At last, on Wednesday in June Raine’s oral evidence, the Covid Inquiry Module 4 hearings touched on one of the most serious vaccine safety issues – ‘Process 1 v Process 2’. To summarise, the Perseus Group had presented evidence to the inquiry that MHRA had no safety data for the Covid vaccines given to the public because they were manufactured differently to those used in the clinical trials. The fundamental issue is that the product given to the public had not been tested in a clinical trial. It was akin to a bait and switch fraud. The company was meant to provide evidence that its mass manufactured product was comparable but it never did. The MHRA did do laboratory testing of batches, but this is not the same as clinical testing on actual people for safety and efficacy.
The story of the significant differences between the Process 1 and 2 products is shocking and has been laid out by Dr Clare Craig in full here. Numerous safety signals were overlooked, including a 13-fold increase in lymphadenopathy in the small fraction given Process 2 product in the trial, who had a rate of 5.2%, compared to those given Process 1 product, who had a rate of only 0.4%. The MHRA also ignored lymphadenopathy leading to overdiagnosis of breast cancer, massive gender disparities in adverse reactions and inconsistencies between adverse reactions for products from different manufacturing sites.
However, Hugo Keith KC this week managed to bungle the question and let June Raine off with an ambiguous, one-line answer. Cock-up or conspiracy? Either way, the inquiry has refused to hear oral evidence from a single qualified professional with concerns about the Covid vaccines. The difficult job of presenting the evidence on vaccine inefficacy and harm has consequently fallen on the shoulders of the injured who have to overcome not only a lack of scientific training but physical challenges in order to present a coherent argument. Under the circumstances they have done brilliantly.
One notable interview was with Ruth O’Rafferty of the Scottish Vaccine Injured group. She tried to bring up this important topic of the differences between the vaccines tested in clinical trials (made on a small scale under Process 1) and the ones given to the public (mass-produced under Process 2). The MHRA had only received data on Process 1 product at the point it agreed to the rollout to millions. The only evidence it for the Process 2 product was laboratory-based testing that compared the two processes. Ms. O’Rafferty’s attempt to discuss this was immediately cut short by Hugo Keith, lead counsel to the Covid inquiry.
Then, on Wednesday, Dr Raine, former CEO of the MHRA, took the stand. Rather than asking a straight question about the trial Process 1 product being comparable to the mass-produced Process 2 product, Hugo Keith asked an apparently meandering one. The result of this apparent roundabout way of asking was that he did not ask the question at all. Instead of asking about the trial safety data and its relevance to the rolled-out product, he asked – I suspect very deliberately – whether the batches that were tested in the lab by the MHRA (which were of course Process 2 batches) were the same as what was given to the public (at 25:35). Of course, such batch testing at best only ensures consistency of quality from the same production process. Also note that he refers to “process A” (a hypothetical batch being tested by MHRA) and “process B” (batches given to the public), rather than using the technical terms Process 1 and Process 2. Naturally, Dr Raine was able to say “process A” and “process B” were the same manufacturing process – but this misses the point: the MHRA did not have safety data for either “process A” or “process B” because both are Process 2, whereas the safety data came from the trials, which used Process 1 product.
The inquiry has thus enabled a situation where the primary failing of the MHRA has apparently been denied. The truth can now be dismissed as yet another ‘conspiracy theory’.
The public deserves answers. Why weren’t these risks properly addressed? Why is this crucial issue being ignored in a process meant to bring accountability?
The Perseus Group has written to Baroness Hallett urging the inquiry to ask MHRA to clarify the position. Here is our letter in full:
Dear Baroness Hallett,
I am a representative of the Perseus Group which provided two written statements to your inquiry. We continue to review the written and oral evidence to the ongoing Module 4 but there are two issues from yesterday’s evidence by Dame June Raine (MHRA) which, in our view, require immediate and public clarification. I hope you will agree.
Process 1 vs Process 2
Page 131 of yesterday’s transcript records Hugo Keith KC asking Dame June Raine:
MR KEITH: Some have suggested that the batches which were delivered to the United Kingdom for use amongst its population, which were then handed out, were not the same batches, or rather were batches that were produced by a different manufacturing process on the part of the manufacturer, as has been – as had been tested by the MHRA? So bluntly, the suggestion has been made, you tested and authorised and certified a certain number of vaccines made by process, manufacturing process A, and then the manufacturers actually delivered vaccines to British population produced as a result of a different manufacturing process, and one, by inference, which had not been tested. Is that right?
A. Well, my understanding is that the manufacturing process would have been the same.
Mr Keith’s question is confusing because it convolves:
- Batch testing which applies only to large scale (Process 2) manufacture for post-Authorisation distribution. MHRA does not batch test product used in clinical trials (made using Process 1). The safety and quality of product for clinical trials is entirely the responsibility of the clinical trial sponsor (i.e., Pfizer, Moderna and AstraZeneca); with
- The known changes in manufacturing process between Process 1 clinical trials product and large scale Process 2 manufacture for distribution.
So June Raine’s answer is, to be generous, ambiguous: to which manufacturing process(es) was she referring? And the same as what? Indeed, if she meant that Process 1 and Process 2 were the same then she would have been contradicting her own written evidence (para 106).
The Perseus Group still contends that:
- At the point of Authorisation of each Covid vaccine, the MHRA had no safety data for the product rolled-out which was manufactured using Process 2 with which to bridge back to the safety data for the product used in the clinical trials which was manufactured using Process 1. MHRA confirmed this in reply to FOI 23/510 in 2023 and paras 32-33 of our first written statement dated August 28th 2024 to your inquiry.
- This is contrary to the standards relating to ‘Process Validation’. These exist because it is common for a medicine to be manufactured at small-scale (Process 1) for clinical trials and then be manufactured for roll-out at large scale using a different (Process 2) manufacturing process. ‘Process Validation’ is actually a requirement of the European Medicines Agency (EMA) to provide evidence of safety, quality and efficacy for both manufacturing processes in order to bridge between the two. MHRA continues to adhere EMA standards post-Brexit.
- Although June Raine’s written evidence (para 106) states that: “Vaccines produced by both ‘Process 1’ and ‘Process 2’ were included in the clinical trials.” This is disingenuous:
- Only 250 subjects were injected with the ‘Process 2’ vaccine in Pfizer’s Phase 3 clinical trial compared to around 20,000 subjects receiving the ‘Process 1’ vaccines. See Page 458 of Pfizer’s C4591001.
- The results for the ‘250’ above were not available to MHRA prior to Authorisation on December 2nd 2020. See Page 36 of Pfizer’s C4591001 above and FOI 23/510.
- Indeed, the requirement for the results of the ‘250’ to be published remained a condition of Authorisation until September 2022 when the condition was dropped (see FOI 23/510).
- MHRA’s batch testing of product for roll-out does not include testing for levels of DNA contamination (a by-product of Process 2) which is an issue of ever increasing scientific concern (paras 36-44 of our first written statement dated 28 August 2024)
We also noted that the MHRA’s submission to Lord Bethell on November 30th 2020 recommending Authorisation of the Pfizer Covid vaccine was silent on whether or not there were safety implications associated with rolling out Process 2 product with no data from the 250 subjects vaccinated late in the clinical trials.
This issue remains of profound significance and we strongly urge the inquiry to ask the MHRA to provide clarification of June Raine’s answer.
Post-Authorisation Trial Data
Page 178 of yesterday’s transcript records Mr Keith KC asking June Raine:
Q. Some concern has been expressed by some people in certain quarters that either the pharmaceutical companies have not published all relevant post-authorisation trial data or that the MHRA has sat on post-authorisation trial data and not released it. Is either proposition correct?
A. No, and there are studies being done on any long-term consequences that will be rigorously examined as soon as they’re available.
The answer is factually incorrect. The Perseus Group’s second witness statement dated December 6th 2024 evidences (at para 4) that MHRA has been in possession of Interim Report 5 from Pfizer’s Post Authorisation Safety Study since March 2024 but has still not published it, despite publishing prior versions (albeit only in reply to an FOI). We strongly urge the inquiry to ask the MHRA to provide clarification of June Raine’s answer above.
We hope you agree.
Yours
Mr N. Hunt (on behalf of the Perseus Group)
Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.
To join in with the discussion please make a donation to The Daily Sceptic.
Profanity and abuse will be removed and may lead to a permanent ban.
Nick Hunt is correct to highlight that prior to 2020 a pre-defined level of batch comparability was mandated by drug-regulatory bodies such as MHRA.
Compliance with regulatory requirements accounts for why in modern times licensing of vaccines (and other drugs) for public use took much longer than the 12 months for SARS-Cov-2 “immunity modulators.” Known in pharma jargon as “adhering to Good Clinical Practice.”
Playing fast and loose with drug-safety regulations was an inevitable consequence of operating at Warp Speed to mitigate a respiratory virus with an age-fatality profile that paralleled general mortality.
In other words, political, media and public hysteria drove injection of criminally badly-tested drugs into the arms of entire populaces, most of whom never needed them in the first place.
Baroness Hallett’s flying circus is a disgrace to the rule of law. Timely to post again a link to a Sceptic article from September 2021, by “an executive in the pharmaceutical industry” writing under a pseudonym:
https://dailysceptic.org/2021/09/16/the-ethical-bankruptcy-of-vaccinating-12-15-year-olds-against-sars-cov-2/
“Government and politicians are ultimately responsible and accountable for what happens to people taking this experimental treatment. So I’d suggest that they familiarise themselves with the principles in the Declaration of Helsinki and the Nuremberg Code and read about Good Clinical Practice, because you never know but perhaps at some future point a competent authority could come knocking on the door.”
Over to the International Criminal Court at The Hague. Don’t hold your breath, Sceptics.
Let’s face it , Nothing that anyone of these mealy mouthed duplicitous so called public servants & politicians does or says can be trusted ! How do they even sleep , Vermin the lot of them !
Because they are mostly psychopaths as well as narcissist control freaks.
And that’s just those who aren’t monstrously corrupt.
And still some people think they should have even more control over our lives.
Great comment. However, we are not yet at the point of “competent authority” and will not be until we get rid of the self-serving, backside covering, complicit uniparty.
Indeed, plenty of Profs, Dames, Sirs and Professor Sirs spouting, and precious little sign of sage wisdom from SAGE, the Royal Society and professional bodies. Same goes of the climate heist.
“Unthinking respect for authority is the greatest enemy of truth…”
…Which a young Einstein may or may not have said, written and meant on 8th July 1901 or thereabouts:
https://bigthink.com/words-of-wisdom/albert-einstein-rebel-scientist/
https://skeptics.stackexchange.com/questions/48443/did-einstein-say-this-quote-about-blind-belief-in-authority-being-the-greatest
“The reason I said no to your question about should people, frankly, for a trivial reason, risk injection with an experimental, new technology vaccine just so they could go on holiday or worse, down to the pub, is one of the most stupid things I’ve heard.
Unfortunately, I think the Government’s counting on people viewing it as a trivial decision because it’s ‘just a vaccine’. Well, the materials in question, I think they probably just qualify because they do ultimately raise an immune response. But the way they do it is … is completely different from any vaccine we’ve used before.”
Dr Mike Yeadon.
https://www.conservativewoman.co.uk/mike-yeadon-on-the-toxicities-deliberately-designed-into-the-covid-vaccines/
I told my MP before the Covid enquiry started that it would be a whitewash and cost a fortune. I am sad to say I was right on both counts. She denied this would be the case of course.
£200 million and counting. Money being laundered of course. The elite pilfering for their own benefit and of course covering themselves.
Conclusion will be: we were not fascist soon or hard enough.
None of the criminals will ever stand to account. No one will be punished.
I do remember the idiots who were in Pharmament, including the speaker, laughing as they extended the 1934 Corona Enabling Act. Actually laughing.
MHRA? Just a group of corrupt clowns owned by Pharma. Twas always thus.
Well put
Twas ever thus? Yes and no. Narrative history tells Dr Francis Kelsey, acting on beghalf of the Food and Drug Administration, emerged honourably from the Thalidomide tragedy by (in contrast with Europe) not approving the drug for morning sickness in the U.S.A:
https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey
The 1960s were a long time ago.
She was right on that,but talk to American doctors decades later and they bemoan the fact that they have been last to be able to use many very good drugs and procedures.
It is always a balance. With Covid vaccines the world and the US got things very wrong,but holding up Kelsey as an unquestionable icon smacks of scientist not science.
I prefer the attitude of Richard Feynman and will always question science.
As an aside,even Thalidomide now has a use.
Understood. I did deliberately say “narrative history”. Like you, I’m a follower of Feynman, and in the same era Jacob Bronowski (who did “The Ascent of Man” for the BBC on the old black and white Bush TV).
“With Covid vaccines the world and the US got things very wrong…”
Oh no they didn’t. This is reverting to cock-up theory which I have lambasted since the start.
Big pharma knew these drugs would injure, sterilise and kill from the off because they were designed to. The politicians and senior scientists such as Whitless, van Tam, Harries, Hancock, Bliar, Johnson, Jabbit and the hundreds of others knew well enough they were participating in mass murder but were delighted to be able to do so. Dr Vernon Coleman was warning against “vaccines” in 2020, as was the esteemed Dr Mike Yeadon.
Absolutely no way did those pushing the injections get anything wrong, it was all planned. Continuing to make excuses via cock-up theory is a serious corruption of the truth and is decidedly harmful now and for the future.
Despite everything I still subscribe to the cock up theory. If this really was a conspiracy then the main players are far cleverer than I believe them to be. In my opinion they are second division players who all panicked, and their refusal to listen to high class scientists was because they were not able to admit that they could be wrong.
Thanks Mr Hunt for all your efforts.
There are some people very dear to me who took the poison – I will live with the worry that it is going to damage them for the rest of my life. I don’t speak to anyone about this because I don’t want to worry them further. Words cannot express my contempt and anger for those responsible for this evil.
Same for me, with a younger generation obliged to ingest a concoction they didn’t need in order to travel abroad.
I remember talking to a couple we know, much younger than we are, who were compliant with all the folly and evil including “vaccination”. I explained we were not “vaccinated” and our reasons. Their first reaction was not “Gosh, you old people were taking a terrible risk in not getting vaccinated, you might die from this deadly pandemic”. Instead they said “But how did you travel”. Sigh. (Answer – we didn’t).
Ditto re travel, not for two years and since then only in Blighty.
We’ve been to a few places since, though not to what seemed like the worst countries (Germany, France, Canada, Australia, NZ).
We can’t even do that now as hubby has ‘heart problems’ which started in 2021 and which no-one can explain or name. He gets breathless if he goes up the smallest incline. He’s had umpteen scans and tests but remains a medical mystery. He’s extremely anxious about travelling distances and it’s not worth the hassle so home is where we mostly are to be found. It’s not a great life I have to say.
Same here.
what a colossal waste of our money this is, its a sham, backside covering and mealy mouthed questions. The Lawyers are literally earning millions from the tax payer, and the likes of Raine, Whitty etc are allowed to get away with what they have done, continue to keep their jobs whlst they are allowed to persue their hobby of experimentation whilst being paid by us and Pharma, then retiring on gold plated pensions again paid by us, when they should be hanging from the gallows.
Financially this country is ruined because of these people and Politicians actions, and yet they continue to squander our money on performative theatre such as this in order to protect themselves.
In short Baroness Whitewash said, “la la la I’m not listening. Next witness please”.
MHRA gets a mention here:
https://www.telegraph.co.uk/news/2025/01/24/dr-sue-pavord-alarmed-results-astrazeneca-vaccine/
just another day in Hallet’s wh*rehouse. Hallet, Keith et al sold themselves body and soul before it even started up in business.
Aren’t we lucky to have such a wonderful legal system whereby a forensic analysis of the Covid/vaccine debacle can be forensically examined by the finest legal minds there are.
Nothing is off the table, all decisions can be questioned, all experts can be questioned – and there’s no such thing as an answer that cannot be questioned nor a question that cannot be answered.
Everyone in the UK can be reassured that her Ladyship will not rest until the whole truth has been exposed, thoroughly analysed and, where appropriate, those who have made mistakes held to account.
In the real world, if you want an accurate appraisal of how the MHRA/UKHSA operate, follow and join TTE –
https://trusttheevidence.substack.com/p/the-mhra-papers-part-15-summing-up
Yes, absolutely marvellous.
“Covid Inquiry Fails to Hold MHRA to Account (Again)”
well slapper my thigh!
For over four years I have said that although the decision makers were advised by experts, they were the wrong experts. Daily it becomes clearer that those wrong experts are being grilled by the wrong interrogators who are asking the wrong questions. How can a barrister, however eminent, comprehend the minutiae of medical science that even doctors struggle with?
The Inquiries in Australia and Alberta, Canada, appear to be reaching the right conclusions faster and cheaper than we are in the UK. In the end no-one is going to be satisfied with the Hallett Inquiry.
based on this DS report, I’d say that through incompetence or malintent (or both) Hugo Keith KC is, in effect, sabotaging the inquiry.