DCGI approves Phase 2, 3 clinical trial of Covaxin for 2 to 18 years
New Delhi, May 13: In a move to expand the COVID-19 vaccination drive, The Drugs Controller General of India (DCGI) has approved Bharat Biotech's Covaxin trials on children from two to 18 years on Thursday.
The company said its phase II and III trials would be carried out on "525 healthy volunteers".
The trial will involve two vaccine doses injected on Day 1 and Day 28. This is the first time in India that a COVID vaccine will be tested on children.
According to a government statement, the drug regulator accepted the recommendation of an expert committee on vaccines after careful thought.
The trials are to take place at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
The DCGI's approval came a day after the subject expert committee on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) recommended the government to approve Covaxin for phase 2 and phase 3 trials on children aged between 2 to 18 years.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive. It is one of the two vaccines being manufactured in India at present.