The Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of the Subject Expert Committee (SEC) to conduct the Phase II/III clinical trial of Covaxin (Covid-19 vaccine) in the age group of 2 to 18 years.
The national regulator of the country has accorded permission to conduct the trial to its manufacturer Bharat Biotech Ltd.
The decision comes after the subject expert committee recommended the permission in favour of Bharat Biotech. The permission has been granted after "careful examination", the government said.
Bharat Biotech will conduct the trials on 525 healthy volunteers, the Hyderabad-based firm said.
During the trial, the vaccine will be administered through muscles in two doses in a gap of 28 days, the government said.
"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," it said.
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 authorisartion for children agaed between 12 and 15 in the US. Canada too has apprved Pfizer for 12-year-olds.