http://www.webmd.com/sexual-conditions/hpv-genital-warts/news/20090909/fda-panel-oks-gardasil-for-boys
How many times has your child fainted from an injection? Merck says this is quite a common occurrence in adolescence.
One truly has to wonder how many 9 year olds have had exposure to sexually transmitted diseases for them to be able to make a claim that it's 89% effective, or were they exposed to genital warts purposely to enable Merck to validate their findings?
An FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts.
Gardasil targets four strains of human papillomavirus, commonly called HPV. Males can carry HPV and transmit it sexually to their partners.
HPV can cause genital warts and penile and anal cancer in men. Each year, about 200 out of 100,000 males are newly diagnosed with genital warts, according to background information cited by the FDA. Penile cancer and anal cancer are much rarer.
Gardasil already has FDA approval for use in females ages 9 to 26. In females, HPV can cause cervical cancer.
The FDA advisory committee ruled 7 to 0, with one abstaining vote, that Gardasil's clinical trial data support the vaccine's effectiveness at preventing genital warts in males ages 9 to 26. And in a 7 to 1 vote, the advisory committee ruled that the data show Gardasil to be safe for males in that age range.
The FDA advisory committeereviewed three studies of Gardasil that together included more than 5,000 males ages 9 to 26 in various countries including the U.S.
Participants got a total of three shots of Gardasil or a placebo spread over six months. They also got checkups and tests to check for HPV infection.
Gardasil was 89% effective in preventing genital warts. The vaccine was less effective in participants who had already been exposed to HPV.
No serious side effects were seen, according to information posted on the FDA's web site.
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http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm
Non-serious adverse event reports
VAERS defines non-serious adverse events as those other than hospitalization, death, permanent disability, and life-threatening illness.
The vast majority (93%) of the adverse events reports following Gardasil have been non-serious. Reports of non-serious adverse events after Gardasil vaccination have included fainting, pain and swelling at the injection site (the arm), headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented by closely observing the vaccinated person for 15 minutes after vaccination.
Serious adverse event reports
VAERS defines serious adverse events as adverse events that involve hospitalization, permanent disability, life-threatening illness, and death. As with all VAERS reports, serious events may or may not have been caused by the vaccine
