India, May 13: The Drugs Controller General of India (DCGI) cleared Bharat Biotech’s Covaxin trials on children from two to 18 years on Thursday (May 13). Bharat Biotech 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 expected 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.
“After detailed deliberation, the committee recommended for the conduct of proposed phase II/III 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 II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study,” an official said.