02 siri child imz schedule 508

SENT VIA EMAIL

Advisory Committee on Immunization Practices
Centers for Disease Control and Prevention
acip@cdc.gov

Re:  Supplement to December 5, 2025 Presentation Titled Development of the U.S.
Childhood Vaccination Schedule: With a Focus on Suggested Improvements

To ACIP:

Please find herein additional sources for various slides for the  above -referenced presentation.  As
disclosed in that presentation, I am the Manag ing Partner of Siri & Glimstad LLP which has over
100 professionals who handle civil rights, exemptions, immigration, employment, and injury
claims related to vaccin es.

SLIDE 11 : IMPORTANCE OF CLINICAL TRIALS

The importance of the clinical trials relied upon to license each recommended childhood vaccine
in ACIP’s decision making is highlighted by the following chart which reflects the time period
between licensure and ACIP’s recommendation for each vaccine. Note that this chart reflects all
routine ly recommended vaccines  as well as any vaccine used as a control to license a routine ly
recommended vaccine, and so forth , down the licensure chain.

Vaccine  Year
Licensed
for
Children  Year ACIP Recommended
for Routine Use in
Children [Earlier Non -
Routine Use]  Days Between
Licensure &
Recommendation
DTP (various)  * 19661 *
M-M-R-II (Merck)  19782 19783          49 days
Menomune  19814     [1985]5 [1264]

1 https://stacks.cdc.gov/view/cdc/633 .
2 https://icandecide.org/article/measles -mumps -and-rubella -vaccine -mmr/ .
3 https://stacks.cdc.gov/view/cdc/1643 .
4 https://www.drugs.com/pro/menomune.html .
5 https://stacks.cdc.gov/view/cdc/35394 .
2
 Recombivax HB
(Merck)  19866     [1987]7   19918 [331] 1948 days
Engerix -B (GSK)  19899     [1990]10  199111 [192]   816 days
PedvaxHIB (Merck)  198912                     199013             133 days
Ipol (Sanofi)  199014     [1994]15   199716 [1691]  2580 days
ActHIB (Sanofi)  199317                     199318               24 days
Varivax (Merck)  199519                     199620                294 days
Havrix (GSK)  199521     [1996]22  200623     [674]  4104 days
Vaqta (Merck)  199624     [1996] 25  200626     [273]  3703  days
Infanrix (GSK)  199727                    199728                  73 days
Prevnar 7  200029                    200030                   -1 days
Daptacel (Sanofi)  200231                    200232                  52 days

6 https://purplebooksearch.fda.gov/productdetails?query=101066 .
7 https://www.cdc.gov/mmwr/preview/mmwrhtml/00019181.htm .
8 https://www.cdc.gov/mmwr/preview/mmwrhtml/00033405.htm .
9 https://purplebooksearch.fda.gov/productdetails?query=103239 .
10 https://stacks.cdc.gov/view/cdc/7460 .
11 https://www.cdc.gov/mmwr/preview/mmwrhtml/00033405.htm .
12 https://www.cdc.gov/mmwr/preview/mmwrhtml/00001600.htm .
13 https://www.cdc.gov/mmwr/preview/mmwrhtml/00001600.htm .
14 https://usa -mama.com/wp -content/uploads/2017/02/us -vaccines.pdf .
15 https://stacks.cdc.gov/view/cdc/26885 .
16 https://www.cdc.gov/mmwr/preview/mmwrhtml/00046568.htm .
17 https://www.cdc.gov/mmwr/preview/mmwrhtml/00020301.htm .
18 https://www.cdc.gov/mmwr/preview/mmwrhtml/00020301.htm .
19 https://stacks.cdc.gov/view/cdc/76570/cdc_76570_DS1.pdf .
20 https://stacks.cdc.gov/view/cdc/76570/cdc_76570_DS1.pdf .
21 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm .
22 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm .
23 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm .
24 https://www.cdc.gov/mmwr/preview/mmwrhtml/00048084.htm .
25 https://www.cdc.gov/mmwr/preview/mmwrhtml/00048084.htm .
26 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm .
27 https://www.cdc.gov/mmwr/PDF/rr/rr4607.pdf .
28  https://www.cdc.gov/mmwr/PDF/rr/rr4607.pdf .
29 https://stacks.cdc.gov/view/cdc/76558 .
30 https://stacks.cdc.gov/view/cdc/76558 .
31 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5126a5.htm .
32 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5126a5.htm .
3
 Boostrix (GSK)  200533                    200534                  24 days
Adacel (Sanofi)  200535                    200536                  20 days
Menactra (Sanofi)  200537                    200538                  27 days
Gardasil (Merck)  200639                    200640                  21 days
Hiberix (GSK)  200941 200942                 30 days
Prevnar 13 (Pfizer)  201043 201044                   0 days
Menveo (GSK)  201045 201046                 19 days
Gardisil -9 201447 201548                 78 days
MenQuadfi (Sanofi)  202049 202050                 62 days
Vaxneuvance  (Merck)  202251 202252                   5 days
Priorix (GSK)  202253 202254                 17 days
Prevnar 20 (Pfizer)  202355 202356                 56 days

33 https://cdc.gov/mmwr/preview/mmwrhtml/rr5517a1.htm .
34 https://cdc.gov/mmwr/preview/mmwrhtml/rr5517a1.htm .
35 https://archive.cdc.gov/www_cdc_gov/media/pressrel/r051109.htm .
36 https://archive.cdc.gov/www_cdc_gov/media/pressrel/r051109.htm .
37 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm .
38 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm .
39 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm .
40 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm .
41 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5836a5.htm .
42 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5836a5.htm .
43 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm .
44 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm .
45 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5909a5.htm .
46 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5909a5.htm .
47 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6411a3.htm .
48 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6411a3.htm .
49 https://www.cdc.gov/acip/grade/mening -MenACWY -TT.html .
50 https://www.cdc.gov/mmwr/volumes/69/rr/rr6909a1.htm .
51 https://www.cdc.gov/mmwr/volumes/71/wr/mm7137a3.htm .
52 https://www.cdc.gov/mmwr/volumes/71/wr/mm7137a3.htm .
53 https://www.cdc.gov/mmwr/volumes/71/wr/mm7146a1.htm .
54 https://www.cdc.gov/mmwr/volumes/71/wr/mm7146a1.htm .
55 https://www.cdc.gov/mmwr/volumes/72/wr/mm7239a5.htm .
56 https://www.cdc.gov/mmwr/volumes/72/wr/mm7239a5.htm .
4

SLIDES 15 -18: CONTROLS; SAFETY DURATIONS; STATISTICAL POWER

When our law firm seeks to establish causation between a vaccine product and a claimed injury,
the primary source for proving such claims is the data from clinical trials for that product. This is
because most of the studies conducted after  licensure are retrospective epidemiological studies
which are not deemed reliable for supporting causation. Hence, obtaining and reviewing the
clinical trial data for each vaccine has been an important part of our legal work.

Clinical trials are also critical for assuring safety, especially for vaccines. This is because after a
vaccine is licensed, many consider it unethical to conduct a placebo -controlled trial and without a
proper trial , determining causation between a vaccine and a claimed adverse event is extremely
difficult.

The control group in clinical trials for a new drug will often receive a placebo.  As defined by the
CDC  and FDA , a placebo is , “[a] substance or treatment that has no effect on living  beings”  and
an “inert substance,” respectively.57 The importance of a placebo control group is explained by the
NIH as follows: “In undertaking a clinical trial, researchers … want to be as certain as possible
that the results of the testing show whether or not a treatment is safe and effective. The ‘gold
standard’ for testing interventions in people is the ‘randomized, placebo -controlled’ clinical trial. ...
A placebo is an inactive substance that looks like the drug or treatment being tested. ”

How well the “pivotal trial ” (the  trial FDA relies upon to license a vaccine ) can determine safety
depends on, among other factors, (i) the duration that safety is reviewed in the trial, (ii) the number
of participants in the trial, and (iii) the use of a valid control, which should be a placebo or another
vaccine for the same disease that has already been licensed based on a trial that properly assessed
safety. Each of these factors is essential because:

• If the control group receives a control whose safety has not been established in its own
clinical trial, the control cannot be relied upon to provide a baseline of what is “safe.”

• If the duration for which safety is reviewed is limited, the trial will miss safety issues that
arise after the time for which safety is reviewed.

• If there are not enough participants, i.e. it is not sufficient ly power ed, it will not detect
safety issues that occur at a rate not detectible at th e lower level of power.

The following is a list of every  stand -alone routine vaccine on the CDC’s childhood vaccine
schedule and a short discussion regarding the pivotal trial FDA relied upon to license each , with
citation to the FDA sources:

• Hep B vaccine (CDC schedule: birth, 1 month, and 6 months)

57
https://www.cdc.gov/vaccines/glossary/?CDC_AAref_Val=https://www.cdc.gov/vaccines/terms/glossary.html#headin
g-p; https:// www.fda.gov/media/130326/download .
5
 o Recombivax HB (Merck) : licensed for babies based on trials with no placebo
control and 5 days of safety monitoring after injection.58
o Engerix B (GSK) : licensed for babies based on trials with no placebo control and
4 days of safety monitoring after injection.59
• DTaP vaccine (CDC schedule: 2, 4, 6, and 15 months, and 4 years)
o Infanrix (GSK) : licensed for babies based on trials with no placebo control (DTP
vaccine used as a control) and up to 30 days of safety review after injection.60 DTP,
used as the control was not licensed in a placebo -controlled trial and  DTP has, in
most studies looking at this issue, repeatedly been found to increase mortality in
infants, meaning DTP -vaccinated infants die at far higher rates than their equally
situated non -vaccinated peers.61
o Daptacel (Sanofi) : licensed for babies based on trials with no placebo control (DT
or DTP vaccine used as control) and 2 months of safety review after injection,
except one trial which had 6 months of safety review, no control, and 1,454 children.
In that trial, “[w]ithin 30 days following any dose of DAPTACEL, 57 (3.9% )
subjects reported at least one  serious adverse event.”62 See Infanrix bullet point
regarding DTP.
• PCV vaccine (CDC schedule: 2, 4, 6, and 12 months)
o Prevnar 13, PCV -13 (Wyeth, part of Pfizer) : licensed for babies based on trials
with no placebo control (Prevnar 7 used as a control, which was licensed based on
a trial in which the control was an “Investigational meningococcal group C
conjugate vaccine,” meaning another experimental vaccine) and  6 months of safety
review after injection which found, “[s]erious adverse events reported following
vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients
and 7.2% among Prevnar recipients.”63
o Vaxneuvance PCV -15 (Merck) : licensed for babies based on trials with no
placebo control (Prevnar 13 used as the control) and up to 6 months of safety review
after injection finding that, “[a]mong children who received VAXNEUVANCE
(N=3,349) or Prevnar 13 (N=1,814) … serious adverse ev ents up to 6 months
following vaccination with the 4 -dose series were reported by 9.6% of
VAXNEUVANCE recipients and by 8.9% of Prevnar 13 recipients.” Deemed “safe”
because, “[t]here were no notable patterns or numerical imbala nces between
vaccination groups.”64
o Prevnar 20, PCV -20 (Pfizer) : licensed for babies based on trials with no placebo
control (Prevnar 13 used as the control), up to 6 months of safety review after
injection, and that showed high rates of serious events (this time broken up into two
categories – “serious adverse events ” and “newly diagnosed chronic medical

58 See Section 6.1 at https://www.fda.gov/media/74274/download .
59 See Section 6.1 at https://www.fda.gov/media/119403/download .
60 See Section 6.1 at https://www.fda.gov/media/75157/download .
61 https://icandecide.org/wp -content/uploads/2021/06/2021.01.28 -Letter -to-Special -Rapporteur -on-Poverty.pdf .
62 See Section 6.1 at https://www.fda.gov/media/74035/download ; https://www.fda.gov/safety/reporting -serious -
problems -fda/what -serious -adverse -event .
63 See Section 6.1 at https://www.fda.gov/media/107657/download ; https://www.fda.gov/media/76076/download .
64 See Section 6.1 at https://www.fda.gov/media/150819/download .
6
 conditions”) in both vaccine groups (experimental and control) but deemed “safe”
because “no notable patterns or imbalances between vaccine groups.”65 Meaning,
PCV -20 was licensed based on a clinical in which PCV -15 was the control, PCV -
15 was licensed based on a clinical trial in which PCV -13 was the control, PCV -13
was licensed based on a clinical trial in which PCV -7 was the control, and PCV -7
was li censed based on a clinical trial in which another experimental, unlicensed
vaccine was the control, and in each of these trials the serious adverse events in
both the control and experimental groups were similar which was sufficient for a
finding of “safe”  for licensure by the FDA.
• Polio vaccine (CDC schedule: 2, 4, and 6 months, and 4 years)
o IPOL (Sanofi) : licensed in 1990 for babies based on trials with no placebo control
and 3 days of safety review after injection. Sanofi reports that, “Although no causal
relationship has been established, deaths have occurred in temporal association
after vaccination of i nfants with IPV.”66 (Note that IPOL is a  different  product than
the polio vaccine developed by Jonas Salk in the 1950s, which was discontinued in
the 1960s, including because it is “grown in vero cells, a continuous line of monkey
kidney cells cultivated on microcarriers.” H ence, the Salk vaccine’s safety or
efficacy was not relied upon to license IPOL .67)
• Hib vaccine (CDC schedule: 2, 4, 6, and 12 months)
o ActHIB (Sanofi) : licensed for babies based on trials with no placebo control
(Hepatitis B vaccine used as control) and 30 days of safety review after injection
during which 3.4% experienced a serious adverse event but “[n]one was assessed
by the investigators [Sonafi] as  related to the study of vaccines.”68
o Hiberix (GSK) : licensed for babies based on trials with no placebo control
(unlicensed Hib vaccines and HibTITER used as the control) and 31 days of safety
review after injection.69
o Liquid PedvaxHIB (Merck) : licensed for babies based on trials with no placebo
control (Lyophilized PedvaxHIB used a control) and 3 days of safety review after
injection.70 (Note that Lyophilized PedvaxHIB was tested in a trial in which the
control group was given placebo, OPV, and DTP but there is no indication
Lyophilized PedvaxHIB was ever licensed.71)

65 See Section 6.1 at https://www.fda.gov/media/149987/download ; https://www.fda.gov/media/150459/
download?attachment .
66 See pages 14 -17 at https://www.fda.gov/media/75695/download .
67 See pages 1 at https://www.fda.gov/media/75695/download ; https://pubmed.ncbi.nlm.nih.gov/6740101/ ; https://
admin.phe -culturecollections.org.uk/media/122249/vero -cell-line-profile.pdf ;  https://www.atcc.org/products/all/ccl -
81.aspx#characteristics .
68 See Section 6.1 at https://www.fda.gov/media/74395/download ; see page 8 at http://wayback.archive -
it.org/7993/20170723144656/https:/www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/
UCM244597.pdf .
69 See Section 6.1 at https://www.fda.gov/media/77017/download ; see pages 20 -21 at http://wayback.archive -
it.org/7993/20170722072902/https:/www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/
UCM182550.pdf .
70 See page 6 -8 at https://www.fda.gov/media/80438/download .
71 See page 6 -8 at https://www.fda.gov/media/80438/download .
7
 • Rotavirus vaccine (CDC schedule: 2, 4, and 6 months) (Note that every vaccine on the
CDC childhood schedule is given via injection, except for one flu vaccine given by nasal
spray and the rotavirus vaccines, which are given by oral drops in the mouth.)
o Rotarix (GSK) : licensed for babies based on trials without a placebo control (the
control group received an oral drop that included Dextran, Sorbitol, Amino Acids,
Dulbecco’s Modified Eagle Medium, and Xanthan) and 31 days of safety review
after oral dose and up to a yea r in some trials to watch for cases of intussusception.
There were more deaths in the group receiving Rotarix than the control group.
“During the entire course of 8 clinical studies (Studies 1 to 8), there were 68
(0.19%) deaths following ad ministration of ROTARIX (n = 36,755) and 50 (0.15%)
deaths following placebo administration (n = 34,454). The most commonly
reported cause of death following vaccination was pneumonia, which was observed
in 19 (0.05%) recipients of ROTARIX and 10 (0.03%) p lacebo recipients (RR: 1.74,
95% CI: 0.76, 4.23).”72
o RotaTeq (Merck) : licensed for babies based on trials without a placebo control
(the control group received an oral drop that included Polysorbate -80, Tissue
Culture Medium, Fetal Bovine Serum, and Sodium Phosphate) and 42 days of
safety review after each oral dose and up t o a year to watch for cases of
intussusception.73
• Flu vaccine (CDC schedule: 6 and 7 months and then annually)
o The formulation for each  influenza vaccine  changes annually and there is no
clinical trial carried out for each new formulation. In any event, none of the clinical
trials for the original formulation of any injected influenza vaccine for children had
a pla cebo control group. In 1980, FDA licensed Fluzone (IIV3) without assessing
its safety against a placebo control.74 Nonetheless, Fluzone (IIV3) was used as the
control in the trials relied upon to license Afluria (IIV3) in 2007 and Fluzone (IIV4)
in 2013 for children .75 Then, Fluzone (IIV4), Fluarix (IIV3), or Havrix were used
as the controls in the clinical trials supporting the licensure of FluLaval (IIV4).76
The safety of these products therefore rests on the safety of Fluzone (IIV3) which
was licensed for pediatric use based on a trial without any control, let alone a
placebo control.77 Similarly, Fluarix (IIV4) was licensed for children in 2012 based

72 See Section 6.1 at https://www.fda.gov/media/163009/download  (claims used a placebo);  see pages 23 -24 at
http://wayback.archive -it.org/7993/20170722073219/https:/www.fda.gov/downloads/BiologicsBlood
Vaccines/Vaccines/ApprovedProducts/UCM133580.pdf  (explains “placebo” included all the foregoing ingredients).
73 See Section 6.1 at https://www.fda.gov/media/75718/download  (claims used placebo); see page 445 et al . at
https://icandecide.org/wp -content/uploads/2023/06/rotateq_placebo.pdf .
(explains the “placebo” included all the foregoing ingredients).
74 https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM619664.pdf ;
(Research ers did conduct one efficacy trial for Fluzone (IIV3) long after  it was licensed which found that “the rate of
hospitalization was actually higher in the vaccine group than in the placebo group” with 60% more vaccinated than
unvaccinated children being hospitalized for insertion of ear draining tubes.
https://www.ncbi.nlm.nih.gov /pubmed/ 14506120 ).
75 https://www.fda.gov/media/81559/download  (placebo control only used in adult trials but never in trials to license this
vaccine for children); https://www.fda.gov/media/119856/download .
76 https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM619548.pdf .
77 https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM619664.pdf .
8
 on a trial using Prevnar 13, Havrix and/or Varivax as controls; Fluarix (IIV4) was
then used as the control to license Afluria (IIV4) in 2016.78 This means Afluria
(IIV4) was licensed because it was deemed as safe as Fluarix (IIV4), and that
vaccine was licensed because it was deemed as safe as Prevnar 13, Havrix, or
Varivax. However, the latter two were licensed without a placebo control; and
Prevnar 13 was licensed because it was as safe as Prevnar, but that vaccine was
only licensed because it was as safe as “an investigational meningococcal group C
conjugate vaccine. ” Hence, none of those vaccines had its safety profile established
based on any placebo -controlled clinical trial. The only exception is one inhaled
influenza vaccine whose original trial had a placebo, but its formulation changes
every year and is not safet y tested in any trial.79
o The following chart includes each licensed trivalent (IIV3) and quadrivalent (IIV4)
influenza vaccine:80

78 https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM220624.pdf  (44% and
45% of the Fluarix (IIV4) and comparator vaccine group, respectively, reported an unsolicited adverse event within 28
days and 3.6% and 3.3%, respectively, reported a serious adverse reaction).
79 https://www.fda.gov/media/160349/download?attachment ;  https://www.fda.gov/media/73706/downloads .
80 Supporting  references  for each vaccine  in the table:  Fluzone  (IIV3)
(https://www.fda.gov/ media/170019/download  (As reflected in section 14.1, nineteen years after licensure
a small effi cacy,  not safety,  trial had a small  group  of children  receiving  a placebo  which  did not contribute  to any
safety  finding  for this product;  ironically,  had this trial been conducted  pre-licensure,  and relied upon for safety, it would
have raised a serious safety issue since “the rate of hospitalization  was actually higher in the vaccine group than in the
placebo group” with 60% more vaccinated  than unvaccinated  children  hospitalized  for insertion  of ear drainage
tubes )); Fluvirin  (IIV3)  (https://www.fda.gov/media/75156/download ); Fluarix (IIV3)
(https://www.fda.gov/media/84804/download ); Flulaval  (IIV3)  (https://www.fda.gov/media/74537/download );
Afluria  (IIV3) (https://www.fda.gov/media/81559/download  (states  placebo  used in adult  trials  but not in trials for
children); Flucelvax (IIV3)  (https://www.fda.gov/media/85322/download ); Fluarix  (IIV4)
(https://www.fda.gov/media/79278/download , states  placebo  used in adult  trials  but not in trials for children); Flublok
(IIV3)  (https://www.fda.gov/media/179778/download ); Fluzone  (IIV4)
(https://www.fda.gov/media/170019/download ); FluLaval  (IIV4)  (https://www.fda. gov/media/115785/download );
Afluria (IIV4) (https://www.fda.gov/media/117022/download ); Flucelvax  (IIV4)
(https://www.fda.gov/media/115862/download , states  placebo  used in adult  trials but not in trials for children).

9

As reflected in this chart, the safety of many influenza vaccines rests on a trial that
used Fluzone (IIV3) as a control or another vaccine that was licensed based on
using Fluzone (IIV3) as a control. But Fluzone (IIV3) was licensed based on a small
trial without any control. Researchers did conduct one efficacy (not safety) trial for
Fluzone (IIV3) long after  it was licensed which found that “the rate of
hospitalization was actually higher in the vaccine group than in the placebo group”
with 60% more vaccinated than unvaccinated children being hospitalized for
insertion of ear drainage tubes.81
• MMR vaccine (CDC schedule: 12 months and 4 years)
o M-M-R-II (Merck) : licensed based on a trial with a total of 834 children, no
control group, and that reviewed safety for 42 days during which one -third of
vaccinated participants developed gastrointestinal and a third respiratory issues.82

81 https://pubmed.ncbi.nlm.nih.gov/14506120/ .
82 See clinical trial reports for M -M-R-II at https://www.sirillp.com/wp -content/uploads/2023/07/MMRII -FOIA.pdf .
package insert ; see package insert for M -M-R-II https://www.fda.gov/media/75191/download  (The package insert for
M-M-R-II does not list any pivotal trial as a basis for determining this product was safe for licensure, presumably
because the trial relied upon to license this product could not establish it was safe for licensure.); see
https://icandecide.org/wp -content/uploads/2023/08/MMR -I-clinical -trials -safety -tables.pdf  (The original MMR’s
clinical trial was also underpowered, among other deficiencies,  and showed a similarly high rate of gastrointestinal,
respiratory and other issues, as compared to the small untreated control group. Also note that the original MMR was
a different product that did not include millions of pieces of human DNA and cellular debris, as does M -M-R-II.).
Because viruses multiply in cells, living cells are used to grow viruses for vaccine production, including the cultured
cell lines of aborted fetuses. Two such cell lines are MRC -5 and WI -38, which are described by a company that sells
them as follows: “T he MRC -5 cell line was derived from normal lung tissue of a 14 -week -old male embryo” and the
“WI-38 cell line is the first human diploid cell line to be used in human vaccine preparation … [and] were isolated
from the lung tissue of a 3 -month -old, female, embryo.” https://www.atcc.org/products/ccl -75;
https://www.atcc.org/products/ccl -171. The ingredients of chickenpox, rubella, and hepatitis A vaccines each include
cellular and DNA pieces from these fetal cell lines. The ingredient list for Varivax (chicken -pox) includes “MRC -5
human diploid cells including DNA & protein,” for MMR -II (whi ch includes rubella) includes “WI -38 human diploid
lung fibroblasts,” and for Havrix (hepatitis A) includes “MRC -5 cellular proteins.”
https://web.archive.org/web/20241120002123/https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/

10
 o Priorix (GSK) : licensed based on trials with no placebo control (M -M-R-II used
as the control) and 6 months of safety review after injection in which both vaccine
groups had a high rate of serious adverse events (2.1% of Priorix group and 1.9%
of M -M-R-II group), emerg ency room visits (10.1% of Priorix group and 10.4% of
M-M-R-II group), and new onset of chronic diseases (e.g., autoimmune disorders,
asthma, type I diabetes, vasculitis, celiac disease, thrombocytopenia, and allergies)
(3.4% of Priorix group and 3.7% of M -M-R-II group ).83
• Varicella vaccine (CDC schedule: 12 months and 4 years)
o Varivax (Merck) : licensed based on trials with no placebo control (the purported
“placebo” was actually an injection of 45 mg of neomycin per milliliter) and 70
days of safety review after injection which included only one controlled trial of 956
children in which approx imately half received Varivax and half received the
injection of 45 mg of neomycin per milliliter, and there was one trial in which 32
children received Varivax and 29 children received nothing and then received
Varivax eight weeks later; du ring this eight -week period, the Varivax group had
double the rate of ear infection and a 50% increase in respiratory infection. As for
serious adverse events, Merck did not consider any related to Varivax.84
• Hep A vaccine (CDC schedule: 12 and 18 months)
o Havrix (GSK) : licensed based on trials with no placebo control (Engerix -B was
used as a control) and 31 days of safety review after injection with a phone call
follow -up at 6 months.85 Note, as discussed above, Engerix -B was  licensed for

b/excipient -table -2.pdf . As for the quantity of human DNA in each vial, for Varivax, as the FDA explains: “human
MRC -5 cells are the substrate upon which the Oka strain of varicella is grown. In the process of isolating virus from
these cells, MRC -5 derived proteins and DNA are also obtained. The nearly 2 ug [2,000 nanograms] of unmodified
mammalian DNA present in each dose of VARIVAX…” https://wayback.archive -
it.org/7993/20170723031730/https:/www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/
UCM142826.pdf . As for MMR -II, during Dr. Plotkin’s deposition, I asked: “Isn’t it true that MMR II contains
approximately 150 nanograms cells substrate double -strand DNA and single -strand DNA per dose purposefully
fragmented to approximately 215 base pairs in length?” Dr. Plotkin answered: “Yeah, that’s probably correct, yes.”
https://icandecide.org/plotkintranscript/  at p. 328. See also https://soundchoice.org/wp -
content/uploads/2021/01/epidemiologic -molecular -relationship -vaccine -manufacture -autism -prevalence.pdf ;
https://pubmed.ncbi.nlm.nih.gov/26103708/  (See Table 3, reflecting an average of 142 nanograms of single -stranded
DNA and 35 nanograms of double -stranded DNA in the rubella vaccine component of each dose of MMR -II; and an
average of 276 nanograms of single -stranded DNA and 35.74 nanograms of doub le-stranded DNA in each dose of
Havrix). For DNA remaining in the final formulation, assuming pharma companies follow FDA’s guidance, they
would fragment “the DNA size to below approximately 200 base pairs.”
https://www.fda.gov/media/113760/download  at pp.29 -30. Doing the math, supposing only 100 nanograms of double -
stranded DNA remain, and are broken down into 200 base pair fragments, this equals approximately 463 billion pieces
of human DNA from an aborted fetal cell line in each vaccine dose; doub le that number for single -stranded DNA.
https://www.technologynetworks.com/tn/tools/copynumbercalculator . In addition to the human DNA, there is also an
unspecified amount of human cellular debris in each vaccine dose. See also  https://thehighwire.com/ark -
videos/aborted -fetal-tissue -in-vaccines/ .
83 See Section 6.1 at  https://www.fda.gov/media/189623/download ; see page 12 at https://pmc.ncbi.nlm.nih
.gov/articles/instance/7192400/bin/piz010_suppl_supplementary_materials.docx .
84 See Section 6.1 at https://www.fda.gov/media/76000/download ; see page 2 at https://pubmed.ncbi.nlm.nih.gov/
6325909/ ; see Varivax  clinical reports at  https://www.sirillp.com/wp -content/uploads/2023/07/Varivax -clinical -
trials.pdf .
85 See Section 6.1 at https://www.fda.gov/media/119388/download .
11
 babies based on trials with no placebo control and 4 days of safety monitoring after
injection.86
o Vaqta (Merck) : licensed based on trials with no placebo control (an injection of
AAHS, an aluminum adjuvant, and thimerosal, a form of mercury, were used as a
control) and up to 42 days of safety review after injection.87 Note that no placebo
control was used despite the fact the trials for Havrix and Vaqta occurred at roughly
the same time when there was no licensed Hepatitis A vaccine yet licensed.
• Tdap vaccine (CDC schedule: 11 years)
o Adacel (Sanofi) : licensed based on trials with no placebo control (Td, for adult use,
was used as a control) and up to 6 months of safety review after injection.88
o Boostrix (GSK) : licensed based on trials with no placebo control (DECAVAC or
Adacel was used as a control) & up to 6 months of safety review after injection.89
• HPV vaccine (CDC schedule: 9 and 9 ½ years)
o Gardasil 9 (Merck) : licensed based on trials in which safety was reviewed after
injection for 1 month in five of the clinical trials, 6 months in a lot consistency trial,
and 4 years in one trial of women aged 16 to 26 years. These Gardasil 9 trials were
either not controll ed or used Gardasil 4 as the control, except for one trial in which
306 participants received a placebo but only after receiving the full series of
Gardasil 4 injections .90 (Note that in  Gardasil 4 ’s clinical trial, controls received an
aluminum adjuvant, AAHS, except 320 people labeled “Saline Placebo” who
actually received all vaccine ingredients except antigens and AAHS; and across all
these trials, 2 -3% of participants receiving vaccine or alumi num adjuvant – a
substance used to induce  autoimmunity  in lab animals – had a suspected
autoimmune disorder.91)
• Men4 vaccine (CDC schedule: 11 and 16 years)
o Menactra (Sanofi) : licensed based on trials with no placebo control (Menomune
used as the control) and up to 6 months of safety review after injection.92 Note
Menomune was licensed without a placebo -controlled trial; rather, the safety
section of the package insert for Menomune lists the same trial used to license
Menactra as the basis for the safety of Menomune despite the fact Menomune was
used as a cont rol in that trial.93

86 See Section 6.1 at https://www.fda.gov/media/119403/download .
87 See Section 6.1 at https://www.fda.gov/media/74519/download  (using term “placebo”); see clinical trial report  at
454 https://www.nejm.org/doi/pdf/10.1056/NEJM199208133270702?articleTools=true  (explains the purported
“placebo” included the foregoing ingredients).
88 See Section 6.1 at https://www.fda.gov/media/119862/download .
89 See Section 6.1 at https://www.fda.gov/media/124002/download .
90 See pages 17 -19 at https://wayback.archive -it.org/7993/20190423065200/https:/www.fda.gov/downloads/
BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM429166.pdf .
91 See https://www.fda.gov/media/74350/download ; https://pubmed.ncbi.nlm.nih.gov/27417999/ .
92 See Section 6.1 at https://www.fda.gov/media/75619/download .
93 See https://archive. org/details/menomune -a-c-y-w-135-prescribing -information .
12
 o Menveo (GSK) : licensed based on trials with no placebo control (Menactra,
Boostrix, or other vaccines used as a control) and up to 6 months of safety review
after injection.94
o MenQuadfi (Sanofi) : licensed based on trials with no placebo control (Menveo or
other vaccines used as a control) and up to 6 months of safety review after
injection.95 Thus, Menomune was licensed without a placebo -controlled trial and
was then used as the control to license Menactra; Menactra is then used as the
control to license Menveo; and then Menveo is used as the control to license
MenQuadfi.

For completeness, the following is a list of the stand -alone non-routine vaccine s on the CDC’s
childhood vaccine schedule and a short discussion regarding the pivotal trial FDA relied upon to
license each with citation to the FDA sources:

• COVID -19 vaccine (CDC schedule: 6, 7, and 10 months, and then annually.)
o Comirnaty (Pfizer) : licensed only for children 12 years of age and older (not for
babies) and had a placebo control (note that the placebo controls were vaccinated
during the trial), 6 months of safety review after injection, and a total of 3,014
participants.96 Note that Pfizer failed to report a serious injury in at least one child
participant in its trial who received the vaccine.97
o Spikevax (Moderna) : licensed only for children 12 years of age and older (not for
babies) and had a placebo control (note that the placebo controls were vaccinated
during the trial), 6 months of safety review after injection, and a total of 3,726
participants.98
• MenB vaccine (CDC schedule: 10 years and older if indicated)
o Bexsero (GSK) : licensed based on trials in which controls were administered
aluminum hydroxide and, in one trial with 120 adolescents, saline injection
followed by injection of Menveo. FDA labels this an “active control,” not a
“placebo control” trial.99
o Trumenba (Pfizer) : licensed based on trials with no placebo control group other
than 12 people in a dose -ranging phase II study (otherwise the controls were
injection of Gardasil+placebo, dTaP -IPV+placebo, HepA+placebo, or

94 See Section 6.1 at https://www.fda.gov/media/78514/download .
95 See Section 6.1 at https://www.fda.gov/media/137306/download .
96 See Section 6.1 at https://www.fda.gov/media/151707/download?attachment .
97 https://icandecide.org/wp -content/uploads/2023/07/3 -08-2022 -Ltr-to-Dr.-Paul-Richards -FDA -re-Maddie -de-
Garay.pdf .
98  https://www.fda.gov/media/155675/download .
99 See pages 14 -15 at https://wayback.archive -it.org/7993/20190425012223/https:/www.fda.gov/
downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM434748.pdf ; see page 40 at https
://wayback.archive -it.org/7993/20190423064855/https:/www.fda.gov/ downloads/BiologicsBloodVaccines/
Vaccines/ApprovedProducts/UCM434714.pdf . See pages 14 -15 at https://wayback.archive -
it.org/7993/20190425012223/https:/www.fda.gov/ downloads/ BiologicsBloodVaccines/Vaccines/ApprovedProducts/
UCM434748.pdf ; see page 40 at https://wayback.archive -
it.org/7993/20190423064855/https:/www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/
UCM434714.pdf .
13
 Menactra+Adacel+placebo and 30 days of safety review after injection for one of
the three trials and up to 11 months in the other two trials.100
• PPSV23 vaccine (2Y+ if indicated)
o Pneumovax 23 (Merck) : licensed for children 2 years and older although there is
no indication that there was any clinical trial involving anyone younger than 16
years of age that the FDA relied upon to license this vaccine.101
• Dengue vaccine (6Y+ if previously had dengue and live in area dengue is endemic)
o Dengvaxia (Sanofi) : licensed based on a trial with 11,474 children receiving a
placebo control (saline injection), over 35,000 children in the trial, and 5 years of
safety review after injection. Meaning, the last listed vaccine on the CDC’s
childhood vaccine schedule is th e only vaccine that underwent a longer -term
placebo -controlled trial prior to licensure with a larger number of children.102
Careful study of this vaccine revealed that children under 6 years old had an
increased risk of severe harm and death from this vaccine and that children older
than 6 who had never had dengue and received this vaccine likewise had a seriously
increased ri sk of severe harm and death. Hence, this vaccine is only indicated for
older children who have previously had dengue. “Those not previously infected are
at increased risk for severe dengue disease when vaccinated and subsequently
infected with dengue virus .”103 This vaccine is only recommended for children in
endemic dengue areas and dengue is not endemic in the  U.S.104

The FDA source material for each vaccine, as set forth above, reflects:

• None of the childhood vaccines recommended for routine use by the CDC were licensed
based on a placebo -controlled trial nor on a trial where the vaccine used as a control was
itself licensed based on a placebo -controlled trial.  Rather, in each trial, there was either no
control group or another vaccine or vaccine ingredient was used as a control, and none of
those control vaccines were licensed based on a placebo -controlled trial.

• None of the childhood vaccines recommended for routine use by the CDC (save for one
limited HPV trial) were licensed based on trials that had long -term safety follow -up after
administration. Rather, safety was reviewed for a limited period, often no more t han
months, and often only days or weeks after administration.

• None of the childhood vaccines recommended for routine use by the CDC were licensed
based on trials which were appropriate to assess whether the vaccine causes more harm

100 See page 4 at  https://wayback.archive -it.org/7993/20190425012035/https:/www.fda.gov/downloads/
BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM548305.pdf ; see pages 9 -10 at https://wayback.archive -
it.org/7993/20190423065758/https:/www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/
UCM424626.pdf .
101 See Sections 6.1 and 14.1 https://www.fda.gov/media/80547/download .
102 See page 10 at https://www.fda.gov/media/125481/download ; see page 4 at  https://www.fda.gov/media/124379/
download .
103 https://www.fda.gov/media/124379/download .
104 https://www.usgs.gov/faqs/what -constitutes -united -states -what -are-official -definitions .
14
 than it prevents. This is because, as seen from the FDA source material, their pivotal trial
typically had only  hundreds or a few thousand children, severely limiting the power of
these trials to assess safety and therefore, not sufficient to conclude, statistically, that the
trialed products prevent more serious harms and deaths than they cause.

The FDA documentation reflects that, as the Secretary of Health and Human Services, Robert F.
Kennedy Jr., has previously explained, none of the routine vaccines on the CDC childhood
schedule (which does not include the dengue vaccine as it’s not routine) underwent a long -term
placebo -controlled trial, nor just a placebo -controlled trial (or even a trial where the vaccine used
as a control was previously established as safe in a long -term placebo -controlle d trial).

SLIDES 26 -27: DTP VACCINE

DTP vaccine is the most widely used vaccine in the world . It was not licensed based on a placebo -
controlled trial, and studies conducted in recent decades have found that DTP increases mortality.
A landmark study on this issue was funded by the Ministry of Foreign Affairs of Denmark and the
European Union and publ ished in 2017.105 After comparing children vaccinated with DTP to
children that received no vaccines, it found that that DTP -vaccinated children were 10 times more
likely to die in the first 6 months of life. The study therefore concluded:

All currently available evidence suggests that DTP vaccine may kill
more children  from other causes than it saves from diphtheria,
tetanus or pertussis.106

This study, and others, found that children vaccinated with DTP were dying from causes never
associated with the vaccine, such as respiratory infections, diarrhea, and malaria.107 This indicated
that, while DTP reduced the incidence of diphtheria, tetanus, and pertussis, it increased
susceptibility to other infections.108

A 2014 review of DTP and mortality by the WHO’s Strategic Advisory Group of Experts (SAGE),
identified 16 studies that compared death rates between children receiving DTP and children not
receiving DTP, and found that a majority of the 16 studies indicated that DTP increases
mortality.109 SAGE discounted the studies showing DTP increases mortality on the basis that: (i)
these studies were not “randomized” ( i.e., children were not randomly assigned to either receive
or not receive DTP, potentially introducing bias); (ii) “OPV [Oral Polio Vaccine] was administered
concomitantly with DTP in most included studies ” and hence it “was not possible to separate any
possible effects of DTP from OPV in the available studies”; and (iii) these studies were often

105 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ).
106 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ).
107 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ).
108 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ).
109 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ).
15
 conducted in communities with existing so -called “herd immunity” that could have introduced
further bias.110

The 2017 study was designed to avoid these limitations stated by SAGE. It addressed the
“randomized” issue by using data whereby vaccines were administered based on birthdates, an
accepted form of randomization.111 It addressed the “OPV with DTP” issue by comparing children
receiving no vaccines with those receiving only DTP.112 It addressed the “herd immunity” issue by
looking at death rates at the time of the introduction of DTP in that region.113 The result was the 2017
study discussed above. And because placebo -controlled trials of DTP are considered unethical, even
though a placebo -controlled trial was never conducted to license this product, the 2017 study on DTP
and morality is likely the best  available evidence that will exist addressing whether DTP kills more
children than it saves.

DTP policy has not, however, changed globally, even after another study published in 2018, which
again did not have the limitations identified by SAGE in 2014, and which again found DTP
increases mortality.114 This time the study looked at children between 6 and 35 months of age. The
2018 study compared children receiving DTP, who were generally healthier and had better
nutritional status, with children who did not receive DTP and who generally were unhealthier  and
had worse nutritional status. There, the children who did not receive DTP should have had worse
health outcomes because they were generally unhealthier and had worse nutrition. The result:

Although having better nutritional status and being protected against
three infections, 6 -35 months old DTP -vaccinated children tended
to have higher mortality than DTP -unvaccinated children. All
studies of the introduction of DTP have found increased over all
mortality.115

A non -profit group contacted UNICEF, a primary distributor of DTP vaccine, regarding these studies,
asking it to provide proof that the studies showing DTP increased mortality were incorrect. UNICEF
asked CDC to help it respond to this request , but when CDC sent a proposed response to UNICEF,
UNICEF asked CDC, “why we cannot prove or disprove this claim despite the fact that this issue
has been followed since 2001.”116 The email exchange between CDC and UNICEF does not appear

110 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ). As an example of the
necessity for utilizing randomization to avoid bias, unvaccinated children often do not receive vaccines because they are
very frail, malnourished, or sick, and hence more likely to die irrespective of vaccination. Thus, the unvaccinat ed group
is often sicker than the vaccinated group, making the vaccine appear safer. By randomly picking which children receive
or do not receive the DTP vaccine, a researcher can avoid this type of bias.
111 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ).
112 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ).
113 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/  (https://perma.cc/6R29 -ZSHK ).
114 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5868131/pdf/fpubh -06-00079.pdf  (https://perma.cc/7F7U -
ZZWJ ).
115 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5868131/pdf/fpubh -06-00079.pdf  (https://perma.cc/7F7U -
ZZWJ ).
116 https://icandecide.org/UNICEF -Emails .
16
 to seriously consider the data or studies but, rather, appeared to view them as a public relations issue.

SLIDES 30 : IMPACT OF IMMUNITY ON MARKET FORCES

Prior to 1986, when there were only 3 routine vaccines totaling 7 injections,117 the financial
liability related to injuries from these products resulted in companies exiting the market.118 Instead
of allowing economic interests to drive innovation of safer vaccine products, the National
Childhood Vaccine Injury Act of 1986 (the “1986 Act”) gave pharmaceutical companies immunity
for vaccine injuries for those products and any routine childhood vaccine added to CDC’s schedule
thereafter.119

As of 2025, CDC’s maternal and childhood schedules lists 19 vaccines totaling 84 injections,
virtually all of which were licensed after 1986 by companies conducting clinical trials with the
knowledge they would generally not be liable for any injuries caus ed by their vaccine products .120
The following graphic reflects the routine vaccines, both injected and oral, an infant following the
CDC’s vaccine schedule would receive in utero and up to 12 months of age in 1986 versus 2025:

The following chart reflects all routine and shared clinical decision -making  vaccines ( COVID -19
and MenB vaccines) a child would receive in 1983 versus 2025:

117 https://www.cdc.gov/vaccines/schedules/images/schedule1983s.jpg .
118 Bruesewitz v. Wyeth , 562 U.S. 223  (2011)  (“the remaining manufacturer [of DTP] estimated that its potential tort
liability exceeded its annual sales by a factor of 200”); Institute of Medicine, Adverse Events Associated with
Childhood Vaccines , at 2 (1994), https://pubmed.ncbi.nlm.nih.gov/25144097/  (By 1986, “litigation costs associated
with claims of damage from vaccines had forced several companies to end their vaccine research and development
programs as well as to stop producing already licensed vaccines.”).
119 42 U.S.C. § 300aa -11 (“No person may bring a civil action for damages … against a vaccine administrator or
manufacturer … for damages arising from a  vaccine -related injury or death  associated with the administration of a
vaccine”); Bruesewitz v. Wyeth , 562 U.S. 223  (2011)  (“[W]e hold that the National Childhood Vaccine Injury Act pre -
empts all design -defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury
or death caused by a vaccine side effects.”).
120 https://www.cdc.gov/vaccines/parents/by -age/pregnancy.html ; https://www.cdc.gov/vaccines/schedules/ down
loads/child/0 -18yrs -child -combined -schedule.pdf  (assumes each vaccine given individually and COVID -19 vaccine
given annually).

17

Because companies remain liable for injuries  caused by  drugs , this provides an incentive to
conduct long -term placebo -controlled trials to confirm the safety of drug products before licensure
to avoid financial loss after licensure. For example, the following chart includes what are reported
as the four most profitable drugs sold by Pfizer as of 2019, along with the control and safety
duration in their licensure trial:

In contrast, for vaccine products, the economic incentive to assess safety prior to licensure was
mostly eliminated by the 1986 Act.121 This is because long -term placebo -controlled trials for
vaccine products do not make financial sense for companies seeking to maximize profits. To the
contrary, while assuring safety in drug trials is aligned with a company’s economic interest, it is
in conflict when it comes to vaccine trials. This provides context for the fact that, as seen in the
prior section, every routine childhood vaccine recommended by the CDC was licensed without a
placebo control; was monitored for safety after administration for typically six months or less,
sometimes only days or weeks; and often had too few participants to detect safety  signals.

Further, HHS and its agencies  have a structural conflict with regard to  vaccine safety . This is
because HHS’s responsibility to  promote and defend vaccines conflicts with its safety duties.

Because duties to promote an industry inherently conflict with duties to identify and address safety
issues within that industry, outside of vaccines, these duties are often separated into independent
agencies. For example,  DOT  promotes  transportation  while  safety  functions  are handled  by the
independent  NTSB.122 Similarly,  DOE  promotes  nuclear  power  while  safety  functions  are handled
by the independent  NRC.123 But with vaccines, these conflicting duties are handled by the same
entity: HHS.

121 42 U.S.C. §§ 300aa -1 through 300aa -34.
122 https://www.ntsb.gov/about/history/pages/default.aspx .
123 https://www.nrc.gov/about -nrc/history.html ; https://www.energy.gov/ne/office -nuclear -energy .

18

Moreover, HHS is statutorily required to and does vigorously defend against vaccine injury claims.
Under the 1986 Act, one can bring a claim for a vaccine injury, but it is brought against the
Secretary of HHS in the Vaccine Injury Compensation Program (“V ICP”). This further conflicts
HHS, including because any safety issues identified can be used against HHS in the VICP.124
Vaccines are the only consumer product I am aware of where the government defends industry
interests against consumers, instead of vice -versa.

These structural conflicts in regulating vaccines can result in regulators viewing and conducting
themselves as partners with pharmaceutical companies rather than as regulators.  Moreover, once
federal regulators have heavily promoted vaccine products, something they do not do with drug
products, later admitting they cause harms could result in a loss of public confidence in HHS, the
FDA, and the CDC and its vaccine schedule . It could also result in liability to HHS where it would
need to pay out damages as the respondent to claims in the VICP and the Countermeasures Injury
Compensation Program (“CICP”). These create intractable and concerning  structural conflicts
with regard to HHS addressing vaccine safety.

SLIDES 34 -37: IOM REPORTS

The degree of thoroughness of the post -licensure vaccine safety literature can be seen from IOM
reviews on vaccine safety paid for by HHS, CDC, and/or other federal health agencies.

In 1991, at HHS’s request per the 1986 Act, the IOM issued a report that evaluated 22 reported
serious injuries from pertussis and rubella vaccines.125 The IOM located sufficient science to
support that 6 serious injuries are causally related to these vaccines, including acute
encephalopathy (brain damage) and chronic arthritis.126 The IOM, however, found that studies had
not been conducted in order for it to conclude whether or not these vaccines caused 12 other
commonly reported serious injuries, including:

Autism, Aseptic Meningitis, Chronic Neurological Damage,
Guillain -Barre Syndrome, Juvenile Diabetes, Learning Disabilities,
Attention -Deficit Disorder, Thrombocytopenia127

In 1994, again at HHS’s request per the 1986 Act, the IOM evaluated 54 commonly reported
serious injuries and vaccines for diphtheria, tetanus, measles, mumps, polio, hep B, and Hib.128

124 42 U.S.C. § 300aa -12 (“In all proceedings brought by the filing of a petition [in VICP] the Secretary [of HHS] shall
be named as the respondent.”); https://www.congress.gov/106/crpt/hrpt977/CRPT -106hr pt977.pdf  (“DOJ attorneys
make full use of the apparently limitless resources available to them,” “pursued aggressive defenses in compensation
cases,” “establish[ed] a cadre of attorneys specializing in vaccine injury” and “an expert witness program to challenge
claims.”);  https://uscfc.uscourts.gov/vaccine -programoffice -special -masters .
125 https://nap.nationalacademies.org/read/1815/chapter/1 .
126 https://nap.n ationalacademies.org/read/1815/chapter/2#7 .
127 https://nap.nationalacademies.org/read/1815/chapter/2#7 .
128 https://www.nap.edu/read/2138/chapter/2#12 .
19
 The IOM located sufficient science to support that 12 serious injuries are causally related to these
vaccines, including death, thrombocytopenia, and GBS.129 The IOM, however, found that studies
had not been conducted in order for it to conclude whether or not these vaccines caused 38 other
commonly reported serious injuries, including:

Arthritis, Aseptic Meningitis, Demyelinating diseases of the central
nervous system, Insulin -Dependent Diabetes Mellitus, Myelitis,
Neuropathy, Residual Seizure Disorder, Sensorineural Deafness,
Sudden Infant Death Syndrome, Sterility, Transverse Optic
Neuritis130

The IOM explained: “The lack of adequate data regarding many of the adverse events under study
was of major concern to the committee. Presentations at public meetings indicated that many
parents and physicians share this concern.”131

Fifteen years later, in 2012, the CDC and HRSA, paid the IOM to review what they stated were
the 158 most common injuries claimed to be caused by various childhood vaccines.132 The IOM
located science to support that 18 serious injuries were causally related to these vaccines, including
pneumonia, meningitis, MIBE, and febrile seizures.133 The IOM, however, found that studies had
not been conducted in order for it to conclude whether or not these vaccines caused 135 other
commonly reported serious injuries, including:

Acute Disseminated Encephalomyelitis, Afebrile  Seizures,
Amyotrophic Lateral Sclerosis, Arthralgia, Autoimmune Hepatitis,
Brachial Neuritis, Cerebellar Ataxia, Chronic Headache, Chronic
Inflammatory Demyelinating Poly -neuropathy, Chronic Urticaria,
Encephalitis, Encephalopathy, Erythema Nodosum, Fibrom yalgia,
Guillain -Barré Syndrome, Hearing Loss, Immune Thrombocytopenic
Purpura, Infantile Spasms, Juvenile Idiopathic Arthritis, Multiple
Sclerosis, Neuromyelitis Optica, Optic Neuritis, Polyarteritis Nodosa,
Psoriatic Arthritis, Reactive Arthritis, Rheumatoid Arthritis, Seizures,
Small Fiber Neuropathy, Stroke, Sudden Infant Death Syndrome,
Systemic Lupus Erythematosus, Thrombocytopenia, Transverse
Myelitis134

This means that even among the 158 serious injuries that the CDC and HRSA (an agency which
defends against vaccine injury claims) identified as the most commonly claimed injuries from

129 https://www.nap.edu/read/2138/chapter/2#12 .
130 https://www.nap.edu/read/2138/chapter/2#12 .
131 https://www.nap.edu/read/2138/chapter/12 .
132 https://www.nap.edu/read/2138/chapter/12 .
133 https://www.nap.edu/read/13164/chapter/2#3 .
134 https://www.nap.edu/read/13164/chapter/2#3 .
20
 vaccines, the CDC nor the greater scientific community have conducted the studies necessary to
rule out vaccines as a cause for over 86% of these commonly claimed vaccine harms. 135

In addition to these IOM reports, HHS has also relied upon what it has asserted is “ the most
comprehensive review ” of the literature on vaccine safety ever conducted —a 740 -page vaccine
safety report from 2014 by AHRQ —to claim that routine childhood vaccines are safe.136
This 2014 report begins by identifying 20,478 studies as related or potentially related to vaccine
safety and excludes 20,312 of them for various reasons including that they did not address vaccine
safety, or had an unacceptable design.137 After this weeding out process, AHRQ was left with only
166 studies it deemed relevant and potentially reliable for assessing vaccine safety, and only 97 of
those involved children.
Hence, AHRQ, in what HHS said is “the most comprehensive review” of the literature on vaccine
safety, found there were only 97 studies ever conducted that it deemed potentially reliable to assess
the safety of childhood vaccines given to babies and childre n in the United States. This initial list
did not mean these 97 studies supported that one or more vaccines were safe, that was just the
initial universe of studies AHRQ said it identified to potentially  answer that question.
These 97 studies were virtually all funded and/or authored (usually both) by a pharmaceutical
company reviewing its own vaccine.138 AHRQ excluded all individual case reports (usually
instances of immediate and obvious vaccine injuries) despite the fact that practitioners can
typically afford to publish only in this form.139 It excluded all experimental studies which could
explain the biological mechanisms of how vaccines can cause injury or death, such as studies on
how vaccines or aluminum adjuvants can cause immune system dysregulation.140 It also excluded
animal studies which – because of ethical restrictions applicable to human research – often provide
the scientific evidence of how vaccines can cause harm.141
The result is that this “comprehensive review” included only 97 studies that are applicable to
children,142 77 of which were directly funded and/or authored (typically both) by the very pharma
company whose vaccine(s) the study reviews.143 As for the remaining 20 studies, almost all were

135 https://www.nap.edu/read/13164/chapter/2#3 .
136 https://www.ncbi.nlm.nih.gov/books/NBK230053/ ; https://archive.org/details/hhs -response -1.
137 Id.
138 Id.
139 Id.
140 Id.
141 Id. (AHRQ also excluded studies using VAERS, one of the few resources available to study vaccine safety without
pharma type funding).
142 Excluding two studies it double counted.
143 https://www.ncbi.nlm.nih.gov/books/NBK230053/ .
21
 funded and/or authored by agencies and/or individuals that directly or indirectly receive funding
from the pharma company whose vaccine(s) the study reviews.144
AHRQ then further cut down these 97 studies, explaining that comparing vaccinated (exposed)
and unvaccinated (unexposed) children is critical for evaluating vaccine safety and asserts that
only 59 of these studies compared “vaccinated versus unvaccinated c hildren or adolescents.”145
As for the 59 studies that AHRQ claims compared “vaccinated versus unvaccinated children or
adolescents,” the following is a breakdown of these studies by vaccine type: rotavirus (34 studies),
HPV (13 studies), influenza (6 studies), Hib (3 studies), menin gococcal (2 studies), and varicella
(1 study). 146 Note that only 20 of these 59 studies involve an injected vaccine; the remainder
involve rotavirus which is given orally and two of the influenza studies involve inhaled strains.147
Hence , among these 59 studies, there are no studies for the following seven vaccines: Hep B, DTaP,
PCV, IPV, MMR, Hep A, or Tdap. These seven vaccines constitute a majority of the routine
childhood vaccines, including four vaccines injected three times each in the first six months of
life—Hep B, DTaP, PCV, and IPV.
This means that the “most comprehensive review” of the literature on vaccine safety, according to
HHS, did not identify any study meeting its own criteria of reliability for a majority of the routine
vaccines on CDC’s childhood schedule.
As for the 59 studies AHRQ did identify for six different vaccines, AHRQ’s claim that they each
had an unvaccinated group is inaccurate . This is because in almost all the studies involving an
injected vaccine, the control group was vaccinated or injected with one or more active vaccine
ingredients.
For example, in the three Hib studies that AHRQ labeled as “vaccinated versus unvaccinated
children or adolescents,” the “control group” were all vaccinated. By way of example, one of these
studies reviewed the Hib -PHiD vaccine made by GSK in a study funde d by GSK and authored by
GSK employees which, incidentally, is not a U.S. vaccine. It compared 199 infants who received
Hib-PHiD, DTPa, HBV, IPV, and Hib (the experimental group) with 101 infants who received
DTPa, HBV, IPV, and Hib (the control group whic h AHRQ labeled “unvaccinated”).148 Labeling
this a “vaccinated versus unvaccinated” study is not accurate. It is noteworthy that approximately
5% of infants in each group reported a serious adverse event, yet because  the rates were similar in

144 Id.
145 Id.
146 Id.
147 The 34 rotavirus studies that AHRQ claims compare “vaccinated with unvaccinated children” compared children
receiving oral drops of rotavirus with children receiving oral drops of the following vaccine ingredients: Polysorbate 80,
Citrate, Phosphate, Dext ran, Sorbitol, Amino acids, Dulbecco’s Modified Eagle Medium, Calcium Carbonate, and/or
Xanthan. See Chapter 10 . The two studies involving LAIV, an inhaled influenza vaccine, involved a pharma company
reviewing its own product: one involved 20 immunocompromised children with cancer in which 10 received LAIV
and 10 received a placebo, https://pubmed.ncbi.nlm.nih.gov/21496468/  (https://perma.cc/8MP9 -EHHT ), and the other
compared 261 children who received LAIV with 65 children who first received placebo and were then offered LAIV
after 28 days, https://pubmed.ncbi.nlm.nih.gov/21060780/  (https://perma.cc/7L2Y -PW9V ).
148 https://pubmed.ncbi.nlm.nih.gov/23432812/  (https://perma.cc/7HDW -4XFY ).
22
 each group, the vaccine was deemed “safe” by the GSK employees studying a GSK vaccine in a
GSK -funded study.149
Using one final example, in all 13 studies involving HPV vaccine that AHRQ labels “vaccinated
versus unvaccinated adolescents,” the “unvaccinated” group either received a vaccine or an
injection of an adjuvant in the HPV vaccine, AAHS (save one study in which 17 girls apparently
received nothing).150 HPV vaccines were studied in adolescent s and older women who, unlike
children or babies, can articulate if they are experiencing a serious adverse reaction, such as
neurological issues. In most of these studies, the rate of serious adverse event reports in both groups
(the vaccinated group and the fake “unvaccinated” group) were , in some instances , in the  double
digits . The vaccine was deemed “safe” in these GSK - or Merck -funded studies using their own
employees reviewing their own vaccine because the rate of harm was similar in both groups.151
For context, and reflecting a bias that may have driven this review, AHRQ’s “comprehensive
review” began by expressing concern that “vaccination rates remain well below established
Healthy People 2020 targets for many vaccines” and that “[i]ncreasing vaccination rates remains
critically important.”152 It laments that “public concerns about vaccine safety continue to persist”
despite “the rigorous processes new vaccines must undergo before receiving approval” and that
they meet “stringent criteria for safety.”153 It is unclear whether the authors of this review reviewed
the clinical trials relied upon to license childhood vaccines.
It is also noteworthy that, despite only accepting a limited number of studies as reliable, it did find
support for one or more childhood vaccines causing: febrile seizures, arthralgia, thrombocytopenic
purpura, meningitis , and encephalitis.154

SLIDES 39 -44: INJURY CLAIMED TO HAVE BEEN MOST THOROUGLY STUDIED
These slides discuss autism  because  is it is the adverse event claimed to have been the most
thoroughly studied in relation to vaccines and hence provides a good indication of how well other
adverse events have been studied.

While autism was relatively uncommon in the early 1980s, it was a serious enough concern that in
the 1986 Act, Congress required that the federal health authorities review the scientific literature
regarding whether there is a connection between pertussis -containing vaccines and autism. As
provided in the 1986 Act: “the Secretary of Health and Human Services shall complete a review
of all relevant medical and scientific information … on the nature, circumstances, and extent of

149 https://pubmed.ncbi.nlm.nih.gov/23432812/  (https://perma.cc/7HDW -4XFY ); https://www.icandecide.org/wp -
content/uploads/ 2019/09/ICAN -Reply -1.pdf  at pp. 36 -42 (https://perma.cc/LX4V -LDVP ).
150 https://www.icandecide.org/wp -content/uploads/ 2019/09/ICAN -Reply -1.pdf  at pp. 36 -42 (https://perma.cc/LX4V
-LDVP ).
151 Id.
152 Id.
153 Id.
154 Id.
23
 the relationship, if any, between vaccines containing pertussis (including whole cell, extracts, and
specific antigens) and … Autism.”155

HHS in turn commissioned the IOM to conduct this review. When that review was published in
1991, the IOM explained that it could not identify any study to support the claim that pertussis
vaccines do not cause autism. As explained by the IOM: “No data were  identified that address the
question of a relation between vaccination with DPT or its pertussis component and autism.”156

The IOM committee included the following warning in its 1991 report:

In the course of its review, the committee found many gaps and
limitations in knowledge bearing directly and indirectly on the
safety of vaccines.  … If research capacity and accomplishment in
this field are not improved, future reviews of vaccine safety will be
similarly handicapped.157

Two decades later, in 2012, the IOM issued another report on vaccine safety, this time
commissioned by the CDC and HRSA, which again assess ed the evidence bearing on whether
pertussis vaccines, including DTaP, cause autism. It did so because, according to HRSA, autism
remained one of the most commonly claimed injuries from this vaccine.158 This time, the request
to the IOM also included reviewing whether tetanus and diphtheria vaccines can cause autism.

The IOM again convened a committee composed of individuals with expertise in pediatrics,
internal medicine, neurology, immunology, immunotoxicology, neurobiology, rheumatology,
epidemiology, biostatistics, and law to answer th ese question s.159

As in 1991, the IOM again was unable to locate a study supporting the claim that DTaP does not
cause autism. The IOM concluded in its 2012 report: “The evidence is inadequate to accept or
reject a causal relationship between diphtheria toxoid –, tetanus tox oid–, or acellular pertussis –
containing vaccine and autism.”160

The following is the IOM’s full explanation for this finding in its 2012 report:

AUTISM
Epidemiologic Evidence
The committee reviewed one study to evaluate the risk of autism
after the administration of DTaP vaccine. This one study (Geier and
Geier, 2004) was not considered in the weight of epidemiologic

155 https://nap.nationalacademies.org/read/12796/chapter/12#268 .
156 https://www.nap.edu/read/1815/chapter/1#v .
157 https://www.nap.edu/read/1815/chapter/9 .
158 https://www.nap.edu/read/13164/chapter/2#2 .
159 https://www.nap.edu/read/13164/chapter/1#v .
160 https://www.nap.edu/read/13164/chapter/12#545 .
24
 evidence because it provided data from a passive surveillance
system and lacked an unvaccinated comparison population.
Weight of Epidemiologic Evidence
The epidemiologic evidence is insufficient or absent to assess an
association between diphtheria toxoid -, tetanus toxoid -, or acellular
pertussis -containing vaccine and autism.

Mechanistic Evidence
The committee did not identify literature reporting clinical,
diagnostic, or experimental evidence of autism after the
administration of vaccines containing diphtheria toxoid, tetanus
toxoid, and acellular pertussis antigens alone or in combination.
Weight of Mechanistic Evidence
The committee assesses the mechanistic evidence regarding an
association between diphtheria toxoid -, tetanus toxoid -, or acellular
pertussis -containing vaccine and autism as lacking.

Causality Conclusion
Conclusion 10.6:  The evidence is inadequate to accept or reject a
causal relationship between diphtheria toxoid -, tetanus toxoid -, or
acellular pertussis -containing vaccine and autism.
The single study the IOM could locate regarding whether DTaP causes autism (Geier and Geier,
2004) concluded that there was an association between DTaP and autism.161 The IOM gave this
study no weight because it was based on VAERS reports.

The 2012 report from the IOM also looked at whether MMR vaccine, recommended for routine
administration after one year of age, can cause autism.162 The IOM identified 22 studies that
evaluated the connection between MMR vaccine and autism, but did not rely on 17 of them due to
lack of “unvaccinated comparison population,” “individual -level data,” or “methodological
limitations.” 163 Based on the remaining five studies, none of which involved  children in the United
States, the IOM concluded that, “The evidence favors rejection of a causal relationship between
MMR vaccine and autism.” 164 This conclusion reflects that studies can be conducted which the
IOM is willing to rely upon to reach a conclusion that a particular vaccine does not cause autism.
That said, the IOM’s conclusion regarding MMR vaccine and autism does not support the much
broader claim that “vaccines do not cause autism,” as it only addresses whether the MMR vaccine

161 https://www.nap.edu/read/13164/chapter/12?term=autism#545 .
162 https://nap.nationalacademies.org/read/13164/chapter/6#145 .
163 https://nap.nationalacademies.org/read/13164/chapter/6#145 .
164 https://nap.nationalacademies.org/read/13164/chapter/6#145 .
25
 can cause autism . It does not address  whether any other vaccines, especially those given to infants,
can cause autism.165

Two years later, in 2014, the AHRQ conducted a review which again included looked at any study
regarding pertussis, tetanus, and diphtheria vaccines, including DTaP, and autism.166 HHS has
explained in 2018 that this report represented “the most comprehensive review to date of published
studies on the safety of routine vaccines recommended for children in the United States.”167 As
with the IOM reports from 1991 and 2012, the “comprehensive review” published by AHRQ in
2014 again concluded that it could not identify a study to support the claim that DTaP,
administered at 2, 4, and 6 months of age, does not cause autism.168

AHRQ also reviewed autism and Hep B vaccine, administered at 1 day, 1 month, and 6 months of
age, and did not identify a study to support the claim that this vaccine does not  cause autism.169
Instead, the only study meeting AHRQ’s criteria for reliability was from the Stony Brook
University Medical Center which found a 300% increased rate of autism among newborns
receiving a Hep B vaccine at birth compared to those who did not get this vaccine  at birth. AHRQ’s
2014 review summarizes the results of this study as follows:

Result was significant for the risk of autism in children who received
their first dose of Hepatitis B vaccine during the first month of life
(OR 3.00, 95% CI 1.11, 8.13), compared with those who received
the vaccination after the first month of life or no t at all.170

AHRQ therefore identified one study that showed an association, and no studies to support that
Hep B vaccine does not cause autism; its conclusion was that it does not know whether the Hep B
vaccine causes autism.171

A subsequent October 12, 2017 letter sent to HHS and signed by Robert F. Kennedy Jr. and others
explained that there are no published studies supporting that the vaccines given in the first year of
life do not cause autism. The letter asked HHS to “ identify the specific studies on which HHS
bases its blanket claim that no vaccines cause autism.”172 The letter also cited to studies which did
find an association between one or more of these vaccines and autism and provided scientific
support and letters from world -leading aluminum scientists on how this particular vaccine
ingredient could cause autism.173

165 https://nap.nationalacademies.org/read/13164/chapter/6#145 .
166 https://www.ncbi.nlm.nih.gov/books/NBK230053/pdf/Bookshelf_NBK230053.pdf .
167 https://archive.org/details/hhs -response -1.
168 https://www.ncbi.nlm.nih.gov/books/NBK230053/pdf/Bookshelf_NBK230053.pdf .
169 Id.
170 Id.
171 Id.
172 https://archive.org/details/ican -hhs-notice -1 at 13 .
173 Id.
26
 On January 18, 2018, HHS  sent a response which provided various links to CDC webpages but
neither those links nor the content of those webpages identified  a study which supports the claim
that the vaccines given to infants  do not cause autism.174 This was explained in a follow -up letter
to HHS which again requested any supporting studies and again reiterated the data regarding how
aluminum adjuvants can cause autism.175 It also specifically asked HHS the following:

The following white paper provides the peer reviewed scientific
support for how aluminum adjuvants injected into the body travel to
the brain, can cause IL -6 production and microglial activation in the
brain, and that this in turn can cause autism: http:// icandecide.
org/white -papers/ ICAN -Aluminum Adjuvant -Autism.pdf. Please
clearly and specifically explain which steps in this chain of
causation or any other aspect of this white paper HHS disputes.176

No response from HHS was ever provided to rebut these studies or scientific findings.177

On December 31, 2019, the CDC was sued in federal court for failing to provide studies in response
to a Freedom of Information Act request submitted to the CDC seeking studies it relied upon to
support that the vaccines the CDC recommends be given in the f irst year of life —DTaP, Hep B,
Hib, PCV13, and IPV, individually and collectively —do not cause autism.178

To resolve the lawsuit, the CDC provided a list of the 16 studies and 4 reviews it claimed support
the claim that the foregoing vaccines do not cause autism. This list was memorialized in a signed
stipulation with the CDC on February 28, 2020, and then ent ered as an order of the Court on March
2, 2020.179 The stipulation and order provided in relevant part as follows:180

WHEREAS, the Institute for Autism Science and Informed
Consent Action Network (“ICAN”) commenced the above -
captioned lawsuit against the Centers for Disease Control and
Prevention (“CDC”) regarding six  Freedom of Information Act
requests (the  “FOIA Requests ”);

WHEREAS,  the FOIA  Requests  were  as follows:

• “All studies  relied  upon  by CDC  to claim  that the

174 https://archive.org/details/hhs -response -1.
175 https://archive.org/details/ican -reply -1.
176 Id at 83 .
177 https://archive.org/details/ican -follow -up-final.
178 https://ecf.nysd.uscourts.gov/doc1/127026118709  (https://www.courtlistener.com/docket/16644712/1/institute -
for-autism -science -v-centers -for-disease -control -and-prevention/ ); https://ecf.nysd.uscourts.gov/doc1/127126484251 .
179 https://ecf.nysd.uscourts.gov/doc1/127126484251  (https://www.courtlistener.com/docket/16644712/15/institute -
for-autism -science -v-centers -for-disease -control -and-prevention/ ).
180 https://ecf.nysd.uscourts.gov/doc1/127126484251  (https://www.courtlistener.com/docket/16644712/15/institute -
for-autism -science -v-centers -for-disease -control -and-prevention/ ).
27
 DTaP  vaccine  does not cause autism.”
• “All studies relied upon by CDC to claim that neither
Engerix -B nor Recombivax HB do not cause
autism.”
• “All studies relied upon by  CDC  to claim  that
Prevnar 13  does not cause autism.”
• “All studies relied  upon by  CDC  to claim  that Hib
vaccines do not cause autism.”
• “All studies relied upon by CDC to claim that
inactivated polio vaccine (‘IPV’) does not cause
autism.”
• “Copies of the studies the CDC relies upon to claim
that the cumulative exposure of vaccines it
recommends that babies be administered  during  the
first six months  of life do not cause  autism.”

WHEREAS,  after conducting  a search  of its records, the
CDC identified  the following studies responsive to the FOIA
Requests:

1. Madsen  KM, Hviid A, Vestergaard M,  Schendel D,
Wohlfahrt J,  et al. A population -based study of  measles,
mumps,  and rubella  vaccination  and autism.  N Engl  J Med.
2002;347  (19): 1477-1482.
2. IOM  (Institute  of Medicine).  2012.  Adverse  Effects  of
Vaccines:  Evidence  and Causality. Washington, DC: The
National Academies Press.
3. IOM (Institute of Medicine). 2004. Immunization Safety
Review: Vaccines and Autism. Washington, DC: The
National Academies Press.
4. IOM  (Institute  of Medicine).  2013.  The childhood
immunization  schedule and  safety: Stakeholder concerns,
scientific  evidence, and  future  studies.  Washington, DC:  The
National  Academies Press.
5. Frombonne E, Zakarian R, Bennett A, et al. Pervasive
developmental disorders in Montreal, Quebec, Canada:
prevalence and links  with immunizations.  Pediatrics.
2006;118(1):el39 -50.
6. Taylor LE, Swerdfeger AL,  Eslick GD. Vaccines are not
associated with autism: An evidence based meta -analysis of
case-control and  coh01t  studies.  Vaccine.  2014;32:3623 -
3629.
7. Ball L, Ball R, Pratt RD. An assessment of thimerosal in
childhood vaccines. Pediatrics. 2001;107:1147 -1154.
8. Hviid  A, Stellfeld  M, Wohlfahrt J,  Melbye  M. Association
between thimerosal -containing  vaccine and autism. JAMA.
2003;290:1763 -6.
28
 9. Madsen  KM, Lauritsen  MB, Pedersen  CB, et al. Thimerosal
and the occurrence  of autism:  negative ecological evidence
from Danish population -based data.  Pediatrics.  2003;112(3
Pt 1):604 -6.
10. Stehr -Green P, Tull P, Stellfeld M, et al. Autism and
thimerosal -containing vaccines: lack of consistent evidence
for an association. Am JPrev Med. 2003;25(2):101 -6.
11. Verstraeten T, Davis RL, Destefano F, et al. Safety of
thimerosal -containing vaccines: a two phased study of
computerized health maintenance organization databases.
Pediatrics. 2003;112(5):1039 -48.
12. Andrews  N, Miller  E, Grant  A, et al. Thimerosal  exposure  in
infants  and developmental  disorders: a retrospective cohort
study in the United Kingdom does not supp01t a causal
association. Pediatrics. 2004;114(3):584 -91.
13. Thompson WW, Price C, Goodson B, et al.  Early thimerosal
exposure and neuropsychological outcomes  at 7 to 10 years.
N Engl JMed. 2007;357(13):1281 -92.
14. McMahon  AW,  Iskander  Il(, Haber  P, Braun  MM,  Ball R.
Inactivated influenza  vaccine (IIV) in children  <2 years  of
age: Examination  of selected  adverse  events  reported  to the
Vaccine  Adverse Event Reporting System (VAERS) after
thimerosal -free or thimerosal -containing vaccine. Vaccine.
2008 Jan; 26(3):427 -429.
15. Schechter R, Grether Il(.  Continuing increases in autism
reported to California's developmental services system:
Mercury in retrograde. Arch Gen  Psychiatry. 2008;65:19 -24.
16. DeStefano F.  Thimerosal -containing  vaccines: evidence
versus public apprehension. Expe1t Opin Drug Saf.
2009;8(1):1 -4.
17. Tozzi AE, Bisiacchi P, Tarantino V, et al.
Neuropsychological performance 10 years after
immunization in infancy with  thimerosal -containing
vaccines. Pediatrics. 2009;123(2):475 -482.
18. Price CS, Thompson WW, Goodson B, et al. Prenatal and
infant exposure to thimerosal from vaccines and
immunoglobulins  and risk  of autism.  Pediatrics.
2010;126(4):656 -64.
19. Barile JP, Kuperminc GP, Weintraub ES, et al. Thimerosal
exposure in early life and neuropsychological outcomes 7 -
10 years  later.  J Pediatr  Psychol. 2012;37(1):106 -18.
20. Destefano F,  Price CS, Weintraub ES.  Increasing exposure
to antibody -stimulating  proteins and polysaccharides in
vaccines is  not associated with risk  of autism. J  Pediatr.
2013;163(2):561 -7.

29
 None of these 20 studies /reviews identified by the CDC included a study to support the claim that
the vaccines on the CDC’s childhood vaccine schedule given to infants —DTaP, Hep B, Hib,
PCV13, and IPV —do not cause autism. Instead, these 20 studies /reviews include:

• 15 studies and 3 reviews concerning MMR and/or thimerosal;
• 1 study concerning antigen (not vaccine) exposure; and
• 1 review concerning MMR, thimerosal, and DTaP.
Hence, only one of the 20 studies /reviews identified by the CDC involved a vaccine given to
infants, DTaP. This was the review the IOM published in 2012, discussed above, which failed to
identify a study to support that DTaP does not cause autism. Instead, it found only one study
regarding DTaP vaccine and autism, and that study found an association between this vaccine and
autism. Hence, the only study or review out of 20 identi fied by the CDC that reviewed a vaccine
given during the first year of life was a study which did find  an associa tion between DTaP vaccine
and autism.

On August 25, 2020, the head of CDC’s Clinical Immunization Safety Assessment (CISA) Project,
one of the four vaccine safety systems listed on the CDC’s website, was questioned under oath in
a case specifically about autism and vaccines . She also confirmed that there are no studies to
support that infant vaccines do not cause autism :

Q: [A]ccording to your profile, you have done most of the clinical trials relied upon
to license many of the vaccines, correct, on the market?
A: Yes, sir.
Q: Okay. So you’re highly experienced at conducting clinical trials; correct?
A: I am highly experienced conducting clinical trials.
Q: ... And you’re familiar with many of the clinical trials that -- relied upon to
license many of the vaccines currently on the market; correct?
A: I am.
Q: Okay. In your opinion, did the clinical trials relied upon to license the vaccines
that [the child] received, many of which are still on the market today, were they
designed to rule out that the vaccine causes autism?
A: No. …
Q: [I]n the expert disclosures for this case, it asserts that among other things you
will testify that, quote, the issue of whether vaccines cause autism has been
thoroughly researched and rejected, end quote. …
Q: … It’s your testimony that MMR vaccine cannot cause autism?
A: That’s correct.
Q: It’s your testimony the HepB vaccine cannot cause autism?
A: That’s correct.
Q: It’s your testimony that IPOL cannot cause autism?
A: Yes.
Q: It’s your testimony that Hib vaccine cannot cause autism?
A: Yes.
Q: It’s your testimony that varicella vaccine cannot cause autism?
A: Yes.
Q: It’s your testimony that Prevnar vaccine cannot cause autism?
30
 A: Yes.
Q: And it’s your testimony that DTaP vaccine cannot cause autism?
A: Yes.  …
Q: And do you have a study that supports that DTaP doesn’t cause autism?
A: I have -- I do not have a study that -- that DTaP causes autism, so I don’t have
either.
Q: … Do you have any study one way or another of whether IPOL causes autism?
A: No, I do not, sir.
Q: Do you have any study one way or another of whether Engerix -B causes autism?
A: I do not have any evidence that it causes autism, nor that it does not.
Q: And what about HibTITERs vaccine, any evidence one way or another of
whether it causes autism?
A: No.  …
Q: … And what about Prevnar vaccine? Any evidence, one way or another?
A: No, sir. No, sir.  …
Q: … And how about varicella vaccines … are there any studies one way or another
that support whether it does or doesn’t cause autism?
A: [As p]art of MMR, but not as varicella by itself, no sir. No studies that say it
does or no studies that say it doesn’t.
Q: … There have been studies that have found an association between hepatitis B
vaccine and autism; correct?
A: Not studies that I feel are credible.
Q: Okay. Which study -- which study … are you referring to when you say that?
A: Well, why don’t you show me the study and then I’ll say whether I agree with
it.181

As the foregoing reflects, and as explained by the Secretary of Health and Human Services, Robert
F. Kennedy Jr., the CDC cannot claim that vaccines given in the first year of life do not cause
autism. It cannot do so because the studies to disprove that t he vaccines given to infants do not
cause autism have not been conducted.

The need for studies regarding whether these vaccines have contributed to the autism epidemic is
acute. Since the 1980s, the rise in cases of autism has occurred in lockstep across all geographic
areas of the United States and across all racial, ethnic, an d religious groups .182

Given the steep rise, the cause of autism is an environmental change that has occurred throughout
the United States since the early 1980s. A study published in Environmental Health  out of the
University of Colorado reviewed the correlations between numerous environmental factors
suspected of potentially causing autism and the change in the level of their exposure during
childhood since the 1980.183 The environmental exposure in the study showing the highest

181 https://archive.org/details/kathryn -edwards -full-pdf-transcript .
182 See The CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network, https://www.cdc. gov/
ncbddd/autism/addm.html , the U.S. Department of Education data collected pursuant to the Individuals with
Disabilities Act (IDEA),  https://sites.ed.gov/idea/data/ , and the California Department of Developmental Services
(CDDS), https://www.dds.ca.gov/transparency/autism/ .
183 https://pubmed.ncbi.nlm.nih.gov/25189402/ .
31
 statistical correlation with autism rates was the increasing doses of vaccination. The following
charts are from this study. The circles represent the number of vaccine doses and the triangles
represents the rate of autism:

Figure S8. Temporal trend in autism compared to temporal trend in
cumulative number of immunizations administered to U.S. infants
and toddlers by 2, 6, 12 and 18 months via immunization according
to the CDC recommended schedule.184

Correlation does not equal causation, but it does provide a safety signal that merits investigation,
including because numerous studies support immune dysfunction as a cause of autism and vaccines
are intended to and do systemically modify the immune syste m. Additionally, a significant
proportion of parents of children with autism identify vaccines as what they believe caused their
child’s autism, including pointing to the vaccines given in the first six months of life.185

SLIDE 45:  ADVERSE REACTIONS MANUFACTURERS HAVE A BASIS
TO BELIEVE ARE CAUSALLY RELATED
Pharmaceutical companies have access to internal vaccine safety data that is unavailable to public
health agencies and the public.

Federal law requires pharmaceutical companies to disclose, in the package insert for each vaccine,
“only those adverse events for which there is some basis to believe there is a  causal
relationship  between the drug and the occurrence of the adverse event .”186 With access to safety
data that is unavailable to the public or to health authorities, the pharmaceutical companies are
able to identify what injuries may be caused by vaccines that committees within HHS, CDC, IOM,
and AHRQ cannot do without access to such data.

184 https://pubmed.ncbi.nlm.nih.gov/25189402/ .
185 https://www.ncbi.nlm.nih.gov/pubmed/16685182 ; https://www.ncbi.nlm.nih.gov/pubmed/25398603 ; https://www.
ncbi. nlm.nih.gov/pubmed/ 16547798 ; https://www.ncbi.nlm. nih.gov/pmc/articles/PMC1448378/ .
186 https://www.ecfr.gov/current/title -21/chapter -I/subchapter -C/part -201.

32

These adverse events identified by pharmaceutical companies are typically listed in Section 6.2 of
each vaccine’s package insert. Only adverse events for which these companies have a basis to
believe have a “causal relationship” with the vaccine are to be listed pursuant to federal law.
Adverse events for which there is only a correlation with the administration of the vaccine should
therefore not be listed.

Many of the chronic diseases that have risen over the prior decades are disclosed on one or more
vaccine package inserts.187

SLIDES 46 -48, 50: STUDYING UNEXPOSED GROUPS
Properly assessing the safety of a product typically requires comparing an exposed group to an
unexposed group and assessing their health outcomes, i.e., comparing a group that receives the
product with a group that does not receive the product. Regarding vaccines, that requires
comparing the health outcomes between vaccinated (one or more vaccines) and unvaccinated ( no
vaccines) children. This can be accomplished by using existing databases that contain this health
data.

In 2013, the IOM published a report after having been commissioned by HHS to review the overall
safety of the CDC childhood schedule “to identify health outcomes associated with some aspect
of the childhood immunization schedule,” including “asthma, autoimmunity, autism, other
neurodevelopmental disorders (e.g., learning disabiliti es, tics, behavioral disorders, and
intellectual disability), seizures, and epilepsy.”188 This was a different IOM report than the ones
previously discussed above as it did not focus on individual vaccines but rather on the safety of
the CDC childhood vaccine schedule as a whole.

The IOM found that no studies had ever been conducted which compared the health outcomes of
children receiving the CDC’s childhood vaccine schedule with children that had not been
vaccinated:

[F]ew studies have comprehensively assessed the association
between the entire immunization schedule or variations in the
overall schedule and categories of health outcomes, and no study …
compared the differences in health outcomes … between entirely
unim munized populations of children and fully immunized children.
Experts who addressed the committee pointed not to a body of
evidence that had been overlooked but rather to the fact that existing
research has not been designed to test the entire immunization
schedule. …

187 https://www.fda.gov/vaccines -blood -biologics/vaccines/vaccines -licensed -use-united -states .
188 https://www.nap.edu/read/13563/chapter/2#5 .
33
 [Also,] 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.189

When the IOM committee expanded its search for any evidence that could help it assess the safety
of the CDC’s childhood vaccine schedule, it stated that it “found a paucity of information,
scientific or otherwise, that addressed the risk of adverse events in  association with the complete
recommended immunization schedule.”190 The IOM  found:  “There is no evidence that the
schedule is not safe.”191

The IOM’s report from 2013 did assert that it “is possible to make this comparison [between
vaccinated and unvaccinated children] through analyses of patient information contained in large
databases such as VSD [the Vaccine Safety Datalink].”192 Subsequently, the CDC commissioned
a 64-page white paper, published in April 2016, that discussed how to conduct such studies using
the VSD .193 But no such study has even been published by the CDC despite the fact this white
paper acknowledges that many chronic disorders children are experiencing today in epidemic
numbers are biologically plausible outcomes from exposure to CDC’s childhood vaccin e schedule
but have not yet been properly studied. 194

While CDC and pharmaceutical -funded scientists have never published such a study, a few such
studies have been published.

A pilot study, based on parental surveys of homeschool children, from the School of Public Health
at Jackson State University, published in 2017, found that 33% of vaccinated preterm babies had
a neurodevelopmental disorder while 0% of the unvaccinated pre term babies had a
neurodevelopmental disorder;195 and another study by the same group found that vaccinated
children, compared to unvaccinated children (receiving no vaccines), had a 74% decreased risk of
chicken pox and a 70% decreased risk of pertussis, but had an increased risk of 290% for allergies,
320% for ADHD, 320% for autism, 190% for eczema, 420% for learning disabilities, and 270%
for any neuro -developmental delay.196

In another study aggregating data from three medical practices in the United States, the health
outcomes of vaccinated and unvaccinated children born between 2005 and 2015 were compared;
this study found that vaccinated children, compared to unvaccinated c hildren, had a statistically

189 https://www.nap.edu/read/13563/chapter/2#5 .
190 https://www.nap.edu/read/13563/chapter/6?term=paucity#70 .
191 https://www.nap.edu/read/13563/chapter/2#12 .
192 https://www.nap.edu/read/13563/chapter/2#13 .
193 https://www.cdc.gov/vaccine -safety/media/pdfs/white -paper -safety -508.pdf?CDC_AAref_Val=https://www.cdc.
gov/vaccinesafety/pdf/WhitePaperSafety_WEB.pdf .
194 Id.
195 https://www.oatext.com/pdf/JTS -3-187.pdf .
196 https://www.oatext.com/pdf/JTS -3-186.pdf .
34
 significant increased rate of 118% for developmental delay, 349% for asthma, and 113% for ear
infections.197

Researchers at State University of New York at Stony Brook  have authored two studies  concerning
the hepatitis  B vaccine. One of those study’s f indings  were that male neonates vaccinated with the
hepatitis B vaccine had a 3 times risk (OR=3.002, 95% CI 1.109 -8.126) for parental report of
autism diagnosis compared to boys not vaccinated as neonates during that same time period .198
The second study found that the odds of receiving early intervention or special education services
were 8.63 times as great (OR=8.63, 95% CI 3.24 –22.98) for vaccinated boys as for unvaccinated
boys after adjustment for confounders.199

Additional  unpublished data, including from the Amish community, reflects similar findings.200

SLIDE 49: CDC SURVEILLANCE SYSTEMS
VAERS

The Vaccine Adverse Events Reporting System ( VAERS ) is jointly administered by the CDC and
the FDA. It is a passive reporting system to which anyone can submit reports of an injury after
vaccination. However, the vast majority of reports are submitted by pharmaceutical companies,
health care providers, an d state immunization programs.201

The CDC explains that VAERS cannot establish causation between a vaccine and an injury and
that, at best, it can be used for signal detection. Hence, CDC explains that it should not be used to
reach a causality conclusion regarding a claimed injury from on e or more vaccines. But it can
provide potential signals of vaccine harm based on the volume and type of reports received.

From 2013 and 2018, VAERS received 261,294 reports of adverse vaccine events, including 2,081
deaths, 5,477 permanent disabilities, and 20,778 hospitalizations.202

A study of VAERS reporting commissioned by the AHRQ stated that “fewer than 1% of vaccine
adverse events are reported.”203 In this study, AHRQ provided a $1 million grant to create a
software program at Harvard Pilgrim Health Care that would automate reporting injuries after

197 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7268563/ .
198 https://pubmed.ncbi.nlm.nih.gov/21058170/ .
199 https://doi.org/10.1080/02772240701806501 .
200 https://www.sirillp.com/wp -content/uploads/2025/01/Ex -D-Dr-Neuenschwander -Declaration -signed -w-exs.pdf ;
http://sirillp.com/Letters -to-NY-DOH .
201 https://web.archive.org/web/20150615195821/http://vaers.hhs.gov/about/faqs .
202 https://wonder.cdc.gov/vaers.html .
203 https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045 -lazarus -final-report -2011.pdf .
35
 vaccination to VAERS.204 The result was the successful creation of a system at Harvard Pilgrim
which automatically created adverse vaccine event reports:

Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and
1.4 million doses were given to 376,452 individuals. Of these doses, 35,570 possible reactions
were identified.205

Regrettably, the CDC did not cooperate with making this new program functional. After creating
a software program that automatically created VAERS reports, the system’s developers asked the
CDC to take the final step of linking VAERS with the Harvard Pilgr im system so that these reports
could be automatically transmitted into VAERS .206 But as the Harvard researchers explained:

Unfortunately, there was never an opportunity to perform system
performance assessments because the necessary CDC contacts were
no longer available and the CDC consultants responsible for
receiving data were no longer responsive to our multiple requests to
proceed with testing and evaluation.207

VAERS cannot be used to determine whether a vaccine causes a harm because, while VAERS can
provide the number of people harmed (numerator), it cannot provide the total number of people
vaccinated (denominator) from which to calculate a rate of harm. Automa ting VAERS reports
from a fixed pool of people would have made calculating a rate and thus reaching a causality
conclusion on a given harm possible. That type of automation has still not been implemented for
VAERS.

It is also noted that on December 4, 2020, before the first COVID -19 vaccine was rolled out, CDC
released the VAERS Standard Operating Procedures for COVID -19 (“VAERS SOP”), which
stated in relevant part:

The analyses for COVID -19 vaccine safety signals will focus on
identifying deviations from preliminary safety data, and possibly
from other vaccines, using disproportionality analyses and
comparisons of reporting rates.

Two main approaches to data mining are Proportional Reporting
Ratios (PRRs) and Empirical Bayesian Geometric Means. Both
have published literature suggesting criteria for detecting “signals”.
PRR will be used at CDC for potential signal detection; Empirica l
Bayesian data mining will be performed by FDA .208

204 Id.
205 Id.
206 Id.
207 https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045 -lazarus -final-report -2011.pdf .
208 https://www.cdc.gov/vaccinesafety/pdf/VAERS -COVID19 -SOP-4-Dec-2020 -508.pdf .
36
 This SOP thus explained that CDC planned to conduct safety signal monitoring using Proportional
Reporting Ratios (“PRR”) and FDA planned to conduct safety signal monitoring using Empirical
Bayesian (“EB”) data mining.

Our firm requested the PRR signal detection data from CDC through FOIA and was denied. In the
denial letter, CDC stated that it had not conducted PRR analyses; it instead highlighted the
superiority of and historical use of EB data mining, calling it the “ gold standard” and the “superior
method” with which to detect safety signals. However, on September 2, 2022, then -CDC Director
Rochelle Walensky sent a letter to Senator Ron Johnson acknowledging that PRR had in fact been
used: “CDC performed PRR analysis between March 25, 2022, through July 31, 2022, to
corroborate the results of EB data mining. Notably, results from PRR analysis were generally
consistent with EB data mining, revealing no additional unexpected safety signals.” Our firm then
sued CDC based on this admission and ultimately received 51 excel files containing PRR data. 209
These files showed that CDC’s own threshold for triggering a signal for adverse events was met
for numerous serious adverse events, including as seen in the following CDC tables noting that
CDC had set anything above a “2” in the PRR row as a safety signal :210

209 https://www.sirillp.com/wp -content/uploads/2024/06/Response -to-FDA -Stay-b390d697ad6bc29544ff90e60795
7c03.pdf .
210 https://icandecide.org/cdc -proportional -reporting -ratio/  (all PRR data is available for download at this site).
37

When the CDC was asked about  the above data, it advised Senator Johnson that it was no longer
relying upon PRR and instead would only rely upon FDA’s EB data mining; as the then CDC
Director wrote to Senator Johnson:

N>=3 (Current Week), PRR>=2.00 (Ratio of
MedDRA Codes
ALL Reports (18+)12/14/2020-
05/06/2022
COVID19 mRNA
N=63272512/14-05/06
Chi-Square12/14-05/06
PRR
CEREBRAL THROMBOSIS 194 69.78 73.46
INTERMENSTRUAL BLEEDING 1323 481.57 62.62
CEREBRAL VENOUS SINUS THROMBOSIS 155 55.02 58.69
HEAVY MENSTRUAL BLEEDING 4246 1543.71 53.59
INTENTIONAL PRODUCT USE ISSUE 141 49.72 53.39
POSITIVE AIRWAY PRESSURE THERAPY 789 283.64 49.79
PULMONARY THROMBOSIS 610 218.11 46.20
DISEASE RECURRENCE 227 79.98 42.98
HYPERPYREXIA 111 38.38 42.03
POSTMENOPAUSAL HAEMORRHAGE 521 184.41 39.46
POLYMENORRHOEA 684 241.57 37.00
RIGHT VENTRICULAR DYSFUNCTION 96 32.71 36.35
INTENTIONAL DOSE OMISSION 94 31.96 35.59
ABNORMAL UTERINE BLEEDING 82 27.43 31.05
OLIGOMENORRHOEA 564 196.16 30.51
CEREBELLAR STROKE 80 26.68 30.29
SUSPECTED COVID-19 550 190.86 29.75
CEREBRAL MASS EFFECT 75 24.79 28.40
RIGHT VENTRICULAR DILATATION 73 24.04 27.64
DYSMENORRHOEA 1821 631.80 27.58
THROMBECTOMY 348 118.98 26.35
MYOCARDIAL STRAIN 64 20.65 24.23
HAEMOFILTRATION 62 19.90 23.48
IMPLANTABLE CARDIAC MONITOR INSERTION 61 19.52 23.10
TRANSVERSE SINUS THROMBOSIS 60 19.15 22.72
MATERNAL EXPOSURE DURING BREAST FEEDING 292 97.84 22.11
BODY HEIGHT DECREASED 57 18.02 21.58
MENSTRUAL DISORDER 2435 822.34 20.96
MENSTRUATION IRREGULAR 3240 1094.66 20.79
MESENTERIC VEIN THROMBOSIS 54 16.90 20.45
NIH STROKE SCALE ABNORMAL 54 16.90 20.45
NIH STROKE SCALE 53 16.52 20.07
CORONARY ARTERY DISSECTION 52 16.15 19.69
JUGULAR VEIN THROMBOSIS 52 16.15 19.69
LEFT VENTRICULAR DILATATION 51 15.77 19.31
ANOSMIA 3546 1186.66 19.18
NEUROLOGIC NEGLECT SYNDROME 50 15.40 18.93
CEREBRAL ARTERY OCCLUSION 98 31.29 18.55
VITAL SIGNS MEASUREMENT 146 47.19 18.43
ILLNESS 4279 1423.54 18.21
INTRACARDIAC THROMBUS 95 30.16 17.99
LYMPHOPENIA 94 29.79 17.80
THROMBOEMBOLECTOMY 47 14.28 17.80
VACCINATION SITE URTICARIA 322 104.80 17.42
COR PULMONALE ACUTE 46 13.90 17.42
HEPATIC MASS 46 13.90 17.42
WRONG PATIENT 45 13.53 17.04
PREMENSTRUAL PAIN 44 13.16 16.66
PRODUCT RECONSTITUTION QUALITY ISSUE 44 13.16 16.66
TOTAL LUNG CAPACITY DECREASED 44 13.16 16.66
PERIPHERAL ARTERY OCCLUSION 43 12.78 16.28
ANTICOAGULANT THERAPY 3684 1204.20 16.22
COLON CANCER 41 12.04 15.53
SYMPTOM RECURRENCE 163 51.45 15.43
ACUTE CARDIAC EVENT 40 11.67 15.15
PERIPHERAL ARTERY THROMBOSIS 78 23.79 14.77
CARDIOVASCULAR SYMPTOM 39 11.29 14.77

38
 CDC and the Food and Drug Administration (FDA) chose to rely on
Empirical Bayesian (EB) data mining —a more robust technique
used to analyze disproportionate reporting —rather than PRR
calculations to mitigate potential false signals. . . . Given the strengt h
of the EB data mining method, CDC and FDA plan to continue
relying upon EB data mining moving forward.211

Given that it decided to abandon the PRR data and rely upon the EB data, our firm requested the
EB data mining results from FDA through FOIA and was denied. Hence, we commenced a lawsuit
against the FDA to obtain the EB data results which  remains ongoing.

VSD

The next system the CDC lists as a vaccine safety surveillance tool is the Vaccine Safety Datalink
(VSD ). While this system could be helpful in assessing vaccine safety, that is not currently the
case. Until around 2001, the VSD was maintained at the CDC. Thus, independent scientists were
able to obtain access to the VSD at the request of members of Congres s and through other legal
means. The studies these independent scientists published identified various harms associated with
vaccination. CDC then moved the VSD to an industry trade association starting in 2001 which
took it out of the reach of the Freedom  of Information Act and also limited the data to only
scientists and studies it approved.212 This resulted in selection bias with regard to studies that were
allowed to access and be published using the VSD. Moreover, every study published using the
VSD violates scientific standards because the underlying data is almost never available for
inspec tion by the public and other scientists .213 Refusal to make this data available raises serious
concerns regarding reproducibility and transparency. HHS regulations provide severe penalties if
researchers, using HHS funding, refuse to share data underlying their studies, but the CDC does
not apply t his same standard to its own VSD studies.214

Putting these issues aside, the VSD is not typically used to study long term health conditions.
While the CDC has acknowledged that public stakeholders “have expressed more concerns about
long-term than short -term health outcomes” and that “long -term healt h outcomes have been less
well-studied in the context of vaccine safety,” VSD is geared toward assessing short -term, and not
long-term, health outcomes:

The current safety surveillance systems such as the VSD … already
have extensive systems in place to assess short -term outcomes …
[despite the fact] the childhood immunization schedule is essentially
a long -term exposure, occurring over 18 to 24 months, [a nd hence]

211 https://www.documentcloud.org/documents/23940343 -sen-johnson -letter -to-fda-on-eb-data-mining .
212 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4708093/ .
213 https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/accessing -data.html .
214 https://www.federalregister.gov/documents/2016/09/21/2016 -22379/nih -policy -on-the-dissemination -of-nih-funded -
clinical -trial-information .
39
 long-term adverse events may be more biologically plausible than
short -term events .215

The deidentified data in the VSD, paid for by taxpayers, should be available to the public so that
independent scientists can conduct vaccine safety studies.  Until that data is released and any
claimed results using this data replicated, it is an improper tool to reach any conclusion regarding
vaccine safety.
V-safe

CDC’s V -safe vaccine safety system is a smartphone -based program which uses “text messages
and web surveys to ask how [users] feel, including if [users] experience any side effects after
vaccination .”216 It was first developed and used with COVID -19 vaccines but has since been
expanded for other vaccines. As explained by the CDC, the program “helps CDC gather important
information and monitor any potential side effects in real time so scientists can quick ly study them
and determine if there is a safety concern with a particular vaccine.”217 The CDC explains that
“[t]his information helps [it] communicate timely and transparent information about the safety of
vaccines to public health officials, healthcare providers, and the public.”218

On November 19, 2020, the CDC published a protocol for developing V -safe titled “V -safe active
surveillance for COVID -19 vaccine safety” ( V-Safe Protocol ).219 The V -Safe Protocol explains
that “[t]he purpose of v -safe surveillance is to rapidly characterize the safety profile of COVID -19
vaccines when given outside a clinical trial setting and to detect and evaluate clinically important
adverse events and safet y issues that might impact policy or regulatory decisions.”220

V-safe was launched simultaneously with the release of the first COVID -19 vaccine in December
2020. Approximately 10 million individuals signed up for V-safe, around 9 million of whom
registered between December 2020 and April 2021.221

This period from December 2020 to April 2021 was a period when there were no Covid -19 vaccine
mandates yet and there was high public interest in receiving this product. The data submitted by
10 million V -safe users is likely a good reflection of the experi ence of the larger population of 265
million Americans who received at least one dose of a COVID -19 vaccine.

V-safe collected data from users in two ways. The first was check -the-box options limited to (a)
symptoms and (b) health impacts. The second was using free -text fields.

215 https://www.cdc.gov/vaccine -safety/media/pdfs/white -paper -safety -508.pdf?CDC_AAref_Val=https://www.cdc.
gov/vaccinesafety/pdf/WhitePaperSafety_WEB.pdf .
216 See https://www.cdc.gov/coronavirus/2019 -ncov/vaccines/safety.html  (listing v -safe as one of the ways “CDC
expanded and strengthened the country’s ability to monitory vaccine safety”).
217 Id.
218 Id.
219 https://web.archive.org/web/20210102024902/https://www.cdc.gov/vaccinesafety/pdf/V -safe-Protocol -508.pdf .
220 Id. at 1.
221 https://data.cdc.gov/Public -Health -Surveillance/v -safe-COVID -19/dqgu -gg5d/about_data .
40

With regard to check -the-box symptoms, V -safe users were asked to select one or more of 10 listed
symptoms that occurred within the first week after vaccination. These symptoms are those that the
CDC explains are normal after vaccination and are a sign the  vaccine is working by producing an
immune response. As the CDC explains: “Any side effects from getting the vaccine are normal
signs the body is building protection.”222 Meaning, the check -the-box symptoms data collected by
V-safe had effectively no value in assessing safety of the COVID -19 vaccines. Indeed, the 10
million V -safe users reported over 70 million check -the-box symptoms, and this did not raise
concerns for th e CDC as seen from the studies the CDC published reflecting these high rates of
check -the-box symptoms.223

The only other check -the-box safety information collected (other than the 10 listed symptoms) was
whether users reported needing medical care, missed school or work, or could not perform normal
daily activities following their vaccination ( “health impact data ”). If a user selected that he or she
needed medical care, the user was then also asked to select whether he or she sought telehealth,
urgent care, emergency care, or was hospitalized.

The health impact data was collected during the first week, then weekly for the first six weeks, and
then at 3, 6, and 12 months after injection. In contrast, the check -the-box symptoms data was
collected for only the first week after injection. Since the CDC dubbed V -safe a “real time”
surveillance program, presumably the health impact data is the data the CDC intended to use to
rapidly detect any safety issues .224

Since 2021, the CDC published dozens of studies to support its claim that COVID -19 vaccines are
safe. Primary data used in these studies is V -safe’s health impact data, with a focus on the rate of
people who reported needing medical care after the vaccine.  The studies form a core of the CDC’s
support for the safety of COVID -19 vaccines. However, the studies only report the first week of
health impact data after injection despite the fact injuries from COVID -19 vaccines can occur after
the first week .225

When the check -the-box data was released to the public, following over two years of litigation by
a non -profit group to compel release of the data, it reflected that 7.7% of V -safe users reported
needing medical care after a COVID -19 vaccine and an additional 25% of V -safe users reported

222 https://www.cdc.gov/coronavirus/2019 -ncov/vaccines/different -vaccines/how -they-work.html .
223 See e.g. , https://www.cdc.gov/mmwr/volumes/71/wr/mm7107e1.htm ; https://www.cdc.gov /mmwr/ volumes/70/wr/
mm7039e4.htm ; https://www.cdc.gov/mmwr/ volumes/70/wr/mm7018e2. htm; https://jamanetwork.com/journals/jama/
fullarticle/2778441 ; https://www.cdc.gov/mmwr/ volumes/ 70/wr/mm7008e3.htm ; https://www.cdc.gov/mmwr/volumes/
70/wr/mm705152a1.htm ; https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e1.htm .
224 https://www.cdc.gov/coronavirus/2019 -ncov/vaccines/safety.html  (“These platforms give CDC scientists information
about the safety of COVID -19 vaccines in real time.”).
225 For example, myocarditis can arise at least 42 days after vaccination.  See https://pubmed.ncbi.nlm.nih.gov/34614329/
at Figure 1. T hrombosis with thrombocytopenia syndrome (TTS), which can also be caused by the COVID -19 vaccine,
can arise up to 18 days after vaccination. See https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2021 -12-
16/02 -COVID -See-508.pdf  at slide 16.
41
 missing school or work or being unable to perform normal activities after receiving a COVID -19
vaccine.226

That finding was not in accord with what the CDC had been reporting to the public, as it reflected
that nearly 1 in 13 individuals in the V -safe system sought medical care after a COVID -19 vaccine,
and on average, users sought medical care two to three tim es each. Since V -safe was supposed to
assess safety, and the only metric that appears to have provided any such measure was when users
reported seeking medical care, it is unclear what measure of vaccinees having to seek medical
would have needed to occur in order to raise a safety concern for the CDC.

Furthermore, the CDC could have designed V -safe to be a rapid and useful safety system by
including check -the-box options for harms that COVID -19 vaccines can or were suspected to cause.
For example, a check -the-box option for myocarditis or for chest pain . As reflected in the first
version of the V -safe Protocol, prior to the program’s launch, it listed adverse events of special
interest ( AESI ) in a chart titled Prespecified Medical Conditions:

This list included acute myocardial infarction, anaphylaxis, coagulopathy, COVID -19 Disease,
death, Guillain -Barre Syndrome, Kawasaki disease, Multisystem Inflammatory Syndrome in
Children, Multisystem Inflammatory Syndrome in adults, myocarditis/pericardi tis,
narcolepsy/cataplexy, pregnancy and prespecified conditions, seizures/convulsions, stroke, and
transverse myelitis.

The CDC also identified all but two (pregnancy and coagulopathy) of these AESIs in an October
22, 2020 presentation titled “CDC post -authorization/post -licensure safety monitoring of COVID -
19 vaccines .”227 Many of these AESIs were also identified in a July 2020 NEJM study,228 as well
as in an October 16, 2020 JAMA article.229

226 https://icandecide.org/v -safe-data/ .
227 See https://cacmap.fda.gov/media/143530/download  at 31.
228 See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7377258/#ap2 .
229 See https://jamanetwork.com/journals/jama/fullarticle/2772137 .

42

Nonetheless, the CDC did not include in the V -safe system any check -the-box options for these
harms or for common symptoms from these harms. Had the agency done so, it would have enabled
the CDC and the scientific community to calculate a rate for which V -safe users had myocarditis,
or other adverse events that had been prespecified by the CDC as potential  problems ( e.g., strokes,
seizures, etc.). Instead, the CDC limited potential reporting of such adverse events to free -text
fields to which fewer people w ould report issues and which would be more difficult to standardize.

V-safe was plainly designed to reach a finding that COVID -19 vaccines are safe rather than
designed to assess whether COVID -19 vaccines are safe. It only included symptoms that the CDC
considers normal and reflect the vaccine is creating immunity, which is  also reflected by the fact
it only tracked those symptoms for one week after administration. It did not include on the list of
symptoms and conditions those that it listed as ones of concern/special interest. It also did not, of
its own accord, reveal the  health impact data to the public, which appears to be the only actual
useful data for assessing safety; only after years of legal demand and litigation did it release the
data, which revealed that 7.7% of V -safe users reported seeking medical care after a  COVID -19
vaccine, and on average two to three times per user.

 CISA

CDC regularly claims that the Clinical Immunization Safety Assessment (“ CISA ”) is a critical
part of the safety monitoring of vaccines. CDC describes CISA as: “ a national collaborating
network of vaccine safety experts from the CDC’s Immunization Safety Office (ISO), eight
medical research centers, and other partners” that was established “to improve the understanding
of adverse events following immunization at t he individual patient level .”230 CISA, like the other
safety surveillance programs, is also problematic for a few reasons.

For one, as CDC states, “CISA provides consultations for U.S. healthcare providers with complex
vaccine safety questions about their patients .”231 Our firm has been advised by many who suffered
adverse events after their vaccination and who were not believed  by their medical providers . Those
individuals  were unable to utilize CISA as it provides consultations only to healthcare providers
and not to individual patients.

Moreover, the Principal Investigator of CISA, Dr. Kathryn Edwards,232 has also been a paid
advisor to Pfizer233 and/or was compensated by numerous other pharmaceutical companies as a

230 https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html .
231 Id.
232 https://www.vumc.org/vvrp/person/kathryn -m-edwards -md.
233 https://www.cbsnews.com/news/covid -19-vaccine -when -will-be-available -ready/ .
43
 consultant , including Merck,234 GSK,235 Sanofi,236 Bionet,237 Connaught, Smith -Kline Beecham,
Wyeth Lederle, Moderna, Roche .238

SLIDE 52: RISE IN CHRONIC DISEASE
Chronic diseases are “conditions that last 1 year or more and require ongoing medical attention or
limit activities of daily living or both.”239 Research confirms that the prevalence of chronic
conditions is on the rise among children. In the early 1980s, data reflects that less than 10% of
children had a chronic disease.240 The current rate is above 40% of children.241

The chronic diseases that have risen sharply during the preceding decades are often related to some
form of immune system dysregulation, including asthma, allergies, ADHD, autism spectrum
disorder, atopic dermatitis, diabetes, epilepsy and mental health di sorders.242

Asthma, allergies, and atopic dermatitis, for example, are caused by a dysregulated immune system
that overreacts or reacts to harmless substances.243 ADHD and autism spectrum disorder are highly
associated with immune dysregulation.244 Epilepsy can be caused by the immune system attacking
brain tissue as well as from neuroinflammation, which can be caused by vaccination.245 Immune

234 https://pubmed.ncbi.nlm.nih.gov/30938299/ .
235 https://openpaymentsdata.cms.gov/physician/651167 ; https://academic.oup.com/jid/article/222/8/1413/5510417 .
236 https://www.nejm.org/doi/10.1056/NEJMoa050824 ; https://openpaymentsdata.cms.gov/physician/651167 .
237 https://pubmed.ncbi.nlm.nih.gov/32753370/ .
238 https://pubmed.ncbi.nlm.nih.gov/32753370/ ; https://pedsinreview.aappublications.org/content/19/ 2/68; https://
pubmed.ncbi.nl m.nih.gov/10617749/ .
239 https://www.cdc.g ov/chronic -disease/about/index.html .
240 https://pubmed.ncbi.nlm.nih.gov/3944229/  (https://perma.cc/NGA9 -93KW ) (“According to data from the National
Health Interview Survey (NHIS) [1979 -1981] over two million children under 17 years (3.8%) are afflicted by chronic
conditions that cause some limitation of activity.”); https://pmc.ncbi.nlm.nih.gov/articles/PMC1646496/
(https://perma.cc/KN4A -94TV ) (“Data from the National Health Interview Survey indicate that the prevalence of
activity -limiting chronic conditions among children under age 17 years doubled between 1960 and 1981, from 1.8 to
3.8 per cent.”); https://pubmed.ncbi.nlm.nih.gov/9551003/  (https://perma.cc/JTZ5 -JBNK ) (Among “children younger
than 18 years who were included in the 1992 -1994 National Health Interview Survey … [a] significant proportion of
children, estimated at 6.5% of all US children, experienced some degree of disability.”); https://www.cdc.gov/chronic -
disease/about/index.html  (https://perma.cc/N4GT -38L2 ) (“Chronic diseases are defined broadly as conditions that last
1 year or more and require ongoing medical attention or limit activities of daily living or both.”).
241 https://pubmed.ncbi.nlm.nih.gov/21570014/ .
242 https://pmc.ncbi.nlm.nih.gov/articles/PMC5010981/ ; https: //www.academicpedsjnl.net/article/S1876 -
2859(25)000 35-X/fulltext .
243 https://pubmed.ncbi.nlm.nih.gov/30741719/ .
244 https://pubmed.ncbi.nlm.nih.gov/28849096/ ;https://pubmed.ncbi.nlm.nih.gov/39426507/ ; https://pmc.ncbi.nlm.
nih. gov/articles/PMC5373490/ ; https://pubmed.ncbi.nlm.nih.gov/39481220/ .
245 https://pmc.ncbi.nlm.nih.gov/articles/PMC10906461/ .
44
 “system dysfunction represents a key mechanism in the onset and pathophysiology of mood
disorders.”246

This widespread disregulation of children’s immune systems has reached concerning  rates and
imposes substantial costs upon society. According to the CDC, “[n] inety percent of the nation’s
$4.5 trillion in annual health care expenditures are for people with chronic and mental health
conditions.”247 The country’s cost of chronic disease is “projected to accumulate by 2030 to more
than $42 trillion, with medical outlays and productivity losses costing $8,600 per person.”248

The sharp rise in immune dysregulation -mediated chronic diseases over the preceding decades
indicates that one or more environmental factors have caused the widespread dysregulation of our
children’s immune systems. In considering what could be causing wid espread immune system
dysregulation, it is critical to rule out products administered specifically to permanently modify
the immune system of our children: vaccines. This is especially true given that the rise in these
immune and immune -mediated disorders has occurred in lock step with the expansion and level of
uptake of CDC -recommended vaccines.

Leading up to and until the late 1980s, the CDC’s immunization schedule had three routine
vaccines: DTP (diphtheria tetanus pertussis), MMR (measles mumps rubella) and OPV (oral polio
vaccine).249 The first two were injected and the latter was given by oral drop.

In the 1980s, the uptake of these three products was also far below current uptake levels. According
to the CDC, as of 1985, the National Health Interview Survey found that among children, only
63.6% had 3 or more doses of DTP, 61.2% had received 1 or more  doses of MMR, and 53.6% had
received 3 or more doses of OPV.250 Uptake in children today is above 90% for all three of these
vaccines or their current equivalent.251

Moreover, the administration of  these three vaccines have increased from 7 injections in 1985 (1
MMR, 5 DTP, and 1 Td) to 13 injections for the equivalent vaccines in 2025 (2 MMR, 5 DTaP, 2
Tdap, including one during pregnancy, and 4 IPV).252 In addition, over 10 additional routine
vaccines have been added to the CDC’s neonatal and childhood vaccine schedule since 1986, each
with multiple doses, including Hep B (3 doses), Hib (3 or 4 doses), and VAR (2 doses) in the
1990s, and PCV (4 doses), IIV (between 1 and 2 d oses annually), Hep A (2 doses), MenACWY,
RV (2 or 3 doses), HPV (2 or 3 doses), and RSV (1 dose during pregnancy) since 2000.253

246 https://pubmed.ncbi.nlm.nih.gov/39681901/ .
247 https://www.cdc.gov/chronic -disease/data -research/facts -stats/?CDC_AAref_Val=https://www. cdc.gov/chronic
disease/about/costs/index.htm .
248 https://doi.org/10.1146/annurev -publhealth -040218 -044008 .
249 https://www.cdc.gov/vaccines/schedules/images/schedule1983s.jpg .
250 https://web.archive.org/web/20190618125412/https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendic
es/e/coverage -levels.pdf .
251 https://www.cdc.gov/childvaxview/about/interactive -reports.html .
252 Compare https://www.cdc.gov/vaccines/schedules/images/schedule1983s.jpg , with https://www.cdc.gov/
vaccines/ hcp/imz -schedules/child -adolescent -age.html .
253 https://www.cdc.gov/vaccines/hcp/imz -schedules/resources.html# .
45

The increase in the number of vaccines since 1986 is especially pronounced during pregnancy and
the first year of a baby’s life. By a child’s first birthdate, assuming no combination vaccines are
used, a child in 1986 following the CDC’s vaccine schedule would have received 3 injections with
a total of 7 injections throughout childhood, whereas a child in 2025 will receive 25injections by
the child’s first birthdate with a total of over 50 injections  throughout childhood.254

When studying environmental factors which could be causing the immune system of our children
to dysregulate en masse , one factor that must be ruled out is vaccines and whether the increase in
vaccine uptake and number of vaccines, especially during infancy, have been a contributing factor.
While c orrelation does not equal causation, it does provide a safety signal that merits investigation,
including because vaccines are intended to and do systemically modify the immune system and,
thus, could be the cause of widespread immune system dysregulation.

See the Appendix which r eview s select  chronic diseases that have risen sharply in the last few
decades and discuss studies related to vaccines and these diseases.

SLIDE 5 3: ALUMINUM ADJUVANTS
After injection, a luminum adjuvant s in vaccine s are picked up by a variety of immune -reactive
cells and is then carried all around the body including into the brain.  There are animal studies that
demonstrate this and the re are clinical studies of autism brain tissue that support th ose animal
studies.255

SLIDE 56: TRANSMISSION

While s ome live -attenuated vaccines, such as Varivax for varicella, generally prevent transmission
of the target pathogen in most recipients for an extended duration post -vaccination , many of the
vaccines routinely recommended by CDC,  including the current pertussis, tetanus,  and polio
vaccines, do not prevent transmission or infection of the diseases they target . See among other
sources: https://www.cdc.gov/poliovirus -containment/diseaseandvirus/  (“Inactivated poliovirus
vaccine (IPV)  [the exclusive polio  vaccine used in the United States ] … does not stop transmission
of the virus. ”); https://www.cdc.gov/mmwr/volumes/71/wr/mm7133e2.htm  (“IPV does not
prevent intestinal infection and therefore does not prevent poliovirus transmission. ”);
https://www.fda.gov/media/181937/download  (“aP [acellular  pertussis] containing vaccines  [the
exclusive pertussis vaccine used in the United States ] induce helper T cells (TH2) memory and
neutralizing antibody responses that effectively prevent symptomatic disease but fail to prevent
colonization and carriage. ”) https://pubmed.ncbi.nlm.nih.gov/31333640/  (“Natural infection
evokes both mucosal and systemic immune responses, while aPVs [acellular pertussis vaccine ]
induce only a systemic immune response. …  Mucosal immunity is essential to prevent

254 Id.
255 Khan 2013 https://pubmed.ncbi.nlm.nih.gov/23557144/ ; Crépeaux 2015 https://pubmed.ncbi.nlm.nih.
gov/26384437/ ; Eidi 2015 https://pubmed.ncbi.nlm.nih.gov/26082187/ ; Gherardi 2015 https://
pubmed.ncbi.nlm.nih.gov/25699008/ ; Masson 2022 https://pubmed.ncbi.nlm.nih.gov/36112128/ ; Angrand 2022
https://pubmed.ncbi.nlm.nih.gov/36136483/ ; Mold 2020 https://pubmed.ncbi.nlm.nih.gov/32368656/ .
46
 colonization and transmission of B. pertussis  organisms. Consequently, preventive measures such
as aPVs that do not induce a valid mucosal response can prevent disease but cannot avoid infection
and transmission.  … aPV pertussis vaccines do not prevent colonization. Consequently, they do
not reduce the circulation of B. pertussis and do not exert any herd immunity effect.”);
https://www.cdc.gov/vaccines/basics/explaining -how-vaccines -work.html  (Tetanus is “not
contagious ” from person to person.”); https://web.archive.org/web/20250112105810/
www.cdc.gov/vaccines/vpd/mening/hcp/about -vaccine.html  (“data suggest MenACWY vaccines
have provided protection to those vaccinated, but not to the larger, unvaccinated community
through population or herd immunity ”).

SLIDES: 66 -73: MORTALITY

The CDC estimate that vaccines saved 1.1 million lives in the United States between 1994 and
2023 is routinely cited by third parties even though it is, at best, unreliable.

First, the article including this estimate is not published in a journal, but rather in the MMWR.
CDC’s own guidelines for the MMWR permit the publi cation of only articles that align with CDC
policy which results in selection bias. As explained by the CDC’s policies for publishing an
MMWR report: “By the time a report appears in MMWR, it reflects, or is consistent with, CDC
policy .”256 And the CDC’s policy is that vaccines are safe and effective.

Second, this report provides  no confidence intervals for its estimates. This is because they are
guesswork. The true rate could be that the vaccine s used in the United States from 1994 to 2023
could have saved 1.1 million lives or they could have result ed in 2 million deaths. Since the report
provides no bounds for its claims, either claim could be true.

Third, the study explains that “factors other than immunization (e.g., hygiene…) might have
contributed to lower disease risks in recent decades, and reductions resulting from these
contributions have not been incorporated into the model .” (Emphasis  added.) Meaning, it did not
account for any other advancement or factor that may have improved health outcomes. This alone
renders this CDC promotion “study” wholly unreliable . It is also why it has no bounds for its
estimates because it cannot calculate them with any confidence.

Finally, just a simple review of the data shows its estimate is contrary to the data . While it claims
vaccines saved 1.1 million lives between 1994 and 2023, it takes only looking at the actual real -
world data to see that this figure is without any merit . This can be seen by reviewing three diseases
the report claims account for almost the entire 1.1  million lives purportedly saved: diphtheria,
hepatitis B, and measles.

 Diphtheria. Around 750,000 of the 1.1  million lives (over 68%) that CDC claims were
prevented are from diphtheria. That means that it claims 25,000 lives were saved per year by this
vaccine. That figure has no basis in reality .

256 https://www.cdc.gov/mmwr/author_guide_rrss.html .
47
 The first vaccine for diphtheria was introduced in 1926.
Between 1900 and 1926, as the population rose, the death
rate from this disease had already declined 81%, from
40.3 to 7.8 deaths per 100,000 individuals .257 A vaccine
had nothing to do with this sharp decline since no vaccine
of any kind for diphtheria existed until 1926. The further
decline from 1926 until at least the mid -1940s also had
little or nothing to do with the vaccine because it was
rarely, if ever , used outside of certain demographics in
major cities, and diphtheria mortality declined at a
similar rate in areas with or without its use.258 To the
right is an official government chart reflecting same.259
So, even as the population increased, the data clearly
shows an 81% mortality decline from 1900 to 1926, a
97.3% decline from 1900 to 1940, and a 97.8% decline
from 1900 to 1948; hence, using any of these time
periods , it is plain vaccination had little to do with almost
all of the decline in mortality from diphtheria in the last
century :260

In 1949, DTP was first licensed, and coverage of this vaccine began to improve, and in 1948, there
was a total of 634 deaths from diphtheria.261 Yet, this MMRW report claims diphtheria vaccine is
now saving 25,000 lives a year in the United States. (Also note that in 1985, the coverage for only
three doses, let alone the six recommended today, was still only 63.6%.262)

257 https://www.cdc.gov/nchs/data/vsus/vsrates1940_60.pdf .
258 https://pmc.ncbi.nlm.nih.gov/articles/PMC1997101/pdf/pubhealthreporig01174 -0001.pdf  (“The simultaneous
decline in diphtheria morbidity and mortality rates in all age groups of individual States located in different sections
of the country, which began after a cyclic increase in incidence between 1915 and 1925, suggests the operation or
influence of other factors besides, or in addition to, artificially induced immunity. Studies such as that included in the
1930 White House Conference on Child Health and Protection indicated that immunization programs were reaching
a relatively large propo rtion of children in some areas or cities and a very low proportion in others , as late as 1930. In
spite of this wide variation, both morbidity and mortality began to decline rapidly after 1925 in all States
simultaneously.”); https://www.cdc.gov/pinkbook/hcp/table -of-contents/chapter -7-diphtheria.html  (“[D]iphtheria
toxoid -containing vaccines became available in the 1940s” and “universal childhood vaccination program which
included diphtheria toxoid -containing vaccines beginning in the late 1940s.”).
259 https://www.cdc.gov/nchs/data/vsus/vsrates1940_60.pdf  at 84 .
260 The death rate per 100,000 individuals in the United States in 1900, 1940, and 1948 for diphtheria was 40.3, 1.1,
and 0.4, respectively, for tetanus was 2.4, 0.4., and 0.3, respectively, and for pertussis was 12.2, 2.2, and 0.8,
respectively. https://www.cdc.gov/nchs/data/vsus/vsrates1940_60.pdf .
261 https://www.cdc.gov/Mmwr/preview/mmwrhtml/00038200.htm .
262 https://web.archive.org/web/20190618125412https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendi
ces/e/coverage -levels.pdf .

48
 This claim becomes more nonsensical when considering that even after six childhood doses,263
adults require a booster dose every ten years in adulthood,264 and about 40% of adults skip these
boosters.265 Despite a large portion of adults not receiving boosters, the last case of respiratory
diphtheria in the United States was nearly three decades ago.266 This may reflect the literature
which supports that its harmful effects may be counteracted by improvement in certain living
conditions .267

There are diseases that had a high mortality in the United States that disappeared without a vaccine.
For many of these diseases, researchers sought to develop a vaccine but failed. For example, scarlet
fever was one of the deadliest infectious diseases fo r children in 1900, with a death rate of 9.6
deaths per 100,000 children. Researchers sought to develop a vaccine but repeatedly failed. By the
1950s, deaths from scarlet fever had significantly declined and by the late 1900s, deaths from
scarlet fever wer e essentially non -existent.268

Had a vaccine for scarlet fever been developed in the 1920s, 40s, or 60s, that vaccine may still be
on the childhood schedule today, and its use considered essential for controlling scarlet fever , and
the MMWR article may estimate that this vaccine today also saves thousands of lives a year from
scarlet fever.

Scarlet fever and diphtheria are similar in that each is caused by a bacterium that releases a
potentially harmful toxin when the bacterium has been “infected” by a certain virus. Both diseases
cause sore throats, and many doctors, without a lab test, will confuse diphtheria with scarlet fever,
and vice versa. These two diseases also both declined at nearly the same rate beginning in 1900.

In any event, the CDC’s claim that 750,000 lives have been saved from diphtheria between 1994
and 2023 is without footing given the failure to account for the actual mortality data, other factors
that reduced morality from diphtheria, the lack of any bounds to its claim, the lack of population
wide immunity and other factors , and the objective  data regarding this disease . The reality is likely
far closer to what occurred with scarlet fever absent vaccination.

 Hepatitis B. As another example, the CDC article claims Hep B vaccines saved over 90,000
lives from 1994 to 2023, amounting to over 3,000 lives purportedly saved per year. This claim
again defies the data because i n 1980,  the year before the first Hep B vaccine was introduced,  there
were 294 deaths in the United States from Hep B.269

263 https://www.cdc.gov/vaccines/hcp/imz -schedules/downloads/child/0 -18yrs -child -combined -schedule.pdf .
264 https://www.cdc.gov/vaccines/hcp/imz -schedules/adult -age.html .
265 https://www.cdc.gov/adultvaxview/publications -resources/vaccination -coverage -adults -2019 -2020.html .
266 https://www.cdc.gov/diphtheria/php/surveillance/index.html .
267 https://pubmed.ncbi.nlm.nih.gov/2151460/ ; https://pubmed.ncbi.nlm.nih.gov/7830565/ ; https://pubmed.ncbi.nlm.
nih.gov/4326212/ ; https://pubmed.ncbi.nlm.nih.gov/189004/ .
268 https://www.statnews.com/2017/11/27/scarlet -fever -cases/ .
269 https://web.archive.org/web/20190615081539/https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/ appen
dices/e/reported -cases.pdf .
49
  Measles . As a final example, CDC’s advertising article claims measles vaccine saved
85,000 lives from 1994 to 2023, amounting to over 2,700 lives purportedly saved per year. This
claim again defies the data. The first measles vaccine came on the market in 1963.270 In the years
leading up to the first measles vaccine in 1963, the CDC data reflects around 400 deaths from
measles each year.271 There were also around 4.2 million births each year in the late 1950s and
early 1960s, whereas there was around 3.8 million births each year between 1994 and 2023.272 Yet,
somehow, despite improvements in standards of living, medical care, etc., and despite smaller
cohort of infants and children to infect, this model makes the data defying claim mortality went
from around 400 deaths per year from measles pre -vaccine to  over 2,7000 deaths per year.

Moreover, the  following U.S. government chart shows the
decline in the measles death rate by over 98% from 1900 to
1960, three years before  the first measles vaccine was
introduced in the United States in 1963.273 Meaning, the
measles vaccine had nothing to do with the over 98%
reduction in the death rate from measles in the United States
from 1900 to 1960.274

Taking a closer look, the CDC data reflects that in 1900, the
rate of mortality from measles was 13.3 deaths per 100,000
individuals.275 By 1960, it was 0.2 deaths per 100,000
individuals.276 The same was true for 1961 and 1962.277
And as noted above, a similar decline of over 99% in
measles deaths occurred between 1900 and 1967 in England
and Wales, and it was only after that decline that the first measles vaccine was introduced there in
1968 —five years after its introduction in the United States.278
Hence, the same factors that caused measles mortality to decline by over 98% from 1900 to 1962
would, absent the vaccine interrupting the ecology of measles, would likely have continued to
cause a further reduction in the measles mortality rate after 1962.  Meaning, at least a portion of
the decline in the 400 deaths per year after  the vaccine was available is no doubt attributable to the
same factors that caused a steady decline in the measles death rate for decades prior  to the

270 https://www.cdc.gov/measles/about/history.html .
271 https://web.archive.org/web/20190615081539/https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/appen
dices/e/reported -cases.pdf .
272 https://www.cdc.gov/nchs/nvss/births.htm .
273 https://www.cdc.gov/nchs/data/vsus/vsrates1940_60.pdf  at 85.
274 Id.
275 Id.
276 https://www.cdc.gov/nchs/data/vsus/VSUS_1962_2A.pdf .
277 Id.
278 https://webarchive.nationalarchives.gov.uk/ukgwa/20160111174808/http://www.ons.gov.uk/ons/publications/re -
reference -tables.html?edition=tcm%3A77 -215593 .

50
 introduction of the measles vaccine. Therefore, even without the measles vaccine, the death rate
would have, no doubt, continued to decline after 1963.

In pockets of the country with poor nutrition, sanitation, and water, deaths from any pathogen,
including measles, can occur at a higher rate. Those conditions still existed in some pockets of the
United States in the early 1960s. As living conditions in t hose pockets of America improved with
the introduction of clean water, improved sanitation, and better living conditions, deaths from
measles declined, which is what typically occurs when these conditions improve. Also  health care,
especially the managemen t and treatment of acute infections, has vastly improved since the 1960s.

Yet, CDC claims that measles vaccines saved  a data defying over 2,800 lives a year from measles
in the United States between 1994 and 2023. CDC’s study also doesn’t account for the increase in
deaths from heart disease and cancer due to the elimination of measles, discussed below  and
reflected by studies that did not engage in estimates.

In sum, the CDC article must conform to CDC policy to be published, does not account for any
external factors, does not account for actual mortality data related to these diseases, and lacks any
confidence intervals because its claims have no statistical  reliability. Thus, this study claiming 1.1
million lives were saved is  unreliable at best.

SLIDE 72: MEASLES

A study which followed over 100,000 individuals in Japan for approximately 21 years found that
those who had been infected with measles and mumps had a statistically significant lower risk of
death from cardiovascular disease, strokes, and heart attacks.279 For example, men who had
measles and mumps (as compared to those who did not have measles and mumps), had a 17%
reduction in strokes, 20% reduction in cardiovascular disease, and 29% reduction in heart
attacks.280 Critically, after 21 years, approximately 7% of the men who had measles and mumps
had died of cardiovascular disease while approximately 14% of the men who never had measles
or mumps died of cardiovascular disease.281 Meaning, the men who never had measles and mumps
were far more likely to die. The statistically significant findings in this study remained statistically
significant even after adjusting its results for: a ge; body mass; family history of cardiovascular
disease; alcohol intake; energy intake; smoking; walking; sports; mental stress; education; and
history of hypertension, cardiovascular disease, or diabetes.282
Cardiovascular disease is the number one killer of Americans, taking the lives of over 900,000
Americans a year.283 In contrast, as discussed above, according to the CDC, around 400 Americans
died of measles annually in the several years before the first measles vaccine arrived in 1963 (and

279 https://pubmed.ncbi.nlm.nih.gov/26122188/  (https://perma.cc/6TJD -5FNZ ).
280 Id.
281 Id.
282 Id.
283 https://www.cdc.gov/heart -disease/data -research/facts -stats/ .
51
 this number was declining without a vaccine), and around 40 Americans died annually of mumps
in the several years before the first mumps vaccine was introduced in 1967.284
This Japanese study  may reflect why measles, unlike most pathogens, may not have died out over
time through natural selection .
Similar to the finding regarding heart disease, some studies, although not nearly as robust, have
found that eliminating measles appears to have caused a measurable increase in certain cancer
rates. For example, the International Agency for Research on Can cer found that those who never
had measles had a 66% increased rate of non -Hodgkin lymphoma and a 233% increased rate of
Hodgkin lymphoma.285 These two cancers are expected to kill an estimated 20,540 Americans in
2025.286 There are also studies documenting children with Hodgkin’s disease experiencing
remission when having measles.287
Likewise, researchers at the Department of Health Care and Epidemiology at the University of
British Columbia and the Department of Biology at the University of Victoria found that those
who never had measles had a 50% increased rate of ovarian cancer, whi ch is expected to kill an
estimated 12,730 Americans in 2025.288
Other studies have reached similar conclusions that measles, as well as mumps, rubella, pertussis,
and chickenpox, reduce the rate of various forms of cancers, including a study from researchers at
the University of Berne, Switzerland that specifically rev iewed these fever -inducing ( i.e., febrile)
infections and found that the “study consistently revealed a lower cancer risk for patients with a
history of FICD [febrile infectious childhood diseases].”289 And as an article in The Quarterly
Review of Biology  explained :
[D]etailed retrospective and prospective clinical studies …
supported the conclusion that frequency of the infectious fever
episodes and cancer diagnoses are inversely related (Abel et al.
1986; Mastrangelo et al. 1998; Kleef et al. 2001; Kleef and Hager
2006). For example, Grossarth -Maticek et al. (1987) performed a
10-year prospective cohort study of 1353 patients, concluding that
episodes of high fever as a typical reaction to an acute illness during
the entire life span are inversely related to later ca ncer incidence.
Kölmel et al. (1992), based on 271 controls versus 139 melanoma
patients, demonstrated an inverse relation between the number of

284 https://icandecide.org/wp -content/uploads/2023/10/cdc -reported -cases -and-deaths -m-vaccine -preventable -disease
s-3.pdf .
285 https://pubmed.ncbi.nlm.nih.gov/16406019/  (https://perma.cc/RHD3 -986B ). See Table 2 and in the Non -
Hodgkin’s Lymphoma (NHL) column divide the odds ratio 1 (never had measles) with .6 (had measles) which results
in a 66% increased risk, and in the Hodgkin’s Lymphoma (HL) column divide the odds ratio 1 (never had measles)
with .3 ( had measles) which results in a 233% increased risk.
286 https://seer.cancer.gov/statfacts/html/hodg.html ; https://seer.cancer.gov/statfacts/html/nhl.html .
287 https://pubmed.ncbi.nlm.nih.gov/4574047/ .
288 https://pubmed.ncbi.nlm.nih.gov/16490323/ ; https://seer.cancer.gov/statfacts/html/ovary.html .
289 https://pubmed.ncbi.nlm.nih.gov/9824838/ .
52
 febrile infections and the incidence of malignant melanoma.
Similarly, Wrotek et al. (2009) have reported a lower frequency of
fever in a population of 355 breast tumor patients, compared to 244
healthy women volunteers.290
This article also explained how a survey of studies of spontaneous cancer remissions found that
“approximately 70% of documented cases [of remission] were immediately preceded by an acute
infection associated with high fever” and that this phenomenon has “ been reported for
centuries.”291
There are also studies that have found that children who have had measles have far fewer allergies
and atopic diseases, such as asthma, and adults who have had measles have a reduced risk of
Parkinson’s disease.292

SLIDE 73: MORTALITY TABLE

290 https://www.journals.uchicago.edu/doi/10.1086/699409 .
291 Id.
292 https://pubmed.ncbi.nlm.nih.gov/19255001/ ; https://pubmed.ncbi.nlm.nih.gov/16854347/ ; https://pubmed.ncbi
.nlm.nih.gov/4061437/ .

53
 Diphtheria, Tetanus, & Pertussis
Scanning down from the top of the table  above , note that when a vaccine was introduced for each
disease, U.S. deaths were already rare. Also, m ost of the deaths are attributed to diseases for which
vaccines were introduced before 1950 (diphtheria, pertussis, and tetanus). The m ortality rate for
these three diseases had already precipitously declined before introduction or material use of a
vaccine and would likely have continued to decline without a vaccine. This chart, using CDC data,
reflects the decline b etween 1900 and 1949, the year DTP was licensed (as well  as the decline
between 1900 and 1940):293

Diphtheria  was discussed  above in the “Slides: 66 -73: Mortality” section. As for tetanus and
pertussis , the mortality  from these diseases  declined by more than 80 -90% between 1900 and the
1940s —long before vaccination played a role.294 These vaccines were first introduced into routine
use in the late 1940s with the licensure of DTP in 1949. As explained by the NIH: “The whole -
cell pertussis vaccine became widely available in the United States in the 1940s, although it was
first licensed in 1914. It was crudely made and had limited use until the 1940s, because of reports
of serious side effects including death.”295 Similarly, as CDC explains regarding the tetanus
vaccine: “In the late 1940s, tetanus toxoid -containing vaccines  were introduced into routine
childhood vaccination .”296

What caused the decline in diphtheria, tetanus, pertussis, and other diseases before introduction of
vaccination (and thereafter)? This decline is likely caused by many factors, including
improvements in sanitation, clean water, nutrition, and medical care . For example, medical care
acutely improved from the 1940s when the Nobel Prize was awarded for the development of the
prefrontal lobotomy.297 Even absent a vaccine, the death rate would have continued to decline as

293 The death rate per 100,000 individuals in the United States in 1900, 1940, and 1948 for diphtheria was 40.3, 1.1,
and 0.4, respectively, for tetanus was 2.4, 0.4., and 0.3, respectively, and for pertussis was 12.2, 2.2, and 0.8,
respectively. https://www.cdc.gov/nchs/data/vsus/vsrates1940_60.pdf .
294 The death rate per 100,000 individuals in the United States in 1900, 1940, and 1948 for tetanus was 2.4, 0.4., and
0.3, respectively, and for pertussis was 12.2, 2.2, and 0.8, respectively.
https://www.cdc.gov/nchs/data/vsus/vsrates1940_60.pdf .
295 https://web.archive.org/web/20250407045130/https://history.nih.gov/display/history/Pertussis .
296 https://www.cdc.gov/pinkbook/hcp/table -of-contents/chapter -21-tetanus.html .
297 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4291941/ .

54
 living conditions improved, including improvements in medical care, and particularly acute
medical care (as well as the decline of certain harmful  medical practices).
Nonetheless, even assuming the number of deaths from a given disease remained stagnant since
the year before the first vaccine for each disease was introduced, the total deaths per year,
combined, would be in the low thousands. Every death is a tragedy, bu t this is far from the millions
often claimed, and the death figures in the above chart  (from a few pages back) do not account for
the fact that, even absent a vaccine, the deaths caused by these diseases were almost universally
on a sharp decline.
This decline would have no doubt continued absent vaccination. Meaning, had the vaccines of the
1940s instead been introduced in the 1960s or 1970s, deaths would have already declined to a mere
fraction of their 1940s levels.
Polio

Next on the above chart  is polio, the only disease for which a vaccine was introduced in the 1950s.
In contrast to every other disease listed, where mortality was sharply declining in the decades
before and after 1900, polio caused almost no deaths in 1900. Instead, it paradoxic ally went from
being nearly innocuous up until around 1890, to then having an increasing rate of mortality, to
then having a sharply increasing reported rate of mortality in the few years leading up to 1952.
From that peak, its mortality rate declined shar ply before introduction of the first polio vaccine in
1955. What this and the greater history about polio reflect is that one or more factors made the
polio virus more lethal in the first half of the 1900s. As these outside factors declined, so did the
mortality of polio.

Measles, Mumps, & Rubella

Next on the above chart  is measles, which is also discussed above. The  rate of mortality from
measles declined by over 98% between 1900 and 1962, prior to the introduction of the first measles
vaccine in 1963 and would have no doubt continued to decline without a measles vaccine.

Next on the list are mumps and rubella. The first vaccine for each was introduced in 1967 and
1969, respectively. By the time a vaccine was developed, both diseases caused few deaths annually
in the several years before a vaccine was developed.298 In addition, between 1960 and 1975, the
rate of decline in mumps deaths continued at roughly the same pace before and after licensure of
mumps vaccine in 1967, and the rubella deaths actually increased  after licensure of the first rubella
vaccine in 1969.299 But either way the number of deaths were few.
Further evidencing that mumps would have disappeared without a mumps vaccine, at most 50%
to 60% of children received this product in the 1970s, and they only received one dose (and we

298 https://web.archive.org/web/20190615081539/https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendic
es/e/reported -cases.pdf .
299 Id.
55
 now know that even two doses of the same formulation, let alone one, often fails to confer
protective immunity), but mortality from mumps reached essentially zero in the 1970s.300
Hepatitis B
Next on the above chart  is Hep B, a primarily blood -borne infection that is typically spread through
sexual contact and contaminated needles. The first Hep B vaccine was introduced in 1981 and
made with human blood plasma from donors who were chronically infected with the Hep B virus.
In 1986, a new Hep B vaccine using recombinant DNA technology without human blood was
licensed. The mortality from Hep B climbed after introduction of the 1981 vaccine, continued to
climb after the introduction of the 1986 vaccine, and ha s never returned to pre -vaccination levels.
In 1980, there were 294 deaths in the United States from Hep B.301 Today, there are around 1,700
deaths per year.302
Hib
Next on the above chart  is Hib vaccine. The first Hib vaccine was introduced in 1985 but was
withdrawn three years later because it was entirely ineffective among children 18 months and
younger and may have increased the incidence of disease in older children.303
In 1991, after another Hib vaccine considered effective was introduced, the CDC for the first time
recommended a three -dose series of Hib vaccine in the first year of life .304 In 1992, only 28.2% of
children were vaccinated for Hib, and there were a total of 17 deaths from Hib in the United States
in 1991.305 Yet, the steady decline in mortality from Hib in the prior decades, which had dropped
rapidly without the existence of any Hib vaccine, is attributed to the Hib vaccine.306

300 Compare  https://web.archive.org/web/20190615081539/https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads
/appendices/ e/reported -cases.pdf  with https://web.archive.org/web/20190618125412/https:/www.cdc.gov/
vaccines/pubs/pinkbook/downloads/appendices/e/coverage -levels.pdf ; see also  https://storage.courtlistener
.com/recap/gov.uscourts.paed.381331.12.0.pdf ; https://pubmed.ncbi.nlm.nih.gov/35728505/ ; https://pubmed
.ncbi.nlm.nih.gov/8277201/ .
301 https://web.archive.org/web/20190615081539/https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendic
es/e/reported -cases.pdf .
302 https://www.cdc.gov/hepatitis/statistics/2021surveillance/hepatitis -b/table -2.8.htm .
303 https://web.archive.org/web/20120506033120/http://www.cdc.gov:80/vaccines/pubs/pinkbook/hib.html  (“A pure
polysaccharide vaccine (HbPV) was licensed in the United States in 1985. The vaccine was not effective in children
younger than 18 months of age. Estimates of efficacy in older children varied widely, from 88% to -69% (a negative
efficacy implies greater disease risk for vaccinees than nonvaccinees). HbPV was used until 1988 but is no longer
available in the U nited States.”).
304 https://www.cdc.gov/acip -recs/hcp/vaccine -specific/hib.html .
305 Compare  https://web.archive.org/web/20190615081539/https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads
/appendices/e/ reported -cases.pdf ; https://www.cdc.gov/acip -recs/hcp/vaccine -specific/hib.html ; with https://web.
archive.org/web/20190618125412 ; /https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/e/coverage -
levels.pdf .
306 https://www.cdc.gov/nchs/data/statab/hist001r.pdf .
56
 Notably, mortality among infants under 1 year of age in the 1980s declined rapidly and sharply
when there was no Hib vaccine for infants (not even an ineffective one like the one introduced in
1985 for children 18 months and older and then withdrawn a few years later for lack of efficacy).307

Hepatitis A

Next is Hep A vaccine. In the decade prior to introduction of this vaccine in 1995, there were fewer
than 100 deaths every year in the United States from Hep A, with an average of 80 deaths per
year.308 Fast forward to the present, there have consistently been more than  100 deaths per year
from Hep A, with an average of 166 deaths during the last five years for which death figures are
available.309

Varicella, Pneumococcal, Meningococcal, & Rotavirus

For the final four diseases on the above chart , varicella, pneumococcal, meningococcal, and
rotavirus, the annual deaths among children for each are so low that the CDC has to estimate them.
This was not always the case. Long before vaccines were introduced, each of these diseases did
cause deaths each year that could be counted. But by the time a vaccine was introduced, the deaths
had already become so exceedingly rare, if they occurred at all, that all they could do for these four
diseases was estimate . For example, the CDC admits regarding meningococcal: “Much of the
decline occurred before the routine use of MenACWY vaccines. In addition, serogroup B
meningococcal disease declined even though MenB vaccines were not available until the end of
2014 .”310

Even assuming the estimated  deaths are accurate, these estimates reflect that an American, prior
to a vaccine even existing, had around the same odds of dying from each of these four diseases as
being killed by lightning.

APPENDIX

While the post -licensure vaccine safety literature is limited, this section lists findings from a
relatively small pool of existing studies and reviews that either reached a positive finding of a
connection between one or more vaccines and a limited number  of diseases or found that the
existing evidence is insufficient to reach any definitive conclusion. Either of these findings warrant
further investigation as they evidence that either the studies indicate there is a basis for vaccines
as a cause or the st udies have not been done to rule out vaccines as a cause of a claimed harm from

307 Id.
308 https://web.archive.org/web/20190615081539/https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendi
ces/e/reported -cases.pdf .
309 https://www.cdc.gov/hepatitis -surveillance -2022/hepatitis -a/table -1-4.html .
310 https://www.cdc.gov/vaccines/vpd/mening/hcp/about -vaccine.html .
57
 these products. Note that this is not intended as a full survey of the literature and there are more
studies to be included below. Note also that this section does not discuss COVID -19 vaccines.

1. Acute Disseminated Encephalomyelitis (ADEM)
a. “The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and
ADEM [acute disseminated encephalomyelitis].” Stratton, K., Ford, A., Rusch, E., Clayton, E. W.,
Committee to Review Adverse Effects of Vaccines, & Instit ute of Medicine (Eds.). (2011). Adverse Effects
of Vaccines: Evidence and Causality . National Academies Press (US).
https://pubmed.ncbi.nlm.nih.gov/24624471/

b. “The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and ADEM
[acute disseminated encephalomyelitis].” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to
Review Adverse Effects of Vaccines, & Institute of M edicine (Eds.). (2011). Adverse Effects of Vaccines:
Evidence and Causality . National Academies Press (US).  https://pubmed.ncbi.nlm.nih.gov/24624471/

c. “The evidence is inadequate to accept or reject a causal relationship between varicella vaccine and ADEM
[acute disseminated encephalomyelitis].” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to
Review Adverse Effects of Vaccines, & Institut e of Medicine (Eds.). (2011). Adverse Effects of Vaccines:
Evidence and Causality . National Academies Press (US).  https://pubmed.ncbi.nlm.nih.gov/24624471/

d. “The evidence is inadequate to accept or reject a causal relationship between influenza vaccine and ADEM
[acute disseminated encephalomyelitis].” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to
Review Adverse Effects of Vaccines, & Institut e of Medicine (Eds.). (2011). Adverse Effects of Vaccines:
Evidence and Causality . National Academies Press (US).  https://pubmed.ncbi.nlm.nih.gov/24624471/

e. “The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and ADEM
[acute disseminated encephalomyelitis].” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to
Review Adverse Effects of Vaccines, & Institute of M edicine (Eds.). (2011). Adverse Effects of Vaccines:
Evidence and Causality . National Academies Press (US).  https://pubmed.ncbi.nlm.nih.gov/24624471/

f. “The evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid –, tetanus
toxoid –, or acellular pertussis –containing vaccine and ADEM [acute disseminated encephalomyelitis].”
Stratton, K., Ford, A., Rusch, E., Clayton, E. W. , Committee to Review Adverse Effects of Vaccines, &
Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality . National
Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

g. “The evidence is inadequate to accept or reject a causal relationship between meningococcal vaccine and
ADEM [acute disseminated encephalomyelitis].” Stratton, K., Ford, A., Rusch, E., Clayton, E. W.,
Committee to Review Adverse Effects of Vaccines, & Inst itute of Medicine (Eds.). (2011). Adverse Effects
of Vaccines: Evidence and Causality . National Academies Press (US).
https://pubmed.ncbi.nlm.nih.gov/24624471/

h. “The evidence is inadequate to accept or reject a causal relationship between hepatitis A vaccine and
ADEM [acute disseminated encephalomyelitis].” Stratton, K., Ford, A., Rusch, E., Clayton, E. W.,
Committee to Review Adverse Effects of Vaccines, & Instit ute of Medicine (Eds.). (2011). Adverse Effects
of Vaccines: Evidence and Causality . National Academies Press (US).
https://pubmed.ncbi.nlm.nih.gov/24624471/

i. “ADEM typically appears with the abrupt onset of neurologic symptoms 2 to 30 days after the occurrence
of a preceding infection or vaccination.” Noorbakhsh F., Johnson RT, Emery D., Power C. (2008). Acute
disseminated encephalomyelitis: clinical and pathogenesis features. Neurologic Clinics 26(3):759 -80.
https://pmc.ncbi.nlm.nih.gov/articles/PMC7132764/

j. “The review focused on 23 cases linking acute disseminated encephalomyelitis (ADEM) to influenza
vaccination, gathered from 19 comprehensive articles.” Mashkoor Y, Nadeem A, Fatima T, Aamir M, Vohra
LI, Habib A, Khan A, Raufi N, Habte A. (2024). Neurological complications of influenza vaccination:
58
 navigating the spectrum with a focus on acute disseminated encephalomyelitis (ADEM).  Ann Med Surg
(Lond). 86(2):1029 -1041. https://pubmed.ncbi.nlm.nih.gov/38333316/

k. “Post -vaccination ADEM has been associated with several vaccines such as rabies, diphtheria –tetanus –
polio, smallpox, measles, mumps, rubella, Japanese B encephalitis, pertussis, influenza, hepatitis B, and the
Hog vaccine. We review ADEM with particular em phasis on vaccination as the precipitating factor.”  Huynh
W, Cordato DJ, Kehdi E, Masters LT, Dedousis C. (2008) Post-vaccination encephalomyelitis: literature
review and illustrative case. J Clin Neurosci. 15(12):1315 -22.
https://pmc.ncbi.nlm.nih.gov/articles/PMC7125578/

2. Acute Renal Failure
a. “This is the fourth case report of acute renal failure after influenza vaccination in patients on statins therapy.
The case we describe could account for a [sic] underestimated, even if very rare, phenomenon.” Novati R,
Nebiolo PE, Galotto C, Mastaglia M, Manes M. (2014) Acute renal failure after influenza vaccination: a
case report.  J Prev Med Hyg. 55(1):31 -2. https://pubmed.ncbi.nlm.nih.gov/25916030/

3. Allergy
a. “This study evaluated different dosage forms of aluminum adjuvant in generating allergic rhinitis animal
models.“  Xi et al. (2014). Role of aluminum adjuvant in producing an allergic rhinitis animal model.  Genetics
and Molecular Research 13(3):5173 -5181. https://pubmed.ncbi.nlm.nih.gov/25061742/

4. Alopecia
a. “Adults receiving HBV had significantly increased odds ratios (OR) for…alopecia (OR = 7.2, p < 0.0001,
95% CI = 3.2 - 20)…in comparison to the TCV [control] group. Minimal confounding or systematic error
was observed.” Geier DA, Geier MR. (2005). A case -control study of serious autoimmune adverse events
following hepatitis B immunization . Autoimmunity. 38(4):295 -301.
https://pubmed.ncbi.nlm.nih.gov/16206512/

5. Amyotrophic lateral sclerosis (ALS)
a. “The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and ALS.”
Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of Vaccines, &
Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality . National
Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

b. “Another issue we should consider in this case is the possibility that the HPV vaccine accelerated the ALS
pathogenesis and hastened the disease onset. The HPV vaccine contains a potent toll -like receptor 4 activator
as an adjuvant, and recent animal studi es have shown that toll -like receptor 4 activation is involved in the
pathogenesis of ALS (9,10). Thus, at this time, it is too premature to conclude whether or not the HPV vaccine
is completely safe in individuals with neurological conditions, and further  investigations are needed.  ”
Hikiami R, Yamakado H, Tatsumi S, Ayaki T, Hashi Y, Yamashita H, Sawamoto N, Tsuji T, Urushitani M,
Takahashi R. (2018). Amyotrophic Lateral Sclerosis after Receiving the Human Papilloma Virus Vaccine: A
Case Report of a 15 -year-old Girl.  Intern Med. 57(13):1917 -1919.
https://pmc.ncbi.nlm.nih.gov/articles/PMC6064690/

6. Anaphylaxis
a. “The evidence convincingly supports a causal relationship between MMR vaccine and anaphylaxis.”
Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of Vaccines, &
Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality . National
Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

b. “The evidence convincingly supports a causal relationship between varicella vaccine and anaphylaxis.”
Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of Vaccines, &
Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality . National
Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

59
 c. “The evidence convincingly supports a causal relationship between varicella vaccine and anaphylaxis.”
Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of Vaccines, &
Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality . National
Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

d. “The  evidence  convincingly  supports  a  causal  relationship between hepatitis B vaccine and anaphylaxis
in yeast sensitive individuals.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review
Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence
and Causality . National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

e. “The evidence convincingly supports a causal relationship between tetanus toxoid vaccine and
anaphylaxis.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of
Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

f. “The evidence convincingly supports a causal relationship between meningococcal vaccine and
anaphylaxis.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of
Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

g. “The evidence favors acceptance of a causal relation between measles vaccine and anaphylaxis.” Institute
of Medicine (US) Vaccine Safety Committee, Stratton, K. R., Howe, C. J., & Johnston, R. B., Jr. (Eds.).
(1994). Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality . National
Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/25144097/

h. “The committee concludes that the evidence favors acceptance of a causal relationship between HPV
vaccine and anaphylaxis.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse
Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and
Causality . National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

i. “The evidence establishes a causal relation between DT, Td, and tetanus toxoid and anaphylaxis.” “The
evidence establishes a causal relation between DT, Td, and tetanus toxoid and death from anaphylaxis.”
Institute of Medicine (US) Vaccine Safety Committee, Stratton, K. R., Howe, C. J., & Johnston, R. B., Jr.
(Eds.). (1994). Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/25144097/

j. “The evidence establishes a causal relation between hepatitis B vaccine and fatal anaphylaxis.” Institute of
Medicine (US) Vaccine Safety Committee, Stratton, K. R., Howe, C. J., & Johnston, R. B., Jr. (Eds.). (1994).
Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality . National Academies
Press (US). https://pubmed.ncbi.nlm.nih.gov/25144097/

k. “Non -physiological AEFI [adverse event following immunization], sometimes referred to as hyper -
reactions, are rare, unexpected and more severe than physiological AEFI, and they tend to occur in
immunocompromised patients or patients allergic to vaccine com ponents []. The most severe AEFI are either
allergic (anaphylaxis) or neurological (encephalopathy, encephalitis, neuritis), and can lead to hospitalization
or death [].” Danova J, Kocourkova A, Celko AM. (2017). Active surveillance study of adverse events
following immunisation of children in the Czech Republic . BMC Public Health. 17(1):167.
https://pmc.ncbi.nlm.nih.gov/articles/PMC5292794/

l. “Six papers pertaining to fatal anaphylaxis following vaccination were found relevant.”  Palmiere C,
Tettamanti C, Scarpelli MP. (2017). Vaccination and anaphylaxis: a forensic perspective . Croat Med J.
58(1):14 -25. https://pubmed.ncbi.nlm.nih.gov/28252871/

m. “We identified 13 anaphylaxis reports following MMR; 11 (84.6%) were serious. Seven reports met
Brighton level 1 case definition of anaphylaxis. The other 6 were Brighton level 2. All had symptom onset
within 24 hours of vaccination; most (10) within 1 hou r.” Sukumaran L, McNeil MM, Moro PL, Lewis PW,
Winiecki SK, Shimabukuro TT. (2015). Adverse Events Following Measles, Mumps, and Rubella Vaccine in
60
 Adults Reported to the Vaccine Adverse Event Reporting System (VAERS), 2003 -2013 . Clin Infect Dis.
60(10):e58 -65. https://pmc.ncbi.nlm.nih.gov/articles/PMC4447805/

n. “Comparison of adverse events in different ages following acellular anti -pertussis vaccines shows no
significant differences in febrile reactions, seizures and allergic reactions, which almost evenly occur in both
age groups.” Patterson J, Kagina BM, Gold M, Hussey GD, Muloiwa R. (2018). Comparison of adverse
events following immunisation with acellular and whole -cell pertussis vaccines: A systematic review.
Vaccine. 36(40):6007 -6016. https://pubmed.ncbi.nlm.nih.gov/30143272/

7. Antiphospholipid syndrome (APS)
a. “Successful induction of antiphospholipid syndrome (APS) in two different non -autoimmune prone mouse
strains …, was achieved by tetanus toxoid (TTd) hyperimmunization using different adjuvants … and
different adjuvant pretreatments. …  In this paper we have  explained our model of APS based on TTd
hyperimmunization which supports the concept of the mosaic of autoimmunity.” L. Dimitrijevic et al. (2012).
Vaccine model of antiphospholipid syndrome induced by tetanus vaccine.  Lupus 21(2):195 -202.
https://pubmed.ncbi.nlm.nih.gov/22235053/

b. “There are few reports of autoimmune diseases, such as rheumatoid arthritis and anti -phospholipid
syndrome after anti -tetanus vaccination. Herein, we describe four cases, of which we believe, show a clear
temporal relation between anti -tetanus vaccination and the appearance of dermatomyositis, systemic lupus
erythematosus, type 1 diabetes mellitus and anti -phospholipid syndrome.” Ruhrman -Shahar N, Torres -Ruiz
J, Rotman -Pikielny P, Levy Y. (2017). Autoimmune reaction after anti -tetanus vaccination -descriptio n of
four cases and review of the literature . Immunol Res. 65(1):157 -163.
https://pubmed.ncbi.nlm.nih.gov/27435706/

c. “We included in this review animal models for rheumatoid arthritis -like disease, for systemic lupus
erythematosus -like disease, autoimmune thyroid disease -like disease, antiphospholipid syndrome,
myocarditis and others. All these models support the concept  of ASIA, as the Autoimmune (Auto -
inflammatory) Syndrome Induced by Adjuvants.” Cruz -Tapias P, Agmon -Levin N, Israeli E, Anaya JM,
Shoenfeld Y. (2013). Autoimmune (auto -inflammatory) syndrome induced by adjuvants (ASIA) --animal
models as a proof of concept . Curr Med Chem. 20(32):4030 -6. https://pubmed.ncbi.nlm.nih.gov/23992328/

8. Apnea
a. “Infants in NICU had an increased incidence of sepsis evaluations and increased respiratory support and
intubation after routine immunization.” DeMeo SD et al. (2015). Adverse Events After Routine Immunization
of Extremely Low -Birth -Weight Infants.  JAMA Pediatr . 169(8):740 –745.
https://pmc.ncbi.nlm.nih.gov/articles/PMC4523398/

b. “For infants in the NICU without apnea during the 24 hours immediately before immunization, younger
age, smaller size, and more severe illness at birth are important predictors of postimmunization apnea.” Klein
et al. (2008). Risk Factors for Developing Apnea After Immunization in the Neonatal Intensive Care Unit.
Pediatrics 121(3):463 –469. https://pubmed.ncbi.nlm.nih.gov/18310193/

c. “The majority of preterm infants tolerated immunizations with DTP and HibC without ill effects. However,
12 (12%) infants experienced a recurrence of apnea, and 11 (11%) had at least a 50% increase in the number
of apneic and bradycardic episodes in the 72  hours after immunization.” Sánchez PJ, Laptook AR, Fisher L,
Sumner J, Risser RC, Perlman JM. (1997). Apnea after immunization of preterm infants.  J Pediatr.
130(5):746 -51. https://pubmed.ncbi.nlm.nih.gov/9152284/

d. “In hospitalized preterm infants, the odds of apnea within 48 hours were higher after 2 -month vaccinations
vs after no vaccinations.”  Greenberg RG, et al. (2025). Apnea After 2 -Month Vaccinations in Hospitalized
Preterm Infants: A Randomized Clinical Trial . JAMA Pediatr. 179(3):246 -254.
https://pubmed.ncbi.nlm.nih.gov/39761016/

9. Arthritis/Arthropathy/Arthralgia
61
 a. “The evidence favors acceptance of a causal relationship between MMR vaccine and transient arthralgia
in women.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of
Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

b. “The evidence favors acceptance of a causal relationship between MMR vaccine and transient arthralgia
in children.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of
Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

c. “The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic
arthralgia in women.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse
Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and
Causality . National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

d. “The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic
arthropathy in children.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse
Effects of Vaccines, & Institute of Medicine (Eds .). (2011). Adverse Effects of Vaccines: Evidence and
Causality . National Academies Press (US).  https://pubmed.ncbi.nlm.nih.gov/24624471/

e. “The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and
arthropathy in men.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects
of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

f. “The evidence is inadequate to accept or reject a causal relationship between varicella vaccine and onset
or exacerbation of arthropathy.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review
Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence
and Causality . National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

g. “The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and onset
or exacerbation of psoriatic arthritis.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review
Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence
and Causality . National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

h. “The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and onset
or exacerbation of reactive arthritis.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review
Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence
and Causality . National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

i. “The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and onset
or exacerbation of rheumatoid arthritis.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to
Review Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines:
Evidence and Causality . National Academies Press (US)  https://pubmed.ncbi.nlm.nih.gov/24624471/

j. “The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and onset
or exacerbation of juvenile idiopathic arthritis.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee
to Review Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines:
Evidence and Causality . National Academies Press (US).  https://pubmed.ncbi.nlm.nih.gov/24624471/

k. “The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and transient
arthralgia.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of
Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

l. “The evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid –, tetanus
toxoid –, or acellular pertussis –containing vaccine and arthropathy.” Stratton, K., Ford, A., Rusch, E., Clayton,
62
 E. W., Committee to Review Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse
Effects of Vaccines: Evidence and Causality . National Academies Press (US).
https://pubmed.ncbi.nlm.nih.gov/24624471/

m. “The evidence is inadequate to accept or reject a causal relationship between influenza vaccine and onset
or exacerbation of arthropathy.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review
Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence
and Causality . National Academies Press (US).  https://pubmed.ncbi.nlm.nih.gov/24624471/

n. “The Advisory Committee of Immunization Practices at the Centers for Disease Control and Prevention
concluded 3 years later that a causal relationship exists between arthritis and two vaccination combinations:
diphtheria -tetanus -pertussis (DTP) and measles -mumps -rubella (MMR).” Agmon -Levin N, Paz Z, Israeli E,
Shoenfeld Y. (2009). Vaccines and autoimmunity . Nat Rev Rheumatol. 5(11):648 -52.
https://pubmed.ncbi.nlm.nih.gov/19865091/

o. “We identified 15 reports of arthritis or arthralgia following MMR. All were in females, and onset ranged
from 0 to 19 days postvaccination. One report was serious and involved a patient subsequently diagnosed
with rheumatoid arthritis.”  Sukumaran L, McNeil MM, Moro PL, Lewis PW, Winiecki SK, Shimabukuro
TT. (2015). Adverse Events Following Measles, Mumps, and Rubella Vaccine in Adults Reported to the
Vaccine Adverse Event Reporting System (VAERS), 2003 -2013.  Clin Infect Dis. 60(10):e58 -65.
https://pmc.ncbi.nlm.nih.gov/articles/PMC4447805/

p. “Adults receiving HBV had significantly increased odds ratios (OR) for…arthritis (OR = 2.01, p < 0.0003,
95% CI = 1.3 - 3.1)…in comparison to the TCV [control] group.” Geier DA, Geier MR. (2005). A case -
control study of serious autoimmune adverse events following hepatitis B immunization . Autoimmunity.
38(4):295 -301. https://pubmed.ncbi.nlm.nih.gov/ 16206512/

q. “Recombinant hepatitis B vaccine may trigger the development of Rheumatoid Arthritis in MHC class II
genetically susceptible individuals.” Pope, J.E., Stevens, A., Howson, W., Bell, D.A. (1998). The
development of rheumatoid arthritis after recombinant hepatitis B vaccination . J Rheumatol.
https://pubmed.ncbi.nlm.nih.gov/9733447/

r. “Adults receiving HBV [Hepatitis B Vaccine] had significantly increased odds ratios (OR)
for…rheumatoid arthritis (OR = 18, p < 0.0001, 95% CI = 3.1 - 740)…in comparison to the [control] group.
Minimal confounding or systematic error was observed.” Geier, D.A., Geier, M.R. (2005). A case -control
study of serious autoimmune adverse events following hepatitis B immunization . Autoimmunity.
https://pubmed.ncbi.nlm.nih.gov/ 16206512/

10. Asthma
a. “The evidence is inadequate to accept or reject a causal relationship between LAIV [live attenuated
influenza vaccine] and asthma exacerbation or reactive airway disease episodes in children younger than 5
years of age.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of
Vaccines, & Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

b. “The evidence is inadequate to accept or reject a causal relationship between LAIV [live attenuated
influenza vaccine] and asthma exacerbation or reactive airway disease episodes in persons 5 years of age or
older.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of Vaccines,
& Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality . National
Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

c. “Among children with eczema, vaccine -associated aluminum was positively associated with persistent
asthma (aHR 1.26 per 1 mg increase in aluminum, 95% CI 1.07, 1.49); a positive association was also
detected among children without eczema (aHR 1.19, 95% CI 1.14, 1.25).” Daley MF, Reifler LM, Glanz JM,
Hambidge SJ, Getahun D, Irving SA, Nordin JD, McClure DL, Klein NP, Jackson ML, Kamidani S, Duffy
J, DeStefano F. (2023).  Association Between Aluminum Exposure From Vaccines Before Age 24 Months and
63
 Persistent Asthma at Age 24 to 59 Months . Acad Pediatr. 23(1):37 -46.
https://pubmed.ncbi.nlm.nih.gov/29458196/

d. “In this study, which only allowed for the calculation of unadjusted observational associations, higher ORs
were observed within the vaccinated versus unvaccinated group for developmental delays, asthma and ear
infections. Further study is necessary to und erstand the full spectrum of health effects associated with
childhood vaccination.” Hooker BS, Miller NZ. (2020). Analysis of health outcomes in vaccinated and
unvaccinated children: Developmental delays, asthma, ear infections and gastrointestinal disorde rs. SAGE
Open Med. 8:2050312120925344. https://pubmed.ncbi.nlm.nih.gov/32537156/

11. Ataxia
a. “The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and ataxia.”
Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects of Vaccines, &
Institute of Medicine (Eds.). (2011). Adverse Effects of Vaccines: Evidence and Causality . National
Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

b. “The evidence is inadequate to accept or reject a causal relationship between varicella vaccine and
cerebellar ataxia.” Stratton, K., Ford, A., Rusch, E., Clayton, E. W., Committee to Review Adverse Effects
of Vaccines, & Institute of Medicine (Eds.). (201 1). Adverse Effects of Vaccines: Evidence and Causality .
National Academies Press (US). https://pubmed.ncbi.nlm.nih.gov/24624471/

c. “The evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid –, tetanus
toxoid –, or acellular pertussis –containing vaccine and ataxia.” Stratton, K., Ford, A., Rusch, E., Clayton, E.
W., Committee to Review Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse
Effects of Vaccines: Evidence and Causality . National Academies Press (US).
https://pubmed.ncbi.nlm.nih.gov/24624471/

d. “550 notification records of adverse events after MMR vaccination at 15 mo of age have been registered,
and a total of 41 notifications have included “gait disturbance”. This corresponds to a frequency of 8 per 100
000 doses of MMR vaccine used for 15 -mo-old children. The symptoms and signs are characteristic of
cerebellar ataxia.” Plesner AM, Hansen FJ, Taudorf K, Nielsen LH, Larsen CB, Pedersen E. (2000). Gait
disturbance interpreted as cerebellar ataxia after MMR vaccination at 15 months of age: a follow -up study.
Acta Paediatr. 89(1):58 -63. https://pubmed.ncbi.nlm.nih.gov/10677059/

e. “The report of most cases of ataxia within the first 6 weeks after vaccination (when the date of vaccination
is known), reveals an unbalanced distribution of occurrence in this time period, with most cases reported in
the first two weeks. This may suggest that some cases of ataxia are triggered by vaccination and warrants
continuous and careful analysis of such cases after vaccination.” Sheikh et al. (2012). Ataxia after
Vaccination in United States, a Report from the CDC/FDA Vaccine Adverse Event Reporting  System [1990 –
2010] (P05.016) . Neurology. 78(Meeting Abstracts 1).
https://www.neurology.org/doi/10.1212/wnl.78.1_supplement.p05.016

f. “Although immunization with meningococcal group C conjugate vaccines has been associated with several
neurological side effects, acute cerebellar ataxia has not been previously reported. The authors describe a
case of a 12 -year-old girl exhibiting acute ce rebellar ataxia following meningococcal group C conjugate
vaccination.” Cutroneo PM, Italiano D, Trifirò G, Tortorella G, Russo A, Isola S, Caputi AP, Spina E. (2014).
Acute cerebellar ataxia following meningococcal group C conjugate vaccination.  J Child N eurol. 29(1):128 -
30. https://pubmed.ncbi.nlm.nih.gov/23275434/

12. Autism
a. “The  evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid –, tetanus
toxoid –, or acellular pertussis –containing vaccine and autism.” Stratton, K., Ford, A., Rusch, E., Clayton, E.
W., Committee to Review Adverse Effects of Vaccines, & Institute of Medicine (Eds.). (2011). Adverse
Effects of Vaccines: Evidence and Causality . National Academies Press (US).
https://pubmed.ncbi.nlm.nih.gov/24624471/

64
 b. “The application of the Hill’s criteria to these data indicates that the correlation between Al in vaccines
and ASD may be causal.” Tomljenovic L, Shaw CA. (2011). Do aluminum vaccine adjuvants contribute to
the rising prevalence of autism?  J Inorg Biochem. 105(11):1489 -99.
https://pubmed.ncbi.nlm.nih.gov/22099159/

c. “In the following article we briefly review the literature on Al neurotoxicity and the use of Al salts as
vaccine adjuvants and consider not only direct toxic actions on the nervous system, but also the potential
impact for triggering autoimmunity. Autoimm une and inflammatory responses affecting the CNS appear to
underlie some forms of neurological disease, including developmental disorders.” Shaw, C. A., Li, D., &
Tomljenovic, L. (2014). Are there Negative CNS Impacts of Aluminum Adjuvants Used in Vaccines  and
Immunotherapy?  Immunotherapy, 6(10), 1055 –1071. https://pubmed.ncbi.nlm.nih.gov/25428645/

d. “There was a suggestion of increased ASD risk among children whose mothers received an influenza
vaccination in their first trimester, but the association was not statistically significant after adjusting for
multiple comparisons, indicating that the findi ng could be due to chance. These findings do not call for
changes in vaccine policy or practice, but do suggest the need for additional studies on maternal influenza
vaccination and autism.” Zerbo O, Qian Y, Yoshida C, Fireman BH, Klein NP, Croen LA. (2017 ).
Association Between Influenza Infection and Vaccination During Pregnancy and Risk of Autism Spectrum
Disorder . JAMA Pediatr. 171(1):e163609. https://pubmed.ncbi.nlm.nih.gov/27893896/

e. “The aluminium content of brain tissue in autism was consistently high…. The pre -eminence of
intracellular aluminium associated with non -neuronal cells was a standout observation in autism brain tissue
and may offer clues as to both the origin of the brain  aluminium as well as a putative role in autism spectrum
disorder.” Mold M, Umar D, King A, Exley C. (2018). Aluminium in brain tissue in autism . J Trace Elem
Med Biol. 46:76 -82. https://pubmed.ncbi.nlm.nih.gov/29413113/

f. By applying Hill's criteria for establishing causality between exposure and outcome we investigated
whether exposure to Al [aluminum] from vaccines could be contributing to the rise in ASD prevalence in the
Western world. Our results show that: (i) childre n from countries with the highest ASD prevalence appear to
have the highest exposure to Al from vaccines; (ii) the increase in exposure to Al adjuvants significantly
correlates with the increase in ASD prevalence in the United States observed over the last  two decades
(Pearson r=0.92, p<0.0001); and (iii) a significant correlation exists between the amounts of Al administered
to preschool children and the current prevalence of ASD in seven Western countries, particularly at 3 -4
months of age (Pearson r=0.89 -0.94, p=0.0018 -0.0248). The application of the Hill's criteria to these data
indicates that the correlation between Al in vaccines and ASD may be causal. Because children represent a
fraction of the population most at risk for complications following expo sure to Al, a more rigorous evaluation
of Al adjuvant safety seems warranted. Tomljenovic L, Shaw CA. (2011). Do aluminum vaccine adjuvants
contribute to the rising prevalence of autism?  J Inorg Biochem. 105(11):1489 -99.
https://pubmed.ncbi.nlm.nih.gov/22099159/

13. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) (Shoenfeld’s syndrome)
a. “In recent years, four conditions: siliconosis, the Gulf war syndrome (GWS), the macrophagic myofasciitis
syndrome (MMF) and post -vaccination phenomena were linked with previous exposure to an adjuvant...
Relating to the current knowledge we would like to suggest to include these comparable conditions under a
common syndrome entitled ASIA, ‘Autoimmune (Auto -inflammatory) Syndrome Induced by Adjuvants ’”.
(2011). Shoenfeld Y, Agmon -Levin N. 'ASIA' - autoimmune/inflammatory syndrome induced by adjuvants.
J Autoimmun. 36(1):4 -8. https://pubmed.ncbi.nlm.nih.gov/20708902/

b. “We included in this review animal models for rheumatoid arthritis -like disease, for systemic lupus
erythematosus -like disease, autoimmune thyroid disease -like disease, antiphospholipid syndrome,
myocarditis and others. All these models support the concept  of ASIA, as the Autoimmune (Auto -
inflammatory) Syndrome Induced by Adjuvants.” Cruz -Tapias P, Agmon -Levin N, Israeli E, Anaya JM,
Shoenfeld Y. (2013). Autoimmune (auto -inflammatory) syndrome induced by adjuvants (ASIA) --animal
models as a proof of concept . Curr Med Chem. 20(32):4030 -6. https://pubmed.ncbi.nlm.nih.gov/23992328/

c. “We have examined the neurotoxicity of aluminum in humans and animals under various conditions,
following different routes of administration, and provide an overview of the various associated disease states.
65
 The literature demonstrates clearly negative impacts of aluminum on the nervous system across the age span.
In adults, aluminum exposure can lead to apparently age -related neurological deficits resembling Alzheimer's
and has been linked to this disease and  to the Guamanian variant, ALS -PDC. … In young children, a highly
significant correlation exists between the number of pediatric aluminum -adjuvanted vaccines administered
and the rate of autism spectrum disorders. Many of the features of aluminum -induced n eurotoxicity may arise,
in part, from autoimmune reactions, as part of the ASIA syndrome.” Shaw CA, Tomljenovic L. (2013).
Aluminum in the central nervous system (CNS): toxicity in humans and animals, vaccine adjuvants, and
autoimmunity . Immunol Res. 56(2 -3):304 -16. https://pubmed.ncbi.nlm.nih.gov/23609067/

14. Autoimmune Encephalitis
a. “ These two cases highlight the potential for AE following the administration of the Shingrix® vaccine
and underscore the importance of prompt recognition and aggressive immunotherapy to prevent morbidity
and mortality.” Madani TA, Khoja AA, Abuzinadah AR,  Abbas GM, Alotaibi AA, Alshehri ZI, Madani ST.
(2025). Post-vaccinal seronegative autoimmune encephalitis following recombinant zoster vaccination in
two immunocompetent patients . J Infect Chemother. 31(6):102713.
https://pubmed.ncbi.nlm.nih.gov/40254183/

15. Autoimmune Diseases (Generally)
a. “Reported post -vaccination autoimmune diseases in the adult include SLE, rheumatoid arthritis (RA),
inflammatory myopathies, multiple sclerosis (MS), Guillain -Barré syndrome (GBS), and vasculitis.” Orbach
H, Agmon -Levin N, Zandman -Goddard G. (2010). Vaccines and autoimmune diseases of the adult.  Discov
Med. 9(45):90 -7. https://pubmed.ncbi.nlm.nih.gov/20193633/

b. “More than 600 cases of illnesses, many with MS -like symptoms, of people who had received the
recombinant HBV vaccine, have been collected in France. A growing fraction of people who have been
vaccinated against HBV claim to have experienced serious side e ffects. Their complaints cover a wide
spectrum of diseases, among which many of an autoimmune nature and nervous system disorders. Those
include rheumatoid arthritis, optic neuritis, and neurodegenerative disorders that resemble MS. The temporal
associatio n of multiple sclerosis (MS) with HBV vaccination has been reported on few occasions [22, 23];
neurological symptoms and signs, as well as magnetic resonance imaging documenting central nervous
system (CNS) demyelinization have occurred days to weeks after  HBV vaccination.” Shoenfeld Y, Aron -
Maor A. (2000). Vaccination and autoimmunity -'vaccinosis': a dangerous liaison?  J Autoimmun. 14(1):1 -
10. https://pubmed.ncbi.nlm.nih.gov/10648110/

c. “The VAERS and PubMed (1966 -2003) were searched for autoimmune conditions including arthritis,
rheumatoid arthritis, myelitis
…[truncated]

Summary: SENT VIA EMAIL     Advisory Committee on Immunization Practices     Centers for Disease Control and Prevention   acip@cdc.gov      Re:  Supplement to December 5, 2025 Presentation Titled Development of the U.S.   Childhood Vaccination Schedule: With a Focus on Suggested Improvements     To ACIP:     Please find herein additional sources for various slides for the  above -referenced presentation.  As  disclosed in that presentation, I am the Manag ing Partner of Siri & Glimstad LLP which has…