Covaxin Approved For Phase II-III Trials In 2-18 Years Age Group, Says Niti Aayog Member

Mumbai: NITI Aayog member (health) Dr VK Paul said on Tuesday that Bharat Biotech is set to begin the second and third phase clinical trials for Covaxin in children aged 2 to 18 years in the next 10–12 days.

“Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days,” Paul said during a press conference.

India’s drug regulator has accepted the recommendation of the Subject Expert Committee (SEC) and given a nod to the Hyderabad-based Bharat Biotech to conduct Phase II/III clinical trial of Covid-19 vaccine Covaxin in the age group 2 to 18 years.

This is the first time in India the COVID-19 vaccine will be tested on children.

Clinical trials include two COVID-19 vaccine shots that have been injected on day 0 and day 28.

The tests will take place at several sites including AIIMS, Delhi, AIIMS, Patna and the Meditrina Institute of Medical Sciences, Nagpur.

Covaxin maker Bharat Biotech had proposed to carry out a Phase-II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted on 525 healthy volunteers.

India’s move to conduct clinical trials for determining the vaccine’s efficacy in children comes on the heels of the US and Canada approving the Pfizer-BioNTech jab for ages 12-15.

The US rolled out a vaccination drive for children aged 12-15 on May 14, and Canada had approved the Pfizer shots for the same age group on May 5. The European Medical Agency is also evaluating the use of Pfizer vaccines in children.

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