The trials are also slated to take place in 525 subjects at various sites, including AIIMS, Delhi, and Meditrina Institute of Medical Sciences, Nagpur
In a significant development, Bharat Biotech has kick started paediatric trials of its Covid-19 vaccine Covaxin at All India Institute of Medical Sciences (AIIMS) in Patna.
The trials were started following Drugs Controller General of India’s (DCGI) approval for the Phase 2 and 3 clinical trials of Covaxin in the age group of 2 to 18 years.
COVAXIN is India’s indigenous COVID-19 vaccine by Bharat Biotech. It is developed in collaboration with the Indian Council of Medical Research (ICMR).
The Covaxin trials on children are scheduled to take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, and Meditrina Institute of Medical Sciences in Nagpur as well.
“The vaccine is developed using Whole-Virion Inactivated Vero Cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection,” Bharat Biotech stated.
At present, Covaxin, Oxford-Astra Zeneca vaccine Covshield which is being manufactured by Serum Institute of India and Sputnik V are being administered to all adults in India.
Covaxin is a 2-dose vaccination regimen given 28 days apart and the Bharat Biotech is providing single dose of vaccine to the Centre at a cost of Rs 150. The company is selling a single dose of Covaxin for Rs 600 to private hospitals and for Rs 400 to state governments.