New Delhi: Drugs Controller General of India (DCGI) has accepted the recommendation of the Subject Expert Committee (SEC) and accorded permission to conduct the Phase II and III clinical trials of `Covaxin' on people in the age group 2 to 18 years.
Hyderabad-based Bharat Biotech International, (BBIL) had proposed to carry out a Phase- II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted on 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on May 11. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.
The trial is expected to be conducted on 525 subjects at various sites, including AIIMS-Delhi, AIIMS-Patna.Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive.