Towards Rigorous Diagnostics for Vaccine Injury

Abstract

Delineating the epidemic of vaccine injury from the coterminous condition long covid is a challenging prospect, but one with many implications not just for treatment, but also has important legal considerations for settlements of vaccine injury. The shared etiological factor of the spike protein in both vaccine injury and long covid make differentiation difficult, and while treatment is largely similar between vaccine injury and long covid, there are important distinctions. Furthermore, diagnostics are important for monitoring treatment progress and assessing the extent of subclinical vaccine injury in population having received a covid-19 vaccine. The development of rigorous diagnostics is an important step towards the recognition of both long covid and vaccine injury, as those suffering these conditions have faced immense challenges in having their conditions recognized, treated, and compensated by insurance companies or national health services.

Full text

Brief Report Not peer-reviewed version
Towards Rigorous Diagnostics for
Vaccine Injury
Matthew Halma *
Posted Date: 12 July 2023
doi: 10.20944/preprints202307.0840.v1
Keywords: Vaccine adverse event; Covid-19; spike protein; diagnosis
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Brief Report
Towards Rigorous Diagnostics for Vaccine Injury
Mahew Halma
EbMC Squared CIC, Bath, United Kingdom, BA2 4BL
Abstract: Delineating the epidemic of vaccine injury from the coterminous condition long covid is a challenging
prospect, but one with many implications not just for treatment, but also has important legal considerations for
selements of vaccine injury. The shared etiological factor of the spike protein in both vaccine injury and long
covid make dierentiation dicult, and while treatment is largely similar between vaccine injury and long covid,
there are important distinctions. Furthermore, diagnostics are important for monitoring treatment progress and
assessing the extent of subclinical vaccine injury in population having received a covid-19 vaccine. The
development of rigorous diagnostics is an important step towards the recognition of both long covid and vaccine
injury, as those suering these conditions have faced immense challenges in having their conditions recognized,
treated, and compensated by insurance companies or national health services.
Introduction
Adverse events after vaccination have been far more common with Covid-19 vaccines than any
other licensed vaccine[1]. Not only are the rates of clinical conditions associated with Covid-19
vaccines high, but there is also extensive subclinical damage. Due to the pathological mechanisms of
the vaccine encoded spike protein, the potential for damage can exist at low levels for long periods
of time, and those having received a vaccine can be in a ‘sword of Damocles’ situation for years or
even decades. Frankly, there is a lot left unknown about the long-term eects of Covid-19 vaccines[2].
The extent of subclinical danger, as well as the increase in sudden and unexplained deaths
motivates the diagnosis of vaccine injury through biomarkers. One immediate biomarker that comes
to the fore is testing for the presence of the spike protein or its subunits in plasma[3], as it is a major
pathological agent driving vaccine injury, long covid, as well as acute covid-19 infection[4].
This conation has important legal implications for those seeking compensation after injury
following Covid-19 vaccination. Pathologists can assign causality to covid-19 vaccination (as opposed
to infection) by immunostaining for the nucleocapsid (N) protein in addition to the spike (S)
protein[5]. Since Covid-19 infection will express both N and S proteins, whereas vaccination only
expresses the S protein, the simultaneous presence of the S protein and absence of the N protein is
strong evidence for vaccine induced causation[5].
Furthermore, there are two important dierentiations between the spike protein induced by
vaccination and the spike protein from infection. First, the viral spike protein will change as the virus
mutates, whereas the vaccine spike protein only changes when the sequence is updated (as with the
bivalent booster). Secondly, the vaccine spike protein is locked into a prefusion conformation through
two proline mutations, and will adopt a more rigid conformation than the viral spike protein[6].
There are three important ways to dierentiate spike protein from viral infection from that of
the vaccine. The following factors can be used to dierentiate vaccine damage from viral damage
(Table 1).
Table 1. Basis of diagnostic dierence between vaccine damage and damage from SARS-CoV-2.
Vaccine Spike
Viral Spike
No N protein present
N protein present
Sequence identical to vaccine sequence
Sequence much les constrained, reflects currently
circulating variants
Locked into prefusion conformation
Conformationally flexible
Diagnostics
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contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting
from any ideas, methods, instructions, or products referred to in the content.
Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 12 July 2023 doi:10.20944/preprints202307.0840.v1
© 2023 by the author(s). Distributed under a Creative Commons CC BY license.

2
General
In guiding treatment, there are multiple biomarkers that one can test with to gain insight into
the progression of the injury sustained from the vaccine. These are non-specic to vaccine injury and
are general biomarkers of cardiovascular risk. These include troponin, D-dimer and C-reactive
protein[3].
[4]. These biomarkers are specic to cardiac injury, and will not be able to determine disease
aetiology.
Troponin is a general biomarker associated with diagnosis of acute coronary syndromes[7,8], as
troponins are released into the blood following damage to cardiac muscle[9]. D-dimer is a biomarker
associated with the breakdown of brin clots by the brinolytic system [10]. As the test measures
breakdown of clots, a high measure can indicate a high level of clot burden, as well as a high degree
of breakdown[11], and this must be taken into consideration by the clinician.
C-reactive protein is an inammatory biomarker, and higher values are associated with
increased cardiovascular risk[12].
Biomarker
Upper limit of normal
Peak cardiac troponin (T)
14 ng/L [3]
Brain natriuretic
Peptide (BNP)
100pg/mL [3]
N-terminal prohormone of brain natriuretic peptide
(NT-proBNP)
450pg/mL [3]
C-reactive protein (CRP)
8mg/L [3]
D-dimer
(patient’s age in years x 10mcg/L) [13]
Specic
A recent paper by Yonker surveyed the biomarkers of vaccinated individuals, both with and
without post-vaccination myocarditis. The main dierentiator between the group with myocarditis
and those without was the persistence of full length spike protein, unbound by antibodies[3]. Given
that this is the sole gene encoded by most of the vaccines and has multiple documented pathological
mechanisms[4], it is a likely aetiological factor in post-vaccination syndrome.
Cases of blood thrombosis after vaccination typically occur within one month of receiving the
injection[14,15]. A test for spike protein contains two important quantities, the concentration of spike
protein, as well as the time since vaccination. While most often after injection spike protein
concentration drops o quickly after one week [16], persistence of high levels of spike protein for
months after injection has been documented in a subset of vaccinated individuals [17]. It is unclear
what the individual factors are aecting long-term spike protein levels; we propose a model for the
long term persistence of spike protein.
The rst factors are the variations in the initial dose of spike protein encoding mRNA, which can
vary due to storage, dilution and administration. Once the mRNA is in the body, the level of spike is
in competition between mRNA degradation and protein expression from the mRNA. We also
propose a third alternative between degradation and expression, that of conversion to a reservoir.
Reverse transcription into the genome is possible [18]. Additionally, a discovery of DNA
contamination in a broad swathe of mRNA vaccine vials[19], potentially opening the possibility of
but microbiota transfection through the mechanism of horizontal gene transfer [20].
While the half-life of RNA is well known, and endogenous mRNA has a half life of
approximately 10 hours [21], it is known that pseudouridinylated RNA is far more persistent[22,23],
and less is known about the degradation of the N1-methyl-psuedouridnylated RNA used in the
mRNA vaccines[2] and persistent spike protein appears to be the factor which dierentiates those
with post-vaccination myocarditis vs vaccinated people without myocarditis[3].
Considerations
Causation
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There is an unprecedented wave of vaccine injury, in addition to any disease burden from long
Covid. The origins of Covid notwithstanding, establishing causation for those experiencing vaccine
injury is an important step both in allowing them to receive just compensation, as well as to establish
the true role of vaccination in the mortality and morbidity burdens. The laer is useful both for
informing regulatory policy going forward, as it is necessary for regulators and the public to know
the true risk prole of this class of intervention. Additionally, establishing causation is useful for legal
seings, including compensation for injured recipients as well as prosecution of any wrongdoing.
The extent of liability is important, as those seeking treatment often have few options, and lile
resources, owing to the often debilitating nature of their illness, and its lack of acknowledgement and
subsequent compensation by health systems[24]. Vaccine injury compensation schemes are
uncommon [25,26].
The experience of the vaccine injured has largely been one of gaslighting and being ignored, and
only now are their concerns being heard[24]. Still, treatment is limited, and limited resources exit for
injury compensation [27]. Treatment of long Covid is receiving some aention and research funds
[28], while treatment of vaccine injury is limited. For example, in the US clinical trials database
(clinicaltrials.gov, accessed July 11, 2023) there is currently one study to test treatment of Covid-19
vaccine injury; the study is not yet recruiting and was last updated May 24, 2022. Multiple studies
exist to treat long Covid, reviewed in [29]. No large university hospital or academic medical center
has published a treatment protocol for vaccine injury, and the current literature is scant [29].
Conclusion
While the situation of the vaccine injured presents a pessimistic view, the situation is improving.
Vaccine injury is increasingly being recognized, as a recent acknowledgement by German health
minister Karl Lauterbach exemplies [30]. Still, for those aected, it is a long road to recovery.
Diagnostics are a necessary part of the path towards health in those experiencing post-vaccination
syndrome and long covid. In some cases, the diagnostics are similar, but the potential also exists to
discriminate the two conditions with diagnostics, as well as by patient history.
Developing rigorous diagnostics is an important step towards gauging treatment progress and
informing the science of treating vaccine injury, as well as long covid. Diagnostic development
ensures that those aected receive the recognition and treatment they deserve, and ensures the
integrity of compensation claims, a and can inform legal action against regulators, pharmaceutical
manufacturers and public health ocials.
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Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those
of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s)
disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or
products referred to in the content.
Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 12 July 2023 doi:10.20944/preprints202307.0840.v1