In Part 1, I discussed the shady past of Moderna, its controversial CEO, and the stubbornly persistent problems inherent in its mRNA technology. In this second installment, we'll take a look at the actual clinical trial data that supposedly shows this vaccine is Safe and Effective!™
Like the Pfizer-BioNTech and Oxford-AstraZeneca vaccines, the results used to make this dubious claim for the Moderna drug were taken from a woefully incomplete study.
So let's unpack (tear apart) that study, starting with a brief background history.
As my previous article recounted, Moderna became the first company to win US federal approval and backing (read: taxpayer money) to develop a COVID-19 vaccine. The company, formed in 2010, did not achieve this feat because of a successful track record of vaccine development - the truth is Moderna has no track record of successful drug development whatsoever. The mRNA technology underpinning all its drugs has long proved problematic and, until 2020, the company had failed to bring a single drug to market. In fact, until last year, few of its numerous candidate drugs had even passed initial, preliminary phase 1 testing.
While the company had little in the way of results to show for itself, it did have an exuberant, quick-talking CEO in Stefan Bancel who knew how to pimp his young company like no other. Having already intimately aligned his company with Anthony Fauci's National Institute of Allergy and Infectious Diseases (several NIAID researchers have a financial interest in the Moderna vaccine), his next master-stroke moment came on 2 March 2020, when the White House held a roundtable convened by President Trump aimed at speeding the development of a COVID vaccine.
With a November election looming, a rabid media intent on magnifying his every flaw (real or imagined), and a growing campaign to falsely paint vaccines as the only medical answer to COVID, Trump was no doubt eager to establish the US as leader in the "race for a vaccine." The knowledge that his arch-enemies in the Chinese Communist Party were commandeering a similar effort likely instilled him with even more urgency.
At the White House roundtable, executives from several drug companies developing a COVID vaccine vied for Trump's attention. The whole thing seemed more like an episode of Shark Tank than a scientific discussion. It quickly became apparent Trump's overriding obsession at the meeting was not efficacy, or safety, or mechanism of action, but how quickly a vaccine could be brought to market.
Bancel told Trump just what he wanted to hear. He first made a point of mentioning his company was already working with the US Government and Fauci's NIAID. Giving a friendly acknowledgement to Fauci, who was also present, he then went onto to tell Trump he could have a drug ready for Phase Two testing in just "a few months."
The very next day, the FDA green-lit Moderna's drug for trial, making it the first COVID vaccine candidate to advance to the first phase of federally-funded clinical study.
Stefan Bancel has a net worth of $6 billion, despite heading a company that has consistently failed to bring its problematic mRNA drugs to market.
The Phase Two Testing that Never Was
What subsequently unfolded was yet another testament to the sloppy, rushed farce that has typified COVID vaccine development and approval.
The next time you see or read some egregious liar claiming the Moderna vaccine has been throughly tested - it hasn't. Bancel promised Trump he would have a drug ready for Phase 2 research within months, but that Phase 2 research never happened. The Moderna drug went straight from Phase 1 testing to Phase 3 testing, a regrettable turn of events made possible by the tsunami of COVID hysteria and resultant Formula One approach to vaccine development.
After Bancel gave Trump the sweet nothings he wanted to hear, Moderna and NIAID quickly got things rolling with a phase 1, non-blinded trial involving 45 healthy adults 18 to 55 years of age. Phase 1 studies are typically concerned with establishing a safe dose; volunteers are given various dosages of a new drug while researchers effectively stand back and see who gets sick at what dosage.
(Free health tip: Don't volunteer for Phase 1 drug studies unless you enjoy playing Russian Roulette with your health).
In the Moderna-NIAID Phase 1 trial, the subjects were given a dose of either 25 μg, 100 μg, or 250 μg of the Moderna vaccine, code-named mRNA-1273. Each participant received two shots of their designated dose, 28 days apart. There were 15 participants in each dose group.
When the results of this study appeared on the New England Journal of Medicine site on 14 July 2020, they revealed 100% of the 45 healthy and young (average age 33 years) participants experienced local and systemic side effects. Three participants in the 250-μg dose group, wrote the researchers, "reported one or more severe adverse events."
Thanks to media reports, we know one of these was a 29 year old guy called Ian Haydon. Twelve hours after getting his second injection, Haydon said he suddenly had severe chills. He tried to sleep but woke in the middle of the night with a fever over 103 degrees. He was nauseous, fatigued and had "quite a headache.” His partner called the 24-hour hotline for the vaccine study and Haydon was advised to go to urgent care, where he received intravenous fluids and Tylenol.
After leaving urgent care, Haydon went home to rest. His fever rose back to 101 degrees and he vomited. “On my way back to bed I fainted," he said. "My girlfriend caught me as I went down and kept me from hitting my head. She woke me up. I remember being confused at the sight of my living room ceiling.”
Needless to say, that's a disturbing turn of events. Granted, Haydon and the other two subjects who experienced similar outcomes were taking the 250-μg dose (the subsequent Phase 3 trial would use the 100-μg dose). But his experience is a pertinent reminder that mRNA-1273 is not the wonderfully benign lolly water health authorities would have you believe. It is a powerful drug capable of powerful side effects.
Moderna and NIAID then decided to expand the Phase 1 research to include 40 folks over 55 (average age 68.7 years). Wanting to avoid a repeat of the earlier drama, they nixed the 250-μg dose. But even at the 100-μg dose, the majority of participants still experienced local and systemic side effects.
The researchers must have performed some really clever filtering during recruitment, because the rate of side effects, while still high, was lower among these older participants than among the younger subjects in the earlier Phase 1 research - which goes against everything we know about elderly drug recipients and their higher propensity for side effects.
Who Needs Phase 2 Research, Anyway
Using reasoning that could only make sense to a government bureaucrat or drug company-sponsored researcher, it was decided no Phase 2 trials were necessary for a drug that had just been shown to cause local and systemic side effects in the vast majority of healthy subjects who took it.
Which brings us to the first Phase 3 trial of mRNA-1273, the interim results of which were first published at the New England Journal of Medicine website on 30 December 2020.
This hallmark trial was allegedly double-blind and compared 2 doses of mRNA-1273, at 100 μg each, with two doses of a saline placebo injection. Again, the injections were given 28 days apart.
When considering the veracity of the research results, one should keep in mind mRNA-1273 co-developer and sponsor Moderna was not only responsible for the overall trial design (with input from, among others, NIAID), research site selection and monitoring, but also the data analysis.
By the way, for anyone with the temerity to retort "yeah, but this is common in drug trials," modesty forbids me from reprinting the first response that pops into my mind. Instead, I'll simply point to the research showing industry-sponsored trials are more likely to - surprise, surprise - return favourable results for the sponsor's wares. Allowing conflicts of interest to proliferate in clinical research does not make them benign and acceptable.
It should also be noted mRNA-1273 was co-developed by Moderna and researchers at Fauci's NIAID Vaccine Research Center. That Moderna has a vested interest in mRNA-1273 is obvious, but so too do the taxpayer-funded NIAID researchers, several of whom "are inventors on US Patent Application No. 62/972,886 227 entitled '2019-nCoV Vaccine.'" Federal law allows these vested researchers to receive compensation outside their normal salary from the project of up to $150,000 a year each. While $150,000 barely covers a month's food, rent and utilities in Australia (okay, I'm exaggerating, but only slightly), it sure goes a long way in the US. Heck, $150,000 in the US can not only buy you a brand new Porsche, but another for your partner.
And there's yet another red flag: The main paper acknowledges the trial is ongoing, and says the investigators in this supposedly double-blind trial remain unaware of participant-level data. However, "Designated team members within Moderna have unblinded access to the data, to facilitate interface with the regulatory agencies and the data and safety monitoring board." (Bold emphasis added)
So right there, we have an admission that at least some employees of the aggressively entrepreneurial Moderna have unblinded access to the participant data. If they wanted to diddle the data, that right there is acknowledgement of one possible mechanism.
Anyways, on to the trial.
Hi Ho, Hi Ho, Off to Phase 3 We Go
The Phase 3 participants received their first trial injection between 27 July and 23 October 2020. In order to rush the first COVID vaccines to market, government agencies okayed a median follow-up duration of only 2 months after completion of the two-dose regimen. And so, using a cut-off date of 21 November 2020, the researchers conducted the interim analysis that appeared in NEJM.
Now ... the trial was originally intended to extend for over 2 years. The study protocol clearly stated: "Participants are considered to have completed the study if they complete the final visit at Day 759 (Month 25), 24 months following the last injection..."
And so, no matter how our sleazy authorities try to paint it, the data used to allow the Moderna vaccine to market was based on a study that is nowhere near complete.
After the initial screening designed to weed out as many people with comorbidities as possible, 30,420 participants with a mean age of 51.4 years underwent randomization into the trial.
After excluding those who tested positive for SARS-CoV-2 at baseline, who missed their second shot or were given the wrong injection, this was further whittled down to 28,027 in the main 'efficacy' analysis: 14,134 participants in the Moderna 'vaccine' group and 14,073 in the placebo group.
Among this sample, the researchers allegedly detected 11 symptomatic cases of COVID-19 in the mRNA-1273 group, compared to 185 in the placebo group. Data for asymptomatic cases was not presented.
And so, from this difference, the researchers proudly declared an efficacy of 94.1% for the Moderna drug. Eleven, you see, constitutes only 5.9% of 185.
But there were 28,027 people in the trial eligible for the interim efficacy analysis. Which means, even in the untreated placebo group, the actual, absolute incidence of symptomatic COVID-19 was a mere 1.3%. To put it another way, 98.7% of participants who did not get the vaccine remained free of COVID-19 during the analysis period.
Remember, that's not hospitalizations or deaths (which we'll get to later) but simply the total number of symptomatic and overwhelmingly mild COVID cases. When you stack that number against the unbridled hysteria that has been generated for the novel coronavirus, it's not hard to see the monumental disparity between hyperbole and reality.
Given that even symptomatic COVID-19 is characterized by mild symptoms and full recovery in most people, these figures hardly constitute a compelling case for taking a risky new drug of unknown long-term safety.
The So-Called 'Severe' Cases
But what about severe COVID-19 cases? Maybe the ability of drugs like mRNA-1273 to prevent more severe cases of COVID could justify this whole vaccine charade?
That's certainly what the study authors would like you to believe. They claimed 30 severe cases of COVID-19 in the placebo group, and 0 in the mRNA-1273 group. This sounds like a stark difference, until you look more closely at just what those 'severe' cases were comprised of.
For that information, you have to download the supplementary appendix (which I'm guessing most commentators haven't. In fact, I'd bet good money most of the people assuring you drugs like mRNA-1273 are Safe and Effective!™ have never even read the main, peer-reviewed papers. This would be true of most doctors, and especially true of politicians. Politicians, it must be remembered, are largely a bunch of lying, sociopathic twats).
But I digress.
Table S13 in the supplementary appendix shows most of the 'severe' COVID cases were in fact absent of any meaningful sign of organ dysfunction. None of those 30 'severe' cases involved liver dysfunction, and only 2 were listed as displaying acute kidney dysfunction. None exhbited a heart rate above 125 beats per minute.
COVID, remember, is a respiratory disease that was marked by an initial mad rush to place patients on ventilators, followed by a much quieter retreat when data emerged evincing a frighteningly high fatality rate from their use. For a respiratory disease that has resulted in such alarmism, the incidence of Acute Respiratory Distress Syndrome (1 patient) and respiratory failure (1 patient) in the 'severe' group was also remarkably low.
Common flu symptoms like shortness of breath, vomiting, chills and body/muscle aches were more frequent in the 'severe' group, but there was a similar incidence of other common symptoms such as fatigue, headache, nasal congestion and runny nose, loss of taste and smell, and sore throat.
So what, exactly, did the researchers use as their criteria for 'severe' COVID?
The only standout difference between 'severe' and non-severe COVID cases was a significantly higher incidence of oxygen saturation readings at or below 93% in the former group. But this in itself is not an actual diagnosis of anything.
Oxygen saturation refers to the degree to which your hemoglobin is saturated with oxygen. Normal oxygen saturation is usually between 96% and 98%. Low oxygen saturation can result from a number of things, including iron deficiency anemia and high altitude in unacclimatized people.
There is no cast-in-stone level at which adverse clinical effects from hypoxia occur, but the current consensus is that an oxygen saturation level below 90-95% is considered abnormal or below normal and warrants further investigation.
Symptoms like headache and cognitive dysfunction become more common as oxygen saturation dips, but only 1 'severe' COVID patient in the trial displayed neurological dysfunction. And, remember, incidence of headache was similar among the non-severe and severe cases (it was, in fact, highest among the non-severe COVID patients in the mRNA-1273 group).
So the 'severe' group was classified as such based largely on non-life-threatening and somewhat subjective test markers. A far more compelling indicator would have been a significantly greater number of ICU admissions and deaths in the severe COVID group, but only 1 'severe' COVID patient was admitted to an ICU due to SARS-CoV-2.
So was the higher incidence of 'severe' COVID in the placebo group real, or an artefact of researcher bias?
I know where my suspicions sit.
The COVID Death: Now You See It, Now You Don't!
The main paper also states there was 1 death among the 'severe' COVID (and hence placebo) group, and refers readers to Table S16 of the supplementary appendix. Table S16 does list the 30 severe cases, but makes no mention of a death. This alleged death was the only COVID-related fatality reported in the study.
But there is something amiss here, because elsewhere in the main paper, and in Table S8 of the supplementary appendix, the overall death count for the placebo group is listed as 3, and none of those deaths were from COVID: One was from intra-abdominal perforation, one from cardiopulmonary arrest, and one from severe systemic inflammatory syndrome in a participant with chronic lymphocytic leukemia and diffuse bullous rash.
Again, no mention of any COVID-caused deaths. Did one of these patients die with COVID, and not because of it, and - in keeping with the sleazy methodology admitted to by Fauci and Birx at a 7 April 2020 White House press briefing - was this death mentioned as a 'COVID' death to tip the otherwise non-inspiring figures in favour of mRNA-1273?
Keep in mind, this study was published in the New England Journal of Medicine, widely hailed as one of the world's most prestigious medical publications - yet none of the journal's reviewers evidently picked up this anomaly during the peer review process.
For the mRNA-1273 group, the main paper and Table S8 list two deaths (one from cardiopulmonary arrest and one by suicide).
So the total death count among the 28,000 participants in this study as of the interim analysis was 3 in the placebo group and 2 in the mRNA-1273, which gives an earth-shattering difference of one (1) death - and even that utterly non-statistically significant difference may not have had anything to do with COVID-19.
And what about the overall rate of side effects?
Side Effects Were Higher in the mRNA-1273 Group
The main paper claimed: "The frequency of grade 3 adverse events in the placebo group (1.3%) was similar to that in the vaccine group (1.5%), as were the frequencies of medically attended adverse events (9.7% vs. 9.0%) and serious adverse events (0.6% in both groups).
This passage gives the impression that side effect rates were similar between the mRNA-1273 and placebo groups. But remember, the data analysis for this study was performed by Moderna, which obviously has a massively vested interest in the results.
There were analyses presented in the appendix for solicited adverse events, unsolicited adverse events, for adverse events within 7 days after first injection, for adverse events 28 days after any injection, and on it went.
Were the researchers being entirely straight with us, or simply picking out the adverse event figures from the numerous safety analyses that best suited their needs?
A look at the supplementary appendix data indicates the latter.
According to Table S5, there were almost twice as many solicited (i.e. reported after prompting by a researcher) adverse reactions in the mRNA-1273 group. After injections 1 and 2, there were a combined 26,853 adverse events in the vaccine group, compared to 13,516 in the placebo group.
After the second shot, the incidence of any solicited adverse reaction was 89% in the mRNA-1273 group, compared to 48% in the placebo group (see Table S7).
The corresponding figures for Grade 3 (serious) solicited adverse events was 5.6% versus 2.4%, respectively.
According to Table S8, the overall rate of unsolicited adverse events (i.e. voluntarily reported by subjects, without prompting) was similar between the two groups (23.9% versus 21.6% in the vaccine and placebo groups, respectively).
But the story again changes upon closer inspection, in this case when the role of the study medication is factored in. Table S8 reveals that, of unsolicited adverse events related to study vaccination, the rate was 8.2% versus 4.5% in the mRNA-1273 and placebo groups, respectively.
In the mRNA-1273 group, 140 (0.9%) of these events required medical attention, compared to 83 (0.5%) in the placebo group.
In the mRNA-1273 group, 71 (0.5%) of these events were classed as "severe", compared to 28 (0.2%) in the placebo group.
And table S15 ("Serious and Severe Treatment-related AEs Up to 28 days after Any Injection, Overall Safety Set") reveals 71 "Severe" adverse events in the mRNA-1273 group, compared to 21 in the control group.
There was unquestionably a higher rate of side effects with the Moderna drug when compared to vaccine. The researchers tried to minimize the importance of this, and emphasized selectively cited figures inferring a similar rate of serious adverse events.
As they say here in Australia, "that's just not cricket!" (Don't ask me why they say this, I think cricket sucks).
mRNA-1273 in the Real World
So let's leave behind the heavily sanitized, heavily edited, hopelessly biased world of pharma-sponsored clinical research, and see what kind of a track record mRNA-1273 is establishing out here in the real world.
I just checked the VAERS database, and there have been 2,654 adverse events reported for the Moderna vaccine as of 29 January 2021 in the US and its territories.
- 205 deaths;
- 62 events resulting in permanent disability;
- 451 hospitalizations;
- 617 emergency room visits.
The Pfizer-BioNtech mRNA vaccine, meanwhile, has logged 8,521 total adverse event reports and 246 deaths in the US and territories.
Authorities are bending over backwards to try and absolve the vaccines of any direct causal link to these events, but I think the figures speak for themselves. The US vaccine rollout began in December, so these drugs haven't even accumulated two months worth of data. And yet they are already establishing quite the track record for triggering adverse event and death reports. And keep in mind, only a small portion of events get reported to voluntary reporting systems like VAERS.
Meanwhile, there does not yet exist a shred of credible evidence that the Moderna or Pfizer-BioNTech vaccines (nor the AstraZeneca drug) can save even a single life.
That's not "conspiracy," folks, it's a documented fact borne out by the research sponsored and conducted by those very same companies.
So after having dissected the research behind the three main COVID vaccines, my considered opinion can be summarized thusly:
- This research is a shoddy farce, an insult to any intelligent person with even a modicum of scientific knowledge;
- Anyone in a position of authority or influence who claims with a straight face these vaccines have been Thoroughly Tested!™ and proven Safe and Effective!™ should be held liable for any subsequent health events suffered by those who acted upon their untruthful advice.
And that's the expletive-free version. You probably don't want to hear what I really think ...
Anyways, that completes my dissection of the so-called 'science' behind the three main COVID vaccines currently available here in the West. If anyone else has performed a more thorough breakdown of the RCT junk science being used to justify the rushed approval of these vaccines, then I take my hat off to them. Seriously, I'm all COVIDed and vaccined out. I'm now going to turn off the computadora, brew an espresso, add what I strongly suspect will be a stronger-than-usual dash of Molinari, then take the World's Most Handsome Dog™ for a walk to the park. As Ramone happily sniffs around and wees on trees, I'll wonder what he would think if I could somehow convey to him the utter madness that is playing out in the human world right now.
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