 By Tetyana Obukhanych, Ph.D.
The recent publications of the (placebo-less) phase I clinical trial of Moderna’s mRNA-1273 (COVID-19) vaccine, followed by the animal study in monkeys, both in the prestigious New England Journal of Medicine, have propelled the vaccine into the final phase II/III clinical trial. This must be a good development for the company, right? But wait… as reported by The Jerusalem Post on August 2, 2020, Moderna’s Chief Medical Officer Tal Zaks just sold almost all of his shares of the company’s stock, raising concerns about his trust in the vaccine: “In general, when stakeholders believe in their product, they increase their shares in order to increase confidence in the market. The move by Moderna officials to do the opposite raised concerns about the company, especially considering that Zaks, who sold almost all of his shares, is on the scientific side of the company, according to Globes.” We won’t ever know what was left unpublished that motivated such a step by Moderna’s Chief Medical Officer, but let’s take a look at what is published and may end up being problematic for vaccine safety and effectiveness. First, both in the animal study and in phase I clinical trial, the COVID-19 mRNA vaccination generated much higher antibody titers than those generated after natural SARS-CoV-2 infections. Why would that be a problem? Don’t we want high antibody titers for better protection—the higher, the better? Not always. Low levels of antibody production to some viral infections might be Mother Nature’s way to limit the effects of potential cross-priming and virally-induced autoimmunity, where such possibility exists. The possibility is present for SARS-CoV-2. Lyons-Weiler and Kanduc have independently published their biocomputational analyses of cross-reactive epitopes between SARS-CoV-2 and human proteins. If antibodies to these epitopes are produced at higher than natural levels, it may spur autoimmunity. In the past, Kanduc & Shoenfeld made a similar biocomputational discovery of cross-reactivity between HPV (human papillomavirus) antigens and human self-antigens. Natural HPV infections generate low levels of antibodies, whereas the HPV vaccine (Gardasil) generates much higher levels. And while natural HPV infections are not accompanied by medical complaints of autoimmunity, there are plenty of such complaints in VAERS after the receipt of the HPV vaccine, and with statistically higher odds than after other vaccines, per this study. Second, by the time Moderna's vaccine could become available, a significant percentage of the population might have already had an asymptomatic or mild infection with the SARS-CoV-2 virus, which was not diagnosed. A recent study showed that 70% of those who had COVID-19 and even 20% of those who were not known to be exposed, had CD8 T-cells that recognized SARS-CoV-2-specific epitopes. CD8 T-cells are known as killer T cells. When reactivated by antigen re-exposure, they are capable of rapidly killing the cells that harbor that antigen. Getting an mRNA vaccine without knowing one's history of a prior SARS-CoV-2 infection (especially when asymptomatic or undiagnosed), and without screening out those with pre-existing SARS-CoV-2-specific CD8 T-cells, is of grave concern. Why? Because after being injected, an mRNA vaccine is incorporated into muscle cells, and some of it diffuses and gets into distant tissues and organs, such as the bone marrow, spleen, liver, and even testes, as found in this mouse study, using a never-licensed influenza mRNA vaccine candidate. Therefore, once the COVID-19 mRNA vaccine gets expressed in various cells and tissues of vaccine recipients who have previously had a natural infection, their SARS-CoV-2-specific killer T cells may get reactivated and damage those tissues and organs. Are we ready to play Russian roulette with our immune systems? Last, but not least, mRNA vaccine technology is known to generate waning antibody responses in the long term. For example, a study of another never-licensed rabies mRNA vaccine candidate showed that “after the initial vaccinations, 17 out of 21 participants had titers of 0.5 IU/mL or more 4 weeks after priming, but 1 year later, only two of the 14 who returned still had detectable antibodies, and neither had a titer of 0.5 IU/mL or more.” The COVID-19 mRNA vaccine trial volunteers have not yet been titer-tested after one year. And after they do, get ready to be told we need annual boosters. Even in a shorter time frame, the nasal infection in the monkeys was not completely blocked by the low vaccination dose of the COVID-19 mRNA vaccine. The high vaccination dose (which had much higher reactogenicity in human volunteers in phase I trial) did prevent viral replication in monkeys’ noses. But since viral challenge of animals was performed at the optimal time (4 weeks following vaccination series), the results may not be representative of a real world scenario, where viral exposure is not so perfectly timed with the peak of antibody production. In summary, with serious gaps in published vaccine assessment, Moderna’s mRNA-1273 vaccine will likely fall short of delivering the long-awaited safe and effective reprieve from the COVID-19 fear narrative. ________________________________ Tetyana Obukhanych, Ph.D. is Immune Science Educator at BBCH (Building Bridges in Children's Health), an international online community of parents, health advocates, and doctors dedicated to learning the science that impacts children's health and supports healthy immunity. Comments are closed.
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