Bharat Biotech's Covaxin, India's indigenous COVID-19 vaccine, received approval from drug regulator DCGI for emergency use for children aged between 12-18 years on Saturday.
Further regulatory process is being streamlined to make children registrations on CoWin platform, reported Moneycontrol.
Bharat Biotech receives approval from DCGI for emergency use of its vaccine for children aged between 12-18 years: Offical Sources pic.twitter.com/WzRuUzqnUT
— ANI (@ANI) December 25, 2021
With this, Covaxin becomes the second COVID-19 vaccine cleared for use for children in India. In August, Zydus Cadila's three-dose DNA jab was allowed to be used on all over the age of 12.
Covaxin will be administered to children in two doses, with a gap of 28 days between the first and second doses. The gap and dosage of vaccine for adults and children will be the same according to the trial data submitted to the government.
Bharat Biotech recently submitted the phase 3 clinical trial application to the Drugs Controller General of India to get approval for the booster dose of its intranasal Covid vaccine named 'BBV154'.
"We have submitted phase 3 clinical trial application to DCGI. An intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns. Intranasal vaccines have the potential to prevent against transmission," said Bharat Biotech in its application as per ANI.
Medanta Chairman Dr Naresh Trehan welcomed the announcement and termed it as a big relief.
"In view of omicron spreading rapidly, it’s great news," he told News18, adding, "It would help if the data were put out in public."