Bharat Biotech’s Covaxin Gets Approval For Phase 2/3 Trials On 2-18 Year-Olds

Covaxin is developed in India by Bharat Biotech in association with the Indian Council of Medical Research (ICMR) that is being used in adults in India’s ongoing COVID-19 vaccination drive.

According to official sources, Bharat Biotech’s COVID-19 vaccine Covaxin was on Tuesday recommended by an expert panel for phase II/III clinical trial on those aged between two to 18 years.

The trial is going to take place at various states including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur in 525 subjects.

A source said, “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.”

On Tuesday the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated upon Hyderabad-based Bharat Biotech’s application to seek permission to conduct phase II/III clinical trials to calculate the safety of reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.

Covaxin is developed in India by Bharat Biotech in association with the Indian Council of Medical Research (ICMR) that is being used in adults in India’s ongoing COVID-19 vaccination drive.

However, earlier the firm was asked to submit a revised clinical trial protocol and the proposal was deliberated in the SEC meeting dated February 24.

 

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