AstraZeneca’s Covid Antibody Treatment Gets FDA Clearance for the Immunocompromised

This week the Food and Drug Administration (FDA) has given the green light to AstraZeneca’s Covid antibody treatment for immunocompromised individuals.

The FDA has authorized the first injectable monoclonal antibody cocktail for long-term prevention of Covid-19 among people with weakened immune systems before they have been exposed to the coronavirus.

Emergency use authorization was issued by the agency on Wednesday for Evusheld, for what is known as pre-exposure prophylaxis, or PrEP, against Covid-19.
These kind of laboratory-produced antibodies have so far been authorized only as early treatment of Covid-19 or as preventive therapy for high-risk people immediately after close contact with someone who has tested positive.

AstraZeneca’s Evusheld can be used as PrEP by people ages 12 and older who are moderately to severely immunocompromised and may not get adequate immune responses from a Covid vaccine.
The company’s therapy is also an option for the rare people who have histories of severe adverse reactions to a Covid vaccine or its components.

The AstraZeneca therapy involves getting preventive injections as often as every six months.

A large placebo-controlled clinical trial had revealed that the cocktail is about 83 percent effective at preventing symptomatic disease during such an interval.

It’s unclear how the highly mutated omicron variant of the coronavirus may affect the efficacy of the monoclonal antibody therapy.

AstraZeneca’s scientists are testing Evusheld against the new variant, said Ruud Dobber, an executive vice president and president of the company’s BioPharmaceuticals Business Unit.

Data are expected in the coming weeks, Dobber said in a statement.

“This new FDA authorization is a very important development for those with immunosuppression,” said Dr. Alfred Kim, a rheumatologist at Washington University in St. Louis.

Evusheld as PrEP, he said, “provides a healthy load of antibodies for the 40 percent to 80 percent of the immunosuppressed who have very poor antibody responses following SARS-CoV-2 vaccination.”

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.