DGCI approves Phase 2/3 clinical trials of COVAXIN for 2-18 years old


New Delhi: Drugs Controller General of India (DGCI) approved the Phase 2 and 3 clinical trials of the COVAXIN which was made by Indian Council of Medical Research and Bharat Biotech. Bharat Biotech will conduct the trials on 525 healthy volunteers

The press release said, “The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021.”

The company will give two does of the vaccine through the intramuscular route within a gap of 28 days. As DGCI said in their press release, “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 Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.”

This is a major step regarding the vaccination drive going on across the country, even though currently there is a shortage of vaccines for the people with age 18-44. India has vaccinated 17,72,14,256 people till Thursday.