On the heels of the US regulatory authority giving emergency approval to AstraZeneca’s long-acting antibody combination Evusheld as a preventive in select people, including those who cannot take a Covid vaccine, regulatory steps have been initiated in India as well, said company officials.
Gagandeep Singh Bedi, Managing Director with AstraZeneca India Pharma Ltd, said the US Food and Drug Administration’s emergency-use authorisation of AZD7442 (Evusheld) for the prevention of Covid was an important milestone, and the company had already “initiated engagements with the relevant health authorities in India to provide them with the latest evidence”.
USFDA gives EUA
The USFDA had given an EUA to AZ’s Evusheld (tixagevimab co-packaged with cilgavimab) long-acting antibody combination for “pre-exposure prophylaxis (prevention)” of Covid in adults and adolescents (aged 12 and older who weigh 40kg or more), with moderate to severe immune compromise due to a medical condition or immunosuppressive medications, and those who may not mount an adequate immune response to Covid vaccination, as well as those individuals for whom vaccination is not recommended, said AZ.
Myron J Levin, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the PROVENT trial, said: “Millions of people in the US and around the world remain at serious risk for Covid 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, added their antibody therapy was the first authorised in the US to prevent Covid symptoms before virus exposure, while also providing long-lasting protection with a single dose. “Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” he said.
About 2 per cent of the global population is considered at increased risk of an inadequate response to avaccine. In India, this percentage could be higher, given the problem of underdiagnosis and ignorance, said AZ. This population included people with cancer and on chemotherapy, and those taking medications after an organ transplant, or who are taking immunosuppressive drugs for conditions that include multiple sclerosis and rheumatoid arthritis.
Published on December 9, 2021
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