DCGI has approved a phase 2 and 3 clinical trial of Covaxin for minors.
The Drugs Controller General of India (DCGI) has authorised phase 2 and 3 clinical trials of Bharat Biotech's Covaxin vaccine in children aged 2 to 18.
Adults are given Covaxin, which was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The total number of Covid-19 vaccine doses given out in India has surpassed 17.70 crore. Since the third phase of the drive began, 4,17,321 people in the 18-44 age group have received their first dose of Covid-19 vaccine.
COVID-19 vaccine from Bharat Biotech An advisory panel recommended Covaxin for a phase II/III clinical trial on children aged two to eighteen years old on Tuesday. The trial will include 525 healthy people at different locations, such as the AIIMS in Delhi, the AIIMS in Patna, and the Meditrina Institute of Medical Sciences in Nagpur.
On February 24, the plan was discussed at an SEC conference, and the company was asked to request a revised clinical trial protocol. Following extensive deliberation, the Committee recommended that permission to perform clinical trials be granted under certain conditions.
Covaxin is one of two vaccines presently manufactured in India.
The vaccine will be administered intramuscularly in two doses on days 0 and 28 of the trial. The proposal was debated in the SEC on May 11 as a fast regulatory response.
As many states continue to record COVID-19 vaccine shortages, SII and Bharat Biotech have submitted their production plan for the next four months. Though Serum Institute in Pune claims it can increase production to 10 crore doses by August, Bharat Biotech in Hyderabad claims it can increase production to 7.8 crore doses by August.