‘Fact check’ website Lead Stories (which Facebook and others rely on to guide censorship) has published an article by journalist Ed Payne claiming to ‘fact-check’ a recent Daily Sceptic article by retired Pharmaceutical Researcher Dr. John D. Flack. The ‘fact check’ is headlined: “Covid Vaccines are NOT Experimental Gene Technology – they ARE Fully Authorised.” Here Dr. Flack responds.
I think Mr. Payne and I are jousting around semantics – none of which addresses my fundamental concerns as to whether appropriate preclinical regulatory test protocols were conducted prior to MHRA/FDA/EMA approval of these novel gene-based ‘vaccines’. In his own admission, “they’re still under trial for about three years after being given the OK”. Under the emergency powers these gene-based ‘vaccines’ were authorised by the Government health regulatory bodies during the clinical trial phase of medicine development. Many products that have yielded promising results in early clinical trials with limited patient numbers have failed in the ‘field’ when larger patient numbers are involved. Therefore, to those practised in the art of pharmaceutical development, an experiment is still being conducted until the trials are fully completed and reported. To date, only interim analysis of the Phase 3 study results has been published, meaning the Phase 3 studies are ongoing (and are now unblinded so the quality of any final results is questionable). Will the product meet or fail to meet the agreed clinical end points? These are very large clinical trials of products however one wants to describe them.
I did make a mistake in saying: “Under the emergency laws surrounding the pandemic, these new injections were not approved but licensed as experimental medicines so there is no transparency as to the regulatory toxicology studies conducted.” Mea culpa. I should have said: “Under the emergency laws surrounding the pandemic, these new injections were approved as experimental medicines and not as licensed medicines.” (This has now been amended.) The MHRA in its statement says its authorisation was given “following a review of safety, quality and efficacy information from the clinical trials”. This begs the question – which is the main thesis of my article – of what preclinical studies were conducted to identify the toxicological profile of the both the gene sequence in the injection and the spike protein that it induces? I think we should know. Frankly, a ‘trust me’ statement that “there is sufficient evidence to demonstrate the safety, quality and effectiveness of the vaccine” is not good enough.
Mr. Payne says that I am “promoting the idea that mRNA-based vaccines… are a form of gene therapy, but this is inaccurate”. He is incorrect. Nowhere in my article do I use the term “gene therapy”. In fact, I was diligent in not doing so for the very reasons he quotes. I don’t need to be lectured by a journalist on what gene therapy is. How to define this new class of medicine is worthy of debate. Given that I was attempting to cover both mRNA and DNA based products, I chose to use the term gene-based ‘vaccines’. I think this is as accurate as one can get and stand by it. Gene technology is of course an umbrella term for a very wide range of research applications. This means the claim on the front of the Lead Stories article (depicted below) is false – indeed, the article itself does not dispute that the ‘vaccines’ are gene technology.
Finally, Mr. Payne plays the old trick of playing the man and not the ball: “Some vaccine-hesitant people like Flack…”. I am not vaccine hesitant, not by any stretch. I shouldn’t have to declare my health status, but needs must in these circumstances. In the last year alone I willingly had shots for shingles, pneumococcal, flu and Covid. As R&D Chief of a biotech company in Australia I was responsible for developing a rotavirus vaccine – which sadly failed in clinical trials through lack of sufficient efficacy (immunogenicity). I was proud to be a volunteer at my local vaccination centre in the early months of 2021 in helping to roll out these gene-based ‘vaccines’ to the vulnerable, and I have a certificate signed by Mr. Javid to prove it! As someone who has spent his whole career in discovering and developing new medicines, I am only interested in one thing – that the highest standards are met in ensuring the safety and efficacy of all medicines.
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Will science recover from this period?
Yes, because science is all about experimentation.
Sometimes, Science has to get it wrong in order to get it right.
The science behind the brakes on my car and my trust in its manufacturing keeps me safe?
Vaccines are twice as old as cars…
but are either really safe?
No, if you don’t trust the manufacturer…
Ford USA in the 50s?and petrol tanks. VW and dieselgate? I had one of the first Uk VW Ups which at its’ will became possessed and would try and steer itself into the kerb. Not a nice experience at speed on a long journey. Met with polite cynicism at the dealer. Turned out it was already a frequent complaint throughout Europe and VW denied responsibility. Eventually solved by a software update. What software update exists for the increasing number of adverse effects recorded for the gene therapies? They are more comparable to burning alive in a car due to saving money alluded to in my first sentence.
No, because science is all about having a hypothesis, testing it by experimentation, getting a result and then publishing what you have done so that others can try the same experiment, see if they can find anything wrong with the findings, and accept them if they seem valid.
If an experiment goes wrong, so long as people can examine and discuss it, science is still advancing.
If, however, having certain hypotheses is banned, funding is withdrawn for any experiments likely to examine these, publishing findings which contradict current beliefs is banned, and anyone who disagrees with these actions is thrown out of their job and attacked as a liar…
Then Science really IS in danger.
The corruption of, let’s call it what it is, the scientific method, starts early. Way back in 1970 when I was studying for my Biology GCE ‘A’ Level, an experiment that I and another lad were performing failed to yield the expected result despite us repeating the experiment. We were instructed to write up the expected results rather then the results we obtained. Perhaps we botched the experiment, who knows, but it was nevertheless an eye-opener.
Yes, it starts very early indeed.
Have you seen Eric Laithwaite’s 4th Christmas Lecture at the “Royal Institution” from 1974?
It got banned by the BBC. ^That link goes to the actual lecture.
The controllers of the “education” system simply don’t want to encourage children (or anybody else) to think that way, to explore, to challenge, to discover for themselves, to ask why, to refuse to accept the answer “because I said so” or “because that’s what I have to tell you”.
Eric made an important contribution to the development of magnetic levitation (maglev) transport.
There is NO WAY that somebody like him would be asked to give an RI Christmas Lecture series nowadays. Somebody like him probably wouldn’t even be allowed to get a university degree.
“Banned by the BBC” – what a Brave New World we live in!
I’ve just watched it, thanks for the link. It was a pleasure to listen to that good old Lancashire accent of Laithwaite’s, clearly inspiring the children watching and hopefully putting a little stone in each shoe. NB I don’t suppose ‘health and safety’ had any bearing on the BBC ban (I’m joking of course.)
Indeed “corruption” and “conspiracy “- two words than must now be fully restored to their rightful place in this debate.
Read Andrew Hill’s documented exchange with Tess Lawrie on the battle for Ivermectin authorisation in RFKJ’s book “The Real Anthony Fauci” ( pages 48-53) to see the reality .
This is a real eye -opener that all should see.
“(S)cience is all about having a hypothesis, testing it by experimentation, getting a result and then publishing what you have done so that others can try the same experiment”
I make that point not to be arsy but to show how Science is basically a false god – and even some of the underlying tenets of the scientific religion are subject to having different interpretations shouted out loudest at different times, according to the needs of the priesthood and, more importantly, according to the needs of those whom the priests serve, who don’t “believe” in any ideology.
I agree with the accepted view that the ideology of science got going in the 16th century, but it didn’t take off in a big way at that time. Nor did it during the industrial revolution, or even in the later 19th century with Maxwell and Michelson and Morley. When it really took off into the big time was in the 1920s at DuPont, the US chemical company.
Footnote: it’s true that science isn’t the same as technology, but I can’t resist referencing how Elias Howe came to make the key invention for the sewing machine…
The Late Prof. Feynman is clear about this…
“(S)cience is all about having a hypothesis, testing it by experimentation, getting a result and then publishing what you have done so that others can try the same experiment”
https://www.youtube.com/watch?v=EYPapE-3FRw
Apply this, of course to “Climate science” and you immediately understand it is not science as we used to know it, rather a belief system. Back to the Middle Ages, in fact.
Amend the question slightly and the nail hits the hammer perfectly; will Science ever recover the trust of the people? No.
What about seat belts!
Science is a dumb beast. But will scientists grow a pair in future?
Depends on the size of their wallets and their access to ‘research’ funds.
Many scientist have self censored but many have had papers rejected for publication. Neither is a good thing
Recover? Not if they have their way – it will be bought by corporates to provide the right answers to fit their investments – …in fact it has already happened.
Our worry should be that it is also the regulators supposed to protect us from Corporate over-reach, power grabs and naked greed, who have also been neutralised.
How come the Tedros WHO wants to treat Gates ( who Bankrolls them) as a “country”?
How has our own MHRA performed during this crisis?
The regulators need to look at their purpose and there has to be reviews of how they are funded.
In the same way it has always done. By somehow filling the ‘god shaped hole’. Which will work well for a time. Then get co-opted by power. And end up back where we are.
Someone will then ask “will science recover from this period?”
And so it goes. The evolution of mankind is a very very long process, if at all.
Sure, mankind(is that term allowed any more?) has ‘evolved’ enormously when it comes to the production of wealth. There’s more wealth today, per capita, than in all of history by a very very long way indeed.
We’ve not done so well with its just distribution of course. That is, are those producing the wealth ending up with equivalent value in pockets?(remembering that all wealth is exchangeable in the economic sense).
And this surely points directly at our lack of authentic evolution and the cycle alluded to above.
It is increasingly doubtful. We are being forced back to a medieval form of “science” where even alchemists would find a home. Disagreeing with government newspeak and “the science” sees people denounced, sacked, slandered and generally abused. While the Davos Deviants continue to wreck mayhem on the world our increasingly dystopian plight is only going to get worse.
Simple question: if they are fully approved, are the vaccine companies still protected via an indemnity from being sued of any serious problems that may arise from these ‘vaccines’?
If they are fully approved, surely not or am I missing something?
Some are fully approved, bio-identical to the ones that are available, but the approved/liable versions aren’t available. If that clears that up?
It varies from place to place.
Depends on the country, in the UK, the nhs are responsible for the vaccine roll out, so, regrettably it’s the tax payer footing the bill, whilst the private companies and their financial clout are protected (yet again)…
How do you approve something with no long term data as to the effects?
Easy! Give me the money and I will approve anything you want….
Or block it… as with Ivermectin.
How? “Nod, nod, wink,wink”?
Exactly. You can’t. Even more so when the short and medium term data is dodgy.
Keep up the good work. I am absolutely astonished at how effective the mainstream propaganda has been in convincing otherwise sensible people to engage in a huge experiment.
When I mention the points raised by the author with friends they are baffled. By baffled I mean they have zero understanding of the contents of the substance they have injected, the shortness of their trials, the lack of any data on medium-term effects neverind longterm effects etc.
When I have mentioned it the standard response is pity. I am clearly some kind of conspiracy theorist. I never thought I would live through a period of total lack of skepticism or even basic analysis. When I asked one acquaintance what vaccine they had been injected with they replied they had no idea, possibly Pfizer, but he wasn’t really sure.
Watching colleagues at work discuss their varied reactions post jab, the sore arms, the fatigue, the roughness, there wasn’t even a hint of skepticism among them. Plus the inevitable comments about antivax lunatics, the same group of crazies who probably voted for Brexit.
An amazing time to be alive. And for me evidence that many people waffle their way through life. Working alongside so many “educated professionals” who lack a basic survival instinct has made me question their intelligence, ability to think and even their humanness. The urge for freedom seems to be rare.
I agree. I struggle to understand people who say that the so called side effects prove the vaccine works. Doctors say this too. But with zero evidence. When I get a hang over from alcohol I do not say that this is making me well. It is a bad thing. Period. Surely, the negative effects of the vaccines simply prove that they are a harmful toxin.
I suspect the side effects reinforce the rightness of the decision, in the same vein as oral medicine needs to taste horrible for you to convince yourself it actually is medicine.
For many the thought process involved was an analysis of social pressure, not medical efficacy. A need to fit in. Given the basic survival instinct most of us possess, that is an exceptionally difficult hurdle to overcome. Most have an inbuilt horror of injecting foreign substances. Piercing the skin is painful for a reason; our aversion is hard wired for obvious evolutionary reasons. Even within living memory people died of blood poisoning from small cuts before the widespread availability of antibiotics.
This is in fact cognitive dissonance in action. Most misunderstand what cognitive dissonance actually is. It is the phenomenon whereby our attitudes and mental frameworks, which we assume to be reasonably fixed and robust, change due to behaviour.
We incorrectly assume our behaviour – the decision to be injected with a foreign substance, for example – is guided by thoughts, knowledge, facts and evidence, all of which create an attitude or position. But cognitive dissonance informs us people are much weaker than this. Persuade them to do something that causes this dissonance, such as injecting an experimental drug, and they swiftly adapt their attitude. I did it for my kids, my granny, your granny, everyone’s grandparents. Hence the vitriol; if I’ve convinced myself I’ve taken a hit for the team to save my fragile mental processes, then your refusal challenges that narrative I’m relying on. Your actions cause me dissonance.
If you are mentally weak enough to go through those kind of cognitive gymnastics, then you’ll lack the strength to resist the calls for hardcore punishment. Your mental health depends upon it. Now multiply that effect by tens of millions and it creates a lot of mental turmoil.
A fantastic comment.
And the Nudge Unit knows every one of your points.
However, as a staunch Conservative US blogger, Sundance states, “once you’ve seen the strings on the marionettes, they can never be unseen”
Every one of us on this and other skeptical sites, have either independently seen the strings or have had the scales removed from our eyes by our friends.
A great response, with which I agree fully.
The same processes are used in war to convince people to kill others, of course. These processes also operated in the 1940s to enable camp guards to do what they did. We can all list numerous other examples if we care to.
More evil has been committed in the name of the Greater Good than for any other end.
Yes the ‘dissonance’ is a state of mental discomfort – a contradiction which causes a strain towards ‘consistency’ and leads to the reviewing of previous assumptions and beliefs – even if this means accepting a change in them.
For example a person reasons thus:
” I used to believe the vaccines were dangerous but all this information from sources I have been taught to trust tells me they are not . I look for an explanation of why I had this contrary belief and conclude that I have now seen persuasive arguments and ‘facts’ which allow me to review my previous position and accept the vaccines and so achieve cognitive consistency. ”
Not much different from marketing and advertising persuasion techniques : “I used to really like butter but now I am feeling worried because I have seen ” scientific proof from experts” that is it bad for me and that oil based margarines are ‘good’ for my health so now I have changed my habit and eat margarine, feel healthier and have peace of mind “. ( All untrue of course)
“These are not vaccines, they are poisons ” (the late great Nobel Laureate, Prof. Luc Montagnier).
(I understand that Javid, Hancock, “Sir” Whitty and Johnson disagree.)
Some vaccines do produce short-term side effects, e.g. Typhoid vaccine causes a very sore arm, and flu vaccines can cause mild flu-like symptoms in some people. But that doesn’t equate to the severe side effects many people experience with the covid jabs (I won’t dignify them by calling them vaccines). Such effects don’t prove they’re working. It’s just another slogan to comfort the gullible into thinking they’re not being adversely affected. It just proves that the jabs are making their bodies manufacture the toxic spike protein, which severely damages some people and kills others.
Check this list of adverse effects reported for standard vaccines pre 2019
Cheng et al (2016),”Post-vaccination myositis and myocarditis in a previously healthy male”, Allergy Asthma Clinical Immunology, 12,6
Dilber et al (letter) (2003), “Acute Myocarditis Associated WithTetanus Vaccination”, Mayo Clin Proc, 78, pp1431-1433
Eckart et al (2005), “Comparison of Clinical Presentation of Acute Myocarditis Following Smallpox Vaccination to Acute Coronary Syndromes in Patients <40 Years of Age”,The American Journal of Cardiology, 95, pp1252-1255
Engler et al (2015),”A Prospective Study of the Incidence of Myocarditis/Pericarditis and New Onset Cardiac Symptoms following Smallpox and Influenza Vaccination”, PLOS One
Helle et al (1978),”Myocardial complications of immunisations”, Annals of Clinical Research, 10,5, pp 280-287
Kim et al (2019),” Acute fulminant myocarditis following influenza vaccination requiring extracorporeal membrane oxygenation”, Acute and Critical Care, 34, 2, pp165-169
Kuntz et al (2018),” Myocarditis and pericarditis are rare following live viral vaccinations in
adults”, Vaccine, 36, pp1524–1527
Mantdakis et al (2010), “Thrombocytopenic Purpura after Measles-Mumps-Rubella Vaccination: A Systematic Review of the Literature and Guidance for Management”, The Journal Of Pediatrics, 156,4
Murphy ey al (2003),”Eosinophilic-lymphocytic myocarditis after smallpox vaccination”, Lancet, 362, pp 1378-1380
Polat et al (2008), “Severe thrombocytopenia after hepatitis B vaccine in an infant from Turkey”, Vaccine, 26, pp 6495-6496
Ronchi et al (1998), “Thrombocytopenic purpura as adverse reaction to
recombinant hepatitis B vaccine”,Archive of Disease in Childhood, 78, pp 273-274
Saurina et al( 2003), Myocarditis after Smallpox Vaccination: A Case Report”, Clinical Infectious Diseases, 37, pp 145–6
Schattner A. (2005),”Consequence or coincidence? The occurrence, pathogenesis and significance of autoimmune manifestations after viral vaccines”, Vaccine, 23, pp 3876–3886
Woo et al (2011), “Thrombocytopenia after vaccination: Case reports to the US Vaccine Adverse Event Reporting System, 1990–2008”, Vaccine, 29, pp 1319-1323
When I raised exactly the same questions and concerns with my sister, who has a PhD, her response was “Well do you know what’s in paracetamol?” I kid you not. It’s utterly astonishing; this really was an intelligence test.
I agree, or at least a test of character. Paracetamol can be judged on it’s long history, unlike new concoctions where we are forced to look deeper at what is being injected. Seemingly lost on your sister.
Good post Vaxtastic.
For me, it largely boils down not just to the ability to think critically for oneself, but having the time, energy and interest to do so. I work on an ad hoc basis for a chippie mate of mine who gets all of his ‘news’ (cough) from the BBC. As far as he’s concerned, he works bloody hard (which he does) and he’s too knackered at the end of the day to read DS, listen to podcasts or watch YouTube for hours on end like I do. Besides which, he ought to be able to rely on the BBC to provide fair and balanced information upon which he can base his decisions. The combination of corrupt government churning out propaganda on an industrial scale – supported by biased and subservient MSM – is why we’re in this mess and why people like my mate think all of us on here are anti-vaxx nutters. I suspect it’s much the same everywhere.
I agree with all of your points. If you are not naturally inclined to seek information beyond mainstream sources your options are limited.
The key insight is probably the difference between an active approach to life and a passive one. I do sympathise with the view that investigation takes effort, and who has the time or energy after a day’s work? All perfectly rational.
However, as I’ve got older I’ve realized the wisdom in the expression, how you do anything is how you do everything. I’ll take a casual, passive approach to many things that don’t really matter to me. But for a long time I’ve cared what is put into my body. For me that started years ago when I changed my diet, and explored different options. Maybe that primed me to be more active than passive.
But the point still stands. If an individual will not take basic steps to investigate the pros and cons of a substance that cannot be uninjected then what can you do? Very alarming. Misplaced trust is a factor, but so is psychology. And history teaches us the lazy get eradicated by the energetic.
Today in Italy, the mandate to be vaxxed kicks in.
(machine translation, corriere.it of Milan)
Fines are automatically applied by the national tax authority, and their tax supercomputer , policing by database : Agenzia del Entrate
……February 15, the strengthened green pass becomes mandatory for workers in the public and private sectors (including self-employed and professionals) who are over 50 years of age. Without valid green certification, the worker cannot enter offices, companies, shops and any other place of work, under penalty of suspension from office and salary.
“From 15 February 2022 – reads the decree – the subjects to whom the vaccination obligation applies for access to workplaces within the national territory must possess and are required to exhibit one of the Covid-19 green vaccination or healing [recovery] certifications”. The over 50s who work must have undergone two doses of vaccine over time, or one dose and recovery [testing to enter work is not permitted]
Super green pass [reinforzato]
The duration of the strengthened green pass is [made permanent forever & ever] unlimited for those who have taken three doses of vaccine or have recovered from Covid after undergoing two doses.
The deadline
The strengthened green pass requirement for all workers over 50 will be in force until June 15, 2022.
Unjustified absence
The worker who communicates that he has no strengthened green pass is considered unjustified absent
The sanctions
The administrative penalty for those obliged by law to get vaccinated and caught in the workplace without a strengthened green pass “is established in the payment of a sum from 600 euros to 1,500 euros and the disciplinary consequences according to their respective sectoral systems remain firm”. In case of repeated violation, the penalty is doubled.
The fine of 100 euros
The [automatic tax] penalty of 100 euros applies to those over 50 who at the date of February 1 have not taken the first dose
(there’s no information available as to how experimental the vaxx is, over here. Information is tightly controlled)
Fascist scum. March on Rome!
You made me laugh…. why?
https://en.wikipedia.org/wiki/March_on_Rome
“The March on Rome (Italian: Marcia su Roma) was an organized mass demonstration and a coup d’état in October 1922 which resulted in Benito Mussolini‘s National Fascist Party (PNF) ascending to power in the Kingdom of Italy. In late October 1922, Fascist Party leaders planned an insurrection, to take place on 28 October. When fascist demonstrators and Blackshirt paramilitaries entered Rome, Prime Minister Luigi Facta wished to declare a state of siege, but this was overruled by King Victor Emmanuel III. On the following day, 29 October 1922, the King appointed Mussolini as Prime Minister, thereby transferring political power to the fascists without armed conflict.[1][2]”
And Musso is believed to have said that his movement was not “Fascist”, rather Corporatist – that is
https://politicalresearch.org/2005/01/12/mussolini-corporate-state
“Fascism should more properly be called corporatism because it is the merger of state and corporate power.”
Assignment to Musso may be apocryphal; regardless, the quote is correct, and is indeed what we are now having to deal with.
I have friends in Italy with family, unjabbed and in despair.
They are desperate to leave.
It is a prison sentence for them, but much worse when one considers they have right on THEIR side.
The real problem is that if you think there are too many sheep here…..
Fascism is alive and well in Italy.
Yet we’re all cast as the fascists, instead.
The reversal of all common sense and undermining of factually based values is all part their deliberate creation of dissonance and cognitive confusion = ‘chaos theory’ in action!
We have even been openly told that they are ‘cancelling’ our Culture and imposing their Wokist hell. We see it all around us. – especially in TV advertising and new styles of Corporate branding.
This goes back to the early days of the “Political Correctness” advanced initially by Extremist Feminists like Dworkin and their war on men and “sexism” – PC was a demon which should have been strangled at birth.
The Marxist Left and unchallenged Loony Extremist Marxist Feminism, rampaging through our Institutions since Blair and the crushing control mania Nanny State are all directly to blame for the living nightmare of where we now find ourselves.
Recommended reading: “Culture Counts” by Roger Scruton
Manifest Evil
Poor Italy, they are trying to destroy you.
So they authorised the experiment… sound familiar, anyone?
Mengele gushing in his grave.
To paraphrase Hitler’s contemplation of defeat and prediction of the future:
( approx words) ” Fifty years will pass and people will realise I was right”
It seems that the young Schwab didn’t need any convincing.
Mr Payne….Your evil, cretinous rhetoric gives me a pain in my heart and my head, or is that the “vaccine”
The only “clinical trial” of any consequence will be the unintended variety that establishes how many millions/billions of people are INJURED or MURDERED by these cytotixic bio-weapons! Hopefully, at some point in the not too distant future, you will suffer karma’s kick in the nutsack!
To answer a question above, I am not sure that “science” ever had a golden age. Ultimately, the people engaged in it are human like the rest of us: with career incentives and all the imperfections of humanity
The Nazis and the Bolsheviks saw themselves as scientists. They had discovered what they saw as natural laws around racial and class conflict. They thought they were virtuous people who simply applied these natural laws that had an iron logic once the false premises behind them were accepted. Many of them were also highly educated. The phd count at Wannsee (for example) was very high.
This is why no group of people should ever be allowed to be omnipotent. Covid allowed certain scientists to become powerful. But most of their so called science is as false as the “science” of the Nazis and Bolsheviks. It is based on the similarly false premises of Germ Theory. And the possible outcomes are just as evil. Climate Change has similar capacity for sheer evil too.
Although I rail against the Global Elites plans to reduce the population I sometimes wonder when so many people are willing to accept experimental jabs, wear unnecessary masks and acquiesce to unnecessary lockdowns whether they have a point.
Dancing on the head of a pin.
In reality are the laboratory synthesized gene sequenced products good or bad?
Yet again, and no apologies, fact check this Ed Payne and others of a similar ilk (can someone send it ) :-
https://www.authorea.com/users/455597/articles/552937-innate-immune-suppression-by-sars-cov-2-mrna-vaccinations-the-role-of-g-quadruplexes-exosomes-and-micrornas
This paper, in preprint on ResearchGate, is a literature review.
You are aware that the lead author is a computer scientist researching into artificial intelligence, particularly voice recognition from MIT. She has published other health related papers despite no medical background.
The second author is a naturopathic oncologist , with qualifications in naturopathic medicine, oriental medicine, a BA in English and a Masters in Humanities.
The third author is at least a scientist, microbiology
These are the main authors.
The fourth author is a cardiologist and was involved in the editing process.
The funding came from Quanta Computers Inc of Taiwan through their Qmulous project a joint venture with MIT.
science is a giant conflict of interests – hence majority science papers are PA / ghostwritten for pharma; FDA rules are that experimental approval of a vax jab requires 50% efficacy (it’s in enhancing the virus territory) ; no effective alternative treatments can be found (safe cheap options availabke from the start); once approved for use on children opens gates for non emergency approval (injuring children for ££). Lies lies and more lies.
I think I know which author I regard as being qualified to comment on this, and it certainly isn’t Payne, an erstwhile stooge of that fountain of veracity and objectivity, CNN.
“Fact-checkers” who are bankrolled to follow a particular line are at best tainted and untrustworthy. Add to this the fact that a remarkable number have no real scientific qualification or background, other than, as journalists, having written something or the other, and they add up to a preposterous mob of opportunists.
I suspect to the average layman, if a “vaccine” hasn’t completed all the Trials which are usually conducted when a new vaccine is being developed, and they are still collecting the data necessary in order to complete the Trials, then they can realistically be classed as experimental.
When I told a double-jabbed friend that Stage 3 Trials wouldn’t be completed until 2023 at the earliest she was stunned: “they didn’t tell me that when I gave consent.” That’s why pro-jab devotees are so determined to deny that the Trials are still underway and insist that they are fully approved.
But are the trials still underway? Are there any which haven’t been unblinded and the placebo arm offered the clotshot?
Are they bothering and longer? I thought they were just going to ram them through the compliant FDA regardless?
Then it will be “open season” on babies and children!
The only stage 3 trials are in the general population.
In the initial trials the placebo groups were injected a few weeks after the start.
There is no clinical stage 3.
I am currently reading Peter C. Gøtzsche’s ‘Deadly Medicines and Organised Crime’ (2013) and was struck by the following sentence on page 243 (referring to the pharmaceutical industry) “Industry money is everywhere, like a metastatic cancer that threatens to kill our societies as we know them and our free speech.”
Yes ….nine years on…….!
Here we are.
From the Monotti/Yeadon channel today:
Anyone still marvelling at the “warp speed” of development of the Covid19 “vaccines”?
So what’s involved? Here’s a summary from someone who spent more than 35y in the pharmaceutical industry.
It’s not me, by the way.
This person has the experience to back up their view that the required steps simply cannot be done in a year or less. You’ve been lied to & the alleged “vaccines” have not not not been tested at all adequately, but the processes of manufacture are also way outside the guardrails of quality & consistency.
It’s hardly surprising that there have been so many injuries & deaths.
Best wishes
Mike
1. Licensing under the conditional marketing authorisation (CMA) provisions requires submission of a conditional marketing application (CMA) by the company seeking to market the product.
2. Provisions in the CMA do not relieve the EMA from proper review and evaluation of the common technical document (eCTD) as submitted in the application, to assure safety, efficacy, and quality standards are met.
3. The lifecycle of a development programme for a medicinal product begins with pre-clinical assessment of a batch (lot), or batches of the active pharmaceutical ingredient (API) at small (pilot) scale. Batches are typically pre-GMP.
4. Data relating to production must be carefully recorded and collected, including but not limited to, manufacturing processes and procedures, suppliers, service providers (manufacturers – eg Lonza, Oxford BioMedica), material specifications, development protocols, and analytical methods.
5. These data must be included in Module 3 (chemistry, manufacturing & controls) section of the eCTD when any submission is made. Similarly, all data applicable to Module 4 (safety) must be included in any future submission.
6. Regulatory (EMA) evaluation and approval to conduct clinical trials in humans will (should) have been based on these data. Failure to carry out this evaluation, prior to human administration, constitutes gross negligence. The average timescale for this initial stage is 2 to 3 years.
7. For the next stage in the development lifecycle, studies in humans, GMP is mandated for production of all of test material. The batch size will still be small given the relative low number of subjects receiving drug product. Further safety data must be generated for each batch, to confirm there has been no change to the character of the final molecule. At this stage, Module 5 (clinical) data from the studies in humans is added to the eCTD for future submission.
8. It is essential that the phases of clinical trials are carried out sequentially. Phase 1 production used in humans must be proven safe before moving to a larger scale for phase 2 studies within the broader patient population. Ditto for phase 3 studies if scale up is required. There is a regulatory limit to scale up set at a factor of 2.5X the existing batch. When phase 3 studies are complete, all data pertinent to the three Modules of the eCTD must be submitted electronically to yourselves at EMA.
9. This stage of clinical development typically takes 5 to 8 years.
10. Once the eCTD is submitted to EMA, the regulatory clock begins ticking. During this time, all sections of the eCTD are evaluated by suitably qualified staff, and a list of unanswered questions prepared for discussion and resolution with the applicant.
11. A critical element of Module 3 is the integrity of the end-to-end supply chain that has been constructed during the development programme, and its ability to produce product of consistent quality throughout its lifetime. This is based on every manufacturer of drug substance and drug product, as a minimum, applying for a manufacturing authorisation (MA) for the product, and that the product application is successful and added to their existing license.
12. This can only be effected following a thorough inspection and written report by suitably qualified EMA staff, and remediation of any issues raised by the applicant. This typically take 6 to 12 months.
During this time and following a successful inspection, the applicant typically produces 3 batches of stock at the validated scale, in anticipation of approval and launch.
13. The conclusion is that the development programme lifecycle of pre-clinical, clinical, and full-scale production and regulatory evaluation cannot safely be condensed into 12 months or less. Anything less than 5 years would raise eyebrows, and 8 – 10 years a more reasonable expectation.
14. In addition, consider that the SARS-CoV-2 injections are gene therapies, classed under the heading of advanced therapy medicinal products (ATMPs).
15. Procedural advice on the evaluation of advanced therapies specifies the need for a Committee for Advanced Therapies (CAT) to lead the scientific evaluation, stating: “The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas bordering on other sectors such as biotechnology and medical devices.”
16. This would further extend the development lifecycle timeline.
When some creep “Fisks” you, or you get “fact checked” for Faecesbook, that’s when you know you were right.
So Mr Payne insists the mRNA vaccines are NOT gene therapy. Well, this chap disagrees…and he should know!
”‘ULTIMATELY, the mRNA vaccines are an example for that sort of gene therapy. I always like to say, if we had surveyed, two years ago, the public,“would you be willing to take gene or cell therapy and inject it into your body?” we probably would have had a 95 per cent refusal rate. I think this pandemic has opened many people’s eyes to innovation in a way that was maybe not possible before.”
Stefan Oelrich. President of Pharmaceuticals at Bayer, one of the biggest pharmaceutical companies in the world, in a speech to the 2021 World Health Summit in Berlin, Oct 24-27 2021
Of course they are Gene Therapy! That’s why they deny it!
They are NOT gene therapy as they do not alter the recipients genome, see the FDA definition.
You will note that John Flack calls them gene based, as they are based on the genes of the SARS-CoV-2 virus (not identical). They do not and cannot change your DNA, anymore than SARS-CoV-2 or most other viruses (HHV-6 can and does in 0.8% of the population).
John, are you suggesting the President of Pharmaceuticals at Bayer doesn’t know what he’s talking about? Or is it possibly the case that, as Flack suggests, the mRNA vaccine technology is so new that there needs to be debate as to what it should be called?
Read the full definition of gene therapy from the FDA, also look at the context within other organisations including GOSH.
FDA definition
Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use 1.
Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms:
Gene therapy products are being studied to treat diseases including cancer, genetic diseases, and infectious diseases.
“The ‘fact check’ is headlined: “Covid Vaccines are NOT Experimental Gene Technology – they ARE Fully Authorised.”
In the UK the Pfizer and Astra Zeneca ‘vaccines’ have emergency use only authorisation as stated in the patient information leaflets posted on the UK government’s own .gov.uk website. The Moderna ‘vaccine’ has conditional approval status pending further ‘evidence’. Extracts posted below, copied today.
Semantics? A qualified authorisation is not a full authorisation, and all three of these authorisations are heavily qualified.
Information for Healthcare Professionals on COVID-19 Vaccine Pfizer/BioNTech
This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 12 years of age and over.
1. Name of the medicinal product
COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection
7. Marketing authorisation holder
Not applicable.
8. Marketing authorisation number(s)
Not applicable.
9. Date of first authorisation/renewal of the authorisation
Not applicable.
10. Date of revision of the text
December 2021
Information for UK recipients on COVID-19 Vaccine AstraZeneca (Regulation 174)
Updated 26 January 2022
Package leaflet: COVID-19 Vaccine AstraZeneca
COVID-19 Vaccine AstraZeneca solution for injection COVID-19 Vaccine (ChAdOx1 S [recombinant])
This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation of individuals aged 18 years and older for the prevention of coronavirus disease 2019 (COVID-19).
MODERNA BIOTECH
Package leaflet: Information for the user Spikevax dispersion for injection
COVID-19 mRNA Vaccine (nucleoside modified)
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Marketing Authorisation Holder:
MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30
28010 Madrid
Spain
Manufacturer:
Rovi Pharma Industrial Services, S.A. Paseo de Europa, 50
28703. San Sebastián de los Reyes Madrid, Spain
This leaflet was last revised on 23-12-2021.
This vaccine has been given ‘conditional approval’. This means that there is more evidence to come about this vaccine.
When they force through the ‘authorisation’ they can really get started!
All they then need is Johnson’s’ “‘in the national interest” and “for the greater good “clauses in his Trojan Horse “Bill of Rights” scam and it will be twenty jabs a year, forced on all for “life” ( how ever long that will be).
This pernicious “Bill of Rights’ ( sic) needs blocking – it is very dangerous for our bodily integrity and could be used to side-line the ‘Nuremberg Code’.
We know that Facebook and Twitter along with are Globalist Great Reset operators, enemies of truth, free-speech and open debate -the question is what to do about it.
The obvious answer which eludes so many of the addicted is to ditch them and find other means of communicating.
I assumed they were ‘experimental’, and under emergency use which was why a non liability clause was required by the pharma companies
In this article, I argue that the nearly universal acceptance of the flu “vaccines” helped pave the way for the successful rollout of the Covid “vaccines.”
Just like the Covid vaccine, the flu vaccines are clearly not “effective” at preventing the flu (at least in many or most years). This didn’t even matter as the definition of what a vaccine does or is supposed to do has clearly been changed.
https://uncoverdc.com/2022/02/14/flu-vaccines-of-dubious-effectiveness-helped-pave-the-way-for-covid-vaccines-of-dubious-effectiveness/
I can only marvel at the sheer audacity of this clown who hails from a line of work that (with few exceptions) makes the world’s oldest profession look positively moral and that requires zero academic ability, challenging someone who has many years of experience in the domain and who, in order to get there, had to pursue academic studies many orders of magnitude more difficult than a “degree” in journalism.
Incorrect use of the term (“begs the question” https://en.wikipedia.org/wiki/Begging_the_question). So, forwarding a logical fallacy.
Using the term in this way indicates the writer is begging the question they want to be asked, rather than attending to the question in hand. Very easy transgression to make under these circumstances granted.
Otherwise, keep up the good work!
We all (should) know that Mrna treatments are NOT true Vaccines. A typical vaccine contains an agent that resembles a disease-causing microorganism made from a weakened microbe. both Pfizer and Moderna do not follow these rules. Before youtube removed it an world leading virologist posted a long video on these 2 so called vaccines stating that he had resigned from his highly paid post as he had grave concerns over the safety of these treatments and to paraphrase his video, there were real concerns that this treatment could attach itself to the lungs, heart etc and the resulting antibodies would see that part of the organ as the enemy and attack it.
Both were fast tracked way before even full human trials could have been run let alone a full study into the long term side effects. Once both these mrna treatments were passed by new legislation as “safe” treatments for covid it did not take long before these replaced the true vaccines at which point i was even more determined to reject any offer of being jabbed. Screwing about with our DNA and RNA is much like Frankenstein trying to build a human from dead parts. If medical science know as much about dna/rna as they have us believe then I ask them this. “Why can you not take my stem cells and inject them into my jaw giving me a brand new set of perfect teeth?” I will leave you to answer this for yourself.
As for long term side effects, I would ask you to ask yourself, “Are we already seeing the 1st in ‘Long Covid’ “? Maybe the truth is medicine is not as advanced as we are led to believe. After all there is no cure for depression hiccups or even the common cold. It chills my heart to think we have forgotten what happens when full trials are not done and we are told to trust the big pharma companies and their expertise. I grew up amongst those who fell fail of this error and were born after their mother went on the birth control drug thalidomide.
Another important question we should all ask ourselves is which of our politicians either have shares in these 2 companies or were paid back handers to vote for its use. It does not take any time to search the internet and find these 2 companies have form and were fined for misrepresenting their drugs etc. even considering these is like buying a car from John Delorean.
Being forced to have these drugs put into your body irreversibly, be you a NHS nurse/doctor or a Canadian Trucker, is reminiscent of the human experiments that we claimed Adolf Hitler was guilty of in death camps. Politicians do NOT give a monkies if we start to die off in 20 years as not only do they hide behind immunity to prosecution but they will de either retired or dead by then and the current government will simply say “sorry” and consider the matter closed for ever as was the case for thalidomide.
the media scream when a minute % of protesters urinate on war memorials or wave a swastika flag. Just MAYBE they are trying to point out that removing our freedoms in this way makes a mockery of the lives lost in 2 world wars to “protect our freedoms” and in doing so, it is the STATE that is in fact urinating on the graves of those dead soldiers.
Power to the covid protesters everywhere and may they win. If not what next? do we get to become unwilling guinea pigs or lab rats for any drug that can make the politicians and their lobbyist super rich? I will happily die before i allow that crap into my body.
Long but informative post from Mike Yeadon on the usual development for vaccine manufacture.
It ties in with SB’s post here yesterday on how corners were cut in bringing these products to market.
Anyone still marvelling at the “warp speed” of development of the Covid19 “vaccines”?
So what’s involved? Here’s a summary from someone who spent more than 35y in the pharmaceutical industry. It’s not me, by the way.
This person has the experience to back up their view that the required steps simply cannot be done in a year or less.
You’ve been lied to & the alleged “vaccines” have not not not been tested at all adequately, but the processes of manufacture are also way outside the guardrails of quality & consistency.
It’s hardly surprising that there have been so many injuries & deaths.
1. Licensing under the conditional marketing authorisation (CMA) provisions requires submission of a conditional marketing application (CMA) by the company seeking to market the product.
2. Provisions in the CMA do not relieve the EMA from proper review and evaluation of the common technical document (eCTD) as submitted in the application, to assure safety, efficacy, and quality standards are met.
3. The lifecycle of a development programme for a medicinal product begins with pre-clinical assessment of a batch (lot), or batches of the active pharmaceutical ingredient (API) at small (pilot) scale.
Batches are typically pre-GMP.
4. Data relating to production must be carefully recorded and collected, including but not limited to, manufacturing processes and procedures, suppliers, service providers (manufacturers – eg Lonza, Oxford BioMedica), material specifications, development protocols, and analytical methods.
5. These data must be included in Module 3 (chemistry, manufacturing & controls) section of the eCTD when any submission is made. Similarly, all data applicable to Module 4 (safety) must be included in any future submission.
6. Regulatory (EMA) evaluation and approval to conduct clinical trials in humans will (should) have been based on these data. Failure to carry out this evaluation, prior to human administration, constitutes gross negligence. The average timescale for this initial stage is 2 to 3 years.
7. For the next stage in the development lifecycle, studies in humans, GMP is mandated for production of all of test material. The batch size will still be small given the relative low number of subjects receiving drug product. Further safety data must be generated for each batch, to confirm there has been no change to the character of the final molecule.
At this stage, Module 5 (clinical) data from the studies in humans is added to the eCTD for future submission.
8. It is essential that the phases of clinical trials are carried out sequentially. Phase 1 production used in humans must be proven safe before moving to a larger scale for phase 2 studies within the broader patient population. Ditto for phase 3 studies if scale up is required. There is a regulatory limit to scale up set at a factor of 2.5X the existing batch. When phase 3 studies are complete, all data pertinent to the three Modules of the eCTD must be submitted electronically to yourselves at EMA.
9. This stage of clinical development typically takes 5 to 8 years.
10. Once the eCTD is submitted to EMA, the regulatory clock begins ticking. During this time, all sections of the eCTD are evaluated by suitably qualified staff, and a list of unanswered questions prepared for discussion and resolution with the applicant.
11. A critical element of Module 3 is the integrity of the end-to-end supply chain that has been constructed during the development programme, and its ability to produce product of consistent quality throughout its lifetime. This is based on every manufacturer of drug substance and drug product, as a minimum, applying for a manufacturing authorisation (MA) for the product, and that the product application is successful and added to their existing license.
12. This can only be effected following a thorough inspection and written report by suitably qualified EMA staff, and remediation of any issues raised by the applicant. This typically take 6 to 12 months.
During this time and following a successful inspection, the applicant typically produces 3 batches of stock at the validated scale, in anticipation of approval and launch.
13. The conclusion is that the development programme lifecycle of pre-clinical, clinical, and full-scale production and regulatory evaluation cannot safely be condensed into 12 months or less. Anything less than 5 years would raise eyebrows, and 8 – 10 years a more reasonable expectation.
14. In addition, consider that the SARS-CoV-2 injections are gene therapies, classed under the heading of advanced therapy medicinal products (ATMPs).
15. Procedural advice on the evaluation of advanced therapies specifies the need for a Committee for Advanced Therapies (CAT) to lead the scientific evaluation, stating: “The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas bordering on other sectors such as biotechnology and medical devices.”
16. This would further extend the development lifecycle timeline.
It has taken the MHRA over 2 years, and still counting, to go through the authorisation process for a product to be reclassified from prescription only to pharmacy sale; a product with over 20 years of safety data. And they approved the so-called ‘vaccines’ in how many months???
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There Are Now 365 Studies that Prove the Efficacy of Ivermectin and HCQ in Treating COVID-19. Any hospital administrator who mandated the shots to employees to comply with the government mandate for Medicare and Medicaid reimbursement and who refused to allow alternative treatments to be tried, doctors who pushed their patients to take the EUA drug without giving fully informed consent, anyone who forcefully administered the shot, the AMA, AAP, Boards of Health, CDC, FDA, NIH, WHO, scientists who participated in the development, Big Pharma (Pfizer, Moderna, J&J, Astra Zeneca, et. al.), anyone who pushed the sick into nursing homes resulting in deaths, all must be arrested, prosecuted, tried and if found guilty sentenced to prolonged imprisonment and fines or death for intentional homicide. Get your ivermectin before it is too late! https://ivmpharmacy.com
Why on earth do people feel they have to rebut the accusation of “Vaccine Hesitant.” I jolly well am Vaccine Hesitant. I’m prepared to hesitate for the full normal trial period of 10-15 years. In the case of other vaccines everyone else has “Hesitated” for this period too. Have they forgotten?!
In a knowledge competition between John Flack and a headline seeking journalist I wonder who would win?
Great article, Dr Flack. “Fact Checking” by the unqualified is a new scourge in our society
These people, journalists or otherwise, can’t compete on the same level as Mr Flack. He’s been very polite in his reply, I don’t think I would have.
They are basically laymen with an opinion trying to discredit others they disagree with. God know why they take up this stance voluntarily.
They should be disregarded as their opinions have no value.
Is the journalist in question, Mr Payne, intending to apologise Dr Flack? He should be made to – publicly.
FoI request to MHRA way back returned that they do NOT consider these new jabs to be experimental, and indeed, classify NO drugs as such.
Neat way of sidestepping international law, I guess
Ah, the good old Dr. “everything I did was legal under German law at the time” Mengele defence.