Bharat Biotech to conduct Covaxin trial on age group between 2 and 18, DCGI gives nod
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 belonging to the age group of 2 to 18 years. Bharat Biotech will conduct the trials on 525 healthy volunteers, the Hyderabad-based firm said.
The decision comes after the subject expert committee recommended permission in favour of Bharat Biotech. The permission has been granted after "careful examination", the government said.
During the trial, the vaccine will be administered through muscles in two doses in a gap of 28 days, the government said. The trial will take place at AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.
"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.
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Bharat Biotech, which developed Covaxin in association with the Indian Council of Medical Research, submitted the proposal of conducting trials on children early this year. The proposal was deliberated in the meeting of the subject expert committee in February as Bharat Biotech was asked to submit a revised clinical trial protocol.
A few days ago, a wrong claim was doing the rounds that Covaxin has been approved for children above 12 years. The Centre refuted the claim and said no such approval was given.
As India is going through the second wave of the pandemic amid which the ongoing vaccination drive has been opened from people between the age group of 18 and 44 years, the need to extend vaccination to those below 18 years has been felt.Pfizer-BioNTech's Covid-19 vaccine has been given emergency use authorisation for children aged between 12 and 15 in the US. Canada too has approved Pfizer for 12-year-olds.