Evusheld injection (tixagevimab and cilgavimab), a latest COVID-19 treatment that folks can take before they develop symptoms. (Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images)
Chris Sweda | Tribune Information Service | Getty’s paintings
The Food and Drug Administration on Thursday withdrew the authorization AstraZenecaEvusheld, an antibody injection that folks with weak immune systems have relied on for extra protection against Covid-19.
The FDA has withdrawn Evusheld from the market because it is not effective against over 90% of the Covid subvariants currently circulating within the US
The XBB.1.5 omicron subvariant, which is adept at evading infection-blocking antibodies, has grown rapidly within the US and is now reported to account for 49% of recent cases data from the Centers for Disease Control and Prevention.
Evusheld is also not effective against BQ.1, BQ.1.1 and XBB sub-variants. Combined with XBB.1.5, versions of Covid which might be resistant to Evusheld now account for nearly 93% of recent cases within the U.S.
“Today’s efforts to limit the usage of Evusheld prevent patients from being exposed to possible negative effects of Evusheld, resembling allergic reactions, which will be potentially serious, at a time when lower than 10% of the variants circulating within the US causing infection are at risk of the product,” he said. the FDA in a Thursday statement.
Individuals with a compromised immune system, resembling cancer chemotherapy patients and organ transplant patients, are among the many groups most vulnerable to severe Covid-19 disease. Many individuals take Evusheld as an additional layer of protection because vaccines do not trigger a robust immune response in them.
The decision to recall Evusheld comes greater than a month after the FDA recalled an antibody treatment called bebtelowimab because it was not effective against the BQ.1 and BQ.1.1 subvariants.
Evusheld is used as a safety measure against Covid exposure. It is a mixture of antibodies, cilgavimab and tixagevimab, taken as two injections every six months.
Just over a million doses of Evusheld have been distributed in the USA for the reason that FDA approved the injections in December 2021, in line with data from the Department of Health and Human Services. About 720,000 of those doses have actually been administered to patients.
Over 7 million adults in the USA have a weakened immune system. They accounted for around 12% of Covid hospitalizations despite being only 3% of the population, in line with a study by the CDC which checked out data from 10 states.
There is currently no substitute for Evusheld. Dr. Ashish Jha, head of the White House Covid Task Force, blamed Congress for the dwindling variety of treatments. He said the failure of lawmakers to channel additional Covid funding meant there was no money to take a position in latest antibodies.
“We hoped to expand our first aid kit over time because the pandemic progressed and our fight against this virus,” Jha told reporters in October. “As a result of a scarcity of congressional funding, this primary aid kit has actually shrunk, putting vulnerable people in danger.”
President Joe Biden told those with weakened immune systems to seek the advice of a health care provider.
“The latest variants may render some existing protections ineffective for immunocompromised people,” the president said in October. “Unfortunately, this implies you might be at particular risk this winter. I encourage you to seek the advice of your doctor about the precise steps to guard yourself and take extra precautions.”