PATH To Pay FDA $480,000 To Speed Creation Of Pneumococcal Vaccine For Developing World

Main Category: Immune System / Vaccines
Also Included In: Pediatrics / Children's Health;  Infectious Diseases / Bacteria / Viruses;  Regulatory Affairs / Drug Approvals
Article Date: 03 Feb 2010 - 5:00 PDT

email to a friend   printer friendly   opinions  

The FDA on Monday said it's entering into a collaboration with the nonprofit group PATH "to speed creation of a pneumococcal vaccine for children in developing nations," United Press International reports (2/1).

"The bacteria, Streptococcus pneumoniae, can cause fatal infections of the ear, lungs, blood and brain; worldwide, it kills almost one million children a year," the New York Times writes. According to the FDA, PATH, which receives funding from the Bill & Melinda Gates Foundation, will pay the agency $480,000 to perform a key step needed to build the vaccine, the New York Times reports (McNeil, 2/1).

According to an FDA press release, its goal "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 (2/1).

"While it unusual for a government agency to be paid by a charity, the work is being done under a law that lets federal laboratories speed outside research in some cases," the New York Times writes of the arrangement. "Ultimately, the plan is for the vaccine to be manufactured by the China National Biotec Group, which makes 80 percent of China's vaccines, and the hope is that it will be approved by the World Health Organization" (2/1).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

• Additional
• References
• Citations