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Gardasil Manufacturer Seeks HPV Vaccine Approval for Young Males

Kathleen Blanchard's picture

Phase III trials involving Gardasil, the HPV vaccine promoted for women, has been shown to protect young males from HPV virus that can lead to cancer. The manufacturer of Gardasil, Merck, now seeks FDA approval for use of the vaccine in young males, age nine to twenty-six. Merck is also awaiting FDA approval for Giardisil use in women age 27 to 45.

Giardisil use in male youths is proposed for the prevention of genital warts and other HPV virus related communicable lesions. Merck's most recent study shows that ninety-percent less boys and young men developed HPV related lesions after receiving the Gardasil vaccine.

A mathematical study, published last year in the New England Journal of Medicine, showed that widespread vaccination of women with Gardasil would be less cost effective than screening programs, a detail that has obviously not deterred Merck from promoting Gardasil. Young males are Merck's newest target for Gardasil vaccination.

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Sales of Gardasil dropped by 4% the latter part of 2008, as the market for the vaccine dwindled once the vaccine's targeted audience was satisfied. Some experts believe too many assumptions about the vaccine have been made, such as whether Gardasil provides lifelong immunity, as well as the long-term effects of the vaccine. The full effect of the HPV preventing Gardasil vaccine will not be measureable in women for decades.

Gardasil vaccine for younger males may prove to be an expense that does not justify the outcome. HPV has minimal impact on males, compared to women. HPV vaccine cost $360 for the recommended three-dose vaccine program given to women. HPV is transmitted from males during sexual contact, no symptoms occur in males.

Gardasil is a blockbuster drug that Merck seems bent on promoting. FDA approval for Gardasil use in young males is likely to breathe financial life into Merck's sales of Gardasil, as might approval from the FDA for Gardasil use in older women.

Source: Associated Press