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Vaccine Safety

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.”
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.

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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Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase from 1997 to 2017
Published: 2019
SYNOPSIS

More than one in ten vaccine-related adverse events in Zimbabwe are serious (11%), and measles-containing vaccines are one of the vaccines most frequently responsible for serious and systemic reactions.

CITATION

Masuka JT, Khoza S. BMC Public Health. 2019;19:1166.

SUMMARY

The authors examined passively collected reports of adverse events following immunization (AEFI) in Zimbabwe from 1997 to 2017. Given widespread underreporting to the country’s still-developing vaccine surveillance system, just 272 Individual Case Safety Reports (ICSRs) were available, of which 11% represented “serious events.” Of these, 6% were deaths and 5% were life-threatening or involved prolonged hospitalization. Measles-containing vaccines had the highest AEFI reporting rate and were also strongly associated with serious events, as was a six-component vaccine containing antigens for oral poliovirus, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and hepatitis B (OPV/DTP-Hib-HepB). The majority of AEFI were systemic (versus vaccine site reactions)—and systemic events, again, were associated with measles-containing vaccines.

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Comment on: Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.
Published: 2018
SYNOPSIS

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

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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Unraveling the enigma: elucidating the relationship between the physicochemical properties of aluminium-based adjuvants and their immunological mechanisms of action
Published: 2018
SYNOPSIS

Aluminum adjuvants in vaccines produce toxic effects ranging from benign to fatal, depending on the physicochemical properties of the adjuvant and the physiological response of the vaccine recipient.

CITATION

Shardlow E, Mold M, Exley C. Unraveling the enigma: elucidating the relationship between the physicochemical properties of aluminium-based adjuvants and their immunological mechanisms of action. Allergy Asthma & Clinical Immunology 2018;14:80.

SUMMARY

The two types of aluminum salts commonly used as adjuvants in vaccines are chemically and biologically dissimilar and may play distinct roles in vaccine-related adverse events. Understanding their physicochemical properties—within the physiological environment of the injection site—can help explain their role in adverse events. The authors suggest that “some degree of toxicity and cell death is probably inevitable” following injection of aluminum salts, but they note that the type of iatrogenic effect observed may “range from benign to fatal” depending on the properties of the specific adjuvant “and, critically, the physiological response of the recipient.” Pointing out that aluminum-based adjuvants have never received approval for intramuscular or subcutaneous injection into humans, the researchers call for evaluation of their safety “independently of their presence in vaccine formulations.”

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Milk containing vaccines cause milk allergies, EoE, autism and type 1 diabetes
Published: 2018
SYNOPSIS

Food proteins in vaccines can sensitize the immune system and trigger development of food allergies and other chronic conditions such as autism and type 1 diabetes.

CITATION

Arumugham V. BMJ. 2018;361:k2396. [Letter in response to Schulze MB et al., Food based dietary patterns and chronic disease prevention, BMJ 2018;361:k2396.]

SUMMARY

Responding to an article about food and chronic illness, the author criticizes the researchers for overlooking “a major cause of why food has become dangerous,” noting that vaccines contain food proteins that can “program the immune system to recognize food as pathogens.” Injection of vaccines containing cow’s milk proteins can cause sensitization to several bovine proteins (casein, folate receptor and insulin). In addition, studies suggest an association between vaccine-induced sensitization to cow’s milk proteins and the development of eosinophilic esophagitis (EoE), autism and type 1 diabetes.

 

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Challenges of independent assessment of potential harms of HPV vaccines
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.

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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Discrepancies in the evaluation of the safety of the human papillomavirus vaccine
Published: 2018
SYNOPSIS

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

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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Reconsideration of the immunotherapeutic pediatric safe dose levels of aluminum
Published: 2018
SYNOPSIS

The levels of aluminum present in individual vaccines and in the modern vaccine schedule as a whole are problematically high.

Citation

Lyons-Weiler J, Ricketson R. Reconsideration of the immunotherapeutic pediatric safe dose levels of aluminum. Journal of Trace Elements in Medicine and Biology. 2018;48:67-73.

 

Summary

The authors show that current levels of aluminum in vaccines derive from “outdated information, unwarranted assumptions and errors.” Whereas aluminum dosing in vaccines should be expressed in terms of micrograms per kilogram of body weight per day, the Food and Drug Administration (FDA) references aluminum amounts in terms of micrograms per dose. As a result, aluminum amounts do not appropriately adjust for toxicological differences between adults and children, males and females or normal-birthweight versus low-birthweight infants. The FDA also ignores dose-related toxicity and body burden despite routine administration of multiple aluminum-containing vaccines at a single health care visit. The levels of aluminum currently present in individual vaccines and in the modern vaccine schedule as a whole are “problematically high.”

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Inter-pathogen peptide sharing and the original antigenic sin: solving a paradox
Published: 2018
SYNOPSIS

The peptides in vaccine pathogens and in human proteins overlap, creating a risk of post-vaccination cross-reactivity that can explain vaccine failure and vaccine-associated adverse events.

Citation

Kanduc D, Schoenfeld Y. Inter-pathogen peptide sharing and the original antigenic sin: solving a paradox. The Open Immunology Journal. 2018;8:16-27.

 

Summary

The authors explain how the overlap between peptides present in vaccine pathogens and in human proteins creates a risk of cross-reactivity following vaccination. Cross-reactivity can explain not only vaccine failure but also vaccine-associated adverse events, including autoimmunity. The “massive microbial vs human peptide overlap” suggests that vaccines cannot be safe and effective unless they are based on peptide sequences that are “uniquely owned by the infectious agent” but absent from the full set of human proteins.

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Autoimmunity, autonomic neuropathy, and the HPV vaccination: a vulnerable subpopulation
Published: 2018
SYNOPSIS

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

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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Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine
Published: 2017
SYNOPSIS

Adolescents given meningococcal vaccines have experienced a wide variety of serious adverse events, including new autoimmune conditions and death.

CITATION

Hansen J, Zhang L, Klein NP, et al. Vaccine 2017;35(49 Pt B):6879-84.

 

SUMMARY

Adolescents receiving the Menactra® meningococcal vaccine (MenACWY-D) in 2005-2006 experienced a variety of adverse events in the six months following vaccination—including death—but the researchers (one of whom was affilated with the vaccine’s manufacturer, Sanofi Pasteur) concluded that only two diagnoses (diabetes and juvenile rheumatoid arthritis) were “possibly related to vaccination.” After comparing 31,000 Kaiser Permanente patients who received the MenACWY-D vaccine to 31,000 matched teens who had received a tetanus-diphtheria (Td) or hepatitis vaccine the previous year, the researchers assessed 1660 outcomes and determined that 1.3% were “significantly elevated” in the meningococcal group. There were two deaths in vaccinees with cancer (“with onset preceding vaccination”) following MenACWY-D vaccination as well as a third cardiac-related death; there was also one fetal death in a young woman who received Menactra® during pregnancy. Many of the adverse events, including difficulty breathing, occurred two or more months following vaccination.

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HPV vaccines—A review of the first decade
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.

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

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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Mechanisms of aluminum adjuvant toxicity and autoimmunity in pediatric populations
Published: 2012
SYNOPSIS

Canadian researchers review literature on autoimmunity and neurological risks from vaccine adjuvant aluminum, express doubts regarding safety testing.

CITATION

L Tomljenovic, CA Shaw. Lupus. 2012;21:223–230.

SUMMARY

“Immune challenges during early development, including those vaccine-induced, can lead to permanent detrimental alterations of the brain and immune function. Experimental evidence also shows that simultaneous administration of as little as two to three immune adjuvants can overcome genetic resistance to autoimmunity. In spite of the widespread agreement that vaccines are largely safe and serious adverse complications are extremely rare, a close scrutiny of the scientific literature does not support this view. For example, to date, the clinical trials that could adequately address vaccine safety issues have not been conducted (i.e., comparing health outcomes in vaccinated versus non-vaccinated children). Infants and young children should not be viewed as ‘small adults.’ Their unique physiology makes them much more vulnerable to noxious environmental insults in comparison with the adult population. In spite of this, children are routinely exposed to much higher levels of Al vaccine adjuvants than adults, even though adequate safety data on these compounds are lacking. That Al vaccine adjuvants can induce significant autoimmune conditions in humans can hardly be disputed, although still debatable is how common such side effects are. However, the existing data (or lack thereof) raise questions on whether the current vaccines aimed at pediatric populations can be accepted as having adequate safety profiles. Because infants and children represent those who may be most at risk for complications following vaccination, a more rigorous evaluation of potential vaccine-related adverse health impacts in pediatric populations than what has been provided to date is urgently needed.”

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