It has been 13 years since the U.S. Food and Drug Administration (FDA) supplied fast-tracked approval for Merck’s Gardasil vaccine—promoted for the prevention of cervical cancer and other conditions attributed to four types of human papillomavirus (HPV). The agency initially licensed Gardasil solely for 9- to 26-year-old girls and women, but subsequent FDA decisions now enable Merck to market Gardasil’s successor—the nine-valent Gardasil 9 vaccine—to a much broader age range—9 to 45 years—and to both males and females.
As a result of Gardasil’s expanding markets not just in the U.S. but internationally, the blockbuster HPV vaccine has become Merck’s third highest-grossing product, bringing in annual global revenues of about $2.3 billion. However, Gardasil’s safety record has been nothing short of disastrous. Children’s Health Defense and Robert F. Kennedy, Jr. have just produced a video detailing the many problems with the development and safety of Gardasil. Please watch and share this video so that you and others may understand why Mr. Kennedy refers to Merck’s methodologies as “fraudulent flimflams.”
What follow are 25 key facts about Gardasil/Gardasil 9, including facts about the HPV vaccines’ clinical trials and adverse outcomes observed ever since Merck, public health officials and legislators aggressively foisted the vaccines on an unsuspecting public.
Inappropriate placebos and comparisons
- A placebo is supposed to be an inert substance that looks just like the drug being tested. But in the Gardasil clinical trials, Merck used a neurotoxic aluminum adjuvant called AAHS instead of using an inert saline placebo.
- Among girls and women who received the vaccine and among girls and women who received AAHS, an astonishing 2.3% in both groups experienced conditions indicative of “systemic autoimmune disorders,” many shortly after receiving Gardasil.
- Multiple scientific studies associate aluminum not just with autoimmune diseases but with autism, Alzheimer’s disease, dementia and Parkinson’s disease as well as behavioral abnormalities in animals.
- Merck lied to study participants, falsely saying that the clinical trials were not safety studies, that the vaccine had already been found to be safe and that the “placebo” was an inert saline solution. [Source: The HPV Vaccine on Trial (photo evidence, pp. 6 and 12).]
- When Merck conducted clinical trials for its next HPV vaccine formulation, Gardasil 9, it used Gardasil as the “placebo” in the control groups, again relying on the lack of an inert placebo to mask safety signals.
- The 500 micrograms of aluminum adjuvant (AAHS) in Gardasil 9 are more than double the amount of aluminum in Gardasil; this raises the question of whether Gardasil 9’s heavy reliance on the Gardasil trials for comparison is justifiable.
- The World Health Organization states that using a vaccine (rather than an inert substance) as a placebo creates a “methodological disadvantage” and also notes that it may be “difficult or impossible” to assess vaccine safety properly without a true placebo.
Inappropriate inclusion and exclusion criteria
- In the only Gardasil trial in the target age group (11- and 12-year-old girls) with a control group design, fewer than 1200 children received the vaccine and fewer than 600 served as controls. This single trial involving fewer than 1800 children set the stage for the vaccine’s subsequent marketing to millions of healthy preteens all over the world.
- The Gardasil clinical trials had numerous exclusion criteria. Not allowed to participate in the trials were people with: severe allergies; prior abnormal Pap test results; over four lifetime sex partners; a history of immunological disorders and other chronic illnesses; reactions to vaccine ingredients, including aluminum, yeast, and benzonase; or a history of drug or alcohol abuse—yet Merck now recommends Gardasil for all of these groups.
- Some of the study participants—but not all—were given “report cards” to record short-term reactions such as redness and itching. The report cards monitored reactions for a mere 14 days, however, and Merck did not follow up with participants who experienced serious adverse events such as systemic autoimmune or menstrual problems.
- Injured participants complained that Merck rebuffed their attempts to report adverse side effects. In numerous instances, Merck maintained that these “weren’t related to the vaccine.”
- Half (49.6%) of the clinical trial subjects who received Gardasil reported serious medical conditions within seven months. To avoid classifying these injuries as adverse events, Merck dismissed them as “new medical conditions.”
Annual deaths from cervical cancer in the U.S. are 2.3/100,000. The death rate in the Gardasil clinical trials was 85/100,000—or 37 times that of cervical cancer.
Cervical cancer risk-benefit ratio not worth it
- The median age of cervical cancer death is 58 years. Gardasil targets millions of healthy preadolescents and teens for whom the risk of dying from cervical cancer is practically zero. Interventions for healthy people must have a risk profile that is also practically zero.
- Annual deaths from cervical cancer in the U.S. are 2.3/100,000. The death rate in the Gardasil clinical trials was 85/100,000—or 37 times that of cervical cancer.
- With 76 million children vaccinated at an average cost of $420 for the three-shot Gardasil series, the cost of saving one American life from cervical cancer amounts to about $18.3 million dollars. By contrast, the value of a human life according to the Department of Health and Human Services’s (HHS’s) National Vaccine Injury Compensation Program is $250,000—the maximum amount that the government program will award for a vaccine-related death.
- According to Gardasil’s package insert, women are 100 times more likely to suffer a severe event following vaccination with Gardasil than they are to get cervical cancer.
- The chances of getting an autoimmune disease from Gardasil, even if the vaccine works, are 1,000 times greater than the chances of being saved from a cervical cancer death.
- Women in Gardasil clinical trials with evidence of current HPV infection and previous exposure to HPV had a 44% increased risk of developing cervical lesions or cancer following vaccination.
- Women who get the Gardasil vaccine as preteens or teens are more likely to skip cervical cancer screening as adults, mistakenly assuming that HPV vaccination is a replacement for screening and that the vaccine will eliminate all risk.
Since Gardasil came on the U.S. market in 2006, people have reported over 450 deaths and over 61,000 serious medical conditions from HPV vaccines to the Vaccine Adverse Event Reporting System.
- Accumulating evidence points to Gardasil’s potentially severe adverse effects on fertility, including miscarriage and premature ovarian failure.
- Merck never tested the vaccine for fertility effects. However, Gardasil and Gardasil 9 clinical trials showed high spontaneous miscarriage rates of 25% and 27.4%, respectively—significantly higher than the background rates of approximately 10%-15% in this reproductive age group.
- Polysorbate 80 and sodium borate (Borax) are associated with infertility in animals. Both are Gardasil ingredients, and both were present in the one clinical trial protocol that professed to use a benign saline placebo.
- In 2015, Denmark opened five new “HPV clinics” to treat children injured by Gardasil. Over 1300 cases flooded the clinics shortly after their opening.
- Since Gardasil came on the U.S. market in 2006, people have reported over 450 deaths and over 61,000 serious medical conditions from HPV vaccines to the Vaccine Adverse Event Reporting System (VAERS).
- Merck lied to VAERS about the case of Christina Tarsell’s death, falsely claiming that her doctor blamed a virus instead of Gardasil. [Source: The HPV Vaccine on Trial (p. 144).]
The vaccine that should never have been licensed
As suggested in the conclusion to the 2018 book The HPV Vaccine on Trial, the rollout of Gardasil in 125 countries worldwide has illustrated—in an all-too-real and shocking manner—the phenomenon that prompted Hans Christian Andersen to write “The Emperor’s New Clothes.” Around the world, over 100,000 Gardasil-related adverse events have now been reported to the FDA and WHO, and accounts continue to multiply of “scandal, lawsuits, severe injuries, and deaths.” For almost 200 years, Andersen’s story has taught readers about the need to speak the truth, pay attention to evidence and listen to children. The rosy narrative manufactured for the dangerous Gardasil vaccine must not be allowed to hold sway any longer. It is time, in the words of the HPV Vaccine on Trial authors, to proclaim—loudly—that “the Emperor has no clothes.”