The Food and Drug Administration Approves the HPV Vaccine

By Kristen Suthers, Ph.D.

In June, the Food and Drug Administration (FDA) approved a Human Papilloma Virus (HPV) vaccine for protection against cervical cancer and genital warts. This HPV vaccine is a very important contribution to the fight against cervical cancer. The research that Merck, manufacturer of the vaccine, has conducted to date shows the vaccine to be highly effective and safe. In approving it, the FDA followed the unanimous recommendation of the FDA’s scientific advisory committee that evaluated the application. The NWHN is pleased to see that the FDA followed a science-based process for approving this product.

There are more than 30 known types of HPV that can be passed through sexual contact. While most HPV infections are harmless, some strains increase the risks for genital diseases, including cervical cancer, genital warts, or precancerous lesions. Two strains, HPV-16 and HPV-18, cause an estimated 70 percent of cervical cancers. HPV is the most common sexually transmitted infection in the United States, and more than 20 million adults currently are infected. Worldwide, 50 percent of sexually active people are estimated to have HPV during their lifetime; 70 percent of all women who develop cervical cancer have either HPV-16 or HPV-18. It is important to note, however, that not all women who are infected with HPV-16 or HPV-18 will develop cervical cancer. In the vast majority of cases, women clear an HPV infection with no ill effects.

The vaccine that was approved in June, Gardasil, prevents infection with HPV-16 and HPV-18, and protects against two other strains of HPV that cause genital warts (HPV-6 and HPV-11). Gardasil, which is provided in three doses, has been approved for women between the ages of 9 to 26. The pharmaceutical company GlaxoSmithKline is also developing a vaccine, called Cervarix, to protect against HPV-16 and HPV-18. Cervarix is not yet available in the United States; clinical trials are currently ongoing in Costa Rica

What the Vaccine Means for Women’s Health

The approval of the HPV vaccine provides an opportunity to make significant progress in preventing cancer in women. The enormous potential of this technology will only be realized, however, if the vaccine is accessible to women who are at greatest risk for cervical cancer: women who face economic, linguistic, and other barriers to health care services. Women’s health advocates are now looking to the Centers for Disease Control and Prevention (CDC) to take the vital steps necessary to ensure that the vaccine is widely available to those who can benefit most from it.

In June, 2006, the CDC’s Advisory Committee on Immunization Practices recommended that the HPV vaccine be incorporated into routine vaccination schedules so that the protection it offers will become established as standard of care. Because the vaccine does not protect against HPV once a person has been exposed to it, it is important for women and girls to receive it before they become sexually active.

The Advisory Committee recommendation is an important first step in the CDC making the vaccine accessible to those who can most benefit from it. The NWHN calls upon the CDC to continue to provide leadership in the programmatic challenges associated with ensuring that the vaccine is available and accessible to women who are most at risk for cervical cancer. The NWHN has also called on Merck to support initiatives to make both vaccinations and cervical cancer screening available to women who are most at-risk.

Finally, while this vaccine significantly decreases a woman's chance of developing cervical cancer, it does not offer 100 percent protection, as it does not prevent infection by all of the cancer-causing strains of HPV. Even women who get vaccinated must continue to be screened regularly for cervical cancer through Pap tests. Therefore, while the NWHN recognizes the vaccine’s enormous potential to enhance women’s health, we also call on all public health organizations to reinforce the importance of continued Pap tests for all women. Regardless of whether a woman decides to get the vaccine for herself or her daughter, she should continue to receive regular exams and Pap tests to detect any abnormalities that could lead to cervical cancer or other reproductive problems.

Kristen Suthers is the NWHN’s Menopause & Aging Program Specialist. She serves on the National Cancer Institute-funded oversight committee for the Cervirex study.