of Omicron threaten to negate the antibody therapies they rely on to stay safe from Covid.

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Dr. Ashish Jha, the White House Covid coordinator, said in October that Congress’ failure to pass additional Covid funding means treatments will dwindle because new variants make them ineffective.

“We hoped that over time as the pandemic continues, as our fight against this virus continues, we will expand our medicine cabinet,” Jha told reporters. “Because of the lack of funding from Congress, the medicine cabinet is already shrinking and that puts vulnerable people at risk.”

President Joe Biden called on people with compromised immune systems to consult with their doctors about additional precautions they should take this winter to stay safe.