The US Food and Drug Administration (FDA) has announced a collaboration with non-profit organisation PATH to develop a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially deadly pneumonia.
The collaboration aims to improve the techniques used to produce effective, safe and affordable vaccines for children in the developing world, of which 1 million younger than five are killed by the bacterium every year.
The collaboration with PATH, which creates sustainable, culturally relevant and affordable solutions to help communities break the cycles of poor health, is expected to run for two years and is being conducted under the Cooperative Research and Development Agreement (CRADA) programme.
Under the agreement, PATH will help the FDA obtain materials to develop the conjugate vaccine technology and PATH will provide approximately $480,000 to the FDA for the development of the conjugation technology and tests to determine if the carrier proteins are properly linked to the polysaccharides.
FDA Center for Biologics Evaluation and Research (CBER) acting director Karen Midthun said that CBER will use its scientific expertise to develop technology for a vaccine that is safe and effective.
“The collaboration with PATH is an example of how the FDA applies technologies it develops to public health issues under the agency’s Critical Path Initiative,” Midthun said.
The goal of the CRADA is to evaluate the application CBER conjugation technology to pneumococcal vaccines.
Under the CRADA programme, if any research shows promise in 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.