We’ve had 137 comments so far that have aided our journey exploring the Cominarty regulatory documents. 

What follows is a record of those that add to our understanding and provide further context. This is a long read, and there’s a lot to take on board. If we've missed anything, let us know. Given the eagle eye of TTE readers, we can predict there will be more comments to come.

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Part 1. Exploring regulatory data sets of the Comirnaty vaccine (9 comments)

Eugenio Florean told us he’s not an “expert in the sector, but which regulator can read and study 8000 pages in a short time before giving the green light?” 

Tom replied, “My Dear Eugenio, 8.5K was just one CSR. The tamiflu data set we went through was about 145K pages and this one is about half a million. Have patience.” Anyone who works with Tom knows patience is the only game in town. 

Cheryl Grainger, a valuable member of the collective effort, pointed out that the Pfizer and Moderna COVID-19 "vaccines" are being analyzed by 3,250 researchers and 250 lawyers under the Daily Clout organization (the links are here). It's one of the multiple sources we check against as we wade through the regulatory documents together.

Part 2. The evidence for provisional registration – structuring our review (6 comments)

John Davison thanks us for our  efforts and reminds us, “There’s nothing like a name change to erase bad memories, is there—Windscale becomes Sellafield…” Sadly for them, Cominarty doesn't quite roll off the tongue. It will forever be the Pfizer jab. Here at TTE, we wonder what Oxford AstraZeneca will come to be known as…..

Part 3. The evidence for provisional registration – the registration trials (9 comments)

Boyd Brogan notes, “'Those who were giving the vaccine or the placebo could see the difference in the content of ampoule or syringe and *so could the recipients*', and *Those dispensing and administering* the vaccine could visually distinguish it from placebo'. 

Tom dipped his foot into the comments to explain  we are proceeding with caution: “One thing we will never do is jump to conclusions; there is enough of that.” Fact: the active principle (Comirnaty) contents were visually distinguishable from placebo in the clinical study reports we have looked at so far.

But do we know what this means? Not yet, and we may never do, as our experience with HPV vaccines has taught us. Yet another post at TTE is needed. 

Part 4. The evidence for provisional registration – getting lost in harms underreporting (17 comments)

John Watkinson thinks, “We ought to run a competition for examples of disinformation. " The MHRA's laughable response to a forthright FOI question will take some beating.

Andrew Bamji told us underreporting of the Yellow Card system was common knowledge in clinical practice. Not least because it would take hours to fill in all the adverse event reports 

John Watkinson says, "Call me old fashioned, Streamlining of the Yellow card system for Covid vacc sequelae should have been an obvious move - and also to open Pharma financed helplines to record reports from the general public.” If improving the system is old-fashioned, then here at TTE, we’re all for it. 

Helen McCardle pointed out that "The computer versions take longer than the old-fashioned system “when they were actually yellow cards in the back of the BNF. The computer versions take longer.” Oh, if only we were old-fashioned. But wait, a small fee for GPs might do it, says Helen - GPs are exceptionally good when responding to additional payments. Eagle-eyed RonL waded in: “ That was tried... it worked... but it was stopped... and reporting dropped. (see here)

David Jory gets straight to the point: “From previous research papers and personal experience I would say there is huge under reporting. At one point in the autumn of 2021 I had reported 2 of the 100 cases of VITT. How likely is it that a community ophthalmologist had truly been such a large part of the figures!?”

Part 5. The registration trials: what’s in the vaccine? (11 comments)

“Slowly, slowly, methodically, systematically, no jumping of the gun,” says Tom.

Dan Shaw asked: “As soon as Pfizer admitted finding it in the liver and spleen, why did the EMA not require a bio-distribution study, as the Japanese regulator did? Why were we allowed to be told the vaccine remained at the injection site when the EMA, at least, knew this was untrue?

Dan Newell says they did a "distribution study." In medical terminology, it just turned out to be "Half-Assed."

Myra has read the book on nanotechnology. Her conclusions were that nanoparticles are inherently more unstable, difficult to mass produce consistently, and more difficult to visualize. Most research is done in vitro, not in vivo, and any research is more difficult as specialist equipment is needed to visualise these extremely small particles.  

By the end of the TTE series, it will be more than just the book; it will also be the Nanoparticle T-shirt to wear.

Alan Richards has seen many references to the ALC-0315 safety data sheet, which warns, “This product is for research use—not for human or veterinary diagnostic or therapeutic use.”

James Jones notified us of the “manufacturing process 1 (MP1) and manufacturing process 2 (MP2); the vials you detail here (many thanks) were boutique products made from MP1. Mass inoculations, we have MP2 and hence the big steaming, bubbling vats of E coli making the mRNA, is that not so? Whereas the mRNA for MP1 was PCR machines; (that we understand cannot make anywhere near enough for the "whole of world" ambitions;)”

Part 6. Review of package inserts at the EMA, MHRA, Health Canada and the FDA. (7 comments)

Ron L asked which of the six recipients of the content of each vial got the insert. Eugenio Florean described that once upon a time, there was a nurse who told me, "You shouldn't read the drug package inserts because they don't count for anything." Eugenio doesn't “understand why trees continue to be cut down to produce these useless sheets…”

Part 6a. What do Cominarty package Inserts say about administration during pregnancy? (5 comments) 

Vivian Evans gets straight to the point of 6a: At the start, the message seems to be: "We don't know nuthin' but say it's safe. Trust us, we're the experts from the NHS/UKHSA/Government!"

Afterwards, the message seems to be: "We've looked a little bit and found nothing bad - so trust us, we're the experts from the NHS etc. and anyway, you don't want to die of covid, do you!"

Part 7. Where is the randomised trial on pregnant women? (27 comments)

Trish C told us that she couldn’t get a straight answer from New Zealand’s regulator, Medsafe, about the evidence for the assurance in pregnancy. Trish was “informed that Medsafe did not examine the studies themselves anyway, but rather relied on the "sponsor" (i.e. Pfizer) to provide them with the information. I'm a bit flabbergasted to be honest.”

Tom replied, “We have a long history of Medsafe correspondence, and yes, they are the world champions at body swerves, but so are WHO, CDC, and countless other bodies, regulatory or not. 

Caroline Gane thinks, “it is just staggering! Telling people it is safe in pregnancy without any trial results.”

Seacat considers, “The discrepancy is really too understandable because of what is at stake for pharma and the regulatory agencies, not to mention the governments in many countries reassuring women these ( literally) degrading therapeutics would have no impact on pregnancy.”

J Dixon says,  “Pfizer did indeed attempt to undertake at least one such study, and better still, they outsourced the work to Charles River Labs (CRL), a publicly-listed multi-national animal breeding and Contract Research Organisation (CRO), with over 20K employees - i.e. a massive business with many clients. By contrast, Ventavia, the CRO which managed some of the Pfizer human “clinical” “trials”, has less than 50 employees (i.e. it can act as a disposable cut-out and is essentially beholden to providing the “right” results to maintain its client’s business, and of those 50 employees, one became a whistle-blower). So what did the (relatively) independent CRL find in the Pfizer “vaccine” Repro studies? A FOIA to the TGA (Australia) ferreted out a Pfizer document that contained a reproductive safety study and its results.

J Dixon gives TTE more work as the report also contains various other eyebrow-raisers. But the bottom line is, “Had the resultant data been squeaky clean, one would imagine both Pfizer and the coercive Governments would have shared it. But it wasn’t… so they didn’t.”

Finally, we'll be back ot pregnancy as there is a lot to digest, but J Dixon also pointed out the noticeable rise in abortions in 2021 that warrants a further post (we’ve bookmarked the ONS data here and the Periodic Safety Update Report #3).

“No rush, lads,” says JD. “Slowly, slowly,” says Tom. “More work,” says Carl. 

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Part 8. The registration trials: what’s in the placebo? (9 comments)

Vivian Evans says” Saline as placebo ... interesting ... However, shouldn't the placebo be exactly the same as the vaccine being tested, only minus the active ingredient, here the mRNA? Have I misapplied scientific procedure when testing something or doesn't this apply when BigPharm tests drugs?”

Tom thanks, Vivian and replies. “Yes, you are right in theory, but the following story will be of interest. HPV vaccine trials were all placebo-controlled. The vaccines were made up of active principle+proprietary adjuvant. So, the design was vaccine vs adjuvant. WOW, perfect, hey?”

“Except that no one knew what the adjuvant on its own did, both containing all sorts of compounds. Why not test the adjuvant to understand whether its use was masking harm in a placebo (saline) controlled trial? Because the FDA considers adjuvants inactive until married with the antigens to make up the active principle.”

John Davison says, “No doubt the MHRA are all ears.” If only they were. 

Part 9. Pharmacokinetic ALC-0315 and ALC-0159 studies from module 4 of the Comirnaty submission to FDA (3 comments)

Helenmcardle asked, “Is there a technical reason why follow-ups were so short?  If ALC-0315 lingers for weeks in the liver, does this have any potential clinical implications?

Cassiopea64 pointed out that Pfizer document 125742_S1_M4_4223_185350.pdf, on page 29, has a purchase invoice that clearly states, "WARNING: This product contains a chemical known to the State of California to cause cancer." 

Tom felt compelled to write, “Cassiopea 64 rules ok - The sharp-eyed reader picked up something we missed (11 comments) 

As Tom points out: “it’s not clear what is carcinogenic: the lipid, the radioactive label, the concentration, the dose or whether it is only carcinogenic in California. But sleep reassured, Acuitas and Pfizer will have done some carcinogenesis studies to get it through regulation. Wanna bet?”

The Proposition 65 List of the California Office of Environmental Health Hazard Assessment lists “a wide range of naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm.” So, what types of chemicals are on the list? See here.

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Part 9a. Pharmacokinetic ALC-0315 and ALC-0159 studies from the Japanese regulator PMDA (2 comments)

James Jones highlighted Neale Hanvey MP, who used the verb "metastasise" to describe the actions of the contents of the mRNA jab when injected into a deltoid muscle (or inadvertently given IV at that site) (link here) 

Helenmcardle considers the Japanese regulators to have been thorough. Not something we hear often about the UK’s MHRA. Helen also points out from the table “There were no cases of hepatitis but there were 14 gallstone/gallbladder events in the Comirnaty compared to 5 in the placebo arm which is intriguing.”

Part 9b. What’s in a name? (26 comments)

Myra says, “I have to admit, this is above my level of expertise.” Can you explain in layman's terms what they are trying to look at? For many of us, it’s back to school, as assimilating all of this differing evidence is part of the slowly slowly approach.

James Jones taught us that the bases of RNA are CGA and U, whereas for DNA, they are CGA and T.

U is uridine. The story I seemed to absorb was that the RNA breaks down very quickly (au naturel), so they changed the U to PU (pseudouridine). I had understood it was a simple methyl group that was added; it seems I was wrong. The official story is that "uracil is attached via a carbon-carbon instead of a nitrogen-carbon glycosidic bond."

Why do it? An explanation is offered here.

Myra also posted a useful Nature link to Modified uridines are the key to a successful message.

Markker also referenced  Dr Mike Williams, “who wrote about the dangers and repercussions we are seeing, way back in September 2021.” 

Helen Mcardle pointed to a Science Article on mRNA vaccines may make unintended proteins, but there’s no evidence of harm. 

Helen finds “it remarkable that people are able to put a positive spin on such a surprise finding and downplay any concerns about the implications. Where is the caution?” Here at TTE, we find it implausible and misleading to state a pharmacological agent has no evidence harms 

As we said -  it's back to school. 

Keith Dudleston handily summarised what we know so far: “So I think you are saying that the development of the product that induces the body to produce antibodies against the spike protein first involves sniping the spike protein component of the SARS-CoV-2's RNA and then modifying this RNA ( by replacing the uridine with synthetic pseudouridine) to make modified RNA. You then reverse transcribe modified RNA to DNA - is this modified DNA?. (You do this by inserting the modified RNA into the plasmids of bacteria). Once you harvest the DNA you then again make modified RNA from it and insert this into lipid nanoparticles which is the core component of the vaccination.”

Have I understood this correctly or is the "modification" of the RNA at a different stage, Keith asked.

Finally, Tom tried to provide an explanation for the confusion over the mRNA name : “The other is that CSR writers found it cumbersome to write modified RNA and went for mRNA. But I am bothered by the lack of clarity on such a potentially important point. By the way, please don’t bother asking MHRA about the metabolism of this stuff, gene toxicity, and so on; they have no idea.”

Vivan didn't lose sight of the irony that the MHRA had no idea. “Now, isn't that just charming?”

Part 9c. The role of two lipid nanoparticles (LNP) carrying the modified messenger RNA (8 comments)

Keith Dudleston sets out one of the issues with the attacks on the dissenters: “So Dr Jayanta Bhattacharya correctly showed the original IFR was much lower than claimed, you correctly showed masks are unlikely to stop transmission, Martin Kulldorff correctly questioned vaccine safety, Dr Bridle correctly exposed the disinformation about the pharmacokinetic properties of lipid nanoparticles, and Dr Kulvinder Kaur Gill correctly warned against lockdowns. What else do these doctors all have in common? They were all attacked and undermined online, and most had their employment either threatened or terminated. Unfortunate to say the least.”

Helenmcardle replies, “They also come across as decent principled people who consistently demonstrate integrity and don't tend to resort to ad hominem arguments, even under circumstances of extreme provocation.”

Decent it is then, Helen. Who also gave some further readings to digest - There’s no time for idle minds at TTE.

• Duration of SARS-CoV-2 mRNA vaccine persistence and factors associated with cardiac involvement in recently vaccinated patients

• A Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after BNT162b2 mRNA Vaccination against COVID-19

• Intramyocardial Inflammation after COVID-19 Vaccination: An Endomyocardial Biopsy-Proven Case Series

• A Large Cluster of New Onset Autoimmune Myositis in the Yorkshire Region Following SARS-CoV-2 Vaccination

The Yorkshire researchers published an update on this: 

'MDA5-autoimmunity and interstitial pneumonitis contemporaneous with the COVID-19 pandemic (MIP-C)' 

It is really well written objective research, says Helen. Perhaps we will find the answer to the Comarty Riddle in Yorkshire -

Finally, Helenmcardle library, which is extensive, to say the least, includes a book about the bloke who called you two sulky men. It is written by a statistician named R N Watteel. The subtitle of the book is 'the rise of Canadian hate science'. I look forward to reading it. 

Here at TTE, I have recommended it as a present for Tom - Fisman's Fraud: The Rise of Canadian Hate Science. Fisman so eloquently referred to us as “Dr Mengele”. 

This summary shows how valuable the comments are and highlights areas we need to review—keep them coming, as all bets are off.