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On December 18, policymakers, researchers, and advocates gathered in PATH’s Washington, DC, office to take a critical look at the way that vaccine research and development can help to enhance capacity in developing countries. The breakfast event was the third in PATH’s Conversations in Global Health series—a venue for global health professionals and policymakers to gather and speak candidly about their challenges and successes in addressing key policy issues.

Dr. Marc LaForce of the Meningitis Vaccine Project (MVP)—a partnership between PATH and the World Health Organization (WHO)—and Dr. Tonya Villafana of the PATH Malaria Vaccine Initiative (MVI) described the role that their programs play in helping to enhance regulatory, manufacturing, and clinical trial capacity in developing and emerging countries.

Strengthening clinical trial capacity

The New England Journal of Medicine recently published very exciting news about one of the malaria vaccine candidates in MVI’s portfolio, Villafana noted. GSK Biologicals’ RTS,S/AS vaccine is currently the world’s most clinically advanced malaria vaccine candidate. In studies conducted with infants and young children, the vaccine was shown to provide significant protection against malaria. However, in order to reach this point, challenges surrounding clinical trial infrastructure, community acceptance, and partnership needed to be addressed.

As MVI helps to pave the way for clinical trials and eventual vaccine introduction, it works to build sustainable infrastructure in Africa by partnering with local scientists, policymakers, communities, and others. Local scientists and communities take a leadership role in the studies, increasing the knowledge and skills available for future clinical trials on other health topics.

Knocking out meningitis through manufacturing partnerships

Every January through July in the “meningitis belt” of sub-Saharan Africa, mothers stand at alert for signs that their children may be suffering from the disease. Meningitis can steal away a child’s life as soon as a day after the first symptoms are observed, LaForce said. While vaccines against strains of meningitis exist in the developed world, this region needs a different type of vaccine.

MVP has partnered with developing-country manufacturers to produce a vaccine that costs less than US$0.50 a dose—a highly effective, affordable solution to combating meningitis. To assure regulatory approval in the countries where the vaccine is needed and where it is manufactured, MVP has partnered with WHO to pursue and support regional regulatory forums and systems. Thus, in the process of producing a highly effective vaccine, MVP is encouraging the growth of both manufacturing and regulatory capacity in developing countries.

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Posted December 30, 2008.