January 28, 2023 – The U.S. Food and Drug Administration has revoked emergency use authorization for the COVID-19 antibody drug Evusheld since the drug shouldn’t be effective against the omicron variants currently prevalent within the country.
Evusheld is designed to forestall COVID infection in individuals with weakened immune systems. The FDA approved the drug in December 2021, before omicron variants equivalent to XBB and XBB.1.5 got here into circulation.
These and another omicron variants at the moment are accountable for greater than 90% of current COVID infections within the United States, the FDA said in a Press release.
“Like other viruses, SARS-CoV-2 can mutate over time, causing certain products to be ineffective against certain variants,” the FDA said. “This is the case with Evusheld and prompted the changes to the approval that FDA is making today.”
However, individuals and facilities with stocks of Evusheld shouldn’t throw away the drug, because the old variants could re-emerge, the press release said.
Evusheld should help individuals who have received organ or other transplants, in addition to individuals who have cancer or are taking immunosuppressive drugs for diseases equivalent to rheumatoid arthritis.
AstraZeneca, the manufacturer of Evusheld, said in a statement that it’s working on a “next-generation, long-acting antibody” to forestall Covid-19 in immunocompromised people.
Other antibody therapies equivalent to Bebtelovimab have also lost their approval because they aren’t effective against the currently dominant variants.
Since Evusheld is not any longer an option, the CDC updated information for immunocompromised people on Friday.
In addition to keeping their vaccinations up up to now, these people should wear high-quality and well-fitting masks, maintain social distancing, improve ventilation indoors, and wash their hands continuously. Immunocompromised people must also develop a “care plan” that features immediate testing in the event that they consider they’ve been exposed to COVID.