Merck's Gardasil Effective At Preventing HPV, Cervical Disease In Older Women, Study Finds

Merck's human papillomavirus vaccine, Gardasil, was 90% effective in preventing infection with the virus and cervical disease in women ages 24 to 45, according to a study published Monday in the medical journal Lancet, Reuters reports (Fox, Reuters, 6/1). In the U.S., the vaccine currently is FDA-approved for girls and women ages nine to 26. Centers for Disease Control and Prevention guidelines recommend routine three-dose vaccination of girls ages 11 and 12 and for girls and women ages 13 to 26 who have not yet been vaccinated (CDC fact sheet, June 2008). It is designed to protect against HPV types 16 and 18, which cause about 70% of all cervical cancer cases, and HPV types 6 and 11, which cause genital warts.

The new study, led by Nubia Munoz of the National Institute of Cancer in Bogota, Colombia, and funded by Merck, involved women ages 24 to 45 with no history of cervical disease or genital warts who either received the vaccine or a placebo injection. The study found that women who received the vaccine were significantly less likely to be infected with certain strains of HPV than those who received placebo shots. According to the researchers, four women out of 1,900 who received the vaccine developed HPV or cervical disease after two years, compared with 41 women out of 1,900 in the placebo group.

Reuters reports that the results of the study could help Merck as it seeks approval for marketing Gardasil for use in older women. The researchers said in the study that older women might be at risk for HPV infection as "[c]hanges in sexual behavior during the past 30 years ... have led to more widespread premarital sexual intercourse and acquisition of new sexual partners around middle age." They added, "As the potential for HPV infection and disease exists in women in their third, fourth and fifth decades of life, these women could benefit from prophylactic HPV vaccination." According to Reuters, a mathematical model published in October 2005 showed that vaccinating older women could cut rates of cervical cancer in women through age 45 by half. Merck also has released data showing the effectiveness of the vaccine in preventing genital lesions in men.

According to the Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection worldwide, and about 20 million U.S. residents are infected with it. The virus is the leading cause of cervical cancer, which causes about 3,870 deaths in the U.S. and 300,000 deaths globally every year, and it also can cause anal, penile, mouth and neck cancer (Reuters, 6/1).


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