Bharat Biotech's Covaxin recommended by expert panel for phase 2/3 trials on children

NEW DELHI: Bharat Biotech’s Covaxin shot has been recommended by the expert panel on Covid-19 for further trials on children aged between 2 and 18 years, said sources.

The Subject Expert Committee (SEC) on Covid-19 has recommended that Bharat Biotech be granted permission to conduct the phase 2/3 clinical trials of Covaxin, on children in the 2-18 age group.

The trial will take place on 525 subjects at various sites, including AIIMS-Delhi, AIIMS-Patna and Meditrina Institute of Medical Sciences in Nagpur, reported PTI.

The Centre recently informed the Supreme Court that no governmental aid, assistance or grant was made either for research or development of Covid-19 vaccines - Covaxin and Covishield - but some financial assistance was given for conducting clinical trials.

The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct the clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs among children.

"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," reported PTI.

Earlier, the proposal to conduct trials on children was deliberated in the SEC meeting dated February 24 and Bharat Biotech was asked to submit a revised clinical trial protocol.

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.

India launched the ‘world’s largest vaccination drive’ on January 16 with the two vaccines Covaxin and Covishield.