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



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,

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

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”.

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. 

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
  • 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
  • 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.

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

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].

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

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

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

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.


Dr. James Lyons-Weiler, PhD

2912 Kilcairn Lane

Allison Park, PA 15101


[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.

[3]  Aaby,
Peter.  2019. “This Vaccine (DPT) is
Killing Children”  Symposium on
Scientific Freedom, Copenhagen 9 Mar 2019.

[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

EBioMedicine. 2017 Mar;17:192-198. doi:

[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:

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

[8] Althouse, BM, SV Scapino. 2015. Asymptomatic
transmission and the resurgence of Bordetella pertussis. BMC Med 13:146.

[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.


[11] Muller, CP. 2001. Measles elimination: old and
new challenges? Vaccine 19:17-19.

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