New Delhi : Informing about the deployment of COVID vaccine for children in India’s
vaccination drive, Minister of State (MoS) for Health and Family Welfare of India Dr Bharati
Pawar told Rajya Sabha that the 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 for children aged less than 18
years. The vaccination drive for children will begin once enough safety data from clinical
trials is made available to the regulatory authorities.

Dr Pawar further highlighted that Cadila Healthcare’s ZyCoV-D has already received approval
for Restricted Use in Emergency Setting for children aged 12 years and above. The world’s
first DNA plasmid vaccine was granted approval by the Drug Controller General of India
(DCGI) based on the results obtained from the interim clinical data of Phase II & Phase III
clinical trials conducted in the country.

List of vaccines that are under clinical trials in the country for age-group of less than 18
years:

• 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. It has been recommended by the Subject Experts Committee (SEC) for Emergency Use.
• Serum Institute of India is conducting Phase II/III clinical trial of Covovax, the Nanoparticle Vaccine (Liquid) in 920 subjects between the age group of 2 to 17 years.
• Biological E Ltd., is conducting Phase II/III clinical trial of RBD of SARS-CoV-2 gene in 624 subjects between the age group of 5 to 18 years.
• Johnson & Johnson Pvt. Ltd., is conducting Global Phase II/III clinical trial of Ad.26 COV.2S vaccine in age group of 12-17 years wherein India is one of the clinical trial sites.

Further highlighted that the approval of aforementioned COVID-19 vaccines will depend on the successful completion of clinical trials and submission of requisite data to the National Regulator DGCI as per the requirements of New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act, 1940.