The Interim Phase II, III clinical trial data of COVAXIN on Healthy Volunteers aged 2 to 18 years submitted by Bharat Biotech was deliberated in the meeting of the Subject Expert Committee (SEC) on August 28 and October 11, informed Ministry of Health and Family Welfare.
The Union Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar stated this in a written reply in the Rajya Sabha.
The committee recommended for grant of market authorization for the age group of 2 to 18 years for Restricted Use in Emergency Situation subject to various conditions. This recommendation is being examined and additional information has been requested at the level of the Central Drugs Standard Control Organisation (CDSCO).
CDSCO has also approved the COVID-19 vaccine (ZyCoV-D) of M/s Cadila Healthcare for restricted use in an emergency situation in the age group 12 years and above.
( With inputs from ANI )
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