Scientific, Legal and Political Rationale Recommended for Modifying the AHS Consent for COVID-19 Immunization Form

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Background

Presently, the Alberta Government Guidelines (1) on the administration of COVID-19 injections to anyone older than 6 months do not consider three lines of new evidence that challenge the premise that the modified RNA COVID-19 vaccines are safe and effective:

i) Residual plasmid DNA that is expected as a process-related impurity in the vials exceeds regulatory guidelines (2) both by amount and size.

ii) In the case of the Pfizer (not Moderna) product, residual DNA includes Simian Virus 40 (SV40) regulatory sequences which the manufacturer “chose not to disclose” to Health Canada (along with FDA and EMA), according to recent FOIA/ATIP disclosures (3). This sequence has been shown in experimental studies to affect DNA entry into the cell nucleus (4) and to interfere with a cancer suppression mechanism (5).

iii) The modRNA COVID-19 vaccines are inherently error prone due to the particular (and same) way both the Pfizer and Moderna products have been modified, according to a recent study from prestigious UK institutions tied to the Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) (6). This study found evidence that, in human subjects, the Pfizer modRNA product evokes the production of uncharacterized proteins of unknown and unstudied toxicology which, according to the authors, have a “huge potential to be harmful”.

Additionally, the risks of the COVID-19 vaccines are now being acknowledged more widely, such as in a recent article in the New York Times (7) and in a paper in the British Medical Journal that questions the possible role of the COVID-19 vaccines in the persistent excess mortality for three consecutive years (8).

Purpose

The purpose of this brief is to provide the scientific, legal, and political rationale for the Alberta Government to disseminate a Public Health Advisory on modified mRNA (modRNA) injections and to require that its citizens sign a modified AHS COVID-19 CONSENT FOR IMMUNIZATION form acknowledging that they have been informed of new evidence regarding the potential risks prior to subjecting themselves or a dependent minor to a modRNA injection. This will serve four purposes:

1. In a libertarian society individual choice is preserved and remains paramount. However, choice must be ethically predicated on the provision of sufficient accurate and up-to- date information to modRNA recipients so that they can make a decision that they deem is rational for themselves or their dependent minor(s).
   
2. That individuals understand that their choice is associated with both the potential benefits and risks of subjecting themselves or their dependent minor(s) to a modRNA injection, i.e., informed consent, which is a choice based on accurate information.
   
3. That the Alberta Government is demonstrably governing in the best health interests of its citizens by ensuring that every citizen has been duly informed of new evidence of potential harm from modRNA injections.
   
4. That neither the Alberta Government nor those administering the modRNA injections are liable for any harm or death of an individual in Alberta attributed to a modRNA injection since the revelation of plasmid DNA in the vials.

Brief Scientific Definitions

It is important to appreciate that the Pfizer and Moderna COVID-19 vaccines differ from classical vaccines because, unlike classical vaccines, they do not contain the target antigen (a bacteria or virus, or protein from a bacteria or virus) to which, it is hoped, the patient will mount an immune response. Rather, these products contain genetic instructions in the form of RNA that, once injected into a patient, will cause the patient to produce the target antigen, in this case the spike protein of the SARS-CoV-2 virus. Although “pro-vaccine” is a more technically accurate term, we will use the term “vaccine” here for brevity.

Although the term “mRNA” is commonly used to refer to the type of RNA present in the Pfizer and Moderna products, the more accurate term used in regulatory documents is “modRNA.” This is an abbreviation for “nucleoside-modified messenger RNA” and refers to the way “natural” mRNA has been modified in these products.

Scientific Rationale Supporting the Modification of the AHS COVID-19 Immunization Form

Since the launch of modRNA injections at the end of 2020 to attempt to control the spread of the COVID-19 virus or its variants, we now know that the injections may not prevent the development of COVID-19. Data from the US CDC show that vaccine effectiveness wanes significantly below FDA’s target effectiveness of 50% down to zero by three months and becomes negative in some cases by about seven months (9,10). Negative effectiveness means that a vaccinee has a greater chance of developing COVID-19 than someone who is not vaccinated. Other reports of negative vaccine effectiveness include Canadian data (11).

Further, the COVID-19 vaccines may not prevent the development nor the transmission of SARS-CoV2, according to the testimony of FDA’s Dr. Marks and CDC’s Dr. Jernigan at the US House Select Subcommittee on the Coronavirus Pandemic on February 15, 2024 (12).

Of even greater concern are several reports from the Cleveland Clinic describing “a possible association with more prior vaccine doses and higher risk of COVID-19” (13) and the finding that adults “not up to date” by the CDC definition have a lower risk of COVID-19 than those “up to date” on COVID-19 vaccination (14).

Beyond the extremely limited benefits of the modRNA COVID-19 vaccines is the ever-wider acknowledgement of the risks associated with the COVID-19 vaccines as found in a recent article in the New York Times (7). The primary source of this concern is the growing number of reports of adverse events associated with these products found within the US Vaccine Adverse Event Reporting System (VAERS)(15). Further detail is found in several recent reports, notably from CDC’s COVID-19 Vaccine Safety Surveillance Datalink (VSD) (16) which reported on myocarditis, pericarditis, Guillain-Barre syndrome and ischemic stroke associated with the COVID-19 vaccines. Similar, or expanded detail can be found in the report of the National Academies of Science, Engineering and Medicine (17) along with comments submitted for that report by Wiseman et al. (18); and the report of a multinational Global Vaccine Data Network cohort study of 99 million vaccinated individuals (19).

Two recent reports using government figures show highly statistically significant increases in cancer mortality in 2021 and 2022 among 15–44-year-olds in the UK and the US respectively (20, 21). This work was further expanded showing cancer mortality signals from US CDC data for all decade cohorts over 15 years, except in 55–64-year-olds (22). This work is consistent with recent reports from Japan (23) and Norway (24). The role of either the SARS-CoV-2 virus itself, or the COVID-19 vaccines, cannot be excluded and must be investigated.

Questions may be asked as to why many public health authorities, but not all, persist in recommending the administration of modRNA injections, even to children who are at little to no risk from COVID-19. For example, Dr. Ladapo, the Surgeon General of Florida, called for a halt in the administration of modRNA injections on Jan 3, 2024, based on the presence of plasmid DNA in the vials as measured by fluorometry that exceed guidelines (2,25).

What is the likely etiology of injury, cancer, and death associated with the modRNA injections? The toxicology of the spike protein elicited by these products is well known and will not be discussed here. New evidence also implicates certain contents of the modRNA vials.

To understand this issue, a brief explanation about the different roles of DNA and RNA is in order. A person’s genes are made from DNA which can be thought of as the archival version of all the instructions needed for normal body function. On an as-needed basis, “working” copies of these instructions are made in the form of RNA which contains the instructions needed for a given circumstance taking them to the parts of the cell where the instructions will be carried out by the production of specific proteins.

This basic scheme is adapted for the production of RNA for the COVID-19 vaccines, first requiring a DNA “master copy” in the form of plasmid DNA. Although the vaccine manufacturing process attempts to remove any DNA once its job is done, it is not possible to remove all of it. Accordingly, some residual DNA will remain in the final vaccine product. To mitigate the acknowledged risks that this DNA may insert into a patient’s DNA (possibly giving rise to cancer), a number of international guidelines recommend certain limits as to the amount and size (length) of the residual DNA.

Although evaluation of the Pfizer and Moderna modRNA vials reveals levels of residual plasmid DNA within regulatory guidelines of FDA and the WHO, that being 10ng per dose measured by PCR (polymerase chain reaction), that is not the whole story. Moderna’s patent 1010077439 B2 teaches that PCR “ does not measure all other smaller DNA molecules.” Thus, PCR underestimates the amount of residual plasmid DNA in the modRNA COVID-19 vaccines. Using a different technique, fluorometry, the amount of residual plasmid DNA contained in the modRNA COVID-19 vaccines has been estimated to be tens to low hundreds of times greater than the guidelines in all vials tested (2). At these levels there is an increased risk of altering one’s DNA by insertional mutagenesis recognized by FDA and WHO guidelines, as well as other risks of DNA that do not require its insertion into the genome. Even measuring DNA by the PCR method gives rise to concern, since the current guidelines do not consider the manyfold (10s to 100s) increased access to the cells afforded the DNA by the use of “fat bubbles” (Lipid Nanoparticles) used to deliver the modRNA into the cell. Further the guidelines do not consider multiple dosing. This may be become an even more important consideration given the recent approval in the USA of modRNA vaccine for Respiratory Syncytial Virus (RSV). Since it is anticipated that modRNA RSV vaccine may be given at or around the same time as COVID-19 vaccine, the cumulative load of residual DNA should be considered.

The DNA that has been found also exceeds guidelines related to its size. Indeed, intact sequences for an antibiotic resistance gene necessary for the modRNA manufacture have also been found.

The Pfizer product also contains a sequence (type) of DNA that had not been disclosed to regulators, contrary to guidelines and standard practice, as has been revealed now in various FOIA/ATIP disclosures from Health Canada or the EMA. Aside from the issues of public trust and the role of regulators as guardians of public trust, the reason why this sequence is concerning is that being that it is a special sort of DNA called a regulatory sequence, it can control how other segments of DNA function. This particular sequence is a part of the DNA makeup of a virus called SV40. It is important to state that the sequence that was found is not the whole SV40 virus, nor the whole SV40 viral genome, nor the part of the SV40 genome that is closely associated with cancer.

However, work by Drayman suggests that the undisclosed SV40 DNA sequence in the vials could bind to the p53 cancer suppressor protein potentially inactivating it (26). Along with El-Deiry’s work suggesting an effect of the spike protein on p53 (27), these are plausible mechanisms that could explain the increased incidence of cancers described above.

The last area of major concern engendered by recent publications involves ribosomal frameshifting in mice and humans described by Mulroney (5) and commented on by Wiseman et al (28). Frameshifting refers to the misreading of the modRNA contained within the Pfizer or Moderna COVID-19 vaccine which results in the inadvertent production of “off-target” proteins capable of eliciting “off-target” immune responses”. Frameshifting occurs because of the way the modRNA has been modified in either the Pfizer or Moderna COVID-19 vaccines by the substitution of one of the gene letters (“U” – uridine) for N1-methyl pseudo uridine” (m1Ψ). Mulroney et al state that the “error prone” code is a safety concern with a “huge potential to be harmful” and that “it is essential that these therapeutics are designed to be free from unintended side-effects.”

Despite this, Mulroney et al. downplay the implications of frameshifting for the currently available modRNA vaccines. It is difficult to understand how this conclusion is justified since their observations were based on only 21 human subjects, none of whom had reported adverse events. Clearly this phenomenon needs to be fully investigated as the uncontrolled production of uncharacterized proteins of unknown toxicology elicited by the modRNA products is anathema to every principle on which the protection of the public from unsafe medical products by regulators is based.

To date, the FDA has eschewed these concerns. In an email disclosed by an ATIP to Health Canada by Epoch Times Canada, a senior medical advisor was concerned about the high level of impurities arising from ribosomal frameshifting, but these concerns were edited by senior Health Canada scientific staff to appear less concerning (29).

At the very least, in the interests of full disclosure, the package insert should be amended by adding the emboldened underlined words as follows: “COMIRNATY (2023 -2024 Formula) is formulated to contain modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5) in addition to unknown, uncharacterized frameshift proteins of unknown distribution and toxicology.”

Separate from the concerns raised by the Mulroney study are other concerns of N1-methyl pseudo uridine (m1Ψ ) discussed by Rubio-Casilla and co-authors who concluded that “future clinical trials for cancers or infectious diseases should not use mRNA vaccines with a 100 % m1Ψ modification, but rather ones with the lower percentage of m1Ψ modification to avoid
immune suppression” (30).

The excess residual DNA, the SV40 regulatory sequences in the Pfizer product and the frameshifting occurring for both the Pfizer and Moderna constitute plausible explanations for their numerous associated adverse effects. Superimposed on the general concerns of COVID-19 vaccine safety and their limited (at best) effectiveness, there is ample reason to exercise abundant caution to either pause further modRNA use, or at least advise recipients of the potential risks.

Based on US Federal law and regulation, the language used by FDA to summarize the regulatory standard for the Emergency Use Authorization of COVID-19 vaccines is “Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may be effective” (31).

Applying the same evidentiary standards and merely changing the last word, we are justified in applying the same test to draw conclusions about safety by stating:

“Based on the totality of scientific evidence available, including data from adequate and well- controlled trials, if available, it is reasonable to believe that the product may be unsafe”.

Legal Rationale Supporting the Modification of the AHS COVID-19 Immunization Form

Given that hundreds of modRNA vaccines are under development, it is incumbent on the medical and legal professions, as well as the Alberta Government, to ensure the safety of all new modRNA technology before citizens once again become experimental subjects. At the very least, Albertans should fully comprehend both the purported benefits and potential risks which, ethically, require transparent disclosure to the recipient. Unfortunately, most physicians, pharmacists and public health nurses are not fully versed in the risks and cannot be relied upon to provide accurate informed consent.

Some jurisdictions, while controversial, have already recommended stopping the administration of modRNA injections (25). In Idaho, a bill would criminalize giving modRNA injections (32). AstraZeneca has just begun a worldwide withdrawal of its Covid-19 DNA vaccine (33).

The Government of Canada recently committed $36M to its vaccine injury compensation fund (34). This is a regulatory acknowledgement of liability for vaccine harms, and by implication, that these drugs are potentially dangerous. In fact, there are at least three vaccine harm class actions ongoing in Canada which, although not settled, should inform the Alberta government to reconsider how modRNA injections are recommended based on the new evidence of plasmid DNA in the modRNA vials that exceeds regulatory guidelines.

To protect against legal jeopardy, the Alberta government is encouraged to require modRNA recipients to sign a waiver (modification of the current AHS COVID-19 Consent Form) acknowledging that they understand the potential ramifications of receiving a modRNA injection (see 2nd document). This will protect them and their dependent minors from proceeding with a modRNA injection absent the understanding that the injection has the potential to cause injury and death, while at the same time protect those administering the vaccine and the Alberta Government from future litigation. Choice, predicated on knowledge of potential benefits and harm, is thereby preserved. And that medical choice should never compromise one’s freedom to work, travel or enjoy life.

Given the recent approval in the USA of modRNA vaccine made by Moderna for Respiratory Syncytial Virus (RSV), many of the same considerations of residual DNA and frameshift proteins pertaining to COVID-19 vaccines are also likely to apply, until established otherwise. Alberta should consider applying similar policies towards these newer kinds of modRNA vaccines.

Political Rationale Supporting the Modification of the AHS COVID-19 Immunization Form

There is a growing sentiment amongst many Albertans to eschew modRNA injections as they become aware that none of the modRNA injections prevent being infected by the SARS-Cov-2 virus or transmitting it, but that the vaccine itself may cause them irreparable harm or death.

Concomitantly, a growing percentage of the Alberta electorate believes that the government is behind the knowledge curve. The electorate is variably both angry and concerned that the modRNA injections are recommended for all citizens, even those under 12 years of age who have almost no risk from COVID-19 or any of its variants. In the USA, the “safety and effectiveness of COMIRNATY in individuals younger than 12 years of age have not been established” (35), and “safety and effectiveness of SPIKEVAX have not been established in individuals less than 12 years of age”, (36) which begs the question of safety for those older than 12 as well.

The political concern is that increasingly more Albertans believe that the Alberta Government is making modRNA vaccine recommendations without fully acknowledging both the risks and benefits to recipients, which is a minimum to balanced informed consent. This poses the political risk to the Alberta Government of losing some of its base at a time when the margin of victory may be only a few thousand votes. Why take the risk when the solution is a win-win for the public and the government?

Conclusion

The Alberta Government is strongly encouraged to:

1. Ensure that all Albertans who receive a modRNA injection in the future, including boosters, sign an accurate waiver (revised AHS Consent for COVID-19 Immunization form), acknowledging that they are aware of new and substantiated evidence of the potential harm that may arise from their decision to proceed with the inoculation.
   
2. Modify the current AHS Consent for COVID-19 Immunization form (37) as recommended in the 2nd document entitled “SUGGESTED ADDITIONS TO THE ALBERTA HEALTH SERVICES CONSENT FOR COVID-19 IMMUNIZATION FORM”.
   
3. Meet with the scientific, legal, and political co-authors if clarification is required (highly recommended).
   
4. Consider funding research to ensure the safety of modRNA injections on behalf of Albertans.

Respectfully,

Scientific Authorship
Dennis L Modry, BSc, MD, MSc, FRCS(C), FACS(C), FACCP(C), Post Doc Immunology
David J Speicher, PhD, DTM
Jessica Rose, BSc, MSc, PhD
L Maria Gutschi, BScPhm PharmD
David Wiseman, PhD, MRPharmS

Legal Authorship and Political Authorship
Dennis L Modry, BSc, MD, MSc, FRCS(C), FACS(C), FACCP(C), Post Doc Immunology
Brian Heck, BA, LLB
Leighton Grey, BA (Distinction), LLB, MBA, PhD
Raymond Strom, ChT, VP Policy and Governance United Conservative Party

Click here to view our “Suggested Additions to the Alberta Health Services Consent For COVID-19 Immunization Form”

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