Hazardous Ingredients of HPV Vaccines Increase Risk to

Young People (Part 4)

FEATUREDVaccines

Allison Krug

Yuhong Dong
Mar 2 2023
biggersmaller

A bottle of the Human Papillomavirus vaccine. (Photo by Joe

Raedle/Getty Images)
0:0019:28

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.

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.

Symptoms of HPV infection among males include the following

symptoms on the penis, anus, scrotum, or mouth:

 warts
 growths
 sores
 lumps
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:

1. Conduct robust trials powered to detect safety signals,

2. Release anonymized, individual trial data promptly for
public inspection,
3. Develop transparent and rigorous risk-benefit analyses
before recommendations are made, and
4. Eradicate vaccine mandates.

Ethical vaccine policies are essential for encouraging lifestyle

choices that promote vibrant mental and physical health.

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