Scientific References & Studies
Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to
particulate aluminum adjuvant in the HPV vaccine Gardasil®
All 16 Gardasil® vaccine samples tested contain residual HPV L1 gene DNA
► The HPV DNA fragments are bound to particles possibly of aluminum adjuvant.
► The bond between the HPV DNA and the particles may be chemical in nature.
► All HPV DNA fragments detected by nested PCR were confirmed by DNA sequencing.
► The results showed that all 16 Gardasil® samples, each with a different lot number, contained fragments of HPV-11 DNA, or HPV-18 DNA, or a DNA fragment mixture from both genotypes. The detected HPV DNA was found to be firmly bound to the insoluble, proteinase-resistant fraction, presumably of amorphous aluminum hydroxyphosphate sulfate (AAHS) nanoparticles used as adjuvant. The clinical significance of these residual HPV DNA fragments bound to a particulate mineral-based adjuvant is uncertain after intramuscular injection, and requires further investigation for vaccination safety.
"an additional item for discussion will be the finding in the baseline PCR positive and seropositive subgroup of study 013 of an INCREASED rate of CIN 2/3 or worse due to the relevant HPV vaccine types among Gardasil™ recipients. The review team found CIN 2/3 or worse cases among recipients of Gardasil™." "Cervical intraepithelial neoplasia grade 2/3 (CIN 2/3) and adenocarcinoma in situ (AIS) are considered to be precursors to cervical cancer."
(see Table 3). Table 3 of this study compared hpvs present in HPV vaccinated and unvaccinated women. The study showed a drop of a mere 0.6% of HPV 16 and 1.1% decrease in HPV 18. At the same time, however, the vaccinated women had a 4 to 10x increase in all of the other high risk, potentially cancerous HPVs. Wright TC Jr, Stoler MH, et al. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol. 2012; 206: 46.el-46.ell.
Cervix vaccine issues
trigger health notice
Jun 15, 2013
The health ministry has issued a nationwide notice
that cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16 because several
adverse reactions to the medicines have been reported.
“It is necessary to gather information immediately to
accurately grasp how often (the side effects) are
occurring,” said Mariko Momoi, who chairs the panel
at the Health, Labor and Welfare Ministry that
decided to suspend the recommendation. Momoi
is vice president of the International University
of Health and Welfare.
Remember Japan has STOPPED their recommendation for this vaccine in 2013 because of too many deaths and adverse events.
“Gardasil failed (and continues to fail) to meet a single one of the four criteria required by the FDA for Fast Track approval. Gardasil is demonstrably neither safer nor more effective than Pap screening combined with LEEP, not can it improve the diagnosis of serious cervical cancer outcomes”
Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental?
"Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies.Cerebral vasculitis is a serious disease which typically results in fatal outcomes when undiagnosed and left untreated. The fact that many of the symptoms reported to vaccine safety surveillance databases following HPV vaccination are indicative of cerebral vasculitis, but are unrecognized as such (i.e., intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits), is a serious concern in light of the present findings. It thus appears that in some cases vaccination may be the triggering factor of fatal autoimmune/neurological events. Physicians should be aware of this association."
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Report of Motor Neuron Disease After HPV Vaccine
7 More Cases
Lead investigator of the second group presenting on this topic said that he agrees that postmarketing pharmacosurveillance is necessary to improve safety.
"[Human papillomavirus] vaccines elicit a strong inflammatory systemic immune response," said Til Menge, MD, from Heinrich-Heine University in Düsseldorf, Germany.
His group suggests that it was this inflammatory response that may have triggered a case of fulminant neuromyelitis optica in a previously healthy 17-year-old girl. Investigators have not established a causal relationship, but they are asking clinicians to closely monitor patients for any emerging side effects."
"We found 42 incidences of Gardasil-related GBS (reported mainly by medical personnel), including pts receiving Gardasil alone (N=27; age 10-26 yrs; mean 16.67 for the 18 subjects for which age was reported). Of the 27 incidences, 33% were complete reports, with 10 reports after the first dose and 4 reports after the third dose. Initial symptoms averaged 30 days post-Gardasil injection for these 11 cases. GBS was confirmed as final diagnosis in 20 reports, and was highly suspected in 7 reports."
"Using data from Vaccine Adverse Event Reporting System, we identified 69 reports of Guillain–Barré Syndrome (GBS) after Gardasil vaccination that occurred in the United States between 2006 and 2009.The onset of symptoms was within 6 weeks after vaccination in 70% of the patients in whom the date of vaccination was known. The estimated weekly reporting rate of post-Gardasil GBS within the first 6 weeks (6.6 per 10,000,000) was higher than that of the general population, and higher than post-Menactra and post- influenza vaccinations. Further prospective active surveillance for accurate ascertainment and identification of high-risk groups of GBS after Gardasil vaccination is WARRANTED. "
"To date, this is the first case report describing POTS after vaccination with Gardasil. Given an increased prevalence of POTS in young women and an
indication for vaccination with Gardasil in the same patient population, physicians should be aware of a possible association between vaccination with Gardasil and de novo POTS."
Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants.
"We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry." JULY 31 2013
American College of Pediatricians – January 2016
Few other vaccines besides Gardasil® that are administered in adolescence contain polysorbate 80. Pre-licensure safety trials for Gardasil® used placebo that contained polysorbate 80 as well as aluminum adjuvant. Therefore, if such ingredients could cause ovarian dysfunction, an increase in amenorrhea probably would not have been detected in the placebo controlled trials. Furthermore, a large number of girls in the original trials were taking hormonal contraceptives which can mask ovarian dysfunction including amenorrhea and ovarian failure.2 Thus a causal relationship between human papillomavirus vaccines (if not Gardasil® specifically) and ovarian dysfunction cannot be ruled out at this time.
Polysorbate 80- Ingredient in Gardasil and other vaccines: linked to infertility
"Neonatal female rats were injected ip (0.1 ml/rat) with Tween 80 in 1, 5 or 10% aqueous solution on days 4-7 after birth. Treatment with Tween 80 accelerated maturation, prolonged the oestrus cycle, and induced persistent vaginal oestrus. The relative weight of the uterus and ovaries was decreased relative to the untreated controls. Squamous cell metaplasia of the epithelial lining of the uterus and cytological changes in the uterus were indicative of chronic oestrogenic stimulation. Ovaries were without corpora lutea, and had degenerative follicles"
Human papillomavirus (HPV) vaccines as an option for preventing cervical malignancies: (how) effective and safe?
We carried out a systematic review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. We find that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate. Additionally, we note evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications). Given this, the widespread optimism regarding HPV vaccines long-term benefits appears to rest on a number of unproven assumptions (or such which are at odd with factual evidence) and significant misinterpretation of available data. For example, the claim that HPV vaccination will result in approximately 70% reduction of cervical cancers is made despite the fact that the clinical trials data have not demonstrated to date that the vaccines have actually prevented a single case of cervical cancer (let alone cervical cancer death), nor that the current overly optimistic surrogate marker-based extrapolations are justified. Likewise, the notion that HPV vaccines have an impressive safety profile is only supported by highly flawed design of safety trials and is contrary to accumulating evidence from vaccine safety surveillance databases and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities). We thus conclude that further reduction of cervical cancers might be best achieved by optimizing cervical screening (which carries no such risks) and targeting other factors of the disease rather than by the reliance on vaccines with questionable efficacy and safety profiles.
Postural Orthostatic Tachycardia (POTS) With Chronic Fatigue After HPV Vaccination as Part of the “Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants”
We report the case of a 14-year-old girl who developed postural orthostatic tachycardia syndrome (POTS) with chronic fatigue 2 months following Gardasil vaccination. The patient suffered from persistent headaches, dizziness, recurrent syncope, poor motor coordination, weakness, fatigue, myalgias, numbness, tachycardia, dyspnea, visual disturbances, phonophobia, cognitive impairment, insomnia, gastrointestinal disturbances, and a weight loss of 20 pounds. The psychiatric evaluation ruled out the possibility that her symptoms were psychogenic or related to anxiety disorders. Furthermore, the patient tested positive for ANA (1:1280), lupus anticoagulant, and antiphospholipid. On clinical examination she presented livedo reticularis and was diagnosed with Raynaud’s syndrome. This case fulfills the criteria for the autoimmune/auto-inflammatory syndrome induced by adjuvants (ASIA). Because human papillomavirus vaccination is universally recommended to teenagers and because POTS frequently results in long-term disabilities (as was the case in our patient), a thorough follow-up of patients who present with relevant complaints after vaccination is strongly recommended.
New Concerns about the Human Papillomavirus Vaccine
American College of Pediatricians – January 2016
"The American College of Pediatricians (The College) is committed to the health and well-being of children, including prevention of disease by vaccines. It has recently come to the attention of the College that one of the recommended vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause. There have been two case report series (3 cases each) published since 2013 in which post-menarcheal adolescent girls developed laboratory documented POF within weeks to several years of receiving Gardasil, a four-strain human papillomavirus vaccine (HPV4). Adverse events that occur after vaccines are frequently not caused by the vaccine and there has not been a noticeable rise in POF cases in the last 9 years since HPV4 vaccine has been widely used.
Nevertheless there are legitimate concerns that should be addressed: (1) long-term ovarian function was not assessed in either the original rat safety studies or in the human vaccine trials, (2) most primary care physicians are probably unaware of a possible association between HPV4 and POF and may not consider reporting POF cases or prolonged amenorrhea (missing menstrual periods) to the Vaccine Adverse Event Reporting System (VAERS), (3) potential mechanisms of action have been postulated based on autoimmune associations with the aluminum adjuvant used and previously documented ovarian toxicity in rats from another component, polysorbate 80, and (4) since licensure of Gardasil® in 2006, there have been about 213 VAERS reports (per the publicly available CDC WONDER VAERS database) involving amenorrhea, POF or premature menopause, 88% of which have been associated with Gardasil®. The two-strain HPV2, Cervarix, was licensed late in 2009 and accounts for 4.7 % of VAERS amenorrhea reports since 2006, and 8.5% of those reports from February 2010 through May 2015. This compares to the pre-HPV vaccine period from 1990 to 2006 during which no cases of POF or premature menopause and 32 cases of amenorrhea were reported to VAERS.
Few other vaccines besides Gardasil® that are administered in adolescence contain polysorbate 80. Pre-licensure safety trials for Gardasil® used placebo that contained polysorbate 80 as well as aluminum adjuvant. Therefore, if such ingredients could cause ovarian dysfunction, an increase in amenorrhea probably would not have been detected in the placebo controlled trials. Furthermore, a large number of girls in the original trials were taking hormonal contraceptives which can mask ovarian dysfunction including amenorrhea and ovarian failure. Thus a causal relationship between human papillomavirus vaccines (if not Gardasil® specifically) and ovarian dysfunction cannot be ruled out at this time."
"the essential lack of saline placebos and the majority of participants taking hormonal contraceptives in those studies preclude meaningful data to rule out an effect on ovarian function."
Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants.
All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome.
We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.