The U.S. Food and Drug Administration (FDA) today announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.
Worldwide, the bacterium also causes infections of the brain (meningitis), blood (sepsis), and middle ear (otitis media) and each year kills about 1 million children younger than 5 years of age. The collaboration aims to improve the techniques used to produce effective, safe, and affordable vaccines against pneumococcal disease for children in the developing world.
PATH is an international nonprofit organization based in Seattle that creates sustainable, culturally relevant, and affordable solutions to help communities worldwide to break cycles of poor health.
The collaborative project, expected to run for two years, is being conducted under the Cooperative Research and Development Agreement (CRADA) program. The program allows federal laboratories and businesses to form partnerships that help expedite research activities.
Under the agreement, PATH will help the FDA obtain materials needed for the agency to develop the conjugate vaccine technology. PATH also will provide approximately $480,000 to the FDA for the development of both the conjugation technology and tests to determine if the carrier proteins are properly linked to the polysaccharides.
The goal of the CRADA is to evaluate the application of Center for Biologics Evaluation and Research (CBER) conjugation technology to pneumococcal vaccines. If it holds promise for fulfilling the goal of providing safe, effective, and affordable pneumococcal vaccines, the CRADA permits transfer of the technology to the China National Biotec Group's Chengdu Institute of Biological Products, and eventually to groups in other developing countries as appropriate.