The Drug Controller General recently approved Bharat Biotech to conduct clinical trials of the Covid-19 vaccine, ‘Covaxin’ on children between the ages of 2 and 18 years.
Hyderabad-based Bharat Biotech said it would conduct trials on 525 healthy volunteers. Bharat Biotech had applied for permission to conduct clinical trials of Covaxin on Children between 2 and 18 years of age.
However, the reliable sources said that the committee had recommended clinical trials of the vaccine on children aged 2-18 years after carefully examining all the protocols. The trials will be held at the Meditrina Institute of Medical Sciences in Delhi, Patna, AIIMS, and Nagpur.
The committee also directed Bharat Biotech to submit the security data of the second phase clinical trials and DSMB recommendations to CDSCO before conducting the third phase trials.