Bharat Biotech’s COVAXIN gets nod for phase 2/3 trials on 2-18 years old


The COVID-19 vaccine of Bharat Biotech, COVAXIN on May 11, 2021, was recommended by an expert panel for phase 2/3 clinical trials on those aged between 2 to 18 years old.

As per the official sources, the trial for the vaccine will take place in 525 subjects at different sites, including AIIMS, Patna, AIIMS, Delhi, and Meditrina Institute of Medical Sciences, Nagpur.

COVAXIN has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research- ICMR. It is currently being used in adults in the ongoing COVID-19 vaccination drive in India. From May 1, 2021, the Indian Government had announced all adults above 18 years be eligible to receive the vaccination.

Approval for phase 2/3 trials on 2-18 years old: Key Details

•   The Subject Expert Committee- SEC on Coronavirus of the Central Drugs Standard Control Organisation on May 11, 2021, deliberated upon the application of Bharat Biotech seeking permission to conduct phase 2/3 clinical trials for evaluating the safety, immunogenicity, reactogenicity of Covaxin jabs in children aged 2 to 18 years.

•   The committee, after the detailed deliberation, recommended conducting the phase 2/3 clinical trial of the whole virion inactivated Coronavirus vaccine in the age group of 2-18 years subject to the condition that the firm must submit the interim safety data of phase 2 clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase 3 clinical trial.

•   The proposal by Bharat Biotech was deliberated in the SEC meeting on February 24, 2021. The firm was asked by SEC to submit a revised clinical trial protocol.

Bharat Biotech directly supplies vaccine to 18 states:

Bharat Biotech has been supplying the Coronavirus vaccine directly to 18 states since May 1, 2021. The firm added that it will continue the steady supply of the vaccine.

Madhya Pradesh, Maharashtra, Uttar Pradesh, Bihar, West Bengal, and Assam are among the 18 states who have been getting the direct supply of COVAXIN by Bharat Biotech.

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