The approvals for the vaccines will accordingly be given after successful completion of clinical trials
The National Expert Group on Vaccine Administration for COVID-19 and National Technical Advisory Group on Immunisation were studying and considering scientific evidence related to the vaccination of people in the 12 -17 age group, the health ministry told Parliament on Friday. The approvals for the vaccines will accordingly be given after successful completion of clinical trials and submission of requisite data as per the Drugs and Cosmetics Act, it added.
“As of now, ZyCoV-D vaccine manufactured by M/s Cadila Healthcare has received the approval for Restricted Use in Emergency Setting by the National Regulator ie, Drug Controller General of India (DCGI) for the age group of 12 years and above based on the interim clinical data of Phase III clinical trial conducted in the country,” minister of state for health Bharati Pravin Pawar said.
Pawar added Bharat Biotech is conducting Phase II/III of the clinical trials of Covaxin on healthy volunteers aged two to 18. She said the Serum Institute of India is conducting Phase II/III clinical trials of Nanoparticle Vaccine (liquid), Covovax, on 920 subjects. Pawar said Biological E Ltd is conducting Phase II/III clinical trials on the receptor-binding domain of the SARS-CoV-2 gene on 624 subjects.
Apart from these indigenous vaccine trials for children, American pharmaceutical company Johnson & Johnson is also conducting global Phase II/III clinical trials for the 12-17 age group. India is one of its clinical trial sites.