Science Library Category:

HPV - Gardasil

Published: 2019
SYNOPSIS

Researchers assert that bivalent HPV vaccination in Scotland has been “highly effective” in reducing pre-malignant cervical disease, but have failed to discuss serious adverse events following HPV vaccination or other secular trends that could provide an explanation for the declines.

TITLE

Comments in response to: “Prevalence of cervical disease at age 20 after immunisation with bivalent HPV vaccine at age 12-13 in Scotland: retrospective population study.”

CITATION

Comments by Exley C, Gervas J, Selley P, Stone J, Thomas N, Vasquez A, Miller NZ, in response to: Palmer T, Wallace L, Pollock KG, et al. Prevalence of cervical disease at age 20 after immunisation with bivalent HPV vaccine at age 12-13 in Scotland: retrospective population study. BMJ. 2019;365:l1161.

SUMMARY

This collection of published comments responds to the assertion by Scottish researchers (Palmer et al., 2019) that bivalent HPV vaccination in Scotland has been “highly effective” in lowering the prevalence of pre-malignant cervical disease. The seven commenters make the following points:

  1. Exley critiques the authors’ “serious omission” in failing to discuss serious adverse events following HPV vaccination; those with “privileged access to human data” should use it “to cover all aspects of both efficacy AND safety of this vaccine.”
  2. Gervas estimates that 4,300 women would need to receive the HPV vaccine to prevent one case of severe cervical dysplasia (the “number needed to treat”).
  3. Selley describes secular trends in teen sexual behavior over the study period and asks whether the falling prevalence of pre-malignant cervical disease attributed to the HPV vaccine could be related to changes in sexual behavior.
  4. Stone calls attention to an article (Castanon and Sasieni, 2018) that reported a “dramatic increase” in England of cervical cancers in the first generation to be targeted for HPV vaccination.
  5. Thomas contests the lead author’s assertion that “In Scotland, as elsewhere, no serious adverse effects have been demonstrably linked to the [HPV] vaccine,” pointing to reports of several hundred thousand adverse events assembled by the World Health Organization (including 400 deaths) and almost 13,000 reported reactions in the UK, and observes that valid informed consent is not possible without communicating information about these risks.
  6. Vasquez points to Scotland’s public health campaign to address endemic vitamin D deficiency implemented in “close chronologic proximity” to its launch of HPV vaccination. “Crediting the reduction in HPV-related disease solely to vaccination…is potentially invalid and misleading, especially when the authors make no account whatsoever of the national program for vitamin D supplementation which started in the same timeframe.”
  7. Miller points out that the Palmer et al. study only included 12- and 13-year-old girls and “did not include older teens and women who are sexually active, have been exposed to HPV prior to HPV-vaccination, and are likely to have significantly worse outcomes than unvaccinated females.”

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Published: 2018
SYNOPSIS

Gardasil clinical trial and post-marketing data should raise a red flag about HPV vaccine safety.

TITLE

Comment on: Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.

CITATION

Martinez-Lavin M. Comment on: Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Database of Systematic Reviews. 2018 October 1.

SUMMARY

This brief comment disputes as flawed the conclusions of a Cochrane systematic review of human papillomavirus (HPV) vaccine safety (Arbyn et al., 2018). The earlier review reported no increased risk of serious adverse events and dismissed post-HPV-vaccine deaths as a “chance occurrence.” However, other published studies show significantly more serious adverse events in (1) women who received Gardasil versus aluminum placebo and (2) women who received 9-valent Gardasil-9 versus 4-valent Gardasil. Stating that “hard statistical data must take preeminence over the expert’s opinion,” the author argues that Gardasil clinical trial and post-marketing data “should raise a red flag on HPV vaccine safety.”

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Published: 2018
SYNOPSIS

Women vaccinated for HPV have a lower probability of conceiving.

TITLE

A lowered probability of pregnancy in females in the USA aged 25–29 who received a human papillomavirus vaccine injection

CITATION

Gayle DeLong (2018) Journal of Toxicology and Environmental Health, Part A, 81:14, 661-674, DOI: 10.1080/15287394.2018.1477640

SUMMARY

Approximately 60% of the single women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived. For married women, 75% who did not receive the shot were found to conceive, while only 50% who received the vaccine had ever been pregnant.

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Published: 2018
SYNOPSIS

French Professors demand immediate stop to Al use in vaccines and medications like antacids, as evidence shows that it poses a deadly danger to humans.

TITLE

French Professors demand immediate stop to Al use in vaccines and medications like antacids

CITATION

Gayle DeLong (2018) Journal of Toxicology and Environmental Health, Part A, 81:14, 661-674, DOI: 10.1080/15287394.2018.1477640

SUMMARY

Approximately 60% of the single women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived. For married women, 75% who did not receive the shot were found to conceive, while only 50% who received the vaccine had ever been pregnant.

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Published: 2018
SYNOPSIS

The evidence does not support HPV vaccine effectiveness in women in their mid- to late 20s.

TITLE

Effectiveness of catch-up human papillomavirus vaccination on incident cervical neoplasia in a US health-care setting: a population-based case-control study

CITATION

Silverberg MJ, Leyden WA, O’Lam J, et al. Effectiveness of catch-up human papillomavirus vaccination on incident cervical neoplasia in a US health-care setting: a population-based case-control study. Lancet Child and Adolescent Health. 2018;2(10):707-714.

SUMMARY

This article reports limited effectiveness of “catch-up” HPV vaccination in women in their 20s. The vaccine showed “no significant effectiveness” in women who initiated vaccination between 21-26 years of age (or who received less than the three-dose series), in line with other studies that likewise have found no evidence of “any vaccine effectiveness” in women in their mid- to late 20s. [Note: Although the study’s results “conflict” with arguments to extend HPV vaccination to women of older ages, the FDA nontheless approved Gardasil-9 for women and men between ages 27 and 45 in October 2018.]

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Published: 2018
SYNOPSIS

Data restrictions imposed by vaccine manufacturers and regulators inhibit independent researchers’ ability to conduct comprehensive and accurate assessments of HPV vaccine safety.

TITLE

Challenges of independent assessment of potential harms of HPV vaccines

CITATION

Jørgensen L, Doshi P, Gøtzsche P, Jefferson T. Challenges of independent assessment of potential harms of HPV vaccines. BMJ 2018;362:k3694.

SUMMARY

Vaccine manufacturer control over clinical study reports inhibits independent researchers’ ability to conduct comprehensive and accurate assessments of HPV vaccine safety. Researchers and regulators evaluating reports of HPV vaccine injuries often do not have access to thousands of pages of clinical study results and must rely on short journal publications. Unpublished reports are also far more likely to contain information about harms, including those that are relatively rare. After three years of efforts to obtain “all potentially eligible reports for a systematic review of HPV vaccines,” the authors had received only half “and these were incomplete and contained redactions.”

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Published: 2018
SYNOPSIS

Discrepancies in how countries define and evaluate difficult-to-diagnose vaccine complications may affect their conclusions about HPV vaccine safety.

TITLE

Discrepancies in the evaluation of the safety of the human papillomavirus vaccine

CITATION

Cervantes JL, Doan AH. Discrepancies in the evaluation of the safety of the human papillomavirus vaccine. Memórias Do Instituto Oswaldo Cruz. 2018;113(8):e180063.

SUMMARY

Discrepancies in how countries define and evaluate difficult-to-diagnose HPV vaccine complications may affect their conclusions about the vaccine’s safety. Japan and Colombia suspended their HPV vaccine recommendations after encountering a significant number of cases of complications; the fact that some cases were “rare” or “clinically undefined” did not sway their decision. There is a need for unbiased monitoring and reporting of adverse reactions to HPV vaccination “to ensure that the benefits of vaccines outweigh the risks of adverse reactions.”

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Published: 2018
SYNOPSIS

Vaccination can trigger a series of cascading events that disturbs the balance between “protective immunity” and “destructive inflammation.”

TITLE

Vaccines and neuroinflammation

Citation

Giannotta G, Giannotta N. International Journal of Public Health & Safety. 2018;3:3.

 

Summary

This study explores molecular mechanisms capable of explaining “post-vaccination inflammatory syndrome” and the neuroinflammation observed in children with autism. Focusing especially on vaccines (such as HPV vaccines) that contain biopersistent aluminum adjuvants, the authors describe how “continuously escalating doses of this poorly biodegradable adjuvant…may become insidiously unsafe,” especially in children who are vaccinated repeatedly or who have an immature or altered blood-brain barrier. Vaccination can trigger a series of cascading events (involving overexpression of the signaling molecules that regulate inflammation and activation of brain cells called microglia) that disturbs the balance between “protective immunity” and “destructive inflammation.”

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Published: 2018
SYNOPSIS

Severe, long-term disability and even death can occur in a subset of individuals vulnerable to “HPV vaccination syndrome.”

TITLE

Autoimmunity, autonomic neuropathy, and the HPV vaccination: a vulnerable subpopulation

Citation

Schofield JR, Hendrickson JE. Clinical Pediatrics. 2018;57(5):603-606.

Summary

The authors describe the first biopsy-proven case of serious nerve damage developing within days of HPV vaccination, with an evident link between symptom onset and vaccination. The authors advocate for “increased [provider] awareness of the potential for neurological complications” resulting from HPV vaccination, particularly due to the “devastating clinical outcome of severe, long-term disability and even death of [a vulnerable subset] affected by the HPV vaccination syndrome.”

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Published: 2017
SYNOPSIS

HPV-vaccinated women, in some settings, are less likely to get routine cervical cancer screening, which is necessary to reduce population incidence of cervical cancer.

TITLE

HPV vaccines—A review of the first decade

CITATION

Harper DM, DeMars LR. HPV vaccines—A review of the first decade. Gynecologic Oncology 2017;146(1):196-204.

SUMMARY

This mostly uncritical review of a decade of HPV vaccination draws attention to an underdiscussed aspect, which is that “[p]revention of cervical cancer must still rely on participation in ongoing screening programs.” The authors show that in many settings, HPV-vaccinated women are significantly less likely to get routine cervical cancer screening than unvaccinated women. Of concern, “the uptake of screening after the HPV vaccine introduction…has been lower than necessary to reduce population incidence of cervical cancer.” The authors comment that administering repeat doses of HPV vaccine to already vaccinated women “causes harm with no evidence of any improved prevention of HPV infections.”

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Published: 2017
SYNOPSIS

Serious adverse events observed in pre-licensure trials of Gardasil-9 cast doubts on HPV vaccine safety, but the trial investigators described the adverse events as not vaccine-related.

TITLE

Vaccine-related serious adverse events might have been under-recognized in the pivotal HPV vaccine randomized trial

Citation

Martínez-Lavín M. Vaccine-related serious adverse events might have been under-recognized in the pivotal HPV vaccine randomized trial [Letter]. Clinical Rheumatology 2017;36(4):975.

 

Summary

The largest pre-licensure trial of the Gardasil-9 vaccine—which compared Gardasil-9 against Gardasil rather than against an inert placebo—showed that Gardasil-9 had significantly more serious adverse events than Gardasil (3.3% versus 2.6%, p=0.01). However, the trial investigators judged that 0% of the serious adverse events in both groups were vaccine-related. Gardasil-9 has “more than double [the] HPV virus-like particles and aluminum adjuvant” as Gardasil. The under-recognition of serious adverse events associated with Gardasil-9 “casts further doubt on HPV vaccine safety.”

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Published: 2016
SYNOPSIS

Israeli, Canadian and Colombian scientists show that the Gardasil vaccine triggers brain inflammation and autoimmunity in mice.

TITLE

Behavioral abnormalities in female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil

CITATION

Inbar R, Weiss R, Tomljenovic L, Arango M-T, Deri Y, Shaw CA, Chapman J, Blank M, Shoenfeld Y. Immunologic Research. 2017;65(1):136-149.

SUMMARY

“Vaccine adjuvants and vaccines may induce autoimmune and inflammatory manifestations in susceptible individuals. To date most human vaccine trials utilize aluminum (Al) adjuvants as placebos despite much evidence showing that Al in vaccine-relevant exposures can be toxic to humans and animals…. It appears that Gardasil via its Al adjuvant and HPV antigens has the ability to trigger neuroinflammation and autoimmune reactions, further leading to behavioral changes…. In light of these findings, this study highlights the necessity of proceeding with caution with respect to further mass-immunization practices with a vaccine of yet unproven long-term clinical benefit in cervical cancer prevention.”

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Published: 2014
SYNOPSIS

FDA’s instruction to health providers that “there is no biologically plausible way in which HPV vaccine could cause infertility” is not science-based and compromises safety monitoring by undermining reporting efficiency, safety signaling and informed consent.

TITLE

Adolescent premature ovarian insufficiency following human papillomavirus vaccination: A case series seen in general practice

CITATION

Little DT, Ward HR. Journal of Investigative Medicine-High Impact Case Reports. 2014;2(4):2324709614556129.

SUMMARY

Published case reports point to a possible link between quadrivalent human papillomavirus (HPV) vaccine and premature ovarian failure. Declining menstrual function in girls aged 14, 15, and 20 years followed quadrivalent HPV vaccination and preceded premature ovarian failure. However, long-term follow-up after HPV vaccination has not surveyed ovarian function, nor recorded, measured or analyzed symptoms or signs of dysfunction. Disparagement of adverse event reporting by licensing bodies, which instruct health providers that “there is no biologically plausible way in which HPV vaccine could cause infertility,” is not science-based and compromises safety monitoring by undermining “reporting efficiency,” safety signaling and informed consent. In the absence of sound research, public reassurance that “studies have not found ovarian failure to be associated with HPV vaccination” may be harmful to vaccine confidence.

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Published: 2013
SYNOPSIS

Israeli, Italian, and Canadian researchers tie HPV vaccine to primary ovarian failure.

TITLE

Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants

CITATION

Selena Colafrancesco, Carlo Perricone, Lucija Tomljenovic, Yehuda Shoenfeld. American Journal of Reproductive Immunology, 2013.

SUMMARY

“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.”

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