Bharat Biotech submits vaccine data for phase 2/3 trials on children between 2-18 years to DCGI

Bharat Biotech has confirmed it has submitted data from its Phase 2 - 3 clinical trials to the Drugs Control General of India (DCGI). The data is from trials that were conducted on children from the 2-18 age group. “Covaxin Clinical trials data of 2-18 years age group has been submitted to the Central Drugs Standard Control Organisation (CDSCO),” the company said. While BB’s vaccine Covaxin has been approved for adults for over a year, separate trials were needed to be done to ensure the vaccine is also safe for children. The Indian Express reported that the paediatric Covaxin is the same product and presentation as the one being administered to adults. During Phase 2-3, two doses of the vaccine were administered to 525 children, 28 days apart. The trials were completed in September. “This is feasible due to the safety of the manufacturing platform and empirical evidence from phase I, II, III clinical trials in adults,” it said. On 21 September, News18 reported that Krishna Ella, Chairman and Managing Director said that the Paediatric Covaxin trials had completed phase 2/3 trials with about 1,000 subjects and the data analysis was going on. If approved, this will be India’s first vaccine to be approved for children. After inoculating more than 920 million of its 1.4 billion citizens, the country is now looking to vaccinate the kids. Other countries are also debating giving children a shot in the arm. The US is also allowing immunocompromised people to get a third dose. Currently, we have three approved vaccines that are in circulation - Covidshield, Sputnik V and Covaxin. However, this won’t be the only vaccine available for children. Reuters reported The DCGI gave Serum Institute the approval to begin enrolling children between the ages of 7 to 11 years for a trial of US drugmaker Novavax’s COVID-19 vaccine. Zydus Cadila’s new DNA-based vaccine was recently given emergency use approval and can be given to adults and children aged 12 years. It is yet to be made available in the market.