In the series, “The HPV Vaccine: A Double-Edged Sword?” we will provide documented evidence of death and severe injuries linked with Gardasil, analyze the root cause of its harm, and offer solutions.
The Gardasil human papillomavirus (HPV) vaccine is linked to undeniable death and undeniable severe injuries as previously reported in this series of reports. An ingredient in Gardasil may contribute to these harms.
Mysterious Post-Vaccine Sheep Illness
In August 2006, an outbreak of bluetongue disease quickly spread to European countries causing a state of emergency.
Bluetongue disease, caused by bluetongue virus (BTV), affects ruminants, mainly sheep, with symptoms of fever, hemorrhages, depression, edemas, and generalized cyanosis, easily observed on the tongue, which explains the disease name.
Sheep Study Identifies the Problem
Dr. Lluis Lujan, an associate professor of veterinary pathology at the University of Zaragoza in Spain, conducted a sheep study to determine the cause of the unusual diseases.
A total of 21 sheep were assigned into three groups (red, yellow, and green) with seven in each group as follows:
1. The red group received commercial sheep vaccines containing aluminum hydroxide.
2. The yellow group received the equivalent dose of aluminum dissolved in water (Alhydrogel®, an aluminum-based adjuvant).
3. The green group was administered a neutral saltwater solution.
‘Placebo’ Trial Participant Had 40+ Symptoms
The Phase 3 clinical trial for Gardasil (FUTURE II study) began in 2002. A particularly large number of participants were recruited in Denmark.
Gardasil clinical trial participant, Sesilje Petersen, developed severe fatigue and a total of 40 symptoms after the second and third shots.
“It was the biggest problem because I was a student at the university and it was very difficult for me to attend the classes as I fell asleep almost daily,” Sesilje said. “I wrote a list with all my symptoms—there were more than 40 symptoms, and some of them had been severe. I had a tumor on my pituitary gland.”
“I received a letter and was invited to this study and it sounded very interesting. So I decided to participate,” recalled Sesilje.
Sesilje kept the information brochure that the participants received at the beginning of the study. It said that the vaccination had already been carefully tested for safety and did not have any serious side effects.
The information about the placebo turned out to be a lie. “It says here that the placebo was saline—the Danish word for saltwater,” she said.
The study brochure the participants received at the beginning of the Gardasil FUTURE II study (L). The placebo information indicated the use of saline (R). (Screenshot via The Epoch Times, courtesy of Ehgartner & Moll Filmproduktion GmbH & Co.)
Aluminum: A Toxin in Vaccines for 90 Years
Sesilje’s “saline” placebo contained something highly unusual—aluminum (Al), an adjuvant commonly used in modern vaccines.
She was obviously misinformed about the study design and was unaware of what she was receiving. Prior to participating in the Gardasil study, Sesilje knew that she could not tolerate deodorants containing aluminum.
“We were not informed about the use of aluminum. The word aluminum was not given to us either in the procedure or in their phone consent form.” Sesilje said.
Aluminum was first used in human vaccines in 1932 and was the only adjuvant used in licensed vaccines for approximately 70 years. This controversial compound is still used as an adjuvant in vaccines, however, what is its actual role?
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Aluminum is the third most abundant metal in the earth’s crust and is widely present in the environment—in plants, soil, water, air, food, and pharmaceuticals. It is present in an ionic form as Al3+.
The absorption of aluminum depends on several factors such as the pH level and the presence of organic acids (citrate, lactate). It is absorbed in a proportion of only 0.1 to 0.3 percent by the gastrointestinal tract in the upper intestine.
(L) Aluminum is the third most abundant metal in the earth’s crust. (R) Bauxite, a sedimentary rock, is a main source of aluminum. (magnetix, RHJPhtotos/Shutterstock)
According to the U.S. Food and Drug Administration (FDA), a placebo is defined as “an inactive pill, liquid, or powder that has no treatment value.” The well-established toxic properties of aluminum therefore suggest that aluminum cannot constitute a valid placebo.
Toxicity Makes Aluminum an Adjuvant
Almost all modern diseases have their origin in a disturbed immune system. No other drug intervenes in the immune system as intensively as vaccines. The role of vaccine components in human immunity is discussed without taboos in the scientific community.
The gold standard to evaluate the effectiveness of a vaccine is based on the antibody level generated. In the beginning, people were not satisfied with a pure inactivated virus to provoke an immune response and wanted to find a substance to help boost immunity and generate a more robust response with longer-sustained antibodies—that is the adjuvant.
Aluminum was found to be a strong adjuvant.
When we inject a vaccine with aluminum into the muscle, we can only imagine what physical and chemical reactions will be triggered. At the very beginning, there may be little response at the injection site. The only reaction may be due to the damage caused by the needle.
“When the vaccine is injected deeply into the muscle tissue, aluminum ions begin to dissolve and start attacking the surrounding cells,” Mr. Exley stated in the documentary “Under the Skin.”
“So depending upon that rate of dissolution, you will get the degree of cytotoxicity—cell toxicity,” he said.
The aluminum ions kill our normal healthy cells and as those cells die, they release chemical messengers, which call for help from the other immune cells.
Immune cells react immediately and start to attack anything suspicious at the vaccination site. A fierce battle takes place.
Manipulated and Unethical Study
Sesilje’s experience of receiving a placebo containing aluminum instead of saline illustrates how a clinical trial can be designed to manipulate the study results while deceiving study participants. The published New England Journal of Medicine (NEJM) paper Gardasil FUTURE II clinical trial data clearly states that subjects were receiving either quadrivalent Gardasil or “a visually indistinguishable aluminum-containing placebo.”
Why did the Gardasil clinical trials choose to use aluminum as a comparator instead of saline?
Based on standard pharma clinical research, a normal vaccine study design should use a real placebo (e.g., saline) as a comparative group. Instead, the placebo group in the Gardasil FUTURE II study used a pseudo placebo, which means that it is not a true placebo, but contains a pharmacologically active compound—in this case, it’s aluminum. This is not normal.
“If some of these girls develop the same rare harms, then you can’t see the difference. It’s magic. You mask it, it’s magic. This should not be allowed,” said Dr. Peter Gøtzsche in the documentary “Under the Skin.”
Dr. Gøtzsche is a Danish physician, professor of clinical research design and analysis, and the former leader of the Nordic Cochrane Center in Copenhagen, Denmark. He is also a co-founder of the Cochrane Collaboration and has published more than 70 papers in the so-called “Big Five” journals: New England Journal of Medicine, The Lancet, Annals of Internal Medicine, British Medical Journal, and Journal of the American Medical Association. His scientific works have been cited over 30,000 times.
“It is necessary to make a very strong scientific case for using a placebo which is itself known to result in side effects, and I have not found any scientific vindication for such in the recent human vaccination literature. While severe adverse effects following vaccination are rare, it should not be acceptable to ignore or nullify those effects, which are due to the aluminum-based adjuvant either acting alone or in combination with the antigen. To do so could place susceptible individuals at risk.”
We see that medical ethics were obviously ignored in the Gardasil trial. Subjects’ health and wellness have been jeopardized without any informed consent.
The true purpose of dosing such an unethical study design appears to have been to hide Gardasil’s ability to harm by keeping it below the manipulated dark background.
Many have been cheated by this blatant lie.
Invalid Risk-Benefit Assessment
Dr. Enrica Alteri, the former head of risk management and epidemiology at Merck-Serono in Geneva, was appointed as the head of EMA’s Safety and Efficacy of Medicines on July 2, 2012. Her move from private industry to a public sector position is an example of “revolving door” regulatory politics, raising serious concerns about the possibility of pro-industry biases in national health care decision-making.
Gardasil was developed by Merck.
“We can confirm today the safety of the HPV vaccine. There is no reason to change the way the vaccines are used or amend the current product information,” she said.
So the magic worked—not only did the health authorities conclude that Gardasil is completely safe, but the scientific community has also been cheated by the Gardasil trial design.
Why couldn’t they see the truth with the placebo group design? Were they easily fooled or complicit?
One of the most shocking findings, based on the source data, was that 96.3 percent of participants in the control groups of those studies received aluminum-based adjuvants. This distorted (to an unknown extent) an accurate assessment of the harms caused by the HPV vaccine.
96.3 percent of participants in the control group of HPV vaccine clinical trials received aluminum-based adjuvants. (Illustration by The Epoch Times, Shutterstock)
The authors judged “all 24 studies to be at high risk of bias” due to their study design. The included trials were primarily designed to assess benefits and were not properly designed to assess harms by using aluminum, a toxin, as the comparator, making it impossible to determine the actual harms caused by the HPV vaccines.
The current risk-benefit assessment for Gardasil is invalid, as they did not compare the Gardasil vaccine with something benign (saline), but instead compared it with a major component of the vaccine (aluminum).
Infant Dies After Vaccination
On Oct. 28, 2022, a 62-day-old baby, Sawyer, died 34 hours after receiving his scheduled childhood vaccines. While living in Maine, his parents had been seeking an explanation for the cause of their son’s death for nearly a year. Finally, a toxicology report indicated that Sawyer’s blood contained 95 μg/L of aluminum, a level considered toxic for adults. Signs of neurotoxicity are observed with blood aluminum levels of more than 60 μg/L.
In fact, by the year 2005, infants started to receive 4925 μg of aluminum in their first 18 months of vaccinations, not counting the other sources of exposure such as food, skin, and milk.
By the year 2005, infants started to receive 4925 μg of aluminum in their first 18 months, a 25 percent increase since the year 2000. (Illustration by The Epoch Times, Shutterstock)
Aluminum in Vaccines ‘Akin to a Lottery’
A lot of vaccines on the childhood schedule in the United States contain aluminum adjuvants. Furthermore, the content of aluminum in vaccines is not under strict control by regulatory authorities.
The amount of aluminum in 13 different brands of vaccines greatly varies. (Illustration by The Epoch Times, Shutterstock)
In 10 of 13 vaccines, the measured quantity of aluminum failed to match up to the amount of aluminum reported by manufacturers in patient information leaflets, according to the study.
- Six of the vaccines, including Pfizer’s Prevnar 13, contained a statistically significant greater quantity of aluminum than the manufacturer stated.
- Four of the vaccines contained significantly less aluminum than the manufacturer stated.
- For each single vaccine brand, the range of aluminum content “varied considerably.”
Neither the EMA nor the FDA could confirm they independently or routinely measure the aluminum content of infant vaccines, instead indicating that they rely upon manufacturers’ (flawed) data.
Sources of Aluminum Exposure
Those who argue that the limited aluminum in childhood vaccines can’t lead to health issues often overlook the accumulated aluminum exposure (the full “body burden”) from various sources in our environment.
Aluminum is found widely in our environment, not only as a vaccine adjuvant, but also in water, processed foods, food packages, cookware, cosmetics, medications, and medical ware.
- Infant formula or breast milk from mothers who have been exposed to aluminum.
- Cookware, foil-like packaging, and aluminum cans.
- Aluminum salts in many prepared foods.
- Aluminum sulfate used for making bread white.
- Food contamination through food processing using aluminum machinery.
- Fish exposed to aluminum contaminants.
- Contamination of tea, coffee, tobacco, marijuana, soy, and other edible plant products from aluminum in acidic soil resulting from poor farming practices. (Acidic soil is better able to take up aluminum, and glyphosate is a strong aluminum binder at low pH levels.)
- Aluminum salts are commonly used as coagulants in the water treatment process to remove impurities and particles.
Medical ware:
- Medications such as antacids, phosphate binders used for kidney dialysis, buffers present in many painkillers, and intravenous preparations for babies and hospitalized adults.
- Transfused fluid such as blood warming devices.
- Prosthetic devices for hip replacements and dental products.
Cosmetics and deodorants may also contain aluminum.
Diseases Linked to Aluminum in Vaccines
While old vaccines contain antigens without adjuvants, a newer generation of vaccines typically requires the addition of adjuvants, a substance as aforementioned that fires the immune system to produce antibodies to the antigen.
Inflammation, Allergies
Tdap, HepA and Pneumococcal vaccines. Many common childhood vaccines contain aluminum, including certain Hepatitis A and B, Pneumococcal, DTaP, and Tdap Vaccines. (Getty Images)
Autoimmune Syndrome
An important side effect of aluminum is “autoimmune/inflammatory syndrome induced by adjuvants.” This happens because aluminum can stick firmly to cells and proteins, which can modify our protein’s three-dimensional shape, making them look different. T-cells may mistake these altered proteins as “nonself,” leading to an autoimmune response.
This is particularly detrimental because if a vaccinated person develops antibodies to the Gardasil vaccine’s proteins, it could potentially train their immune system to attack some of their own cells, leading to a range of autoimmune diseases.
As a result, a person vaccinated with Gardasil has an immune system response that generates not only antibodies to the HPV antigen but also attacks components of their nerves and mitochondria, substances inside the cell nucleus.
Even though the health authorities and Merck have repeatedly denied any serious injury from Gardasil, medical doctors and research scientists have been approached by patients, triggering research to examine whether these vaccines cause harm, and if they do, to determine the cause.
Not only Marika but also Paula and Sara (from Part 2) may also have experienced autoimmune-induced severe injuries. Some of these girls can no longer walk or even stand, and they’ve all lost their ability to lead normal lives.
A schoolgirl receives a vaccine injection during an HPV vaccination campaign in Le Bouscat, southwestern France, on October 5, 2023. (Philippe Lopez/AFP via Getty Images)
Biologist Gerd Wallukat, an HPV vaccine-related autoantibodies testing expert, stated in the “Under the Skin” documentary, “For many diseases, the doctors have not yet realized that this could be an autoimmune disorder.”
Mr. Wallukat has established a special method to detect suspicious antibodies using heart cells to beat at a specific frequency. This beat rate is measured and used as a basis for determining the presence of antibodies in the blood. An increase in the beat rate means that antibodies are present, indicating an autoimmune disorder.
The immune attack on our cells’ energy factory (mitochondria) clearly explains the severe fatigue experienced by Sesilje and Elizabeth. Both have tested positive for three types of autoantibodies.
Merck ‘Upgraded’ Aluminum Toxicity
According to Mr. Exley, “We can buy all of the usual aluminum adjuvant used in clinical vaccines, but we cannot get hold of that particular one that’s used in Gardasil. No one will share that with us.” (“Under the Skin” documentary)
Compared with traditional aluminum, AAHS has a smaller particle size, faster dissolution time, higher uptake by immune cells, and absorbs more antigens, resulting a greater toxicity to our immune system.
Moreover, the smaller the size, the faster the immune cells can swallow them. Subsequently, the faster the immune cells die, the more toxicity the vaccine will generate.
Mr. Exley commented on the chemical rationale of using AAHS: “What it appears to be, is a form of aluminum hydroxy-phosphate, in which some of the phosphate groups have been replaced by sulfate groups. We don’t know why and won’t guess why that might be a more effective adjuvant in this case than another. The sulfate group is a more acidic group than the phosphate group.” (‘Under the Skin’ documentary)
The authors speculated it could be because Gardasil 9 contains 2.7 times more HPV proteins than the original and over two times the amount of aluminum-containing adjuvant. A 0.5 ml dose of Gardasil 9 compared to Gardasil contains 270 μg versus 100 μg virus-like particles, respectively, and 500 μg versus 225 μg of an aluminum-containing adjuvant, respectively.
A Silent Killer With Inadequate Regulation
To summarize, the clinical and experimental evidence collected so far identifies three main risks associated with vaccine aluminum:
- It can persist in the body and can’t be excreted due to binding to vaccine proteins.
- It can trigger pathological immune responses.
- It can pass through the blood-brain barrier into the central nervous system where it can trigger immuno-inflammatory processes, resulting in brain inflammation and long-term neural dysfunction.
The vast majority of people are consuming higher amounts of aluminum through dietary and non-oral intake than what expert authorities consider safe.
Based on the above risks, aluminum is a commonly used adjuvant in many vaccines including DTaP, HepB, HepA, HiB, and HPV.
Third, this recommendation does not take into account aluminum persistence in the body and the constant intake from the environment. Since aluminum pervades our environment, the scientific community has raised concerns regarding our exposure to aluminum for many years.
In 2015, the concern about aluminum in dietary intake was reinforced by the Food and Agriculture (FAO) World Health Organization Expert Committee, which lowered the provisional tolerable daily intake of aluminum by seven times.
It’s essential to consider adherence to the principle “first do no harm” when injecting such an obvious toxin used in Gardasil into healthy people worldwide. Ethical pharmaceutical industry standards demand strict regulation.
According to Mr. Exley, “When something works and works as well as an aluminum salt does, first of all then, that’s great news. It works incredibly well, you’re doing what you want it to do. You’ve then got, well how much does it cost? Well, relatively nothing. So aluminum costs nothing in a vaccine. So that’s good—it is not adding to the price and the cost. You then say, ‘What are the regulations about the use of aluminum in everyday life?’ And you find there are none. So this is not regulated.” (“Under the Skin” documentary)
Christopher Exley, one of the most knowledgeable and widely-cited aluminum researchers in the world. (Screenshot via The Epoch Times, courtesy of Ehgartner & Moll Filmproduktion GmbH & Co.)
EMA’s Approval of Gardasil Aluminum Suspect
It appears that the approval of AAHS by EMA did not follow standard regulatory procedures but was arbitrary and without any documented safety data.
R. Gonzalez in the Stakeholders and Communication division of EMA responded, “To our knowledge ‘amorphous aluminum hydroxyphosphate sulfate’ was first used and licensed in Europe through the centralized procedure for Procomvax (Hib-HBV; EU MA 1999). This vaccine is no longer available in the EU (the marketing authorization expired in 2009).”
In summary, the EMA reports that AAHS was introduced without any prelicensure safety evaluation. The adjuvant is described by the company to be both physically and functionally distinct from all other previously used aluminum adjuvants.
So let’s recap. Neither the old nor the new aluminum compounds in vaccines have been tested for safety using serious scientific methods. If we actually look “under the skin,” things come to light that are not mentioned in any of the package inserts. The authorities apparently do not want to question the good reputation of the vaccines and prefer to completely avoid this sensitive issue.
Whether people choose to ignore or try to hide them, the severe injuries linked to HPV vaccines are undeniable, and the toxicity of the aluminum ingredients in the HPV vaccines is undeniable.
What Dr. Lujan revealed about the root cause of the mystery illness in sheep after a massive vaccine campaign is unfortunately the same thing happening in humans after vaccination with Gardasil. Both are related to the same toxin—aluminum.
The Epoch Times contacted the EMA, the FDA, and Merck for comment. No response was received from the FDA or Merck at the time of publication.
“Regarding your question on Gardasil, the use of aluminium adjuvant in the clinical trials is described in the European public assessment report (EPAR), which is publicly available on EMA’s website: Gardasil, INN-Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) (europa.eu). On page 10, it is explained that the safety of the different HPV vaccine formulations has been evaluated in a total of 16,041 subjects. Of these 11,813 received quadrivalent HPV vaccine and the remaining monovalent vaccine formulations. All studies were placebo-controlled and the total population that received placebo included 9,701 subjects (the placebo was aluminium adjuvant in all studies except study 018 (pre-/adolescent safety study) which used a non-aluminium-containing placebo).”
However, based on aluminum’s documented toxicity and health impact, aluminum could never be judged as a placebo. EMA’s response has again confirmed that almost all HPV vaccine trials used aluminum as a false “placebo” control group.
EMA insists that “the safety of the aluminium adjuvant alone or in combination with the antigen is well established. Data generated from clinical trials with aluminium-containing vaccines worldwide and the safety data gathered from the use of aluminium-containing vaccines over the past six decades have shown that their safety profile is acceptable, with only local reactions as possible side effects linked to aluminium, which normally resolve in a short timeframe. In addition, a thorough safety and toxicology assessment in non-clinical studies is performed before any vaccine can enter clinical trials. There are no scientific reasons to reconsider its use.”
The assessment report provided by EMA on aluminum’s safety does not provide adequate safety and toxicology data to validate the safe use of aluminum in vaccines. On the contrary, we have found a large body of evidence of aluminum toxicity in animals and humans, especially recorded by the aluminum “placebo” group in HPV vaccine clinical trials.
“Amorphous aluminum hydroxyphosphate sulfate, used in Gardasil to help elicit an immune response, has been used in a number of vaccines approved by the FDA for over 6 decades. The amount of aluminum in the vaccine arm and control arm were the same, 225 micrograms. Title 21 of the Code of Federal Regulations, Part 610.15(a), limits the amount of aluminum in biological products, including vaccines, to 850 – 1,250 micrograms/dose, unless the manufacturer has been granted an exemption to this requirement. However, no such exemption has been granted for any vaccine by the FDA. The amount of aluminum in vaccines currently licensed in the U.S. is consistent with the World Health Organization standards per single human dose of a product.”
The FDA limit of 850 μg of aluminum per dose was derived from data demonstrating that this amount per dose enhanced the “antigenicity” and “effectiveness” of the vaccine, but was not based on safety considerations. It was based on a paper published in 2002 in the journal Vaccine from the FDA Center for Biologics Evaluation and Research (CBER) which stated, “The amount of 15 mg of alum or 0.85 mg aluminum per dose was selected empirically from data that demonstrated that this amount of aluminum enhanced the antigenicity and effectiveness of the vaccine (Joan May, FDA/CBER, personal communication).”
Furthermore, it is a matter of common sense that a pediatric drug dose must be proportionally calculated based on body weight. Similarly, the pediatric equivalent aluminum dose must also be calculated based on body weight.
However, the FDA’s recommended amount of aluminum per dose in vaccines for kids does not consider their body weight. They haven’t calculated a safe dose for children based on the risks for potential harm. The current vaccine schedule doesn’t account for these factors, which is a serious problem that needs to be addressed.
- Compared to an adult whose body weight is 60 kg—for a male child, 850 μg is equivalent to 254 μg/kg at birth; 152.7 μg/kg at 2 months; 121.4 μg/kg at 4 months; 107.1μg/kg at 6 months; 92.8μg/kg at 1year; and 69.9 μg/kg at 2 years (as compared to 12.5 to 14.2 μg/kg for an adult).
- For a female child, body weight is generally less than a male, so their burden of aluminum is even higher.
For 1250 μg in each vaccine dose, adjusted by body weight:
- Compared to an adult whose body weight is 60 kg—for a male child, 1250 μg is equivalent to 373.5 μg/kg at birth; 224.5 μg/kg at 2 months; 178.5 μg/kg at 4 months; 157.5 μg/kg at 6 months; 136.4 μg/kg at 1 year; and 102.9 μg/ kg at 2 years (as compared to 18.4 to 20.8 μg/kg for an adult).
- Similarly, for a female child, body weight is generally less than a male, so their burden of aluminum is even higher.
The only available safety dosing limit for parenteral exposures to aluminum from the Code of Federal Regulations (CFR/FDA 21CFR201.323) is placed at 4 to 5 μg/kg/day.
Accordingly, the above vaccine dose limits of 850 to 1,250 μg/dose of aluminum set by the FDA vastly exceed the aluminum parenteral dose safety limit of 4 to 5 μg/kg/day.
We have not considered babies with renal dysfunction, a condition that is very common among premature infants.