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Ocugen, Inc. has submitted a request to the US Food and Drug Administration for emergency use authorization (EUA) for their COVID-19 vaccine candidate for use in children aged 2-18 years.
Ocugen, Inc. has submitted a request to US Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate BBV152 for use in children aged 2 to 18 years. The submission is supported by an immuno-bridging clinical trial that was conducted in India. The vaccine a whole-virion, inactivated vaccine, which was manufactured using a Vero Cell platform.
The company submitted results from a phase 2/3, open-label, multicenter study that ran from May 2021 to July 2021 that evaluated the safety, reactogenicity and immunogenicity of the vaccine in pediatric volunteers aged 2 to 18 years. The participants were separated into 3 age groups: 2-6 years, 6-12 years and 12-18 years. Every participant was given 2 doses, 28 days apart. The results indicated a similar level of protection in the pediatric population to that seen in earlier adult trials. No serious adverse effects, such as myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions, were reported in the group. Reported adverse events were all mild to moderate in nature and typically resolved within 24 hours of onset.
1. Ocugen, Inc. Ocugen, Inc. announces submission of emergency use authorization request to the US FDA for investigational COVID-19 vaccine COVAXIN™ (BBV152) for children ages 2-18 years. Published November 5, 2021. Accessed November 5, 2021. https://ocugen.gcs-web.com/news-releases/news-release-details/ocugen-inc-announces-submission-emergency-use-authorization