Gardasil Effective In Women Ages 25 To 45, Young Men, Merck Studies Show

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Colorectal Cancer;  Men's health;  Sexual Health / STDs
Article Date: 18 Feb 2010 - 3:00 PDT

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Merck's human papillomavirus vaccine, Gardasil, effectively prevented precancerous cervical lesions and genital warts in women ages 24 through 45, and it prevented anal cancer and precancerous anal lesions in young men who have sex with men, according to two studies released by the company on Wednesday, the AP/Philadelphia Inquirer reports. Merck released the studies in conjunction with a European conference of physicians and researchers who specialize in cancer and genital infections.

Gardasil currently is approved for the prevention of cervical cancer and genital warts in girls and women ages nine through 26. Merck is using the data from the women's study to support its application for FDA approval to market Gardasil for cervical cancer and genital wart prevention in women up to age 45. The company expects a ruling by June on the application to use the vaccine in older women (Johnson, AP/Philadelphia Inquirer, 2/17).

Gardasil helps block four of the most common HPV strains -- two types that cause 70% of cervical cancer cases and two other types that cause 90% of genital warts cases (Women's Health Policy Report, 10/22/09). The vaccine also is approved to prevent genital warts in boys and men ages nine through 26. Gardasil is among Merck's 10 best-selling products, generating $1.12 billion in sales in 2009.

In late 2009, Merck, which funded both studies, provided FDA with more-detailed data from the women's study. The agency previously rejected the company's request to market the drug to older women and requested longer-term follow-up data. The newly released women's study tracked participants for an additional one and one half years. The study involved 3,819 women ages 24 through 45 from multiple countries who did not have cervical cancer, genital warts or HPV, the AP/Inquirer reports. Precancerous cervical lesions and genital warts did not occur in about 89% of the women who received three injections of Gardasil over six months, compared with women in a group that received a placebo shot. Twenty-three women receiving the placebo and one woman who was vaccinated developed lesions or warts. All participants were periodically examined for an average of about four years, the AP/Inquirer reports.

The second study found that three injections of Gardasil prevented precancerous anal lesions and anal cancer in about 77% of young men. While no men in either the Gardasil group or a placebo group developed anal cancer, 24 who received the placebo and five who were vaccinated developed precancerous lesions. The men were tracked for an average of three years after the first shot. According to Merck spokesperson Pam Eisele, the company plans to submit data on anal cancer in men to FDA and apply for marketing approval (AP/Philadelphia Inquirer, 2/17).

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