In very good news for parents in India who are looking forward to getting their children vaccinated, the Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group.
Bharat Biotech is the manufacturer of Covaxin and the Hyderabad-based pharma company completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs and Comptroller General of India (DCGI) at the start of this month, reports India Today.
“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 emergency situation,” the subject expert panel said in a statement.
The made-in-India vaccine will now be administered in two doses, with a gap of 20 days between the first and second dose. However, the emergency use authorisation is subject to certain conditions as the Bharat Biotech will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol.
Bharat Biotech will provide updated prescribing information/package Insert (PI), Summary of Product Characteristics (SmPC), and factsheet and submit safety data including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per the requirement of New Drugs & Clinical Trials Rules, 2019.
Meanwhile, the World Health Organisation (WHO) is yet to grant emergency use authorisation to Covaxin eventhough all documents that are required for the listing to the WHO was submitted by July 9, and the WHO review process, which takes close to six weeks, had commenced by July-end.
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