All Roads Lead to Spike (Protein)
US FDA issues warning of myocarditis for Novavax's COVID vaccine, suggesting a common factor being the spike protein across all vaccine platforms.
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Note: Please refer to Robin Whittle of Nutrition Matters’ pinned comment below. As he mentioned, there appears to be several cases of myocarditis/pericarditis in those who have already been provided Novavax. Australia appears to be one of the nations with the highest administration of Novavax as of now, which again suggests further concerns about the spike protein.
Today several FDA employees raised concerns about the risk of myocarditis from the heavily awaited Novavax vaccine.
For many vaccine skeptics the Novavax vaccine was considered to be a hopeful alternative. I’ve written about Novavax before so please refer to that article:
Essentially the Novavax vaccine is based on older vaccine technology, such that the spike from the virus is embedded into a saponin structure called an ISCOM and provided intramuscularly.
Aside from the shoddy clinical trials conducted, I remarked that Novavax would serve as the pivotal vaccine for elucidating all of these adverse events because the common feature across all vaccine platforms would indeed be the spike protein. If Novavax itself produces myocarditis, then we can fully guarantee that the spike itself is the main agent of concern.
Now, the FDA has not fully elaborated on the rates of myocarditis, but they have mentioned in a briefing that there are concerns with Novavax’s vaccine moving foward.
Here’s an excerpt from Reuters:
(Reuters) -U.S. Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc's vaccine, even as the company's data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19. […]
"These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines," the FDA staff wrote in briefing documents released on Friday.
This comes ahead of an evaluation scheduled between the FDA and Novavax for approval of the COVID vaccine, and apparently the release of this information has begun to tank Novavax’s stocks. For now the FDA wants a warning issued on Novavax’s vaccine, which they [Novavax] appears to be fighting against as of this moment since they believe there’s no noticeable signal in the data.
Even though there is not enough evidence so far, this warning at least suggests a causal commonality across all vaccines- the spike protein.
As Joomi Kim remarked in one of her pieces, the concerns over the virus’ spike protein being cytotoxic were not raised until the time that the vaccines were released. Only then did we start to see evidence within the literature that the virus’ spike was indeed cytotoxic, and thus concerns were carried over to the spike produced by the vaccines itself. Unfortunately, that time was a little too late, and billions of people were vaccinated with a highly experimental agent.
And this is the reason why I have been using the phrase: the cure is the disease.
Actually, it should be prophylactic, but that doesn’t quite roll off the tongue as well.
But this does raise questions as to why myocarditis rates were so high among mRNA vaccine recipients, or why the Adenovirus vector recipients experienced higher rates of thrombosis.
My perspective is that the spike is the main concern while all other aspects of the vaccine serve as accoutrements to the adverse events.
Here’s a few of my hypotheses:
Frontloading effect: If the spike protein is the toxic agent in question, then we should consider that higher rates of spike would lead to higher rates of damage. It explains why myocarditis varies so extensively in those who are naturally infected. It also explains why children are rarely affected- their robust innate immune system can readily deal with the virus before it invades deeper into the body. This also explains why myocarditis rates are higher among Moderna recipients vs Pfizer or Adenoviral Vector recipients. So even though all avenues of vaccines and infection introduce spike, they don’t necessarily all introduce the same level. Natural infection takes time via viral replication in order to produce more spike. These vaccines, however, introduce a large level of either genetic material and spike all at once. This frontloading effect likely explains the adverse reactions seen, especially in children who may otherwise never experience such high levels of spike through natural infection.
Accentuating the spike’s toxicity: The mRNA vaccines appear to have the highest rates of myocarditis, and this could be due to the travelling of the LNPs as well as the spike protein that is produced. We know full well that the vaccine travels, and the LNPs themselves may contribute to inflammation. The pairing together may mean that the LNPs may travel to various areas and cause damage that would otherwise not be seen except for those who suffered from severe COVID infections. The Adenoviral Vector vaccines have higher rates of thrombosis- which is also caused by the virus itself. Although the evidence isn’t quite clear there are some suggestions that the viral vector themselves could cause their own increased rates of thrombosis. I wrote about that before with the link below. So the spike protein itself is the main toxic agent while all other components likely aid in exacerbating further damage. It’s the sum of all toxic agents that likely contributes to the adverse reactions we are seeing.
What’s most striking is that, as far as I am aware, no studies have been conducted to examine whether the spike produced by the vaccines are cytotoxic. Most evidence is correlative with a big assumption that the minor modifications to the spike aren’t enough to fully change the bioactivity of the spike. Yet even if that were the case why is it that so many people have remained steadfast in the safety of these vaccines? I’ve even tried to see if I could find any evidence, but all I have come across are websites from 2021 “fact checking” these claims about the spike’s protein.
We need more studies, but more specifically studies in which we can see the effects of the spike protein in vitro to fully determine if the vaccine’s spike is still an active agent. We also need more medical professionals, and those within the FDA and CDC to admit that the spike itself, whether from the vaccines or from the virus itself are harmful. We need more transparency and for people to not pretend as if we really don’t know what is causing the adverse reactions we are seeing.
Joomi Kim made the term consilience quite popular, and we can clearly see that the risk of myocarditis across all vaccine platforms is a clear example of consilience- the evidence has converged, and the primary culprit is the spike protein.
(3) The Epoch Times is reporting the FDA's concern: https://www.theepochtimes.com/fda-flags-heart-inflammation-risk-over-covid-19-vaccine_4510371.html .
AN FDA briefing document with the Novavax myocarditis/pericarditis case details (page 45 onwards - 7 cases): https://www.fda.gov/media/158912/download .
Page 71 of Novavax's briefing notes: https://www.fda.gov/media/158914/download mentions: ". . . data received up to April 30, 2022. More than 740,000 doses of vaccine have been administered in Indonesia, Australia, EU, New Zealand and South Korea. The report included 35 spontaneous reports of suspected myocarditis or pericarditis, none of which met a definitive case definition. Ten reports met a probable case definition of pericarditis and 1 report met a probable case definition of myocarditis. All of the probable cases originated from Australia." . . . "Many of these reports are missing important information including diagnostic workup. Two cases appear to be duplicates reports which, if confirmed, will reduce the total number of probable pericarditis cases to 8." and "It is worth noting that there are currently a number of anomalies in the preliminary reporting of these cases. Most notably, all of the probable and possible cases that have been reported from Australia, a country that represents ~17% of the doses administered to date.".
Yes indeed your hypotheses are quite plausible. I don't know why on earth EVERYBODY (with power, that is) has forgotten we have an innate immune response! None of us were born immune to anything and considering that the overwhelming majority of people do not suffer from SCIDS we have managed to create an immune response to countless pathogens (or perhaps pollen or bee venom much to our chagrin). Sadly the vaccine does potentially seem to illicit more harm than good by by-passing our innate immune system. I think the majority of people would be able to fight off the disease before it got out of control as opposed to the vaccine where it seems like it could get out of control (in regards that there is uncontrolled cytotoxic spike protein production). And now seeing how many vaccinated people are contracting the disease it makes you wonder WHY was this even attempted in the first place.