'Life-saving' vaccine or just another medication?
The word vacccine has become a meaningless term used to bypass any appearance of rigorous testing to expedite new drugs into an arm near you
While headlines in 2021 and 2022 proclaimed the novel technology described as mRNA vaccines a miracle saviour technology, few might have predicted the rapidity with which new uses for this technology might arise. Indeed, even fewer might have correctly guessed how quickly these new uses might progress to use in humans.
Fewer still in the offices of regulators, health departments, pharmaceutical companies, academia or even the maintream media are stopping to consider whether the breakneck pace with which they are being rushed to human trials is prudent.
Or wise…
Background
That mRNA strands coding for particular proteins when combined with tiny droplets of fat were seen to first enter, and later cause cells to reproduce the encoded protein was the finding of an ex-vivo laboratory experiment conducted by Robert Malone in 1987. And while testube fondlers had been playing with liposomes and mRNA for a decade or more at this point, what was novel was that prior to Malone’s work, they had not been synthesising or manufacturing specific genetic material that would enable use as a medicinal product.
Several pharmaceutical companies had been incorporated since the year 2000 to investigate lipid-enveloped mRNA for medicinal delivery, however the BioNTech, Moderna and later CureVac Covid-19 vaccines were the first to market. While most medications take 12-15 years to go from idea to market with the majority of that time spent refining the preparation and safety and efficacy testing the resulting medication, the Pfizer BioNTech product went from conception in March 2020 through human trials and on to emergency use authorisation in only 8 months.
Whether you consider the significant rise in adverse events described in vaccine adverse event reporting system (VAERS) data, that while downplaying incidence rates various governments (e.g.: here, here and here) have acknowledged a causal link between these vaccines and cardiac conditions like myocarditis, that numerous postmortems and coronial inquests have describe the Covid-19 vaccines as the primary cause of death (e.g.: here, here, here and here), or the simple fact that they don’t appear to have prevented infection, transmission or even severe infection by the virus - rushing the mRNA Covid-19 vaccines to market should no longer look as prudent as it once did to anyone but the most fervent of pro-vaccine stalwarts.
Or those profiting from them…
They’re doing it again?!?
Yesterday, the preeminent journal Nature published this article on a new mRNA medication that the authors are disingenuously terming a neoantigen vaccine.
In the article the authors describe conduct of a Phase-1 clinical trial that enrolled 19 fairly homogeneous individuals (all white, all over 55). Of these, 16 received the novel mRNA treatment in conjunction with a chemotherapeutic monoclonal antibody drug (Atezolizumab) for pancreatic cancer, leaving 3 as controls who only received the chemotheraputic drug…
Except that they didnt.
Safety
The authors describe their primary endpoint as safety. They assessed ‘safety’ by comparing the specifically elicited side effects of Atezolizumab against those of the mRNA. The results from the article are shown in the bar chart below.
The study methodology describes that participants received a single large dose of the chemotherapeutic drug on week 6 of the trial, and the first of nine doses of the mRNA ‘vaccine’ (with the first seven administered weekly) beginning on on week 9. While the results clearly show that mRNA recipients experienced a higher number of more frequent side effects, there appears to be undeniable potential for confounding with this study approach - especially if the individual still had any lingering side effects from the chemotherapeutic drug when mRNA injections commenced. Further, the authors describe that each mRNA pancreatic cancer ‘vaccine’ recipient also received at least one dose of the Covid-19 mRNA ‘vaccine’, making it difficult to identify the absolute cause of each side effect - and especially that of the the recipient (1/19 which equates to 5.3% or 53/1000) hospitalised for a grade 2 (more severe) thromboembolism (blood clot). Blood clots are one of the accepted potential severe adverse events (SAEs) of the Covid-19 mRNA ‘vaccines’ as well.
It should have been acknowledged by the authors that 100% of mRNA recipients suffered an adverse event, with 12% suffering a grade 2 or SAE.
Finally, for a safety trial it is damning that the authors casually brush over the fact that the three participants who were only reported in the chemotherapy arm and not evaluated in the mRNA ‘vaccine’ arm were removed from the ‘vaccine’ arm because they did not receive all 9 doses of the ‘vaccine’. In one case because of disease progression, in another case because of death, and in the third case due to mRNA ‘vaccine’ toxicity. That means 15% (or 150/1000) of those who started the the mRNA ‘vaccine’ safety trial had to discontinue because the ‘vaccine’ was unsafe for them.
That result is significant and should have been more thoroughly discussed and emphasised in the conclusion.
Efficacy
While the authors lauded their novel mRNA technology as having produced a ‘substantial’ response in patients whose pancreatic tumours had been surgically resected, it is notable that only half of the recipients produced any evaluable response at all.
That half of all recipients failed to respond to the ‘vaccine’ treatment at all is also a significant result that the authors do not thoroughly explore or mention in their conclusion.
Confounders
Several confounders cloud assessment of this novel mRNA-based ‘vaccine’. The first was that all mRNA recipients also received the chemotherapeutic monoclonal antibody drug. The second is that the mRNA T-cell ‘vaccine’ response was observed in those patients whose pancreatic tumours had been surgically removed. In this way it becomes difficult to credibly argue that any positive result arose from the mRNA ‘vaccine’ or these traditional treatment modalities.
(Ab)use of the term ‘Vaccine’
Misuse of the term ‘vaccine’ to describe both the Covid-19 and these pancreatic cancer mRNA injections is disingenuous and egregious. While most people casually ignore the fact that the Covid-19 injections continue to fail to produce any lasting immunity to Sars-CoV-2, even after multiple booster injections, it becomes more obvious that these are therapies and not vaccines when you see in this trial that the base regimen was 7 weekly injections and 2 monthly follow-up injections - for a total of 9 mRNA injections. Given the medical condition, cancer, and leaving aside that they failed to produce any response in half of the recipients, the excessive number of necessary subsequent injections and discussion of potentially administering boosters is more consistent with a definition as chemotherapy rather than ‘vaccine’. As with the Covid-19 injections, the only reason for attaching the term ‘vaccine’ to them is to reduce the time and requirements for safety testing and get authorisation to bring them to human trials more rapidly.
mRNA therapies are simply not consistent with more than a century of use of the term ‘vaccine’.
If the last two and a half years watching the abject failure that was the Covid-19 ‘vaccines’ has taught us nothing else, rushing a new medicine to market is imprudent, dangerous and downright negligent. The Nature paper discussed in this substack is yet another example for why the mRNA technology needs considerably more development and testing before it is brought to market. It has demonstrably been rushed to human trials, clearly suffers from many of the same issues as the Covid-19 injections, and should be returned to the drawing board. It, like the Covid-19 mRNA injections, should also not be called a ‘vaccine’.
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Fools rush in (where angels fear to tread).
Alexander Pope.
If I'm not mistaken, this was the original intended use for mRNA which had abysmal results. Its part of the reason I knew to expect everything happening to people now.
I was told on several occasions that the reason successful covid mRNA vaccines had been produced safely so quickly was thanks partly due to the work carried out 10 to 20 years ago in the pursuit of a vaccine first for the original SARS & then for MERS.
This is false. In fact, those working on SARS & MERS vaccines came up against major hurdles, including ADE, Antibody Dependent Enhancement, which often brought serious or fatal results in the animal test subjects. These serious problems brought those doing the work to warn that moving coronavirus vaccine research onto human subjects must be done only with the utmost caution. Rushing a decades worth of R&D into less than six months strikes me as the polar opposite of "cautious".
Of course, many of us now know that in fact the new vaccines aren't successful & aren't safe. Perhaps those who argued that the prior research helped warp speed the novel vaccines haven't got that memo either.