Policy analysis: an essential research tool for the introduction of vaccines in developing countries.

To address the unacceptable levels of disease in developing countries and the lack of vaccines to address infectious diseases, the public sector has been expanding its funding for, and involvement in, vaccine research and development. The public sector is becoming a full participant in the spectrum of translational research taking candidates from the laboratory to use in national immunization programmes. As these programmes and the continuing work of the private sector achieve success, an extensive analysis of policy will be needed to support the introduction of vaccines. Based on the early experience with the introduction of hepatitis B vaccine in several developing countries, there is a defined framework for the introduction of vaccines. This framework lays out five essential overlapping and complementary elements of introduction of vaccines in developing countries. Each element requires a clear understanding of policy-related issues. There is a pressing need to include and expand policy analysis on a wide range of topics to ensure that the poor in developing countries can have access to the fruits of modern biotechnology.