[E] Novel mRNA technologies – no silver bullet

The vaccine has a limited role in preventing ongoing infection.

The trial data that supported vaccine approval showed effectiveness over a very short time period – 7 days. Since approval, it has become clear that the peak protection appears two months post-dose, and this declines from then on, at different rates based on an individual’s age and immune health. The waning may not necessarily be a function of a stronger Delta variant, but may simply because the mRNA treatment - well – doesn’t work. Perhaps the short-term 2-month benefit arises from short-term tolerance following exposure to the antigen, rather than robust immune changes observed in traditional live attenuated virus (such as for measles or rubella), or inactivated vaccines (such as for polio)? From the commencement of the pandemic, the mRNA treatment was preferred because it could be quickly rolled out, however it appears inadequate for the task of achieving optimal herd immunity.[i]

Pfizer data

The studies supplied to the FDA in the FDA Briefing document (December 10, 2020)[ii] for approval based efficacy success on prevention of COVID-19 symptoms - not prevention of transmission. The efficacy claims of around 95% were based on efficacy 7 days after dose 2 (page 24) and a participant group of 9. The application noted that there was not sufficient data to assess the effect of treatment against prevention of transmission of the infection to others. Benefit/Risk Assessment in the Context of Proposed Indication and Use Under EUA - The known benefits among recipients of the proposed vaccine relative to placebo are:

Reduction in the risk of confirmed COVID-19 occurring at least 7 days after Dose 2
Reduction in the risk of confirmed COVID-19 after Dose 1 and before Dose 2
Reduction in the risk of confirmed severe COVID-19 any time after Dose 1

One of the nine BNT162b2 participants became infected with severe COVID-19 disease after dose 2 and this was reported to be less severe than the placebo group (page 30). Secondary efficacy analyses occurred 14 days after dose 2. A The paper noted that 'the total numbers of severe cases were small, acknowledging that the results suggested 'protection from severe COVID-19 disease' (page 31). The placebo group contained 162 participants, and 8 of these experienced infection, of these five of these remaining six placebo recipients who had severe disease had at least one risk factor for severe disease. The studies demonstrated that adverse events were relatively common. For example 6% of an 18,801 participant BNT16282 group experienced nervous system disorders (page 39). Heart failure, myocardial infarction and liver disease was higher in the dosed group. Lymphadenopathy occurred at significantly higher rates in the BNT126282 group. A 2021 paper found worrisome features following ultrasounds in treated groups. Unfortunately the age for this group 18-65 made it difficult to understand risk to younger adults (page 22). Of the combined 16-18 population of 153, only one infection case was recorded. The study acknowledged that 'available data are insufficient to make conclusions about benefit in individuals with prior SARS-CoV-2 infection. (page 47)'. Two deaths occurred in the BNT126282 group (55+) and 4 deaths occurred in the placebo group. Of the deaths in the placebo group, 3 were in the age group 55+.Inoculation/vaccination does little to prevent infectivity.

Two major findings have come out of a 12-month U.K. study which considered household transmission rates. Vaccinated and unvaccinated individuals carry similar viral loads and were equally able to pass on the sars-cov-2 infection. In the households studied, ¼ (25%) of double vaccinated individuals were likely to catch the infection from a household case, while unvaccinated individuals had a slightly increased 2/5 (38%) risk of catching the infection.[iii]

It is clear the mRNA COVID-19 vaccines also wane. For individuals who are elderly, or with persistent multimorbid populations who are at high risk of harm if infected, boosters may be necessary. [iv] However, as Cho and colleagues note ‘individual memory antibodies selected over time by natural infection have greater potency and breadth than antibodies elicited by vaccination’.[v]

Recently, a large Swedish study over 9 months demonstrated that vaccine effectiveness waned progressively from the first month onwards. By 4 months, effectiveness against symptomatic infection for the Pfizer BNT162b2 treatment was 47%, insignificant with the study authors noting ‘From 7 months and onwards, no effectiveness of BNT162b2 could be detected’. Vaccine effectiveness waned more quickly for men and for older individuals.[vi]

Vaccines are administered primarily for prevention of severe COVID-19 (to prevent hospitalisation and death). The Swedish study observed 74% effectiveness against Covid-19 hospitalization or death at 4-6 months, noting a notable decline in the capacity to prevent severe COVID-19 among men, older frail individuals, and individuals with comorbidities (including diabetes and hypertension). For others, prevention of severe COVID-19 was observed to be high to 9 months following the injection. The study authors acknowledged that although they excluded all individuals with previous confirmed infection, some individuals may still have been included, with the result that ‘natural immunity due to a previous infection attenuated the estimated vaccine effectiveness.’ [vii]

A vaccine that doesn’t meaningfully prevent transmission is not a vaccine.

It is increasingly theorised that, as opposed to the vaccine induced herd immunity theory, that the mRNA treatment is a ‘leaky vaccine’. Identified as the imperfect-vaccine hypothesis, if the vaccine is non-sterilizing, ‘naturally acquired pathogens can transmit from immunized individuals (what we hereafter call a “leaky” vaccine), virulent strains will be able to circulate in situations in which natural selection would have once removed them.’ [viii] Read and colleagues emphasised that the leaky vaccine/ vaccine-driven virulence evolution was conceptually different from antigenic escape where ‘variants of target antigens evolve because they enable pathogens that are otherwise less fit to evade vaccine-induced immunity. The evolution of escape variants has been frequently observed.’ [ix]

A key characteristic of vaccines is that they prevent transmission of infection. The changing definition of ‘vaccine’ has been identified by Dr This vaccine failure has been acknowledged by Boris Johnson, the World Health Organisations Director Tedros Adhanom and by Dr. Fauci.

There appears to be rolling changes to the definition of vaccine across publishers and regulators, as a consequence of vaccine failure, and of the mRNA treatment never having been designed to prevent ongoing transmission of infection. Dr Peter Doshi, during a panel discussion held by U.S. Senator Ron Johnson[x] [xi] explained the phenomenon of definition changes in the Merriam Webster dictionary (also explained by linguist Professor Eric Baković [xii]):

“I found it fascinating to learn that Merriam Webster changed its definition of ‘vaccine’ earlier this year. mRNA products did not meet the definition of ‘vaccine’ that has been in place for 15 years at Merriam Webster, but the definition was expanded such that mRNA products are now ‘vaccines’.” [xiii]

In September 2021 the U.S. Centre for Disease Control (CDC) altered the definition of vaccine from:

Vaccine: A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease. Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.

Vaccination: The act of introducing a vaccine into the body to produce immunity to a specific disease.

To a new definition:

Vaccine: A preparation that is used to stimulate the body’s immune response against diseases. Vaccines are usually administered through needle injections, but some can be administered by mouth or sprayed into the nose.

Vaccination: The act of introducing a vaccine into the body to produce protection from a specific disease.

Freedom of Information Act requests (by Technofog) identified that the definition was altered as the CDC recognised that the performance of the vaccines did not accurately reflect the mRNA treatment, as a CDC official stated ‘definitions are outdated and being used by some to say COVID-19 vaccines are not vaccines per CDC’s own definition’.[xiv]

Similarly, governments are advising that they will adjust the definition of fully vaccinated to ensure that citizens comply and keep up to date with the booster regime. Therefore, if citizens are to maintain their status of ‘fully vaccinated’ and wish to access commercial and public services, they will be required to receive the boosters when they are available.

Adverse Events

Rarely does the science build a picture and then do an about-turn that negates that knowledge. The evidence continues to grow that risk from vaccines must be considered, due to the potential for – we emphasise - rare - adverse events. It is evident that adverse events can be short term and acute, or longer term, arising immediately after mRNA inoculation, or over a longer period. [xv] Doctors are increasingly attempting to draw attention to the adverse events they observe both personally,[xvi] and in clinical practice [xvii].

States – including New Zealand[xviii] - have avoided discussing personal risk, either to Sars-Cov-2 infection or from mRNA treatment by age group. This deficiency has meant that there is no public discussion on the differential risk experienced by younger groups from the mRNA treatment. The ignorance around this - combined with pervasive pressure to inoculate all age groups in order to protect family and friends, leaves families unable to engage in informed debate, despite the evidence that the mRNA treatment does not meaningfully prevent transmission of the Sars-Cov-2 infection.

The spike protein appears to be a driver of many of the harms from both infection and inoculation. Long-Covid – also known as post-acute sequelae SARS-CoV-2 infection (PASC) occurs in 10-30% of people post-infection. PASC groups are likely to have higher levels of non-classical monocytes (white blood cells) carrying the Sars-Cov-2 S1 protein up to 15 months post infection. [xix] The study author is now researching the potential for the S1 protein to persist post-inoculation.

There is concern that ongoing 6-monthly inoculations will expose the public to persistently high levels of spike protein that will increase risk of inflammation and clotting; impair the immune system over a longer period and set in place conditions for the development of autoimmune diseases. The potential for an individual to degrade the spike protein may depend on a robust immune system. However repeat exposures may impair this. The development of a particular chronic condition will depend on individual vulnerabilities (such as nutritional impairment) and genetic predisposition.

A conference abstract (which lacks supporting data) presented to the American Heart Association claimed that a 566 patient study observed significantly elevated endothelial inflammatory markers in patients following vaccination with the mRNA treatments, and that the biomarker changes persisted for over 2 months. The study authors concluded ‘the mRNA vacs dramatically increase inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination.’[xx]

Thrombosis and myocarditis

It’s important to recognise risk by age group. Thrombotic events following Sars-Cov-2 infection (in comparison to effects following vaccinations) are more likely to be men over 60 with associated cardiovascular risk factors.[xxi] [xxii] In comparison, younger people have an extraordinarily low risk of thrombotic events.

The experience of the adverse event of myocarditis in young people appears to be 19x the standard background rate that young people would normally experience.[xxiii] One of the authors Dr Jessica Rose, has discussed the myocarditis risk and problems with the reporting of adverse events at length. Rose earlier drew attention to the failure of the VAERS to appropriately signal, and then take appropriate regulatory action when safety signals concerning the mRNA treatment identified harm was occurring beyond conventionally accepted levels of risk following a medical treatment.[xxiv]

The spike protein induces abnormal inflammatory blood clots.[xxv] Recently, a cohort of doctors have theorised that the mRNA vaccine spike protein may enter the bloodstream and attach itself to the endothelial cells on vessel walls, inducing clotting and causing leakage of vessel walls. This remains speculative.[xxvi]

Risk to the Brain

Substantial neurological distress has been associated with infection and mRNA treatment. Cerebral thrombosis occurs following infection and mRNA treatment. (Studies should reveal the breakdown of cases by age group when comparing effects occurring through natural infection and following mRNA treatment, but often they do not. [xxvii]) The Sars-Cov-2 spike protein is increasingly observed to enhance clotting. An increasing body of studies documenting cerebral venous sinus thrombosis (CVST) and thrombocytopenia following mRNA treatment are published in the scientific literature.[xxviii] [xxix] [xxx] [xxxi] [xxxii] [xxxiii] One mechanism may be through preventing anticoagulant activity in the brain. The spike protein may accelerate neurodegeneration through its potential to bind strongly (through molecular docking) with heparin and heparin binding proteins. The results indicated that the stable binding to aggregation-prone proteins, might initiate aggregation of brain protein and accelerate neurodegeneration.[xxxiv]

Ongoing inflammation and immune impairment

There is potential for an autoimmune response to evolve after vaccination.[xxxv] [xxxvi] Anecdotal reports from doctors have expressed concern about potential immunomodulating effects of the mRNA vaccine, including lower levels of CD8 killer T cells post-vaccination. Killer T cells constrain other viruses, such as herpes, papilloma and shingles. Lowered immune status increases potential for diseases including cancer to surge following inoculation. A recent study of 11 participants reviewed antibody and neutralizing antibody levels and a range of clinical parameters after inoculation of inactivated SARS-CoV-2 vaccine. The authors identified a significant drop in CD8 + T cells and increase in classic monocyte content, the study showed increased NF-κB signalling and reduced type I interferon responses. The authors noted that ‘[s]urprisingly, type I interferon responses, which had been linked to reduced damages after SARS-CoV-2 infection and milder symptoms, appeared to be reduced after vaccination, at least by 28 days post the 1st inoculation.[xxxvii] An earlier study demonstrated that the BNT162b2 vaccine induced reprogramming of the innate and adaptive (humoral and cellular) immune responses. The authors expressed uncertainty as to whether the immune modulation resulted in a balanced response to COVID-19 infection, or whether it reduced the capacity of the immune system to counter infection.[xxxviii]

In an invitro study which observed that the spike protein entering the cell and impeding the cellular DNA damage repair machinery, the authors inferred that vaccines based on the full-length spike protein might act similarly. [xxxix]

The ethics of state silence – when industry acknowledges risk

There is an obligation in law to protect vulnerable groups, including young adults and children and take into account individual circumstances. Infection with Sars-Cov-2 produces long-standing immunity from multiple variants. It means that future boosters are not likely to be required. What is the responsibility of the state to recognise that healthy young people are more likely to benefit from infection for the rest of their life, such as has been seen with other coronaviruses. This is not the stuff of conspiracy theory. The implication, if silence relating to natural immunity is sustained, is that children and young people must face the short and long term risk profile of a new technology or face being an ‘anti-vaxxer’. Their risk is higher from the vaccine – without discussion – young adults and children are effectively treated as collateral by a state that does not care, to take the care, to act accordingly to their needs. Unlike a 60 year-old accepting the vaccine, if the thrombotic potential, for example, is correct, the health risk could produce cascading health effects for decades. Yet somehow, to raise this discussion is disloyal and recalcitrant.

Long-term effects remain unconsidered, including the decline of trust in the state and the potential for representative democracy to act transparently and accountably. Dismissal of adverse or off-target effects may result in a reduction of take-up in traditionally considered safe vaccines that have undergone extensive trials and been deployed for years, if not decades.[xl]

Recently, Biontech have released a Report regarding the third (booster) dose. The company was frank about the considerable uncertainties relating to this dose, stating[xli]:

Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; whether and when our Phase 3 clinical trial will demonstrate protection from infection or disease following a booster (third) dose, which is the subject of ongoing study; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious;' (pages 3-4)

The Report included Important Safety information:

The data supporting boosters is substantially underpowered & the reporting window too short.

The data supporting boosters is inadequate and underpowered, and unable to support the claims of efficacy and safety. The application for the booster dose is based on the reduction of symptoms, not the capacity for the booster to reduce infectivity in the population:

‘Some observational studies have suggested declining efficacy of COMIRNATY over time against symptomatic infection or against the Delta variant, while others have not. However, overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.[xlii]

Trials do not sufficiently break up the population by age group in order to clearly convey risk profiles in younger populations, nor do they represent non-white populations. The FDA Briefing Document for the Vaccines and Related Biological Products Advisory Committee Meeting concerning the application for the booster dose, based the application predominantly on a one-month trial:

Phase 1: participants 18-55 years of age (N=11) and 65- 85 years of age (N=12). C4591001

Phase 2: participants 18 through 55 years of age (N=306) (one month trial for booster)

Phase 3: (Larger study) Efficacy was not evaluated BNT162b2 booster group participants.

‘In February and March 2021, the protocol was amended to evaluate the safety and immunogenicity of booster dose of BNT162b2 in Phase 1 participants (N=12 per age cohort: 18-55 years and 65-85 years) and a subset of Phase 2/3 adults (N=300, ages 18-55 years), who completed the 2-dose primary vaccination series with 30 µg BNT162b2. A booster dose of 30 µg BNT162b2 was administered approximately 7 to 9 months after a primary series for Phase 1 participants and approximately 6 months after a primary series for Phase 2/3 participants.’

The primary data, referred to as the ‘Phase 2/3’ study cannot adequately identify risk across the population. The study looks at the immune response after one month (assessed based on analyses of GMT ratio and seroresponse rates for neutralizing antibody titers to the reference strain). However the GMT ratio data is only supplied for 210 of the 306 participants and the seroresponse rates are only supplied for 179 of the 306 participants.

Adverse reactions were only reported within the 7-day window post vaccination. The 7-day window is too short to recognise longer term effects. Adverse reactions appeared at a high level: ‘289 (94.4%) recorded local and systemic solicited adverse reactions (ARs) in an e-diary within 7 days following vaccination. Overall, 83.0% of participants reported any local reaction and 77.2% reported any systemic reaction’ however the study author considered only 24 (7.8%) of participants effects were related to the booster.

The paper notes that males in the 16-17 year old were at highest risk for myocarditis and pericarditis, however this trial did not study that age bracket. The paper states on page 3:

Pfizer is requesting approval of the booster dose for use in individuals 16 years of age and older; therefore, safety and effectiveness of the booster dose in individuals 16 and 17 years of age would be based on extrapolation from safety and effectiveness data in adults.

The paper (page 9) recognises that ‘The benefit of a booster dose must be weighed against potential risk’ recognising that pre-licensing and pre-authorisation clinical trials might not have been adequately powered to elucidate uncommon but serious adverse reactions, such as myocarditis/pericarditis.

NEXT: Multi-target therapies: Weight of evidence supporting nutritional therapies

REFERENCES

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[iii] Singanayagam et al. Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study. The Lancet (2021). Doi 10.1016/S1473-3099(21)00648-4

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[xvi] Letter to FDA. Firsthand Reports of COVID-19 Vaccine Injuries. October 6, 2021. Siri Glimstad Lawyers

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[xx] Gundry SR. mRNA COVID vaccines dramatically increase endothelial inflammatory markers and ACS risk as measured by the PULS cardiac test: a warning. Presented at: AHA Scientific Sessions 2021; November 13-15, 2021. Poster VMP41.

[xxi] Munoz-Rivas et al 2021. Systemic thrombosis in a large cohort of COVID-19 patients despite thromboprophylaxis: A retrospective study. Thrombosis Research. 199:132-142

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[xxv] Ryu et al. Sars-Cov-2 spike protein induces abnormal inflammatory blood clots neutralized by fibrin immunotherapy. bioRxiv preprint. (2021) doi: 10.1101/2021.10.12.464152

[xxvi] Doctors 4 Covid Ethics. The Dangers of Covid-19 Booster Shots and Vaccines: Boosting Blood Clots and Leaky Vessels. September 2021.

https://doctors4covidethics.org/wp-content/uploads/2021/09/Vaccine-immune-interactions-and-booster-shots_Sep-2021.pdf

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[xxviii] Yagi et al. Cerebral venous sinus thrombosis after mRNA‑based COVID‑19 vaccination. Neurological Sciences (2021) https://doi.org/10.1007/s10072-021-05714-0

[xxix] Mazzeo et al. Cerebral venous sinus thrombosis (CVST) associated with SARS-CoV-2 vaccines: clues for an immunopathogenesis common to CVST observed in COVID-19. J Anesth Analg Crit Care. (2021) 1:1;15 doi: 10.1186/s44158-021-00020-9

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[xxxi] Zakaria et al 2021. Cerebral venous sinus thrombosis 2 weeks after the first dose of mRNA SARS-CoV-2 vaccine. Vascular Neurosurgery. 163:2359-2362

[xxxii] Syed et al. Central Venous Sinus Thrombosis with Subarachnoid Hemorrhage Following an mRNA COVID-19 Vaccination: Are These Reports Merely Co-Incidental? (2021) Am J Casee Rep 22: e933397-1–e933397-5.

[xxxiii] Sharifian-Dorche et al. Vaccine-induced immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis post COVID-19 vaccination; a systematic review. J Neur Sci (2021). 428:117607 doi 10.1016/j.jns.2021.117607

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[xxxvii] Liu et al. Comprehensive investigations revealed consistent pathophysiological alterations after vaccination with COVID-19 vaccines. Cell Discovery. (2021) October 7:99 https://doi.org/10.1038/s41421-021-00329-3

[xxxviii] Föhse et al. The BNT162b2 mRNA vaccine against SARS-CoV-2 reprograms both adaptive and innate immune responses. medRxiv Preprint. Doi 10.1101/2021.05.03.21256520

[xxxix] Jiang H. & Mei Y. SARS–CoV–2 Spike Impairs DNA Damage Repair and Inhibits V(D)J Recombination In Vitro. Viruses 2021, 13, 2056. https://doi.org/10.3390/v13102056

[xl] Fisher Chasing Immunity: How Viable Is a Mandatory COVID-19 Vaccination Scheme for Australia? J Law Med (2021) 28:3;718-733

[xli] Turner et al. SARS-CoV-2 mRNA vaccines induce persistent human germinal centre responses. Nature 596:

[xlii] FDA Briefing Document. Vaccines and Related Biological Products Advisory Committee Meeting. September 17, 2021. Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA). 4. Rationale for Booster Doses. https://www.fda.gov/media/152176/download

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