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Countries Face Tough Decisions on Making Cervical Cancer Vaccine

With vaccines against the virus that causes most cases of cervical cancer, a disease that kills more than 250,000 women each year, now on the market, the United Nations health agency today stressed the tough decisions countries face before making the vaccine widely available, including cost-effectiveness, delivery and education.

"Even for developed countries, cost is a major barrier to making the vaccine widely available," the UN World Health Organization (WHO) <"http://www.who.int/bulletin/volumes/85/2/07-020207/en/index.html">said in a news release, noting that developing countries, where the vast majority of deaths from the disease occur, face additional hurdles, such as not having a complete set of epidemiological data or a mechanism to deliver the vaccine.

The market price for Merck's Gardasil for human papillomavirus (HPV), approved by the United States Food and Drug Administration last year, is about $90 a dose for each of a three-dose series, and that is before agents' fees.

The vaccine, so far been approved in 49 countries, with more expected to join the list this year, gives 100 per cent protection against infection from HPV types 16 and 18, responsible for 70 per cent of all cervical cancers. It also protects against HPV types 6 and 11 that cause genital warts.

"The HPV vaccine is no magic bullet: it has the potential to substantially reduce the prevalence of cervical cancer, but not to eradicate it," WHO cautioned. But it noted that it is on the agency's prequalification list, which could open the door to purchases in developing countries via UN agencies.

"There are challenges for countries in terms of cost and so on, but this vaccine is unique and offers tremendous possibilities," WHO coordinator for the Initiative for Vaccine Research, Product Research and Development team Teresa Aguado said.

Cervical cancer is the second most common type of cancer among women, with deaths projected to rise by almost 25 per cent over the next 10 years, according to WHO. In 2005 there were more than 500,000 new cases, 90 per cent of them in developing countries. Left untreated, invasive cervical cancer is almost always fatal.

In December, the UN Population Fund (<"http://www.unfpa.org">UNFPA) stressed the need for funding to make the vaccine available in the developing world and WHO Assistant Director-General for Health Technology and Pharmaceuticals Howard Zucker told a London conference it could save hundreds of thousands of lives if delivered effectively in developing countries.

Last year, WHO issued policy, programme and technical notes, driving home the need to educate governments, health professionals and the public about both viruses and vaccines, and the importance of collaboration between reproductive health, immunization, child and adolescent health and cancer control programmes.

"The guidelines make it clear that partnership between health programmes is vital for a coordinated introduction of the vaccine," WHO Department of Reproductive Health and Research official Nathalie Broutet said today. "Vaccine introduction gives these programmes the opportunity to deliver other interventions while immunizing against HPV."

This year promises to be significant for HPV vaccination with WHO's six regions planning meetings on the issues, starting with one in April of WHO experts and government officials from South-East Asia and the Western Pacific.

Developing countries that acquire the vaccine would need to decide whether to start vaccinating females alone or both adolescent girls and boys. The most successful vaccination programmes have been community-wide and avoid any stigma associated with single sex vaccination, but the cost may restrict HPV vaccination to girls, especially since clinical data on efficacy in boys are still being gathered.

A second question is how to reach the population. Although the vaccine is approved for women up to the age of 26, it is generally considered to be best administered at the age of nine to 13 years, before girls become sexually active and potentially exposed to HPV.

"For countries where schools are well attended by girls, a school-based vaccination programme can be the answer. Otherwise, alternatives for vaccine delivery will have to be identified and tailored to the country context," Ms. Aguado said.

Promoting an anticancer vaccine and, at the same time, making it clear that <"http://www.who.int/reproductive-health/publications/hpvvaccines/index.html">HPV is a sexually transmitted infection will require deft handling in the wording of policy, education and publicity materials.

"Screening and treatment services will still be required, because the vaccines only prevent about 70 per cent of cervical cancer cases and because it will be years, if not decades, before we see the full benefit of vaccination in terms of a reduction in the incidence of cervical cancer," Andreas Ullrich, medical officer with WHO's department of Chronic Disease and Health Promotion, said.

Source: United Nations