Following careful examination, the Drugs Controller General of India (DCGI) on Wednesday accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covid-19 vaccine - Covaxin in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd. Covaxin Phase 2/3 clinical trials for 2-18 age group get GREEN SIGNAL from DCGI Bharat Biotech gets approval for clinical trials of Covaxin on children aged 2-18 years Proposal was deliberated in Subject Expert Committee (SEC) COVID-19 on Tuesday. DCGI accepts recommendation of Subject Expert Committee (SEC). Trials to take place at various sites, including AIIMS, Delhi & Patna and Meditrina Institute of Medical Sciences, Nagpur. The trial will be conducted in 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
Published: Diptiranjita Patra
Last updated: 13 May 2021, 03:04 PM IST
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