Memo to HHS et al:Personal Exemptions are an Essential Safety Valve on Whole-Population Vaccination Programs

MEMO

Date: 10/24/2019

TO: Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services (HHS).

FROM: Dr. James Lyons-Weiler, PhD

RE: Request for Information (RFI) From Non-Federal Stakeholders: Developing the 2020 National Vaccine Plan

Non-experts in vaccine science such as policy makers and lawmakers have no frame of reference for skepticism of the claims of wholesale and universal safety of vaccines.  To non-expert who have not read vaccine safety studies, and who do not have knowledge of important principles and proper practices of clinical trial study, claims of universal vaccine safety and the robustness and reliability of vaccine safety science appear reassuring.  The thinking is that universal vaccination will lead to “herd immunity”, and thus individuals “should” vaccinate for the “greater good”.

However, a few cogent facts, such as the existence of a National Injury Compensation Program, the existence of a limited Table of Vaccine Injuries (published by HHS), the fact that the National Vaccine Injury Compensation Program has paid out over US $4Billion in settlements and awards to families who have members who have experienced on-table and off-table vaccine injury. 

A moment’s reflection on these facts, however, should cause such individuals to pause and realize the following:

•  Any paradigm of 100% forced vaccination will reveal, by injury, maiming or death everyone in the population who is susceptible.
• Science has not defined any way (yet) to identify, contra the 1986 National Childhood Vaccine Injury Act, the individuals in the population who are most susceptible.
• Susceptibility to vaccine injury and death almost certainly has a genetic risk that is not universally shared across the population.
• By placing some potentially identifiable individuals at risk, universal forced vaccination is discriminatory and therefore places some families at increased risk of carrying all of the burden of morbidity and mortality
• Under the 14th Amendment, this potentially identifiable, albeit heterogeneous population, is entitled to Equal Protection from harm from vaccines.
• Families learn, via direct, personal empirical observation and experience, ahead of the ability of science, that they are at increased risk compared to the general population
• Non-medical exemptions, put in place by past generations, provide citizens who have already tried to participate in the whole-population vaccination program to opt out without carrying an undue burden of vaccine injury and harm.
• Vaccination programs without non-medical exemptions are cruel and inhumane to an identifiable subset of individuals and families who should not vaccinate..
• Vaccine injury and death denialism based on the absence of studies that have yet to be conducted is cruel.

The above points alone are sufficient to warrant the continuance of universal personal exemptions to vaccine mandates (aka “philosophical exemptions”).

The counterarguments to this position are falsifiable, and include

• CLAIM: Vaccine studies have been conducted that should have detected the adverse events claimed by citizens who no longer want to vaccinate.

REALITY: Most vaccine safety studies that could have detected serious adverse events now being claimed by tens of thousands or in some cases hundreds of thousands have been too brief, too small, correct for outcome variables related to likely vaccine adverse events, or exclude individual likely at high risk of serious vaccine adverse events.  Unlike trials for drugs, clinical trials of vaccines have short outcome follow-up periods.  We rely on post-market “surveillance” studies that employ passively collected vaccine adverse events, which capture less than 1% of vaccine injuries[1].  This means that although they are required by law to do so, most doctors fail to report ill health following vaccination to the Vaccine Adverse Events Reporting System (VAERS).  The requirement to report any ill health following vaccination exists whether the physician thinks the ill health is due to the vaccination or note, but there is no penalty to physicians who refuse to submit reports to VAERS. Post-market surveillance studies of VAERS data therefore cannot find new, real vaccine adverse events that doctors think are attributable to vaccines. Further, by most short-term randomized clinical trials on vaccine safety have been conducted without a proper inert placebo. Remarkable, nearly all have been conducted comparing the safety to other vaccines or to active vaccine ingredients such as various forms of aluminum, an adjuvant designed to activate the immune system Fig 1; [2].

Figure 1. Comprehensive literature analysis and review of vaccine safety studies by ICAN (Informed Consent Action Network) published in 2018[2] reveals the absence of studies that use inert placebo in a control group to study vaccine safety.

The absence of appropriate control for potential harm to health from aluminum adjuvants puts the US vaccination program in a state at risk of being rejected by the public as poor science.  The reliance of observational studies for long-term health outcomes and the lack of studies focused on the effects of receipt of multiple vaccines at once also places the vaccination program at risk of rejection by an increasingly vaccine-risk aware public.

CLAIM: Vaccines are such a boon to public health that individuals are not entitled to a choice or to informed consent.

REALITY: Current vaccines – and post-market surveillance studies – are not exempt from Federal rules and laws protecting the individual’s right to informed consent.  Nothing in the Code of Federal Regulations, for example, distinguishing individuals’ rights to decline to participate in vaccine safety studies, including whole-population human subject post-market surveillance studies.  Vaccination programs without personal exemption violate provisions of the National Research Act [Title II, Public Law 93-348], Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research [45 CFR 46] and revisions of various regulations, rules, and laws ([21 CFR 50, [21 CFR 56], [45 CFR 46 Subpart D], [10 CFR 745]. Pregnant women and fetuses are afforded special protections by [45 CFR 46 Subpart B], and children are afforded additional protections by [45 CFR 46 Subpart D]. Currently, rights of pregnant women and fetuses are violated with each and every vaccine administered to them because not only is there a paucity of pre-licensing clinical trials, no vaccine has been licensed for use to protect fetuses, and pregnant women are not told any of this as they are pressured to get vaccinated. Of note, in the Common Federal Policy for the Protection of Human Subjects (“Common Rule”) [10 CFR 745] Sec 745.103(b)(3), none of these rights were revoked by any subsequent legislation, including [21 CFR 50.24], which allows the relaxation of requirements for informed consent during emergencies. In fact, the Common Rule re-asserted safeguards both for informed consent, and for special protections against coercion:

I cite here section §46.116, “General requirements for informed consent”:

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

“When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.”

Any whole-population vaccination program that does not include personal exemptions subjects the entire population to coercion, thus violating the US Code of Federal Regulations.  Personal exemptions allow individuals to react to adverse events they experience while participating in post-market surveillance studies, and such decisions should be respected.  The rights of any individual to opt-out of human subjects experimentation should be preserved.

The question of the value of entire vaccination on public health has two problems at this time (10/2019) based on two points.  First, some studies show significant population health reduction from vaccination (e.g., 3-6). Current vaccines are aging, and many appear to be no longer effective at preventing transmission of the wild-type pathogens they were designed to protect against.  These include influenza vaccines (annually announced in the press as inexact), pertussis vaccines [7,8], and the MMR for mumps[9], rubella[10] and possibly measles [11].  Outbreaks of pertussis and mumps in completely vaccinated populations are now commonplace, and individuals up to date on measles vaccination now develop measles after exposure to other vaccinated or unvaccinated who are infected. For influenza and measles, vaccinated individuals tend to have milder symptoms, but can carry the pathogens into schools and other public places. For mumps, rubella and chickenpox, break-through infections in vaccinated persons can be more serious, Instead of acknowledging the role of asymptomatic transmission, now routinely reported in numerous studies and discussed openly in the vaccine science literature [7], public health policy and the whole-population vaccination agenda blames the 1-2% who are not vaccinated.  This is different from individuals “shedding” vaccine-type live organisms, it is now also known that a large percentage of individuals who were diagnosed with measles in the 2014 Disneyland outbreak had breakthrough viremia and symptoms of measles from the vaccine type. It is now impossible to blame unvaccinated individuals on outbreaks, which will continue even if the US achieves 100% vaccination coverage in all children for all vaccines on the CDC schedule.  No form of herd immunity can exist when the vaccine in question masks the infection. The vaccinated asymptomatic carriers of infectious agents can carry infections into schools and into other public places just as well, but for longer periods of time, because, unlike the unvaccinated, they have no symptoms.  It is even reasonable to assert that the unvaccinated serve an important public health service by alerting schools of the presence of an active transmission chain of viruses and bacteria that can threaten the lives of the immunocompromised.

Given these realities, the claim that vaccines are such a boon to public health that individuals are not entitled to a choice or to informed consent is clearly falsified.

Clearly, those pushing for universal vaccination with current vaccines are hoping to continue their contracts by masking symptoms of illness from circulating wild-type pathogens that their vaccines no longer effectively target.  A case in point in the case in a PA court in which two whistleblowers report that their supervisors at Merck told them to spike human samples with rabbit-derived anti-mumps virus antibodies to defraud the FDA and the US public to continue Merck’s contract for the MMR vaccine. The systematic fraud is not sustainable, and removal of personal exemptions will not prevent the obvious failure of many of the current vaccines.

In the meantime, US citizens are asserting their rights under the US CFR and will continue to do so; no parent who has witnessed serious adverse events in their child or children will continue to vaccinate no matter what laws are passed to coerce them.  Personal exemptions are a safety valve not only the vaccination program – they are the way our society enacts the ethos embodied by our own national, and international laws protecting human beings from harm from human experimentation.  Loss of personal exemption options may appear to be a trivial change to the majority of Americans, but for some, it means certain death and destruction of their lives.

For these reasons and realities, it would be both immoral and unethical to remove or deny personal exemptions to vaccination.

Respectfully,

Dr. James Lyons-Weiler, PhD

2912 Kilcairn Lane

Allison Park, PA 15101

[1] https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

[2]ICAN. 2018. Letter to US Department of Health & Human Services re:HHS Vaccine Safety Responsibilities and Notice Pursuant to 42 U.S.C. § 300aa-31. https://www.icandecide.org/wp-content/uploads/2019/08/ICAN-Reply-1.pdf

[3]  Aaby, Peter.  2019. “This Vaccine (DPT) is Killing Children”  Symposium on Scientific Freedom, Copenhagen 9 Mar 2019. https://www.youtube.com/watch?v=udbUKD28K28

[4] Mogensen SW, Andersen A, Rodrigues A, Benn CS, Aaby P.

The Introduction of Diphtheria-Tetanus-Pertussis and Oral Polio Vaccine Among

Young Infants in an Urban African Community: A Natural Experiment.

EBioMedicine. 2017 Mar;17:192-198. doi: 10.1016/j.ebiom.2017.01.041.

[5]Bodewes et al., 2011. Annual Vaccination against Influenza Virus Hampers Development of Virus-Specific CD8+ T Cell Immunity in Children J Virol 85:11995-12000.

[6] Cowling, BJ et al., 2012. Increased risk of noninfluenza respiratory virus infections associated with receipt of inactivated influenza vaccine. Clin Infect Dis. 54(12):1778-83. doi: 10.1093/cid/cis307.

[7] Cherry, JD. 2015. Epidemic Pertussis and Acellular Pertussis Vaccine Failure in the 21st Century Pediatrics 135(6):1130-1132. https://pediatrics.aappublications.org/content/135/6/1130

[8] Althouse, BM, SV Scapino. 2015. Asymptomatic transmission and the resurgence of Bordetella pertussis. BMC Med 13:146. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482312/

[9] Atrasheuskaya AV, Neverov AA, Rubin S, Ignatyev GM 2006.Horizontal transmission of the Leningrad-3 live attenuated mumps vaccine virus. Vaccine. 24(10):1530-6.

[10] https://www.ncbi.nlm.nih.gov/books/NBK8200/

[11] Muller, CP. 2001. Measles elimination: old and new challenges? Vaccine 19:17-19. https://www.sciencedirect.com/science/article/pii/S0264410X00004552