The Phase 2 and 3 clinical trials of Bharat Biotech’s Covaxin in the age group of 2 to 18 years will begin in June, sources in the Hyderabad-based vaccine maker has said.
Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing Covid-19 vaccination drive. Earlier this month, Bharat Biotech was granted permission to conduct the Phase 2/3 clinical trial of Covaxin in the age group of 2 to 18 years.
Sources at Bharat Biotech told that the Phase 2/3 trails for children will begin in June. Dosing will begin in June and end by mid-July. The youngest child recruited for the clinical study is a two-year-old, Bharat Biotech sources added.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur. In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.
Vaccine for children
The Drugs Controller General of India on May 13 approved Bharat Biotech’s Covaxin to conduct the Phase 2-3 clinical trials in children aged 2-18 years.
After critical examination, DCGI has accepted the recommendation of the Subject Expert Committee (SEC) on Covid-19 and accorded permission to conduct the phase 2-3 clinical trial of Covaxin on the age group 2-18 years.
Hyderabad-based Bharat Biotech had earlier proposed to carry out the phase 2-3 clinical trials of Covaxin in the age group of 2 to 18 years. In the trial, the Covaxin shot will be given via the intramuscular route in two doses spread over 28 days.
As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) at the Covid-19 meeting held on May 11.
The committee, after detailed deliberation, recommended the grant of permission to conduct a proposed phase 2/3 clinical trial to certain conditions.
Earlier, the proposal was deliberated in the SEC meeting on February 24 and the firm was asked to submit a revised clinical trial protocol.