Vaccine Mandates Violate the Right to Informed Consent1 On 11 March 2020, the World Health Organization (WHO) declared pandemic status for COVID-19, the disease caused by severe acute respiratory syndrome 2 (SARS-CoV-2). Governments responded by implementing unprecedented “lockdown” measures globally with no clear exit strategy apart from the stated goal of rapidly developing a vaccine. Concurrently, advocates of this hypothetical solution have called for lawmakers to make COVID-19 vaccinations compulsory.
However, compulsory vaccination violates the right to informed consent, one of the most fundamental ethics in medicine and a human right recognized under international law, including the United Nations International Covenant on Civil and Political Rights of 1966, the Universal Declaration on Bioethics and Human Rights of 2005, the Convention on the Rights of Persons with Disabilities and its Optional Protocol of 2006 and under internationally recognized agreements such as the Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects of 2002, and the World Medical Association Declaration Of Helsinki of 1964, revised in 2013.
The United Nations (UN) and WHO are legally obligated to uphold the right to informed consent yet have instead been complicit in violating it.
For example, the United Nations Children’s Fund (UNICEF) praised the Maldives government for passing a law in November 2019 that effectively outlawed the exercise of the right to informed consent by threatening parents with prosecution for non-compliance with public vaccine policy.
In January 2020, two articles in The BMJ (formerly British Medical Journal) revealed that the WHO had been sponsoring a malaria vaccine trial that included 720,000 children in three African countries without having ensured that the prior informed consent of the parents had been obtained. Most egregiously, parents had not been informed that earlier trials had found the vaccine to be associated with an increased risk of childhood mortality, particularly among girls.
WHO also promotes the diphtheria, tetanus, and whole-cell pertussis (DTP) vaccine in global vaccination campaigns, despite the best available scientific evidence showing it to be associated with an increased rate of childhood mortality. While the vaccine may protect against the target diseases, it appears to detrimentally affect the immune system in a way that makes children more vulnerable to other diseases. This “non-specific effect” has been found to be true for non-live vaccine generally
WHO is aware of the evidence, but has dismissed it on the grounds that it comes from observational studies, which are prone to selection bias. However, WHO accepts the findings of observational studies showing beneficial non-specific effects of measles vaccination.
Additionally, the members of the WHO committee tasked with reviewing the evidence had conflicts of interest, including three having ties to GlaxoSmithKline (GSK), one of the manufacturers of DTP vaccines and the manufacturer of the experimental malaria vaccine.
WHO also receives funding from vaccine manufacturers, including GSK, Sanofi, and Merck. The single largest source of funding for WHO presently is the Bill and Melinda Gates Foundation, which promotes vaccines while holding investments in vaccine manufacturers including GSK, Sanofi, and Merck.
The public is repeatedly assured by public health officials and the media that “vaccines are safe and effective”, but in the absence of randomized placebo-controlled trials comparing long-term health outcomes, including mortality, between vaccinated and unvaccinated individuals, that statement is not justifiable.Vaccines do not undergo such trials before licensing. Nor are whole vaccine schedules studied for safety. With respect to the routine childhood vaccine schedule recommended by the United States of America (US) Centers for Disease Control and Prevention (CDC), the Institute of Medicine in 2013 observed that “studies designed to examine the long-term effects of the cumulative number of vaccines or other aspects of the immunization schedule have not been conducted.”
There are many legitimate concerns about vaccines in addition to their non-specific effects. Policymakers do not consider the opportunity costs of vaccination, such as the superiority of immunity acquired naturally compared to that conferred by vaccination.
For example, studies have found that having a flu shot annually could increase the risk of infection with novel influenza strains, as well as with non-influenza viruses, in part due to the lost opportunity to acquire the cross-protective, cell-mediated immunity conferred by infection.
A complementary hypothesis is the phenomenon of “original antigenic sin”, whereby the first experience of the immune system with an antigen determines future responses. Priming the immune system with antigen components of the influenza vaccine could potentially cause a mismatched antibody response to strains that the vaccine is not designed to protect against, thereby increasing the risk of infection as compared to an immune response in which naive T and B cells are instructed to fight off the infecting virus.
This phenomenon might help explain an increased risk of serious dengue infection among Filipino children who received the dengue vaccine and who had not already experienced a prior infection. This finding led the Philippines to the withdrawal of the vaccine, which the government had implemented into its childhood schedule upon the recommendation of WHO, despite earlier data having indicated that the vaccine might cause precisely that outcome.
A related hypothesis is that of “antibody dependent enhancement” (ADE), whereby vaccine-induced antibodies, instead of protecting the individual from subsequent infection, enhance the infection and thereby increase the risk of severe disease.
Attempts to develop a vaccine for severe acute respiratory syndrome coronavirus (SARS) were impeded by this phenomenon, whereby vaccinated animals were found to be at increased risk of viral infection. This past experience has raised concerns about the potential for ADE with vaccines under development for SARS-CoV-2.
As another example of opportunity cost, surviving measles is associated with a reduced rate of all-cause mortality in children, and this survival benefit appears to more than offset measles deaths in populations with a low mortality rate from acute measles infection.
Additionally, measles infection has been observed to cause regression of cancer in children and has been associated with a decreased risk of numerous diseases later in life, including degenerative bone disease, certain tumours, Parkinson’s disease, allergic disease, chronic lymphoid leukaemia, both non-Hodgkin lymphoma and Hodgkin lymphoma, and cardiovascular disease.
Other infections have also been associated with health benefits, such as a reduced risk of leukaemia among children who experience Haemophilus influenzae type b infection during early childhood.
There is also the potential for mass vaccination to put evolutionary pressure on pathogens, as has been seen with the diphtheria, tetanus and acellular pertussis (DTaP) vaccine, and the emergence of pertussis strains lacking pertactin, a key antigen component of the vaccine. According to CDC, such strains “may have a selective advantage in infecting DTaPvaccinated persons.”
Population effects of vaccination must be considered in addition to their effects on individuals. Data suggest that the varicella (chicken pox) vaccine has not been cost-effective but has rather increased health care costs due to the inferiority of vaccine-conferred immunity. This is because mass vaccination appears to have shifted the risk burden away from children, in whom it is generally a benign illness, and onto adolescents and adults, who are at greater risk of complications. Due to the loss of immunologic boosting from repeated exposures, elderly people who had chicken pox as children are at greater risk of shingles. But rather than reconsider existing recommendations, policymakers respond to this problem by recommending a shingles vaccine for the elderly
In the US, many parents are concerned that manufacturers of vaccines recommended by CDC for routine use in childhood enjoy legal immunity from injury lawsuits because this represents a disincentive to pharmaceutical companies in terms of developing safer and more effective means of disease prevention. The Vaccine Injury Compensation Program (VICP) of the US government effectively shifts the financial burden for vaccine injuries away from the industry and onto taxpaying consumers.
Another major problem is that policymakers treat vaccination as a one-size-fits-all solution to disease prevention, when the science is unequivocal in establishing that a risk-benefit analysis must be carried out for each vaccine and each individual. Not everyone is at the same risk from the target disease, and not everyone is at the same risk of harm from the vaccine.
For example, children with a mitochondrial disorder may be at increased risk of vaccine injury. In one case adjudicated under the VICP, the US government acknowledged that vaccinations can cause brain damage manifesting as symptoms of autism.
In a 2018 interview, the director of the CDC Immunization Safety Office acknowledged the possibility that vaccines could cause autism in genetically susceptible children but stated that it was “hard to predict who those children might be.”
Legislators do not have the specialized knowledge required to conduct the necessary riskbenefit analysis of the individual. Only the individual, or in the case of a child, the parents, possess that knowledge.
All vaccines carry risks. Compulsory vaccination constitutes a gross violation of the right to informed consent. Governments urgently need to orient health policies towards protecting rather than violating this human right.
“Vaccine Mandates Violate the Right to Informed Consent”
References to the document submitted on August 20, 2020 to the United Nations Human Rights Council (UNHRC) by the Planetary Association for Clean Energy (PACE, inc.). Neil M Ferguson et al., “Impact of non-pharmaceutical interventions (NPIs) to reduce COVID-19 mortality and healthcare demand,” Imperial College London, March 16, 2020, https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-CollegeCOVID19-NPI-modelling-16-03-2020.pdf  Dort R. Reiss and Arthur L. Caplan, “Considerations in Mandating a New Covid-19 Vaccine in the USA for Children and Adults”, Journal of Law and the Biosciences, May 8, 2020, https://doi.org/10.1093/jlb/lsaa025
New York State Bar Association, “Report of the New York State Bar Association’s Health Law Section: Task Force on COVID-19,” May 13, 2020, https://nysba.org/app/uploads/2020/05/HealthLawSectionTaskForceCOVID-19Report_5.13.20.pdf
Spence Neale, “‘Power’ to ‘plunge a needle into your arm’: Dershowitz says forced vaccinations are constitutional”, Washington Examiner, May 19, 2020, https://www.washingtonexaminer.com/news/power-to-plunge-a-needle-into-your-arm-dershowitz-saysforced-vaccinations-are-constitutional
Lawrence O. Gostin and Daniel A. Salmon, “The Dual Epidemics of COVID-19 and Influenza: Vaccine Acceptance, Coverage, and Mandates,” JAMA, June 11, 2020, https://doi.org/10.1001/jama.2020.10802
Dr. Michael Lederman, Maxwell J. Mehlman, and Dr. Stuart Youngner, “Defeat Covid-19 by requiring vaccination for all. It’s not un-American, it’s patriotic,” USA Today, August 6, 2020, https://www.usatoday.com/story/opinion/2020/08/06/stop-coronavirus-compulsory-universal-vaccinationcolumn/3289948001/ UNICEF Maldives, November 14, 2019, https://twitter.com/UNICEFMaldives/status/1194926669502590979
Republic of Maldives, “President signs bills on Child Rights Protection and Juvenile Justice into law,” President’s Office, November 20, 2019, https://presidency.gov.mv/Press/Article/22631 “President ratifies landmark child protection laws,” Maldives Independent, November 21, 2019, https://maldivesindependent.com/society/president-ratifies-landmark-child-protection-laws-149361
Hussain Shameem, January 29, 2020, https://twitter.com/HuShameem/status/1222464632989741058
UN Children’s Fund, “Maldives ratifies Child Rights Protection Act,” Press Release, February 20, 2020, https://www.unicef.org/maldives/press-releases/maldives-ratifies-child-rights-protection-act Peter Aaby et al., “WHO’s rollout of malaria vaccine in Africa: can safety questions be answered after only 24 months?” British Medical Journal, January 24, 2020, https://doi.org/10.1136/bmj.l6920.
Peter Doshi, “WHO’s malaria vaccine study represents a ‘serious breach of international ethical standards,’” British Medical Journal, February 26, 2020, https://doi.org/10.1136/bmj.m734. Søren Wengel Mogensen et al., “The Introduction of Diphtheria-Tetanus-Pertussis and Oral Polio Vaccine Among Young Infants in an Urban African Community: A Natural Experiment,” EBioMedicine, January 31, 2017, https://doi.org/10.1016/j.ebiom.2017.01.041.
Peter Aaby et al., “Evidence of Increase in Mortality After the Introduction of Diphtheria–Tetanus–Pertussis Vaccine to Children Aged 6–35 Months in Guinea-Bissau: A Time for Reflection?” Frontiers in Public Health, March 19, 2018, https://doi.org/10.3389/fpubh.2018.00079.
Peter C. Gøtzsche, “Expert Report: Effect of DTP Vaccines on Mortality in Children in Low-Income Countries”, Vaccine Science Foundation, August 12, 2019, https://vaccinescience.org/expert-report-effect-ofdtp-vaccines-on-mortality-in-children-in-low-income-countries/. Gøtzsche.  Gøtzsche.  World Health Organization, “Contributors,” accessed August 11, 2020, http://open.who.int/2020-21/contributors/overview/vcs.  Tim Schwab, “Bill Gates’s Charity Paradox,” The Nation, March 17, 2020, https://www.thenation.com/article/society/bill-gates-foundation-philanthropy/.  Institute of Medicine, The Childhood Immunization Schedule and Safety (Washington, D.C.: National Academies Press, 2013), p. 6; https://doi.org/10.17226/13563.  Danuta M. Skowronski et al., “Association between the 2008–09 Seasonal Influenza Vaccine and Pandemic H1N1 Illness during Spring–Summer 2009: Four Observational Studies from Canada”, PLoS Medicine, April 6, 2010, https://doi.org/10.1371/journal.pmed.1000258.
Rogier Bodewes et al, “Annual Vaccination against Influenza Virus Hampers Development of Virus-Specific CD8+ T Cell Immunity in Children”, Journal of Virology, November 2011, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3209321/. Skowronski et al.  Jacky Flipse and Jolanda M. Smit, “The Complexity of a Dengue Vaccine: A Review of the Human Antibody Response,” PLOS Neglected Tropical Diseases, June 11, 2015, https://doi.org/10.1371/journal.pntd.0003749.
Seema Yasmin and Madhusree Mukerjee, “How the World’s First Dengue Vaccination Drive Ended in Disaster,” Scientific American, April 2019, https://www.scientificamerican.com/article/how-the-worlds-firstdengue-vaccination-drive-ended-in-disaster/. Pallaval Veera Bramhachari, “Antibody-Dependent Enhancement of Viral Infections,” Dynamics of Immune Activation in Viral Diseases, November 5, 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7119964/.  Nikolai Eroshenko et al., “Implications of antibody-dependent enhancement of infection for SARSCoV-2 countermeasures,” Nature Biotechnology, June 45, 2020, https://doi.org/10.1038/s41587-020-0577-1.
Ann M. Arvin et al., “A perspective on potential antibody-dependent enhancement of SARS-CoV-2,” Nature, July 13, 2020, https://doi.org/10.1038/s41586-020-2538-8. Peter Aaby et al., “Low mortality after mild measles infection compared to uninfected children in rural west Africa,” Vaccine, November 22, 2002, https://doi.org/10.1016/S0264-410X(02)00430-9.
Søren Wengel Mogensen et al., “Introduction of standard measles vaccination in an urban African community in 1979 and overall child survival: a reanalysis of data from a cohort study,” British Medical Journal Open, December 20, 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5223649/.
Christine Stabell Benn, “How to evaluate potential non-specific effects of vaccines: the quest for randomized trials or time for triangulation?” Expert Review of Vaccines, May 10, 2018, https://doi.org/10.1080/14760584.2018.1471987. “Harnessing The Measles Virus To Attack Cancer”, Science Daily, October 31, 2006, https://www.sciencedaily.com/releases/2006/10/061030143318.htm.
Rønne T, “Measles virus infection without rash in childhood is related to disease in adult life”, Lancet, January 5, 1985, https://doi.org/10.1016/S0140-6736(85)90961-4.
Annie J. Sasco and Ralph S. Paffenbarger, Jr., “Measles Infection and Parkinson’s Disease”, American Journal of Epidemiology, December 1, 1985, https://doi.org/10.1093/oxfordjournals.aje.a114183.
Stefano Parodi, et al., “Childhood infectious diseases and risk of leukaemia in an adult population”, International Journal of Cancer, October 15, 2013, https://www.ncbi.nlm.nih.gov/pubmed/23575988.
S. O. Shaheen et al., “Measles and atopy in Guinea-Bissau”, Lancet, June 29, 1996, https://doi.org/10.5555/uri:pii:S0140673696916177.
Helen Rosenlund et al., “Allergic Disease and Atopic Sensitization in Children in Relation to Measles Vaccination and Measles Infection”, Pediatrics, March 2009, https://doi.org/10.1542/peds.2008-0013.
Maurizio Montella et al., “Do childhood diseases affect NHL and HL risk? A case-control study from northern and southern Italy”, Leukemia Research, August 2006, https://doi.org/10.1016/j.leukres.2005.11.020.
Yasuhiko Kubota, Hiroyasu Iso, and Akiko Tamakoshi, “Association of measles and mumps with cardiovascular disease: The Japan Collaborative Cohort (JACC) study”, Atherosclerosis, August 2015, https://doi.org/10.1016/j.atherosclerosis.2015.06.026. F D Groves et al., “Haemophilus influenzae type b serology in childhood leukaemia: A case–control study,” British Journal of Cancer, July 31, 2001, https://doi.org/10.1054/bjoc.2001.1903.  Centers for Disease Control and Prevention, “Meeting of the Board of Scientific Counselors, Office of Infectious Diseases”, December 11-12, 2013, https://www.cdc.gov/maso/facm/pdfs/BSCOID/2013121112_BSCOID_Minutes.pdf.
Stacey W. Martin et al., “Pertactin-Negative Bordetella pertussis Strains: Evidence for a Possible Selective Advantage”, Clinical Infectious Diseases, January 15, 2015, https://doi.org/10.1093/cid/ciu788.
Lucy Breakwell, et al., “Pertussis Vaccine Effectiveness in the Setting of Pertactin-Deficient Pertussis”, Pediatrics, May 2016, https://doi.org/10.1542/peds.2015-3973. G.S. Goldman and P.G. King, “Review of the United States universal varicella vaccination program: Herpes zoster incidence rates, cost-effectiveness, and vaccine efficacy based primarily on the Antelope Valley Varicella Active Surveillance Project data,” Vaccine, March 25, 2013, https://dx.doi.org/10.1016%2Fj.vaccine.2012.05.050.  United States Government, 1986 National Childhood Vaccine Injury Act (Public Law 99-660), November 14, 1986, https://www.ncbi.nlm.nih.gov/books/NBK220067/.
Supreme Court of the United States, Brueswitz et al. v. Wyeth LLC, FKA Wyeth, Inc., et al., February 22, 2011, https://www.supremecourt.gov/opinions/10pdf/09-152.pdf. CNN, House Call With Dr. Sanjay Gupta, March 29, 2008, http://transcripts.cnn.com/TRANSCRIPTS/0803/29/hcsg.01.html
David Kirby, “The Vaccine-Autism Court Document Every American Should Read”, Huffington Post, February 26, 2008. In the case of Hannah Poling, the government conceded that multiple vaccinations simultaneously administered “significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder.” Sharyl Attkisson, “CDC: ‘Possibility’ that vaccines rarely trigger autism”, December 10, 2018, SharylAttkisson.com, https://sharylattkisson.com/2018/12/10/cdc-possibility-that-vaccines-rarely-triggerautism/.