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 also 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.
Covaxin is the second Covid-19 vaccine to be authorised for emergency use in children in India, following Zydus Healthcare’s ZyCoV-D, which is intended for children over the age of 12.
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.
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 also submit risk management plan.