An Indian expert committee on Covid-19 has given emergency use approval to Covaxin for children in the 2-18 group, it was announced on Tuesday, reports Khaleej Times.
“After detailed deliberation the subject expert committee recommended for grant of market authorisation of the vaccine for the age group of two to 18 for restricted use in emergency situation,” said a statement by the official panel. The vaccines will be administered in two doses with a gap of 20 days in between.
Bharat Biotech, the Hyderabad-based company, had last month completed phase two and three trials of Covaxin on children below 18. The expert committee has imposed certain conditions for the emergency use authorisation. The company will have to provide safety data after every 15 days during the first two months, and monthly thereafter.
Earlier in August, the government had granted emergency use approval for ZyCov-D, a vaccine made by Indian pharma major Zydus Cadila for children in the same age group.
The World Health Organization (WHO), however, has still to grant emergency use authorisation to Covaxin. Bharat Biotech had submitted the requisite documents to WHO in July and is awaiting its approval.