For the first time in India, the Covid19 vaccine will be tested on children. The Drugs Controller General of India has approved Phase two and three clinical trials of Covaxin for the
two-18 age group.
The expert panel suggested the phase two and three trials which now will be carried out on 525 healthy volunteers. The trails will take place at various sites, including AIIMS Delhi, AIIMS Patna, and Meditrina Institute of Medical Sciences, Nagpur.
On May 12, the Subject Expert Committee on Covid19 deliberated Bharat Biotech’s application seeking permission to conduct phase II and III clinical trials to “evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs” in children of age group 2-18 years. The committee has put up a condition that Bharat Biotech has to submit the interim safety data of phase two clinical trials before proceeding to phase three.
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According to sources, “After deliberation, the committee recommended for the conduct of proposed phase two/three clinical trial of the whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase two clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase three part of the study.”
Earlier, On February 24 the proposal was deliberated in the SEC meeting and the firm was asked to submit a revised clinical trial protocol.
Covaxin, indigenously developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology, is pitched as the only made-in-India coronavirus vaccine. Another vaccine used in adults in India’s ongoing Covid19 vaccination drive is Oxford-Astra Zeneca’s Covishield produced by Serum Institute.
Earlier, Bharat Biotech had said that it was disheartened to listen that several stated are complaining about their intentions regarding Covaxin supply. Joint Managing Director Suchitra Ella had tweeted, “18 states have been covered though in smaller shipments. Quite disheartening to the team to hear some states complaining about our intentions. 50 of our employees are off work due to Covid, yet we continue to work under pandemic lockdowns 24*7 for you..”