NEW DELHI: The Drugs Controller General of India (DCGI) on Tuesday granted a restricted emergency use authorisation to Bharat Biotech’s Covaxin for children aged 6-12 years. Covaxin is one of the first COVID-19 vaccines in the world to generate data in the 2-18 year age group.
The authorisation is given to Bharat Biotech after two-month-long deliberations on the recommendation given by the Subject Expert Committee.
Bharat Biotech has been asked to submit safety data every 15 days for the first two months and monthly thereafter up to five months.
Till now, Covaxin had the authorisation for Emergency Use Listing by the DCGI for the 12-18 years age group. Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity Covaxin in healthy children and adolescents in the 2-18 age group.
The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data readouts were submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received emergency use nod for children aged 12-18 from DCGI during December 2021.
Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “We have established COVAXIN as an universal vaccine for adults and children. Safety of the vaccine is critical for children and we are glad to share that COVAXIN has now proven data for safety and immunogenicity in children. We have achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children.”
Clinical trials in children documented seroconversion at 95-98%, four weeks after the second dose, indicating superior antibody responses in children when compared to adults and also displayed Th1 bias. In earlier COVAXIN studies in adults, cross reactive memory T cells against all variants of concern was reported. Data from neutralization studies against Delta and Omicron variants have been published along with impact of cell mediated immune responses. Since COVAXIN, is an inactivated vaccine corroborative results are expected in children similar to that of adults.
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