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

 
• By Sue Sutter

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.

Rock climber
Convincing the US FDA that data support an EUA for pediatric use of Covaxin could be a multi-pitch effort for Ocugen. • Source: Alamy

Ocugen Inc.’s request for emergency use authorization of the COVID-19 vaccine Covaxin in children and adolescents appears to lack alignment with US Food and Drug Administration recommendations on the amount and type of data it expects to see in a pediatric vaccine EUA request.

Based upon the FDA’s publicly disclosed evidentiary expectations, there are several aspects of Ocugen’s data package that put it at a severe disadvantage

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