SEC recommendations for emergency use authorisation to Covaxin for 2-18 year olds being examined.
The Covid Subject Expert Committee's recommendations on granting emergency use authorisation to Bharat Biotech's Covaxin for the 2-18 age group are being examined and additional information has been sought, Rajya Sabha was informed Tuesday.
Responding to a question on whether the government is considering Covaxin for children under 12, Union Minister of State for Health Bharati Pravin Pawar said in a written reply the interim phase 2/3 clinical trial data on healthy volunteers aged 2 to 18 years submitted by Bharat Biotech was deliberated upon in the meeting of SEC on August 26 and October 11.
"The committee recommended for grant of market authorisation for 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 Central Drugs Standard Control Organisation (CDSCO)," Ms Pawar said.
The CDSCO has also approved COVID-19 vaccine (ZyCoV-D) of Cadila Healthcare for restricted use in emergency situation in the age group 12 years and above, she added.
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