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Vaccine White Paper 2017
Vaccine White Paper 2017
Unlike nearly every other company in explained by the Institute of Medicine (IOM)1,
America, pharmaceutical companies have by 1986, the litigation costs associated with
almost no liability for injuries caused by their claims of damage from vaccines had forced
vaccine products. How did this happen? As several companies to end their vaccine
1In 2016, the IOM formally changed its name to the National
Academies of Sciences, Engineering, and Medicine.
1
Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
research and development programs as well released and marketed to the public.
as to stop producing already licensed Manufacturers ... will often have little or
vaccines.2 Instead of letting market forces no incentive to improve the designs of
compel vaccine makers to create safer vaccines that are already generating
vaccines, Congress granted pharmaceutical significant profit margins.7
companies financial immunity from injuries
caused by vaccines recommended by the Recognizing that the 1986 Act
CDC.3 Congress did so by passing the eliminated the incentive for vaccine makers to
National Childhood Vaccine Injury Act (the assure the safety of their vaccine products, the
1986 Act).4 1986 Act explicitly places this responsibility in
the hands of the United States Department of
By granting immunity from actual or Health & Human Services (HHS).8
potential liability from injuries caused by
vaccines, Congress eliminated the market As provided in the 1986 Act, HHS is
forces that are generally relied upon to assure responsible for research ... to prevent adverse
the safety of all other products. As the 1986 reactions to vaccines, develop[ing] the
Act expressly provides: No person may bring techniques needed to produce safe ...
a civil action against a vaccine vaccines, safety ... testing of vaccines,
administrator or manufacturer in a State or monitoring ... adverse effects of vaccines,
Federal court for damages arising from a and shall make or assure improvements in ...
vaccine-related injury or death.5 the licensing, manufacturing, processing,
testing, labeling, warning, use instructions,
The 1986 Act even shields vaccine distribution, storage, administration, field
makers from liability where it is clear and surveillance, adverse reaction reporting, ...
unmistakable that the vaccine in question and research on vaccines in order to reduce
could have been designed safer.6 As recently the risks of adverse reactions to vaccines.9
explained in a U.S. Supreme Court opinion:
Since passage of the 1986 Act, the
[N]o oneneither the FDA nor any other number of required pediatric vaccines has
federal agency, nor state and federal grown rapidly. In 1983, the CDCs childhood
juriesensures that vaccine vaccine schedule included 11 injections of 4
manufacturers adequately take account of vaccines.10 As of 2017, the CDCs childhood
scientific and technological advancements. vaccine schedule includes 56 injections of 30
This concern is especially acute with different vaccines.11
respect to vaccines that have already been
2 https://www.nap.edu/read/2138/chapter/2#2 9 Ibid.
3 42 U.S.C. 300aa-1 et seq. 10 https://www.cdc.gov/vaccines/schedules/images/schedule
4 Ibid. 1983s.jpg
5 42 U.S.C. 300aa-11 11 https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adol
6 Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) escent.html (note that the influenza vaccine is different every
7 Ibid. year)
8 42 U.S.C. 300aa-2; 42 U.S.C. 300aa-27
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Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
CDC Childhood Immunization Schedule12 liability for vaccine injuries. And due to a
federal funding scheme, CDC recommended
1986 2017
DTP (2 months) Influenza (pregnancy) Influenza (18 months) vaccines are then made compulsory to
Polio (2 months) TDaP (pregnancy) Influenza (2 years)
DTP (4 months)
Polio (4 months)
Hepatitis B (one day)
Hepatitis B (one month)
Influenza (3 years)
Influenza (4 years)
American children under state laws and
DTP (6 months)
MMR (15 months)
DTaP (2 months)
Polio (2 months)
DTaP (4 years)
Polio (4 years)
subsidized by the Federal government for
DTP (18 months)
Polio (18 months)
Hib (2 months)
PCV (2 months)
MMR (4 years)
Varicella (4 years) children unable to afford the vaccine.13
DTP (4 years) Rotavirus (2 months) Influenza (5 years)
Polio (4 years) DTaP (4 months) Influenza (6 years)
Tetanus (14 years) Polio (4 months) Influenza (7 years)
Hib (4 months) Influenza (8 years) The end result is that under the 1986
PCV (4 months) Influenza (9 years)
Rotavirus (4 months)
DTaP (6 months)
Influenza (10 years)
HPV (11 years)
Act, every pediatric vaccine recommended by
Polio (6 months)
Hepatitis B (6 months)
Men (11 years)
TDaP (11 years)
the CDC creates for its manufacturer a
Hib (6 months)
PCV (6 months)
Influenza (11 years)
HPV (11 years)
liability-free captive market of 78 million
Rotavirus (6 months) Influenza (12 years)
Influenza (6 months) HPV (12 years) children with guaranteed payment. This
MMR (12 months) Influenza (13 years)
Varicella (12 months) Influenza (14 years) incentive structure is unequal in the
Hib (12 months) Influenza (15 years)
Hepatitis A (12 months)
PCV (12 months)
Men (16 years)
Influenza (16 years)
marketplace and eliminates the normal
DTaP (15 months)
Hepatitis A (18 months)
Influenza (17 years)
Influenza (18 years)
market forces driving product safety.
Hence the 1986 Act transferred
essentially all responsibility for vaccine
It is only when the CDC adds a vaccine safety from the pharmaceutical companies
to its recommended vaccine schedule that the to HHS.
manufacturer is granted immunity from
HHS, through the FDA, licenses all controls received a saline injection.14 Lipitors
vaccines used by the American public. pre-licensure trials lasted a median of 4.8
years and controls received a sugar pill.15
All non-vaccine drugs licensed by the Botoxs pre-licensure trials lasted a median of
FDA undergo long-term multi-year double- 51 weeks and controls received a saline
blind safety studies during which the rate of injection.16 And even with these long-term
adverse reactions in the group receiving the studies, drugs are still often recalled.
drug under review is compared to the rate of
adverse reactions in a group receiving an inert While most drugs, like the ones above,
placebo, such as a sugar pill or saline injection. are given to sick adults, pediatric vaccines are
typically given universally to babies and
For example: Enbrels pre-licensure toddlers. And while pharmaceutical comp-
trials followed subjects up to 80 months and anies remain liable for injuries caused by their
http://www.phrma.org/press-release/medicines-in-developme 020702s056lbl.pdf
nt-vaccines (listing 2,300 trials in search for vaccines between 16 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/
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Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
non-vaccine drugs, as discussed above, they reaction in the limited four or five day safety
have no liability for injuries caused by their review period was even caused by the
vaccines. One would therefore expect that Hepatitis B vaccine being evaluated.
pre-licensure safety testing for vaccines would
be more rigorous than that conducted for Similarly, the HiB vaccines man-
drugs. ufactured by Merck and GlaxoSmithKline
were licensed by the FDA based on trials in
Unfortunately, unlike all non-vaccine which adverse reactions were monitored for
drugs licensed by the FDA, vaccines are not only three days and four days, respectively,
required to undergo long-term double-blind after vaccination.19 The only stand-alone polio
inert-placebo controlled trials to assess safety. vaccine in the United States was licensed after
In fact, not a single one of the clinical trials for a mere 48-hour follow-up period.20
vaccines given to babies and toddlers had a
control group receiving an inert placebo. Even more amazing is that unlike
Further, most pediatric vaccines currently on every drug licensed by the FDA, the control
the market have been approved based on groups in these vaccine trials did not receive
studies with inadequate follow-up periods of an inert placebo.21 Rather, the control group
only a few days or weeks. was given one or more previously licensed
vaccines as the placebo.22 This means each
For example, there are two Hepatitis B new vaccine need only be roughly as safe as
vaccines licensed for one day old babies in the one (or in some cases numerous) previously
United States one manufactured by Merck licensed vaccines. Such flawed and un-
and the other by GlaxoSmithKline. Mercks scientific study designs cannot establish the
Hepatitis B vaccine was licensed by the FDA actual safety profile of any vaccine. The real
after trials which solicited adverse reactions adverse event rate for a vaccine can only be
for only five days after vaccination.17 Similarly, determined by comparing subjects receiving
GlaxoSmithKlines Hepatitis B vaccine was the vaccine with those receiving an inert
licensed by the FDA after trials which solicited placebo. Yet, this study design, required for
adverse reactions for only four days after every drug, is never required before or after
vaccination.18 licensing a vaccine.
17 https://www.fda.gov/downloads/BiologicsBloodVaccines/ https://www.fda.gov/downloads/BiologicsBloodVaccines/
Vaccines/ApprovedProducts/UCM110114.pdf Vaccines/ApprovedProducts/UCM179530.pdf
18 https://www.fda.gov/downloads/BiologicsBloodVaccines/ 20 https://www.fda.gov/downloads/BiologicsBloodVaccines/
Vaccines/ApprovedProducts/UCM224503.pdf Vaccines/ApprovedProducts/UCM133479.pdf
19 https://www.fda.gov/downloads/BiologicsBloodVaccines/ 21 Ibid. (prior two footnotes)
Vaccines/ApprovedProducts/UCM253652.pdf; 22 Ibid.
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Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
IOM, explains: Because [vaccine] trials are conclusions about vaccine safety derived from
primarily for determination of efficacy, these trials are limited.23
HHS also fails to conduct proper post- In 2016, VAERS received 59,117
licensure monitoring and studies of vaccine reports of adverse reactions following
safety. vaccination including 432 deaths, 1,091
permanent disabilities, 4,132 hospitalizations,
1. CDC Blocks Automation of Vaccine and 10,284 emergency room visits.28
Adverse Events Reporting
A problem with VAERS is that it is a
passive reporting system, relying on
The paucity of pre-licensure safety voluntary, rather than mandatory, reporting.29
reviews for vaccines (see discussion above) As such, numerous reviews of VAERS have
leaves the assessment of adverse reactions to found that only a tiny fraction of vaccine
the post-licensing period when they are being adverse events are reported. For example, an
administered to children in the real world. HHS-funded review of vaccine adverse events
over a three-year period by Harvard Medical
In order to capture adverse events that School involving 715,000 patients found that
may arise from vaccination in the real fewer than 1% of vaccine adverse events are
world, the 1986 Act established the Vaccine reported.30 A U.S. House Report similarly
Adverse Events Reporting System (VAERS) stated: Former FDA Commissioner David A.
operated by HHS and co-sponsored by the Kessler has estimated that VAERS reports
CDC and FDA.24 VAERS is a passive, not currently represent only a fraction of the
mandatory, reporting system.25 Anyone, serious adverse events.31
including health care providers, on a
voluntary basis, may report adverse vaccine Assuming VAERS captures 1 percent
reactions to VAERS.26 HHS compiles these of adverse events (which is more than is
adverse reaction reports in VAERS and the estimated), then the number of adverse events
CDC uses VAERS as a safety signal detection reported to VAERS in 2016 would reflect for
and hypothesis generating system to identify that year 5,911,700 adverse events, 43,200
potential injuries caused by vaccines. 27 deaths, 109,100 permanent disabilities, 413,200
hospitalizations, and 1,028,400 emergency
23 https://www.nap.edu/read/13563/chapter/4 29 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/
24 https://wonder.cdc.gov/vaers.html 30 https://healthit.ahrq.gov/sites/default/files/docs/publication/
25 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/ r18hs017045-lazarus-final-report-2011.pdf
26 Ibid. 31 https://www.congress.gov/106/crpt/hrpt977/CRPT-106hrpt
27 Ibid. 977.pdf
28 https://wonder.cdc.gov/vaers.html
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Preliminary data were collected from June While HHS generally strongly
2006 through October 2009 on 715,000 supports automating public health
patients, and 1.4 million doses (of 45 surveillance systems, when it comes to vaccine
different vaccines) were given to 376,452 safety, the CDC has only supported projects
individuals. Of these doses, 35,570 that would limit VAERS to passive
possible reactions ... were identified.34 surveillance.36 Automation would improve
safety and address many of the long-standing
These results should have been issues and limitations raised by CDC
startling to HHS since they show that over regarding VAERS.37
only a three-year period, there were 35,570
reportable reactions in just 376,452 vaccine Capturing fewer than 1% of vaccine
recipients. Given HHSs statutory mandate to adverse events thirty years after the passage
assure safer vaccines, it should have rushed of the 1986 Act is unacceptable and
forward with automating VAERS reporting. potentially deadly.
However, this is not what happened.
32 https://healthit.ahrq.gov/ahrq-funded-projects/electronic- 35 Ibid.
support-public-health-vaccine-adverse-event-reporting-system 36 http://www.ajpmonline.org/article/S0749-3797(12)00249-
33 https://healthit.ahrq.gov/sites/default/files/docs/publication/ 8/pdf; https://www.ncbi.nlm.nih.gov/pubmed/26209838;
r18hs017045-lazarus-final-report-2011.pdf https://www. ncbi.nlm.nih.gov/pmc/articles/PMC4632204/
34 Ibid. 37 Ibid.
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38 http://www.national-academies.org/about/whoweare/ 43 https://www.nap.edu/read/1815/chapter/2#8
index.html 44 https://www.nap.edu/read/1815/chapter/9
39 Ibid. 45 Ibid.
40 https://www.nap.edu/read/1815/chapter/2#7 46 Ibid.
41 Ibid. 47 https://www.nap.edu/read/2138/chapter/1
42 Ibid.
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Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
commonly reported serious injuries and As in 1991, this IOM Report from 1994
vaccination for diphtheria, tetanus, measles, again stated: The lack of adequate data
mumps, polio, hepatitis B, and Hib.48 regarding many of the adverse events under
study was of major concern to the committee.
For this Report, the IOM located Presentations at public meeting indicated that
sufficient science to support a causal many parents and physicians share this
connection between these vaccines and 12 concern.54
injuries, including death, anaphylaxis,
thrombocytopenia, and Guillain-Barre Another acute concern raised by the
syndrome. 49 IOM in 1994 was the potential risks posed by
combining vaccines. The IOM noted that this
Again, as with the IOM Report from subject simply had not been studied: The
1991, for the majority of vaccine-adverse committee was able to identify little
event pairs the evidence was considered information pertaining to the risk of serious
inadequate to accept or reject causality.50 The adverse events following administration of
problem that basic scientific studies had not multiple vaccines simultaneously. This is an
been done continued to persist. The IOM issue of increasing concern as more vaccines
could not determine whether there was a and vaccine combinations are developed for
causal connection between vaccination and 38 routine use.55
of the most common serious injuries parents
reported their children experienced following In 2011, HHS paid the IOM to conduct
these vaccines, including: another assessment regarding vaccine safety.56
This Report, entitled Adverse Effects of Vaccines:
Demyelinating diseases of the central Evidence and Causality, was the culmination of
nervous system, Sterility, Arthritis, the largest review by the IOM regarding
Neuropathy, Residual seizure disorder, vaccine safety since the IOMs reports from
Transverse myelitis, Sensorineural 1991 and 1994.57
deafness, Optic neuritis, Aseptic
meningitis, Insulin-dependent diabetes This third IOM Report reviewed the
mellitus, SIDS51 158 most common vaccine injuries claimed to
have occurred from vaccination for varicella,
This means that of the 54 vaccine-injury pairs hepatitis B, tetanus, measles, mumps, and/or
studied, there was sufficient science to find a rubella.58 The IOM located science which
causal relationship of harm for 12, and to reject convincingly supports a causal relationship
a relationship for 4.52 But for the remaining 38, for 14 of these serious injuries, including
there was insufficient science to reach any pneumonia, meningitis, hepatitis, MIBE
conclusion.53 (deadly brain inflammation a year after
vaccination), febrile seizures, and
48 https://www.nap.edu/read/2138/chapter/2#12 54 https://www.nap.edu/read/2138/chapter/12
49 https://www.nap.edu/read/2138/chapter/2#12 55 https://www.nap.edu/read/2138/chapter/12#307
50 https://www.nap.edu/read/2138/chapter/1#vi 56 https://www.nap.edu/read/13164/chapter/2#2
51 https://www.nap.edu/read/2138/chapter/2#12 57 Ibid.
52 Ibid. 58 Ibid.
53 Ibid.
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Informed Consent Action Network
Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
that the science simply had not been have a preexisting susceptibility. These
performed.63 predispositions can exist for a number of
reasonsgenetic variants (in human or
3. CDC Ignores IOMs Calls to Identify microbiome DNA), environmental
Children Susceptible to Vaccine Injury exposures, behaviors, intervening illness, or
developmental stage, to name just a few
all of which can interact as suggested
Compounding the lack of adequate graphically in Figure 3-1.
science to simply ascertain whether the most
commonly reported serious adverse reactions Some of these adverse reactions are specific
following vaccination are caused by vaccines, to the particular vaccine, while others may
the IOM Reports discussed above have not be. Some of these predispositions may
consistently acknowledged there is individual be detectable prior to the administration of
susceptibility to serious vaccine injuries. vaccine. [M]uch work remains to be
done to elucidate and to develop strategies
The IOM has also acknowledged that to document the immunologic mechanisms
research on such susceptibility must be done that lead to adverse effects in individual
on an individual basis, considering a childs patients.
personal genome, behaviors, microbiome,
intercurrent illness, and present and past
environmental exposure.64 Unfortunately,
HHS has not conducted this research.
63 Ibid. 66 Ibid.
64 https://www.nap.edu/read/13164/chapter/5#82 67 https://www.nap.edu/read/13164/chapter/5#82
65 https://www.nap.edu/read/2138/chapter/12#307. See also 68 https://www.nap.edu/read/13563/chapter/1
https://www.nap.edu/read/1815/chapter/9
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Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
found that evidence assessing outcomes in vaccine makers have accumulated hundreds
sub populations of children who may be of billions in vaccine revenue.72 Yet, during
potentially susceptible to adverse reactions this time, no material funds have been
to vaccines (such as children with a family allocated to identify susceptible
history of autoimmune disease or allergies subpopulations, let alone what injuries are
or children born prematurely) was limited caused by vaccines.73
and is characterized by uncertainty about
the definition of populations of interest and 4. CDC Views Vaccine Safety as a Public
definitions of exposures and outcomes.69 Relations Issue
The IOM correctly points out in 2011 Indeed, as part of the IOMs 2011
that given the widespread use of vaccines review of vaccine safety, it was asked by HHS
and state mandates requiring vaccination of whether there is a causal relationship between
children it is essential that safety concerns autism and the DTaP vaccine administered to
receive assiduous attention.71 This is the children at two, four, six, and fifteen months
same call for diligent attention that the IOM of age.75 The IOM could not locate a single
made in 1991 and 1994. Unfortunately, all of study supporting that DTaP does not cause
these calls for action have gone unheeded. autism.76 The IOM therefore concluded: The
The critical scientific inquiry to identify evidence is inadequate to accept or reject a
individuals susceptible to serious vaccine causal relationship between diphtheria
injury has simply never commenced. toxoid, tetanus toxoid, or acellular
pertussiscontaining vaccine and autism.77
Since the IOMs first call for this The IOMs full explanation for this finding is
science in 1991, HHS has spent tens of billions as follows:
promoting and purchasing vaccines, and
e538-11e5-a09b-1f8b0d268c39 76 https://www.nap.edu/read/13164/chapter/12#545
73 For example, while in 2016 vaccine makers reported over $33 77 Ibid.
billion from vaccine sales and the CDC reported spending over
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78Ibid. 80 https://www.cdc.gov/vaccines/schedules/hcp/imz/child-
79 Ibid. Ironically, this study was disregarded "because it adolescent. html
provided data from a passive surveillance system [VAERS] and 81 https://www.cdc.gov/vaccinesafety/concerns/autism.html
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Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
CDCs overarching declaration that Vaccines have been part of the problem the CDC
Do Not Cause Autism. is so paralyzed right now by anything
related to autism. Theyre not doing what
As for the MMR vaccine, the CDCs they should be doing because theyre afraid
senior scientist for its seminal MMR-autism to look for things that might be associated.
study has recently revealed that the CDC So anyway theres still a lot of shame with
concealed an association between MMR and that. I am completely ashamed of what I
autism. Dr. William Thompson has been a did.87
scientist at CDC for nearly two decades and is
the CDCs Senior Scientist on dozens of the Dr. Thompson also provided the
CDCs peer-reviewed publications, including following statement explaining the CDCs
the core group of the CDCs vaccine-autism concealment of the autism-MMR association
safety studies.82 with regard to African-American males:
82 https://www.ncbi.nlm.nih.gov/pubmed/?term=Thompson+ 84 https://soundcloud.com/fomotion/cdc-whistle-blower-full-
WW%5BAuthor%5D audio
83 http://www.rescuepost.com/files/william-thompson- 85 Ibid.
statement-27-august-2014-3.pdf 86 Ibid.
87 Ibid.
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Vaccine Safety: Introduction to Vaccine Safety Science & Policy in the United States
because I assumed it was illegal and would mean that vaccines are not good. What a
violate both FOIA and DOJ requests, I susceptible group will tell us is that maybe
kept hardcopies of all documents in my there is a group of individuals, or a group
office, and I retain all associated computer of children, that shouldn't have a
files. I believe we intentionally withheld particular vaccine or shouldn't have
controversial findings from the final draft vaccine on the same schedule.
of the Pediatrics paper.88
I think the government, or certain
Hence, for the only vaccine (MMR) actually health officials in the government, are -
studied by the CDC with regard to autism, it have been too quick to dismiss the concerns
appears the CDC concealed an association of these families without studying the
between that vaccine and autism. population that got sick. I haven't seen
major studies that focus on - three hundred
When the former Director of the kids, who got autistic symptoms within a
National Institutes of Health, Dr. Bernadine period of a few weeks of a vaccine.
Healy, was asked about whether public health
authorities are correct to claim that vaccines I think that the public health
do not cause autism, she answered: You cant officials have been too quick to dismiss the
say that.89 When asked again, Dr. Healy hypothesis as irrational, without sufficient
explained: The more you delve into it if you studies of causation. I think that they often
look at the basic science if you look at the have been too quick to dismiss studies in
research that's been done, in animals if you the animal laboratory, either in mice, in
also look at some of these individual cases primates, that do show some concerns with
and, if you look at the evidence that there is no regard to certain vaccines.
link - what I come away with is: The question
has not been answered.90 The reason why they didn't want
to look for those susceptibility groups was
Former NIH Director Dr. Healy goes because they're afraid if they found them
on to explain: however big or small they werethat that
would scare the public away. First of all, I
This is the time when we do have think the public's smarter than that; the
the opportunity to understand whether or public values vaccines. But, more
not there are susceptible children, perhaps importantly, I don't think you should ever
genetically, perhaps they have a metabolic turn your back on any scientific hypothesis
issue, mitochondrial disorder, because you're afraid of what it might
immunological issue, that makes them show! 91
more susceptible to vaccines plural, or to
one particular vaccine, or to a component The CDCs claim that Vaccines Do
of vaccine. A susceptible group does not Not Cause Autism also fails to address the
88 https://www.c-span.org/video/?c4546453/senator-posey- 90 Ibid.
calls-investigation-cdc-fraud 91 Ibid.
89 http://www.cbsnews.com/news/the-open-question-on-
vaccines-and-autism/
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92 https://www.cdc.gov/vaccinesafety/concerns/autism.html 96 http://digitalcommons.pace.edu/cgi/viewcontent.cgi?article=
93 http://hisunim.org.il/images/documents/scientific_literature/ 1681&context=pelr
Gallagher_Goodman_HepB_2010.pdf 97 Further, studies of MMR and autism are simply erroneous
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102 https://www.ncbi.nlm.nih.gov/pubmed/27540164
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[Also,] studies designed to examine the have been demanding for decades that HHS
long-term effects of the cumulative number perform such a study. Even the CDCs
of vaccines or other aspects of the internal vaccine committee recognizes that
immunization schedule have not been assessing adverse events require more
conducted.108 detailed epidemiologic studies to compare the
incidence of the event among vaccinees to the
While most of the 78 million children incidence among unvaccinated persons.112
in America follow the CDCs childhood
vaccine schedule, currently at 56 injections, no HHS has nonetheless consistently
science has been done to confirm the safety of refused to study health outcomes of the
this schedule.109 Even more alarming is that completely unvaccinated. There have been,
the IOM acknowledges that science does not however, small-scale studies performed
yet even know if there is a relationship outside of HHS comparing vaccinated with
between short-term adverse events following completely unvaccinated children. And these
vaccination and long-term health issues.110 smaller studies have consistently reported
that the unvaccinated have much better health
Due to the lack of science regarding the outcomes.
safety of the CDC vaccine schedule, the best
the IOM could do was conclude: There is no Dr. Peter Aaby is renowned for
evidence that the schedule is not safe.111 Left studying and promoting vaccines in Africa
unsaid, but equally true: There is no evidence with over 300 published studies.113 In 2017, he
that the schedule is safe. published a study finding children vaccinated
with DTP were 10 times more likely to die in
6. CDC Refuses to Conduct Vaccinated the first 6 months of life than the
vs. Unvaccinated Study unvaccinated.114 Dr. Aabys study therefore
concluded that: All currently available
evidence suggests that DTP vaccine may kill
The best and most efficient way to more children from other causes than it saves
answer a large portion of the questions raised from diphtheria, tetanus or pertussis.115
regarding vaccine safety would be a long- More disturbing is that children vaccinated
term, properly powered (i.e., sized) study with DTP were dying from causes never
comparing the overall health outcomes of associated with this vaccine, such as
vaccinated and completely unvaccinated respiratory infections, diarrhea, and
children. Parents and safety advocacy groups malaria.116 This indicated that while DTP
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reduced the incidence of diphtheria, tetanus, Like the DTP study, the flu vaccine increased
and pertussis, it increased susceptibility to susceptibility to other infections.
other infections.117
As a final example, the CDC in 2001
It is equally troubling that Dr. Aabys unwittingly conducted a narrow vaccinated
study was based on data that had been versus unvaccinated study comparing
collecting dust for over 30 years.118 This begs children receiving the Hepatitis B vaccine
the question: what other serious vaccine during the first month of life versus those who
injuries are we missing because of neglect to did not. 124 The results of this study were never
conduct proper vaccine safety science? released by the CDC, and an abstract of the
study was only recently obtained under a
A pilot study comparing 650 FOIA request.125 Children vaccinated with
vaccinated and unvaccinated homeschooled Hepatitis B vaccine in the first month of life,
children in the United States provides a compared to children receiving no vaccines in
glimpse of the potential scope of vaccine the first month of life, had an increased risk of
harm.119 The study found that, compared to 829% for ADHD, 762% for autism, 638% for
completely-unvaccinated children, fully- ADD, 565% for tics, 498% for sleep disorders,
vaccinated children had an increased risk of and 206% for speech delays.126
390% for allergies, 420% for ADHD, 420% for
autism, 290% for eczema, 520% for learning The foregoing limited studies should
disabilities, and 370% for any neuro- have raised alarm bells at the CDC regarding
developmental delay.120 Fully-vaccinated pre- the urgency of a proper vaccinated versus
term infants had an increased risk of 1,450% unvaccinated study that stakeholders have
for a neurodevelopmental disorder, which been demanding the CDC perform for over 20
includes a learning disability, ADHD or years. The IOM has even confirmed such a
autism, compared to completely unvaccinated study can be conducted using the CDCs VSD,
preterm infants.121 a database of health records for almost ten
million individuals maintained by the CDC.127
Another recent study compared As explained by the IOM: It is possible to
children receiving the flu shot with those make this comparison [between vaccinated
receiving a saline injection in a prospective and unvaccinated children] through analyses
randomized double-blind study.122 Both of patient information contained in large
groups had the same rate of influenza but the databases such as VSD.128 Such a
group receiving the flu shot had a 440% retrospective epidemiological study would be
increased rate of non-influenza infection.123 quick, cheap and efficient; CDC could literally
117 Ibid. Since the only vaccine recommended by one month of age was
118 Ibid. Hepatitis B, and since only thimerosal containing Hepatitis B
119 http://www.oatext.com/pdf/JTS-3-186.pdf vaccine was available at the time of this study, this study
120 Ibid. primarily compared children receiving Hepatitis B with
121 http://www.oatext.com/pdf/JTS-3-187.pdf children that did not receive this vaccine.
122 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3404712/ 125 Ibid.
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conduct this study using the VSD in a matter Meningitis (acute inflammation of
of minutes. Yet it has never, as far as the protective membranes covering the brain and
public knows, been done. 129 spinal cord); Thrombocytopenia (low blood
platelet count which can result from autoimmune
Every year tens of millions of action); Stevens-Johnsons Syndrome (severe
American children are compelled to receive autoimmune reaction in which the top layer of skin
pediatric vaccines. Yet a large-scale study is burned off and dies); Alopecia Areata
with completely-unvaccinated controls has (autoimmune skin disease resulting in the loss of
never been performed to assess the long-term hair on the scalp and elsewhere on the body);
safety of the CDCs recommended vaccine Arthritis (painful and disabling autoimmune
schedule.130 When vaccine makers are disease that includes joint pain, swelling and
generating over $33 billion in vaccine revenue progressive stiffness in the fingers, arms, legs and
annually and the CDC is spending over $5 wrists); Rhinitis (irritation and inflammation of
billion annually to promote and purchase nasal mucous membranes impacting ability to
vaccines, there is no justification for not breathe properly); Insomnia; Lupus
performing this study.131 Erythematosus (autoimmune disease in which
immune system attacks healthy tissue, including
7. CDC Ignores Vaccine Manufacturer skin, joint, kidney, brain, and other organs);
Disclosures of Potential Adverse Hypotension (abnormally low blood pressure);
Guillian-Barre Syndrome (autoimmune disease
Reactions
that attacks the nerves in the legs, upper body, arms
and/or face); Polyarteritis Nodosa (systemic
Vaccine makers are required by law to vasculitis that affect medium-sized and small
report to the FDA complaints they receive muscular arteries resulting in ruptures and other
from consumers of serious adverse reactions damage); Encephalitis (inflammation of the brain,
from their vaccines.132 A partial list of these which can result in permanent injury); Bells
serious adverse reactions is detailed below. Palsy (disfiguring paralysis or weakness on one
While studies have been conducted for a few side of the face); Radiculopathy (compressed or
of these to confirm whether they are in fact pinched nerve); Myelitis (inflammation of spinal
caused by vaccines, the CDC has failed to cord that can involve nerve pain, paralysis and
conduct such studies for most of them. incontinence); Multiple Sclerosis (immune
system attacks nerve fibers, causing them to
deteriorate); Optic Neuritis (inflammation
129The CDCs inaction does not appear to be mere neglect since 130 In fact, due to the CDCs refusal to act, bills have been
CDC Senior Scientist, Dr. Thompson, recently stated that a proposed in Congress to require such a study, but, the political
proper large scale vaccine safety study needs to be done but clout for passage could not be mustered. See, e.g., H.R. 1757
that the CDC is not doing what they should be doing because (2013) and H.R. 1636 (2015) (to conduct or support a
theyre afraid to look for things that might be associated. comprehensive study comparing total health outcomes ... in
https://soundcloud.com/fomotion/cdc-whistle-blower-full- vaccinated populations in the United States with such outcomes
audio Dr. Thompson even explained that they have the data to in unvaccinated populations in the United States).
conduct such a study and that were insane to be sitting on this 131 https://www.hhs.gov/sites/default/files/fy2017-budget-in-
data and not have an independent group conduct this study brief.pdf; https://www.bccresearch.com/market-research/
but that it will not happen because they dont really want pharmaceuticals/vaccine-technologies-markets-report-
people to know that this data exists. Ibid. phm014f.html
132 21 C.F.R. 600.80(c)
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causing eye pain and partial or complete vision energy found in food); Pancreatitis (pancreas
loss); Aplastic anemia (damage to the bone attacks its own digestive enzymes);
marrow which slows or shuts down the production Encephalomyelitis (inflammation of the brain
of new blood cells); Aseptic Meningitis (acute and spinal cord); Transverse myelitis
inflammation of the brain and spinal cord which (autoimmunity causing inflamed spinal cord
can lead to death); Henoch-Schonlein purpura which may result in paralsis); Pneumonitis
(abnormal immune response resulting in (inflammation of lung tissue); Ocular Palsies
inflammation of microscopic blood vessels which (damage to the nerve of the eye that controls eye
can result in multiple organ damage); Myalgia movement); Ataxia (brain damage resulting loss of
(muscle pain that can become chronic); Radial full control of bodily movement, impaired speech,
nerve and recurrent nerve paralysis (nerve eye movement, and swallowing); Retrobulbar
injury to the radial nerve that can cause weakness Neuritis (inflammation and damage to the optic
or difficulty moving the wrist, hand or fingers); nerve between the back of the eye and the brain);
Encephalopathy with EEG disturbances Epididymitis (inflammation testicle tube which
(damage or malfunction of the brain with severity can lead to abscess formation, testicular pain,
ranging from altered mental status to dementia, painful urination, tissue death, and decreased
seizures and coma); Grand Mal Convulsion (loss functionality of gonads); Orchitis (inflammation
of consciousness and violent muscle contractions); of one or more testicles that can cause infertility,
Sudden Infant Death Syndrome (sudden death testicular atrophy, pain, and severe pain); Nerve
of infant in good health); Diabetes mellitus Deafness (hearing loss from damage to the nerve
(chronic, lifelong condition effecting ability to use that runs from the ear to the brain).133
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vaccine injury. The result as reflected in By the year 2000, most pediatric
scathing reports by Congress and the HHS vaccines on the CDCs vaccine schedule were
Inspector General is that the Vaccine already licensed by the FDA. That same year,
Program is fraught with pervasive conflicts of the U.S. House of Representatives Committee
interests both structurally and literally with on Government Reform (the Committee)
pharmaceutical company insiders. issued a report revealing serious conflicts of
interest in the VRBPAC.135 The Committee
Usually, when a government determined that conflict of interest rules
watchdog becomes ineffective or conflicted, employed by the FDA and the CDC have been
consumers turn to the last line of recourse weak, enforcement has been lax, and
against harm caused by a product: class action committee members with substantial ties to
and product liability attorneys. But in the case pharmaceutical companies have been given
of vaccines, even they have been neutered waivers to participate in committee
because of the immunity from financial proceedings.136 The Committee further
lability given to pharmaceutical companies for explained that:
harms caused by their vaccines.
Perhaps one of the major problems
The Vaccine Program created by the contributing to the overall influence of the
1986 Act has unfortunately resulted in a pharmaceutical industry over the vaccine
complete lack of accountability for vaccine approval and recommendation process
safety. may be the loose standards that are used by
the agency in determining whether a
1. HHS Licenses Vaccines conflict actually exists. In many cases,
significant conflicts of interest are not
The introduction of a new vaccine deemed to be conflicts at all.137
begins with its licensure by the FDA. A
committee at the FDA, the Vaccines and For instance, the Committee found
Related Biological Products Advisory that 3 out of 5 FDA advisory committee
Committee (VRBPAC), advises the FDA on [VRBPAC] members who voted to approve
whether or not to license new vaccines for the rotavirus vaccine in December 1997 [then
commercial use.134 In reality this committee the most recently approved vaccine by the
effectively decides whether a new vaccine gets VRBPAC] had financial ties to pharmaceutical
licensed since its recommendations for companies that were developing different
licensure are almost always accepted by the versions of the vaccine.138
FDA. Unfortunately, the members of this
board are often pharmaceutical insiders and, Among these five VRBPAC members
as discussed in Section II above, they license present and voting to license the rotavirus
vaccines with virtually no safety data. vaccine: one members employer had a
$9,586,000 contract for a rotavirus vaccine;
Reform.pdf
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another member was the principal committee rife with conflicts of interest,
investigator for a grant from Merck for the another HHS committee, the CDCs Advisory
development of a rotavirus vaccine; two other Committee on Immunization Practices
members received almost $1,000,000 from (ACIP), decides whether to recommend the
vaccine manufacturers toward vaccine vaccine for all children in America.
development; and even the consumer
advocate member (an ardent vaccine ACIP is the only federal entity to make
supporter) had received honoraria, in vaccination recommendations and these
addition to travel expenses, from Merck.139 recommendations are consistently approved
by the CDC.142 A recommendation by ACIP
These members voted to approve this for routine use of a vaccine is tantamount to
pediatric vaccine even though a temporary a Federal mandate for vaccine use.143 This is
voting member raised the following concern: because HHS regulations require that all
I would ask the FDA to work with the grants for childhood immunizations are
sponsor to further quantitate what these subject to the States implementation of
serious side effects are specifically the procedures to ensure routine vaccination ...
adverse effects, driven in particular by febrile [and] vigorous enforcement of school
illness is inducing hospitalizations and what immunization laws.144
is that level of access. I still dont feel like I
have a good grasp of that at this point.140 ACIP-recommended vaccines are also
subsidized by the federal government.145 In
Regarding the VRBPAC, the fact, 41% of the entire childhood vaccine
Committee concluded: The overwhelming market is purchased through ACIP
majority of members, both voting members resolutions.146 This currently amounts to over
and consultants, have substantial ties to the $4 billion paid to vaccine makers by the CDC,
pharmaceutical industry.141 Hence, even accounting for a third of the CDCs current
putting aside the astonishing lack of safety budget.147
review prior to licensure, extensive conflicts
were found to pervade the HHS committee Putting all this together: as a result of
that largely determined whether to license the the 1986 Act, when the ACIP votes to
pediatric vaccines currently on the market. recommend a pediatric vaccine for general
use, the pharmaceutical industry is handed a
2. HHS Recommends Vaccines liability-free, captive market of 78 million
children with guaranteed payment. It is not
After a pediatric vaccine is licensed surprising that with this economic incentive,
with virtually no safety data by an HHS
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financial ties to a competing firm developing a opinions regarding a vaccine under review,
similar vaccine.157 provide more than just the opinions.162 The
Committee found them more like a voting
Highlighting these conflict issues, the member of ACIP than an advisory
Committee drew focus on the vaccine most representative.163 The advice of these liaison
recently approved by the ACIP, a rotavirus representatives is solicited frequently by
vaccine, and whatever conflicts they could CDC personnel on issues where their
identify for the eight members of the ACIP organization has a financial interest.164
that voted to approve that vaccine for routine
pediatric use.158 The Committees findings The ACIP also routinely forms
were damning: (1) The chairman served on subcommittees (called working groups)
Mercks Immunization Advisory Board; (2) which convene behind closed doors and
another member, who shared the patent on a whose recommendations are typically rubber
rotavirus vaccine, had a $350,000 grant from stamped by the ACIP.165 The Committee was
Merck to develop the vaccine, and was a troubled by extensive and routine use of
consultant for Merck; (3) another member was working groups since the participants in these
under contract with the Merck Vaccine working groups often had conflicts which
Division and received funds from various would have prohibited them from voting
vaccine makers including Pasteur, and was a during an actual ACIP meeting.166 The
principal investigator for SmithKline; (4) Committee explained: The ACIPs prolific use
another member received a salary and other of working groups to draft vaccine policy
payments from Merck; (5) another member recommendations outside the specter of
participated in vaccine studies with Merck, public scrutiny opens the door to undue
Wyeth, and SmithKline; and (6) another special interest access.167 Regarding the
member received grants from Merck and ACIPs most recent working group
SmithKline.159 recommending approval of a vaccine, the
Committee found:
The Committee was deeply troubled
that these members were nonetheless allowed The working group has ten
to vote to recommend a pediatric vaccine for members, seven of whom have identifiable
universal use.160 conflicts of interest with vaccine
manufacturers or vaccine interest groups.
The Committee was further concerned The groups meetings were held in private
by its finding that ACIP liaison with no minutes or records of the
representatives have numerous ties to vaccine proceedings taken. It appears that members
manufacturers.161 The Committee found that who were not allowed to vote because of
these liaison members, through whom third- conflicts of interest ... were allowed to work
party organizations are permitted to provide
162 Ibid.
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040814.mp3
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funding from industry, adding that, it is The most prominent example is former CDC
outrageous that industry apparently is Director Dr. Julie Gerberding who headed the
allowed to punish the CDC if the agency CDC from 2002 to 2009. Dr. Gerberding
conducts research that has the potential to cut oversaw several controversial studies
into profits.189 regarding vaccines produced by Merck,
including notably the MMR vaccine, which
As another example, Congress sought to silence those calling for an increase
expressly created a private foundation, the in the safety profile of those vaccines. When
CDC Foundation, through which private she left the CDC she was rewarded with the
entities, such as pharmaceutical companies, position of President of Merck Vaccines in
can support programs at the CDC, endow 2010 with a reported estimated $2.5 million
positions at the CDC, and even place annual salary and lucrative stock options.196
individuals to work at the CDC, paid through
private funding.190 In contrast, the few CDC officials who
have attempted to blow the whistle on how
Since 1995 the CDC Foundation has vaccine safety research is conducted and
raised $620 million to pay for 824 programs at treated at the CDC have become targets of
the CDC.191 In 2015 alone, the CDC character assassination. For example,
Foundation raised $157 million for privately following revelations of Dr. Thompsons
funded programs at the CDC, which then statements regarding the CDCs improper
obtain the stamp of legitimacy of the CDC.192 conduct197 (some of which was discussed
Merck, for example, funded an $832,916 above), he soon found himself marginalized
program through the CDC Foundation to and publicly maligned, despite the CDCs
expand CDCs ... viral hepatitis prevention prior reliance on him for over a decade to
and vaccination activities.193 As a result, the produce most of its core vaccine safety
CDC is reliant on the CDC Foundation for the science.198
continued funding of these projects, and even
for the services of the staff placed at the CDC As Congressman Bill Posey explained
by the CDC Foundation, since the CDC is only in 2014 after investigating the CDCs approach
permitted to use these funds as expressly to vaccine safety: the CDC and vaccine
directed by the CDC Foundation.194 This industrys media network [will] twist the
foundation even funds and thus directs CDC truth to disparage, to malign, to vilify, to
management training courses.195 denigrate anybody who wants any kind of
accountability and added that his review of
Worse, the promotion track for CDC CDC emails discussing vaccine safety will
management extends into vaccine makers. make you absolutely sick to your stomach.199
pdf/CDCF-Form990-2014.pdf 040814.mp3
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200 42 U.S.C. 300aa-10 et seq. 205 See Sections II and III above.
201 42 U.S.C. 300aa-12 206 See Section III(2) above.
202 Ibid. 207 See Section III(6) above.
203 42 U.S.C. 300aa-15 208 Althen v. Secretary of Health and Human Services, 418 F.3d
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209 https://www.congress.gov/106/crpt/hrpt977/CRPT-106hrpt 093833.htm) But since babies cant talk, the symptoms which
977.pdf would explain a neurological injury, for example, are not
210 Further compounding the above issues, babies are unable to knowable until later in life when it is too late to assert a claim.
describe their symptoms which may explain why most VICP 211 https://www.hrsa.gov/vaccinecompensation/vaccineinjury
claims are filed by adults. Most adults bring claims for injury table.pdf
after a single flu shot. (https://www.hrsa.gov/vaccinecompens 212 42 U.S.C. 300aa-13
ation/data/vicpmonthlyreporttemplate8_1_17.pdf) In contrast, 213 Stevens v. Secretary of the Department of Health & Human
babies receive between five and seven injections of numerous Services, No. 99-594V (Office of Special Masters 2001)
vaccine doses at two months, four months, six months, etc. (See 214 http://www.gao.gov/assets/670/667136.pdf
Section I above.) If babies could talk, they may be able to 215 https://www.congress.gov/106/crpt/hrpt977/CRPT-106hrpt
appetite reactions that are considered normal side effects of 217 http://www.gao.gov/assets/670/667136.pdf
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219See, e.g., Kuperus v. Sec'y of the HHS, No. 01-0060V, 2003 U.S. 01-230V, 2004 U.S. Claims LEXIS 116 (Fed. Cl. Apr. 23, 2004)
Claims LEXIS 397 (Fed. Cl. Oct. 23, 2003) (Acute Disseminated (Hypoxic seizure leading to Death from DTaP); Loving v. Sec'y
Encephalitis from DTaP); Lerwick v. Sec'y of HHS, No. 06-847V, of HHS, No. 02-469V, 2013 U.S. Claims LEXIS 1570 (Fed. Cl. Sep.
2010 U.S. Claims LEXIS 398 (Fed. Cl. May 26, 2010) (Acute 20, 2013) (Infantile Spasms and Seizure Disorder from DTaP);
Disseminated Encephalitis from DTaP); Price v. Sec'y of HHS, Herrell v. Sec'y of the HHS, No. 08-123V, 2009 U.S. Claims LEXIS
No. 11-442V, 2015 U.S. Claims LEXIS 1554 (Fed. Cl. Oct. 29, 577 (Fed. Cl. Jan. 6, 2009) (Idopathic Thrombocytopenic Purpura
2015) (Anaphylaxis from DTaP); Rodriguez v. Sec'y of the HHS, from MMR); Zatuchni v. Sec'y of HHS (In re Snyder), No. 94-58V,
No. 06-559V, 2007 U.S. Claims LEXIS 685 (Fed. Cl. Sep. 14, 2007) 2006 U.S. Claims LEXIS 127 (Fed. Cl. May 10, 2006)
(Death from DTaP); Harry Tembenis & Gina Tembenis v. Sec'y of (Fibromyalgia leading to death from MMR); Francis v. Sec'y of
HHS, No. 03-2820V, 2010 U.S. Claims LEXIS 950 (Fed. Cl. Nov. the HHS, No. 99-520V, 2007 U.S. Claims LEXIS 172 (Fed. Cl. May
29, 2010) (Death from DTaP); Agresti v. Sec'y of HHS, No. 05- 23, 2007) (Ocular Myasthenia Gravis from Varicella).
0752V, 2009 U.S. Claims LEXIS 517 (Fed. Cl. Mar. 17, 2009) 220 https://www.congress.gov/bill/109th-congress/house-bill/58
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CONCLUSION
We can do better. With hundreds of cause serious adverse reactions, the studies to
vaccines in the pipeline we must do better. quantify the rate at which it causes these
Children susceptible to vaccine injury are as harms have never been done. While we know
deserving of protection as any other child. that certain children are predisposed to
Avoiding injury to these children is not only a serious injury from vaccines, the studies to
moral and ethical duty, but will, in fact, identify which children are so disposed have
strengthen the Vaccine Program. Every never been done. While we know that valid
parent that does not witness their child suffer pre-licensure safety trials take years and must
a serious reaction after vaccination, such as a use an inert placebo control, such pre-
seizure or paralysis, is another parent that will licensure safety trials are never done for any
not add their voice to the growing chorus of vaccine. While we know that post-licensure
parents opposed to the Vaccine Program due surveillance of vaccines captures less than one
to safety concerns. percent of adverse reactions, the CDC refused
to cooperate to automate VAERS reporting.
These parents and their kindred
doctors, scientists and politicians, are also in In the zeal to protect the Vaccine
fact correct that the system for vaccine safety Program the primary objective of protecting
is broken. While we know that vaccines can every children to the greatest extent possible
221http://vaccine-safety.s3.amazonaws.com/Weldon_
Statement_Vaccine_Safety_final.pdf
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from harm has been lost. Every child comparing total health outcomes
susceptible to a vaccine injury or injured by a between vaccinated children and
vaccine deserves better. completely unvaccinated children.
The good news is that fixing this 6. Create a vaccine safety agency
system is not complicated and would require independent of HHS with a budget
a tiny fraction of the resources already equal to 50% of HHSs budget for
devoted to the Vaccine Program. The quickest promoting and purchasing
solution would be to repeal the 1986 Act and vaccines.
let normal market forces drive vaccine safety.
Alternatively, the following actions would 7. Automate creation and
immediately correct many of the issues transmission of adverse reactions
identified in this white-paper: reports at hospital/clinic to VAERS.
Reduce Conflicts
222HHSs vaccine committees include the Advisory Committee Biological Products Advisory Committee (VRBPAC), the
on Immunization Practices (ACIP), the Vaccine and Related National Vaccine Advisory Committee (NVAC), and the
Advisory Commission on Childhood Vaccines (ACCV).
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Most pediatric vaccines do not contain live Inflammation in the brain is a cause of
viruses. For example, (i) polio vaccine (IPV) only
223 neurodevelopmental disorders (e.g. autism) and
contains a killed virus, (ii) hepatitis b vaccine mental illnesses (e.g. schizophrenia).231 The
contains a portion of a killed virus, and (iii) resulting mental illness can occur years or decades
diphtheria vaccine contains only a modified toxin after the inflammation starts.232
released by the diphtheria bacteria.224 These pieces
of killed bacteria or virus or modified toxins are Exposure to aluminum adjuvants has
commonly referred to as antigens. An injection increased dramatically in the last 50 years, in
of antigen alone, with nothing more, produces a parallel with the increasing incidence of
weak immune response insufficient for creating neurodevelopmental disorders in children.233
long-term immunity.225
Some vaccines also contain other
Therefore, many vaccines also contain an biological matter, both intended and
adjuvant, an immune-stimulating substance that unintended.234 These include cell lines from
increase the immune response to the antigen, so aborted human fetuses and biological material
that immunity is created. Aluminum compounds from animal tissue.235 Before being killed in the
are by far the most commonly used adjuvants in vaccine manufacturing process, the virus, disease,
vaccines. They are made of particles of aluminum or toxin (against which the vaccine is supposed to
hydroxide, aluminum phosphate or aluminum protect) is grown on these human and biological
sulfate, or mixtures thereof.226 mediums.236
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2819810/; appendices/b/excipient-table-2.pdf
https://www.ncbi.nlm.nih.gov/pubmed/23932735 235 Ibid.
https://www.ncbi.nlm.nih.gov/pubmed/19740540 http://soundchoice.org/wp-content/uploads/2012/08/DNA_
231 https://www.ncbi.nlm.nih.gov/pubmed/27540164;
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The CDCs list of ingredients for the These fragments of cultured human tissue and
vaccines also includes the following animal parts: animal tissue, which have also been found to
include various monkey, retro and other
monkey kidney cells, vero (monkey kidney) unintended viruses, are injected into the muscle
cells, embryonic guinea pig cell cultures, tissue of babies and children, along with the
lactose, chick embryo cell culture, bovine calf adjuvant intended to generate a sustained immune
serum, bovine serum albumin, calf serum response to the biological matter in the vaccine.240
protein, fetal bovine serum239
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