New Delhi: The Drugs Controller General of India (DCGI) cleared Covaxin trials on children from two to 18 years on Thursday. This is the first time in India that a COVID-19 vaccine will be tested on children.
Covaxin maker Bharat Biotech said its phase 2 and 3 trials would be carried out on 525 healthy volunteers.
According to a government statement, the drug regulator accepted the recommendation of an expert committee on vaccines after careful thought.
The trial involves two vaccine doses injected at day 0 and day 28.
The trials are to take place at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
Earlier on Tuesday, the Subject Expert Committee (SEC) on COVID-19 had discussed Bharat Biotech’s application seeking permission to conduct phase 2 and 3 trials “to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years”, NDTV reported.