An expert panel of the Central Drug Authority has recommended granting emergency use authorisation to Bharat Biotech's Covaxin for children in the 2 to 18 years age group with certain conditions. With this, Covaxin becomes the first COVID-19 vaccine that can be administered to children in India.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid 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 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 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 Drugs Controller General of India (DCGI) for final approval.
The company 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 the 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 August 26.
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 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, a source said. 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.
Bharat Biotech in a statement said that it had submitted data from clinical trials in the 2-18 years age group for COVAXIN to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations. "This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of COVAXIN for Children."
Meanwhile, the World Health Organisation (WHO) is yet to take a call on granting Emergency Use Listing (EUL) status for Covaxin. The global health body is likely to a final call this week. Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional info at WHO’s request on September 27. WHO experts are currently reviewing this info & if it addresses all questions raised, the WHO assessment will be finalized next week.
According to the WHO, its officials and an independent group of experts are scheduled to meet this week to carry out the risk/benefit assessment before taking a final decision on whether to grant Emergency Use Listing to Covaxin. The Emergency Use Listing process - done by WHO and the Technical Advisory Group of independent experts - is centred on determining if a manufactured product is quality-assured, safe and effective.
The indigenously developed Bharat Biotech's Covaxin is one of the six vaccines that have received emergency use authorisation from India's Drug Regulator and is being used in the nationwide anti-COVID-19 inoculation programme along with Covishield and Sputnik V.