AstraZeneca has had its share of vaccine setbacks during the pandemic, but its preventative antibody is turning out to be an asset for people who can't otherwise get protection.
In a late-stage pre-exposure prevention trial, Evusheld slashed the risk of symptomatic COVID-19 after six months by 83% compared with placebo, AstraZeneca said.
The results follow data from a primary analysis released last summer. At that time, AZ said the drug cut the risk of symptomatic infection by 77% versus placebo. The primary analysis weighed outcomes after a median of 83 days.
Over the six-month stretch, no cases of severe disease or COVID-19 related deaths cropped up among Evusheld patients. That compared with five cases of serious COVID and two COVID-related deaths in the Provent placebo group, AZ said.
More than 75% of participants in AZ’s phase 3 Provent trial entered the study with underlying conditions that put them at high risk for severe COVID-19 if they were to become infected. The study population included immunocompromised individuals who may muster an inadequate response to a vaccine.
The drug was generally well-tolerated and no safety issues cropped up during either the primary or six-month analysis, the company said.
The data, published Wednesday in the New England Journal of Medicine, “add to the growing body of evidence supporting the use of Evusheld to help prevent symptomatic and severe COVID-19, especially for those individuals who can’t respond adequately to vaccination and need additional protection,” Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca, said in a release.
Last December, Evusheld won an emergency FDA nod to prevent COVID-19 before exposure to the virus. Specifically, the FDA authorized Evusheld for people with moderately to severely compromised immune systems, either because of a medical condition or from the use of immunosuppressive medications. People with a history of negative reactions to COVID-19 vaccines are also eligible to receive AZ’s antibody combo.
AstraZeneca says roughly 2% of the world’s population may muster a poor response to a COVID-19 vaccine. Those people make good candidates for prevention with Evusheld, the company reckons.
AstraZeneca has predicted that sales of its COVID vaccine will slide in 2022, but it expects those losses to be offset, in part, by Evusheld.
Earlier this year, the company sold an additional 1 million doses of its long-acting antibody combo to the U.S., building on an initial order for 700,000 doses that were already being administered nationwide as of February.