FDA recalls Evusheld because it is not effective against sub-options
Evusheld (tixagevimab and cilgavimab) is a new COVID-19 drug that people can take before symptoms appear. (Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images)
Chris Sveda | Tribune News Service | Getty Images
The Food and Drug Administration on Thursday withdrew its approval for AstraZenecaEvusheld, an antibody injection that people with weak immune systems relied on for extra protection against Covid-19.
The FDA has taken Evushheld off the market because it is not effective against more than 90% of the Covid sub-variants currently circulating in the US.
A sub-variant of omicron XBB.1.5 that can evade infection-blocking antibodies is growing rapidly in the US and currently causes 49% of new cases, according to Data from the Centers for Disease Control and Prevention.
Evusheld is also not effective against sub-variants BQ.1, BQ.1.1 and XBB. Combined with XBB.1.5, Evusheld-resistant versions of Covid now account for almost 93% of new cases in the US.
“Today’s action to limit Evucheld’s use prevents patients from being exposed to the possible side effects of Evusheld, such as allergic reactions, which can be potentially serious, while less than 10% of the infection-causing variants circulating in the US are sensitive to the product. “, the FDA said in a statement on Thursday.
People with weakened immune systems, such as cancer chemotherapy and organ transplant patients, are among the groups most vulnerable to severe illness from Covid. Many people take Evusheld as an extra layer of protection because vaccines don’t elicit a strong immune response.
The decision to withdraw Evusheld comes more than a month after the FDA withdrew an antibody treatment called bebtelovimab because it was not effective against sub-options BQ.1 and BQ.1.1.
Evusheld is taken as a preventive measure before exposure to Covid. It is a combination of antibodies, cilgavimab and tixagevimab, given as two injections every six months.
Just over a million doses of Evusheld have been distributed in the US since the FDA approved injections in December 2021, according to the Department of Health and Human Services. About 720,000 of these doses were actually administered to patients.
More than 7 million adults in the US have a weakened immune system. They account for about 12% of Covid hospitalizations despite only making up 3% of the population. according to CDC study who looked at data from 10 states.
There is currently no replacement for Evusheld. Dr. Ashish Jha, head of the White House task force on Covid, has accused Congress of cutting back on treatments. He said lawmakers’ refusal to allocate additional Covid funding means there is no money to invest in new antibodies.
“Our hope was that over time, as the pandemic evolved, as our fight against this virus continued, we would expand our first aid kit,” Jha told reporters in October. “Due to a lack of Congressional funding, this first aid kit has actually dwindled and this is putting vulnerable people at risk.”
President Joe Biden advised people with weakened immune systems to consult a doctor.
“The new options could render some existing protections ineffective for immunocompromised people,” the president said in October. “Unfortunately, this means you may be at particular risk this winter. I urge you to consult with your doctors about the right steps to take to protect yourself and take extra precautions.”