Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase 2-3 clinical trials in the age group of 2 to 18 years. Dr VK Paul, Member, NITI Aayog said this on Tuesday during a press briefing.
The Phase 2-3 clinical trials of COVID-19 vaccine, Covaxin, which has been approved by the Drugs Controller General of India (DCGI), for in the age group of 2 to 18 years, will begin in 10 to 12 days.
"I have been told that trials will begin in the next 10-12 days, Niti Aayog Member-Health, Dr VK Paul said on Tuesday.
This is the first time in India that a COVID-19 vaccine will be tested on children. The clinical trials involve two COVID-19 vaccine shots injected on day 0 and day 28.
The trials will take place at several sites, including AIIMS Delhi, AIIMS Patna, and Meditrina Institute of Medical Sciences, Nagpur.
Hyderabad-based Bharat Biotech had proposed to carry out the clinical trial in the age group of 2 to 18 years.
In the trial, Covaxin will be given by intramuscular route in two doses at day 0 and day 28. The trial will be conducted on 525 healthy volunteers.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Covaxin is one of the three vaccines which have been given a green signal by authorities and is being used on adults in India's ongoing COVID-19 vaccination drive.
