The Subject Expert Committee on Covid19 has granted ‘Covaxin’ of Bharat Biotech an emergency permit for children 2-18 years old.
Bharat Biotech of Hyderabad has completed the trials of phase 2 and phase 3 with ‘Covaxin’ in children under 18 years of age. Bharat Biotech of Hyderabad has submitted the trial data to the Comptroller General of Drugs and India (DCGI) earlier this month.
“After an extensive deliberation, the committee recommended that the vaccine can be granted market authorization for the age group 2 to 18 years for restricted use in an emergency,” said a statement from the expert committee.
The Indian-made vaccine is given in two doses, with a 20-day interval between the first and second doses.
However, the emergency use authorization is tied to certain conditions. The firm must:
- Continue to study ‘Whole Virion’, Inactivated Corona Virus Vaccine (the approved clinical trial protocol)
And also submit:
- an updated prescribing information / package Insert (PI)
- A summary of Product Characteristics (SmPC)
- A fact sheet
- A 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 requirement of New Drugs & Clinical Trials Rules, 2019
Meanwhile, the WHO (World Health Organisation) has not yet approved Covaxin for the emergency. Bharat Biotech had reportedly submitted all documents required for listing to WHO by July 9, and the nearly six-week WHO review process had started in late July.
India had already issued an emergency approval for ZyCovD’s Covid19 vaccine for children ages 12-18 in August. The vaccine is being developed by the pharmaceutical company Zydus Cadila and is the first DNA vaccine approved worldwide.
