Covid-19: DCGI Approves Phase 2 and 3 Clinical Trials of Covaxin in Children 2-18 Years | India News
“The country’s National Regulator, the Comptroller General of Drugs of India (DCGI), after careful examination, has accepted the recommendation of Committee of experts in the field (SECOND) and granted permission to carry out 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 May 12, 2021, “said the ministry .
Bharat Biotech will carry out trials on 525 healthy volunteers. “In the trial, the vaccine will be given intramuscularly in two doses on day 0 and day 28,” he said.
As a quick regulatory response, the proposal was deliberated in the Committee of Experts on the Matter (SEC) (Covid-19) on May 11, 2021.
The Committee, after detailed deliberation, recommended the granting of permission to conduct the proposed phase 2 and 3 clinical trials for selected diseases.
Covaxin is one of two vaccines manufactured in India today and has been developed by Bharat Biotech in association with Indian Council of Medical Research and the National Institute of Virology.
The firm reported Tuesday that it has been supplying its Covid-19 vaccine directly to 18 states since May 1.
(With inputs from agencies)