There is ample scientific evidence that suggests that the mixture of adjuvants contained in HPV vaccines and other vaccines is responsible for post-vaccination-induced autoimmune diseases in some patients.
Adjuvant-induced disorders have become so widespread that medical experts have coined a new term to describe this umbrella syndrome: Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA).
In Part 1, Part 2, and Part 3 of this series, we have discussed HPV vaccines and their links to ovarian insufficiency, neurological and autoimmune disease, the vaccine’s effectiveness in preventing cervical cancer, and the inability of clinical trials to detect safety issues. In Part 4, we will discuss concerns regarding particular vaccine ingredients and provide a reflection on the HPV vaccine development.
Summary of Key Facts
- Adjuvants are used in HPV vaccines including Gardasil to get the attention of the immune system.
- Aluminum is a common adjuvant in Gardasil that may be responsible for adverse events.
- Another discovered “secret” ingredient of Gardasil “HPV DNA”, may also be responsible for adverse events.
- Both immunogenic adjuvants may induce a strong immune response or autoimmune conditions.
- Research should focus on careful risk-benefit analyses to determine which populations benefit from vaccination. Some people may not benefit from vaccination but would be best served by cancer screening outreach.
Aluminum, A Problematic Vaccine Adjuvant
The CDC lists vaccines that use aluminum as an adjuvant, and Gardasil is on the list.
To stimulate an enhanced immune response intended to last for 50 years, Merck added a particularly toxic aluminum-containing adjuvant, amorphous aluminum hydroxyphosphate sulfate (AAHS), to the Gardasil vaccine.
Aluminum is the third most abundant metal in the earth’s crust and is widely present in the environment—in plants, soil, water, air, the food chain, and pharmaceuticals. Meanwhile, aluminum is a potent toxin that can severely harm multiple human body systems, including but not limited to nervous, respiratory, musculoskeletal, digestive, renal, and hepatic systems.
The brain is the main target organ of aluminum. It can penetrate the barrier into the brain. Aluminum has been linked to mechanisms of action including, but not limited to:
- generates reactive oxygen species
- induces apoptosis of astrocytes
- plays a crucial role in β-amyloid oligomerization
- induces tau protein to aggregate
- induces autoimmune conditions
- increases blood-brain-barrier permeability
- alters intracellular calcium homeostasis
- affects cellular energy production
- alters DNA
Peer-reviewed studies show that aluminum binds to non-vaccine proteins, including host proteins and latent viruses, triggering autoimmune and other severe conditions.
Pediatric vaccine experts are determining children’s acceptable exposure level to aluminum.
In a 2020 article published in Frontiers in Microbiology, Paul Offit, M.D., and colleagues argued that an infant’s cumulative exposure to aluminum via vaccines through six months of life is less than the natural exposures through breastmilk and infant formula.
Offit is the director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia. He and his colleagues have developed vaccines and have written extensively on vaccine safety.
But this argument is not reassuring. At issue here is a child’s cumulative exposure to aluminum. These exposures come from natural sources, such as breastmilk and infant formula. Various vaccines and other pharmaceutical products layered on top of these natural exposures (e.g., several brands of vitamin K shots given to infants at birth also contain aluminum).
Even more concerning is that the newer version of this vaccine (Gardasil 9) contains nearly double the amount of AAHS as the earlier version of the vaccine.
Gardasil’s ‘Secret’ Ingredient
Medical practitioners in nine countries submitted samples of Gardasil to be tested for human papillomavirus (HPV) DNA because they suspected that residual recombinant HPV DNA left in the vaccine might have been a contributing factor leading to unexplained post-vaccination side effects.
To conduct this research, scientists requested samples of Gardasil from Australia, Bulgaria, France, India, New Zealand, Poland, Russia, Spain, and the United States. Each sample was confirmed to be from a different lot number.
The lab tests revealed that all 16 Gardasil samples contained fragments of HPV DNA. The specific fragments included: HPV-11 DNA, HPV-18 DNA, or fragments comprising elements of both genotypes.
The fragments of HPV DNA were found firmly attached to the adjuvant (AAHS).
Whether these findings have clinical significance is an open question. Additional vaccine safety research must consider this and design the appropriate studies to understand the biological impact of residual HPV DNA fragments bound to a particulate mineral-based adjuvant.
The FDA’s website states this finding: “FDA information on Gardasil-presence of DNA fragments expected, no safety risk.” However, the content of this page was not found due to unknown reasons when access was attempted on Feb. 25, 2023.
This Ingredient May Stimulate Inflammation
Vaccine adjuvants cause the immune system to mount a robust response. This is helpful when vaccinating the elderly, who have an immune system in “senescence,” meaning it is beginning to wind down. However, adjuvants in vaccines designed for young people with healthy immune systems who undergo tremendous metabolic changes during adolescence require more caution.
These DNA fragments may act as a toll-like receptor 9 (“TLR9”) agonist. TLR is a group of proteins on the surface or inside cells, acting in the immune system’s front line, detecting various pathogens or harmful signals from the environment and responding to them.
TLR9 preferentially binds DNA present in viruses and bacteria and triggers signaling cascades that lead to a pro-inflammatory cytokine response, which may trigger distinct neuroinflammatory responses in the nervous system.
Dr. Sin Hang Lee, director of Connecticut-based Milford Molecular Diagnostics, has surmised that, without adding the TLR9 agonist, Gardasil would not be immunogenic. According to Lee, the DNA fragments bound to the AAHS virus-like nanoparticles act as the TLR9 agonist in both Gardasil and Gardasil 9 vaccines, creating the strongest immune-stimulating adjuvant in use in any vaccine.
Lee also found HPV DNA fragments from the Gardasil vaccine in post-mortem spleen and blood samples taken from a healthy teenage girl who died six months after a third HPV vaccine.
A 2015 textbook, Vaccines and Autoimmunity, edited by Dr. Yehuda Shoenfeld, the father of autoimmunity research, includes articles by many of the world’s leading autoimmunity experts. These scientists concluded that Gardasil could cause autoimmune disorders because of the vaccine’s potent immune-stimulating ingredients.
Serious Adverse Events After Receiving HPV Vaccines
1. Neurological and Autoimmune Disorders
The literature has reported potential immune-based inflammatory neurodegenerative disorders involving the central nervous system, known as acute disseminated encephalomyelitis, following Gardasil injections. Extensive registry-based studies conducted in Denmark, Sweden, and Germany identified plausible associations between HPV vaccination and autoimmune conditions. This topic is covered in Part 2 of this series.
2. Unexplained Death
In a JAMA Network Open study published in 2009, 12,424 reported adverse events were recorded in the Vaccine Adverse Event Reporting System (VAERS) following Gardasil vaccination from June 1, 2006, through Dec. 31, 2008. Among these were 32 deaths with a mean age of 18. The deaths occurred two to 405 days after the Gardasil injection.
Of the 32 deaths, medical records and autopsy reports were reviewed for 20. These reviews confirmed four unexplained deaths and six cardiac-related deaths. There was no attempt to establish a causal relationship, meaning any effort to ensure or exclude a link to Gardasil vaccination. However, the authors reported that the Gardasil recipients’ syncope (loss of consciousness caused by a drop in blood pressure) and thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) were disproportionately high.
Syncope occurred in 1,896 cases, half within 15 minutes of injection. Among those who fainted, 15 percent resulted in a fall, and most of these falls (68 percent) resulted in a head injury. Vaccine recipients are advised to sit for 15 minutes after the injection.
The proportional reporting ratio for thromboembolic events was 4.8 for six- to 17-year-olds (p=0.04) and 6.7 for 18- to 29-year-olds (p=0.006). Of the 31 cases, 28 had a known risk factor for venous thromboembolism. Risk factors included estrogen-containing birth control in 20 of the 31 cases.
Anaphylaxis among young women receiving Gardasil vaccination is approximately 10 to 53 times higher than identified in a comparable school-based program for meningococcal C vaccination. HPV-related anaphylaxis incidence was 1.0 to 5.3 per 100,000, whereas it was 0.1 per 100,000 for meningococcal C vaccination. All cases of anaphylaxis were identified using the Brighton case definition of anaphylaxis.
HPV Vaccination Among Males
Routine vaccination of boys and men has been implemented in only a few countries, including Australia, Canada, and the U.S. Population-based vaccination programs are designed to increase herd immunity among males and females and reduce the incidence of anal, penile, head, and neck cancers among males specifically.
Symptoms of HPV infection among males include the following symptoms on the penis, anus, scrotum, or mouth:
A systematic review of HPV vaccination effectiveness and safety among males was conducted to gather research through 2017. Seven studies were included in the analysis, comprising data on approximately 5,000 males; four studies were randomized and three were non-randomized. Only two studies included serious adverse events and none of them were judged by the investigators to be vaccine-related.
This study suggests that vaccination is more effective among males if administered before the onset of sexual activity. This finding supports research leading to the same conclusion about females.
The authors highlighted that more research is needed to establish the benefits of large-scale vaccination programs among males. While this 2018 systematic review of HPV vaccination effectiveness and safety was the first to be published for males, seven systematic reviews among nearly 46,000 participants had been conducted for females, demonstrating a disproportionate share of research among females at the time.
Certain risk factors increase the likelihood of HPV anal, penile, and throat cancer among men, including smoking, early onset of sexual activity, HIV-positive status, and men who have sex with men. Using a condom, maintaining stable sexual networks, and starting sexual activity later in life all reduce the risk. Some healthcare providers can offer an anal Pap test to men who are at greater risk of anal cancer, such as men living with HIV and those who receive anal sex.
The CDC states that vaccination is not universally recommended for males older than 26: “HPV vaccination for ages 27 through 45 provides less benefit. Most sexually active adults have already been exposed to HPV, although vaccination does not target all HPV types.” Those in a stable relationship are unlikely to get a new HPV infection.
Do We Really Need HPV Vaccination?
HPV infection is a risk factor for cervical cancer. However, there are many other risk factors for cervical cancer. These include engaging in sexual intercourse before the age of 16, having multiple sexual partners, exposure to HIV, smoking, and being exposed to carcinogens at a young age.
Future research should consider differential screening rates by ethnicity, age, and socioeconomic status. Results should be stratified by age at first sexual contact and vaccination history to begin disentangling the effects of early vaccination coupled with disparities in screening rates.
Research must also consider the protective effects of natural immunity against HPV.
Call for More Ethical Sexual Behaviors
Would it make sense to test women before vaccination if they had already engaged in sexual activity? Perhaps. Because vaccination is prophylactic, we could optimize vaccine benefits and reduce harm by offering vaccination to those not yet infected (primary prevention) and focusing on cancer screening (secondary prevention) among those who have already been infected with an HPV strain.
Teenagers who engage in early sexual activity are at higher risk for an array of mental and physical health problems. The CDC recently released a report stating, “Almost one in five young women have experienced sexual violence—a 20 percent increase since 2017.” Approximately one in 10 teen girls reported being forced to have sex.
Sexual violence is a serious concern, and preventing unwanted sexual contact should be a priority. Parents, public health authorities, and doctors can help protect teen girls by coaching them on anticipating high-risk situations. This will also help prevent cervical and genital cancers by reducing unwanted intimate contact. Strengthening the cancer-screening process among those who are already sexually active is another way to reduce mortality from cervical cancer.
Aside from the evidence that HPV vaccines cause harm and absent a robust risk-benefit analysis, vaccinating teenagers against a sexually transmitted disease raises ethical and moral issues. Giving tweens, teens, and very young adults a vaccine that promises to prevent a sexually transmitted disease introduces a moral hazard—they may engage in higher-risk practices because they feel it is safe to do so.
With the sense of being protected, teens may engage in sexual behaviors at a very young age, which is often associated with other high-risk activities such as substance use. Instead, we could be directing resources to help teens take concrete steps toward making self-care a priority at a time when events and people around them challenge their self-esteem.
Encourage Positive Social Influence
Community leaders and public health professionals could invest in health-promoting activities, such as building community centers and gyms to make regular physical activity and social connections accessible regardless of family income, enabling all teens to build a robust social network with shared values.
Young adults must also set good nutrition and sleep habits, develop a healthy relationship with alcohol, and understand the link between mental and physical health.
Finally, busy parents must be supported in enhancing their child’s sense of belonging within his or her community.
While the promise of human vaccine technology is alluring for preventing disease and even curing cancer, we should reflect rationally on the longstanding relationship between viruses and humans.
Certainly, vaccines have dramatically improved important pediatric outcomes, but newer vaccines targeting otherwise healthy young adults must be held to the most rigorous standards to estimate associated risks and benefits.
Data Quality and Transparency Is Required
When considering the evidence for inclusion in risk-benefit analyses, care must be taken to evaluate the quality of systematic reviews. A recent publication compared the rate of industry-funded vs. non-industry-funded vaccine systematic reviews. The non-industry-funded studies had a higher quality score than those funded by the industry.
Public health officials should refrain from blanket recommendations predicated on flimsy science and instead invest in robust trials which can truly elucidate for whom a vaccine offers the most benefit. Clinical trials must be appropriately sized and conducted for a period long enough to detect benefits and risks. Surely some subgroups do stand to gain value while others may not.
To protect the United States vaccine program, officials in industry and health authorities must:
- Conduct robust trials powered to detect safety signals,
- Release anonymized, individual trial data promptly for public inspection,
- Develop transparent and rigorous risk-benefit analyses before recommendations are made, and
- Eradicate vaccine mandates.
Ethical vaccine policies are essential for encouraging lifestyle choices that promote vibrant mental and physical health.
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