The pharma regulator’s Subject Expert Committee (SEC) has recommended that Bharat Biotech’s Covaxin be approved for emergency use in children aged 2 to 18.
The SEC has submitted its proposal for final clearance to the Drugs Controller General of India (DCGI).
“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation,” the expert panel said in a statement.
It said that the emergency use authorisation, however, is subject to four conditions.
“The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol,” SEC added.
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The expert panel also mentioned the following conditions:
The company should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC), and Factsheet; the company should submit safety data, including AEFI and AESI data, with due analysis, every 15 days for the first two months and monthly thereafter, as required by the New Drugs and Clinical Trials Rules, 2019; and the company should submit risk management plan.
(With inputs from agencies)
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