The All India Institute of Medical Sciences (AIIMS) in Delhi plans to begin clinical trials of Bharat Biotech’s Covid-19 vaccine “Covaxin” on children, news agency ANI cited sources as saying. AIIMS Patna has been already been conducting a Paediatric clinical trial of Covaxin after Bharat Biotech gained approval from the Drugs Controller General of India (DCGI) to begin paediatric clinical studies on May 11.
At AIIMS Patna, trials for children aged 12 to 18 have begun. Following this, trials will be conducted for the age groups of 6-12 years and 2-6 years, Dr Prabhat Kumar Singh, Director, AIIMS, Patna, told the news agency.
Earlier, VK Paul, Member (Health), Niti Aayog had said, “Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years.”
The trial will be conducted on 525 healthy volunteers across different sites across the country and the vaccine will be given by intramuscular route in two doses at day 0 (the first day) and day 28, according to the Health Ministry.
The trial will look into the vaccine’s safety in this age range (children), as well as, the adverse reactions and their causes. The vaccine’s ability to elicit an immunological response will also be tested in the trial.
Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing COVID-19 vaccination drive.
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