Dengue Vaccines Regulatory Pathways: A Report on Two Meetings with Regulators of Developing Countries

摘要

The Pediatric Dengue Vaccine Initiative (PDVI) is a product development partnership (PDP) based at the International Vaccine Institute (IVI) in Seoul, Korea, and is supported by the Bill & Melinda Gates Foundation. PDPs are nonprofit entities that seek to accelerate the development, evaluation, and introduction of vaccines, drugs, devices, diagnostics, and other technologies to reduce the burden of disease in developing countries. They operate through partnerships with public and private organizations to assemble networks with the needed skills for the work required to achieve the goal of disease reduction. PDPs have been formed for vaccines against malaria, HIV, tuberculosis, meningitis, and other diseases, including dengue. PDVI's mission is to reduce the burden of dengue disease by accelerating the development, evaluation, and introduction of safe, effective, and affordable dengue vaccines. The PDVI collaborated with the Developing Countries' Vaccine Regulators Network (DCVRN) to convene two meetings in 2007 concerned with the regulatory issues that will need to be addressed to license dengue vaccine(s). (As of January 1, 2011, the Pediatric Dengue Vaccine Initiative is renamed the Dengue Vaccine Initiative Consortium and is composed of IVI, the Initiative for Vaccine Research of the World Health Organization, the International Vaccine Access Center of Johns Hopkins University, and the Sabin Vaccine Institute.)