Approximately 3,800 women age 24 to 45 participated in the study; two thirds were not infected with any of the targeted HPV strains, while one third were infected with at least one strain. Half were immunized with the recommended three doses of Gardasil, while the remaining half of women were given a placebo. The women were followed for 20 months.
Results are Encouraging and PromisingMerck reported a 91% reduction of persistent infection, low-grade cervical abnormalities, cervical pre-cancers, and external genital lesions caused by the four strains of HPV that the vaccine protects against.
Merck plans to submit data from this study to the FDA in order to seek approval for expanded use of Gardasil in older women.
It is important to keep in mind that Gardasil is meant to prevent HPV infection, not treat existing infections. Gardasil protects against four strains of HPV known to cause cervical cancer and genital warts in women. If approved for use in older women, the vaccine will aim to prevent infection in those who have never been exposed to the targeted strains. If a woman is infected, the vaccine will aim at preventing infection of other targeted strains.
How the Study Affects YouThe results of this study are promising. Still, the potential approval of Gardisil for use in older women does not mean that Pap smears will become obsolete for this age group. Because Gardasil does not protect against all strains of HPV, women still need to have regular Pap smears, even after immunization.
Gardasil is approved for use in younger women (9 to 26) and is available at doctors' offices and public health clinics. Call ahead to check for availability, as not all doctors carry the vaccine. Gardasil is covered by many insurance companies. Out-of-pocket expense averages about $360 for the three-dose series.
- "New Data Presented on GARDASIL®, Merck's Cervical Cancer Vaccine, in Women Through Age 45." Merck.com. 05 Nov 2007. Merck. 12 Nov 2007 http://www.merck.com/newsroom/press_releases/product/2007_1105.html.