FDA expands HPV vaccine approval for prevention of vulvar, vaginal cancers

Vulvar and vaginal cancers are rare, but the opportunity for prevention is an additional benefit of the HPV vaccine.

The FDA on Friday approved the HPV quadrivalent vaccine for the prevention of vaginal and vulvar cancers caused by HPV types 16 and 18 in girls and women aged 9 years to 26 years.

“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” Jesse L. Goodman, MD, MPH, director of the FDA’s center for biologics evaluation and research, said in a press release. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from vaccination against HPV.”

According to the CDC, HPV is the most common sexually transmitted infection in the United states and HPV types 16 and 18 cause 70% of cervical cancers, as well as some vulvar and vaginal cancers.

Study continuation

In continuation of Merck & Co. Inc.’s original studies, 15,000 participants were followed for an additional two years. Half of the study population received the HPV vaccine (Gardasil, Merck) and half received no vaccine (control group).

Data indicated the vaccine was highly effective in preventing HPV-related precancerous vulvar and vaginal lesions among women who tested negative for HPV types 16 and 18 at baseline.

Among the group that did not receive the vaccine, 10 participants developed precancerous vulvar lesions and nine developed precancerous vaginal lesions.

Researchers found no evidence for benefit among women who were infected before immunization.

The vaccine’s label has also been revised to indicate that available information is insufficient to support use of the HPV vaccine in women older than 26 years of age. Also, additional information has been added indicating the vaccine does not protect against diseases caused by HPV types not contained in the vaccine.

For more information, visit www.fda.gov/cber/products/gardasil.htm. – by Jennifer Southall

Overall, vaginal and vulvar precancers are a small component to the protective benefits of HPV4 vaccine. It is welcome, but as far as adding any impetus to getting the vaccination, we already had a tremendous rationale to vaccinate our young ladies. The bulk of HPV disease occurs in the cervical precancers and venereal wart categories.

– Stan L. Block, MD

Professor of Clinical Pediatrics, University of Louisville and University of Kentucky, Lexington, Ky.
President, Kentucky Pediatric Research Institute, Lexington, Ky.