Expert panel okays use of Covaxin in 2-18 age group

By Neetu Chandra Sharma
Bharat Biotech has stated that it had submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO, which thoroughly reviewed it and provided their positive recommendations. (AP)

NEW DELHI : Children as young as two may soon be eligible to get vaccinated against covid-19, with a top government panel recommending the use of Bharat Biotech Ltd’s Covaxin for those aged 2 to 18.

An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting emergency use authorization (EUA) for the vaccine, Bharat Biotech said on Tuesday. A Drugs Controller General of India (DCGI) official confirmed the development, adding final approval 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 CDSCO and subject experts committee (SEC), and they have provided their positive recommendations," Bharat Biotech said.

“This represents one of the first approvals worldwide for covid-19 vaccines in the 2-18 age group. Bharat Biotech sincerely thanks DCGI, SEC, and CDSCO for their expedited review. We now await further regulatory approvals from CDSCO," the Hyderabad-based pharmaceutical company said in a statement. SEC examined the data and took up the EUA application on Monday.

The official cited earlier said on condition of anonymity that the committee has recommended granting market authorization to the vaccine for 2 to 18-year-olds for restricted use in emergency situations subject to certain conditions. The recommendations have been sent to DCGI for final approval, the official added.

SEC had reviewed the interim safety data of the phase 2/3 clinical trial on 26 August. 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 said. GMT is a measure of neutralization of the virus by antibodies.

SEC has asked the company to continue the studies as per the approved clinical trial protocol and provide updated prescribing information/package insert (Pl), summary of product characteristics (SmPC) and factsheet, the official added. The recommendations say the company should also update the drug regulator on any adverse event following immunization (AEFI).

Doctors have welcomed the move, as schools across the country await reopening. “This will be a major step as school, coaching centres and sports 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 comes down even in case they end up contracting covid," said Dr. Akshay Budhraja, senior consultant, pulmonology at Aakash Healthcare in New Delhi’s Dwarka.


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