Covid Inquiry Fails to Hold MHRA to Account (Again)
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.
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