Drugs Controller General of India has granted permission to Hyderabad-based Bharat Biotech to conduct Phase II and III clinical trials of Covaxin on children between the ages of two to 18. In a release, the Ministry of Health and Family Welfare said that the trial will be conducted in 525 healthy volunteers, and in the trial, the vaccine will be given by the intramuscular route in two doses, first at day 0 and second at day 28.
“The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021,” the government said in a release.
Bharat Biotech’s proposal was deliberated by the Subject Expert Committee (SEC) (COVID-19) on May 11 and the Committee after detailed deliberation, recommended the grant of permission to conduct the proposed Phase II/III clinical trial to certain conditions, the government said. 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. Bharat Biotech on Tuesday said it will continue the steady supply of its COVID-19 vaccine Covaxin, adding the jab has been directly supplied to 18 states since May 1. The states include Andhra Pradesh, Delhi, Bihar, Gujarat, Haryana, Uttar Pradesh and West Bengal, the Hyderabad-based firm added.
On April 29, Bharat Biotech had announced a cut in the price of Covaxin for states to Rs 400 per dose from the earlier Rs 600. This followed widespread criticism of its pricing policy as it sold Covaxin to the central government at Rs 150 per dose. India has expanded its COVID-19 vaccination drive by allowing its large 18-plus population to get inoculated from May 1.