The Drug Controller General of India (DCGI) today gave emergency use authorisation to Bharat Biotech's vaccine, Covaxin, for use on kids aged 12-18 years, sources told CNBC-TV18.
The sources added that further regulatory process is being streamlined to make children's registrations on the CoWin platform.
With this, Covaxin has become 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 adults and children over the age of 12. Covaxin will be administered in 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, News18 reported.
Medanta Chairman Dr Naresh Trehan welcomed the announcement and termed it as a big relief amid a surge in Omicron cases. “In view of Omicron rapidly spreading, it’s great news," he told News18. “It would help if the data were put out in public," he said.
News18 also reported that Biocon executive chairperson Kiran Mazumdar Shaw called the announcement “extremely important" and said it is a huge relief for parents and schools. “There is enough data showing that children are catching COVID… parents are anxious. Giving vaccines to children will be very useful," she said.
Bharat Biotech had submitted data from clinical trials in this age group to Central Drugs Standard Control Organisation (CDSCO) in October. The data was thoroughly reviewed by the CDSCO and the Subject Experts Committee (SEC), who provided positive recommendations, the vaccine maker had said in a statement.
According to a permission letter accessed by CNBC-TV18, the Subject Expert Committee (SEC) has sought more data from Bharat Biotech for the use of Covaxin on children in this age group. On December 24, after the additional data was submitted, the DCGI decided to issue emergency use approval to Covaxin.
Covaxin was granted emergency use listing by the World Health Organisation on November 3. This vaccine is a whole virion inactivated vaccine against COVID-19, developed in partnership with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
The vaccine maker also recently submitted the phase 3 clinical trial application to DGCI for approval for the booster dose of its intranasal COVID vaccine, named 'BBV154'.
(Edited by : Vijay Anand)
First Published: Dec 25, 2021 9:19 PM IST