India’s indigenous Covid-19 vaccine, approved for phase 2/3 clinical trial on children

India's indigenous Covid-19 vaccine, Covaxin, manufactured by Bharat Biotech, has been approved by the government's panel of experts for phase 2/3 clinical trial on children aged 2-18, official sources said today.

The trial will take place on 525 participants at various sites across India, including New Delhi, Patna and Nagpur, our New Delhi correspondent reports.

The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday is understood to have given the approval after deliberating on Hyderabad-based Bharat Biotech's application seeking permission to conduct phase 2/3 clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.

"After detailed deliberation, the committee recommended the conduct of proposed phase II/III clinical trial of 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 II clinical trial to the CDSCO before proceeding to phase III part of the study," the sources said.

Covaxin, developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR), is being used in adults in India's ongoing Covid-19 vaccination drive that began on January 16.

Some Indian epidemiologists have already warned that children below 18 years would be at risk in a possible third wave of Covid-19 which may hit the country between October and December this year.

Meanwhile, the US on Tuesday said it is looking at joint production of Johnson and Johnson's Covid-19 vaccine in India and ways to help manufacturers like Serum Institute of India (SII) to boost production.