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FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Children in Developing Countries
Date:2/1/2010

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.

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SOURCE U.S. Food and Drug Administration
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