An expert panel of India's Central Drug Authority has recommended emergency use of Bharat Biotech's Covaxin for children in the 2-18 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 Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month.
Bharat Biotech 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.
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 2 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.
The committee noted that 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 phase -3 efficacy study, the recommendations stated.
After detailed deliberation, the committee recommended the grant of market authorisation 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 (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 requirement of New Drugs and Clinical Trials Rules, 2019, according to the recommendations.
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.
The DCGI in July also 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.
Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella, had said on September 21 that the Paediatric Covaxin completed phase 2/3 trials with about 1,000 subjects and the data analysis was going on.
As part of the Phase II/III trial, the two-dose Covaxin was administered with 28 days apart. He also had said that Phase 2 trials of intranasal vaccine to prevent COVID-19 were going on and expected to be over in October.
Meanwhile, the World Health Organization on Monday recommended that immunocompromised people be given an additional dose of COVID-19 vaccine, due to their higher risk of breakthrough infections after standard immunisation.
The Indian government said the developments are being closely watched as the science relating to booster doses of Covid vaccines still being evolved.
NITI Aayog Member (Health) Dr V.K. Paul said there are several studies that are looking into the subject of booster doses.
"This is an evolving science and a paradigm of information...that data is still emerging. We are watching this science very very carefully through our NTAGI system. We know that COVAXIN has done a study on booster doses and those results can be available anytime. We are also aware that although the antibody can disappear, the presence of T-cell immunity is a huge protection that also has to be accounted for," he said.
"We also know that WHO has not given a clear-cut recommendation on the matter. The situation is that it is an evolving, learning phase and we are watching science as it emanates and in India also, there are studies which are looking at this aspect," Paul said.
