Central Drugs Standard Control Organisation (CDSCO), the Biological Division of Directorate General of Health Sciences has given approval to Bharat Biotech International Ltd to conduct trials to develop COVID-19 vaccine for children in the age group of 2 to 18 years. Drugs Controller General (India) which is the Central Licencing Authority too has permitted Bharat Biotech to conduct clinical trials. Bharat Biotech will conduct these world’s first vaccine trials for kids at four centres and Nagpur’s Meditrina Institute of Medical Sciences in one of those four centres. Dr Vasant Khalatkar, a well-known Paediatrician has been appointed as its Principal Investigator.

 

 

 

In the permission letter CDSCO has said, permission is given for conducting a Phase II/III clinical trial titled ‘A phase II/III, Open Label, Multicentre study to evaluate the safety, Reactogenicity and Immunogenicityof the Whole Wirion Inactivated SARS-CoV-2 Vaccine (COVAXIN) in healthy volunteers ages 2 to 18 years.’ Bharat Biotech was seeking permission for conducting these trials since December 2020 from Central Drugs Standard Control Organisation (CDSCO). Confirming the development Dr Vasant Khalatkar said, “We received a letter and I will be working as Principal Investigator. But we will have to wait to get approval from Ehical Committee, 10-15 days after which we can start actual trials.” Dr Sameer Paltewar, Managing Director of Meditrina said, “It is the development where Nagpur must feel proud for. Everybody is exciting to start work on this project. Our laboratory is ready to conduct the trials. After the permission of ethical committee, the trials will begin.” Meditrina was a part of trials conducted by Bharat Biotech for adults vaccination. Along with Meditrina, the other institutes which would be part of the trials include All India Institute of Medical Sciences (AIIMS), Patna, Bihar; Felix Hospital, Noida, Uttar Pradesh; Institute of Child Health Niloufer Hospital for Women and Children, Hyderabad.

 

The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages =2 to 6, 6 to 12 and 12 to 18 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN) 28 days apart. Participants will be recruited in age de-escalatory manner as follows: The study will be conducted in three groups. In Group1 a total of 175 healthy volunteers ages =18-12, years will be enrolled in this group and will receive two doses of COVAXIN vaccine through intramuscular route on Day 0 and Day 28+2. After completion of 7 days post 1st dose for 25 participants in the Group 1, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 150 participants in the group 1. After completion of recruiting participants in group 1, study will progress by starting recruitment of participants for group 2. Same procedure will be applied for the group 2 where children of age group 6-12 years of age would be involved and Group 3 too which would deal with the children of age group 2-6 years.