Bharat Biotech’s Covaxin has been given emergency use approval by the Covid-19 Subject Expert Committee (SEC) for children aged 2 to 18. In September, Hyderabad-based Bharat Biotech completed Phase 2 and Phase 3 studies of Covaxin on children under the age of 18 and submitted the trial data to the Drugs and Comptroller General of India (DCGI). The committee recommended that the vaccine be granted market authorization for the age category of 2 to 18 years for restricted use in emergencies, as per a statement from the topic expert panel.
The vaccine, which was developed in India, would be given in two doses, with a 20-day interval between the first and second doses. Bharat Biotech announced in a statement that the clinical trial data it filed had been properly examined by the Central Drugs Standard Control Organisation (CDSCO) and the SEC, who both gave good recommendations. This is one of the first global approvals for Covid-19 vaccinations for children aged 2 to 18. Bharat Biotech expresses its gratitude to the DCGI, the Subject Experts Committee, and the CDSCO for expediting the review process. Before the commercial introduction and market availability of Covaxin for children, we are awaiting additional regulatory clearances from the CDSCO, as per the vaccine producer.
However, the emergency usage authorization is subject to specific restrictions. The study will be continued as per the authorized clinical trial protocol for the Whole Virion, Inactivated Corona Virus Vaccine. It will be required to give updated prescription information in the form of a package insert (PI), a summary of product characteristics (SmPC), and a factsheet. Furthermore, the company will provide safety data, including AEFI and AESI data, every 15 days for the first two months and then monthly afterward, as required by the New Drugs and Clinical Trials Rules, 2019.
Covaxin’s emergency use authorization has yet to be granted by the WHO. Bharat Biotech allegedly submitted all needed paperwork to the WHO by July 9, and the WHO review procedure, which takes around six weeks, had begun by the end of July. India had already given emergency use permission to ZyCov-Covid-19 D’s vaccination for youngsters aged 12 to 18 in August. Zydus Cadila, a pharmaceutical company, created the vaccine, which is the world’s first DNA vaccine to be licensed.
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