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Bharat Biotech International has submitted clinical trial data pertaining to Covaxin for those in the 2-18 age group to the Central Drug Standard Control Organisation (CDSCO). This was confirmed by the Hyderabad-based vaccine marker in response to a query from BusinessLine.
Covaxin is also the first vaccine to be used for trials in the 2-6 age group, said Bharat Biotech, adding: “This is feasible due to the safety of the manufacturing platform and empirical evidence from Phase I, II, III clinical trials in adults.
In May, the Drug Controller General of India had permitted the company to carry out the clinical trials of Covaxin in those under 18 years.
Size of the trial
The size of the trial, however, was smaller compared to the one for adults. It was tested in about 600 healthy volunteers, according to the company. In the case of Covaxin for adults, 26,000 volunteers were roped in by the firm.
In the trials for the pediatric version of the vaccine, which is the same as the one being given to the adults now, it was given via the intramuscular route in two doses with a gap of 28 days.
As the pace of vaccination for adults has been gaining momentum across the country, vaccinating those under 18 becomes important to tame the pandemic in the wake of the possibility of a third wave, say experts.
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