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).
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.
- 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
Pediatric vaccine experts are determining children’s acceptable exposure level to aluminum.
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).
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.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.
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.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.3. Syncope
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.4. Thromboembolism
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.5. Anaphylaxis
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.- warts
- growths
- sores
- lumps
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.
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.
Call for More Ethical Sexual Behaviors
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.
Encourage Positive Social Influence
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.
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.
Data Quality and Transparency Is Required
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.
- 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.
◇ References:
STD Facts - Human papillomavirus (HPV) (cdc.gov)https://n.neurology.org/content/72/24/2132
https://jnnp.bmj.com/content/82/11/1296
https://journals.sagepub.com/doi/10.1177/1352458508096868
https://www.sciencedirect.com/science/article/pii/S0213485310700232?via%3Dihub
https://www.cmaj.ca/content/179/6/525