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Gardasil - One Step Closer to Approval for Use In Boys and Young Men

An FDA (Food and Drug Administration) advisory council met on September 9th, 2009, and approved the use of Gardasil as a genital warts vaccine for young men ages 9 to 26.  The recommendation is taken into consideration by the FDA for the final approval process.  Gardasil has only been recommended as a genital warts vaccine for boys at this time and not as a method for prevention of male cancers nor as a way to prevent transference of HPV to females.

 

Of the advisory council's 8 members, 7 voted that Gardasil study data shows effectiveness in preventing genital warts in males ages 9 to 26 as well as voting that data also shows that Gardasil is safe for boys in this same age range.  One member abstained from voting on the effectiveness and one member voted against the hpv vaccine's safety.

 

Gardasil prevents against 4 strains of HPV.  It is administered in a series of 3 shots over 6 months.  The human papilloma virus vaccine was shown to be 89% effective for the prevention of genital warts.

 

Three different studies that included 5000 males were reviewed by the FDA Advisory Committee.  The committee had enough data to recommend approval of Gardasil as a male genital warts vaccine, but there wasn't enough data from the studies to recommend Gardasil for preventing male cancers because of the low occurrence of this condition. (Web MD, FDA Panel OKs HPV vaccine Gardasil for Boys, 9/9/2009)

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