HPV vaccine should be used on boys too: drugmaker

Drugmaker Merck & Co.is asking U.S. federal regulators to give the OK for males to takeits vaccine against the human papillomavirus, an infection that can lead tocervical and other cancers.

The application to expand the use of Gardasil was submitted to the U.S. Food and Drug Administrationin late December, Merck spokeswoman Amy Rose confirmed Tuesday.

Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as acondition for school attendance.

However, it is one of the priciest vaccines on the market, typically costing $360 USfor a three-dose regimen.

Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a U.S. government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s.

FDA decision could take months

The FDA has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or more.

The application includes research data from a Merck study that looked at 4,000 males ages 16 to 26. The study suggested thatGardasilbrought about a90 per cent reduction in cases of penile cancer and genital warts caused by the four common virus strains that the vaccine targets.

The agency approved use of Gardasil in females ages 9 to 26 years old in June 2006, but last June rejected expanding that to include women ages 27 to 45. The vaccine has since been approved for use by young women in dozens of foreign countries.

Health Canada has approved Gardasil for use on girls and women aged nine to 26.

Gardasil works by boosting the immune system so that it effectively fights off four types of HPV, one of the most prevalent STDs in modern society.

In most women, HPV clears up on its own but for some, the infection persists and can lead to cervical cancer.Some scientific studies have also suggested that certain strains ofHPV can lead to cancersof the anus, vulva, vagina or penis.