Autoimmune syndromes induced by adjuvants – another anti-vaccine myth

One of the enduring myths (there are so many) about the HPV vaccine is that it is linked to one or more autoimmune syndromes, an abnormal immune response to a healthy body part. These claims, pushed by an Israeli physician, Yehuda Shoenfeld, are called “autoimmune syndrome induced by adjuvants (ASIA)” and, sometimes, Shoenfeld’s Syndrome.

Of course, ASIA is not accepted by the scientific and medical community (and see this published article), was rejected by the United States vaccine court as a claim for vaccine injury, and should not be accepted by parents deciding whether they should vaccinate their children. Furthermore, the European Medicines Agency, which is the primary regulatory body in the EU for pharmaceuticals, has rejected any link between the HPV vaccine and various autoimmune disorders. The science stands in direct opposition to autoimmune syndromes being caused by any vaccine.

Despite the lack of evidence supporting the existence of autoimmune syndrome induced by adjuvants, and even more powerful evidence that it doesn’t exist, the anti-vaccine religion still cherry-picks articles to support their preconceived conclusions that the HPV cancer-preventing vaccine is dangerous.

All about HPV vaccines

Many of you have read this section an enormous number of times, however, for some of the readers of this blog, this article might be their first bit of research into the human papillomavirus (HPV) vaccine. I feel it is important to a new reader to review the facts behind the human papillomavirus, the HPV vaccines, and HPV-related cancers. This section is constantly updated for even regular readers, but you can skip ahead if you know all of this.

Genital and oral  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. 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:

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.

There is also some fairly strong evidence that HPV infections might be linked to prostate and some skin cancers, which would vastly increase the number of HPV-related cancers diagnosed every year. The HPV vaccine could be one of the best prevention tools for cancer we’ve ever found.

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 31,000 HPV-related cancers are diagnosed in the USA every year.

There were two HPV vaccines on the world market before 2014. GSK, also known as GlaxoSmithKline manufactured 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 deadly cancers that are related to HPV. It is definitely a cancer-preventing vaccine.

(Just a quick note. There are actually two cancer-preventing vaccines. Along with the HPV vaccines, the hepatitis B vaccine is also important for the prevention of some cancers.  The vaccine prevents hepatitis B viral infections. Chronic hepatitis B infections can lead to liver cirrhosis or cancer. Liver cancer is actually one of the few cancers in the USA where the incidence has increased over the past few years. And if you follow the anti-vaccine rhetoric, you know the hepatitis B vaccine is almost as controversial as the HPV vaccine.)

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.

One autoimmune syndromes induced by adjuvants “study”

In a recent study published in the low impact factor journal, Immunologic Research, the authors reviewed, Jara et al., the literature that claims that ASIA is a real issue. To be clear, this is a review article, but it is not a systematic or meta-review, which sits at the top of the hierarchy of medical research.

Basically, Jara et al. reviewed 4479 ASIA cases, from 2011 to 2016, which included 305 “severe” cases, along with 11 deaths. They claim that the severe ASIA cases were related to the HPV cancer preventing vaccine, silicone, flu vaccine or mineral oil injections. The 4479 cases were culled from published articles over that time period.

The authors then conclude:

Efforts should be made to discover the connection between adjuvants, autoimmunity and autoimmune diseases, because there is an increase in cases severe and life-threatening of ASIA.

You might think this is a definitive “proof” that ASIA exists, and it’s caused by vaccines (mostly the HPV vaccine, but also adjuvants and the flu vaccine). To disabuse anyone who would assume this conclusion, let’s critique this study from an unbiased scientific perspective:

  • This was not a systematic review. It did not establish whether any of the articles actually showed evidence of causality between the vaccines/adjuvants and autoimmune diseases. It did not include huge studies that have shown no relationship between the HPV vaccine and autoimmune diseases.
  • This study makes absolutely no effort to compare results to a control group, say the general population. ASIA-like symptoms are found at the same (and sometimes higher) rate in the unvaccinated population as the vaccinated one. In other words, ASIA may be a syndrome that’s simply found in individuals irrespective of vaccine status. All of the studies included in this “review” lacked adequate controls that might establish a causal link between vaccines and ASIA.
  • The study relies upon 40 published articles only. Worse yet, 19 of those studies were authored or co-authored by Yehuda Shoenfeld, who has a vested interest in “proving” that ASIA exists. These studies seem to indicate a high level of bias of the authors, as if they were trying to find the published research that established a link, rather looking at all of the research to se if there is even a link.
  • Sixteen of the 40 studies cited had nothing to do with vaccines or adjuvants – most of them were trying to link silicone breast implants to ASIA, not vaccines. It’s possible that the authors were trying to imply that silicone is a vaccine adjuvant, but as far as I can tell, it is not used as such.

This study does not actually provide us with any data to conclude that vaccines are causally related to autoimmune syndrome induced by adjuvants. At best, it provides us a list of studies that can be cherry picked to ignore the well-designed epidemiological studies that actually establish that there is no link between the HPV vaccine and various autoimmune diseases.

Anoter HPV vaccine and autoimmune disorders study

A while ago, I reviewed another study, which was a properly designed case-control epidemiological study. According to the study published in the Journal of Autoimmunity, HPV vaccines do not increase the risk of developing autoimmune diseases (ADs). This adds to the body of research, based on ma ethodology that helps us establish correlation and causation, that rejects the hypothesis that the HPV vaccine is related to ASIA.

In this study, the authors evaluated the risk of autoimmune diseases over 6.5 year period after exposure to HPV vaccines (quadrivalent Gardasil and bivalent Cervarix) in adolescent and young adult women using data from a French medical registry, Pharmacoepidemiologic General Research eXtension (PGRx). The PGRx is a surveillance database that helps researchers monitor the occurrence of rare or delayed health events that may be related to the use of medications, including vaccines.

Here are the published results of the study:

  • A total of 478 cases with AD against 1869 matched controls with no AD were included in the case-control study. A large majority of individuals in both the AD and control groups had received the quadrivalent Gardasil vaccine (95.3%). Additionally, over half of the study population had been exposed to at least one other vaccine during the 24 months before inclusion in the study
  • The HPV vaccine uptake rate was lower in the patients with AD than in the controls without AD (10.9% vs 22.5%).
  • Surprisingly, the group receiving an HPV vaccine had a more than 40% lower observed risk of developing AD. A similar lowered risk of central demyelination/multiple sclerosis (CD/MS) and autoimmune thyroiditis (AT) was observed in the HPV vaccine group. The researchers observed a statistically nonsignificant trend for reduced risk of connective tissue disease (CTD) and type 1 diabetes (T1D) after vaccination.
  • No correlation was found between HPV vaccine exposure and idiopathic thrombocytopenic purpura (ITP). The relationship between HPV vaccine exposure and Guillain-Barré syndrome (GBS) could not be established since no cases of GBS occurred in individuals who received an HPV vaccine.

The authors concluded:

Exposure to HPV vaccines was not associated with an increased risk of ADs within the time period studied. Results were robust to case definitions and time windows of exposure. Continued active surveillance is needed to confirm this finding for individual ADs.

This data not only show us that there is no link between the HPV vaccine and autoimmune diseases, but, in a few cases, seems to indicate that there is a higher risk of these autoimmune diseases in the non-vaccinated group.

More autoimmune disorders from Shoenfeld

Shoenfeld has published over 60 articles on adjuvants and autoimmune disorders. For even a top-level science researcher, that would be impressive at the meta level. However, there are many issues:

  1. Most of the studies are published in low impact factor journals, which often have low or no peer-review, or even in predatory journals that publish any article as long as they are paid. On the other hand, none of his articles are published in the premier journals for autoimmune disease, like The Journal of Allergy and Clinical Immunology or the Annals of the Rheumatic Diseases. If these anti-vaccine “researchers” actually had groundbreaking work that is supported by robust data, these journals would be begging to publish it.
  2. Almost all of his publications are opinion pieces or reviews (not systematic reviews) that don’t contribute data that could be used to further the science behind Shoenfeld’s claims. I’ve noticed this a lot with anti-vaccine “science” – the provide very little in data, but a lot in rhetoric.
  3. Shoenfeld receives much of his research funding from the Children’s Medical Safety Research Institute (CMSRI), which was founded by the Dwoskin Foundation, who also supports the oft-retracted team of Christopher Shaw and Lucija Tomljenovic.
  4. Of course, one of his studies, co-authored with the aforementioned Shaw and Tomljenovic, was retracted as a result of a “review by the Editor-in-Chief and evaluation by outside experts, confirmed that the methodology is seriously flawed, and the claims that the article makes are unjustified.”
  5. In the rare studies that are backed by original data, Shoenfeld seems to rely upon small animal studies or case studies, both near the bottom of biomedical research. Their value as evidence needs to be supported by real clinical research.

Vincent Iannelli’s blog, Vaxopedia, has a much more in depth criticism of Shoenfeld, it is worth a read. Dr. Iannelli concludes that “it is the ‘actual science’ of his studies that is ‘being methodologically assessed and critiqued.’ And it has been found to be lacking.”

Shoenfeld is just wrong

But here’s the most important thing that both Dr. Iannelli and I agree on – large clinical and epidemiological studies have found no safety signals for autoimmune syndromes from HPV vaccines. Several studies shown no link between the HPV vaccine and autoimmune syndromes.

A recent systematic review, that included over 73,000 patients, found no difference in autoimmune syndromes between vaccinated and unvaccinated groups.

Another large study of over 1 million women found no safety signals for autoimmune diseases, neurological and venous thromboembolic (venous blood clots) events in HPV vaccinated women. The researchers deduced that,

This large cohort study found no evidence supporting associations between exposure to qHPV vaccine and autoimmune, neurological, and venous thromboembolic adverse events. Although associations for three autoimmune events were initially observed, on further assessment these were weak and not temporally related to vaccine exposure. Furthermore, the findings need to be interpreted considering the multiple outcomes assessed.

A recent meta-review (considered the pinnacle of biomedical research) of over 100 different safety studies of the HPV vaccine, that included over 2.5 million individuals, found no increased risks of adverse events of special interest (AESI), which are events that can cause serious harm. The authors of this study concluded that,

There was no consistent evidence of an increased risk of any AESI, including demyelinating syndromes or neurological conditions such as complex regional pain or postural orthostatic tachycardia syndromes. The risk-benefit profile for HPV vaccines remains highly favourable.

These aren’t case studies or torturing mice for results – these are huge studies that include millions of data points. And these were published in predatory journals that require payment to get your nonsense published – these are important, high impact factor journals that are respected across the world.

Science wins.

Conclusion

There is robust and overwhelming evidence that HPV vaccines are not related to autoimmune syndromes. These are large, well-controlled and well-designed studies, not biased “reviews” of biased research. There is simply no known link between HPV vaccines and autoimmune syndromes induced by adjuvants.

The HPV vaccines, like Gardasil, help prevent some serious and dangerous cancers. I’m hoping parents begin to understand that there are few if any risks for the vaccine, with the substantial benefit of preventing cancer.

ASIA is a bogus claim used by the anti-vaccine religion to denigrate the lifesaving HPV vaccine. It needs to go away.

Editor’s note – this article was published in May 2017. It was updated to include more information about Shoenfeld, since he’s the key proponent of this pseudoscientific claim about the HPV vaccine. In addition, new citations, heavy copyediting, some reformatting, and various other things were done to clean up the article.

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!