Long-Acting Pre-Exposure Antibody Treatment Maintains Neutralizing Activity Against Omicron – Precision Vaccinations
Delaware-based AstraZeneca today announced that EVUSHELD, a long-acting antibody combination to prevent COVID-19, has retained neutralizing activity against the Omicron SARS-CoV-2 variant.
According to news preclinical data, the inhibitory concentration 50 (IC50) of EVUSHELD, a measure of the neutralizing power 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 a person who has previously been infected with COVID-19[FEMININE[FEMININE
The EVUSHELD 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 first data, generated by the full Omicron variant peak pseudovirus testing against the combination of tixagevimab and cilgavimab, the antibodies that make up EVUSHELD, add to the growing body of preclinical evidence demonstrating that EVUSHELD retains its activity against all variants tested of concern to date.
EVUSHELD received Emergency Use Clearance (EUA) in the United States in December 2021 for pre-exposure prophylaxis (prevention) of COVID-19 in people with moderate to severe immunosuppression due to a medical condition or immunosuppressive drugs and who may not mount an immune response to COVID-19 vaccination, as well as people for whom COVID-19 vaccination is not recommended.
The study was performed independently by researchers from the United States Food and Drug Administration (FDA), Center for Biologics Evaluation and Research.
Led Pangalos, EVP BioPharmaceuticals R&D, AstraZeneca, said in a press release issued on December 16, 2021, “This study shows that EVUSHELD retains neutralizing activity against the Omicron variant.”
“By combining two potent antibodies with different and complementary activities against the virus, EVUSHELD was designed to escape potential resistance with the emergence of new variants of SARS-CoV-2.”
“EVUSHELD is the first long-acting antibody to receive emergency use authorization in the United States 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 COVID-19 treatment[FEMININE”[FEMININE”
The Omicron variant (B.1.1.529) was not in circulation during the clinical trials of EVUSHELD. The Company continues to collect additional data to better understand the implications of this observation for clinical practice.
Further analysis to evaluate EVUSHELD against the Omicron variant is underway by AstraZeneca and third party laboratories, with data expected very soon.
About 2% of the world’s population is considered to be at increased risk of an inadequate response to a COVID-19 vaccine.
New evidence indicates that protecting vulnerable populations from COVID-19 could help prevent viral progression, a critical factor in the emergence of viral variants.
In addition, the EVUSHELD TACKLE phase III outpatient treatment trial was shown to reduce the risk of developing severe COVID-19 or death (from any cause) by 50% compared to placebo in patients without hospitalized 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 received EUA from the FDA. However, the clinical data available are limited and serious and unexpected adverse events not previously reported with the use of EVUSHELD may occur.
EVUSHELD is contraindicated in people who have had previous severe hypersensitivity reactions, including anaphylaxis, to any of the ingredients of EVUSHELD.
Note: U.S. government research funds supported the work.