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Memórias do Instituto Oswaldo Cruz
Fundação Oswaldo Cruz, Fiocruz
ISSN: 1678-8060
EISSN: 1678-8060
Vol. 110, No. 1, 2015, pp. 114-124
Bioline Code: oc15010
Full paper language: English
Document type: Review Article
Document available free of charge

Memórias do Instituto Oswaldo Cruz, Vol. 110, No. 1, 2015, pp. 114-124

 en 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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