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COVID-19 Vaccines: Ocugen’s EUA Request For Covaxin In Kids Faces Steep Climb At US FDA

Executive Summary

Company says it is pursuing authorization for 2-18 year-olds due to unmet need and lack of an authorized vaccine in the youngest age group; however, the relatively small size of the safety database, the single-arm design of the pediatric immunobridging study conducted solely in India, and lack of authorized use in adults spell trouble for the request.

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