HPV vaccine unrelated to primary ovarian insufficiency – debunking anti-vaccine myth

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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.

Photo by Alexis Brown on Unsplash

All about HPV and HPV vaccines

I know I cut and paste this section to every article I write about HPV vaccines, but it’s the first step to HPV vaccine myth debunking. Some readers may be coming here for the first time, and they ought to know just how the HPV vaccine prevents cancer. 

However, I try to update this section when necessary with new information about either the disease or the vaccine. If you’ve read this section 47 times, just skip down to the next section where I discuss the key point of this article.

Genital and oral human papillomavirus (HPV) infections are the most common sexually transmitted infections (STI) in the USA.  HPV is generally transmitted from personal contact during vaginal, anal, or oral sex.

It’s important to note that there are more than 150 strains or subtypes of HPV that can infect humans – however, only 40 of these strains are linked to one or more different cancers. Of those 40 strain, most are fairly rare.

Although the early symptoms of HPV infections aren’t serious and many HPV infections resolve themselves without long-term harm, HPV infections are causally 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:

In addition, there is some evidence that HPV infections are causally linked to skin and prostate cancers. The link to skin cancer is still preliminary, but there is much stronger evidence that HPV is linked to many prostate cancers.

HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco in that respect. According to the CDC, roughly 79 million Americans are infected with HPV – approximately 14 million Americans contract a new HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. The CDC also states that over 43,000 HPV-related cancers are diagnosed in the USA every year. It may be several times that amount worldwide.

There were two HPV vaccines on the world market before 2014. GSK, also known as GlaxoSmithKline, produced Cervarix, a bivalent (protects against two HPV strains) vaccine. It has been withdrawn from the US market (although available in many other markets), because of the competition from the quadrivalent (immunizes against four different HPV strains) and 9-valent (against nine HPV strains) Gardasil vaccines.

Merck manufactures Gardasil, probably the most popular HPV vaccine in the world. The first version of the vaccine, quadrivalent Gardasil, targets the two HPV genotypes known to cause about 70% of cervical cancer and two other HPV genotypes that cause genital warts. In Europe and other markets, Gardasil is known as Silgard.

The newer Gardasil 9, approved by the FDA in 2014, is a 9-valent vaccine, protecting against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It targets the four HPV strains found in the quadrivalent version, along with five additional ones that are linked to cervical and other HPV-related cancers. Both versions of Gardasil are prophylactic, meant to be given to females or males before they become exposed to possible HPV infection through intimate contact.

Gardasil is one of the easiest and best ways to prevent a few dangerous and, to abuse the definition slightly, common cancers that afflict men and women. Without a doubt, the HPV vaccine prevents cancer.

Currently, in the United States, the Advisory Committee on Immunization Practices (ACIP) recommends that preteen girls and boys aged 11 or 12 are vaccinated against HPV. The immunization is also recommended for teenage girls and young women up to the age of 26 who did not receive it when they were younger, and teenage boys and young men up to the age of 21.

Let me sum this all up so that if you come away from this section with nothing else, you get this summary. HPV is a sexually transmitted disease. HPV causes 43,000 cancers a year in the USA alone. The HPV vaccine prevents becoming infected by HPV, which means you are protected from these cancers.

woman carrying baby
Photo by Jonathan Borba on Pexels.com

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 the 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 a proper use of statistics, getting the HPV vaccine theoretically reduces the risk of POI. Again, my statistical example would cause my statistics professor in grad school to 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 the 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.

medical stethoscope with red paper heart on white surface
Photo by Karolina Grabowska on Pexels.com

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 them, 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 is 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 the 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 the 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.

conclusion word formed from lettered yellow tiles
Photo by Ann H on Pexels.com

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!