Expert panel recommends emergency use approval for Covaxin in 2-18 age group
An expert panel of India's central drug authority has recommended granting emergency use authorisation to Bharat Biotech's Covaxin for children and adolescents in the two 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, which completed the Phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between two and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab at 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 authorisation of the vaccine for the age group of two to 18 years for restricted use in emergency situations subject to the 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 authorisation of its Whole Virion, Inactivated coronavirus Vaccine (BBV152) in the two to 18 years age group for restricted use in an emergency, along with the interim safety and immunogenicity data of Phase 2/3 clinical trial conducted.
The committee noted the interim safety data of the Phase 2/3 clinical trial was reviewed in a meeting on August 26, sources said.
The overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in the Phase 3 efficacy study, the recommendations stated.
After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the two to 18 years age group for restricted use in emergency 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 (Pl), Summary of Product Characteristics (SmPC), and Factsheet.
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 the requirement of 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, besides.
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 five and 18 years with certain conditions.
The DCGI, in July, also granted permission to Serum Institute of India (SII) for conducting Phase 2/3 trials of Covovax on children aged two to 17 years with certain conditions.