Drugmaker Seeks FDA Approval For Gardasil For Males

Drugmaker Merck has asked the FDA to approve the Gardasil vaccine’s use for boys ages 9 to 26. For those who don’t know, Gardasil is a vaccine that protects against HPV and cervical cancer.

Gardasil first hit the market in 2006 and was initially recommended for girls and young women, ages 12-26. Due to aggressive marketing, Gardasil quickly became one of Merck’s top-selling vaccines, with sales of $1.5 billion in 2007 (which were perhaps aided by the high cost- $360 for a three-dose regimen). Despite becoming a requirement for immigrant women, sales slowed in 2008 after a government-funded Harvard study found that it was not cost-effective to administer Gardasil to women in their 20s.

Gardasil for men is not a new idea. Merck has long planned to release a vaccine specifically for males, which seems like a great idea considering that men are more than simply the carriers of HPV. Men infected with HPV run the risk of getting cancer of the genitals or mouth, not to mention genital warts. In Merck’s initial testing, Gardasil prevented 90 percent of cases of penile cancer and genital warts in the 4,000 males, ages 16-26, who received the vaccine.

But before Gardasil for men becomes available to the general public, the FDA must approve Merck’s request, a process that can take up to a year to complete. And while Gardasil is effective at preventing certain types of cancer, the vaccine is not without controversy. In 2008, reports of several deaths that were believed to be linked to the Gardasil vaccine surfaced, leading several news outlets to claim that Gardasil was a factor. While the CDC contends that the deaths are unrelated to Gardasil shots, there is a lingering resentment against the vaccine, which is currently requirement for all immigrant women seeking their green cards. A rival (and less costly) vaccine called Cervarix is available in many foreign markets, but has yet to be approved for use in the U.S.

Drugmaker Merck Seeks Gardasil Approval For Boys [USA Today]
Cervical Cancer Vaccine- For Boys? [CBS News]
Merck Seeks FDA Approval for Gardasil in Boys [WSJ Health Blog]

Related: Experts Appalled At Gardasil Requirement For Immigrant Women, CDC Finds Deaths Unrelated To Gardasil Shots