The US Food and Drug Administration (FDA) has announced a collaborative project with PATH (Program for Appropriate Technology in Health) to advance development of a vaccine to protect children in developing countries against diseases caused by Streptococcus pneumoniae.
The bacterium is responsible for pneumonia and other pneumococcal infections of the brain (meningitis), blood (sepsis) and middle ear (otitis media), killing around one million children under the age of five each year.
The FDA is looking to improve the efficiency of conjugation technology used in the development of pneumococcal vaccine candidates. The ultimate goal is safe, effective and affordable vaccines against pneumoccal disease that can be given to children in developing countries.
The collaboration with PATH, an international non-profit organisation based in Seattle, US, is being pursued under the Cooperative Research and Development Agreement (CRADA) programme, which enables federal laboratories and businesses to form partnerships that help to expedite research activities. The project is expected to run for two years.
PATH will help the FDA obtain the materials it needs to develop the conjugate vaccine technology. PATH will also provide the agency with funding of around US$480,000 for development both of the conjugation technology and of tests to determine whether the carrier proteins involved in the process are properly linked to polysaccharides.
If the resulting technology has potential to deliver safe, effective and affordable pneumococcal vaccines, the CRADA permits its transfer to the China National Biotec Group’s Chengdu Institute of Biological Products, and eventually to groups in other developing countries as appropriate.
The conjugation technology will be developed by the FDA’s Center for Biologics Evaluation and Research (CBER). The Meningitis Vaccine Project, a partnership between PATH and the World Health Organization, has already used CBER conjugation technology to develop a vaccine against meningococcal meningitis in Africa.
