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.
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Where is the scepticism here?
It looks as if on the subject of Israel + Gaza DS has totally suspended all critical thinking/questioning, research/verification of data, etc.
I was surprised by its failure to look behind the establishment and mainstream media narratives in the case of Ukraine, but this time it’s even worse.
I’m now wondering whether I want to carry on paying £5/mth to support a platform that buys the Israeli lies so obediently. 🙁
I think we’ve had various points of view on Ukraine, bit less so on Israel. Still think it’s £5 well spent.
My concern with the Israel thing is not so much who they are “supporting” but the implications for freedom of speech. Would be interested to see some articles from DS writers and others on where they think the line should be drawn.
It’s an absolute powder keg of a situation that’s been created. It’s divided the West, and even the sceptics, right down the middle. A job well done. There’s so much contrary information it’s impossible to wholly stand with one side or another (was reading yesterday that the Israeli military killed many of the civilians – read, not believed). What I am sure about, however, is this: there is significant support for Hamas within Palestine, there is little/no anger at the atrocities committed by Hamas, there is very little support for Jews, many, many Muslims joining pro-Palestine demonstrations in the West will also support Hamas, and I’m sure that we have lost some more humanity. People in the West seem to have got so obsessed with the Palestinian plight that they are failing to remember the complete incompatibility that their culture has with the Wests. Huge swathes of people are supporting other people who want them eradicated from the planet. That is a separate consideration to Israel, Palestine and Hamas, but a pretty important one in my mind. The Alphabet soup brigade’s support was the epitome of this. If we further forget our own values (if there’s any left), then we’re ripe for the picking.
……I don’t believe every Muslim wants to eradicate me from the planet..same as I don’t believe that all Russian’s are evil, same as I don’t believe China wants to take over the world and make us all slaves…
They are ALL, each and every one a good way to make people remain in a state of anxiety and to separate us from each other. They are all supported and promoted by corrupt Governments and their mouthpiece the MSM…
…they all make money for the massive Military Industrial Complex….
I do believe that uncontrolled immigration is wrong, for many reasons..and I agree that if people want to live in a country they must adhere to its laws..no argument…
…and being originally from South Yorkshire..and having family still in Rotherham, I’m well aware of the evils some people are capable of…I’m not vaguely naive about these things…
Mass immigration of Muslims has been an unmitigated disaster. It has been intentional and designed to destroy the West. It is well on the way to succeeding. At the weekend we had 100,000 Islamists chanting for another holocaust of Jews and plod allowed this.
Those calling for genocide have no place in this country and I don’t care which bloody flag they are waving.
And another point – if this government were genuinely committed to removing wannabee einsatzgruppen volunteers they would start by sacking Rowley.
“I don’t believe every Muslim wants to eradicate me from the planet“. No, neither do I. But I never said that I did – that’s a huge distortion of what I wrote. My point is there are a huge number, possibly a majority, of radical Arabs (including many who have migrated to the West) that do support a holy war, and do want our removal from the planet – whether that be physical removal or complete removal of our values and beliefs. Anyone that doesn’t believe this would have an extremely rude awakening if they chose to live somewhere like Iran.
I think we can talk about immigration into the UK and all the problems associated with it…but I don’t think it particularly helps to conflate it with what is happening in Israel at the moment.…and I think it causes disunity..when we should all be blaming the people really responsible…the Government…
…I don’t think any of the Palestinians from Gaza are coming here any time soon..and they are the ones we are talking about.
I think it’s a very easy thing to manipulate, as it is easy to think that because excessive Muslim immigration is bad for us….then, somehow, Israel must be right….I think it’s a false premise, divisive, and as I say, an easy emotion and fear to manipulate…
Hammas only just won the election a few points ahead of Fatah in 2006….. and nearly 60% of Gaza didn’t vote for them..and of course who knows how legitimate the elections were anyway…?
Since then half of the population, the ones under 17, have never voted for anything….
I don’t want my own country ‘overrun’ as you put it….but the blame for that lies squarely with my Government, who are supporting and encouraging it..we should band together against them…If it wasn’t for them we wouldn’t even have a problem to talk about….?
I think you must be getting my posts confused with others. I’ve never mentioned mass immigration or have ever mentioned anything at all about being ‘overrun’. What I said was this: “People in the West seem to have got so obsessed with the Palestinian plight that they are failing to remember the complete incompatibility that their culture has with the Wests. Huge swathes of people are supporting other people who want them eradicated from the planet. That is a separate consideration to Israel, Palestine and Hamas, but a pretty important one in my mind”.
Yes, of course we should hold governments accountable for the massive pot of sh*t they’re stirring, but we do need to consider other factors that are key during this conflict – just as most sceptics did for Covid, lockdown and the Russia-Ukraine war etc. We cannot consider these events without context and solely as Government Vs The People (even though I agree that’s an incredibly important thing to understand). If, for example, you would not be willing to live under Sharia law then that means you have a concern that should feed into your considerations, and are outside of the question of Government interference.
Anyway, I’m not totally sure what we’re disagreeing about tbh, so I’m going to leave this one here!
yes..not disagreeing on the whole, just probably having too much of a ramble….!!?
You might like to pop over to Dr Richard North’s turbulenttimes.co.uk
plenty of granularity there:
https://www.turbulenttimes.co.uk/news/front-page/israel-reading-the-small-print/
Which ever side you belive, I don’t think hog tying children, piling them up in a heap and setting fire to them, alive, is acceptable by any section of the human race!
You clearly have a side though don’t you?
..but blowing them to bits, and burying them to suffocate and die under rubble is acceptable?
Neither is OK is it? ..or are you someone who thinks it doesn’t matter because ‘the others’ aren’t really human beings?
I dont have a side! Your at it again trying to tell people what they believe!
All deaths of innocence is a tradgedy but specifically attacking children intentionally is not the same as collateral damage in a war situation and never will be!. All wars kill civilians and always will, but as I have said, it is not intentional.
No one on any side in any war should target children and civilians on purpose!
Has this explained my side?
Your comment clearly intimates that you think that Israel have a ‘claim’ to some sort of superior atrocity…the deaths of their children are somehow worse..it seems pretty clear from what you’ve said.
I disagree with you, that’s all. It seems clear to me that claiming over 2000 Palestinian children can’t be written off as collateral damage is utterly ridiculous…and heartless…and absolutely intentional.
If anyone reads this response from this poster, please try to explain to that person they are just twisting my words to fit their beliefs because this person doesn’t realise they are doing so!
They are like the climate cult, they will not accept even the mildest disagreement with their faith!
Well it’s going the same way as the MSM Covid stories..and bit by bit they will devalue themselves…..
I’m waiting for the…’man says anti-Semitic Persian cat peed on his doorstep’ story
..it can only be a matter of time…
The MSM have picked their ‘side’…it’s up to us to keep the balance and to not be bullied into ‘right think’….
I appreciate that racism in all its forms is everywhere, but I have to say that as a northerner I’ve seen this many many times, when a specific story seems like a peculiarly London-centric obsession…while the rest of the country continues with business as usual…
“I’m now wondering whether I want to carry on paying £5/mth to support a platform that buys the Israeli lies so obediently.”
That’s like Pfizer saying to mainstream media,”If you don’t say what we want you to say, we’re going to stop funding you” – though not quite on the same scale!
🙂 no, it’s not. I’m not selling anything.
“Killer Storm Triggers Climate Fear”. These straplines appear everywhere now. Seen them with Andrew Bridgen’s debate. I think they must have occured before, but now they are being used to push emotional messages. Anyway, bad weather is not climate, as bad weather has always happened.
Covid Gateway to Agenda 2030 Tyranny – latest leaflet to print at home or forward to politicians, media, friends online.
This guy is great. He’s actually an Imam, originally from Iran now an Australian citizen, he’s wanting to reform Islam and basically has all of the same views as we do. He opposes terrorism, supports equal rights for women, and everything else that you’d expect in a civilised society. A reminder that all Muslims ( hopefully most ) are not totalitarian, misogynistic terrorist supporters, incapable of integrating into Western cultures;
( <3min )
https://twitter.com/Imamofpeace/status/1713230588079956015
Spot on Aethelred.
“AI hysteria is out of control”
Ai doesn’t exist! It’s augmented at best but not artificial, just powerful computers with advanced programming!
All these stories making ordinary people freaked out makes you wonder what THEY will blame on AI. It’s a useful fallback for THEM in explaining why certain situations/events are happening. Whatever the truth of it, THEY will be thinking about how to use this to their advantage to create more fear and panic.
AI exists. AGI does not. ACI is the worry (C=capable). I reviewed Suleyman’s book here:
https://glitches.substack.com/p/containing-frankensteins-monsters
I suspect the reaction here is going to be 50:50 on this excellent (my view!) piece of big-picture thinking from Rusere Shoniwa:
https://plagueonbothhouses.substack.com/p/if-you-arent-supporting-an-immediate
I think people have this idea that the Government in Israel are somehow fluffy teddy bear democrats..which couldn’t be further from the truth…
There are numerous column inches taken up in Israel, literally calling the Government fascist..it’s definitely very far-right..in the real meaning of the word..
Benjamin Netanyahu, leader of the Likud party and Israel’s longest-serving prime minister, has never wanted a two-state system … he had said this on numerous occasions..one of the reasons for his ‘support’ of Hammas has been to separate Gaza and the West Bank, specifically so that they can’t show a United front….he is currently being indicted on charges of bribery, fraud and breach of trust…
Far-right Religious Zionism party leader Bezalel Smotrich is Israel’s finance minister as well as being responsible for governing the occupied West Bank through a new role created for him within the defence ministry. Smotrich is a notorious racist, homophobe and Jewish ultra-nationalist. He is a staunch supporter of building illegal Jewish settlements on occupied Palestinian lands. In a speech to the parliament this week, he said he plans to “regulate and strengthen our grip on the homeland” as part of his role as a minister in the defence ministry.
He recently said…”there is no such thing as a Palestinian nation. There is no Palestinian history. There is no Palestinian language,”
Itamar Ben-Gvir, is the leader of the far-right Jewish Power party, and is national security minister. He was previously convicted in Israel of incitement to racism and supporting a terrorist organisation. Following an agreement signed with Netanyahu, Ben-Gvir will take control of the border police, a branch of the military operating in the occupied West Bank and East Jerusalem, including security at al-Aqsa Mosque. Ben-Gvir, who lives in an illegal settlement in the West Bank city of Hebron, also has expanded powers over the police.
National Security Minister Itamar Ben Gvir announced that his ministry is purchasing 10,000 rifles in order to arm civilian security teams, specifically those in towns close to borders, as well as mixed Jewish-Arab cities and West Bank settlements.
4,000 assault rifles have already been bought from an Israeli manufacturer and will be distributed immediately.
Helmets and bulletproof vests have also been acquired and will be distributed along with the assault rifles.
Yoav Gallant Minister of Defence…
…has imposed a ‘total siege’ on Gaza enforcing a total blockade saying… “There will be no electricity, no food, no water, no fuel. Everything is closed. We are fighting human animals and we are acting accordingly.”
All four particularly have been instrumental in trying to change the law, which is basically to give them more judicial power, while by-passing the courts, the Parliament, and the will of the people..a power-grab…and it’s the reason that Israelis have been protesting all year…
Just if anyone wants to do a bit of further reading….
As Shoniwa argues here and in his previous article, and you have pointed out before, the effort being made in the media (including the DS) to decontextualise this, to see it as a good vs evil morality tale, is a distraction on multiple levels.
Great read, thank you.
The Western World being put to shame…
https://www.spectator.co.uk/article/all-is-not-lost-for-argentinas-chainsaw-wielding-presidential-hopeful/
Yesterday evening’s guest presenter to MD4CE was Foster Gamble who has spent the last 20 or so years working on Free to Thrive. He promotes anarcho-capitalism, or as he prefers to call it, voluntaryanism. It was a long meeting – over 3 hours – lots of interesting information & some thoughtful contributions from some major thinkers (Daniel Estulin, Alex Krainer, David Webb) around how to move away from the current system, build a new system & let the old failed one naturally wither & die.
There is free access to all his material on his site https://www.freetothrive.com/
The recording of yesterday’s presentation can be viewed here:https://rumble.com/user/cbkovess
Time to wave goodbye to the UN
Baloney…
He said that the attacks ‘didn’t happen in a vacuum’ and they didn’t….
he said, quite rightly in my opinion, “.…”the grievances of the Palestinian people cannot justify the appalling attacks by Hamas. And those appalling attacks cannot justify the collective punishment of the Palestinian people.”
Gaza is completely controlled by Israel, who we have seen can turn off all amenities, food and medicine included….the IDF enter and leave at will..I don’t know if you call that being occupied .. or something worse.
The occupation of the West Bank by Israel, has nothing to do with Hammas, and is totally illegal under International Law…
Hammas bear 100% responsibility for what happened on the 7th, there is no argument
but Israel cannot and should not be excused from the responsibility for the thousands of deaths they are causing now.….…
You, meanwhile can make as many excuses for it as suits your purpose..
Plus..if they occupy the West Bank to stop Hammas, what excuse did they have three days ago, to bomb the civilians in the Jenin Refugee Camp situated there…?
Yesterday, Thomas Fazi posted this excellent summary of the peace process since 1967:
https://unherd.com/2023/10/why-peace-in-israel-failed/
Reposting this, and a supporting thread on X, got him deboosted:
https://twitter.com/battleforeurope/status/1716857255558066206
When I last ran a checker, his account had a Ghost Ban.
Yaccarino’s regime is no different from the past under Roth. Free speech platform my *rs*.
It’s a good article….I think he strives to be very fair….and it’s a shame that the censorship is rearing its head again..especially on what I would call ‘learned’ or ‘informational’ articles.. articles which in other circumstances (i.e not about Israel) wouldn’t raise any questions at all..?
Dane Giraud is absolutely right. To censor your opponent before a debate means you´ve lost the debate before it´s even begun. And deserve to do so.
As Goethe said: “One man´s word is no man´s word. Justice needs that both be heard”.
Andrew Bridgen was up again today with the 10 minute Rule Bill raising Parliamentary Sovereignty ( Referendums) Bill , he spelt it out in layman’s terms what the WHO will be able to do to us ! No one there again & can it be stopped ??…