Vaccination program for children and under-18 population under clinical trials

New Delhi, Dec 7: National Expert Group on Vaccine Administration for Covid (NEGVAC) and National Technical Advisory Group on Immunization (NTAGI) are deliberating and considering scientific evidences related to vaccination of beneficiaries aged less than 18 years. Government of India has been supplying Covid-19 vaccines free of cost to the States/UTs for administration to prioritized beneficiaries as recommended by NEGVAC. ZyCoV-D vaccine manufactured by M/s Cadila Healthcare has received the approval for Restricted Use in Emergency Setting by the National Regulator i.e., Drug Controller General of India (DCGI) for the age group of 12 years and above based on the interim clinical data of Phase II &Phase III clinical trial conducted in the country. Following COVID-19 vaccines are under clinical trials in the country for age-group of less than 18 years: i.      M/s Bharat Biotech is conducting Phase II/III clinical trial of COVAXIN on Healthy Volunteers aged 2 to 18 years & firm has submitted interim safety & immunogenicity data to the National Regulator. ii.     M/s Serum institute of India is conducting Phase II/III clinical trial of Nanoparticle Vaccine (Liquid) (COVOVAX) in 920 subjects of >2 to 17 years age group. iii.    M/s Biological E Ltd., is conducting Phase II/III clinical trial of RBD of SARS-CoV-2 gene in 624 subjects of ≥5 to <18years age group. iv.    M/s Johnson & Johnson Pvt. Ltd., is conducting Phase II/III clinical trial of Ad.26COV.2S vaccine in age group of 12-17 years (Global Clinical trial wherein India is one of the clinical trial sites). The approval of aforementioned COVID-19 vaccines is dependent on the successful completion of clinical trials and submission of requisite data to the National Regulator i.e., Drug Controller General of India as per the requirements of New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act, 1940. The Union Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar stated this in a written reply in the Rajya Sabha today.