Bharat Biotech’s Covaxin Recommended For Phase II / III Trials On 2-18 Year-Olds

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New Delhi: The Subject Expert Committee (SEC) on Wednesday gave its nod to Bharat Biotech for the phase 2 and 3 human clinical trials of its Covid-19 vaccine Covaxin on 2 to 18-year-olds, according to reports.

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

 

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