FDA- PATH announce vaccine collaboration on pneumococcus

The U.S. Food and Drug Administration (FDA) announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. The project is expected to run for two years and 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. PATH “will help the FDA obtain materials needed for the agency to develop the conjugate vaccine technology, and will 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 stated 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.”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199479.htm

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