Rohit Shishodia

The Drugs Controller General of India (DCGI) has approved the phases two and three clinical trials of Covaxin in the age group of two to eighteen years. The approval has been given after accepting the recommendations of the Subject Expert Committee (SEC) and permission has been accorded to conduct the phases two and three clinical trials of Covaxin.

The trials will be conducted in 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.

“As rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (Covid-19) on May 11, 2021. The committee, after detailed deliberation, recommended grant of permission to conduct proposed Phase II and III clinical trials to certain conditions,” said the Indian Health Ministry in a press release on May 13, 2021.

Earlier, Bharat Biotech International, Hyderabad, (BBIL) had proposed to carry out a Phase II and III clinical trial of Covaxin in the age group of 2 to 18 years.