Issues (Archived 04/20/2006)

Vaccine Technology Developed by FDA Scientists Licensed by NIH OTT to PATH for Developing Country Use

On March 15, 2006, the Meningitis Vaccine Project and the Serum Institute of India announced the successful completion of Phase I clinical trials of a new conjugate vaccine against meningitis A, a bacterium that causes deadly epidemics in sub-Saharan Africa. According to the Meningitis Vaccine Project, a partnership between the World Health Organization and the non-profit organization PATH, these results set the stage to pursue Phase II clinical studies later this year, following regulatory approval, such that a vaccine could be introduced in Africa in the next few years.

The underlying technology for the meningitis A conjugate vaccine was developed by scientists at the FDA's Center for Biologics Evaluation and Research. NIH's Office of Technology Transfer licensed this technology to PATH for development of the vaccine.

Meningitis is an infection of the thin lining that surrounds the brain and spinal cord. The disease may be transmitted from person to person through coughing, sneezing, and living in close quarters. At least 10 percent of infected patients, even if treated with antibiotics, die from the illness, while up to 20% of patients suffer brain damage, hearing loss, and other complications, according to the Meningitis Vaccine Project.