The Drugs Controller General of India has approved the Hyderabad-based pharma giant Bharat Biotech’s Covaxin for emergency use in children aged 2 to 18. (DCGA).
The Covid-19 Subject Expert Committee awarded its clearance for emergency usage in children.
“After careful consideration, the committee recommended the issuance of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in an emergency case,” the expert panel said in a statement.
At the beginning of this month, Bharat Biotech submitted the trial results for phases 2 and 3 of Covaxin on children to the apex body – the DCGI. The vaccination will be given in two doses, separated by 20 days.
Bharat Biotech, on the other hand, must report safety data with proper analysis every 15 days for the first two months and then monthly after that.
Surprisingly, the World Health Organization has refused to award Covaxin an emergency use authorization. The World Health Organization said last week that it will conduct a risk and benefit analysis with experts next week before making a final judgement on the long-awaited EUL for the Covid vaccination Covaxin.
“WHO and an independent committee of experts are expected to meet next week to carry out the risk/benefit evaluation and come to a final decision whether to award Covaxin Emergency Use Listing,” the WHO announced at the last meeting.
Meanwhile, the daily trajectory of Covid caseloads in India continues to exhibit downward tendencies. India reported 14,313 new Covid cases in the last 24 hours on Tuesday, the lowest number in 224 days. In the same time period, 181 fatalities were reported, bringing the total death toll to 4,50,963, according to the Union Health Ministry.