Planning for the Promise of HPV vaccines

With a one-year grant from the Bill & Melinda Gates Foundation, PATH is planning activities to accelerate access to human papillomavirus (HPV) vaccines in developing countries. Efforts include:

• Building partnerships with industry.
• Evaluating the investment case for financing HPV vaccines in developing countries.
• Developing criteria for and identifying potential early-introduction countries.
• Synthesizing information from four developing countries on sociocultural, logistical, policy, and clinical needs related to HPV vaccine introduction.
• Identifying available information on the HPV vaccine and key information needs.

A Coordinated Approach to HPV Vaccine Introduction

In addition to PATH's activities, Harvard University, the International Agency for Research on Cancer, and the World Health Organization (WHO) also are preparing for HPV vaccine introduction in low-resource settings. The collective activities of these four organizations, funded by the Bill & Melinda Gates Foundation, represent a coordinated strategy for exploring how to make HPV vaccines available, acceptable, and affordable to those most in need. Read WHO's June 2005 press release.

Why HPV vaccines?

HPV is the primary cause of cervical cancer, a preventable disease that kills more than 270,000 women each year. Most of these deaths and the estimated half a million cervical cancer cases that occur yearly take place in developing countries. Research to date suggests that vaccines against HPV, available in the developed world as early as 2006, are likely to be highly effective in preventing HPV infection, high-grade cervical lesions, and cancer. Decision-model analysis suggests that an HPV vaccine has the potential to reduce the total burden of cervical cancer by 51 percent over a 40- to 50-year period.

These encouraging preliminary study results must be met with efforts to address the technical, political, social, economic, and logistical challenges in providing HPV vaccines to developing countries. A collaborative effort among industry, the public sector in developing countries, global vaccine distributors, and other key stakeholders is needed to ensure access to these promising vaccines.

Current vaccine candidates are being developed to protect against HPV types 16 and 18, the oncogenic types that are believed to be responsible for about 70 percent of cervical cancer. One vaccine candidate protects against HPV types 6 and 11, which cause genital warts. Because some 30 percent of cancers are caused by other HPV types, women can still become infected with other cancer-causing HPV types, even if the vaccines are completely effective. Additionally, the impact of a vaccine on reducing cervical cancer mortality, particularly if administered to young adolescents, will not be measurable for decades to come—the amount of time it would take for girls to reach an age when they might otherwise have developed cancer. Therefore, new vaccines will need to be introduced in conjunction with other prevention strategies, such as screening and treatment of precancer.

Read our HPV Vaccine Fact Sheets:

• A Status Report on Human Papillomavirus Vaccines
• HPV and Cervical Cancer: Unique Challenges and Opportunities for Disease Prevention
• Introducing HPV Vaccines in Developing Countries: Overcoming the Challenges

For more information on cervical cancer prevention, view the Alliance for Cervical Cancer Prevention publications.

Current Status of First Generation Vaccines

 

Manufacturer	Vaccine type	HPV types	Status	Study characteristics
Merck & Co., Inc.*	L1 VLP based on recombinant yeast technology	16, 18, 6, 11	Phase III underway; regulatory submissions expected late 2005.	Enrolled 23,000 women and children to date in North America, Latin America, Europe, Southeast and East Asia, Australia, and New Zealand
GlaxoSmithKline (GSK)*	L1 VLP (Cervarix™) based on recombinant baculovirus technology	16, 18	Phase III underway; regulatory submission expected in 2006.	15,000 women aged 18–25 in Costa Rica (run by NCI**); 13,000 women aged 15–25; multicenter representing four continents

*These manufacturers’ HPV vaccines are the closest to being introduced in developing country markets.

**United States National Cancer Institute

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