Bharat Biotech on Sunday will launch the clinical trial of Covaxin on children in the age group of 12-18 years in Maharashtra’s second capital Nagpur. Of the four locations shortlisted by Bharat Biotech across the country, Nagpur is one of them.
The trial will be conducted at the Meditrina Hospital under the supervision of paediatrician Dr Vasant Khalatkar.
According to the sources from the district collectorate, blood samples were collected from children between the age group of 12 and 18 years. A screening of 50 volunteers (children) has been conducted and the clinical trials will begin after the blood reports are received.
The trials will be held in three phases. Children in the age group of 12-18 years will be given the shots first followed by the 6-12 years age category before inoculating children in the 2-6 years age bracket. Children with good results will be given a second dose after 28 days.
These trials at Nagpur are being launched days after Bharat Biotech was granted permission to conduct Phase- II and III trials of Covaxin on children in the age group of 2-18 years. The expert panel of the Central Drugs Standard Control Organisation (CDSC) had recommended the conduct of trials. The Drugs Controller General of India (DCGI) has accepted the recommendation of the Subject Expert Committee (SEC).
The trial will be conducted in 525 healthy volunteers. During the trial, the two doses of vaccine will be administered to the volunteers. The gap between the first and second dose will be 28 days.
Earlier, the Subject Expert Committee of Central Drugs Standard Control Organisation deliberated upon Bharat Biotech application seeking permission to conduct Phase-II and III trials to evaluate the safety and immunogenicity of Covaxin vaccine in Children aged between two and 18 years.
Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research. This vaccine is currently being used in the nationwide vaccination drive for the vaccination of people aged above 18 years.