The global health non profit PATH launched a five-year effort to make sure that new cervical cancer vaccines-the first vaccines developed and approved just for women's health-reach women in the developing world. A quarter-million women, most of them from the world's poorest countries, die of cervical cancer each year. The new vaccines protect against human papillomavirus (HPV), the virus that causes most cervical cancer case.

"Cervical cancer disproportionately affects women in developing countries because infrastructure is lacking. Local health systems don't support preventive care like routine Pap smears," explained PATH programme director Dr. Jacqueline Sherris. "While simpler screening approaches are emerging, vaccines are the best hopes for lowering the death toll of this disease in the long run, and could even make rates in the developing world as low as in wealthier countries."

In order to get these vaccines to communities, ministries of health in developing countries must have the evidence they need to justify allocating resources to new vaccines, and plans must be made to integrate the new cervical cancer vaccines into existing health programmes or new immunization initiatives.

With a $27.8 million grant from the Bill & Melinda Gates Foundation, PATH will conduct programme research in India, Peru, Uganda, and Vietnam to gather the evidence countries need to make informed decisions about how to introduce the vaccine. PATH will help plan for and pilot introduction in the four countries, with the goal of informing regional and global vaccine introduction efforts and international financing plans.

"The pharmaceutical industry has demonstrated great leadership in developing vaccines to prevent cervical cancer," said Dr. Regina Rabinovich, director of infectious diseases at the Gates Foundation. "PATH will help determine how to deliver these vaccines in developing countries, where systems to reach young women with health services are fragile, and cervical cancer may not be seen as a problem because so few women are screened."

PATH will collaborate with international agencies and government officials in the four countries, and with industry partners Merck & Co., Inc., and GlaxoSmithKline Biologicals. Both pharmaceutical companies are expected to have approved vaccines available, and they will provide them to the demonstration projects.

"Merck is pleased to collaborate with PATH to explore the most effective and expeditious ways to bring the benefits of HPV vaccines to individuals living in developing countries," said Dr. Mark Feinberg, Vice President for Medical Affairs and Health Policy for the Merck Vaccine Division. "Given the significant burden of cervical cancer in the developing world, PATH's initiative to define effective strategies for overcoming the formidable challenges to successful implementation of HPV vaccines in resource-poor countries is a critical step at the vanguard of what needs to be a comprehensive and highly collaborative effort by the global public health community."

"This grant represents a major step forward in the battle against cervical cancer worldwide," said Jean Stéphenne, President of GlaxoSmithKline Biologicals. "Cervical cancer kills a quarter of a million women each year, mostly in poor countries, and these vaccines have enormous lifesaving potential. We are committed to engaging with PATH to find productive ways we can contribute to this important effort."

India, Peru, Uganda, and Vietnam were selected for this effort because ? among other reasons ? they have a commitment to projects aimed at preventing cervical cancer, and they have effective childhood vaccine programmes. Lessons learned from these countries could be applied to countries with similar cultural, economic, and health contexts.

PATH will address several issues specific to introducing an HPV vaccine in the developing world. The vaccine would best be given to preadolescents or adolescents, and these groups rarely access health systems. Also, because genital HPV is common sexually transmitted infection, international health experts anticipate that some communities may view the vaccine as condoning early sexual activity. Some communities may also be reluctant to adopt what might be perceived to be a "girls only" vaccine. PATH will conduct research on community attitudes on these issues, in order to develop appropriate introduction approaches for each country.

While conducting this work, PATH will also coordinate closely with the World Health Organization, the International Agency for Research on Cancer, Harvard University, the Catalonian Institute of Oncology, and other key partners.

Cervical cancer is a preventable disease, affecting an estimated 490,000 women each year and leading to more than 270,000 deaths. About 85 percent of women dying from cervical cancer reside in developing countries. If current trends continue, by 2050, there will be more than one million new cases annually.

Genital HPV is the primary cause of cervical cancer. Two high-risk HPV types-16 and 18-account for approximately 70 percent of cervical cancer cases worldwide. In clinical trials, vaccines against these types were at least 95 percent effective in preventing persistent HPV infection and 100 percent effective in preventing type-specific cervical lesions.

PATH has been working to prevent cervical cancer since the mid-1990s, when the organization first began researching the problem and raising awareness at international for a. From 1999 to 2004, PATH served as the coordinating agency for the international Alliance for Cervical Cancer Prevention and conducted pilot projects on innovative ways to bring screening and treatment to low-resource settings in Kenya and Peru.

Since 2005, PATH has been working with vaccine manufacturers, the World Health Organization, and other global agencies, researchers, and country officials to identify the issues that must be addressed to introduce an HPV vaccine in the developing world. This latest effort will build on that work and allow PATH to put that knowledge into practice.