Evusheld (tixagevimab and cilgavimab) injection, a recent COVID-19 treatment that folks 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 pulled its authorization for AstraZeneca‘s Evusheld, an antibody injection that folks with weak immune systems relied on for extra protection against Covid-19.
The FDA pulled Evusheld from the market since it just isn’t effective against greater than 90% of the Covid subvariants which might be currently circulating within the U.S.
The omicron XBB.1.5 subvariant, which is adept at evading antibodies that block infection, has quickly risen within the U.S. and is now causing 49% of latest cases, based on data from the Centers for Disease Control and Prevention.
Evusheld can also be not effective against the BQ.1, BQ.1.1 and XBB subvariants. Taken along with XBB.1.5, versions of Covid which might be proof against Evusheld now represent nearly 93% of latest cases within the U.S.
“Today’s motion to limit using Evusheld prevents exposing patients to possible unwanted side effects of Evusheld akin to allergic reactions, which could be potentially serious, at a time when fewer than 10% of circulating variants within the U.S. causing infection are at risk of the product,” the FDA said in an announcement Thursday.
Individuals with compromised immune systems, akin to cancer chemotherapy and organ-transplant patients, are among the groups most vulnerable to severe disease from Covid. Many take Evusheld as an extra layer of protection since the vaccines don’t trigger a powerful immune response for them.
The choice to drag Evusheld comes greater than a month after the FDA withdrew an antibody treatment called bebtelovimab since it was not effective against the BQ.1 and BQ.1.1 subvariants.
Evusheld is taken as a safety measure before exposure to Covid. It’s a mixture of antibodies, cilgavimab and tixagevimab, taken as two injections every six months.
Just over a million doses of Evusheld have been distributed within the U.S. because the FDA authorized the injections in December 2021, based on data from the Health and Human Services Department. About 720,000 of those doses have actually been administered to patients.
Greater than 7 million adults within the U.S. have a compromised immune system. They represented about 12% of Covid hospitalizations, despite making up just 3% of the population, based on a study from the CDC that checked out data from 10 states.
There’s currently no substitute for Evusheld. Dr. Ashish Jha, head of the White House Covid task force, has blamed Congress for the dwindling variety of treatments. He said lawmakers’ failure to pass additional Covid funding means there is not money to take a position in recent antibodies.
“We had hoped that over time because the pandemic went along, as our fight against this virus went along, we could be expanding our drugs cabinet,” Jha told reporters in October. “Due to lack of congressional funding, that medicine cabinet has actually shrunk and that does put vulnerable people in danger.”
President Joe Biden told individuals with compromised immune systems to seek the advice of with a health care provider.
“Latest variants may make some existing protections ineffective for the immunocompromised,” the president said in October. “Sadly, this implies you might be at a special risk this winter. I urge you to seek the advice of your doctors on the proper steps to guard yourself, take extra precautions.”