Five Medical institutions across the country have so far received institutional ethics committee approvals for Covaxin’s clinical trials on children aged two to 18 years.
A total of 525 children will be part of the trial in three age groups where safety, reactogenicity and immunogenicity of the vaccine in children will be assessed.
Pfizer’s trial enrolled 2,260 children aged 12-15 years in the United States. Moderna will enrol approximately 6,750 children in the US and Canada between the age of six months and 11 years.
The three age groups in India are 2-6 years, 6-12 years, and 12 years-18 years, with 175 children required to be inoculated in each age group. Currently, each site has a target of inoculating at least 35 children in each age group starting with the oldest age group.
According to the Clinical Trial Registry of India, the five institutions include Prakhar Hospital, Kanpur, All India Institute of Medical Sciences (AIIMS), Patna, Mysore Medical College and Research Institute (MMCRI), Mysuru, Pranaam Hospital, Hyderabad, and Meditrina Institute of Medical Sciences, Nagpur.