NEW DELHI, 12 Oct: An expert panel of India’s central drug authority has recommended granting emergency use authorization (EUA) to Bharat Biotech’s Covaxin for children and adolescents in the 2 to 18 years age group, with certain conditions, sources said on Tuesday.
If approved by the drugs controller general of India (DCGI), it will be the second Covid-19 vaccine after Zydus Cadila’s needle-free ZyCoV-D to receive EUA for use in those below 18 years.
Hyderabad-based Bharat Biotech, which completed the Phase 2/3 trials of Covid-19 vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organization for verification and subsequent approval for EUA for the jab in the beginning of this month.
The subject expert committee (SEC) on Covid-19 examined the data and deliberated on the EUA application on Monday.
“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 certain conditions,” the SEC recommendations stated.
The recommendations have been forwarded to the DCGI for final approval.
Bharat Biotech had presented its proposal for grant of market authorization for 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 26 August, sources said.
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.
After detailed deliberation, the committee recommended the grant of market authorization 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, summary of product characteristics and fact sheet.
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 the New Drugs and Clinical Trials Rules, 2019, according to the recommendations.
So far, indigenously developed Zydus Cadila’s needle-free Covid-19 vaccine ZyCoV-D has received EUA from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.
The DCGI had on 1 September 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.
The DCGI in July also granted permission to the Serum Institute of India for conducting Phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions. (PTI)