U.S. FDA Authorizes AstraZeneca’s COVID-19 Antibody Treatment for Emergency Use for Immunocompromised

The United States Food and Drug Administration (FDA) authorized on Dec. 8 the first drug for widespread use in preventing COVID-19 for people with weakened immune systems.

The FDA issued an emergency use authorization for AstraZeneca’s Evusheld, its “long-acting” COVID-19 antibody treatment, for people aged 12 years and older who are moderately and severely immunocompromised before they have been exposed to the virus disease.

The FDA said that Evusheld, administered as injections, may be effective at preventing COVID-19 for six months.

According to AstraZeneca, a clinical trial showed that Evusheld was about 83% effective at preventing symptomatic COVID-19 during the six-month interval.

It is unclear how the new Omicron variant might affect the efficacy of Evusheld as studies are still underway.

“We are working quickly to establish its efficacy against the new Omicron variant,” AstraZeneca Executive Vice President Mene Pangalos said in a statement.

AstraZeneca said the first doses of Evusheld are expected to become available “very soon.”

FDA also noted that Evusheld is not a substitute for vaccination for those who are recommended to take the vaccine.

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