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India Covid: Regulator nod for Phase 2, 3 clinical trials of Covaxin on 2-18-year-olds
New Delhi - The trial involves two doses injected on days 0 and 28.
The Drugs Controller General of India (DCGI) on Thursday cleared Covaxin trials on those between two and 18 years, the first time such vaccines will be tested on children.
The DGCI accepted the recommendations of an expert committee on vaccines. The trial involves two doses injected on days 0 and 28 and will take place at the All India Institutes of Medical Science in Delhi and Patna and Meditrina Institute of Medical Sciences, Nagpur, among others.
Bharat Biotech along with the Indian Council of Medical Research and the National Institute of Virology is only Indian Covid shot maker. The company said its second and third phase trials will be done on 525 healthy volunteers.
The company and the Indian Council of Medical Research recently claimed that Covaxin had proved to be 78 per cent effective against Covid and had worked against most variants of the virus. It was also 100 per cent effective in preventing severe symptoms and hospitalization.
A government committee on Covid-19 earlier this week discussed Bharat Biotech’s application for conducting phase two and three trials to evaluate “the safety, reactogenicity and immunogenicity” of the jabs in children aged between two and 18.
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