HPV Vaccines

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HPV – human papillomavirus – is a sexually transmitted disease. Anyone who is sexually active, especially those with multiple sexual partners, can contract one of the several strains of HPV. A small portion of HPV infections may progress into cervical cancer; however, most infections occur without any symptoms at all, and more than 80% clear on their own. (1,2) The incidence of cervical cancer continues to decline in Canada; it is a slow-progressing, preventable disease that can be detected and treated at an early stage.

Gardasil & Cervarix: Are They Safe for My Daughter?

What is HPV?

Gardasil, produced by Merck, targets two of the fifteen high-risk HPV strains (16 and 18), and two low-risk strains (6 and 11). Strains 16 and 18 can lead to cervical cancer; strains 6 and 11 cause genital warts, and do not lead to cervical cancer. (3) Cervarix, produced by Glaxo Smith Kline, also targets strains 16 and 18.

Doubts have been raised about the long-term effectiveness of both vaccines due to a lack of long-term testing. Clinical trials have shown that Gardasil’s effectiveness can begin to drop after 5 years.(4) As Gardasil’s package insert states, “The duration of immunity following a complete schedule of immunization with Gardasil has not been established.” (5)

Neither vaccine protects against the other strains of HPV. They are not effective against HPV infections present at the time of vaccination. It is for these reasons that women and girls who have been vaccinated should still receive regular Pap screening. (6) Does it not seem misleading that Gardasil has been advertised as a “cervical cancer vaccine”? There has been concern that this could give women a false sense of security and result in less cancer screening. (7)

 

When healthy children are vaccinated, the risk of adverse reactions is weighed against the potential benefits of the vaccine. In the case of Gardasil and Cervarix, the number of adverse reactions is troubling. Is it worth the risk?


A 2012 article in the Journal of Law, Medicine & Ethics states:

What Do HPV Vaccines Do?

Are They Safe?

“Compared with all other vaccines, Gardasil alone was associated with more than 60% of all serious [adverse reactions] … in females younger than 30 years.” (8)

 

Gardasil was associated with over 80% of reactions leading to permanent disability, and over 60% of deaths. Adverse reactions include loss of consciousness (sometimes accompanied by convulsions, and often leading to injury due to fall), dizziness, nausea, injection site reactions, vision loss, autoimmune disorder, Guillain-Barré Syndrome, motor neuron disease, blood clots, and death. The rate of occurrence of an anaphylactic reaction is six times higher for Gardasil compared to the meningococcal C vaccine. (9)

Some argue that the adverse reactions associated with Gardasil are mere ‘coincidence’. However, consider that around 40% of these reactions occur on the day of the vaccination. (10) The rate of adverse reactions to Cervarix is even higher than that of Gardasil (42.5% vs. 36.5%). (11) In the UK, the number of reactions to Cervarix is 24-104 times higher than that of any other vaccine. (12)

 

A 2013 article emphasizes the clear imbalance of risk and benefit:

“In the US, the current age-standardized death rate from cervical cancer… is 2.5 times lower than the rate of serious adverse reactions (ADRs) from Gardasil. In the Netherlands, the reported rate of serious ADRs from Cervarix … is nearly 4-fold higher than the age-standardized death rate from cervical cancer.” (13)

Gardasil has not been tested to see if it will cause cancer (14)


It was precisely due to such safety concerns that Japan announced they would no longer be using the vaccine (15)

HPV Vaccines & Cervical Cancer

The mortality rate due to cervical cancer in developed countries is so low (1.7 per 100,000 women in the US, 1.5/100,000 in the Netherlands) (16) because of the success of Pap screening, a method that is safer and more effective than HPV vaccines. A 2012 article in the Journal of Law, Medicine & Ethics suggests that introduction of HPV vaccines is not likely to reduce this number any further. (17) The rate of cervical cancer is highest in developing countries, where Pap screening may not be available. If the HPV vaccines prove effective in preventing cancer, they would still not be easily accessible to countries with high cervical cancer rates. Why? Because they’re one of the most expensive vaccines in the world(18,19)

On the other hand, there is concern that if the HPV vaccines prove effective, there will just be a higher incidence of infection from the other high-risk strains that they do not protect against. (20) This is a phenomenon that has been witnessed with other vaccines.

 

Lack of Objective Evaluation

 

All the clinical trials for Gardasil and Cervarix were either fully or partially funded by the vaccine manufacturers. (21) Unbiased research is needed to ascertain the safety of a vaccine, especially when they are so lucrative for the companies selling them. Merck began to promote Gardasil in 2006, before important safety and efficacy data were made available. (22)

One of the concerns about Merck’s clinical studies is that though they studied 20,000 females, only 1,200 of these were in the age range primarily targeted by the vaccine (9 to 15 years). (23) Only 100 girls were 9 years old, and the younger participants were only followed for 18 months.

Diane Harper, a researcher for the vaccine, has called vaccinating 11-year-old girls “a great big public health experiment.” (24)

Gardasil’s aggressive advertising campaign and premature fast-track FDA approval have led to tens of millions of girls receiving the vaccination. Both Gardasil and Cervarix may put these girls at unnecessary risk from serious side effects.

  1. Canadian Women's Health Network, "HPV, Vaccines, and Gender: Policy Considerations," (Winnipeg, 2007): 6.

  2. Public Health Agency of Canada, "What Everyone Should Know About Human Papillomavirus (HPV)" http://www.phac-aspc.gc.ca/std-mts/hpv-vph/hpv-vph-qaqr-eng.php

  3. Canadian Women's Health Network, "HPV, Vaccines, and Gender: Policy Considerations," (Winnipeg, 2007): 6.

  4. D.M. Harper and K.B. Williams, “Prophylactic Hpv Vaccines: Current Knowledge of Impact on Gynecologic Premalignancies,” Discovery Medicine 10, no. 50 (2010): 7-17. Cited in Lucija Tomljenovic and Christopher A. Shaw, "Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil," Journal of Law, Medicine & Ethics, Fall 2012: 673-681.

  5. Merck, Gardasil package insert (2011), 28, available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM094042

  6. Public Health Agency of Canada, "What Everyone Should Know About Human Papillomavirus (HPV)" http://www.phac-aspc.gc.ca/std-mts/hpv-vph/hpv-vph-qaqr-eng.php

  7. Canadian Women's Health Network, "HPV, Vaccines, and Gender: Policy Considerations," (Winnipeg, 2007): 12.

  8. Lucija Tomljenovic and Christopher A. Shaw, "Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil," Journal of Law, Medicine & Ethics, Fall 2012: 676.

  9. Julia M.L. Brotherton, Mike S. Gold, Andrew S. Kemp, Peter B. McIntyre, Margaret A. Burgess and Sue Campbell-Lloyd, "Anaphylaxis following quadrivalent human papillomavirus vaccination," CMAJ 179, no. 6 (September 2008): 525-533.

  10. Barbara A. Slade, et al., "Postlicensure safety surveillance for quadrivalent human papillomavirus recombitant vaccine," JAMA 302, no. 7 (August 2009): 752.

  11. National Advisory Committee on Immunization, "Update on Human Papillomavirus (HPV) Vaccines," Advisory Committee Statement, Public Health Agency of Canada (2012): 28.

  12. Lucija Tomljenovic and Christopher A. Shaw, "Human papillomavirus (HPV) vaccine policy and evidence-based medicine: are they at odds?," Annals of Medicine, 2013: 185.

  13. Tomljenovic and Shaw, "Human papillomavirus (HPV) vaccine policy and evidence-based medicine: are they at odds?," 183.

  14. Merck, "Gardasil package insert" (2011): 14.

  15. LifeSiteNews, "Japan withdraws support of controversial HPV vaccine over safety concerns," October 16, 2013, http://www.lifesitenews.com/news/japan-withdraws-support-of-controversial-hpv-vaccine-over-safety-concerns

  16. Tomljenovic and Shaw, "Human papillomavirus (HPV) vaccine policy and evidence-based medicine: are they at odds?," 183.

  17. Tomljenovic and Shaw, "Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil," 679

  18. CBC News, “The debate over Gardasil continues,” last updated August 20, 2009, http://www.cbc.ca/news/technology/the-debate-over-gardasil-continues-1.719098

  19. Lauri E. Markowitz, et al., "Human papillomavirus vaccine introduction - the first five years," Vaccine 30S, 2012: 146.

  20. Canadian Women's Health Network, "HPV, Vaccines, and Gender: Policy Considerations," (Winnipeg, 2007): 9.

  21. Madeline Boscoe, Abby Lippman, Ryan Melnychuk and Carolyn Shimmin, "Human papillomavirus, vaccines and women's health: questions and cautions," Canadian Medical Association Journal 177, no. 5 (August 2007): 484.

  22. Tomljenovic and Shaw, "Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil," 674.

  23. Canadian Women's Health Network, "HPV, Vaccines, and Gender: Policy Considerations," (Winnipeg, 2007): 7-8.

  24. Bob Marshall, “Gardasil: Hyper Over Health” Celebrate Life Magazine, American Life League, accessed Dec. 30, 2013, http://www.clmagazine.org/article/index/id/OTMwNw/