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The national drug regulator said that it has accepted the recommendation of the SEC “after careful examination” and accorded permission to Covaxin manufacturer Bharat Biotech.
DCGI approves Covaxin clinical trials for children aged 2-18 years - The trial will involve two vaccine doses injected on Day 1 and Day 28. This is the first time in India that a COVID vaccine will be tested on children
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Bharat Biotech s COVAXIN reportedly recommended by expert panel for phase 2 and 3 clinical trials on 2-18 year-olds
Bharat Biotech s COVAXIN reportedly recommended by expert panel for phase 2 and 3 clinical trials on 2-18 year-olds
PTIMay 13, 2021, 11:48 IST
Business Insider
Covaxin was on Tuesday recommended by an expert panel for
phase II/III
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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Bharat Biotech s Covaxin approved for phase 2/3 trials on children
The Drugs Controller General of India (DGCI) has approved Bharat Biotech s COVID-19 vaccine
Covaxin for phase II/III clinical trial on those aged between two to 18 years. The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. The DCGI, after careful examination, has accepted the recommendation of Subject Expert Committee and accorded permission to conduct the Phase II/III clinical trial of Covaxin in the age group 2 to 18 years, to its manufacturer Bharat Biotech, the government said in a press note.