Merck approves use of its HPV vaccine Gardasil in males
Human papillomavirus, or HPV, is an oncogenic virus implicated in causing nearly 100% of all cervical cancer cases, but it does not just target females. It also infects males, and can cause anal, penile, neck and head cancer in male population. While an HPV vaccine became available for females in 2006, no research was conducted to determine whether the vaccine would be effective in men. Today, Merck & Co., Inc. announced the vaccine has 90% efficacy in protecting males from infection by four major HPV strains – 6, 11, 16 and 18. This opens a whole new market for Merck, one of the largest pharmaceutical companies in the world. By the end of the year, Merck hopes to submit an application for permission to sell its vaccine to males. Given women are more likely to get infected with HPV than men during sexual intercourse, vaccinating men might substantially reduce HPV infections in females.
A vaccine designed to protect women and girls from cervical cancer caused by a wart virus may protect men, too, maker Merck and Co reported on Thursday.
The Gardasil vaccine was 90 percent effective in preventing lesions, mostly sexually transmitted warts, caused by the virus in men, Anna Giuliano of the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida, and colleagues found.
It was about 45 percent effective in preventing infection with the four strains of HPV that it targets.
"We see 90.4 percent efficacy is reducing external genital lesions in males related to these four types of HPV -- 6, 11, 16, 18," Giuliano said in a telephone interview.
The human papilloma virus, or HPV, is the most common sexually transmitted disease in the world. About 20 million Americans currently are infected with HPV, according to the U.S. Centers for Disease Control and Prevention.
It is the main cause of cervical cancer, which kills 3,870 women a year in the United States and 300,000 globally.
It can also cause other types of cancer, including anal and penis cancer as well as mouth and neck cancer. The CDC estimates that HPV caused 25,000 cases of cancer a year in the United States between 1998 and 2003.
Gardasil and its rival, GlaxoSmithKline's Cervarix, are only approved for use in girls and women, but the companies are seeking new markets and some experts say it should be used in boys and men, to protect them and their future sexual partners.
Merck said it remains on track to submit a U.S. application by the end of the year for the use of Gardasil in males ages 9 to 26.