Historical review of clinical vaccine studies at Oswaldo
Cruz Institute and Oswaldo Cruz Foundation - technological development
issues |
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Authors: | Reinaldo de Menezes Martins Cristina de Albuquerque Possas Akira Homma |
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Institution: | Conselho Político e Estratégico, Bio-Manguinhos-Fiocruz, Rio de Janeiro, RJ, Brasil |
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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. |
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Keywords: | clinical studies vaccines technological development innovation regulatory barriers |
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