FDA turns down Gardasil, the vaccine to prevent cervical cancer and genital warts, for women over 26

syringeby James Hubbard, M.D., M.P.H.

The well-known vaccine Gardasil has gotten a no-go from the Food and Drug Administration. Merck reports the FDA turned down their request to increase the recommended vaccination age up to 45. They had questions about its effectiveness in those older than 26.

Gardasil is the new vaccine to prevent the genital warts virus HPV (human papillomavirus) , which can lead to cervical cancer . The vaccine is about 70 percent effective. You have probably seen the ads by Merck Pharmaceutical. It’s recommended for femals ages 9 to 26. The idea is to take the vaccine to prevent HPV before you are exposed through sexual transmission. Once you get the virus there is no cure.

The NIH reports that at least 20 million people in the U.S. already have the virus, with 6.2 million newly reported cases each year. Many people have HPV with no symptoms but can still sexually transmit it to others.

The virus can cause warts around or on the genitalia of either sex. It can also occur in the mouth or throat. Rarely, pregnant women with warts can deliver babies with life-threatening warts in their throat or mouth. HPV can lead to cancers of the cervix, male or female genitalia, and anus. There are recent studies that suggest an increased risk in throat, mouth or tonsil cancer.

Some parents and groups frown upon this new vaccine, which they think assumes sexual promiscuity of the child instead of waiting until married. They think it may give subliminal approval for premarital sex or just show a giving in to the inevitable. But what if the spouse has not been as responsible?

What do you think? Have you had the vaccine? Did you have any side effects? Are you going to give the vaccine to your children?

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2 Responses to “FDA turns down Gardasil, the vaccine to prevent cervical cancer and genital warts, for women over 26”

  1. Amanda Says:

    I feel lucky that I’m only 25 and am still able to get the vaccine. My doctor has written a prescription for me to pick it up, but it’s been a few months and I’m still not sure about it. I’m afraid we’re going to find out in 10 years or so that it actually causes cancer or birth defects or something.

    If parents think it’s a bad idea to give their children a vaccine that prevents cancer, then they are being absurd. If you can prevent something, why not?

    That’s like denying a tetanus shot because “my child will NEVER play with mean dogs or step on a rusty nail”. You just don’t know. Better safe than sorry.

    Amandas last blog post..video blogging is badass.

  2. James Hubbard, M.D., M.P.H Says:

    Amanda, thanks for the thoughtful comments.

    I emphasize with your concern about long-term side effects. We hear about some new medicine doing that on a regular basis. However, in the overall scheme of things these incidences are rare.

    I don’t think Gardasil has been evaluated regarding cancer because, as you said, it would be several years down the road for this to start showing up. However, I don’t think that other common immunizations have been shown to be cancer causing. Do not get the shot unless you are sure you are not pregnant just to be cautious. To read more specifics you can see the package insert that FDA requires to be posted at http://www.fda.gov/cber/label/gardasilLB.pdf . You will probably be more interested in the last half of the insert. So far it looks pretty safe, but no one can predict the future.

    The bottom line with any treatment is to weigh the risks vs benefits. If you have concerns, ask your doctor or the one who will give you the injections.

    If you have further questions that I can answer, I will be glad to.

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