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VACCINES:    HUMAN PAPILLOMAVIRUS VACCINE
GARDASIL - INVESTIGATE THE SAFETY ISSUES

Overview: HPV Vaccine Gardasil®

"This vaccine should not be mandated for 11-year-old girls.... It's not been tested in little girls for efficacy. At 11, these girls don't get cervical cancer—they won't know for 25 years if they will get cervical cancer. Giving it to 11-year-olds is a great big public health experiment."
Dr. Diane Harper, lead researcher, HPV vaccine development

In Canada, the funding of a new Human Papillomavirus (HPV) vaccine program—as detailed in the 2007 federal government budget—is making Canadian taxpayer history; it's the costliest vaccine yet. Are we getting value for our money? Should the provinces adopt this program? What unknown health risks will young girls face who submit to this vaccine?

  1. FDA documents reveal HPV vaccine may increase your risk of cancer if you already have HPV. In trials, Gardasil increased risk by 44.6% of developing high-grade precancerous lesions in women who are already sero-positive and PCR-positive for vaccine-relevant genotypes of HPV. However, pre-screening for HPV infections has not been included in the vaccination program. (Sources: FDA document, PDF format http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-vol1.pdf & RenewAmerica.us article by Cynthia A. Janak, December 11, 2007 http://www.renewamerica.us/columns/janak/071211.)
  2. The actual cause of cervical cancer is a persistent HPV infection: A "persistent HPV infection that may act as a tumor promoter in cancer induction", according to journalist Cynthia A. Janak's assessment of FDA document "Reclassification Petition for Human Papillomavirus (HPV) DNA, Nested Polymerase Chain Reaction (PCR) Detection" published March 7, 2007. "It is the persistent infection, not the virus, that determines the cancer risk". (Sources: FDA document, PDF format http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-vol1.pdf & RenewAmerica.us article by Cynthia A. Janak, December 12, 2007 http://www.renewamerica.us/columns/janak/071212.)
  3. Reactions and deaths to date in the U.S.:

    In the U.S., vaccine reactions are available to the public via VAERS, the U.S.A.'s official Vaccine Adverse Events Reporting System. However, journalist Cynthia Janak recently noted that the some of the new reports refer to multiple patients—her research uncovered the above total numbers. Note that VAERS receives only an estimated 1-10% of vaccine reactions/injuries; the vast majority of reactions and injuries (90-99%) are never reported or followed up. Canada has no publicly accessible reporting system, thus enabling health officials to keep the public in the dark about vaccine reactions, injuries and deaths.
  4. Excessive cost: Merck's Gardasil, the vaccine to be used for this program, will cost approximately $400 per person injected. The federal government is contributing $300 million, estimated to be about one third of the vaccine cost nationwide. The other two thirds must come from the provinces, bringing the total cost nationwide for this one vaccine to almost one billion dollars. This cost is to cover the specified 3 doses of Gardasil for all females 9—13 years as well as females 14—26 years who are deemed to be reasonably sure of not already being infected with one or more of the 4 HPV types in the vaccine.
  5. FDA approval was NOT based on actual cancer prevention: FDA did not approve Gardasil based on the vaccine's actual prevention of cervical cancer but on the prevention of precancerous lesions. How effective is Gardasil in decreasing the incidence of cervical cancer? No one knows because this question has not yet been answered. As of April 2007, Gardasil vaccine has never been proven to decrease the actual incidence of cervical cancer. (See article in Cancer Monthly.)
  6. Lack of testing in 9—13 yr olds: The Gardasil monograph states: "efficacy of the vaccine in this age group [9—13 yr olds] has not been demonstrated".
  7. Lack of evidence of duration of protection: The only evidence of duration of protection stated on the Gardasil monograph is: "A subset of participants (n=241) in the Phase II quadrivalent vaccine study has been followed for 60 months after dose 1 with high sustained vaccine efficacy and no evidence of waning immunity." This means that the only test for duration of efficacy was in a minor sample of 241 older females, few of whom tested positive for any of the HPV types in the vaccine in a study that lasted a mere 5 years after the first dose of vaccine was given. Therefore, it can be said that, in general, the duration of any long term efficacy has not been demonstrated and is unknown. In fact, there's already been talk of the need for booster shots.
  8. Benefit of Gardasil to 9—13 year olds is dubious: Due to the unknown duration of efficacy in older women, the benefit of Gardasil to 9—13 year olds is even more dubious than statement two reveals. To be reliably effective, HPV vaccine would need to be given reasonably near the time when one or more of the HPV types in the vaccine enters the body. This time is an unknown factor; vaccine efficacy could wane long before virus infiltration occurs or a child might already be infected at the time of vaccination. HPV infection occurs through skin-to-skin contact that's not necessarily due to sexual activity.
  9. Safety in conjunction with other vaccines is questionable: The Gardasil monograph states that Gardasil "has no components that have been found to adversely affect the safety or efficacy of other vaccines." Does this mean that Merck has looked for adverse affects and not found any or that they just haven't bothered to look? Certainly the accumulation of ingredients aluminum and polysorbate, both known to cause cancer in lab animals and to alter immune response, together with similar types of ingredients in other vaccines is cause for concern. And Merck's statement doesn't mean that the vaccine as a whole does not affect safety or efficacy. Simultaneous injection of Gardasil with other taxpayer funded vaccines (such as meningococcal, chickenpox, DPT or influenza vaccines) could result in lowered efficacy and/or more adverse reactions.
  10. Gardasil could cause other types of cancer: Unlike other drugs, vaccines are never tested for their ability to produce cancer. Gardasil could provoke other types of cancer, including cervical cancer that's associated with HPV types not in the vaccine. In addition, Gardasil has been very aggressively marketed with no emphasis on the fact that it can only possibly prevent HPV infection, not clear HPV that's already present; it may actually cause an increase in cervical cancer due to a false feeling of security in the females who receive it.
  11. Gardasil does not guarantee safety from HPV: Since vaccination with Gardasil is obviously not a guarantee of freedom from HPV infection with vaccine type virus or others, regular Pap screening tests with their incumbent costs will still be needed.
  12. Rate of targeted HPV infections is extremely low: The National Advisory Committee on Immunization (NACI), the panel of "experts" who recommended funding of Gardasil states: "It [HPV infection] is not a nationally notifiable disease in Canada and, to date, no population-based studies have been published." A study estimating the American population prevalence of HPV infection published in the Feb 28, 2007 edition of the Journal of the American Medical Association found that only 3.4% of women aged 14—59 yrs were infected with one of the HPV types in Gardasil; only 2% were infected with one of the two types that are in the vaccine and are associated with cervical cancer.
  13. Incidence of cervical cancer is low: Annually, U.S. statistics (and we can assume that Canadian statistics follow suit) show only 3—4 cases of cervical cancer per 100,000 females aged 9—26 years. In her article "Not So Miraculous", Dr. Moira Terese Dolan, M.D. states in reference to the U.S.: "Gardasil's reduction of pre-cancers by 12.2% in the general population would mean that instead of 30—40 cases of cancer, there would only be 26—35 cancers. So it would take vaccination of a million girls to prevent cancer in 4—5 girls. About 37% die from cervical cancer, so that would prevent 1—2 deaths. So $360 million [U.S] in vaccine would prevent 1—2 [U.S] deaths."
  14. HPV is usually benign: The March 21, 2007 article on fwdailynews.com states: "75% or more of girls and women may test positive for HPV at some points in their lives. But, in adolescents, in 75—90% of those cases, the virus clears up on its own within 8—12 months, including those that may be cancer-causing".
  15. Pap screening already works: According to the NACI, "the time it takes for an infection to progress to invasive cervical cancer can vary widely, with typical progression estimated to take up to 10 years or longer." And that's why Pap screening has been very effective in reducing cervical cancer.

Conclusion: Allocating government funds for this vaccine would be a shameful waste of Canadian taxpayer's money. More importantly, lack of evidence of Gardasil's safety and effectiveness for the 9—26 year olds targeted makes this program a public health experiment that endangers our precious young women. Don't buy into it; take action! Learn more about the vaccine or contact your governmental representative today; follow the links below.


More information:

VRAN letters to government officials:

Contact your governmental representative:

©2003 Vaccination Risk Awareness Network Inc.  All rights reserved.  
The contents of this publication reflect the opinion of the authors only. This publication is for informational purposes only. Opinions expressed should not be construed as medical advice. The particulars of any person's concerns and circumstances should be discussed with a qualified health care practitioner prior to making any decision which may affect the health and welfare of that individual or anyone under his or her care. 

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