Clinical Trials of Bharat Biotech’s Covaxin Begins on Children at AIIMS

The trials commenced after the Drugs Controller General of India’s (DCGI) nod for the Phase 2 and 3 clinical trials of Covaxin on children on May 11.

Patna: In a major development, Bharat Biotech has begun clinical trials of its COVID-19 vaccine on children aged 2 to 18 years at All Indian Institute of Medical Sciences (AIIMS) in Patna.

The trials commenced after the Drugs Controller General of India’s (DCGI) nod for the Phase 2 and 3 clinical trials of Covaxin on children on May 11.

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The trials are also slated to take place in 525 subjects at various sites, including AIIMS, Delhi, and Meditrina Institute of Medical Sciences, Nagpur.

Earlier this month, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) had 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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