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On the heels of the US regulatory authority’s emergency approval for AstraZeneca’s long-acting antibody combination Evusheld as a preventive in select people, including those who cannot take a Covid-19 vaccine, regulatory steps have been taken in India as well, company officials said.
Gagandeep Singh Bedi, Managing Director, AstraZeneca India Pharma Limited, said the US Food and Drug Administration’s emergency use authorisation (EUA) of AZD7442 (Evusheld) was an important milestone and the company had “initiated engagements with the relevant health authorities in India to provide them with the latest evidence”.
The USFDA had given an EUA for Evusheld (tixagevimab co-packaged with cilgavimab) long-acting antibody combination for “pre-exposure prophylaxis (prevention)” of Covid-19 in adults and adolescents (aged 12 and older, weighing 40 kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to Covid-19 vaccination, as well as individuals for whom Covid-19 vaccination is not recommended, AZ said.
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Myron J Levin, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the PROVENTtrial, said: “Millions of people in the US and around the world remain at serious risk for Covid-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine.”
Mene Pangalos, AZ Executive Vice-President, BioPharmaceuticals R&D, said that the company’s antibody therapy was the first authorised in the US to prevent Covid-19 symptoms before virus exposure, while also providing long-lasting protection with a single dose.
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“Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant.”
About 2 per cent of the global population is considered at increased risk of an inadequate response to a Covid-19 vaccine. In India, this percentage could be a bit higher given the problem of underdiagnosis and ignorance, an AZ note said. This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.
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