A subject expert committee on Covid-19 vaccines on Tuesday recommended the emergency use authorisation for administering Bharat Biotech’s Covaxin among those in the age group of 2 years to 18 years, NDTV reported.
The Drugs Controller General of India is soon expected to give final authorisation for use of the vaccine to children and teenagers. The vaccine will be administered in two doses with a gap of 20 days, reported India Today.
“After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” the expert committee said in its recommendations to the drug controller, according to PTI.
In a statement, Bharat Biotech thanked the expert committee and said that it was now awaiting the final approval from the drug regulator, PTI reported.
“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group,” the vaccine maker said.
Once Covaxin gets the nod from the Drugs Controller General of India, it would become the second vaccine after Zydus Cadila’s, ZyCov-D, to get emergency use for inoculating children in India against coronavirus.
However, ZyCov-D is meant for children only above aged 12.
Serum Institute’s Novavax is a third potential Covid-19 vaccine for children. The drug regulator cleared trials for the vaccine to be used on children between seven and 11 years last month.
Bharat Biotech had said last week that it has submitted data for vaccine trials on children aged between two and 18.
The Hyderabad-based firm had in May received permission to conduct phase two and three trials of the vaccine on children. The trials were completed in September.
In August, NK Arora, the head of the National Immunisation Technical Advisory Group, had said that vaccines for children aged between 12 and 17 years would likely be rolled out by October.
Meanwhile, 27,26,52,701 citizens have received both doses of the vaccine in India, data on CoWin portal showed.
On Tuesday morning, India registered 14,313 coronavirus cases, pushing the infection tally to 3,39,85,920 since the pandemic broke out in January last year. This is the lowest single-day infection count in over seven months, according to the Union health ministry.
The toll climbed by 181 to 4,50,963. The number of active cases dropped to 2,14,900 and the recovery tally increased to 3,33,20,057.