Covaxin gets emergency use approval for kids aged 2-18 years
New Delhi: The Hyderabad-based pharma major Bharat Biotech’s Covaxin has got the emergency use approval for children in the age group of 2 to 18 years from the Drugs Controller General of India (DCGI). The Subject Expert Committee on Covid-19 gave the approval for the emergency use in the children.
The expert panel said in a statement, “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 emergency situation.”
Bharat Biotech had submitted the trial data of phase 2 and 3 of Covaxin on children in the beginning of this month to the apex body — DCGI at the start of this month. The vaccine will be administered in two doses with 20 days of interval. However, Bharat Biotech needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.
Remarkably, the global health body World Health Organisation has not granted the emergency use authorisation to Covaxin. The World Health Organisation said last week that it will carry out the risk and benefit assessment next week with experts and take a final decision on the much awaited EUL to Covid vaccine Covaxin.
The WHO said in the last meeting, “WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin”.
Meanwhile, India continues to show declining trends in the daily trajectory of Covid caseloads. India on Tuesday reported 14,313 fresh Covid cases in the last 24 hours, lowest recorded cases in the 224 days. Total 181 deaths have also been reported in the same time span, pushing the death toll to 4,50,963, the Union Health Ministry said.
The Active Caseload is presently 2,14,900, which is the lowest in 212 days. The active Covid cases presently constitute 0.63 per cent of the country’s total positive cases.
Bharat Biotech awaits further regulatory approval
Hyderabad: Vaccine maker Bharat Biotech on Tuesday said that it is awaiting further regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for its Covid-19 vaccine Covaxin for the 2-18 years age group. The Hyderabad-based company submitted data from clinical trials of the vaccine in the 2-18 years age group to CDSCO.
The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have given their positive recommendations, the company said. According to the form, this represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group.
“Bharat Biotech sincerely thanks the DCGI, Subject Experts Committee and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” it said.