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FDA panel approves Gardasil HPV vaccine for males, and competing Cervarix might hit shelves soon

fda approves gardasil males, cervarix panel approvalVaccines for the human papillomavirus (HPV) might not be just for girls anymore. A medical advisory panel for the U.S. Food and Drug Administration (FDA) voted today that the use of Gardasil to prevent HPV, a sexually transmitted disease, in males ages nine to 26 would be both safe and effective.

Each year about six million people in the U.S. get HPV, which can cause genital warts and cancer in both men and women. The resulting cancer (cervical in women) is diagnosed in about 11,000 women each year, according to the American Cancer Society. Males can also acquire cancer from HPV—anal or penile—which is diagnosed in about 2,100 and 1,300 U.S. men, respectively. Prevention of genital warts would be Gardasil's primary target for use in males. Experts have also noted that staving off the virus in males could help protect women by preventing further spread.

The panel's decision could open up a large market for Gardasil maker, Merck, which has been approved to market the vaccine in the U.S. to females ages nine to 26 since 2006 and has distributed more than 50 million doses globally. A market analyst told Forbes, however, that sales of Gardasil to males will likely be remain below 20 percent of the vaccine's total. But even that nudge could bring in upward of an additional $300 million a year, said Seamus Fernandez, an analyst at health care investment company Leerink Swan.

Despite the male-market bump, Gardasil will likely face new competition on the female side. An FDA advisory panel also voted today that Cervarix—another HPV vaccine, made by GlaxoSmithKline PLC—is safe and prevents the infection in girls.

The FDA will take all panel recommendations into consideration but is not bound to follow their advice.

Out of more than 100 strains of HPV, two types (six and 11) are responsible for 90 percent of genital wart cases, and two others (16 and 18) are responsible for 70 percent of cases of cervical cancer. Gardasil protects against all four, and Cervarix protects against 16 and 18—making it unlikely to be marketed to males.

Image courtesy of Wikimedia Commons/Eugene Peretz

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  1. 1. Narient 11:22 PM 9/9/09

    This drug is dangerous: http://au.tv.yahoo.com/video/-/watch/14202454/

    Reply | Report Abuse | Link to this
  2. 2. ClockworkSoul 01:12 AM 9/10/09

    @Narient Oh, please. With millions of doses being give worldwide since the product's release, by pure chance some people will have died of entirely unrelated causes some time after receiving it. That's the law of averages.

    The people in that video have, sadly, been deprived of an explanation for their daughter's death, so in their desperation they decided that it simply must be the vaccine. Unfortunately, grief and anger aren't especially conducive to rationality.

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  3. 3. Lowndes 07:07 AM 9/10/09

    Narient, I heard that cancer is dangerous, too.

    Please remember, none of us are getting out of this alive.

    Have a nice day.

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  4. 4. LovingTruth 08:30 AM 9/10/09

    Gardasil is pharmaceutical gospel.
    Everybody is repeating its psalms (HPV 16 and 18 are responsible for 70% of the cases of cervical cancer), yet nobody is checking the reality.
    Finding HPVs in the cervix means only one thing: the immune system and probably the nutrient status of the woman in question are lacking. With cancer many times also fungi are found. Same reason.
    What I found during the research for my book (in Dutch) on the HPV vaccines is that vaccines have been maiming and killing people from day one. And that vaccination is responsible for the enormous upsurge of cancer in our world.
    Doctors in the 1890s witnessed the earliest vaccination results. They not only unanimously state that these [cow pox] vaccination drives caused several smallpox epidemics, but also that cancer was a practically unknown entity before these forced vaccination campaigns started [in 1853].
    Regarding Gardasil nobody adresses the fact that with this vaccine all sorts of poisons (aluminium compounds), foreign proteins (HPV-L1 proteins, yeast) and dangerous substances (Tween 80) are injected into the body tissues. Not surprisingly, according to the FDA, Gardasil takes one woman's life each month...
    Let's not make that even worse by vaccinating boys and men.
    And does anybody realise what will happen when everybody additionally gets force-vaccinated with the novel H1N1 vaccines?
    I have no qualms calling that genocide.(

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  5. 5. zbfelt 12:33 PM 9/10/09

    There is an amazing amount of misinformation flying around about vaccines. The anti-vax conspiracy is just one of the silly conspiracies that point to correlation and call it causation.

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  6. 6. Health talker 02:52 PM 9/10/09

    Seems like the company would really push this as males are a whole new market. However, I think it'll get those on the controversial side of the fence just angry.

    http://vaccinereview.com/what-about-the-hpv-vaccine-controversy

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  7. 7. Chrisfs in reply to LovingTruth 08:14 PM 9/10/09

    "but also that cancer was a practically unknown entity before these forced vaccination campaigns started [in 1853]"

    Could that be because more people were living longer and not getting smallpox, so they died from something else ?

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  8. 8. Bobwama 12:55 AM 9/16/09

    @LovingTruth
    Oh please - had you done any research on vaccines you would know that a vaccine is one of the proteins that makes up the virus against which it protects - the only reaction that can be had to something like this is an allergic reaction to the specific protein. Those reactions are rarely severe, and the few unfortunate cases that are fatal each year are a far better price to pay than the amount that would die without vaccines.

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  9. 9. mjb7877 02:52 PM 11/30/09

    The FDA thinks that the HPV vaccine that screens against cervical cancer is extremely important. Do you agree? Who am I supposed to believe. My doctor doesn't offer the vaccine. I read this article: http://www.orderonlinedrugs.com/drug-news/2009/09/10/ceravix-receives-commendatory-advice-from-fda-advisory-committee/ can anyone else recommend a reliable source? There is so much information out there!

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