Pneumococcal Conjugate Vaccine Development Aided by FDA Collaboration

The US Food and Drug Administration will collaborate with PATH, an international nonprofit organization based in Seattle, to advance development of a conjugate vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. The collaboration aims to improve the techniques used to produce effective, safe, and affordable conjugate vaccines against pneumococcal disease for children in the developing world.

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 of long chains of sugars, to 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.

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. If the conjugation technology 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. The goal of the CRADA is to evaluate the application of Center for Biologics Evaluation and Research (CBER) conjugation technology to pneumococcal vaccines.

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 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.