What Govt said on India’s COVID-19 vaccination program for children and under-18 population

KEY STORY

• The Union Ministry of Health and Family Welfare on Tuesday gave an update on India’s COVID-19 vaccination program for children and the population below 18 years of age. Addressing the Rajya Sabha, Union Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar informed that the National Expert Group on Vaccine Administration for Covid (NEGVAC) and National Technical Advisory Group on Immunization (NTAGI) are deliberating and considering scientific evidence related to vaccination of beneficiaries aged less than 18 years.

• The ZyCoV-D vaccine which is the world’s first DNA plasmid vaccine against the Covid-19 virus has been manufactured by Cadila Healthcare.

• ZyCoV-D vaccine received 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 II and Phase III clinical trial conducted in the country, the MoS Health said in a written reply.

• The vaccine was approved by the drug regulator on August 20, 2021. It is also the world’s first COVID-19 vaccine which is needle-free and a three-dose vaccine. The second dose of ZyCoV-D vaccine should be administered on day 28 from the first dose and the third one on the 56th day from the first dose.

• The government issued a list of COVID-19 vaccines that are under clinical trials in the country for age group of less than 18 years:

COVAXIN: Bharat Biotech is conducting phase II/III clinical trial of COVAXIN on healthy volunteers aged 2 to 18 years. The Hyderabad-based company has submitted interim safety and immunogenicity data to the DCGI.

COVOVAX: 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.

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.

Johnson & Johnson 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 statement of the minister read.