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Gardasil Approval for Boys Sought

Jan 6, 2009 | Parker Waichman LLP

Gardasil maker Merck & Co. is officially seeking approval for use of the cervical cancer vaccine in boys.  The company is also asking the U.S. Food & Drug Administration to expand the approval of Gardasil in women ages 27 to 45 years.  The vaccine is currently only approved for women and young girls ages 9 to 26.

Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the U.S. Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.

But not everyone has been so enthusiastic about Gardasil, mainly over safety concerns.  There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006.   Those side effects, which were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.

Other questions have been raised about the cost effectiveness of HPV vaccines like Gardasil.  Those concerns were explored by an article in the New England Journal of Medicine this past August.  The article detailed a analysis done by Harvard researchers on the cost effectiveness of Gardasil, and another HPV vaccine called Cevarix.  Cevarix, made by GlaxoSmithKline, has not been approved by the FDA yet, but is widely used in Europe.

To measure the health benefit of vaccination, the researchers looked at the cost savings from preventing cervical cancer with the vaccine and Pap tests compared with prevention via the tests alone. A treatment is typically considered cost effective if it is less than $50,000 or $100,000 for one additional year of life

The Harvard analysis predicted that it would $43,600 to extend life expectancy by one year when girls are vaccinated at 12. When girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26, the study found. That’s because vaccination is less effective after a woman is sexually active, and may have already been exposed to HPV.

In Western countries like the U.S., regular screening via Pap tests has already greatly reduced incidences of cervical cancer and deaths. But even after vaccination, regular Pap tests are necessary because the shots don’t protect against all HPV strains known to cause the cancer.

Despite questions surrounding its safety and cost-effectiveness, Merck still wants the uses of Gardasil expanded.  According to The Wall Street Journal, Gardasil is a key product for Merck, which estimates sales this year of as much as $1.6 billion. But sales have slowed, down 4% in the third quarter compared to a year earlier.  Merck's crusade for expanded approval may be part of a strategy to lift these sagging sales.


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