Historical review of clinical vaccine studies at Oswaldo Cruz Institute and Oswaldo Cruz Foundation - technological development issues

This paper presents, from the perspective of technological development andproduction, the results of an investigation examining 61 clinical studies withvaccines conducted in Brazil between 1938-2013, with the participation of the OswaldoCruz Institute (IOC) and the Oswaldo Cruz Foundation (Fiocruz). These studies havebeen 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 timesignificant knowledge and experience for the performance of studies in all clinicalphases and are prepared for the development of new vaccines products and processes.We recommend national policy strategies to overcome existing regulatory and financingconstraints.