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Study finds HPV vaccine is safe
October 1st, 2012
04:49 PM ET

Study finds HPV vaccine is safe

A vaccine against human papillomavirus, commonly known as HPV, a virus known to cause genital warts and cervical cancer, is safe, according to a study of almost 200,000 girls who received the vaccine.

Concerns over the safety of the Gardasil vaccine emerged shortly after the Food and Drug Administration approved it in 2006, despite  the Centers for Disease Control and Prevention, the American Academy of Pediatrics and the American Academy of Family Physicians all deeming the vaccine safe and recommending it be given to girls ages 11 and 12.

Dr. Nicola Klein, pediatrician and lead author of the study published Monday in the Archives of Pediatrics & Adolescent Medicine, says she hopes the study puts those rumors to rest.

“All parents should feel assured this was a very comprehensive study and that the vaccine is safe for use,” said Klein, of the Kaiser Permanente Vaccine Study Center in Oakland, California.

The HPV vaccine is administered in three doses over the course of six months. Researchers looked at emergency room records and hospital visits for 60 days after each dose given to the 189,629 females in the study.

The only side effects associated with the HPV vaccine were same-day fainting and skin infection around the injection side, according to the study.

Merck & Co., the makers of Gardasil, funded the research and worked in collaboration with the Kaiser study team. While it is common for the FDA to request or require post-marketing safety studies, the researchers say an independent safety review committee - made up of experts from the Mayo Clinic and Johns Hopkins University, among others -  reviewed all final data and results.

HPV is the most common sexually transmitted infection. At least 50% of women and men will acquire it at some point in their lives. The virus itself is the leading cause of cervical cancer in women, and can also lead to other health problems like mouth cancer and genital warts.

The vast majority of infected people will never have symptoms, and continue to pass along the disease to their partners. Previous research published in the Journal of the American Medical Association found the virus is most prevalent in people right after they start having sex.“In order to for the vaccine to combat to virus as designed, it is very important to vaccinate girls prior to them being sexually active,” said Klein.

The FDA has approved two HPV vaccines - Cervarix and Gardasil - for use in females ages 9 to 26 years old. Earlier this year, the CDC and American Academy of Pediatrics recommended that boys also get the HPV vaccine.


soundoff (49 Responses)
  1. l'asperge

    And the paranoid anti-vaxers appear in three, two, one ...

    October 1, 2012 at 21:29 | Report abuse | Reply
    • VladT

      I was thinking this while reading the article.....

      Beat me to it, but still gave me a laugh

      October 2, 2012 at 07:13 | Report abuse |
  2. Mike

    damn i swear, only in america do you have 40% of people who believe the earth is only a couple thousand years old AND think vaccines give them bs side effects.

    October 1, 2012 at 22:59 | Report abuse | Reply
  3. georgia england

    women dont' get cervical cancer until they are in their 50's usually and the few that die from it are usually those that lack adequate gyn care for years – NOT the population that is being given a very expensive series of shots in their teens years.

    Basically no one knows if it will work or not.. HPV doesn't "cause" cervical cancer since the vast majority of women have had an HPV infection but very very very few develop cancer.. it is just found in those that develop it, indicating a lowered immune function. We are inoculating the women who were never at risk in the first place and there is a HUGE opportunity cost (900 for the series) with NO evidence for 30 years if it works or not.

    October 2, 2012 at 02:04 | Report abuse | Reply
    • medschoolkid

      Actually we know for sure that HPV causes cervical cancer. Over 90% of cases are caused by HPV, the rest are associated with HIV and known highly carcinogenic agents. The "inadequate gyn" care that those who die have been subject to is almost definitely associated with late detection, although I'm not sure where you got that statistic. Please don't try to spread this kind of nonsense, especially when you are trying to convince people to avoid care that could potentially save their lives. If there aren't any major side effects, whats the harm? The benefit far outweighs the risk in this case.

      October 2, 2012 at 02:26 | Report abuse |
    • mc36

      I agree with medschoolkid, however, i think the point that georgia was trying to make (or at least i hope so) is that the best prevention of cervical cancer isn't a costly vaccine, but early detection. I see the positive impacts this vaccine can have for women in the long-term, but i think it gives women, especially younger women, the false impression that just because you have the vaccine, you won't get HPV or cervical cancer. Truth is, the vaccine only protects against some of the more common types, but certainly not all types of HPV strains, which means you can still get cervical cancer even if you do have the vaccine. What we need to teach young women, is how to properly care for their sexual health. This includes regular gynecologist check ups and pap smears. This is how you lower the instances and death rates of cervical cancer, not thru a vaccine. And if women's health cervices were more affordable and covered by insurance, we would also have more cases of early detection and prevention. The answer to this issue isn't an incredibly expensive vaccine, it's making health services more accessible to women.

      October 2, 2012 at 14:23 | Report abuse |
    • yllee

      @mc36 "i think the point that georgia was trying to make (or at least i hope so) is that the best prevention of cervical cancer isn't a costly vaccine, but early detection" -which would still be wrong. because prevention is still better than early detection. we know for a fact that hpv causes cervical cancer. no ifs, ands, or buts. another fun bit of info, the increase in hpv-related laryngeal cancers is on the rise as well, roughly matching public health statistics in the increase in oral-genital sex (with females). we have a pretty good idea that this vaccine protects against the dominant strains of hpv. early detection may allow you to catch disease before it becomes fatal, but prevention is even better.

      October 2, 2012 at 17:38 | Report abuse |
    • peridot2

      There are 30 strains of HPV that cause cervical cancer in women and penile cancer in males. You haven't kept up with the latest reports. Penis cancer has a single treatment: amputation of the member.

      My son decided on the vaccine on his own. I'm glad he did. He's protected and so are his future partners.

      October 2, 2012 at 22:22 | Report abuse |
    • peridot2

      @MC36 The point of this vaccine is to PREVENT cervical and penile cancer, not to detect it and catch it early when it's occurred. Why is this not getting across? If we can PREVENT CANCER, why not do it?

      I survived ovarian cancer. Cancer's a horrible and terrifying thing. Parents, have your daughters vaccinated, please. Don't take chances with their health that can be prevented. It's not worth it. Save their future. Please, protect them from harm. Think about saving your sons, too. Penis amputation's a horrible thing to face. Vaccination's safe and easy. Protect your child.

      October 2, 2012 at 22:30 | Report abuse |
    • Nathan Rowley

      Your post is full of misleading inaccurate information. Who on Earth told you the cost was 900 dollars? The shots are approx. 150-170 dollars each (aka about 450-500 each) and covered by almost all insurance providers for males and females aged 9-26. The vaccinations are extremely effective (and clearly safe) and to minimize the dangers and risks of cervical cancer is irresponsible. If you have some credentials to back up your information, by all means, let us know! Otherwise, let people who spend $200,000 and 8-10 years of their lives do the talking.

      October 2, 2012 at 23:51 | Report abuse |
    • lam81208

      Wrong. Just wrong. Pretty much everything you said here. Sad.

      October 3, 2012 at 12:37 | Report abuse |
    • MedSchoolDoc

      @medschoolkid
      Don't forget to cite your sources, lest we figure out that you're just BSing...

      October 3, 2012 at 12:55 | Report abuse |
  4. Cleopatra1981

    "Merck & Co., the makers of Gardasil, funded the research..."

    This just says it all...

    October 2, 2012 at 10:05 | Report abuse | Reply
    • Debbie

      Yes, they funded the research. I guess you didn't read the part about Kaiser Permanente Vaccine Study Center.
      I guess you wanted the federal government to fund it.

      October 2, 2012 at 13:28 | Report abuse |
    • bob ewell

      I agree

      October 2, 2012 at 14:22 | Report abuse |
    • Nathan Rowley

      Duh! Merck was mandated by the FDA to fund the study to ensure the safety of the vaccination. What is more insane is that irresponsible people like you try to influence the logical thoughts of people who are smart enough to think things through without uneducated theories being shoved down their throats. I guess you would propose that elves and the tooth fairy fund and perform the studies on new medications that are being developed? You know what you can't make up? The value of researching something before you inform the world of your profound beliefs.

      October 2, 2012 at 23:54 | Report abuse |
  5. dave

    mmm...paranoid about what someone wants to inject directly into your bloodstream or blind trust of the u.s. government which is made up of non evil very good and moral people who never ever lie and would do nothing bad to anybody? decide which you want to be.

    October 2, 2012 at 12:09 | Report abuse | Reply
    • Nathan Rowley

      What does the government have to do with any of this. The whole article is about how non-government/non-Merck clinicians performed a study of 200,000 thousand (TWO-HUNDRED THOUSAND!) vaccination recipients. When did this become crazy conspiracy theory forum?

      October 2, 2012 at 23:55 | Report abuse |
  6. thesaj

    If it is SOOO SAFE....than why won't the FDA allow an adult over the age of 26 who is negative for HPV, to have the vaccine?

    Seriously...

    Think about it, you want to mandate this vaccine for our children and tell us it's completely safe but you're to !@#$ afraid of it to let me or my wife get the vaccine.

    And that doesn't sound any RED flags for any of you?

    October 2, 2012 at 12:15 | Report abuse | Reply
    • AvatarofAwesome

      Because the FDA tests based on specific criteria and approves based on the same. The vaccine has been tested and approved for those within a certain age range. It is less pertinent to vaccinate people, or to test a vaccine on those who are already sexually active and have a good chance of having already been exposed to HPV. The FDA does not approve for uses it has not tested yet. They do this to keep uneducated folks who have no medical background safe. Personally, I think we'd be better off if we still let said uneducated twits use tapeworms as a weight-loss solution and let Darwinian principles sort everything out, but that's just because I'm an idealist.

      October 2, 2012 at 13:25 | Report abuse |
    • Kel

      Crazy people who don't think vaccines work... Seriously? They work.

      October 2, 2012 at 15:48 | Report abuse |
    • yllee

      because people over the age 26 have for the most part already been exposed to the virus, at which point the vaccine becomes pointless. lrn2science

      October 2, 2012 at 17:33 | Report abuse |
    • James Bolton

      If we stand by the claim that the FDA approves only for certain tested groups, there would be MANY medications NOT used for children. There is an ethical, moral, and legal limit to testing drugs in children, therefore, finding drugs that are tested in this group, and approved for use in children, is not as easy as you think. Regarding scientific knowledge and approving things that are ONLY proven, Vitamin D is only "proven" in whilte males aged 40-60 yoa, thus ALL the doctor recommendations for Vitamin D for women and children, bunk. Consistency and PROOF are NOT things practiced in mainstream medicine.

      October 2, 2012 at 20:48 | Report abuse |
    • Nathan Rowley

      Please explain to all of us who this vaccination is MANDATED for? Let me help you, NOBODY! It's optional.

      October 2, 2012 at 23:56 | Report abuse |
  7. I Trust the Government

    I trust the government. After all, they brought us the Tuskegee Experiment. I trust the government for everything.

    October 2, 2012 at 12:38 | Report abuse | Reply
  8. LastoftheZucchiniFlowers

    When oral cancer began showing up in young, non-smoking men everyone was flummoxed. Pap smears do a very good job screening for Cervical CA which is more indolent than oral CA. Grant Achatz (of Chicago's Alinea) is a good example of the 'atypical' patient with oral cancer who didn't fit the profile but he is NOT alone. HPV virus is implicated in this dread form of cancer which is an ugly, horrible way to die. The increase in oral sex in BOTH genders is huge risk factor for oropharyngeal carcinoma scc. You do NOT want this nor do you want your son or daughter to die from it! BAD disease, disfiguring surgery and often a death sentence. Read, "My Voice', by pediatrician Itzhak Brook, MD for a wake up call.

    October 2, 2012 at 13:10 | Report abuse | Reply
  9. amdachel

    While we’re told that experts at Johns Hopkins and the Mayo Clinic concurred on the research, lots of people at both places have endless pharma ties. Mayo Clinic's Dr. Gregory Poland works for Merck.
    Parents need to look beyond industry-funded studies. See the National Vaccine Information Center: for more information.
    http://www.nvic.org/.
    Anne Dachel, Media editor: Age of Autism http://www.ageofautism.com/

    October 2, 2012 at 13:59 | Report abuse | Reply
  10. amdachel

    If anyone is interested in TRULY INDEPENDENT RESEARCH on vaccines and their side effects they only have to look at the website for the new film, “The Greater Good,” (See trailer: http://www.youtube.com/watch?v=ulmEGbwQsOU) which explores the question of vaccine safety from both sides. There are over 200 studies that raise serious concerns about vaccine side effects.
    Here you will see real-life stories about the harmful side effects of the HPV vaccine.
    http://www.greatergoodmovie.org/learn-more/research/
    Anne Dachel, Media editor: Age of Autism http://www.ageofautism.com/

    October 2, 2012 at 14:00 | Report abuse | Reply
    • smitvict

      I'll catch the video right after I finish watching The Innocence of Muslims.

      October 2, 2012 at 18:46 | Report abuse |
  11. amdachel

    For far too long we've allowed the agency (the Centers for Disease Control and Prevention) that approves, recommends, and vigorously promotes vaccines to also be in charge of vaccine safety. The CDC is also the place where hundreds of individuals have conflict waivers because of their direct financial ties to the vaccine makers. The last head of the CDC, Dr. Julie Gerberding is now the head of the vaccine division at Merck.
    This is the question CBS News asked in 2008, “How Independent Are Vaccine Defenders?”
    http://www.cbsnews.com/2100-500690_162-4296175.html
    Anne Dachel, Media editor: Age of Autism http://www.ageofautism.com/

    October 2, 2012 at 14:00 | Report abuse | Reply
  12. amdachel

    It’s highly unlikely that anyone will be convinced about the safety of the HPV vaccine because of a study THAT WAS FUNDED BY THE VACCINE MAKER. The fact that Merck was able to find doctors with impressive credentials to back their research findings should raise even more concern.

    Sept 21, 2012 The LA Times ran this story: “Doctors found to lack trust in drug company studies .”
    http://www.latimes.com/health/boostershots/la-sci-sn-doctors-lack-trust-in-drug-companies-20120921,0,807790.story
    Doctors are less likely to trust research studies performed with funding from corporate interests such as pharmaceutical companies, according to a new study.
    The report, published this week in the New England Journal of Medicine, reveals a long-suspected bias against such research among physicians. It also demonstrates the price companies have paid for public violations of trust, including examples of data manipulation and misrepresentation of study results.
    If DOCTORS DON’T TRUST THESE STUDIES, why should parents?
    Anne Dachel, Media editor: Age of Autism http://www.ageofautism.com/

    October 2, 2012 at 14:01 | Report abuse | Reply
  13. DCMom

    The original study used to justify this purported vaccine was extremely slim (a few thousand women over a short period of time) and did not involve ANY children. The new drug-company sponsored study finds it is safe - what a surprise. Kind of like the presidential polls. Ask the right questions get whatever result you want. It will take decades before there is any real proof of (1) whether this drug is effective and (2) whether this drug itself causes harm. It took 30 years before the medical profession figured out that DES caused cancer in women and sterility in men. Hopefully those who have put this untested drug into their children will not learn years from now that they caused their children great harm, whether as a result of the drug itself (as in DES) or having a false sense of security and not following up with regular pap smears or other tests. As a DES baby myself, I will never subject my child to this drug. It is just not worth the risk.

    October 2, 2012 at 15:05 | Report abuse | Reply
    • medschoolkid

      This is not a synthetic hormone like DES. I am not a fan of any form of hormone therapy unless it is absolutely necessary (as in a hysterectomy or after testicular cancer). I am waiting for the prostate cancer rates to surge thanks to Androgel. But this is a vaccine that simply stimulates a mild immune response and creates an immune system "memory" of the specific HPV strains. Gardisil doesn't even contain the virus (live or dead), just the particles that make up its protein coat, which is how the immune system would recognize it. Other than that it has very common ingredients: yeast proteins, saline, histidine (an amino acid), polysorbate-80 (found in most ice cream), borax, and aluminum hydroxyphosphate which has been used in vaccines for 70+ years and has repeatedly been found to have no ill effects.

      October 2, 2012 at 19:29 | Report abuse |
  14. mother

    My concern is what happens down the road when these girls start having kids I want to know if there are any long term side effects that we don't know about. Are there any studies that show no birth defects from this?

    October 2, 2012 at 15:42 | Report abuse | Reply
  15. Kel

    Wow, a study found that a vaccine that had to undergo rigorous health hazard testing was found to be safe? People who don't immunize because of some fabricated conspiracy theory are idiots. I wonder why we don't have polio anymore? Hmm... Vaccines work. Quit putting kid's lives at risk to prove a point.

    October 2, 2012 at 15:46 | Report abuse | Reply
  16. DCMom

    Polio vaccine actually prevents polio. This doesn't prevent anything. It "may" prevent. Read the disclosure statements. Also, i has NOT gone through "rigorous health hazard testing." That is the point. A study that didn't involve the target group and then a target group study paid for by the drug company that is making billions off of this drug and is over a very short period of time "prove" nothing.

    October 2, 2012 at 16:38 | Report abuse | Reply
    • medschoolkid

      Actually the familiar oral polio vaccine gives you an active subclinical infection. With HPV, the "may prevent" refers to the strains it is not designed to protect against, which are not very common. Strains 6, 11, 16, and 18 are 100% prevented with Gardisil. It does not include live or dead virus. There has never been any serious side effect associated with this vaccine, but in the US alone thousands of women die from cervical cancer every year. The numbers speak for themselves.

      October 2, 2012 at 19:11 | Report abuse |
    • peridot2

      What Gardasil prevents is the most common and virulent strains of HPV that cause cervical cancer. These infections also cause malignant cancer of the penis and head and neck cancers. Anyone who doesn't protect their child is an uncaring parent or a fool. This is a chance to prevent deadly cancer. There is no HPV test. HPV is carried in pubic hair and transferred from person to person during oral or genital sexual contact.

      October 2, 2012 at 22:48 | Report abuse |
  17. Fainter

    As someone who got the vaccine, I have had no side side effects, (other than passing out). Although that was unpleasant, it's over and done with so I can frolic along happy meadows and continue my life.

    October 2, 2012 at 19:42 | Report abuse | Reply
  18. Jkb

    How funny. Merck funded the study...the maker and profiter of the vaccine. Can't make this stuff up.

    October 2, 2012 at 21:24 | Report abuse | Reply
    • peridot2

      So? What's your point? Gardasil protects against the 30 most virulent strains of HPV. It prevents CANCER. It's a win/win in my book.

      October 2, 2012 at 22:50 | Report abuse |
    • PLZ

      yeah you would think most people would see a conflict of interest but it just falls on deaf ears. people unable or unwilling to process or correlate information

      October 3, 2012 at 11:18 | Report abuse |
  19. tomhua

    The e-book website copy to a new browser to open http://www.znjnn.com

    October 2, 2012 at 22:02 | Report abuse | Reply
  20. acrosssea

    We all have the HPV in our bodies!! if this vaccine was sooo good why do we not all get this shot to avoid getting cancer?

    October 3, 2012 at 08:52 | Report abuse | Reply
  21. Sarah

    The people I know who are concerned about the safety of this vaccine would not be comforted by this study at all. It is not the immediate side effects like fainting that concern them. They are concerned with potential long term effects like reduced fertility. A study that only looks for problems 60 days after girls receive this vaccine does not even begin to address potential long term consequences. Really, the vaccine hasn't been around long enough to do a study of potential long term side effects. That being said, I had this vaccine and had no trouble getting pregnant.

    October 3, 2012 at 10:40 | Report abuse | Reply
  22. PLZ

    Looks like all the brain-washed big pharma cheer-leading sheep beat me me here...You clueless, misinformed conforming masses can keep defending the largest and most profitable industry on the planet and fooling yourself they operate with your best interest in mind.. Open your eyes.. So naive...

    October 3, 2012 at 11:08 | Report abuse | Reply
  23. KWM

    All you have to do is search the internet for horror stories about this vaccine. Of course they are going to say it is safe, of course it is necessary, of course your child should have it. Please do other research because as we all know, of course they always tell the truth.
    Realistically do you know how hard it is to actually "report" a problem or reaction to a vaccine...should probably check on that as well. Being informed is your best bet!

    October 3, 2012 at 11:57 | Report abuse | Reply
  24. Don't believe everything you read...

    All of you people decrying "vaccine paranoia" and insisting this "study" proves Gardisil is safe realize you just read a Merck press release right? There was a similar study they were "forced" to do to prove their drug Fosamax was safe, and guess what, the study determined that it's safe. Yet for some reason, the vast majority of respected experts continue to believe Fosamax causes dangerous side effects. In other words- this study proves NOTHING. Anyone who knows how Merck works will attest to that. A lot of you sound really intelligent, which is alarming to me because it shows just how effective the pharmaceutical industry is at conning people.

    October 3, 2012 at 12:08 | Report abuse | Reply
  25. mercenary76

    a small search on the internet finds many issues with this vaccine , including massive changes in quality of life . this does include early expiration of the vaccinated subject .

    October 3, 2012 at 12:55 | Report abuse | Reply

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