Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for verification and subsequent approval for emergency use authorisation (EUA) at the beginning of this month.
The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday.
The recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval.
The company had presented its proposal for grant of market authorisation of its Whole Virion, inactivated coronavirus vaccine (BBV152) in the 2 to 18 years age group for restricted use in emergency situations along with the interim safety and immunogenicity data of phase 2/3 clinical trial conducted.
The committee noted that the interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26, the sources said.