The Phase 2-3 clinical trials of Covid-19 vaccine, Covaxin, has been approved by the Drugs Controller General of India (DCGI), for in the age group of 2 to 18 years and it will begin in the upcoming 10 to 12 days, Dr VK Paul, Member, NITI Aayog said. Bharat Biotech, which developed the Covaxin Covid-19 vaccine in the partnership with Indian Council of Medical Research and the National Institute of Virology, will begin clinical trials of the vaccine on paediatrics from June 1.
This is the first time in India that a Covid-19 vaccine will be tested on children. The clinical trials involve two Covid-19 vaccine shots injected on day 0 and day 28. The trials will take place at several sites, including AIIMS, Delhi, AIIMS, Patna, and Meditrina Institute of Medical Sciences, Nagpur.
“It will be a trial on children aged 2-18 years,” said Raches Ella, Bharat Bio’s head-business development and international advocacy, addressing a Ficci Ladies Organisation (FLO) meeting in Hyderabad on Saturday. Further, Ella said the vaccine maker has also applied to obtain the approval of the World Health Organisation (WHO) for Covaxin and expects the approval soon.