The Drugs Controller General of India (DCGI) has approved Phase 2 and 3 clinical trials of Bharat Biotech’s Covid vaccine Covaxin for kids in the age group of 2 to 18 years, informed the Ministry of Health and Family Welfare.
“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 May 12, 2021,” the Union Health Ministry said.
Bharat Biotech will conduct trials on 525 healthy volunteers.
“In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28,” it said.
As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on May 11. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase 2 and 3 clinical trials to certain conditions.
Covaxin is one of the two vaccines being manufactured in India at present and has been developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.
The firm on Tuesday informed that it has been supplying its COVID-19 vaccine directly to 18 states since May 1.
Bharat Biotech, the Hyderabad-based firm, is supplying Covaxin to 18 states, including Andhra Pradesh, Haryana, Odisha, Assam, Jammu & Kashmir, Tamil Nadu, Bihar, Jharkhand and Delhi. The other states are Chhattisgarh, Karnataka, Telangana, Tripura, Madhya Pradesh, Uttar Pradesh, Gujarat, Maharashtra and West Bengal.
India added 3,62,727 new coronavirus infections in a day taking the COVID-19 tally of cases to 2,37,03,665, while the death toll rose to 2,58,317 with 4,120 daily fatalities, according to the Union Health Ministry data updated on Thursday.
The active cases have increased to 37,10,525 comprising 15.65 per cent of the total infections.