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Gardasil for Males Now Recommended by FDA September 14, 2009
Boys may soon also be eligible to obtain the Gardasil vaccine, which is currently given to girls and young women to help prevent infection by four types of human papillomavirus.
An advisory committee from the FDA voted Wednesday to recommend that the vaccine be made available to boys and young men between the ages of 9 and 26 to help protect against genital warts caused by HPV.
The Gardasil vaccine helps protect against four type of HPV, and two of those are believed to be responsible for approximately 70% of anal and cervical cancers, as well as HPV-associated penile and throat-and-neck cancers. Researchers say that the other two types cause approximately 90% of all cases of genital warts.
Merck & Co., maker of the Gardasil vaccine, presented data to the FDA from three clinical trials that the company claims supports broadening the distribution of the vaccine to include boys and young men. The three trials included more than 5,400 boys and men that were from 23 countries and 6 continents.
Anna Giuilano, who is an independent scientist at Moffitt Cancer Center, and the trials’ principal investigator says, “The data clearly demonstrates that there was a benefit to men in receiving Gardasil. Overall, we saw a 90% reduction in disease—genital warts and pre-cancerous lesions—caused by HPV in men and an 89% reduction in genital warts incidence. Essentially, we have a really fantastic opportunity to extend the benefit of the vaccine to men. This is a sexually transmitted infection’ if we can reduce infection and related diseases in men, we have the potential to have a much broader public health impact by reducing the overall burden of infection and disease in the community at large.”
Guiliano states that there were no serious adverse events that were related to the vaccine. There were some minor side effects such as running a low grade fever and pain at the injection site. The Gardasil vaccine would be administered in boys and young men exactly the same way it has been given to girls and young women: three doses over a span of six months.
According to the CDC, approximately 20 million Americans are infected with HPV, with about 6.2 million new infections annually. The CDC states that at least 50% of women and men that are sexually active get an HPV infection at some point in their life. The American Social Health Association said that HPV is the most common sexually transmitted virus and puts that number at 75% or above.
The CDC says that although HPV is very common for both sexes, most men will not develop symptoms or any serious health problems, and there is no test that will detect the virus in men. The only test that is approved for HPV on the market is for women, for the use in cervical-cancer screening. The FDA's advisory committee also voted that Cervarix, which is new HPV vaccine that is made by GlaxoSmithKline, appeared to be safe and effective for girls and young women between the ages of 10 and 25. Cervarix has already been approved for use in Europe.
Still, the panel recommend that GlaxoSmithKline do more studies that would closely monitor miscarriages and other problems that were reported by patients. In a final review of this proposal, both of the applications will be considered by the FDA, which usually follows the recommendations of its advisory committees.
Source: HealthNews
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