Bharat Biotech's Covaxin gets DCGI nod for emergency use for children aged 12-18

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. The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech’s EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions. “The recommendations of the SEC were evaluated by another experts committee after which DCGI had sought additional data from the firm,” a source said. 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.” Reacting to the development, Bharat Biotech in a statement said, “Covaxin is formulated uniquely such that the same dosage can be administered to adults and children. Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants. We have documented excellent safety and immunogenicity data readouts in children. We look forward for Covaxin to provide similar levels of protection for adults and children alike.” The DCGI on 1 September granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trial of its made in India COVID-19 vaccine on children and adolescents aged between 5 and 18 years with certain conditions. In July, it had granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions. With inputs from agencies