FDA withdraws Evusheld because it is not effective against subvariants

Injection of Evusheld (tixagevimab and cilgavimab), a new COVID-19 treatment that people can take before becoming symptomatic. (Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images)

Chris Sweda | Tribune News Service | Getty Images

The Food and Drug Administration on Thursday withdrew its approval for Astra Zeneca‘s Evusheld, an antibody injection that people with weakened immune systems relied on for extra protection against Covid-19.

The FDA has pulled Evusheld from the market because it is not effective against more than 90% of Covid subvariants currently circulating in the United States

The omicron XBB.1.5 subvariant, which is able to evade antibodies that block infection, has grown rapidly in the United States and now causes 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. Together with XBB.1.5, Evusheld-resistant versions of Covid now account for nearly 93% of new cases in the United States

«Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when less than 10% of variants circulating in the United States causing infection are susceptible to the product,” the FDA said in a statement Thursday.

People with weakened immune systems, such as cancer chemotherapy patients and organ transplant patients, are among the groups most vulnerable to severe Covid illness. Many take Evusheld as an extra layer of protection because vaccines don’t trigger a strong immune response for them.

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 the BQ.1 and BQ.1.1 subvariants.

Evusheld is taken as a preventive measure before exposure to Covid. It is a combination of antibodies, cilgavimab and tixagevimab, taken in two injections every six months.

Just over one million doses of Evusheld have been dispensed in the United States since the FDA cleared the injections in December 2021, according to data from the Department of Health and Human Services. About 720,000 of those doses were actually given to patients.

More than 7 million adults in the United States have weakened immune systems. They accounted for about 12% of Covid hospitalizations, despite making up just 3% of the population, according to a CDC study that looked at data from 10 states.

There is currently no replacement for Evusheld. Dr Ashish Jha, head of the White House Covid task force, blamed Congress for the dwindling number of treatments. He said lawmakers’ failure to pass additional Covid funding means there is no money to invest in new antibodies.

«We had hoped that over time, as the pandemic progressed, as we fought this virus, we would expand our medicine cabinet,» Jha told reporters in October. “Because of the lack of Congressional funding, that medicine cabinet has actually shrunk and that puts vulnerable people at risk.”

President Joe Biden has told people with weakened immune systems to seek medical attention.

“New variants may render some existing protections ineffective for the immunocompromised,” the president said in October. «Unfortunately this means you could be at particular risk this winter. I urge you to consult your doctors on the right steps to take to protect yourself, take extra precautions.»

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