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Pre-Exposure, Long-Acting Antibody Treatment Retains Neutralizing Activity Against Omicron

December 16, 2021 • 12:08 pm CST
(Precision Vaccinations News)

Delaware-based AstraZeneca today announced EVUSHELD, a long-acting antibody combination to prevent COVID-19, retained neutralizing activity against the Omicron SARS-CoV-2 variant.

According to new preclinical data, EVUSHELD's Inhibitory Concentration 50 (IC50), a measure of neutralizing potency of an antibody, was 171 ng/ml and 277 ng/ml in two confirmatory tests, which is within the range of neutralizing titers found in someone who has been previously infected with COVID-19.

EVUSHELD's IC50 for the original strain of SARS-CoV-2, previously referred to as the Wuhan strain, was approximately 1.3 ng/ml and 1.5 ng/ml, respectively.

The early data, generated by pseudovirus testing of the full Omicron variant spike against the combination of tixagevimab with cilgavimab, the antibodies that comprise EVUSHELD, add to the growing body of preclinical evidence demonstrating that EVUSHELD retains activity against all tested variants of concern to date.

EVUSHELD received Emergency Use Authorization (EUA) in the U.S. in December 2021 for pre-exposure prophylaxis (prevention) of COVID-19 in people with moderate to severe immune-compromised due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended.

The study was performed independently by investigators at the U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research.

Mene Pangalos, EVP BioPharmaceuticals R&D, AstraZeneca, said in a press release issued on December 16, 2021, "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 U.S. 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 (B.1.1.529) was not in circulation during the EVUSHELD clinical trials. The Company continues 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, with data anticipated very soon.

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.

Emerging evidence indicates that protecting vulnerable populations from getting COVID-19 could help prevent viral evolution, an essential factor in the emergence of virus variants.

Additionally, 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.

EVUSHELD (tixagevimab co-packaged with cilgavimab) has not been approved but has been granted a EUA by the FDA. However, there are limited clinical data available, and serious and unexpected adverse events that have not been previously reported with EVUSHELD use may occur.

EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of EVUSHELD.

Note: U.S. government research funds supported the work.

Medical Review by

Our Trust Standards: Medical Advisory Committee

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