Covaxin manufacturer Bharat Biotech has submitted the trial data for its coronavirus vaccine in 2-18-year-olds to Drugs Comptroller General of India (DCGI) for approval, chairman and managing director Krishna Ella told a TV channel on Saturday.
The Hyderabad-based company, the maker of India's first indigenous Covid-19 vaccine, completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September. Covaxin is yet to be given the EUL (emergency use listing) by WHO.
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So far, only drugmaker Zydus Cadila's DNA Covid-19 vaccine has received emergency use approval in India to be used in adults and children aged 12 years and above.
Meanwhile, the country's drug regulator on September 28 allowed Serum Institute to enrol kids between 7 and 11 years for its trial of US drugmaker Novavax's coronavirus 19 vaccine.
(With agency inputs)
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