For the first time in the world, a Covid vaccine will be tested on children.
This has become possible after the Drugs Controller General of India approved Bharat Biotech’s double-dose Covexin trials on children in the age group of 2 to 18.
The doses will be injected on Day 1 and Day 28 under the trial.
The vaccination will take place at AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Hyderabad-based Bharat Biotech had sought 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 company had submitted its application to the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO).
After a deliberation, the panel gave the nod for Bharat Biotech to conduct the clinical trials.
“After detailed deliberation, the committee recommended for 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 along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study,” an official said.
The trials are to take place at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.