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Historical review of clinical vaccine studies at Oswaldo Cruz Institute and Oswaldo Cruz Foundation - technological development issues
de Menezes Martins, Reinaldo; de Albuquerque Possas, Cristina & Homma, Akira
Abstract
This paper presents, from the perspective of technological development and production, the results of an investigation
examining 61 clinical studies with vaccines conducted in Brazil between 1938-2013, with the participation
of the Oswaldo Cruz Institute (IOC) and the Oswaldo Cruz Foundation (Fiocruz). These studies have been identified
and reviewed according to criteria, such as the kind of vaccine (viral, bacterial, parasitic), their rationale,
design and methodological strategies. The results indicate that IOC and Fiocruz have accumulated along this time
significant knowledge and experience for the performance of studies in all clinical phases and are prepared for the
development of new vaccines products and processes. We recommend national policy strategies to overcome existing
regulatory and financing constraints.
Keywords
clinical studies; vaccines; technological development; innovation; regulatory barriers
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