The Drugs Controller General of India (DCGI) has granted emergency use authorisation to indigenously-developed Bharat Biotech's Covaxin for children above 12 years with certain conditions, official said on Saturday.
It 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 government, however, has not taken any decision on vaccinating children against Covid-19.
The National Expert Group on Vaccine Administration for Covid-19 and National Technical Advisory Group on Immunization are deliberating and considering scientific evidences related to vaccination of those in the 12-17 age group, the Centre recently informed Parliament.
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 said.
The DCGI gave its approval Friday, the official said.
"... 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.
It 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.
Reacting to the development, Bharat Biotech in a statement said, "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."
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.
In July, it had granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.