Bharat Biotech's Covaxin Get DCGI Nod For Emergency Use For Children Aged Above 12 Yrs

The vaccine of Bharat Biotech was trialed in children in phases 2 and 3 and the subject expert committee had recommended it to be given to children.

(File Photo/ Getty)

New Delhi: In yet another boost to India's vaccination spree, the Drugs Controller General of India (DCGI) has given emergency use approval to Bharat Biotech's vaccine - Covaxin - for children aged between 12-18 years, official sources told ABP News.

The vaccine of Bharat Biotech was trialed in children in phases 2 and 3 and the subject expert committee had recommended it to be given to children.

The vaccine trial was divided into three age groups: 2 to 6, 6 to 12 and 12 to 18 years.

Covaxin is already included in the vaccination program and is being given to people over the age of 18.

Covaxin is the second vaccine to receive the regulator's nod for use among those below 18 years after Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D.

The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on October 11 after deliberating Bharat Biotech's emergency use authorisation (EUA) application had recommended granting emergency use approval to Covaxin for use in the 2-18 years age group with certain conditions.

"The recommendations of the SEC were further evaluated and examined after which DCGI had sought additional data from the firm," an official told news agency PTI.

"Based on the recommendations of SEC experts and submission of additional safety data, this directorate has no objection at this stage for additional indication of Whole Virion inactivated corona virus vaccine for use in age group of more than 12 years to 18 years with the dose schedule of 0 and 28 days for restricted use in emergency situation with the condition to submit SmPC, PI, Factsheet incorporating clinical information for said age group along with pharmacovigilance & risk management plan," the DCGI approval order issued said.

Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covaxin for use among those aged between 2 and 18 years, had submitted the data to CDSCO for its verification and subsequent approval for emergency use authorisation EUA for the jab in the beginning of October.

"Covaxin is formulated uniquely such that the same dosage can be administered to adults and children. Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants. We have documented excellent safety and immunogenicity data readouts in children. We look forward for Covaxin to provide similar levels of protection for adults and children alike," Bharat Biotech said in its statement.

The DCGI on September 1 granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trial of its made in India COVID-19 vaccine on children and adolescents aged between 5 and 18 years with certain conditions.

(With inputs from PTI)