As the ruckus and discussion over reopening of schools grows louder, there is a new development that might help parents and educators make the tough decision.
While WHO approval for Covaxin is still awaited, the Subject Expert Committee (SEC) has given a recommendation to the Drugs Controller General of India (DCGI) for the use of Bharat Biotech's Covaxin for 2 to 18 year olds, as per ANI report dated October 12, 2021.
With that nod, Covaxin takes a lead in becoming the country's first Covid-19 vaccine that can be administered to children. Although official comment, statement or social media post from the authorities, is still awaited, but the news put the social media into a frenzy, with some supporting the development and others highly sceptical of it.
It's been a week since the news quoting unnamed official sources came out on Bharat Biotech completing the Phase 2/3 trials of Covaxin for use in children under 18 years of age and submitting the data to CDSCO (Central Drugs Standard Control Organisation).
"Covaxin clinical trial data of 2-18 years age group has been submitted to CDSCO. This is feasible due to the safety of the manufacturing platform and empirical evidence from Phase 1, 2 and 3 clinical trials in adults," said a PTI report quoting officials.
Bharat Biotech said in a statement that it's awaiting the other approvals. "We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children," the vaccine developer said.
Vaccine to be available soon?
It was only in August that Priya Abraham, director of Indian Council of Medical Research (ICMR)'s National Institute of Virology revealed that an indigenous Covid-19 vaccine for children will be available from September, though it's October now. Meanwhile, Zydus Cadilla's application for the grant of emergency use authorisation is pending before the Drugs Controller General of India (DGCI). Once the DGCI approval is given, Bharat Biotech's vaccine will be made available to children as well.
It must be noted that Covaxin has been developed by Hyderabad based Bharat-Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology. India's home grown vaccine was approved for emergency use, amidst a lot of criticism, on January 3 of this year, in the absence of complete Phase 3 trial data.