The Drug Controller General of India on Thursday gave permission to Bharat Biotech to conduct clinical trials of its Covid-19 vaccines Covaxin on children between the age group of 2 to 18 years.
On 525 healthy volunteers the trials will be conducted by the Bharat Biotech said the Hyderbad-based firm.
The government said, the permission has been granted after “careful examination” and this decision comes after the subject the expert committee recommended permission in favour of Bharat Biotech.
🔵Phase II/III clinical trial of COVAXIN in the age group of 2 to 18 Years approved by DGCI
— Ministry of Health (@MoHFW_INDIA) May 13, 2021
The trial will take place at AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.
While the vaccines will be administered through muscles in two doses in a gap of 28 days during the trial, said the government.
“As a 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,” it said.
The proposal of conducting the trails on children early this year was submitted by the Bharat biotech, which developed Covaxin in association with the Indian Council of Medical Research. While the proposal was considered in the meeting of the subject expert committee in February as Bharat Biotech was asked to submit a revised clinical trial protocol.