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FDA withdraws Evusheld due to ineffectiveness against subvariants

Evusheld (tixagevimab and cilgavimab) injections are new COVID-19 treatments that can be taken before symptoms appear. (Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images)

Chris Sweda | Tribune News Service | Getty Images

The Food and Drug Administration withdrew its license on Thursday AstraZenecaEvusheld is an antibody injection that people with weakened immune systems rely on for extra protection against Covid-19.

The FDA has withdrawn Evusheld from the market because it is ineffective against over 90% of the Covid variants currently prevalent in the United States.

Adept at evading infection-blocking antibodies, the omicron XBB.1.5 variant has surged in the United States and is now responsible for 49% of new cases. Data from the Centers for Disease Control and Prevention.

Evusheld is also ineffective against BQ.1, BQ.1.1 and XBB subvariants. Combined with XBB.1.5, Evusheld’s resistant version of his Covid now accounts for almost 93% of new cases in the US.

“Today’s action to limit the use of Evusheld will prevent potentially serious allergic reactions and other diseases at a time when less than 10% of the circulating variants causing infections in the United States are susceptible to the product. It prevents exposing patients to Evusheld’s potential side effects,” the FDA said in a statement Thursday.

People with compromised immune systems, such as cancer chemotherapy and organ transplant patients, are some of the groups most vulnerable to severe illness from COVID-19. Because the vaccine does not elicit a strong immune response, many people take Ebsheld as an extra layer of protection.

A decision to withdraw Evusheld will be made more than a month after the FDA. stopped an antibody treatment called bebuterobimab because it had no effect on BQ.1 and BQ.1.1 subvariants.

Evusheld is used as a preventive measure before exposure to Covid. It is a combination of silgavimab and tixagevimab antibodies, given as two injections every six months.

More than one million doses of Evusheld have been distributed in the United States since the FDA approved the injection in December 2021, according to Department of Health and Human Services data. About 720,000 of these doses were actually administered to patients.

More than 7 million adults in the United States have a compromised immune system. Despite making up just 3% of the population, they accounted for about 12% of Covid hospitalizations. According to a CDC study We looked at data for 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 drop in treatment numbers. said that it means that there is no

“As the pandemic progressed and the fight against this virus progressed, we hoped to expand our medicine cabinet,” Jha told reporters in October. , whose cabinet is actually being downsized, putting vulnerable people at risk.”

president Joe Biden I told anyone with a compromised immune system to consult a doctor.

new variant “Some of the existing precautions may be ineffective for people with weakened immune systems,” the president said in October. We strongly recommend that you consult your doctor about the correct steps to take to protect yourself and take extra precautions. ”

https://www.cnbc.com/2023/01/27/covid-fda-pulls-evusheld-because-its-not-effective-against-subvariants.html FDA withdraws Evusheld due to ineffectiveness against subvariants

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