Does McCullough's paper really "establish a mechanistic framework" for mRNA vaccine harm?

Peter McCullough & colleagues have just published a paper in Food and Chemical Toxicology that posits biological mechanisms underlying purported innate immune suppression and harm from SARS-CoV-2 mRNA vaccination, and uses VAERs to support their hypotheses

This paper proposes that distinct from COVID infection, mRNA vaccines suppress type I IFN leading to a cascade of deleterious downstream effects that lead to various pathologies they associate with vaccination based on VAERs report, claiming to “establish a mechanistic framework”

This very long review article presents many details about various biological pathways, most related to cancer, but their links to mRNA vaccines are almost wholly speculative. In some cases, they link to other vaccines, old mRNA technology, or COVID-19 infection, but are not directly linked to mRNA vaccines.

In fact, so much of their evidence is from papers on severe COVID-19 infections, not vaccination, much of the evidence in this article might be better suited to a paper pointing out potential downstream dangers of severe COVID-19 infections than on trying to raise alarm about mRNA vaccination.

A number of places in the article seem to make stronger statements linking mRNA vaccines to some of these processes, but they self-cite a previous review article by senior author McCullough and do not reference any primary biological research making these connections.

They suggest connections of these mechanisms to various anecdotal case reports for herpes zoster reactivation, liver damage, optic neuropathy, T cell lymphoma progression, Hepatitis C reactivation, events not yet confirmed to be related to mRNA vaccination.

The paper amounts to laying out a series of hypotheses about mechanisms of harm that may come from mRNA vaccines. Hypothesis generation is a valuable exercise, including in this context of understanding downstream biological effects of vaccination that might induce harm.

However, not all hypotheses are equally supported. Some are well-girded in direct evidence from relevant studies, while others are more speculative and extrapolate principles from other settings, e.g. SARS-CoV-2 infections or other injected vaccines, as done here. Indeed the speculative nature of their exploration is implicitly acknowledged by the authors in their choice of wording throughout, including “is plausible”, “one can speculate”, “might be a mechanism”, “one can hypothesize”, “it appears”, “we expect”, “could eventually lead to”, "might trigger", "a potential factor", "apparently", "could produce", "seemed to be", etc.

It seems to me that rather than “establish a mechanistic framework”, this paper simply lays out speculative mechanistic hypotheses with little direct connection to mRNA vaccines. It lays out hypotheses to validate, not principles to assume true unless disproven, as their conclusion implies

Challenging public health institutions to disprove the assertions made by this article, rather than taking responsibility to validate them or urge other scientists to do so, is a bold move. This type of statement in which one makes a claim and presumes it should assumed true unless other scientists can disprove it, is the classic "shifting the burden of truth" trick. A scientist proposing a hypothesis has the burden of validating it; it is not the responsibility of the scientific community to disprove it, and the hypothesized claim certainly does not have the benefit of presumption of truth unless disproven. This is a common tactic used by many during the pandemic.

The entire last part of the paper presents results from VAERs attempting to “strengthen” a causal link between mRNA vaccinations and broad classes of pathologies, including nerve inflammation, heart disorders, liver disease, thrombosis, neurodegenerative diseases, and cancer.

Their case for causation is driven by their claim that the mechanisms discussed in this paper represent “causal pathways”, the fact that most VAERs reports occur soon after infection, and that the vast majority of VAERs reports in 2021 are from COVID, not other vaccines.

This follows a line of argument used by others that the only possible explanation for higher VAERs reports close to time of injection is vaccine causation, ignoring that events immediately following injection are more likely to be considered vaccine related and thus reported.

They step through their chosen symptom categories and list what % of VAERs reports in 2021 were for COVID rather than other vaccines, supposing that high % indicates that event is “especially significant as a potential toxic effect of these vaccines”

Of course, this approach assumes that event reporting rates in 2021 do not vary across vaccine type, i.e. that COVID vaccines are not more likely to be reported to VAERs than flu or other vaccines, a highly dubious assumption.

From various negative control events I looked up in VAERs, we can see that indeed reporting is higher for COVID than other vaccines across the board, unless you believe that vaccines cause toothaches, urinary incontinence, Xrays of limbs, or baldness.

There are other ways to show that events are being reported to VAERs at a much higher rate for COVID vaccines during the pandemic than for other vaccines pre-pandemic. I previously showed from USA Medicare data purportedly coming from a CMS whistleblower that the rate of deaths within 14d of flu vaccination in 2018-2020 was just as high as within 14d of COVID vaccination in 2021, which given the orders of magnitude higher reported number of VAERs deaths within 14d of COVID vaccination than flu vaccination in the >65yr USA population, demonstrates clearly that the level of VAERs reporting is much higher for COVID in 2021.

Gordan T Cormack published a preprint in which he downloaded VAERs data and demonstrated that indeed the relative distribution of VAERs death counts across days since vaccination are identical for COVID-19, flu, and Zoster, demonstrating that there is a natural tendency for more reports closer to the day of vaccination (unless you think flu and Zoster are killing people).

Results from several symptom categories demonstrates how their conclusions tend to overreach and ignore important confounding effects.

Here are nerve inflammation symptoms they analyzed.

One nerve inflammation symptom is anosmia. They claim this “clearly demonstrates” the spike injected into arm reached the olfactory nerve.

This claim ignores the fact that anosmia is a common long term sequelae after COVID-19 infection, has not been linked to vaccine, and could be simply caused by previous COVID-19 infection, not vaccine.

Here are results for neurodegenerative diseases.

In presenting neurodegenerative diseases, they acknowledge that they take decades to develop, yet imply some sort of connection with COVID-19 vaccines rather than considering the higher numbers for COVID-19 vaccines might be from higher reporting rates for COVID-19 vaccines.

Here are their results on cancers.

They conclude by suggesting these VAERs results reflect increased cancer risk from mRNA vaccination, citing their mechanistic hypotheses.

They initially acknowledge that cancer takes months or years to form, but then go on to imply that the high proportion of cancer reports in VAERs from COVID vaccines suggests the vaccines increase cancer risk, and that this claim is undergirded by their mechanistic hypotheses. Indeed, most all of molecular pathways described in this paper and posited to be related to mRNA vaccination are cancer related, so it is natural that in this paper they would try to make a link between mRNA vaccination and cancer risk even though it is scientifically and medically implausible for a vaccine to cause cancer within a matter of days, weeks, or even months. It took several years for cancers to develop in those exposed to the fallout of the nuclear bombs dropped on Hiroshima and Nagasaki at the end of World War 2.

Their suggestions that they have evidence that mRNA vaccines increase cancer risk and that their literature review in this paper indicate mechanisms of action further demonstrate the overreaching nature of the claims made in this paper.

BTW these are the “highlights” listed by the authors at the beginning of the article.

Read the article and ask yourself, “Are any of these points actually demonstrated in the article?"

Scientists have detected, validated, and characterized various minority harm risks of vaccines, including anaphylaxis/myocarditis for mRNA vaccines, and VITT/GBS for viral vectors. Detection, validation, and characterization of any other risk is critically important. And deep characterization of the subgroups at highest risk of these serious complications, and of the severity and long-term effects of them needs to be highly prioritized research and considered in refining vaccination recommendations. Studies integrating information from existing literature to posit hypotheses explaining these harms and others are potentially useful, which this paper purports to do. However, the purported “mechanistic frameworks” laid out in this paper lack any documented connections to mRNA vaccines, instead linking them to other vaccines, old mRNA technologies, or COVID-19 infections and speculating connections to mRNA vaccines. This makes their hypotheses speculative at best. Additionally, their case for vaccine relatedness is built upon flawed VAERs analyses that link higher reporting rates with significance as potential toxic vaccine effect, ignoring that events COVID-19 vaccination might be reported more often, as strongly suggested by these data and many others.

The bottom line is that this paper is comprised of a number of speculative hypothesis that can be viewed as unsubstantiated assertions.

Certainly any paper proposing hypotheses needs to acknowledge they need to be investigated and validated, not assumed true unless disproven as the conclusion of this paper seems to imply. This is especially true when the proposed hypotheses are as weakly supported as they are in this paper.

I have a feeling that is not how this paper will be represented, but that the "shifting the burden of truth" tactic will be used to oversell the level of evidence of its claims and try to suggest they have demonstrated biological principles and established risks that they clearly have not.