The clinical trials will be conducted to evaluate Covaxin’s safety and efficacy on a population group left out of India’s current COVID-19 immunisation programme
Bharat Biotech Intl Ltd will begin a new clinical trial of Covaxin on children and young adults. The Central Drugs Standard Control Organisation (CDSCO) has allowed the phase 2/3 trials of India’s indigenous vaccine on children aged between 2-18.
The clinical trials will be conducted to evaluate Covaxin’s safety and efficacy on a population group left out of India’s current COVID-19 immunisation programme. Some 525 subjects from Delhi, Patna and Nagpur will be selected for these trials.
AIIMS, Delhi; AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur will be part of these trials. On February 24, 2021, an expert committee had studied Bharat Biotech’s proposal and asked it to revise its clinical trial protocol.
Covaxin has been developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology. It is an inactivated vaccine, with an efficacy rate of 81 per cent. Bharat Biotech plans to make 700 million doses Covaxin a year.
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