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Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19

Stephanie Seneff1 and Greg Nigh – Computer Science and Artificial Intelligence Laboratory, MIT, Cambridge MA, 02139, USA, E-mail: seneff@csail.mit.edu / Naturopathic Oncology, Immersion Health, Portland, OR 97214, USA

ABSTRACT

Operation Warp Speed brought to market in the United States two mRNA vaccines, produced by Pfizer and Moderna. Interim data suggested high efficacy for both of these vaccines, which helped legitimize Emergency Use Authorization (EUA) by the FDA.

However, the exceptionally rapid movement of these vaccines through controlled trials and into mass deployment raises multiple safety concerns. In this review we first describe the technology underlying these vaccines in detail.

We then review both components of and the intended biological response to these vaccines, including production of the spike protein itself, and their potential relationship to a wide range of both acute and long-term induced pathologies, such as blood disorders, neurodegenerative diseases and autoimmune diseases.

Among these potential induced pathologies, we discuss the relevance of prion-protein-related amino acid sequences within the spike protein. We also present a brief review of studies supporting the potential for spike protein “shedding”, transmission of the protein from a vaccinated to an unvaccinated person, resulting in symptoms induced in the latter.

We finish by addressing a common point of debate, namely, whether or not these vaccines could modify the DNA of those receiving the vaccination. While there are no studies demonstrating definitively that this is happening, we provide a plausible scenario, supported by previously established pathways for transformation and transport of genetic material, whereby injected mRNA could ultimately be incorporated into germ cell DNA for transgenerational transmission.

We conclude with our recommendations regarding surveillance that will help to clarify the long-term effects of these experimental drugs and allow us to better assess the true risk/benefit ratio of these novel technologies.

Introduction

Unprecedented. This word has defined so much about 2020 and the pandemic related to SARS-CoV-2. In addition to an unprecedented disease and its global response, COVID-19 also initiated an unprecedented process of vaccine research, production, testing, and public distribution (Shaw,

2021). The sense of urgency around combatting the virus led to the creation, in March 2020, of Operation Warp Speed (OWS), then-President Donald Trump’s program to bring a vaccine against COVID-19 to market as quickly as possible(Jacobs and Armstrong, 2020). OWS established a few more unprecedented aspects of COVID-19.

First, it brought the US Department of Defense into direct collaboration with US health departments with respect to vaccine distribution (Bonsell, 2021).

Second, the National Institutes of Health (NIH) collaborated with the biotechnology company Moderna in bringing an unprecedented type of vaccine against infectious disease to market, one utilizing a technology based on messenger RNA (mRNA) (National Institutes of Health, 2020).

The confluence of these unprecedented events has rapidly brought to public awareness the promise and potential of mRNA vaccines as a new weapon against infectious diseases into the future. At the same time, events without precedent are, by definition, without a history and context against which to fully assess risks, hoped-for benefits, safety, and long-term viability as a positive contribution to public health.

In this paper we will be briefly reviewing one particular aspect of these unprecedented events, namely the development and deployment of mRNA vaccines against the targeted class of infectious diseases under the umbrella of “SARS-CoV-2.

”We believe many of the issues we raise here will be applicable to any future mRNA vaccine that might be produced against other infectious agents, or in applications related to cancer and genetic diseases, while others seem specifically relevant to mRNA vaccines currently being implemented against the subclass of corona viruses. While the promises of this technology have been widely heralded, the objectively assessed risks and safety concerns have received far less detailed attention. It is our intention to review several highly concerning molecular aspects of infectious disease-related mRNA technology, and to correlate these with both documented and potential pathological effects.

UNPRECEDENTED

Many aspects of Covid-19 and subsequent vaccine development are unprecedented for a vaccine deployed for use in the general population.

Some of these includes the following.

1. First to use PEG (polyethylene glycol) in an injection (see text)

2. First to use mRNA vaccine technology against an infectious agent

3. First time Moderna has brought any product to market

4. First to have public health officials telling those receiving the vaccination to expect an adverse reaction

5. First to be implemented publicly with nothing more than preliminary efficacy data (see text)

6. First vaccine to make no clear claims about reducing infections, transmissibility, or deaths

7. First coronavirus vaccine ever attempted in humans

8. First injection of genetically modified polynucleotides in the general population

Vaccine Development

Development of mRNA vaccines against infectious disease is unprecedented in many ways. In a 2018 publication sponsored by the Bill and Melinda Gates Foundation, vaccines were divided into three categories: Simple, Complex, and Unprecedented (Young et al., 2018). Simple and Complex vaccines represented standard and modified applications of existing vaccine technologies.

Unprecedented represents a category of vaccine against a disease for which there has never before been a suitable vaccine. Vaccines against HIV and malaria are examples. As their analysis indicates, depicted in Figure 1, unprecedented vaccines are expected to take 12.5 years to develop. Even more ominously, they have a 5% estimated chance of making it through Phase II trials (assessing efficacy) and, of that 5%, a 40% chance of making it through Phase III trials (assessing population benefit). In other words, an unprecedented vaccine was predicted to have a 2% probability of success at the stage of a Phase III clinical trial. As the authors bluntly put it, there is a “low probability of success, especially for unprecedented vaccines.” (Young et al., 2018)

Figure 1.Launching innovative vaccines is costly and time-consuming, with a low probability of success, especially for unprecedented vaccines (adapted from Young et al, 2018).

With that in mind, two years later we have an unprecedented vaccine with reports of 90-95% efficacy (Baden et al. 2020). In fact, these reports of efficacy are the primary motivation behind public support of vaccination adoption (U.S. Department of Health and Human Services, 2020). This defies not only predictions, but also expectations.

The British Medical Journal(BMJ) may be the only prominent conventional medical publication that has given a platform to voices calling attention to concerns around the efficacy of the COVID-19 vaccines. There are indeed reasons to believe that estimations of efficacy are in need of re-evaluation. Peter Doshi, an associate editor of the BMJ, has published two important analyses (Doshi 2021a, 2021b) of the raw data released to the FDA by the vaccine makers, data that are the basis for the claim of high efficacy. Unfortunately, these were published to the BMJ’s blog and not in its peer-reviewed content. Doshi, though, has published a study regarding vaccine efficacy and the questionable utility of vaccine trial endpoints in BMJ’s peer reviewed content (Doshi 2020).

A central aspect of Doshi’s critique of the preliminary efficacy data is the exclusion of over 3400 “suspected COVID-19 cases” that were not included in the interim analysis of the Pfizer vaccine data submitted to the FDA. Further, a low-but-non-trivial percent of individuals in both Moderna and Pfizer trials were deemed to be SARS-CoV-1-positive at baseline despite prior infection being grounds for exclusion. For these and other reasons the interim efficacy estimate of around 95% for both vaccines is suspect.

A more recent analysis looked specifically at the issue of relative vs. absolute risk reduction. While the high estimates of risk reduction are based upon relative risks, the absolute risk reduction is a more appropriate metric for a member of the general public to determine whether a vaccination provides a meaningful risk reduction personally. In that analysis, utilizing data supplied by the vaccine makers to the FDA, the Moderna vaccine at the time of interim analysis demonstrated an absolute risk reduction of 1.1% (p= 0.004), while the Pfizer vaccine absolute risk reduction was 0.7% (p<0.000) (Brown 2021).

Others have brought up important additional questions regarding COVID-19 vaccine development, questions with direct relevance to the mRNA vaccines reviewed here.

For example, Haidere, et. al. (2021) identify four “critical questions” related to development of these vaccines, questions that are germane to both their safety and their efficacy:

•Will Vaccines Stimulate the Immune Response?

•Will Vaccines Provide Sustainable Immune Endurance?

•How Will SARS-CoV-2 Mutate?

•Are We Prepared for Vaccine Backfires?

Lack of standard and extended preclinical and clinical trials of the two implemented mRNA vaccines leaves each of these questions to be answered over time. It is now only through observation of pertinent physiological and epidemiological data generated by widescale delivery of the vaccines to the general public that these questions will be resolved. And this is only possible if there is free access to unbiased reporting of outcomes –something that seems unlikely given the widespread censorship of vaccine-related information because of the perceived need to declare success at all cost.

The two mRNA vaccines that have made it through phase 3 trials and are now being delivered to the general population are the Moderna vaccine and the Pfizer-BioNTech vaccine.

The vaccines have much in common. Both are based on mRNA encoding the spike protein of the SARS-CoV-2 virus. Both demonstrated a relative efficacy rate of 94-95%. Preliminary indications are that antibodies are still present after three months. Both recommend two doses spaced by three or four weeks, and recently there are reports of annual booster injections being necessary (Mahose, 2021). Both are delivered through muscle injection, and both require deep-freeze storage to keep the RNA from breaking down. This is because, unlike double-stranded DNA which is very stable, single-strand RNA products are apt to be damaged or rendered powerless at warm temperatures and must be kept extremely cold to retain their potential efficacy (Pushparajah et al., 2021).

It is claimed by the manufacturers that the Pfizer vaccine requires storage at -94 degrees Fahrenheit (-70 degrees Celsius), which makes it very challenging to transport it and keep it cold during the interim before it is finally administered. The Moderna vaccine can be stored for 6 months at -4 degrees Fahrenheit (-20 degrees Celsius), and it can be stored safely in the refrigerator for 30 days following thawing (Zimmer et al., 2021).

Two other vaccines that are now being administered under emergency use are the Johnson & Johnson vaccine and the AstraZeneca vaccine. Both are based on a vector DNA technology that is very different from the technology used inthe mRNA vaccines.

While these vaccines were also rushed to market with insufficient evaluation, they are not the subject of this paper so we will just describe briefly how they are developed. These vaccines are based on a defective version of an adenovirus, a double-stranded DNA virus that causes the common cold.

The adenovirus has been genetically modified in two ways, such that it cannot replicate due to critical missing genes, and its genome has been augmented with the DNA code for the SARS-CoV-2 spike protein. AstraZeneca’s production involves an immortalized human cell line called Human Embryonic Kidney (HEK) 293, which is grown in culture along with the defective viruses (Dicks et al., 2012).

The HEK cell line was genetically modified back in the 1970s by augmenting its DNA with segments from an adenovirus that supply the missing genes needed for replication of the defective virus (Louis et al., 1997).

Johnson & Johnson uses a similar technique based on a fetal retinal cell line. Because the manufacture of these vaccines requires genetically modified human tumor cell lines, there is the potential for human DNA contamination as well as many other potential contaminants.

The media has generated a great deal of excitement about this revolutionary technology, but there are also concerns that we may not be realizing the complexity of the body’s potential for reactions to foreign mRNA and other ingredients in these vaccines that go far beyond the simple goal of tricking the body into producing antibodies to the spike protein.

In the remainder of this paper, we will first describe in more detail the technology behind mRNA vaccines. We devote several sections to specific aspects of the mRNA vaccines that concern us with regard to potential for both predictable and unpredictable negative consequences.

We conclude with a plea to governments and the pharmaceutical industry to consider exercising greater caution in the current undertaking to vaccinate as many people as possible against SARS-CoV-2.

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Conclusion

Experimental mRNA vaccines have been heralded as having the potential for great benefits, but they also harbor the possibility of potentially tragic and even catastrophic unforeseen consequences.

The mRNA vaccines against SARS-CoV-2 have been implemented with great fanfare, but there are many aspects of their widespread utilization that merit concern. We have reviewed some, but not all, of those concerns here, and we want to emphasize that these concerns are potentially serious and might not be evident for years or even transgenerationally.

In order to adequately rule out the adverse potentialities described in this paper, we recommend, at a minimum, that the following research and surveillance practices be adopted:

•A national effort to collect detailed data on adverse events associated with the mRNA vaccines with abundant funding allocation, tracked well beyond the first couple of weeks after vaccination.

•Repeated autoantibody testing of the vaccine-recipient population. The autoantibodies tested could be standardized and should be based upon previously documented antibodies and autoantibodies potentially elicited by the spike protein. These include autoantibodies against phospholipids, collagen, actin, thyroperoxidase (TPO), myelin basic protein, tissue transglutaminase, and perhaps others.

•Immunological profiling related to cytokine balance and related biological effects. Tests should include, at a minimum, IL-6, INF-α, D-dimer, fibrinogen, and C-reactive protein.

•Studies comparing populations who were vaccinated with the mRNA vaccines and those who were not to confirm the expected decreased infection rate and milder symptoms of the vaccinated group, while at the same time comparing the rates of various autoimmune diseases and prion diseases in the same two populations.

•Studies to assess whether it is possible for an unvaccinated person to acquire vaccine-specific forms of the spike proteins from a vaccinated person in close proximity.

•In vitro studies to assess whether the mRNA nanoparticles can be taken up by sperm and converted into cDNA plasmids.

•Animal studies to determine whether vaccination shortly before conception can result in offspring carrying spike-protein-encoding plasmids in their tissues, possibly integrated into their genome.

•In vitro studies aimed to better understand the toxicity of the spike protein to the brain, heart, testes, etc.

Public policy around mass vaccination has generally proceeded on the assumption that the risk/benefit ratio for the novel mRNA vaccines is a “slam dunk.” With the massive vaccination campaign well under way in response to the declared international emergency of COVID-19, we have rushed into vaccine experiments on a world-wide scale. At the very least, we should take advantage of the data that are available from these experiments to learn more about this new and previously untested technology. And, in the future, we urge governments to proceed with more caution in the face of new biotechnologies.

Finally, as an obvious but tragically ignored suggestion, the government should also be encouraging the population to take safe and affordable steps to boost their immune systems naturally, such as getting out in the sunlight to raise vitamin D levels (Ali, 2020), and eating mainly organic whole foods rather than chemical-laden processed foods (Rico-Campà et al., 2019). Also, eating foods that are good sources of vitamin A, vitamin C and vitamin K2 should be encouraged, as deficiencies in these vitamins are linked to bad outcomes from COVID-19 (Goddek, 2020; Sarohan, 2020).

Acknowledgements

This research was funded in part by Quanta Computers, Inc., Taiwan, under the auspices of the Qmulus project.Competing interests

The authors have no competing interests or conflicts to declare.

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