Evusheld consists of two antibodies.
The data adds to the growing body of preclinical evidence demonstrating that Evusheld works activity against all tested variants of concern to date, according to an AstraZeneca release.
The study was performed independently by investigators at the U.S. Food and Drug Administration Center for Biologics Evaluation and Research. The work was supported by US government research funds.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “This study shows Evusheld retains neutralization activity against the Omicron variant. By combining two potent antibodies with different and complementary activities against the virus, Evusheld was designed to evade potential resistance with the emergence of new SARS-CoV-2 variants. Evusheld is the first long-acting antibody to receive emergency use authorization in the US for pre-exposure prophylaxis of Covid-19, in addition to authorizations in other countries, and we are working with regulators on applications for the use of Evusheld in treating Covid-19.”
The Omicron variant was not in circulation during the Evusheld clinical trials. The company is continuing to collect further data to better understand the implications of this observation in clinical practice. Additional analyses to evaluate Evusheld against the Omicron variant are being conducted by AstraZeneca and third-party laboratories.
Evusheld received Emergency Use Authorization (EUA) in the US this month for people who are immunocompromised, due to a medical condition or medications and who may not mount an adequate immune response to Covid-19 vaccination, as well as those individuals for whom vaccination is not recommended. The first doses are expected to become available within days.
About 2% of the global population is considered at increased risk of an inadequate response to a Covid-19 vaccine. In the U.S. alone, that amounts to 6.5 million people. Emerging evidence indicates that protecting vulnerable populations from getting Covid-19 could help prevent viral evolution that is an important factor in the emergence of variants.
The TACKLE Phase III outpatient treatment trial of Evusheld showed it reduced the risk of developing severe Covid-19 or death (from any cause) by 50% compared to placebo in non-hospitalized patients with mild to moderate Covid-19 who had been symptomatic for seven days or less.
AstraZeneca has 1,500 employees in Delaware. No cases of the Omicron varaint have been detected, although it is believed to already be in the state.