NEW DELHI: The central drug regulator’s expert panel has recommended granting marketing authorisation with certain conditions to Bharat Biotech’s Covaxin for restricted emergency use (EUA) in children and adolescents in the age group of two to 18 years.
However, the final approval of EUA from the drug regulator and inclusion of the vaccine in the national Covid immunisation programme for the paediatric population will take a few more days as data submitted by the company will be further evaluated, top government sources said on Tuesday.

“The subject expert committee (SEC) has only partly recommended EUA for Covaxin. The recommendations are given along with many conditions. The application is still under evaluation and will take a few more days before we arrive at a final conclusion,” a top regulatory official said.
Once the Drugs Controller General of India grants the final regulatory approval to Covaxin for restricted emergency use in the 2-18 age group, the National Technical Advisory Group on Immunisation (NTAGI) for Covid-19 will also evaluate the data before including it in the national programme.
Besides Covaxin, Zydus Cadila‘s ZyCov-D has been granted EUA for children above 12. Serum Institute of India is carrying out phase II and III trials for Covovax among children seven to 11 years of age. With Covaxin likely to receive EUA soon, availability of vaccines for children is likely to improve holding out hope that vaccination will move beyond the initial plan to cover children with co-morbidities.
There are around 44 crore children in the country. While Zydus Cadila’s ZyCoV-D has already been approved for emergency use in children above 12 years of age, a final approval to Covaxin will be significant because it will help increase supplies to cover the paediatric population. The government is yet to start inoculating children with anti-Covid jabs under the national programme.
The conditions prescribed by Subject Expert Committee includes continuation of clinical trials by Bharat Biotech. The firm has also been asked to submit updates prescribing information, package insert, summary of product characteristics as well as factsheet. It will also have to submit adverse event data and analysis every 15 days for first two months and monthly thereafter.
“The firm should submit risk management plan,” the SEC recommendations said.
Bharat Biotech said the data have been thoroughly reviewed by the drug regulator and SEC which have provided positive recommendations.
“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group… We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for Children,” the company said.
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 its verification and subsequent approval for EUA in the beginning of this month.
The SEC 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 said in its recommendations.
The recommendations have been forwarded to the DCGI for final approval.