The Subject Expert Committee (SEC) has given a recommendation to the Drugs Controller General of India (DCGI) for the use of Bharat Biotech's Covaxin for kids aged 2-18 years against COVID-19.
If approved, Covaxin will be the first COVID-19 vaccine that will be administered to children in India.
Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella, had said on September 21 that the Paediatric Covaxin completed phase 2/3 trials with about 1,000 subjects and the data analysis was going on. As part of Phase II/III trial, the two-dose Covaxin was administered 28 days apart.
The pricing of the Paediatric Covaxin is yet to be disclosed.
Bharat Biotech had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of October.
The SEC on COVID-19 examined the data and deliberated on the EUA application on Monday. "After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions," the SEC recommendations stated.
According to the conditions, the firm should continue the study as per the approved clinical trial protocol and provide updated prescribing information/package Insert (Pl), Summary of Product Characteristics (SmPC) and Factsheet, a source said.
Besides, the firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per the requirement of New Drugs and Clinical Trials Rules, 2019.
Currently, India is administering three vaccines against COVID-19 for people aged 18 years and above - Covaxin, Serum Institute of India's Covishield and Russia's Sputnik V.
With inputs from PTI