Bharat Biotech’s COVID-19 vaccine, Covaxin got DGCI’s approval on Tuesday for usage on kids aged 2-18.
This came after Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin in September on children below 18 years of age. The company had submitted the trial data to the Drugs and Comptroller General of India (DCGI) earlier this month.
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The drug regulator said, “After detailed deliberation, the committee recommended for grant of market authorization” to children in age group of 2-18 years.
The DGCI added, “The emergency use authorisation, however, is subject to certain conditions. The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol.”
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