The Union Health Minister Mansukh Mandaviya on Thursday said that Ministry of Health will be waiting for National Technical Advisory Group of India (NTAGI) recommendation to begin the vaccination of 5 to 12-year-olds. The health minister's statement comes days after vaccine maker Biological E. Ltd on Tuesday announced that its Covid-19 vaccine Corbevax has received a nod from the Drugs Controller General of India (DCGI) for emergency use authorisation for the 5-12-year age group.
The approval comes after the Subject Expert Committee (SEC) recommendation based on the review of interim safety and immunogenicity data of Corbevax for this age bracket. This approval comes a month after Corbevax was given the nod for children between 12 and 15 years, Hyderabad-based BE said.
The company has developed India's first indigenous sub-unit Covid-19 against the novel coronavirus. It performed a multi-centric, Phase 2/3 clinical trial in 624 children aged between 5 and 18 in two age subsets, i.e., 12 to less than 18 years and 5 to less than 12 years. As a part of the trial, children were administered two doses of 0.5 ml each of the vaccine or placebo in a gap of 28 days.
The company revealed that it has so far manufactured 30 crore doses of Corbevax and has already supplied nearly 10 crore doses to the government.
Currently, over 3 crore doses of Corbevax have been administered in children between 12-15 years of age. With an approval for the 5-12 age group, this move will not only reduce the risks children face from the infectious disease, but it will also enable them to concentrate on their education and social development, which were severely impacted by the pandemic.
COVID-19 vaccination for minors in India started from January 3 onwards for those in the 15-18 age group with Bharat Biotech's Covaxin. The drive later expanded on March 16 to include children aged above 12 for Corbevax. India is currently administering two COVID-19 vaccines for children above 12.