In the news ... 2008

FDA approves new indication for HPV vaccine

by Alan McCord, September 16, 2008

This month the FDA extended the indications for using the HPV vaccine, Gardasil, to also include preventing vulvar and vaginal cancers. Gardasil was approved in 2006 to prevent HPV (human papillomavirus) infections in girls and women aged 9 to 26. Different types of HPV can cause genital warts as well as cancerous and pre-cancerous conditions, such as cervical and anal dysplasia.

Gardasil protects against four types of HPV: 6 & 11, which cause 80% of genital warts, and 16 & 18, which cause 70% of cervical cancers. HPV is the most common sexually transmitted infection in the US, so a vaccine that reduces its transmission can help reduce the number of genital cancers. About 11,000 cases of cervical cancer and more than 5,000 cases of vulvar and vaginal cancers are diagnosed each year.

The FDA reviewed data from Gardasil’s maker, Merck. In the follow-up of 15,000 women, two groups were compared: those who did and those who did not take Gardasil. In women who had not taken the vaccine, 10 had developed precancerous lesions of the vulva while another 9 had developed precancerous lesions of the vagina. All of these were due to HPV types 16 and 18. In those women who had taken Gardasil, no cases of these types of lesions were reported.

Though highly effective, Gardasil does not protect 100% of the women who take the vaccine, nor does it protect against HPV types that a woman has already been exposed to. Therefore, getting the HPV vaccine should not replace routine Pap smears and other gynecological screenings. These procedures are especially important for women with HIV to help them avoid possibly serious conditions since they are at higher risk for HPV infection and disease.

Gardasil is not approved for women older than 26 years of age due to insufficient information to support its use in this population.