CDSCO  panel recommends EUA for Bharat Biotech’s Covaxin for 12-18 yrs group

While the office of Drugs Controller General of India (DCGI) confirmed the development, it also said the final approval from the drug regulator is still awaited.

“Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations,” said Bharat Biotech in a statement.

“This represents one of the first approvals worldwide for covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of covaxin for Children,” the Hyderabad based pharma company said.

The SEC examined the data and deliberated on the EUA application on Monday as Biotech completed the phase 2/3 trials of Covaxin for use in children aged between 2 and 18 years and had submitted the data to the CDSCO for verification and subsequent approval for EUA to the vaccine.

“After detailed deliberation, the committee recommended grant of market authorization 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 moved to the DCGI for final approval, a senior official said. The company had presented its proposal for grant of market authorization 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 overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in phase -3 efficacy study, the recommendations stated.

GMT is a measure of neutralization of the viral by antibodies.

As the recommendations are subject to certain conditions, SEC said, 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, the recommendations said. The recommendations have also said that company should also update the drug regulator on the adverse event following immunization (AEFI).

The development holds significance in the context of opening of schools amid the pandemic. Doctors have welcomed the move. “This will be a major step as school, coaching centres and sport centres are gradually opening. Since the covid vaccination is yet to arrive for children and is at the trial stage, we need to see that we provide proper protection to them by giving them timely vaccination so that the severity of the infection significantly come down even in case they end up contracting covid, said Dr Akshay Budhraja, Senior Consultant, Pulmonology, Aakash Healthcare, Dwarka.