The National Expert Group on Vaccine Administration for COVID-19 and the National Technical Advisory Group on Immunisation are deliberating and considering scientific evidences related to vaccination of children between the age group 12 to 17 years, the Lok Sabha was informed on Friday.
Minister of State for Health Bharati Pravin Pawar, in a written reply, said at present, no proposal is pending related to import of Covid vaccine for use among children and adolescents.
The National Expert Group on vaccine administration for COVID-19 (NEGVAC) and the National Technical Advisory Group on Immunisation (NTAGI) are mandated to take decisions related to offshore COVID-19 vaccine, she said.
Asked if the government has laid a roadmap to administer the Covid vaccines in children between the age group 12 to 18, the Minister said, “The National Expert Group on Vaccine Administration for COVID-19 and National Technical Advisory Group on Immunization are deliberating and considering scientific evidences related to vaccination of children between the age group 12 to 17 years.”
On whether any COVID-19 vaccine for children is likely to be developed indigenously, Ms. Pawar said as of now, ZyCoV-D vaccine manufactured by Cadila Healthcare has received the approval for restricted use in emergency setting by the Drug Controller General of India (DCGI) for the age group of 12 years and above based on the interim clinical data of phase 3 clinical trial conducted in the country.
She further said Bharat Biotech is conducting phase 2/3 clinical trial of Covaxin on healthy volunteers aged 2 to 18 years and the firm has submitted interim safety and immunogenicity data to the national regulator DCGI.
Serum institute of India (SII) is also conducting phase 2/3 clinical trial of Nanoparticle Vaccine (liquid) (Covovax) in 920 subjects in more than 2 to 17 years age group, she said.
The MoS added that Biological E Ltd is conducting phase 2/3 clinical trial of RBD of SARS-CoV-2 gene in 624 subjects aged 5 and above to less than 18 years age group.
Besides Johnson and Johnson Pvt Ltd is conducting phase 2/3 clinical trial of Ad.26COV.2S vaccine in the age group of 12-17 years — global clinical trial wherein India is one of the clinical trial sites, she said.
“The approval of aforementioned COVID-19 vaccines will be dependent on the successful completion of clinical trials and submission of requisite data as per the requirements of the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940,” Ms. Pawar added in the written reply.
According to the Registrar General of India (RGI) estimates, there are 14,52,14,000 children in the 12-17 years age group in India.