FDA and PATH collaborate to advance pneumococcal vaccine development for children

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.

"CBER will use its scientific expertise to develop technology for a vaccine against pneumococcal disease that is safe and effective," said Karen Midthun, M.D., acting director of the FDA's CBER. "The collaboration with PATH is an example of how the FDA applies technologies it develops to public health issues in the United States and throughout the world under the agency's Critical Path Initiative."
The goal of the FDA's work is to improve the efficiency of a key technology in the development of pneumococcal conjugate vaccine candidates. The technology is used to link a piece of the bacterium's surface coating, a polysaccharide made up of long chains of sugars, to a special molecule called a carrier protein in a  process called conjugation.

When carrier proteins are joined with the polysaccharides, they significantly increase the strength of the immune response. Without these proteins, the polysaccharides by themselves would not trigger an adequate immune response in young children.

CBER conjugation technology has already been used by the Meningitis Vaccine Project—a partnership between PATH and the World Health Organization—for the development of a conjugate vaccine to prevent meningococcal meningitis in Africa.