The national regulator Drugs Controller General of India (DCGI) has accepted the recommendation of the Subject Expert Committee (SEC) and given a nod to Bharat Biotech Ltd to conduct Phase II/III clinical trial of COVID-19 vaccine Covaxin in the age group 2 to 18 years.
Hyderabad-based Bharat Biotech had proposed to carry out a Phase-II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. As a rapid regulatory response, the proposal was deliberated in the SEC on May 11. The committee after detailed deliberation recommended for the grant of permission to conduct a proposed Phase II/III clinical trial to certain conditions.
Earlier, the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol. Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive.
Apart from Covaxin, vaccine giant Serum Institute of India's Covishield is being used to vaccinate people in India. The vaccine bankrolled by the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, has also received regulatory approval in India to make and sell its vaccine Sputnik V in India. Dr Reddy's will manage its vaccine operations in India.
Meanwhile, SII and Bharat Biotech have submitted their production plan for the next four months as several states continue to report the shortages of COVID-19 vaccines. While Pune-based Serum Institute said it can ramp up the production to 10 crore, the Hyderabad-based Bharat Biotech said they can raise the production to 7.8 crore doses by August.