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Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 1 of 27
National Academies Committee on Review of Relevant Literature Regarding Adverse Events Associated with
Vaccines March 30 2023: Written material accompanying oral remarks.
Submitted March 31 2023 to: vaccines@nas.edu
David Wiseman PhD, MRPharmS
Synechion, Inc. Dallas, TX
david.wiseman@synechion.com
Josh Guetzkow PhD Hebrew University, Jerusalem, Israel. joshua.guetzkow@mail.huji.ac.il
Spiro Pantazatos PhD spiropan@gmail.com
Jessica Rose PhD jessicarose1974@protonmail.com
Hervé Seligmann PhD varanuseremius@gmail.com
Oral remarks at: https://player.vimeo.com/video/809903500#t=84m37s
Capsule
A committee of the National Academies convened on March 30 2023 to “review relevant literature regarding adverse events
associated with [Covid-19] vaccines.” To supplement oral remarks delivered at the meeting and to assist the committee’s
deliberations, further detail is provided here along with a summary (with original documents) of our written comments
submitted to FDA and CDC advisory committees on Covid-19 Vaccines. These comments contain a number of novel
analyses conducted relating to Covid-19 vaccine safety. This document further discusses:
• Hasty vaccine development, undisclosed sequences and kinetics of modRNA and spike protein
• Novel heterotrimers formed after bivalent vaccination
• Gene therapy nature of the Pfizer, Moderna and Janssen Covid-19 vaccines
• VAERS underreporting
• Safety signal analysis
• Masking of safety signals
• Ischemic stroke
• Negative efficacy: an indicator of immune suppression?
• All-cause mortality and vaccination
• Concerning cancer reports
• Transparency, scientific engagement, rebuilding trust in public health
We show here a number of instances of FDA or CDC analyses being unreliable or highly limited.
According to a recent article in Nature,(1) Covid-19 vaccine hesitancy has spilled over to other vaccinations reaching their
lowest point since 2008 and jeopardizing the health of millions. This is attributed an erosion of trust and confidence in
governments and public-health institutions exacerbated with the advent of COVID-19 vaccines.
Restoring trust in public health institutions must surely be your highest priority. Unless the setting of parameters that will
determine whether someone is eligible for compensation for alleged vaccine-injury is seen as just, there will be further
erosion in trust of public health institutions, exacerbated as the specter of unknown long-term harms related to the hastily
deployed novel gene therapy, becomes appreciated.
Restoration in trust can only be begin if your work is transparent and open to scientific dialog. Yours cannot be another
exercise in “going through the motions” of the kind we have seen with FDA and CDC committees. My colleagues and I are
ready to participate in meaningful and necessary scientific discourse.
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 2 of 27
Table of Contents
1. Original oral remarks ................................................................................................................................................ 3
2. Introduction ............................................................................................................................................................... 3
3. Summary of written comments submitted to FDA and CDC on Covid-19 Vaccines .......................................... 4
4. Expanded detail of oral remarks.............................................................................................................................. 5
4.1. Hasty vaccine development, undisclosed sequences and kinetics of modRNA and spike protein ................ 5
4.2. Novel heterotrimers .................................................................................................................................................. 7
4.3. Gene therapy nature of the Pfizer, Moderna and Janssen Covid-19 vaccines ................................................... 8
4.4. VAERS underreporting ............................................................................................................................................. 8
4.5. Safety signal analysis ............................................................................................................................................... 9
4.6. Masking of safety signals ....................................................................................................................................... 14
4.7. Ischemic stroke signal in more than one database ............................................................................................. 14
4.8. Negative Efficacy: an indicator of immune suppression? .................................................................................. 18
4.9. All cause mortality (ACM) and vaccination .......................................................................................................... 20
4.10. Concerning cancer reports .................................................................................................................................... 21
4.11. Transparency, scientific engagement, restoring trust in public health institutions ........................................ 22
5. Bio ............................................................................................................................................................................. 23
6. List of files provided ............................................................................................................................................... 23
7. References ............................................................................................................................................................... 23
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 3 of 27
1. Original oral remarks
“Thank you. I am a PhD with a background in experimental pathology, pharmacy and pharmacology. I led a research
program at Johnson and Johnson where my duties included pharmacovigilance. I focus on fibrosis and pain, running my
own company since 1996. I joined Dr. McCullough on Senator Johnson’s panel.
These expedited and still experimental vaccines are the most complicated medical products ever deployed. Sequences
remain undisclosed and questions about the persistence of mRNA and spike have been evaded despite reports that they
linger many months. The Moderna, and likely Pfizer bivalents elicit up to four distinct spike proteins, including two novel
heterotrimers with likely new toxicology.
Despite meeting FDAs biologic definition of gene therapy products, these vaccines are excluded from the gene therapy
guidance, with no public comment from FDAs gene therapy infectious disease vaccine labs. Concerns for autoimmune,
neurological, hematological and other diseases must remain on the table. We see cancer signals.
VAERS is underreported (2), up to 14 times for myocarditis. FDA have ignored their own estimates for underreporting up
to 36 times (3) when dismissing the now three fold excess of death reports for covid vaccines over all other vaccines for
all years.
I will provide our 17 submissions to FDA and CDC. PRR signal analysis is useful but limited. Using vaccination coverage,
we found more accurate age stratified normalized event ratios up to 7 for GBS, 34 for serous events, 370 for coagulopathies,
98 for deaths and 403 for myocardial infarction.
Significant PRR ratios for events of interest are published in NIH funded work (4)
Kwan (5) found elevations in POTS and other diagnoses. FDA’s Harpaz (6) despite finding masking also hinted at signals
for events on your list.
In their recent discussion of ischemic stroke, CDC and FDA claimed that they found a transient signal in VSD and nowhere
else. And yet, in CDC’s own FOIA disclosure appeared significant PRR signals for ischemic stroke in VAERS form last July.
We obtained a similar result from an online PRR calculator funded by NIH. (7)
Most concerning are data, including CDCs’, showing negative vaccine efficacy, indicating immune suppression. A Cleveland
clinic study (8) recently remarked that theirs was not the only one to find “a possible association with more prior vaccine
doses and higher risk of COVID-19.
We have found from European data, correlations between vaccination coverage and all cause mortality. There is a time
dependency critical to understand the effect of these vaccines with mostly periods of detrimental associations, punctuated
by briefer periods of benefit.
Your work must be open to scientific dialog that is not just “going through the motions” we have seen with FDA and CDC. I
welcome your further interaction.”
2. Introduction
Per its web site:
1
The National Academies of Sciences, Engineering, and Medicine has convened an ad hoc committee to
review the epidemiological, clinical, and biological evidence regarding the relationship between:
• COVID-19 vaccines and specific adverse events i.e. Guillain-Barrè Syndrome (GBS), chronic inflammatory demyelinating
polyneuropathy (CIDP), transverse myelitis (TM), Bell’s palsy, hearing loss, tinnitus, chronic headaches, infertility, sudden
death, myocarditis/pericarditis, thrombosis with thrombocytopenia syndrome (TTS), immune thrombocytopenic purpura
(ITP), thromboembolic events (e.g., cerebrovascular accident (CVA), myocardial infarction (MI), pulmonary embolism, deep
vein thrombosis (DVT)), capillary leak syndrome, and
• intramuscular administration of vaccines and shoulder injuries.
The committee will make conclusions about the causal association between vaccines and specific adverse events.
This document provides further detail to assist the committee’s deliberations.
1
https://www.nationalacademies.org/our-work/review-of-relevant-literature-regarding-adverse-events-associated-with-vaccines
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 4 of 27
This document is not all encompassing with many areas requiring further consideration, most notably the effects of Covid-
19 on reproductive function.
Further it is to stressed that any discussion of safety reports, present of a signal does not prove causality.
3. Summary of written comments submitted to FDA and CDC on Covid-19 Vaccines
Below are summarized our written comments on adverse event related topics contained within made to FDA or
CDC. The files are provided as attachments to this document and numbered according to their citation n this
document.
Date
Year
Agency
Committee
AE related topics/ filename
Ref
8/29
2021
CDC
ACIP
• Disproportionality Signal Analysis discussion. Calculation of Normalized
Event Ratio
• Calculation of VAERS under reporting for death
• Covid-19 and non-Covid-19 deaths after vaccination
• Wiseman09-CDC-2021-0089-0023_attachment_1.pdf
(9)
8/29
2021
CDC
ACIP
• Supplement to (9)
• Full approval of COMIRNARY – vaccine hesitancy
• Waning immunity
• Wiseman10-CDC-2021-0089-0039_attachment_1.pdf
(10)
9/17
2021
FDA
VRBPAC
• Disproportionality Signal Analysis discussion. Calculation of Normalized
Event Ratio (similar to (9))
• Wiseman11-FDA-2021-N-0965-0016_attachment_1.pdf
(11)
10/15
2021
FDA
VRBPAC
• Cases and deaths increase in Israel after booster rollout.
• Evidence of immunosuppression from our analysis of early Israeli published
(12) and MoH data.
• Wiseman13-FDA-2021-N-0965-0146.pdf
(13)
10/15
2021
FDA
VRBPAC
• Critique of disproportionality analyses. Calculation of Normalized Event
Ratio (NER) vs. PRR
• Wiseman14-FDA-2021-N-0965-0164-SUPPLEMENT.pdf
(14)
10/21
2021
CDC
ACIP
• Additional NER/ vs. PRR calculations. Ineffectiveness (negative efficacy?)
from Israeli data presented at 10/15/21 VRBPAC
• Wiseman15-CDC-2021-0098-FDA-2021-N-1088.pdf
(15)
11/19
2021
CDC
ACIP
• VAERS underreporting for myocarditis by 4.8x according to Pfizer
• Wiseman16-CDC-2021-0125-0003_attachment_1.pdf
(16)
12/16
2021
CDC
ACIP
• Coagulopathies with mRNA vs DNA vaccines
• All-cause mortality with vaccination coverage: lag analysis of European
data. Need to analysis data by lag time.
• NER/PRR for various AEs.
• Inconsistent treatment of TTS for Janseen vs. other coagulopathies/
thromboembolic evets with mRNA products
• Wiseman17-CDC-2021-0133-0002_attachment_1.pdf
(17)
1/5
2022
CDC
ACIP
• Manipulation of UK graphs to conceal waning v Omicron
• Waning and negative efficacy, evidence of immunosuppression?
• Wiseman18-CDC-2022-0002-0002_attachment_1.pdf
(18)
2/4
2022
CDC
ACIP
• CDC fails to inform ACIP of negative efficacy data – evidence of immune
suppression?
• Inaccurate risk-benefit analysis.
• Discrepancies of CDC reports for rates of myocarditis provided at ACIP,
VRBPAC meetings vs. CDC’s published work.(19)
• Comments by EMA official and ACIP members on possible harms of
boosting.
• Wiseman20-CDC2022-0022-0009-Feb4ACIP-FDA-2022-N-0082-FINAL.pdf
(20)
4/6
2022
FDA
VRBPAC
• Update waning VE vs. Omicron
• All population booster COVID19 vaccine injections are associated with all-
cause mortality amidst limited periods of benefit in all ages: European and
US data
• Consistent data found with CDC data
• Gene therapy concerns
• Wiseman21-FDA-2022-N-0336-2500_attachment_1.pdf
(21)
4/20
2022
CDC
ACIP
• Very high rates of myocarditis after booster presented by Israeli MoH
(22)
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 5 of 27
• Other information similar to VRBPAC 4/6/22
• Wiseman22-CDC-2022-0051-0260_attachment_1.pdf
5/19
2022
CDC
ACIP
• Estimates of VAERS underreporting, including by Kaiser Permanente – of
6-14 times for myocarditis.(23)
• Wiseman24-CDC2022-0065-ACIP051922-corrected2.pdf
(24)
6/10
2022
FDA
CTGTAC
• Cell Therapy Gene Therapy Advisory Committee
• C19 vaccines meet FDA’s biological definition of a gene therapy product.
Safety concerns discussed relating to gene therapy, as well as lack of
genotoxicty and carcinogenicity studies.
• Wiseman25-FDA-2022-N-0470-June10-CTGTAC-LINKS.pdf
(25)
6/23
2022
CDC
ACIP
• Stunningly poor data for infants < 5years: Negative VE in some scenarios.
• High rates of myocarditis found in VSD vs VAERS by about 6x in some
cases
• Evasion of questions concerning persistence of mRNA and spike.
• Wiseman26-CDC-2022-0085-0017_attachment_2.pdf
(26)
7/19
2022
CDC
ACIP
• High rates of myocarditis for Novavax glossed over by CDC.
• CDC fail to provide PRR analysis per protocol(27)
• Guo et al., publish a PRR analysis(4)
• Wiseman28-CDC-2022-0085-0017_attachment_1.pdf
(28)
9/1
2022
CDC
ACIP
• Disclosure by Moderna of novel heterotrimers
• Wiseman29-CDC-2022-0103-0049_attachment_1.pdf
(29)
10/19
2022
CDC
ACIP
• Unethical pregnancy studies by CDC
• Evasive answers to question about mRNA and spike distribution and
persistence.
• Early (May 2021) indications of negative efficacy from Denmark.(30)
• Discussion of novel heterotrimer
• Wiseman31-CDC-2022-0111-126227-OCT19-ACIP.pdf
(31)
1/26
2023
FDA
VRBPAC
• Analysis of FDA briefing document re: new strain selection.
• Wiseman32-2023-VRBPACJan23-FDA-2022-N-2810-CommentsonBrefingDocument-TRACKING.pdf
(32)
2/24
2023
CDC
ACIP
• Ischemic stroke signal – FDA/CDC ignore its own PRR signal i VAERS.
• Consideration of bivalent vaccines as primary series.
• Wiseman33-CDC-2023-0007-0496_attachment_1.pdf
(33)
4. Expanded detail of oral remarks
4.1. Hasty vaccine development, undisclosed sequences and kinetics of modRNA and spike protein
These expedited and still experimental vaccines are the most complicated medical products ever deployed. Pfizer’s recently
retired head of vaccine research, Dr. Kathrin Jansen, was quoted as saying ““We flew the aeroplane while we were still
building it.” (34) Much about the pharmacology and toxicology of this novel class of vaccine remain to be discovered, but
should have been known prior to roll out, or even now. A review of the preclinical investigations performed or not performed
by Pfizer and Moderna is helpful in assessing plausibility of an adverse event, but is beyond the scope of this document.
Sequences remain undisclosed. Questions about the persistence of modRNA and spike have been evaded (see discussion
in 20)) despite reports that they linger many months. Bansal et al., (35) found that exosomes demonstrated spike protein
antigens on their surface and that “Exosomes with spike protein and antibodies decreased in parallel after four months.”
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 6 of 27
This persistence, far longer than that popularly communicated to be in the order of a few days, is a key factor in analyzing
the causality of adverse events.
The potential toxicity of LNP components has been reviewed recently(36) and was already anticipated in the above
mentioned 2016 paper from Langer’s group: (37)
“Among the most problematic are the potential toxicity of LNP components, including cationic lipids, phospholipids or
combinations thereof. The immunogenicity of PEG and the decreased interaction of the LNPs with the endosomal
membranes that hinders endosomal escape are also important issues for both siRNA and mRNA delivery.”
A further consideration in assessing the toxicity of the Covid-19 vaccines relates to the Lipid Nanoparticles (LNPs) used to
deliver the modRNA payload. Contrary to popular misconception that the Covid-19 vaccines stay close to the site of injection
in the arm, LNPs distribute widely around the body.
Study 18530 released by FOIA and conducted by Pfizer
2
looked at the distribution of Lipid Nanoparticles (LNP) in rats
following intramuscular injection. The study only proceeded for 48 hours, but the LNPs accumulated in a number of tissues,
including (highlighted below), adrenal glands, bone marrow, liver, lymph nodes, ovaries, spleen, and to a smaller extent,
testes. This indicates that we should be particularly vigilant for possible adverse effects in these tissues. The study should
have been continued to determine the point at which the LNPs (or their breakdown products), were eliminated from the
body.
2
https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_26_pharmkin-tabulated-summary.pdf
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 7 of 27
4.2. Novel heterotrimers
The Moderna, and likely Pfizer bivalents elicit up to four distinct spike proteins, including two novel heterotrimers with likely
new toxicology.
As we discuss (31) Moderna revealed at the Sept 1st ACIP (29,31) that their bivalent vaccine elicits the formation of novel
spike protein heterotrimers to produce a superior immunological response. This would mean that these vaccines might have
a different toxicological profile, as yet untested.
Based on EMA documents, it is likely that the same occurs for the Pfizer bivalent vaccine. This represents novel chemistry,
novel pharmacology and potentially novel toxicology.
Indeed Wagenhauser et al. recently reported (38) that the “rate of adverse reactions for the second booster dose was
significantly higher among participants receiving the bivalent 84.6% (95% CI 70.3%-92.8%; 33/39) compared to the
monovalent 51.4% (95% CI 35.9-66.6%; 19/37) vaccine (p=0.0028).”
Graphical results from Wagenhauser et al. (38)
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 8 of 27
4.3. Gene therapy nature of the Pfizer, Moderna and Janssen Covid-19 vaccines
“FDA generally considers human gene therapy products to include all products that mediate their effects by transcription or
translation of transferred genetic material or by specifically altering host (human) genetic sequences. Some examples
of gene therapy products include nucleic acids (e.g., plasmids, in vitro transcribed ribonucleic acid (RNA)),….” (39)
Despite meeting FDAs biologic definition of gene therapy products, these vaccines are excluded from the gene therapy
guidance, with no public comment from FDAs gene therapy infectious disease vaccine labs. Concerns for long term effects
of autoimmune, neurological, hematological and other diseases must remain on the table, especially cancer (see 4.10).
Indeed FDA’s guidance on long term follow up for gene therapy products (39) suggests follow up times of 5-15 years. The
long-term studies committed to by Pfizer and Moderna have not yet been completed or reported. Accordingly, it may not be
possible for this committee to rule out many effects of these vaccines.
The mRNA vaccines are more properly described in FDA documents as “nucleoside modified mRNA” (modRNA) vaccines.
mRNA has been modified by codon optimization and by substitution of N1-methylpseudouridine. There are two proline
amino acid substitutions and the modRNA contains Untranslated Regions (UTR) with gene sequences of human origin.
This is critical in understanding the toxicology of these products. We discuss this matter more fully in our submission to
FDA’s Cell Therapy and Gene Therapy Advisory Committee. (25)
Along with the finding by European regulators of residual DNA (from the plasmid vector used in manufacturing), these issues
recall the concerns expressed by FDA in its 2007 guidance for plasmid vectored vaccines for infectious diseases (40):
“Plasmid biodistribution, persistence and integration studies were initially recommended to examine whether subjects in
DNA vaccine trials were at heightened risk from the long-term expression of the encoded antigen, either at the site of
injection or an ectopic site, and/or plasmid integration. Theoretical concerns regarding DNA integration include the risk of
tumorigenisis if insertion reduces the activity of a tumor suppressor or increases the activity of an oncogene. In addition,
DNA integration may result in chromosomal instability through the induction of chromosomal breaks or rearrangements.
FDA’s own staff have addressed concerns about residual DNA in vaccines,(41) which are surely heightened with a study
that suggests that vaccinal mRNA can be reversed transcribed.(42) Transcriptionally competent DNA carried by exosomes
can enter spermatozoa and inherited extra-chromasomally.(43)
4.4. VAERS underreporting
FDA have acknowledged that VAERS is mis- and underreported (2), up to 14 times for myocarditis from FDA, Israel MoH
and Kaiser-Permanente sources, as we discuss mor fully. (24)
The disproportionately large number of death reports for Covid-19 vaccines in VAERS is well known. A search of VAERS
(3/30/23) for reports of death with any Covid-19 vaccine in the US and Territories revealed 17,185 reports, compared with
5539 reports for all other vaccines, all years combined. Flu vaccine accounted for 1361 of these reports.
VAERS 3/30/23 Covid vax
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 9 of 27
All other vaccines
Flu vaccine
FDA’s Day et al. (3) have attempted to dismiss this sort of discrepancy by comparing the death rates with those normally
expected with data we excerpted here:
These data show, despite mandatory reporting, that the VAERS Under Reporting Factor (URF) for deaths associated with
Covid-19 vaccines is about 10 for a 7-day window and 36 for a 42-day window. This certainly does not rule out any
association between deaths and vaccination, but highlights the severe shortcomings of the VAERS database.
In August 2021 we (9) used CDC published methodology (44) to estimate the degree of under-reporting of in VAERS for
the Pfizer product, by comparing the death of AEs published in clinical trials, with death rates normalized for population
found in VAERS. Using a 30 day window, our estimate of 4.9-15 times underreporting is highly consistent with the figure of
9.6 derived from FDA’s Day et al. (3)
4.5. Safety signal analysis
Disproportionality Signal Analysis (DSA) is commonly used in pharmacovigilance. The use of the Proportional Reporting
Ratio (PRR) is described in the VAERS SOP for analyzing safety signals for the Covid-19 vaccines.(27) As we discuss
extensively (11,14,15) the flaws of the PRR method are well known. It was developed to detect small single or low double
digit increases in the numbers of a reported event after use of a particular drug, using the surrogate denominator of the total
number events reported. This surrogate was necessary because the exact number of drug doses administered is not known.
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 10 of 27
This problem does not exist for the Covid-19 vaccines, as CDC maintains updated statistics on vaccine coverage, including
how many doses of any given vaccine were actually administered, stratified by age.
We therefore used CDC’s vaccination coverage statistics to calculate a more accurate “normalized event ratio” (NER), using
flu vaccines as the comparator. This removes masking type artifacts that can lead to underestimates of an event
frequency.(6) (see 4.6) The NER appears far more sensitive than the PRR, shown below.
We conducted a number of analyses in the Fall of 2021 which we reported to FDA and CDC committees. In this analysis
(11) we show high NER values, despite small PRR values by event category, for all Covid-19 vaccines. The same calculation
is also shown for H1N1 vaccines, collected at a time when AE reporting was encouraged by CDC as an example as
“stimulated reporting.” The ratios calculated for the Covid-19 far exceed those for a vaccine whose reporting was considered
to be “stimulated.”
In the next analysis (11) for all Covid-19 vaccines we show NER values exceeding the PRR equivalent value in five major event
categories, by age. We find NER value up to 7 for GBS, up to 34 for serious events, up to 370 for coagulopathies, up to 98 for
deaths and up to 403 for myocardial infarction. In most cases these values correspond to a statistically significant PRR
value.
(also in (17) )
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 11 of 27
Of note is the apparent reduction in GBS assessed by PRR, in the face of an increase by NER.
We then (14,15,17) stratified by vaccine type and more granular event type. We found greater NER values for coagulopathy and
embolic/thrombotic events for Janssen than Pfizer or Moderna, which are nonetheless high. NERs for death and myocardial infarction
are high for all three vaccines. This means that reporting of deaths after Covid-19 vaccination is 119-297 times the rate than after flu
vaccination.
Montano used similar method to ours (45) and remarked:
“The largest absolute risks were observed for allergic, constitutional reactions, dermatological, gastrointestinal, neurological
reactions, and localised and non-localised pain. The largest relative risks between COVID-19 vs. influenza vaccines were
observed for allergic reactions, arrhythmia, general cardiovascular events, coagulation, haemorrhages, gastrointestinal,
ocular, sexual organs reactions, and thrombosis.”
Significant PRR ratios for events of interest are published in NIH funded work (4) excerpted here.
Of note are a number of neurological events in the same study.
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 12 of 27
Using a different method with electronic health records, Kwan et al. (5) (below) found elevations in POTS, dysautonomia,
and myocarditis. and other diagnoses. Statistically significant but smaller (14-30%) elevations in a number of other
diagnoses were also found, which may be clinically significant.
Using CMS data FDA staff (Wong et al. (46) ) reported:
“Four outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism
(PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91),
and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold
for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination
with either the mRNA-1273 or Ad26 COV2.S vaccines.”
From VAERS, Yan et al (47) calculated Reporting Odds Ratios, a metric related to PRR, finding signals for a number of
thrombo-embolic events.
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 13 of 27
Applying sequential testing (Poisson Maximized Sequential Probability Ratio Test - PMaxSPRT) and near real time
surveillance to data from three medical databases, FDA’s Lloyd et al., (48) compared outcomes of 17 AESIs after Covid-19
vaccination with a historical dataset. The AESIs were:
• unusual site thrombosis (broad) with thrombocytopenia (tp)
• common site thrombosis with thrombocytopenia (tp)
• acute myocardial infarction
• deep vein thrombosis
• pulmonary embolism#
• disseminated intravascular coagulation
• non-hemorrhagic stroke
• hemorrhagic stroke
• immune thrombocytopenia
• myocarditis/pericarditis
• Guillain-Barré syndrome
• Bell’s palsy
• encephalomyelitis/encephalitis
• transverse myelitis
• narcolepsy
• appendicitis
• anaphylaxis
15/17 outcomes evaluated failed to meet the statistical signal threshold in any database. Myocarditis/pericarditis failed to
met the threshold after use of the Pfizer product in one of the databases. Anaphylaxis met the threshold in all three
databases for both the Pfizer and Moderna products. These somewhat surprisingly non-uniform findings for events well-
recognized to be associated with vaccination highlight the limitations in datasets considered more reliable than VAERS. It
is worth reproducing here the limitations described by Lloyd et al. as they might apply to a number of studies that analyze
health record databases:
1. Signal may not persist in a fully adjusted epidemiologic study. Historical comparator group selected without selection
criteria to ensure comparability. Did not adjust for confounding factors other than age and sex.
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 14 of 27
2. Events identified by reimbursement codes in claims databases, subject to coding errors. Only conditions triggering
a health encounter were captured.
3. Risk intervals prespecified based on literature and clinical input - subject to misclassification or are incorrect for C19
vaccines, e.g. with delayed risk or longer intervals.
4. Although the overall population in RCA provides greater precision to detect rare AEs, AESI risk of certain subgroups
may be masked.
5. Differences in population for each health plan may result in different findings, possibly explaining missing signal for
myocarditis/pericarditis in 1/3 data sources.
6. Covid-19 vaccination administration data are not fully captured (linked) in claims data. [this is reflected in a separate
paper by FDA authors, who, on using algorithmic methods increased by 16.8% identification of vaccine
administration compared with use of unstructured data alone. (49)]
7. Sequential testing requires a wide range of prespecified parameters, and their misspecification could result in errors
in either direction.
8. While some uptake of booster doses in late 2021 was captured in the all-dose mRNA vaccine analyses, this study
did not include third or booster dose specific analyses.
9. Results from these commercially insured populations may not be generalizable to those uninsured or covered by
other plans.
4.6. Masking of safety signals
FDA’s Harpaz et al. (6) describe the problem of masking with disproportionality signal methods:
“Signals […] are hidden by the presence of other reported products. Due to vaccine novelty, and an unprecedented dynamic
of reporting, statistical signals […] related to ]…] COVID-19 vaccines are more prone to masking and, therefore, to being
undetected or delayed. The results also suggest that properly identifying and addressing the masking effect exposes strong
statistical associations that would otherwise be deemed uninteresting.”
Harpaz further commented on signals where there is likely a high masking component: Bell’s palsy, appendicitis, pulmonary
embolism, Herpes Zoster, tinnitus.
4.7. Ischemic stroke signal in more than one database
In their recent discussion of ischemic stroke, CDC and FDA claimed that they found a transient signal in VSD and nowhere
else. And yet, in CDC’s own FOIA disclosure appeared significant PRR signals for ischemic stroke in VAERS form last July.
We obtained a similar result from an online PRR calculator funded by NIH. (7)
At the January 26th VRBPAC meeting, data were presented (selected slides shown below) by CDC’s Dr. Shimabukuro
3
and FDA’s Dr. Forshee
4
regarding a signal found in the VSD system relating to ischemic stroke and the Pfizer bivalent
Covid-19 vaccine. They suggested that if this was a true signal, it was only in those over 65, and likely associated with
injection of a flu vaccine on the same day as the Covid-19 vaccine.
CDC described a number of follow up actions, including what sort of further evaluation they would be
conducting:
3
https://www.fda.gov/media/164811/download
4
https://www.fda.gov/media/164815/download
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 15 of 27
FDA provided analyses from the BEST and other systems.
However, it was not felt that this signal warranted any change to CDC’s recommendations regarding the use of
the vaccine.
There were extensive comments from FDA and CDC extolling the robustness of the various safety monitoring
systems, for example those of FDA’s Dr. Marks:
5
≫
DR. PETER MARKS: This is Peter Marks . Dr. Gans, this is actually I can answer for you and Dr. Forshee can help, as well .We during
the pandemic have been working with a network through the international conference of medicine regulators . It's about 60 countries that
have been exchanging pharmacovigilance information and that's why when a safety signal comes up, we can actually query the other
countries. And it was very re -- it was reassuring with the latest stroke question that that was not seen in millions of doses given overseas
I couldn't agree with you more that this is a fantastic opportunity to collaborate with VAERS other regulators to be able to put together the
maximum amount of safety information that we can
The overall impression from these remarks, particularly that of FDA’s Dr. Forshee, is that “with the multiple systems in
place, it is not at all surprising that we sometimes get signals in one system but not in another” In other words, the
signal for stroke could not be found in any other system queried.
This is inaccurate.
Recently, pursuant to a FOIA request, CDC’s PRR analyses were released from July 29 2022. The data files
have been made available online.
6
The “Evans” criteria(50) adopted by the VAERS SOP(27) applied to determine if a signal is present is that the
PRR value should be >2 with a chi-square value of >4. There must be 3 or more cases of the AE following receipt
of the specific vaccine of interest. The screen shot below shows the output for ischemic stroke with all mRNA
vaccines, ages 18+.Here the Evans criteria have been met with PRR = 4.83, and chi-square = 103.61.
5
https://youtu.be/ZjULNuSYfd0?t=31115
6
https://childrenshealthdefense.org/defender/cdc-safety-signals-pfizer-moderna-covid-vaccines-et/
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 16 of 27
A similar picture is obtained examining only serious events, with PRR = 2.64 and chi-square of 29.95/
As a further check, we interrogated Cov19VaxKB, an online database
7
described by Huang et al.(7) some of whom were
affiliated with NIH, and which work was funded partly by NIH-NIAID. This database calculates PRR values, but adds to the
Evans criteria the condition that the number of cases must be >0.2% of the total number. This is a condition not used in the
original Evans criteria(50) nor in the VAERS SOP.(27) The imposition of this criterion contradicts the intent of the Evans
method to detect small changes in numbers of unusual events.
Here is the screen shot showing that for ischemic stroke, the Pfizer vaccine exceeds the Evans criteria (ignoring the added
0.2% criterion) with PRR = 2.4 and chi-square = 93.3
7
http://www. violinet.org/cov19vaxkb/
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 17 of 27
For Moderna, the same analysis for ischemic stroke, yields PRR = 1.6 and chi-square = 24.4. Although this does not meet
the Evans criteria, the result is highly statistically significant with p = 7 x 10-7. Since the Evans criteria were established to
detect small absolute changes in event frequency (e.g. 4 “control” events and 8 “new drug” events), those limits were
appropriate to provide sufficient power. However, where there are over 100 events in this case, the PRR shown here,
supports the result from the Pfizer analysis.
Evidently, the impression left by the CDC and FDA presentations that a signal for ischemic stroke was only found in one
system is incorrect. It is seen here in VAERS, both with CDC’s PRR analysis, and that obtained using the Cov19VaxKB
systems.
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 18 of 27
4.8. Negative Efficacy: an indicator of immune suppression?
Data showing negative vaccine efficacy are most concerning as they may indicate immune suppression. Prominent among
the several studies reporting this finding (which we discuss in more depth (18) (20) ) is this work from CDC showing no statistical
effect of the vaccine by 3 months, becoming negative by 7 months.
Slide 5 presented by Dr. Ruth Link-Gelles at VRBPAC Meeting of June 14 2022
8
Other studies for example from Canada (51) and Denmark (52) reported greater negative vaccine efficacy.
A Cleveland clinic study (8) recently remarked that theirs was not the only one to find “a possible association with more
prior vaccine doses and higher risk of COVID-19. Alarmingly, the authors found that the risk “of COVID-19 increased with
time since the most recent prior COVID-19 episode and with the number of vaccine doses previously received.”
Shrestha et al., (8) further remarked: “it is important to examine whether multiple vaccine doses given over time may not
be having the beneficial effect that is generally assumed.”
There were early suggestions of negative efficacy after vaccination, which we discussed in a submission to CDC in August
2021.(9) In an analysis of the data from the initial use (first 44 days) in 596,000 subjects of the Pfizer vaccine in Israel
reported by Dagan et al. in NEJM (12), one of us (HS) observed an early (<7 days) uptick in Covid-19 cases following
vaccination.
8
www.fda.gov/media/159225/download
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 19 of 27
Covid-19 cases following vaccination in Dagan et al.
A letter to NEJM (March 11 2021) was rejected but described in an article in France Soir – May 5.
9
There, the incidences
of Covid-19 tripled from day 1 to 7 among the vaccinated,
10
and decreased to the initial rate 20 days after 1st injection,
remaining at that level until day 28.The letter continues: “This suggests a weakened immunity of the vaccinees which causes
other, unreported, short-term (non-COVID-19) adverse effects, including some deaths. This analysis should have influenced
decisions about who to vaccinate and when. Long-term risks can be expected with age and sex factors.”
Combining data in Dagan et al., with statistics from the Israeli Ministry of Health, an increase in the number of Covid-19
deaths in vaccinated subjects could be found following vaccination. These Israeli data were particularly informative because
by the cut-off date, 54% of adult Israelis had been vaccinated, mitigating to some degree biases due to early vaccination of
those most at risk. Further, by combining these data sources, we could see what was happening among vaccinated
patients. There are a number of limitations as to causality and potential time biases, but this analysis suggested that there
may have been at that time 121-413 excess deaths/million associated with vaccination, in those vaccinated (>= 1 dose),
equating to about 25,000-85,000 deaths in the USA at that time. Again, we cannot ascribe cause, merely association. The
finding from a large Israeli cohort of and increased risk of Herpes zoster infection(53) may also indicate immunosuppression
related to vaccination in some subjects. In one study naïve vaccinees had a 13.06-fold (95% CI, 8.08 to 21.11) increased
risk for breakthrough infection with the Delta variant compared to those previously infected.(54)
Results from Denmark also from Spring 2021 are consistent with the findings in the Israeli data. The Danish Statens Serum
Institut,(30) found in priority vaccination groups (LTCF, FLHW) negative VE (unadjusted) for Covid-19 related death up to
the 2nd dose.
9
francesoir.fr/societe-sante/le-new-england-journal-medecine-refuse-une-lettre-davertissement-du-dr-seligman-sur
10
The imbalance between the two groups on initiation poses a separate problem as to the matching of the two groups.
0
10
20
30
40
50
60
70
80
90
0 5 10 15 20 25
Time hazard100k
Days from First dose
Vaccin
e
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 20 of 27
Upon adjustment, these estimates became positive. However, the large swings between unadjusted and adjusted estimates
necessitate detailed examination of the raw datasets to assuage concern that there is an association between vaccination
and ACM.
Assessing data for all-cause mortality (ACM) avoids the problem of mischaracterization of cause of death, as discussed
below.
4.9. All cause mortality (ACM) and vaccination
We have found from European and CDC data, correlations between vaccination coverage and all-cause mortality, which
we describe more fully in (21) for the booster doses, but consistent with earlier work on the primary series.(55)
Rather than take static snapshots in time common in other analyses, this analysis constructs correlations across 23
European countries using Euromomo data for every lag in time (by week) between vaccination and an estimate of ACM.
The most recent version of this analysis (3/25/23) is shown here (courtesy Dr. H. Seligmann). Yellow and blue areas indicate
detrimental and beneficial associations between vaccination coverage and ACM. The dotted lines indicate significance
boundaries, outside of which denotes statistical significance. They are wider for the longer lag times, where there are fewer
data points. The analysis aggregates time lags of the same length regardless of the calendar data when vaccination
occurred.
This analysis shows an early (~0-6 weeks) detrimental effect of Covid-19 vaccination, followed by a brief (~6-20w) beneficial
period. Another detrimental period (20-40w) is then followed by a mostly neutral period (40-75w), again followed by a
detrimental period. At longer lag times, a number of people will receive booster doses.
The following analysis of correlations between booster (3rd dose) and ACM, shows largely detrimental associations.
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 21 of 27
We are unaware of other work that uses a lag analysis which is essential to understanding the obviously time dependent
effects of the Covid-19 vaccines.
The subject of the effect of vaccination on ACM requires detailed review beyond the scope of this document.
Suffice to say that there were indications as early as Spring 2021 about the association between the two. The table below
from same Danisg study cited above,(30) shows estimates for negative VE (unadjusted) for ACM for priority vaccination
groups (LTCF, FLHW) for all time periods except 0-7 days after 2nd dose.
Upon adjustment, these estimates become positive. However, the large swings between unadjusted and adjusted estimates
necessitate detailed examination of the raw datasets to assuage concern that there is an association between vaccination
and ACM.
4.10. Concerning cancer reports
It is particularly concerning that according to the package insert (eg for COMIRNATY), “no carcinogenicity or genotoxicity
studies were done”
11
We searched VAERs for cancer signals and found an excess for the Covid-19 vaccines compared
with all other vaccines for all years in VAERS from 1990.
12
Additional cancer signals were found CDC’s PRR analyses disclosed after a FOIA request,
13
shown below.
11
fda.gov/media/151707/download
12
Search parameters are saved in VAERS, but data update automatically.
https://wonder.cdc.gov/controller/saved/D8/D316F828
https://wonder.cdc.gov/controller/saved/D8/D316F827
https://wonder.cdc.gov/controller/saved/D8/D316F892
https://wonder.cdc.gov/controller/saved/D8/D316F891
13
www.theepochtimes.com/exclusive-cdc-finds-hundreds-of-safety-signals-for-pfizer-and-moderna-covid-19-vaccines_4956733.html
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 22 of 27
There are a number of mechanisms published that provide biological plausibility to causation, a discussion of which is
beyond the scope of this reveiew.
4.11. Transparency, scientific engagement, restoring trust in public health institutions
To date (3/30/23) according to CDC,
14
only 16.5% of those eligible have received the bivalent booster doses of the Covid-
19 vaccine. According to a recent article in Nature,(1) Covid-19 vaccine hesitancy has spilled over to other vaccinations
reaching their lowest point since 2008 and jeopardizing the health of millions.
The article attributes this alarming trend to an erosion of trust and confidence in governments and public-health institutions
exacerbated with the advent of COVID-19 vaccines. One of no doubt many reasons for this mistrust is the opacity of
government agencies.(56)
Vaccine injury is among the most controversial topics related to the use of the Covid-19 vaccines. At its open public session,
(3/30/23) the committee heard from a number of vaccine-injured patients, many of whom were among the first to become
vaccinated to “do their part” in the pandemic. A theme common to many of those remarks was the feeling of abandonment
and betrayal by public health institutions they had trusted.
Restoring trust in public health institutions must surely be your highest priority. Most of all, unless the setting of parameters
that will determine whether someone is eligible for compensation for alleged vaccine-injury is seen as just, there will be
further erosion in trust of public health institutions in general and in vaccine acceptance in particular. This will only be
14
https://covid.cdc.gov/covid-data-tracker
Wiseman2023-NAS-March31-CovidVaccineAdverseEvents Page 23 of 27
exacerbated as the specter of unknown long-term harms related to the hastily deployed novel gene therapy, becomes
appreciated. I need not spell out the medical and economic consequences of such mistrust.
Restoration in trust can only be begin if your work is transparent and open to scientific dialog. Yours cannot be another
exercise in “going through the motions” of the kind we have seen with FDA and CDC committees where public comment
from patients and scientists passes unidirectionally without engagement or reaction. My colleagues and I are ready to
participate in meaningful and necessary scientific discourse.
5. Bio
I am an experimental pathologist with a background in pharmacy, pharmacology and immunology. At Johnson & Johnson,
as one of only 66 Research Fellows, I led a research program in the prevention of post-operative adhesions where my
duties included pharmacovigilance. I focus on fibrosis and pain, running my own company providing R&D services for the
development of medical products since 1996. I was invited to participate in Senator Johnson’s expert Covid-19 panels in
January and December 2022.
6. List of files provided
Files (20) are provided containing written comments submitted to FDA or CDC advisory committees. They are numbered
as per the citation list.
Wiseman09-CDC-2021-0089-0023_attachment_1.pdf
Wiseman10-CDC-2021-0089-0039_attachment_1.pdf
Wiseman11-FDA-2021-N-0965-0016_attachment_1.pdf
Wiseman13-FDA-2021-N-0965-0146.pdf
Wiseman14-FDA-2021-N-0965-0164-SUPPLEMENT.pdf
Wiseman15-CDC-2021-0098-FDA-2021-N-1088.pdf
Wiseman16-CDC-2021-0125-0003_attachment_1.pdf
Wiseman17-CDC-2021-0133-0002_attachment_1.pdf
Wiseman18-CDC-2022-0002-0002_attachment_1.pdf
Wiseman20-CDC2022-0022-0009-Feb4ACIP-FDA-2022-N-0082-FINAL.pdf
Wiseman21-FDA-2022-N-0336-2500_attachment_1.pdf
Wiseman22-CDC-2022-0051-0260_attachment_1.pdf
Wiseman24-CDC2022-0065-ACIP051922-corrected2.pdf
Wiseman25-FDA-2022-N-0470-June10-CTGTAC-LINKS.pdf
Wiseman26-CDC-2022-0085-0017_attachment_2.pdf
Wiseman28-CDC-2022-0085-0017_attachment_1.pdf
Wiseman29-CDC-2022-0103-0049_attachment_1.pdf
Wiseman31-CDC-2022-0111-126227-OCT19-ACIP.pdf
Wiseman32-2023-VRBPACJan23-FDA-2022-N-2810-CommentsonBrefingDocument-TRACKING.pdf
Wiseman33-CDC-2023-0007-0496_attachment_1.pdf
7. References
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2022; 612:S44-s6. Epub Dec 19 http://doi.org/10.1038/d41586-022-04341-9
2. Funk PR, Yogurtcu ON, Forshee RA, et al. Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for
age 16-29 years. Vaccine 2022. Epub 2022/04/05 http://doi.org/10.1016/j.vaccine.2022.03.030
3. Day B, Menschik D, Thompson D, et al. Reporting Rates for VAERS Death Reports Following COVID-19
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Vaccine X 2021:100139. Epub 2022/01/05 http://doi.org/10.1016/j.jvacx.2021.100139
8. Shrestha NK, Burke PC, Nowacki AS, et al. Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent
Vaccine. medRxiv 2022:2022.12.17.22283625. Epub Dec 19 http://doi.org/10.1101/2022.12.17.22283625
9. Wiseman D, Guetzkow, J,, Seligmann H. Comment submitted to August 30 2021 meeting of the Advisory
Committee on Immunization Practices (Centers for Disease Control). Docket CDC-2021-0089-0023. 2021 Aug 29. at
https://www.regulations.gov/comment/CDC-2021-0089-0023.)
10. Wiseman D. Follow up Comment submitted to August 30 2021 meeting of the Advisory Committee on
Immunization Practices (Centers for Disease Control). Docket CDC-2021-0089-0039. 2021 Aug 30. at
https://www.regulations.gov/comment/CDC-2021-0089-0039.)
11. Wiseman D, Guetzkow, J, Seligmann H, Saidi S. Written comments submitted to: Vaccines and Related Biological
Products Advisory Committee (VRBPAC) September 17, 2021 Meeting: Booster Doses for Pfizer-BioNtech Vaccine. 2021
Sep 13. at https://www.regulations.gov/comment/FDA-2021-N-0965-0016
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https://youtu.be/WFph7-6t34M?t=15844.)
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N Engl J Med 2021. Epub 2021/02/25 http://doi.org/10.1056/NEJMoa2101765
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Products Advisory Committee (VRBPAC) October 14-15, 2021 Meeting: Booster Doses for Janssen and Moderna
Vaccines. 2021 October 12. at https://www.regulations.gov/comment/FDA-2021-N-0965-0146.)
14. Wiseman D, Guetzkow, J,, Seligmann H. Supplemental Written comments submitted to: Vaccines and Related
Biological Products Advisory Committee (VRBPAC) October 14-15, 2021 Meeting: Booster Doses for Janssen and
Moderna Vaccines. 2021 October 13. at https://www.regulations.gov/comment/FDA-2021-N-0965-0164
https://downloads.regulations.gov/FDA-2021-N-0965-0164/attachment_1.pdf.)
15. Wiseman D, Guetzkow, J,, Seligmann H. Booster Doses for Moderna and Janssen Vaccines. Written comments
submitted to: Advisory Committee on Immunization Practices (ACIP), October 20-21, 2021 Meeting and Vaccines and
Related Biological Products Advisory Committee (VRBPAC), October 26, 2021,. 2021 October 20. at
https://www.regulations.gov/comment/CDC-2021-0098-0071
https://downloads.regulations.gov/CDC-2021-0098-0071/attachment_1.pdf.)
16. Wiseman D. Comment submitted to November 19 2021 meeting of the Advisory Committee on Immunization
Practices (Centers for Disease Control). Docket CDC-2021-0125-0003. An Open Letter to Dr. Grace Lee, CDC ACIP
Chairperson on Transparency. 2021 Nov 19. at https://www.regulations.gov/comment/CDC-2021-0125-0003
https://downloads.regulations.gov/CDC-2021-0125-0003/attachment_1.pdf
https://trialsitenews.com/an-open-letter-to-dr-grace-lee-cdc-acip-chairperson-on-transparency/.)
17. Wiseman D, Rose, J, Guetzkow, H, Seligmann H. Why limit contraindication to Janssen? Using same criteria
revisit EUA/BLA for all C19 quasi-vaccines. Transparency: Emergency ACIP Meeting Dec 16 2021: A second open letter to
Dr. Grace Lee, ACIP Chair: CDC-2021-0133. Researchgate 2021 Dec 23. Epub
http://doi.org/dx.doi.org/10.13140/RG.2.2.32783.51368
https://www.regulations.gov/comment/CDC-2021-0133-0002
https://downloads.regulations.gov/CDC-2021-0133-0002/attachment_1.pdf
18. Wiseman D, Rose, J, Guetzkow, H, Seligmann H. The last wackamole of boosting in an omicron environment of
negative quasi-vaccine efficacy and possible immunological addiction. Transparency concerns remain. A third open letter
to Dr. Grace Lee, ACIP Chair: CDC-ACIP Written comments Docket CDC-2022-0002. Researchgate 2022 Jan 7. Epub
http://doi.org/10.13140/RG.2.2.13112.88327
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19. Oster ME, Shay DK, Su JR, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US
From December 2020 to August 2021. Jama 2022; 327:331-40. Epub 2022/01/26
http://doi.org/10.1001/jama.2021.24110
20. Wiseman D. ACIP recommends Spikevax based on CDC review omitting negative efficacy Omicron data.
Regulators drift further from the science of all risk-no-benefit as infant vaccination is considered. ACIP Feb 4, VRBPAC
Feb 15 2022. Research Gate 2022 Feb 11. Epub http://doi.org/doi.org/DOI:10.13140/RG.2.2.31523.73769
21. Wiseman D, Seligmann, H, Pantazatos SP. COVID-19 vaccine booster doses and COVID-19 vaccine strain selection
to address current and emerging variants. Boosters: More risk, less benefit. FDA hiding gene therapy concerns in plain
sight? 2022 April 6. at https://www.regulations.gov/comment/FDA-2022-N-0336-2500
https://downloads.regulations.gov/FDA-2022-N-0336-2500/attachment_1.pdf
https://downloads.regulations.gov/FDA-2022-N-0336-2500/attachment_2.pdf
https://youtu.be/2-MeLcvwu78?t=13514.)
22. Wiseman D SH, Pantazatos SP. COVID-19 vaccine booster and new variant doses. Confusion and lack of a plan
evident to ACIP. Comments submitted to ACIP April 20, 2022. 2022 Apr 20. at https://downloads.regulations.gov/CDC-
2022-0051-0260/attachment_1.pdf
https://www.regulations.gov/comment/CDC-2022-0051-0260.)
23. Sharff KA, Dancoes DM, Longueil JL, Johnson ES, Lewis PF. Risk of Myopericarditis following COVID-19 mRNA
vaccination in a Large Integrated Health System: A Comparison of Completeness and Timeliness of Two Methods.
Pharmacoepidemiol Drug Saf 2022. Epub 2022/04/12 http://doi.org/10.1002/pds.5439
24. Wiseman D. Written comments submitted to ACIP May 19 2022. Data again withheld on safety and waning
efficacy in consideration of 5-11 year boosting. 2022 May 19. at https://www.regulations.gov/comment/CDC-2022-
0065-0088
https://downloads.regulations.gov/CDC-2022-0065-0088/attachment_1.pdf.)
25. Wiseman D S, H, Pantazatos SP. Covid-19 gene therapy vaccines: Why no review by FDA’s Office of Tissues and
Advanced Therapies (OTAT) and Cell Therapy Gene Therapy Advisory Committee (CTGTAC) Written comments submitted
re: FDA- CTGTAC Meeting June 10th 2022 FDA-2022-N-0470. 2022 June 2. at
https://www.regulations.gov/comment/FDA-2022-N-0470-0179
https://downloads.regulations.gov/FDA-2022-N-0470-0179/attachment_1.pdf
https://downloads.regulations.gov/FDA-2022-N-0470-0179/attachment_2.pdf
Oral comments: https://youtu.be/Eo2BXnGienc?t=11547.)
26. Wiseman D. Stunningly poor data. Labelling confusion. What could possibly go wrong? ACIP June 23 2022 - Oral
and Written Remarks. ACIP June 23 CDC-2022-0062. Research Gate 2022 June 23. Epub
http://doi.org/10.13140/RG.2.2.22843.90404
27. VAERS. Immunization Safety Office, Division of Healthcare Quality Promotion National Center for Emerging and
Zoonotic Infectious Diseases Centers for Disease Control and Prevention. Vaccine Adverse Event Reporting System
(VAERS) Standard Operating Procedures for COVID-19. 2021 Jan 29. at https://www.cdc.gov/vaccinesafety/pdf/VAERS-
v2-SOP.pdf.)
28. Wiseman D, Guetzkow J. CDC scores own goals with Novavax. ACIP members fear another confusing label will
add to dose errors, question high myocarditis rates and seek direction on Omicron boosters. NIH conducts PRR work
CDC is denying. ACIP July 19 2022. Research Gate 2022 July 19. Epub http://doi.org/10.13140/RG.2.2.25887.23209
29. Wiseman D. BA4/5 bivalent quasi-vaccines: Further relaxation of FDA standards, manufacturing changes and
novel spike protein heterotrimers. Written comments to CDC ACIP meeting of September 1 2022. CDC-2022-0103-0049.
Research Gate 2022 Sep 1. Epub http://doi.org/10.13140/RG.2.2.25633.28007
30. Emborg H-DV-B, Palle; Schelde, Astrid Blicher; Nielsen, Katrine Finderup; Gram, Mie Agermose; Moustsen-
Helms, Ida Rask; Chaine, Manon; Seidelin, Ulla Holten; Nielsen, Jens. Vaccine effectiveness of the BNT162b2 mRNA
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COVID-19 vaccine against RT-PCR confirmed SARS-CoV-2 infections, hospitalisations and mortality in prioritised risk
groups. medRxiv 2021:2021.05.27.21257583. Epub June 2 http://doi.org/10.1101/2021.05.27.21257583
31. Wiseman D. ACIP October 19-20-2022. BA4/5 bivalent quasi-vaccines in yet younger children: Further erosion of
scientific and ethical standards. Written and Oral Comments. Research Gate 2022 Oct. Epub Oct 19
http://doi.org/10.13140/RG.2.2.25782.98889
www.regulations.gov/comment/CDC-2022-0111-126227
32. Wiseman D. Annotations on FDA Briefing Document for VRBPAC Meeting January 26 2023: Future Vaccination
Regimens Addressing COVID-19. FDA-2022-N-2810/ Tracking ldc-mhyo-7aj3. Research Gate 2023 Jan 25. Epub
http://doi.org/10.13140/RG.2.2.23232.40965
33. Wiseman D. Covid-19 vaccine safety, bivalent primary series, future directions. Written comments submitted to
CDC- ACIP February 24 2023. CDC-2023-0007-0496. Research Gate 2023 Feb 24. Epub
http://doi.org/10.13140/RG.2.2.25839.10404
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