Covaxin for children: In big development on the coronavirus vaccine front, the homegrown Covaxin has been cleared for use on children aged between two and 18, reports said Tuesday. So far, the vaccine from Hyderabad-based Bharat Biotech was only in use for the adult population.
The nod from the Subject Expert Committee (SEC) for Covaxin use for children comes following the completion of Phase II and III trials in the stated age group, as reported earlier. The trial data was submitted to top drug regulation body Drugs Controller General of India (DCGI) for approval.
“After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation,” a statement from the SEC, as quoted by Moneycontrol, reads.
Covaxin, meanwhile, still awaits clearance from the World Health Organisation (WHO). As per reports, a policy expert group of the global health authority has completed a review of the data presented and a technical review remains. WHO recognition for Covaxin could come as early as next week.
Covaxin For Children In Much-Awaited Move: What You Should Know
Bharat Biotech has said their vaccine for children uses the same formula as that for adults. Covaxin is a two-dose vaccine administered with a gap of 28 days. More on the vaccine here.
According to India Today, the company has been asked to duly submit safety and analysis data every 15 days for the initial two months of rollout and every month thereafter.
This move makes Covaxin among the first COVID-19 vaccines to be approved for minors in India. Meanwhile, the indigenous ZyCoV-D vaccine developed by Gujarat-based pharma company Zydus Cadila has also received authorisation for use on children aged 12 and up. ZyCoV-D is set for a rollout soon.
Serum Institute’s Novavax is a third vaccine potential for children in India and has been given the go-ahead for trials by DCGI.