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Federal University of Minas Gerais Brazil, Brazil
Title: Ethical issues in the production, design and clinical trials of new vaccines for emerging diseases in low income countries

Bachelor degree in Biological Sciences from Universidade Federal do Paraná (1975), masters Degree in Genetics from Universidade Federal do Paraná (1986) and PhD in Biochemical and Molecular Pharmacology from Universidade Federal de Minas Gerais (2005) and Post-Doc in Bioethics in Clinical Research ( Facultad Latino Americana de Ciências Sociales, FLACSO, Argentina). Has experience in Immunology, focusing on Applied Imunology, acting on the following subjects: Immunology and Public Health. Chair Ethics Commitee in Research at Universidade Federal do Paraná and member of Group of Studies in Bioethics ( NEB) , Curitiba, PR


Statement of the Problem: Since first developed by Jenner and Pasteur vaccines have shown to be an important tool for the eradication (cow pox) and prevention of communicable diseases with high morbidity and mortality rates, and became one component of public health policies. However, good quality housing, appropriate disposal of sewage, nutrition, education and adequate sanitary conditions have also been an important determinant in health promotion. In this way, upper level societies have witnessed a significant reduction of diseases such as zoonosis, communicable diseases and vector born infections. Nevertheless, populations in low income countries still face poor sanitary and living conditions which contribute to the emergence of new diseases. Recently countries in Latin America witnessed the epidemics of a vector borne viral infection that resulted in microcephaly to the fetuses born from infected women. Purpose: The purpose of this text is to present a reflection on the life conditions of these populations, their vulnerability, the need for new vaccines, the public health policies to be implemented and the ethical issues to be considered in this reality. Methodology: An analysis on the ethical issues concerning the development of new vaccines and their trials in low income countries. Conclusion & Significance: It is undeniable all benefits that have been reached in health promotion through immunization protocols worldwide. However insufficient supply, the rationale of use and distribution of vaccines in low income countries, the health condition of the participants in the trials, inclusion and exclusion criteria, the comparative arm, the inclusion of pregnant women, risks and benefits, the availability of the final product once trial is finished and the voluntary or compulsory character of immunization are some of the ethical issues that deserve consideration in the development and distribution of vaccines as a part of public health policies in low income countries.

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