Evusheld injection (tixagevimab and cilgavimab), a new COVID-19 treatment that people can take before they become symptomatic. (Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images)
Chris Sweda | Tribune News Service | Getty Images
The Food and Drug Administration withdrew its approval for Thursday AstraZeneca‘s Evusheld, an antibody injection that people with weak immune systems rely on as extra protection against Covid-19.
The FDA pulled Evusheld from the market because it is not effective against more than 90% of the Covid subvariants currently circulating in the US
The subvariant omicron XBB.1.5, which can evade infection-blocking antibodies, has been growing rapidly in the US and now accounts for 49% of new cases, according to data from the Centers for Disease Control and Prevention.
Evusheld is also not effective against the BQ.1, BQ.1.1, and XBB subvariants. Along with XBB.1.5, versions of Covid resistant to Evusheld now account for almost 93% of new cases in the US
“Today’s action to restrict the use of Evusheld prevents patients from being exposed to possible side effects of Evusheld, such as allergic reactions, which can be potentially serious, while less than 10% of the variants circulating in the US that cause infections are susceptible to the product are,” the FDA said in a statement Thursday.
People with weakened immune systems, such as cancer chemotherapy and organ transplant patients, are among the groups most vulnerable to serious illness from Covid. Many take Evusheld as an added layer of protection because the vaccines do not elicit a strong immune response.
The decision to stop Evusheld comes more than a month after the FDA withdrew an antibody treatment called bebtelovimab because it was not effective against subvariants BQ.1 and BQ.1.1.
Evusheld is taken as a preventive measure before exposure to Covid. It’s a combination of antibodies, cilgavimab, and tixagevimab given as two injections every six months.
According to data from the Department of Health and Human Services, just over a million doses of Evusheld have been distributed in the United States since the FDA approved the injections in December 2021. About 720,000 of these doses were actually administered to patients.
More than 7 million adults in the US have a compromised immune system. They made up about 12% of Covid hospital admissions, despite making up just 3% of the population, according to a study by the CDC examining data from 10 states.
There is currently no replacement for Evusheld. dr Ashish Jha, head of the White House Covid task force, has blamed Congress for the dwindling number of treatments. He said lawmakers’ failure to pass additional Covid funds meant there was no money to invest in new antibodies.
“We had hoped that as time went on as the pandemic progressed and as our fight against this virus progressed, we would expand our medicine cabinet,” Jha told reporters in October. “Due to a lack of congressional funding, this medicine cabinet has actually shrunk and that is putting vulnerable people at risk.”
President Joe Biden urged people with compromised immune systems to see a doctor.
“New variants may render some existing protections for immunocompromised people ineffective,” the president said in October. “Unfortunately, that means you may be at particular risk this winter. I urge you to consult with your doctors on the right steps to protect yourself and take extra precautions.”
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