HPV vaccine causes infertility and primary ovarian insufficiency – myth

The HPV vaccine causes infertility through primary ovarian insufficiency (POI) – a belief unsupported by evidence. And the claim appears to be based on anti-vaccine ideology instead of real science.

Yes, I know, this story seems to repeat itself, but stay tuned, this is a good one. So let’s examine this myth from a scientific aspect and show how the HPV vaccine is actually unrelated to POI.

All about HPV and the vaccine

I know, I’ve written about this vaccine over 100 times – however, this might be your first bit of research into the HPV vaccine, so it’s important to get a brief overview of HPV and the vaccines. If you’ve read this before, just skip to the next section if you want.

Genital and oral human papillomavirus (HPV) are the most common sexually transmitted infections (STI) in the USA. There are more than 150 strains or subtypes of HPV that can infect humans, although only 40 of these strains are linked to a variety of cancers. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.

Although the early symptoms of HPV infections aren’t serious, those infections are closely linked to many types of cancers in men and women. According to current medical research, here are some of the cancers that are linked to HPV:

(All data is for the USA only.)

These are all dangerous and disfiguring cancers that can be mostly prevented by the HPV cancer vaccine. If you’re a male, and you think that these are mostly female cancers, penile cancer can lead to amputation of your penis. Just think about that guys.

HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco with respect to cancer. According to the CDC, roughly 79 million Americans are infected with HPV–approximately 14 million Americans contract HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. About 27,000 HPV-related cancers are diagnosed in the USA every year.

There were three HPV vaccines on the market. GSK, also known as Glaxo SmithKline manufactured Cervarix, a bivalent vaccine which has been withdrawn from the US market. Merck manufactures Gardasil9, a 9-valent vaccine, along with Gardasil, a quadrivalent HPV vaccine.

What is primary ovarian insufficiency?

Primary ovarian insufficiency, formerly known as premature ovarian failure, is defined as the cessation of normal ovarian function before age 40 years. It is the scientifically accurate term for the condition that was previously referred to as premature menopause or premature ovarian failure.

Some studies suggest rates of 22 cases of POI per 100 000 person years in girls 15–19 years of age in the era prior to HPV vaccine introduction. Additionally, researchers have stated that POI occurs in about 1% of all women under the age of 40.

In other words, the background, non-HPV, vaccine rate of POI has always been well above zero.

HPV vaccine causes infertility through primary ovarian insufficiency

A recent article by Gruber and Shoenfeld proposed a possible link between Gardasil and POI, based on some very weak (almost useless) evidence. Gruber and Shoenfeld seem to ignore widespread and robust evidence that the HPV vaccine isn’t related to POI. For example, a case control study of nearly 1 million teenage girls showed no incidence of POI within 180 days of HPV vaccine.

A broad, unbiased review by Hawkes et al. of the safety of the HPV vaccines have found – almost nothing.

In the nearly 9 years since the introduction of the HPV vaccine, which included over 170 million doses of Gardasil, only six cases of POI have been reported after an HPV vaccination. That’s an incidence rate of around 0.003 per 100,000 far below the non-HPV vaccine risk of around 22 per 100,000. In other words, and I know this is not proper statistics, getting the HPV vaccine theoretically reduces the risk of POI. Again, my statistical example would cause my statistics professor in grad school have a stroke.

So, let’s review these six cases, just to be thorough:

The article by Gruber and Shoenfeld (who also was one of the coauthors of the third case study listed above) reviews the case studies as part of their proposed evidence that Gardasil and POI are related. However, in a curious editorial decision, failed to mention the temporal relationship between the HPV vaccination and the appearance of symptoms.

In fact, five of the six cases only appeared after the full course of 3 vaccinations, and none of them were less than a few months after the last vaccination. It stretches the credibility of the relationship of these cases with the HPV vaccine if the timeline is so long, especially since there is limited or no biological plausibility that HPV vaccine is related to POI.

Shoenfeld has attempted to provide a biologically plausible mechanism for many rare conditions post-HPV vaccination by claiming the existence of “autoimmune syndrome induced by adjuvants” (ASIA). However, a review by Hawkes and others of the research disputes the existence of ASIA, and the National Vaccine Injury Compensation Program has rejected ASIA as a vaccine injury.

Even in a recent paper, Shoenfeld admits that “every attempt for an epidemiological study has so far failed to deliver a connection.” Sometimes, the absence of evidence is evidence of absence.

Debunking HPV vaccine causes infertility

A December 2015 article by Hawkes and Buttery examined the link between the cancer preventing HPV vaccine and POI – they found several troubling issues:

  1. There is no biological plausibility. So to establish a potential correlation, large epidemiological studies are required. Sadly, many people will accept implausible relationships unless evidence disproves it, even if there’s no evidence of a relationship based on several large epidemiological studies.
  2. As of today, the evidence of the relationship between HPV vaccines and POI are based on a handful of case studies. In general, case studies cannot provide evidence of a causal link, but casual readers of scientific studies overstate their value. This causes the creation of a hypothesis, despite lack of even observational evidence for that hypothesis, that scientists have to debunk. See #1 again.
  3. The worst part of these studies is a high degree of conflicts of interest, a typical accusation of the antivaccination community against nearly every scientific article published about vaccines.Yehuda Shoenfeld is acting as an expert witness for two of the three women who were featured in the case studies. In other words, Shoenfeld, whether deliberately or not, published articles that support her claims about the vaccine and POI – worse yet, she did not declare that conflict in those papers. This could lead to retraction of those articles.The paper by Colafrancesco et al. was also published to be used as a part of the litigation regarding the HPV vaccine and POI.Surprisingly, Shoenfeld and Tomljenovic did not dispute these claims. And as I’ve mentioned previously, Tomljenovic’s ties to antivaccination groups is impressive. For example, he has received substantial funding (at least US$950,000) from the Dwoskin Family Trust, a well-known antivaccination group

 

As Hawkes and Buttery state regarding Tomljenovic’s COI,

It could be argued that the COI statement ‘The authors thank the Dwoskin Family Foundation for support’ is inadequate to describe this level of funding. Additionally, in three other studies written by Tomljenovic over the same time period, she states that her work was funded by the Katlyn Fox Foundation. This is another antivaccine organization and it could be reasonably expected that this COI should have been stated.

When real scientists publish about vaccines, they are absolutely transparent about COIs, if there are any. Apparently, those rules are not applicable to the antivaccination “researchers.”

And there’s one more thing. A large 2017 study examined whether there was any association between the HPV vaccine and fertility – there was none, except in some women who previously had sexually transmitted infections, who had increased fertility. If the HPV vaccine showed no fertility issues, which POI would cause, then there should have been lower fertility rates.

The conclusions

David Hawkes and Jim P Buttery have presented a powerful deconstruction of the “evidence,” more like lack thereof, that claims that the HPV vaccine causes primary ovarian insufficiency.

There is no biological plausibility.

There are no epidemiological studies that show correlation between the vaccine and POI.

All of the claims are based on six case studies, one of the least reliable forms of scientific evidence, whose authors have serious conflicts of interest, as they have a personal interest in the legal cases for these studies, or receive huge amounts of funding from antivaccination groups.

As Hawkes and Buttery conclude in their article,

While postlicensure safety surveillance is critical for all vaccines, including HPV vaccines, young women deserve better than being scared by the overinterpretation of a handful of distressing cases presented without thought to potential bias.

Gardasil is safe, it prevents HPV, and it prevents cancer. And the myth that HPV vaccine causes infertility through primary ovarian insufficiency – debunked.

Editor’s note. This article was originally published in December 2015. Apparently, this myth has risen its head again, so I cleaned up the formatting, links and information in this article.

Key citations:



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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!