Covaxin Recommended for Phase II/III Trials on 2-18 Age Group

Bharat Biotech's Covaxin was on Tuesday, 11 May, recommended by an expert panel for Phase II and Phase III clinical trials on those aged between two to 18 years, official sources said.

The trial will take place on 525 subjects 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 Organisation (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application, seeking permission to conduct Phase II and Phase III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years, PTI reported.

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As per a source, "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 data and safety monitoring board (DSMB) recommendations to the Central Drugs Standard Control Organisation (CDSCO), before proceeding to Phase III part of the study."

Earlier, the proposal was deliberated in the SEC meeting dated 24 February and the firm 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.

(With inputs from PTI)

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