The trial will take place at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
Photo used for representational purpose. Pic/AFP
The Drug Controller General of India (DCGI) on Thursday gave permission to Bharat Biotech to conduct clinical trials of Covaxin on those aged between two to 18 years, Union Health Ministry said on Thursday.
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The decision comes after Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) recommended Covaxin for phase II/III clinical trial on those aged between two to 18 years.
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The trial will take place at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur. "The trial will be conducted in 525 healthy volunteers," said the ministry.
In the trial, the Ministry said, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India's ongoing Covid-19 vaccination drive.
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