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Bharat Biotech's Covaxin gets nod for phase 2, 3 trials for 2 to 18-year-olds


Bharat Biotech s Covaxin gets nod for phase 2, 3 trials for 2 to 18-year-olds
News Network
May 12, 2021
New Delhi, May 12: An expert panel on Wednesday gave its nod to Bharat Biotech for the phase 2 and 3 human clinical trials of its Covid-19 vaccine Covaxin to be conducted on 2 to 18-year-olds, sources said.
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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