In June 2006, the FDA approved the use of Gardasil in females ages nine to 26 to protect against cervical cancer caused by the human papillomavirus (HPV). Following its approval, the Centers for Disease Control recommended that all girls between the ages of 11 and 12 receive the vaccine. Merck undertook an aggressive campaign and attempted to get states to make the vaccine a requirement for school attendance, thereby forcing parents to subject their daughters to the vaccine. Gardasil quickly became one of Merck’s top-selling vaccines, but sales began slowing in 2008 after a study concluded it was not cost-effective for women in their 20s.
In an attempt to increase the market for Gardasil, Merck is seeking to broaden usage of the vaccine. In late December, Merck asked the FDA to approve the use of Gardasil for males. In the application, Merck claims a 90% reduction in risk of pre-cancerous lesions and genital warts based on its study of approximately 4,000 males from ages 16 to 26. If the application meets FDA standards, the review process will take several months before a decision is made.
Sources: Associated Press
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