Bharat Biotech, a major pharma company based in Hyderabad, has been granted an emergency approval by the Drugs Controller General of India for Covaxin. This is for children aged 2-18 years.
The emergency use of the children was approved by the Subject Expert Committee on Covid-19
In a statement, the expert panel stated that “After extensive deliberation, committee recommended for market authorization of the vaccine for the aged group of 2-18 years for restricted use when it is necessary to protect the public.” Bharat Biotech had submitted data from phase 2 and 3 of Covaxin to the DCGI at the beginning of the month. Two doses of the vaccine will be administered with intervals of 20 days.
Bharat Biotech must submit safety data and analysis every 15-day for the first two months, and every month thereafter.
The World Health Organisation, a global health organization, has yet to grant Covaxin an emergency use authorization. Last week, the World Health Organisation stated that it would conduct a risk and benefit assessment with experts next week and make a decision about the long-awaited EUL for Covid vaccine Covaxin.
According to the WHO, the WHO stated at the last meeting that “WHO and an independent group are set to meet next week to conduct the risk/benefit analysis and make a final decision on whether or not to grant Emergency Use Listing to Covaxin”.
India continues to exhibit declining trends in daily Covid caseloads. India reported Tuesday 14,313 new Covid cases within the last 24 hours. This is the lowest number of cases recorded in the past 224 days. The Union Health Ministry reported that 181 deaths were also reported during the same period. This brings the death toll up to 4,50,963,
The current Active Caseload of 2,14,900 is the lowest level in 212 days. The country’s active Covid cases currently make up 0.63 percent of its total positive cases.