New preclinical authentic ‘live’ virus data from Washington University School of Medicine demonstrated that AZD7442 (tixagevimab co-packaged with cilgavimab) retains potent neutralising activity against the emerging and highly transmissible Omicron SARS-CoV-2 BA.2 subvariant.1 The data also showed that AZD7442 retains activity against Omicron BA.1 and BA.1.1.1
In addition, in vivo (live organism) data generated using mice infected with Omicron BA.1, BA.1.1 and BA.2 demonstrated that AZD7442 significantly reduced the viral burden and limited inflammation in the lungs for all three subvariants.1 SARS-CoV-2 viral load is associated with increased disease severity and mortality as well as post-COVID conditions (long COVID).2,3
The study used a transgenic mouse model to evaluate AZD7442 in pre-exposure prophylaxis (prevention) of COVID-19, similar to how AZD7442 is used in the clinic. These are the first in vivo data evaluating efficacy of AZD7442 against the Omicron variants versus previous in vitro neutralising activity assays in cultured cells.
The Washington University findings were reported online on bioRxiv, a preprint server.
Michael S. Diamond, MD, PhD, The Herbert S. Gasser Professor, Departments of Medicine, Molecular Microbiology, Pathology & Immunology, Washington University, US, said: “These new in vivo mouse model data confirm previous in vitro neutralisation activity results for AZD7442 against Omicron. The findings demonstrate that AZD7442 was effective at protecting against infection in the lungs, a critical disease site for severe COVID-19, across all Omicron subvariants tested.”
John Perez, Senior Vice President, Head of Late Development, Vaccines & Immune Therapies, AstraZeneca, said: “These important data show that AZD7442 reduced viral burden and limited inflammation caused by Omicron. The findings further support AZD7442 as a potential important option to help protect vulnerable patients such as the immunocompromised who could face poor outcomes if they were to become infected with COVID-19.”
Additional ‘live’ virus data from Aix-Marseilles University and pseudovirus data from the US Food and Drug Administration also demonstrated that AZD7442 neutralises BA.2.4,5 According to the World Health Organization, cases of BA.2 have been identified in 85 countries to date, with prevalence increasing in several parts of the world.6
AZD7442 is authorised for pre-exposure prophylaxis (prevention) of COVID-19 in the US and several other countries. AZD7442 is intended for vulnerable populations who have a medical condition or are receiving immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. AZD7442 is not yet approved in the Philippines.