Covaxin recommended for trial on those aged between 2 to 18: Report

Covaxin recommended for trial on children aged between 2 to 18: Report

The Bharat Biotech’s COVID-19 vaccine Covaxin has been recommended by an expert panel for phase 2 and 3 clinical trials on children aged between 2 to 18, the official sources said on Wednesday.

The trial of the COVID-19 vaccine Covaxin will take place in 525 subjects at various sites. These include AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.

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Bharat Biotech COVID-19 vaccine Covaxin recommended by an expert panel for phase 2 and 3 clinical trials on children aged between 2 to 18.

As per the report, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated upon the Bharat Biotech’s application seeking permission to conduct phase 2 and 3 clinical trials to evaluate the safety, of Covaxin in children aged 2 to 18 years.

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Bharat Biotech COVID-19 vaccine Covaxin recommended by an expert panel for phase 2 and 3 clinical trials on children aged between 2 to 18.

A source said that the committee, after detailed deliberation, recommended for the conduct of proposed phase 2 and 3 clinical trials of COVID-19 vaccine in the 2 to 18 years age group subject to the condition that the company should submit the interim safety data of phase 2 clinical trial along to the CDSCO before proceeding to phase 3.

Bharat Biotech COVID-19 vaccine Covaxin recommended by an expert panel for phase 2 and 3 clinical trials on children aged between 2 to 18.

Earlier, it was discussed in the Subject Expert Committee meeting on February 24. The firm was asked to submit a revised clinical trial protocol.

Covaxin is indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). It is already being used in adults amid the ongoing COVID-19 vaccination.

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-PTC News