Merck Hopes To Extend Gardasil Vaccine to Men

Extract

Gardasil, the vaccine that protects women from common strains of the human papillomavirus (HPV) responsible for about 70% of cervical cancers, has proved successful. According to the Centers for Disease Control and Prevention's National Immunization Survey, about 25% of women have received the vaccine. Now Merck, the pharmaceutical giant that manufactures Gardasil, is looking to match that success in men.

In a November press release, Merck announced completion of an initial study showing that Gardasil has a 90% efficacy in preventing external genital lesions caused by HPV types 6, 11, 16, and 18 in men aged 16–26 years. On the basis of this latest study as well as earlier studies in younger boys, Merck plans to seek approval from the U.S. Food and Drug Administration for Gardasil use in males aged 9–26 years to prevent external genital lesions, including genital warts, according to Tracy Ogden, a company spokesperson.

“This is the first clinical trial to demonstrate that a vaccine directed against HPV is efficacious in preventing both infection and lesions in men,” said Anna Giuliano, M.D., who led the Merck study at the H. Lee Moffitt Cancer Center in Tampa, Fla. Although the study did not produce data on whether Gardasil can protect men from penile, perineal, or anal cancers, Giuliano said that there is definitive evidence that HPV causes these cancers in men. According to the National Cancer Institute, more than 1,200 new cases of penile cancer and about 2,000 new cases of anal cancer are diagnosed in men each year in the U.S. Between 80% and 90% of anal canal cancer cases are the result of HPV—usually HPV-16—as are about 40% of all penile cancers, Giuliano said.