Gardasil HPV Vaccine Studies

There is a growing body of research outlining the risks associated with the HPV vaccine, Gardasil, which include (among others):

• Autoimmune disorders
• Chronic fatigue syndromes
• Chronic pain syndromes, including Chronic regional pain syndrome (CRPS)
• Death
• Dysautonomia
• Fibromyalgia
• Guillain-Barré syndrome
• Idiopathic Thrombocytopenic Purpura (ITP)
• Lupus
• Neurological disorders
• Postural orthostatic tachycardia syndrome (POTS)
• Reproductive disorders, including premature ovarian failure (POF) and infertility
• Small fiber neuropathy

If you have suffered from side effects after Gardasil, please contact the HPV vaccine attorneys at Wisner Baum to learn more about your legal rights. We offer free case evaluations and are more than happy to answer any questions you may have about pursuing a Gardasil lawsuit against Merck.

Background on HPV and Gardasil

• Gardasil is the only vaccine on the market in the U.S. for prevention of only nine of the over 200 strains of the human papillomavirus (HPV). HPV is so common, most sexually active people will get it at some point in their lives.
• A 2016 study found that 30% of children under age 10 have already been exposed to HPV through skin-to-skin contact or in the birth canal.
• According to one study, more than 90% of HPV infections cause no clinical symptoms, are self-limited, and are removed from the human body by its own immunological response (de Freitas et al., 2012).
• Not every HPV infection puts one at risk for cervical cancer. Only persistent HPV infections (not short-term or transient infections or sequential infections with different HPV types) in a limited number of cases with certain strains of the virus may cause the development of precancerous lesions.
• Public health officials have long recommended the Pap test (also known as Pap Smear), which detects abnormalities in cervical tissue, and HPV DNA testing, as the most effective frontline public health response to the disease.
• Since its introduction, cervical cancer screening through the Pap test has reduced the rates of cervical cancer in developed countries by up to 80%. Incidences of cervical cancer have been declining dramatically worldwide as countries have implemented Pap screening programs.
• Cervical screening is proven to reduce the cases of cervical cancer, and young women who have taken the vaccine are less likely to undergo cervical screenings.
• Data show that young women who received HPV vaccines before turning 21 are far less likely to get cervical cancer screening than those who receive the vaccines after turning 21.
• New cases of cervical cancer in the U.S. affect approximately 0.7 percent of women in their lifetime.
• For those who are diagnosed, cervical cancer is largely treatable if caught early. Anal cancer is even more rare, and according to current data, approximately 0.2 percent of people will be diagnosed with anal cancer in their lifetime.
• According to data from the National Cancer Institute’s (NCI) Surveillance, Epidemiology and End Results Program (SEER), the incidence of deaths from cervical cancer prior to Gardasil’s introduction in the United States had been steadily declining for years and, in 2006, was 2.4 per 100,000 women or approximately 1 in every 42,000 women. The currently available rate is essentially unchanged, 2.2 per 100,000 women, based on data through 2017.
• Because it can take decades for a persistent HPV infection to proceed to development of cervical or anal cancer, and because cervical and anal cancers are so rare, a true efficacy study would require decades and likely hundreds of thousands – if not millions – of trial participants to demonstrate that eliminating certain HPV infections would prevent the development of cervical and anal cancer.
• Merck’s clinical trials of Gardasil did not test whether HPV vaccines prevent cervical, anal or other cancers. Instead, Merck tested the vaccines against development of certain lesions, which some researchers suspect are precursors to cancer, although the majority of these lesions – even the most serious – regress on their own.
• At the time FDA approved Gardasil, Merck’s research showed only that Gardasil prevented certain lesions (the vast majority of which would have resolved on their own without intervention) and genital warts – not cancer itself, and only for a few years.
• The median age of death from cervical cancer is 58, and death from anal cancer is 66. Teenagers essentially have zero risk of dying from cervical or anal cancer.

Before Gardasil, There Was Vioxx

In the 2000s, tens of thousands of patients filed suit against Merck alleging they suffered heart attacks and other cardiovascular injuries as a result of ingesting the company’s blockbuster drug Vioxx. Documents unsealed during the Vioxx litigation revealed a culture wherein Merck knew early on that its drug was linked to fatal cardiovascular adverse events but nonetheless intentionally chose to conceal these risks from the public and medical community and, instead, orchestrated a scheme to downplay the severity of the risks.

According to the lawsuits, Merck misrepresented the results of its clinical trials, failed to undertake the clinical trials that would reveal risks, and blacklisted medical professionals who dared to publicly criticize the safety of Vioxx. In the end, Merck paid nearly $5 billion to settle the allegations, along with an additional $1 billion to settle a securities class action brought by investors who had lost money when Merck’s stock tanked following revelations of the drug’s risks and subsequent lost sales. Merck was also forced to pay $950 million in civil and criminal fines to the Department of Justice and other governmental entities as a result of various criminal activities Merck had engaged in with respect to Vioxx.

“Sadly, it is clear to me that Merck’s commercial interest in [Vioxx] sales exceeded its concern about the drug’s potential cardiovascular toxicity,” wrote Dr. Eric J. Topol in the New England Journal of Medicine (2004).

In an article published in the Journal of the American Medical Association (Kesselheim et al., 2007), it was reported that Merck worked to “diminish the impact of reported cardiovascular adverse effects by not publishing adverse events and failing to include complete data on myocardial infarctions that occurred during a key clinical trial. The information came to the public attention through a subpoena 5 years after the article’s publication, when [Vioxx] was already off the market.” The article concludes:

“These case studies indicate that clinical trials and routine regulatory oversight as currently practiced often fail to uncover important adverse effects for widely marketed products. In each instance, the litigation process revealed new data on the incidence of adverse events, enabled reassessment of drug risks through better evaluation of data, and influenced corporate and regulatory behavior.”

After Merck pulled Vioxx from the market in 2005, Gardasil was viewed as the answer to the company’s financial woes. It was around this time that Merck’s senior director of clinical research, Eliav Barr, M.D., proclaimed of Gardasil: “This is it. This is the Holy Grail!”

According to Gardasil lawsuits, certain Merck employees, scientists, and executives involved in the Vioxx scandal were also involved with Gardasil, “and it appears they employed the very same methods of manipulating science and obscuring risks as they did with Vioxx.”

Academic Criticisms of Gardasil Clinical Trials

Numerous medical professionals have sharply criticized Merck’s conduct of its Gardasil clinical trials. In one paper, the authors issued a “call to action” for independent researchers to reanalyze or “restore the reporting of multiple trials in Merck’s clinical development program for quadrivalent human papillomavirus (HPV) vaccine (Gardasil) vaccine.”

Doshi et al. (2019) – Call to Action: RIAT Restoration of Previously Unpublished Methodology in Gardasil Vaccine Trials

In 2019, numerous medical professionals published an article in the British Medical Journal outlining the flaws and incomplete nature of the publications discussing Merck’s Gardasil clinical trials. The authors issued a “call to action” for independent researchers to reanalyze or “restore the reporting of multiple trials in Merck’s clinical development program for quadrivalent human papillomavirus (HPV) vaccine (Gardasil) vaccine.”

The authors explained that the highly influential publications of these studies, which formed the basis of Gardasil’s FDA approval, “incompletely reported important methodological details and inaccurately describe the formulation that the control arm received, necessitating correction of the record.” The authors further explained that, while the publications claimed the clinical trials of Gardasil were “placebo-controlled,” participants in the control arm of these trials did not receive an inert substance, such as saline injection. Instead, they received an injection containing [AAHS], a proprietary adjuvant system that is used in Gardasil to boost immune response.”

The researchers further opined that “the choice of AAHS-containing controls complicates the interpretation of efficacy and safety results in trials…We consider the omission in journal articles, of any rationale for the selection of AAHS-containing control, to be a form of incomplete reporting (of important methodological details) and believe the rationale must be reported. We also consider that use of the term ‘placebo’ to describe an active comparator like AAHS inaccurately describes the formulation that the control arm received and constitutes an important error that requires correction.”

The authors pointed out that Merck’s conduct “raises ethical questions about trial conduct as well” and that they and other scientists would need to review the Gardasil clinical trial raw data, in order to be able to analyze the safety and adverse event profile of Gardasil meaningfully and independently.

Jørgensen et al. (2020) – Benefits and Harms of the Human Papillomavirus (HPV) Vaccines: Systemic Review with Meta-Analyses of Trial Data from Clinical Study Reports

In this study, a group of Danish scientists conducted a systematic review to assess the benefits and harms of HPV vaccines.

The researchers obtained all available randomized controlled clinical studies, which included a total of 95,670 participants, most of whom were women.

Almost all individuals in the control arm (i.e., those who did not receive the vaccine) received an active comparator vaccine with a comparable aluminum-based adjuvant instead of a saline placebo. Because the adjuvant is designed to be highly immunogenic (meant to boost the immune system’s response to the vaccine), this kind of trial design makes it very difficult to detect adverse reactions. According to the researchers, “[t]he use of active comparators may have underestimated harms related to HPV vaccines,” and “[t]he degree of harms might therefore be higher in clinical practice than in the trials.”

The researchers pointed out that, while the clinical trials were designed to assess benefits, they were not adequately designed to test potential harms. They judged the clinical trials “to be at high risk of bias” because “[s]erious harms were incompletely reported for 72% of participants” and study documentation was incomplete.

Despite the clinical trials’ shortcomings, the authors concluded that “HPV vaccines increased serious nervous system disorders” and, in reanalyzing the association between HPV vaccines and one specific autoimmune disease, POTS, the HPV vaccines were associated with a statistically significant nearly two-fold increased risk of POTS.

Riva et al. (2020) – Has the HPV vaccine approval ushered in an era of over-prevention?

This paper investigated the impact of US regulators’ choices on the quality of available evidence regarding the HPV vaccine’s efficacy in preventing precancerous cervical lesions.

According to the authors, “the accelerated approval and fast track procedures prompted FDA advisory committees to make methodological choices such that only weak claims could be made regarding the vaccine’s efficacy and to approve a product whose benefit-to-harm ratio cannot be appropriately assessed. By giving more weight to the HPV vaccine’s hypothetical promises rather than to compliance with best methodological principles, regulatory authorities’ decisions turned out to be more favorable to commercial interests than to public health thereby allowing HPV vaccine manufacturers to escape the usual burden of proof while generating huge profits.”

The authors add that Merck’s marketing of Gardasil “inaugurated a new form of medical overuse in the field of prevention: the introduction of a low-value primary prevention measure (vaccination) whose effectiveness can never be completely assessed since the secondary prevention measure (screening) cannot be removed. Meanwhile, health authorities promote the product and society bears the costs of vaccination campaigns and health risks. This is a concerning outcome. Such over-prevention creates a societal and individual burden of unnecessary medical expansion that undermines science.”

Peterson et al. (2021) – Was amorphous aluminum hydroxyphosphate sulfate adequately evaluated before authorization in Europe?

In this paper, the authors noted:

“Criticisms have been raised of the prelicensure randomized clinical trials, that forms the body of evidence for the approval of Gardasil, a Merck Sharp & Dohme Corp manufactured human papilloma virus (HPV) vaccine made of recombinant HPV types 6, 11, 16 and 18 L1 virus-like particles. One criticism is the use of amorphous aluminum hydroxyphosphate sulfate (AAHS) as a comparator in the prelicensure trials.”

Gardasil Studies – POTS, Dysautonomia, and Other Autoimmune Disorders

Blitshetyn (2010) – Postural Tachycardia Syndrome After Vaccination with Gardasil

In this study, the author concludes: “Given an increased prevalence of POTS in young women and an indication for vaccination with Gardasil in the same patient population, physicians should be aware of the possible association between vaccination with Gardasil and de novo POTS.”

Blitshetyn (2014) – Postural Tachycardia Syndrome Following Human Papillomavirus Vaccination

Two HPV vaccine studies by Blitshetyn came to similar conclusions: “POTS may occur following vaccination with HPV vaccine, Gardasil. Given an increased prevalence of POTS in young women and an indication for vaccination with Gardasil in the same patient population, physicians should be aware of a possible association between vaccination with Gardasil and new onset POTS. Further studies are necessary to investigate whether there is a causal relationship.”

Blitshetyn (2018) – Autonomic dysfunction and HPV immunization: an overview

This article published in 2018 reviews case series reported from several countries describing patients with suspected severe side effects to the HPV vaccines. The described symptom clusters are remarkably similar and include disabling fatigue, headache, widespread pain, fainting, gastrointestinal dysmotility, limb weakness, memory impairment episodes of altered awareness, and abnormal movements. This constellation of symptoms and signs have been labeled with different diagnoses such as complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), small fiber neuropathy (SFN), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), or fibromyalgia.

The authors write:

“There is substantial evidence from case series reported from various countries that the HPV vaccine may be associated with phenotypic syndromes that share common pathogenesis involving the autonomic nervous system, potentially including underlying autoimmune processes.”

Blitshetyn (2019) -- Human papillomavirus (HPV) vaccine safety concerning POTS, CRPS and related conditions

This is a Letter to the Editor regarding the American Autonomic Society’s position statement on HPV vaccines. Citing previous research, Svetlana Blitshetyn wrote:

“[W]e cannot dismiss the mounting evidence from different countries of patients developing POTS, complex regional pain syndrome (CRPS) and other related conditions after HPV vaccines, given the appropriate temporal association with vaccination and plausible mechanism as outlined in the recent reviews.”

“Much like Guillain-Barré syndrome or acute disseminated encephalomyelitis, POTS, CRPS and other related conditions may occur in certain healthy individuals, possibly with a genetic predisposition toward adverse events, following immunization with HPV vaccines. In the future, identifying those at-risk individuals through genetic testing might be possible as part of personalized medicine, which may lead to a reduction in serious adverse events following vaccination. Until those tests become available, detailed package insert and informed consent serve to acknowledge the possible rare adverse events following vaccination. Including POTS, CRPS and related conditions as part of the informed consent for HPV vaccines rather than denying their occurrence after immunization is a better way to ensure vaccination compliance and improved HPV vaccination rates in the United States.”

Brinth et al. (2015) – Orthostatic Intolerance and Postural Tachycardia Syndrome As Suspected Adverse Effects of Vaccination Against Human Papilloma Virus

This 2015 study evaluated 35 women who received the HPV vaccine. Of those, 60% fulfilled the criteria for POTS diagnosis. According to the study authors, “[f]urther work is urgently needed to elucidate the potential for a causal link between the vaccine and circulatory abnormalities and to establish targeted treatment options for the affected patients.”

Chandler et al. (2017) – Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase®

This large study explored global adverse event reporting patterns for the HPV vaccine using VigiBase, the WHO international database of suspected adverse drug reactions. The authors reported a combination of headache and dizziness with either fatigue or syncope which was found to be more commonly reported in HPV vaccine reports than in non-HPV vaccine reports for girls and women between the ages of nine and 25. This disparity remained when results were stratified by age and when countries reporting the signals of CRPS (Japan) and POTS (Denmark) were excluded. Cluster analysis in the study also revealed additional reports of serious adverse events, including hospitalization following HPV vaccination that overlapped in signs and symptoms with safety signals for POTS, CRPS and CFS.

Martinez-Lavin et al. (2015) – HPV vaccination syndrome. A questionnaire-based study

In 2015, researchers analyzed 45 questionnaires completed by patients living in 13 different countries to investigate if a patterned illness might develop after HPV vaccination. The researchers concluded, “emerging evidence suggests that a disabling syndrome of chronic neuropathic pain, vexing fatigue, and profound autonomic dysfunction may appear after HPV vaccination.”

Kinoshita et al., (2014) – Peripheral Sympathetic Nerve Dysfunction in Adolescent Japanese Girls Following Immunization With Human Papillomavirus Vaccine

In 2014, researchers in Japan found autonomic nervous system dysfunction associated with Gardasil. The authors concluded:

“Based on the temporal relationship between immunization and the development of symptoms, we cannot deny the possibility that immunization with HPV vaccines may secondarily induce sympathetically mediated disorders, including CRPS-I, OH, and POTS.”

Ozawa et al. (2017) – Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan

Another study in Japan confirmed an association between the HPV vaccine and autonomic injuries. Using a new diagnostic criteria for adverse symptoms after human papillomavirus vaccination, 163 patients with various post-vaccination symptoms were examined and 72 were diagnosed with human papillomavirus vaccine-related symptoms. “Symptoms or signs frequently observed in these 72 girls were prolonged general fatigue, chronic headache, widespread pain, limb shaking, dysautonomic symptoms, motor dysfunction, abnormal sensation, sleep disturbance, learning impairment, and menstrual abnormality.”

Brinth et al. (2015) – Is Chronic Fatigue Syndrome/Myalgic Encephalomyelitis a Relevant Diagnosis in Patients with Suspected Side Effects to Human Papilloma Virus Vaccine?

In 2015, researchers in Denmark analyzed 39 patients who were referred to a clinic for evaluation due to orthostatic intolerance and symptoms compatible with autonomic dysfunction occurring in a close temporal association to vaccination with the HPV vaccine. The researchers found that 34 (87%) and 35(90%) of the patients fulfilled the diagnostic criteria for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The study also found that 20 of the patients (51%) fulfilled the criteria for a diagnosis of POTS. The data suggests that CFS/ME may be a suitable diagnosis for patients with severe and persistent suspected side effects to the HPV vaccine.

Schoefield et al. (2017) – Autoimmunity, Autonomic Neuropathy, and the HPV Vaccination: A Vulnerable Subpopulation

This is a case study of an 11-year-old girl who developed POTS and other autoimmune disorders after the Gardasil vaccine.

According to the authors:

“The severe disability seen in many patients with the HPV vaccination syndrome, including several deaths, led the Japanese Ministry of Health to suspend its recommendation for HPV vaccination. Investigation into the HPV vaccine has also been initiated in Europe and many parents are choosing to forgo vaccination of their children given the numerous reports that have surfaced on social media. It is clear, however, that only a vulnerable subset of the population is at risk for the HPV vaccination syndrome. A reasonable alternative to complete avoidance would be to consider forgoing this vaccine in select patients with a personal or family history of autoimmune disease and/or auto nomic disorders. Additionally, increased awareness of the potential for neurological complications is important, particularly for primary care providers, since multiple case reports have documented clinical worsening with subsequent HPV vaccine doses. It would seem prudent for patients who develop new persistent headaches, fatigue, presyncope, tachycardia, gastrointestinal symptoms, and/ or limb pain or weakness after the first vaccination to avoid subsequent doses. Further studies aimed at defining the at- risk phenotype and/or genotype are warranted, given the devastating clinical outcome of severe, long-term disability and even death of some affected by the HPV vaccination syndrome.”

Mehlson et al. (2022) – Autoimmunity in patients reporting long-term complications after exposure to human papilloma virus vaccination

The authors of this study analyzed a large group of patients referred to the “Center for Patients with Possible Side-effects to HPV- vaccination” in the Capital Region of Denmark. The aim was to analyze a possible connection between changes and symptoms experienced by girls and young women referred to the center.

The study found a risk for POTS and other autoimmune disorders after HPV vaccination. Per the authors:

“This study has shown that girls and young women with probable side effects to HPV-vaccination have symptoms and biological markers compatible with an autoimmune disease closely resembling that seen in ME/CFS and subsets of long-COVID. Together with previous studies, demonstrating increase morbidity in this group of patients preceding vaccination, this raises the probability that prior disease may precondition some individuals for vaccine related adverse events. The HPV- vaccine possesses a strong immunogenicity, and it is suggested that possible vulnerability should be further investigated and considered when counselling for such vaccines. ”

Miranda et al. (2017) – Human papillomavirus vaccination and risk of autoimmune diseases: Alarge cohort study of over 2 million young girls in France

A 2017 study of more than two million young girls in France found an increased risk of Guillain-Barré syndrome (GBS) associated with the HPV vaccine. Guillain-Barre is a condition that arises when a person’s antibodies attack the nerves.

GBS was observed to be 1.4 per 100,000 person-years among the girls in the vaccinated group compared to 0.4 per 100,000 among the unvaccinated group, which means the HPV vaccine had an increased risk of more than 200%. The researchers noted that the risk was “particularly marked in the first months following vaccination.”

Souayah et al. (2011) – Guillain–Barré syndrome after Gardasil vaccination: Data from Vaccine Adverse Event Reporting System 2006–2009

In 2011, a U.S. study found that the estimated weekly reporting rate of GBS within the first six weeks (6.6 per 10,000,000) after the Gardasil HPV vaccine was higher when compared to the general population, and higher than the reporting rate after other vaccines.

Researchers observed a nearly two-and-a-half to 10 times greater risk of acquiring Guillain-Barre within six weeks of receiving the HPV vaccine when compared to the general population. Additionally, the study reported that the Gardasil vaccine was associated with approximately eight-and-a-half times more emergency room visits, 12.5 times more hospitalizations, 10 times more life-threatening adverse events, and 26.5 times more disability than the Menactra vaccine.

Gøtzsche et al. (2020) – EMA's mishandling of an investigation into suspected serious neurological harms of HPV vaccines

In this paper, researcher Peter C. Gøtzsche and his colleagues discuss the European Medicines Agency’s (EMA) investigation into concerns about whether HPV vaccines might cause postural orthostatic tachycardia syndrome (POTS) and chronic regional pain syndrome (CRPS). EMA reviewed the issue and declared in 2015 that there is no link between HPV vaccines and serious neurological adverse events.

However, according to Gøtzsche and his colleagues, EMA mishandled its investigation. A leaked, confidential EMA document revealed “substantial disagreement among the agency's appointed experts.”

“EMA trusted flawed data and analyses provided by the vaccine manufacturers and dismissed compelling evidence from independent researchers,” the authors wrote. Furthermore, EMA “sought advice from experts with financial conflicts of interest with vaccine manufacturers, failing to follow its own rules about conflicts of interest.”

Gardasil Cervical Cancer Studies

The Gardasil 9 label states: “GARDASIL9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility.” According to Gardasil lawsuits, Merck concealed from the public data from its clinical trials indicating that the HPV vaccine enhances the risk of cervical cancers. According to Merck’s data, women exposed to HPV before being vaccinated were 44.6% more likely to develop cancerous lesions compared to unvaccinated women, even within a few years of receiving the vaccine. The data from Merck’s studies suggest that its HPV vaccine may cause cancer in women who have previously been exposed to HPV, particularly if they also have a current infection.

Lyons et al. (2018) – Biased Cochrane Report Ignores Flaws in HPV Vaccine Studies, and Studies of HPV Type Replacement

In this review, the authors point out that peer-reviewed studies, including CDC’s own analyses, have suggested that the suppression of the HPV strains targeted by the Gardasil vaccine may actually open an ecological niche for replacement by more virulent strains. In other words, Gardasil may increase the chances of getting cancer. The Gardasil vaccines, which Merck markets as anti-cancer products, may themselves cause cancer or mutagenetic changes that can lead to cancer.

Guo et al. (2015) – Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20–26 years)

This study found that vaccinated young adult women had a higher prevalence of high-risk types of HPV other than HPV 16 and 18 (these are HPV strains considered to be associated with cancer risk) when compared to unvaccinated women, and thus are still at risk for cervical cancer.

Fischer at al. (2016) – Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccinations

In this study, the authors noted there may be a continuous shift in the prevalence of HPV types as a result of vaccination. By eradicating vaccine-targeted HPV types, the vaccine may enhance the chance that non-targeted types occupy an ecological niche in their absence.

Gardasil and Infertility Studies – Premature Ovarian Failure (POF)

Concerns that the vaccine may be negatively affecting fertility have been detailed in the scientific literature. Premature Ovarian Failure (or Premature Ovarian Insufficiency) has been linked to vaccination, particularly Gardasil.

Tatang et al. (2022) – Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System

This 2022 study looked at the potential safety signal of premature ovarian failure after HPV vaccination using the Vaccine Adverse Event Reporting System (VAERS) database. The authors found a strong disproportionality in the reporting of POF events after HPV vaccine in VAERS. “Besides amenorrhea, which is the most frequently mentioned POF event, other events such as ovarian failure, premature menopause, oligomenorrhea, and blood follicle hormone and estrogen hormone levels were also reported,” the authors write.

“These findings along with other sources of evidence such as the published case series and the biological plausibility lend support to the presence of a safety signal. The public has been reassured by health authorities of the absence of a causal relationship between HPV vaccine and POF not only based on safety studies that lacked data on ovarian dysfunction but also on those studies with sources of data that were insufficiently powered to detect events of declining ovarian function. With an increase in the uptake of HPV vaccination programs in more countries, the population of adolescent girls (9–16 years) at risk of potential ovarian dysfunction after HPV vaccination is increasing and combined with the significant negative consequences on future health and prospects of motherhood, this signal warrants well-designed and appropriate epidemiological research.”

Little et al. (2014) – Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination: A Case Series Seen in General Practice

In 2014, a peer-reviewed case series describing premature ovarian failure among Australian women following HPV vaccination was published in the Journal of Investigative Medicine. The paper prompted other researchers to systematically examine the VAERS data to see if there was a connection between premature ovarian failure and Gardasil. Their study found a “potential safety signal” and concluded that “further investigations are warranted.”

Colafrancesco et al. (2013) – Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants

In this study, the authors found evidence of the potential for the HPV vaccine to trigger a life-disabling autoimmune condition, including premature ovarian failure. “The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry,” the study authors wrote.

Little et al. (2012) – Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination

This 2012 case study identified premature ovarian failure after HPV vaccination in a well adolescent. POF among adolescents is exceedingly rare, and the authors noted the following:

“Since there may potentially be a group for whom this vaccine is contraindicated, and since the occurrence of this event may possibly represent broader health implications, it is also suggested that long-term follow-up of ovarian function in a cohort of vaccinated girls and women be undertaken.”

HPV Vaccine Mechanisms of Harm

Gardasil contains adjuvants, which are designed to stimulate the immune system and provoke a stronger response. The CDC states:

“An adjuvant is an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. Adjuvants help the body to produce an immune response strong enough to protect the person from the disease he or she is being vaccinated against. Adjuvanted vaccines can cause more local reactions (such as redness, swelling, and pain at the injection site) and more systemic reactions (such as fever, chills and body aches) than non-adjuvanted vaccines.”

In 2008, Jesse L. Goodman, M.D., MPH., then Director of FDA’s Center for Biologics Evaluation and Research said, “the toxicology of vaccines, not to mention the toxicology of adjuvants, has been a really neglected area.”

Molecular Mimicry After HPV Vaccine

Researchers have identified molecular mimicry as a mechanism of action that can induce autoimmune disorders following HPV vaccination.

Molecular mimicry is an occurrence in which sequence similarities between foreign (e.g., pathogens) and self-peptides are sufficient to result in the cross-activation of autoreactive T or B cells. If a 5-amino acid sequence is shared between the vaccine and host tissue, cross reactivity can occur. Molecular Mimicry plays a role in the pathogenesis of diseases of the central nervous system, autonomic nervous system, and other organ injuries.

Kanduc et al. (2019) – Human Papillomavirus Epitope Mimicry and Autoimmunity: The Molecular Truth of Peptide Sharing

Researchers in this 2019 study found that the Gardasil HPV vaccine contains epitopes (portions of the virus proteins) which overlap with human proteins.

The presence of epitopes means that people who receive the vaccine and develop antibodies to HPV may also generate autoantibodies to their own cells—the root cause of autoimmune dysfunction. According to the study, most of the immunoreactive HPV epi­topes were found to be overlapping peptides present in human proteins.

“This study shows a massive viral versus human peptide sharing that involves immunoreactive HPV epitopes and a highest number of human proteins that may be associated – when inhibited, deleted, mutated, modified, or improperly functioning – with pathologies and autoimmune disorders. Specifically, the present data indicate that, via cross-reactivity, the immune responses that follow HPV infections/active immunizations might lead to premature ovarian failure, oocyte DNA damage, lupus manifestations, susceptibility to breast/ovarian cancer, neuropsychiatric diseases, hypotension and dysregulation of blood pressure, cardiac disorders, and, even, sudden death.”

Kanduc (2011) – Potential cross-reactivity between HPV16 LI protein and sudden death-associated antigens

An earlier study by Kanduc explained that the HPV antigen shares amino acid sequence similarity with numerous human proteins. Per the study:

“In exploring the primary sequence of the human papilloma virus (HPV) 16 major capsid L1 protein for peptide sharing with human proteins, we find that 34 pentamers from the viral capsid protein are shared with human proteins that, when altered, have been linked to short QT syndrome, arrhythmogenic cardiac disorders, cardiovascular diseases and sudden death.”

Aluminum

To induce anti-HPV immune reactions, Merck added various adjuvants, including Merck’s unique propriety amorphous aluminum hydroxyphosphate sulfate (AAHS), to the Gardasil vaccine.

According to Caulfield et al., Effect of Alternative Aluminum Adjuvants on the Absorbption and Immunogenicity of HPV 16 L1 FLPs in Mice (2007), Merck’s AAHS is both physically and functionally distinct, with more powerful immunogenicity than all other conventional aluminum adjuvants.

Adjuvants, such as aluminum, are inflammatory substances that hyperactivate the immune system. Adjuvants are thus the “secret sauce” used by Merck to hyperactivate the immune system and make HPV immunogenic.

Below are some studies that link aluminum to autoimmune disorders and other harms.

Shaw et al. (2014) – Aluminum-Induced Entropy in Biological Systems: Implications for Neurological Disease

In this review, the authors cite some of the ways in which aluminum and its compounds can impact the biosemiotic systems encompassed by the central nervous system:

• Impaired cognitive and motor function
• Impaired sensory development and systems interaction
• Linked to cognitive impairment, Alzheimer’s, ALS, dialysis encephalopathy, and seizure disorders

Per the authors:

“While higher doses may rapidly affect multiple levels, as in dialysis-associated encephalopathy (DAE), low doses over time, for example, from vaccines, can degrade metabolism and disrupt repair and defense systems and can spiral out of control as in ASIA. Al adjuvants in vaccines may hyperdrive the immune functions of the body but they also directly disrupt biosemiotic systems. Sound theory, empirical research, and reasonable inferences from sources cited here show that Al and its compounds damage biological systems.”

Kanduc (2012) – Peptide Cross-reactivity: The Original Sin of Vaccines

Peer-reviewed studies, including this 2012 study, show that aluminum binds to non-vaccine proteins, including the host’s own proteins, or to latent viruses, triggering autoimmune disorders and other serious conditions.

Luján et al. (2013) – Autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA syndrome) in commercial sheep

This animal study from 2013 revealed that aluminum adjuvants can induce autoimmune disease in tested animals. In a series of studies conducted by Lluís Luján, DVM, Ph.D., and his colleagues, sheep injected with aluminum-containing adjuvants commonly came down with severe autoimmune diseases and other adverse reactions.

Petersen et al. (2021) – Was amorphous aluminum hydroxyphosphate sulfate adequately evaluated before authorization in Europe?

The authors concluded:

“Aluminum is a known neurotoxin and inflammagen, and interferes with several biomolecules and biochemical pathways, for example, disturbs calcium metabolism, increases oxidative stress, binds to phosphate groups of nucleoside diphosphates and triphosphates such as ATP, and competes with iron and magnesium. Several research groups have raised concerns about the health effects of using aluminum in vaccines.”

“…AAHS was introduced without any prelicensure safety evaluation. The adjuvant is described by the company (Merck) to be both physically and functionally distinct from all other previously used aluminum adjuvants. There is a need for rigorous evaluation of benefits and harms of the adjuvant AAHS.”

Jørgensen et al. (2020) – Benefits and Harms of the Human Papillomavirus (HPV) Vaccines: Systemic Review with Meta-Analyses of Trial Data from Clinical Study Reports

Jørgensen and his co-authors noted in their review that Gardasil 9 induced more harms than the original Gardasil 4, which could be explained by the fact that Gardasil 9 contains more of the AAHS aluminum adjuvant (500 micrograms of AAHS in Gardasil-9 vs. 225 micrograms of AAHS in Gardasil), and this dose-response relationship further corroborates the plausible claim that the AAHS aluminum adjuvant is a culprit in causing adverse events.

Israeli et al. (2009) – Adjuvants and autoimmunity

In this 2009 study, researchers found:

“Alongside their supportive role, adjuvants were found to inflict by themselves an illness of autoimmune nature, defined as ‘the adjuvant diseases’…Owing to the adverse effects exerted by adjuvants, there is no doubt that safer adjuvants need to be developed and incorporated into future vaccines.”

Polysorbate 80

Brotherton et al. (2008) – Anaphylaxis Following Quadrivalent Human Papillomavirus Vaccination

Polysorbate 80 is known to cross the blood-brain barrier. It is used to open the blood brain barrier in order to allow active ingredients in drugs to reach the brain to elicit the intended response. It acts as an emulsifier for molecules like AAHS and aluminum enabling those molecules to pass through resistive cell membranes.

This 2008 study implicated Polysorbate 80 as a cause, possibly with other components, of anaphylaxis among Gardasil recipients in Australia.

Genetically Modified Yeast

Gardasil contains genetically modified yeast. Study participants with yeast allergies were excluded from Gardasil clinical trials, and yet a hypersensitivity or allergy to yeast is a contraindication to Gardasil. Merck has performed no studies to determine the safety of injecting yeast into millions of children and young adults.

Rinaldi et al (2013) – Anti-Saccharomyces Cerevisiae Autoantibodies in Autoimmune Diseases: from Bread Baking to Autoimmunity

In this 2013 article, researchers reported on the growing body of research linking high levels of yeast in autoimmune diseases like lupus and other conditions.

HPV Vaccine Side Effects – Gardasil Lawsuit

If you or your child suffered HPV vaccine side effects, you may be able to pursue a lawsuit against Merck. Wisner Baum is one of the leading law firms in the nation representing people harmed by the Gardasil HPV vaccine.

To learn more about your legal rights, we recommend you review our Gardasil Injury Compensation Guide. If you have any questions or would like an attorney to review your case, please get in touch with us. We are here to help and can answer any questions you may have about your legal rights.