An expert panel of India's central drug authority has recommended granting emergency use authorisation to Bharat Biotech's Covaxin for children in the 2 to 18 years age group with certain conditions, sources said on Tuesday.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation for its verification and subsequent approval for emergency use authorisation for the jab in the beginning of this month.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
"After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions," the SEC recommendations stated.
The recommendations have been forwarded to the Drugs Controller General of India for final approval.
The company had presented its proposal for grant of market authorisation of its Whole Virion, Inactivated coronavirus Vaccine (BBV152) in the 2 to 18 years age group for restricted use in emergency situation along with the interim safety and immunogenicity data of phase 2/3 clinical trial conducted.
The committee noted that the interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26, the sources said.
The overall geometric mean titre for the paediatric population is comparable with GMT of the adult population in phase -3 efficacy study, the recommendations stated.
After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the 2 to 18 years age group for restricted use in emergency situations subject to certain conditions, they stated.
According to the conditions, the firm should continue the study as per the approved clinical trial protocol and provide updated prescribing information/package Insert (Pl), Summary of Product Characteristics (SmPC) and Factsheet, a source said.
Besides, the firm should 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 requirement of New Drugs and Clinical Trials Rules, 2019.