Merck announced on Friday that U.S. regulators cleared its vaccine Gardasil to prevent genital warts in boys, a new use for a product already approved to prevent cervical cancer in women. The vaccine protects against a sexually transmitted infection called human Papillomavirus, or HPV, which infects approximately 20 million Americans.
“A fair number of people can carry the HPV virus and show no symptoms, so it can easily be passed on without people even knowing it. This vaccine will help cut down on the transmission of the virus,” said Dr. Paul Shin a urologist at George Washington University Hospital in Washington.
According to Vitals.com, Dr. Shin received his medical degree and completed his specialty training at the University of Virginia.
In a Merck-funded study released last year, researchers gave 4,065 males aged 9-26 the vaccine or a placebo. After 30 months three men getting Gardasil developed genital wart and none had precancerous growths compared with 28 cases of warts and three precancerous growths in the placebo group. Studies have found it safe and nearly 100 percent effective in preventing the cancers targeted by the vaccine.
Expanding the shot’s use could add as much as 200 million in annual sales. Gardasil generated revenue of 1.4 billion last year, having already sold 50 million doses worldwide. Sales had been slowing amid questions about the longevity of the vaccine’s effect and it’s price tag of almost 400 dollars. Merck plans to expand a patient rebate and dose replacement program to help cover the cost of the vaccine for 19-26 years old men without health insurance and those with private insurance but no coverage.
Theoretically the approval could double the market for Merck. But analysts do not expect the vaccine to be widely used by boys, because the public health benefit might be outweighed by the expenses. A study by researchers from Harvard School of Public Health found that using the vaccine for girls was well within being a good value, but when boys were added to the equation the benefits did not outweigh the costs.
Certain doctors disagree with this result, believing that if it’s cost effective to vaccinate girls against cervical cancer it would be cost effective to vaccinate boys to prevent oropharyngeal, pineal and anal cancer. They especially feel this way when they see their patients suffering from treatment and others dying of these diseases.


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