An expert panel under India's Central Drug Authority has recommended granting of Emergency Use Authorisation (EUA), to Bharat Biotech's Covaxin for children in the 2 to 18 years age group under certain conditions. The SEC has submitted its recommendation to the Drugs Controller General of India (DCGI) for final approval.

Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid-19 vaccine Covaxin for administering 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 emergency use authorisation (EUA) for the jab in the beginning of this month.

The Subject Expert Committee (SEC) on Covid-19 examined the data and deliberated on the EUA application.

However, before the final approval is granted, Bharat Biotech will have to submit the updated prescribing information, package insert, summary of product characteristics and factsheet. Second, a comprehensive plan for risk management and finally after the approval it must provide adverse event data every 15 days for two months, and once a month thereafter.

Two doses of Covaxin are likely to be administered to children with a gap of 28 days. For adults, the government has set a gap of 4-6 weeks between the two shots.

Covaxin is the first vaccine developed indigenously for Covid-19 by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). It is being administered to adults in India’s ongoing Covid-19 vaccination drive and it is awaiting WHO EUA.

Speaking on the subject of vaccination for children, Dr Kanchan Channawar, consultant Paediatrician, Kamineni Hospitals said, "Covaxin is an inactivated killed vaccine which is made by a conventional method same as other vaccines we are using from decades like DPT polio Flu. It has proven very effective in the adult population without significant side effects so hopefully, it will have a similar effect in the pediatric population from above 2 years. It will not only give the protection but also help to restore the faith among parents to send their kids to school. "

This is the second Covid-19 vaccine to get approved for children in India. DGCI had, in August, approved ZyCoV-D for children aged 12 and above as well as adults.