I’m not one prone to hyperbole but MHRA’s latest response to one of my freedom of information (FOI) requests seems to me to be a straightforward admission that it missed Covid vaccine safety signals up to mid 2022 (not to mention safety signals with other vaccines).
Last year, whilst trawling through minutes of meetings of the Commission on Human Medicines (here and specifically here), I discovered that MHRA had been concerned about the large numbers of Covid vaccine Yellow Card reports swamping the database and distorting the statistical analysis it relies on to detect safety signals. MHRA was concerned enough to conduct an investigation, write a report and consult the Commission on Human Medicines about it in June 2022. So I submitted an FOI last December asking for a copy of MHRA’s report. This was all mentioned in the Perseus Report of which I was a co-author.
Nearly four months after my FOI, and after two complaints to the ICO (here and here) including the threat of legal action, MHRA eventually sent me its report. It’s quite technical but it makes very interesting reading.
First, though, a bit of background. I expect this will come as a shock, but MHRA’s safety monitoring of medicines doesn’t rely on investigating individual Yellow Card reports and assessing causality (more on that at the end). Instead, it relies on statistical analysis called ‘disproportionality analysis’. This involves mining the database of Yellow Card reports looking for statistically significant differences in the frequencies of different types of side-effect between the drug of interest and other drugs. All medicine regulators use disproportionality analysis but there are differences in the algorithms (ROR, PRR, EBGM etc.) and the signal detection thresholds they use.
As its report says, MHRA was concerned about the effect on its own disproportionality analysis due to the very large proportion of COVID-19 vaccine reports in its Yellow Card database (by June 2022 it was over 80% of all vaccine-related Yellow Cards). Specifically, they were concerned that:
- “With the majority of the vaccine dataset now comprised of reports for COVID-19 vaccines, these have the potential to unduly influence the disproportionality statistics for other vaccines.”
- “If the safety/reporting profile for the COVID-19 vaccines differs significantly from other vaccines then this will impact disproportionality statistics and either mask potential signals or result in more false positive signals.”
- “Additionally, there are potential issues with the large volume of COVID-19 vaccine reports impacting the disproportionality analyses for the COVID-19 vaccines themselves.”
The report concluded that the high number of Covid vaccine Yellow Cards was indeed suppressing signal detection for other vaccines. So the MHRA decided to remove Covid vaccine Yellow Cards from disproportionality analysis of other vaccines.
For disproportionality analysis of Covid vaccine Yellow Cards, the investigation led MHRA to decide to assess Covid vaccines against other drugs (rather than other vaccines) and ditch the use of EGBM/EB05 based on RRR (relative risk ratio, used since 2006) and revert to just using the simpler PRR (proportional risk ratio) technique.
So what, I hear you say. It’s somewhat reassuring that MHRA spotted a potential problem with its safety signal detection methods and acted on it. But it’s the opposite of reassuring, for at least three reasons. First, it is evidence that potential safety signals for the Covid vaccine (and other vaccines) were being missed as the number of Covid vaccine Yellow Cards quickly mounted. Secondly, the Commission on Human Medicines seems to have just meekly accepted MHRA’s report and recommendations (here) without asking any probing questions – such as what about the missed signals, can signals still be missed, what are other regulators doing? Thirdly, it should have been (but wasn’t) a reminder to MHRA that it should also actively follow-up individual fatal and serious Yellow Card reports and not rely so heavily on statistical analysis.
On that last point, MHRA said here that “the MHRA carefully evaluates reports of serious suspected side-effects as soon as they are received to consider whether the medicine or vaccine may have caused the event, or whether the event was likely to be purely coincidental”. However, I can’t see how that can possibly be true because it has also said that it:
- has no process for investigating individual Yellow Card reports;
- doesn’t know how many its has investigated;
- doesn’t know for all fatal and serious Yellow Card reports important things like the age of the subject, his or her medical history or the batch number of the Covid vaccine.
So how confident are you feeling about whether it does, indeed, “consider whether the medicine or vaccine may have caused the event, or whether the event was likely to be purely coincidental”?
To check this out, I’ve submitted an FOI to find out how many Covid vaccine Yellow Card reports of suspected serious adverse events MHRA has assessed as i) not related, ii) unlikely related, iii) possibly related, iv) probably related and v) definitely related. Those are the categories used for describing causality of adverse events in clinical trials, so it makes perfect sense it would use the same ones for assessing causality of spontaneous reports to the Yellow Card system – if indeed it actually does it at all. Watch this space.
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. drugs regulator the MHRA.
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Hang on a minute.. are you telling me that an organisation that’s 86% funded by the pharmaceutical industry missed some safety signals.. haha.. as my old Dad used to say.. go tell that to the Marines..
Bad phrasing there Will. Kind of thing the Pharmaceutical industry would say. “We missed some safety signals” is a bit like saying “Whoops, those tens of thousands of deaths. Silly me. Shucks, I put those in the check later folder and forgot to go and check. Darn it.”
Whoops, those tens of thousands of deaths. Something’s not working properly with the AI which detects what ought to go into the spam folder.
Sorry made that sound critical of your comment. I know you were giving a tongue in cheek response.
No problem Mind.. yes my tongue was stuck firmly in my cheek..
In other words, the MHRA did not ‘miss’ anything, but rather outright ignored and/or refused to investigate AEs, particularly if they were serious (all so-called regulatory authorities have had no problem admitting that there have been multiple reports of ‘pain at injection site’, for example).
As did all other regulatory authorities across the world – former CDC bimbo in chief Walensky recently testified before the House Oversight Committee that they had no records of the vaccination status of people being admitted to hospital for covid – even though in 2021 apparently she could categorically state that virtually all hospital admissions for covid were unvaxxed people.
When they needed to convince people to get/keep taking the poison, they ‘knew’ that everyone who was sick was unvaxxed (with a lot of fiddling the records), now they can no longer hide that it is primarily those who are vaxxed who are falling ill, all of a sudden they have no records and don’t know nothing.
It will all come out, no matter how hard they try to hide it. Why do they not see that rather than owning up to having made a massive mistake, continuing to triple-down will only increase the anger and desire for accountability, particularly on a personal level.
Yes Jane.. and it was the MHRA that requested the special software from Europe to measure the huge number of expected side effects. I can’t find the link at the moment, but if I do I’ll post it..
Yes. Fantastic work by Nick and I really appreciate his diligence in uncovering this. I do think he now has sufficient evidence that there should be a stronger level of condemnation then there is. Across the various responses this is evidence lies have been told around the number of adverse events. Evidence someone within the MHRA has been negligent, possibly criminally negligent. If I have a criticism of the article (sorry) it is that it is made to sound clerical and pedestrian, when this IMO easily passes the line for something warranting criminal investigation.
Just taking these key quotes relating to the contradictory things the MHRA itself has said:
“Last year, whilst trawling through minutes of meetings of the Commission on Human Medicines (here and specifically here), I discovered that MHRA had been concerned about the large numbers of Covid vaccine Yellow Card reports swamping the database and distorting the statistical analysis it relies on to detect safety signals.”
So it works statistically. And the FOI response received confirms that :
“[the] MHRA’s safety monitoring of medicines doesn’t rely on investigating individual Yellow Card reports and assessing causality […]. Instead, it relies on statistical analysis called ‘disproportionality analysis’.”
But then it is noted:
“[… the] MHRA said here that “the MHRA carefully evaluates reports of serious suspected side-effects as soon as they are received to consider whether the medicine or vaccine may have caused the event, or whether the event was likely to be purely coincidental”.”
So then they have publicly saidthey don’t work statistically.
“However, I can’t see how that can possibly be true because it has also said that it:
This is prima facia evidence they have been outright lying about their performance of the key task they are responsible for performing. I’m sure working in the civil service has meant Nick has a regard for his now ex colleagues. But this goes beyond politeness. In my non lawyer opinion this shows criminal negligence.
I agree Mind. If I design bridges and even one of them gets cracks, or even falls down, can I claim that “this is a statistical anomaly”? The point they miss, deliberately I suggest, is that statistics is not the way to do this. It might give a first indication (many more yellow cards than should be expected), but then needs complete analysis (with statistics, but not only statistics) of the actual reports. How many have very serious outcomes, and full report on what exactly. Even one or two should trigger consider withdrawing the drug, not the “safe and effective” parroted by the Government. This outcome has to be criminal. Heads must roll into prison. Incompetent is nowhere near strong enough.
Can’t post a link Jane, but here’s what I was talking about via a screenshot. Open in a separate tab to view clearly..
This entire industry is a sham. Quackcines are poisons – the lot of them. Been doing research on Saint Jenner the quack. A complete fraud. His poison did nothing except kill and injure. Everyone knew it including himself, lamenting near his death that the quackcines had failed. By then gov’t had invested £130 K into his quackery and was the main business partner. MHRA is a pharma funded joke with a long history dating back to the gov’t who denied that the smallpox quackery killed or injured. Nothing has changed. Just that the industry is more powerful and criminal than ever.
Sorry but I respectfully disagree. There have been good vaccines (extremely good) and there have been bad vaccines. But done properly and for the right reasons they are a wonderful tool that have saved many many lives. It’s wrong to confuse the shitshow that has happened recently + some of the WHO’s other recent failed programs with decades of great work.
This is what really saddens me, the completely unnecessary breakdown of trust thanks to the disgraceful behaviour of public health recently.
“Who has it right in the great vaccine debate – the critics, who claim that vaccines often cause serious harm, or the medical establishment, which tells us that vaccines are safe and effective and the science is settled?
Turtles All the Way Down: Vaccine Science and Myth will resolve the vaccine question for you, once and for all. By the time you finish reading, not only will you see the answer clearly for yourself, you will also have the scientific references and specific quotes at your disposal that prove it – more than 1,200 of them – all from mainstream scientific papers and textbooks, the official publications of relevant government agencies, or manufacturers’ documents…”
https://www.amazon.com/Turtles-All-Way-Down-Vaccine/dp/9655981045/ref=sr_1_1?crid=1WL5APWX8CQRK&keywords=turtles+all+the+way+down&qid=1686905666&sprefix=Turtles%2Caps%2C183&sr=8-1
…the Moth in the Iron Lung by Forest Maready..is a must read..as he says the Polio vaccine is the lynch pin they use..and if you can dismantle that you can bring the whole fraudulent edifice down….
Name me a good one (in your opinion).. just one.. and I’ll disprove it..
Can I respectfully ask what research you have done to help form your stated opinion? Have you read Virus Mania Shop – Dr Sam Bailey?
Have you read Dissolving Illusions | Disease, Vaccines, and the Forgotten History – Dissolving Illusions details facts and figures from long-overlooked medical journals, books, newspapers, and other sources. Using myth-shattering graphs, this book shows that vaccines, antibiotics, and other medical interventions are not responsible for the increase in lifespan and the decline in mortality from infectious diseases.?
Have you read Miller’s Review of Critical Vaccine Studies: 400 Important Scientific Papers Summarized for Parents and Researchers: Amazon.co.uk: Neil Z. Miller (author): 9781881217404: Books ?
Have you read Vaccination And Immunisation: Dangers, Delusions and Alternatives (What Every Parent Should Know): Amazon.co.uk: Chaitow, Leon: 9780852071915: Books ?
Have you read The WDDTY Vaccination Handbook, A What Doctors Don’t Tell You Publication: Amazon.co.uk: Edited by Lynne Mctaggart: Books ?
I have a barrister friend who impressed me very much by saying “I don’t have enough information to form an opinion…” We all need to know that there is a lot of information out there and our opinions might need to change with more information. Faith and belief are not good enough. Yes it is very upsetting to have all our foundation beliefs overturned but “a wise man (can) change his mind, a fool never does”?
I agree entirely with this. I was taken in by the vaccine scam until Covid. Now I have looked into this, I regret having agreed to the MMR vaccines for my children. Andrew Wakefield called out a potential link between vaccines and autism and got struck off for his endeavours. Virtually all vaccines have substances added (eg aluminium) which we really would not want in our bodies. The previous reported successes of vaccines is very dubious. After reading on the subject, I am now very much an ‘anti vaxxer’
Andrew Wakefield called out a potential link between vaccines and autism and got struck off for his endeavours.
If Wakefield tried to claim that autism is some kind of avoidable disease, they should have hanged him.
NB: That’s my unfettered, emotional reaction to that after suffering about 44 years of more or less continuous abuse for the horrible sin of being different, especially, oftentime preferring to be alone over partaking in other people’s noise-generating group rituals (I really regard them as some kind of aliens with mostly incomprehensible behahviour).
NB^2: I have about as little sympathy for the people who claim that down syndrome Gretna with her endless fascination for attention whoring must be an autist because that’s somehow cooler than having a learning disability.
Andrew Wakefield was the first really prominent ‘sacrificial lamb” to the Pharma beast. His study didn’t say the two were definitely linked..in fact if you ever get to read it, it is fairly mild..the conclusion was that there was something worthy of further investigation…..that’s it…..
Having seen what happened to all the doctors etc who didn’t kowtow to the Convid narrative, I now see, very clearly, their campaign against Andrew Wakefield……
The Highwire, with Del Bigtree and the ICAN studies that they have done, I think clearly shows there is a link….
I remember a funny game people were playing with me in 3rd year elementary school (could have been 4th): A bunch of guys would corner me somewhere and try to kick me such that it really hurt. I, in turn, would try to kick them as well, as there was little else I could do. That must have happened some time between 1981 – 1983. That clearly shows that some people already had a manical hatred for autists way before the MMR-vaccine was even invented and I take Wakefield’s statements as a superficially more learnt manifestation of that.
Good post.. and one that very much aligns with my experiences and now opinions..
Jenner’s dates were 1749 – 1823. Given the state of knowledge at the time, ie they had no idea about disease vectors, sepsis, antiseptics etc etc, all his potions would have done is transfer infectious agents into humans, from human to human and animal to human. Vaccination would have spread TB, syphilis, smallpox and many other diseases, and doubtless caused bacterial infections and sepsis as nothing would have been been sterilised. They transferred pus and infectious material from pox scabs into wounds they made on children. 100s of thousands probably died from this practice. It spread smallpox throughout the world, keeping epidemics going for 200 years more than had nothing been done.
Routine antisepsis wasn’t even recognised or used in hospitals until after the 1860s, Semmelweiss had had his ideas of the need to wash hands between the dissecting room and maternity ward trashed by the medical professors! So you think that stuff used in smallpox vaccines 60 years earlier would have been safe? No-one knew about cancer causing viruses until the late 20th century, you think all those vaccines for children brewed up on minced green monkey kidneys were safe?
There is no proof any vaccine ever prevented disease; diagnostic criteria have been adjusted, environmental poisons like DDT ignored. Clean water supplies were universally available in the US and UK in the 1950s, why would polio break out in that era?
Ever looked into organophosphate poisoning? Symptoms are runny nose and eyes as your body tries to wash it out. I wonder if a proportion of hayfever sufferers / “summer colds” are actually being triggered by spraying of pesticides etc on fields.
I had a coworker who was going to “space out” all the numerous jabs young children get these days. I half wonder if he said that because it was more palatable than telling people he and his wife weren’t going to vax his children at all. The three of us had the same mandate-crazed employer but I retired just as the pressure was mounting. He was very much a respect-authority kind of guy but I do hope he and his wife got religious accommodations or were able to stay strong until the mandate was lifted.
Thanks for this. The type of article that makes DS so valuable. More of this kind of thing please.
As for the MHRA, it seems like their concerns were more that the large volumes of covid “vaccine” related stuff would mess up their reporting rather than worried that it might be a sign that the “vaccines” could be dangerous.
Yes. It’s like saying “OMG there’s a safety signally so stupendously big, it can’t be true” and then ignoring it.
Which of course is utterly incredible (as in not credible) as a response. So more likely this is an attempt at an excuse by management now worrying about jail time for the charge of negligence or worse.
So MHRA gave emergency use authorisation to a gene therapy but used the less rigorous vaccine assessment criteria rather than gene therapy criteria to authorise. Then when the safety signals started flashing crimson the MHRA decided to assess the signals not against other vaccines but against other drugs.
In layman’s terms, this seems to be saying that the safety profile of the mRNA Gene Therapies was so bad and frequent, that it had to be removed from the analysis because it negatively affected the baseline for the other vaccines. And yet they never bothered to follow up to the logical conclusion about these barely tested novel shots. Amazing but, not surprising all the same.
Which leads to the question: Is it the mRNA technique itself that is hazardous, or just the C-!9 product? If it’s the first possibility, money will say no to anything that undermines the market, if the trade is interested in adopting it for many other “vaccine” products.
It has been known for some time (lots of literature) that MRNA is very dangerous, with many reports of test animals dying in number of all kinds of things. This has been ignored, and given to humans, along with a lot of lies to make them accept it. The latest bad news is that the MRNA travels all over the body (they lied about that, “stays at the injection site”), and the spike protein is now found in large quantities in mens testes, which is very allarming. In these men fertility is seriously compromised. Suprise, suprise.
That’s really too good to make it up. A laymen’s summary could be: The safe and effective COVID vaccines are causing such an enormous amount of harmful side effects that simply ignoring them didn’t work anymore and action was urgently called for. The MHRA settled for deleting them before doing further analysis of safety data. After all, detecting that a highly profitable product is as ineffective as it is dangerous would benefit no one. And there’s a silver lining: As opposed to Thalidomide, covaxxing women doesn’t result in crippled children which remain an embarrasment for the medical establishment for decades to come. They’re safely and effectively killing them instead. Much better.
I wouldn’t bet on the children born to mothers injected with the C1984 not having a poor quality of life. Myocarditis has already been revealed in infants born to such mothers.
Why is sarcasm always wasted on the internet??
Myocarditis is also a good condition. Nobody can see that without instruments.
You’ve lost me.
Children affected by Thalidomide would be born without proper arms and legs, ie, with their hands and feet directly attached to their torso. That’s a very visible and very shocking disfigurement. Covaxx damages are invisible to the eye. That’s much better this way for the people who want or wanted to sell them.
Will the ill effects of the vaccine in children show up in time to affect the 2024 US election with one candidate espousing “anti-vax” theories? Maybe without the visuals of missing limbs, head-in-the-sand mothers can persuade themselves that their children’s poor health is just bad luck–nothing to do with the insane decision to try a new medication on their pregnant selves or on their young children.
This screenshot should tell you all you need to know about the devious MRHA.. as I mentioned in an earlier post to Jane Doe.. this despicable organisation were gearing up to monitor vaccine injuries before they started..
For some reason I can’t post a link.. I’m sorry about that..
One of the weird factors is that in the world of medicine, and pharmacology, the concept of safety and acceptable risk is quiet different from other industries. It is evidently true that there are many medical procedures that are worthwhile compared with the alternative of giving up to whatever, but it appears that it somehow clouds their attitude to the whole field, including the current matter under discussion.
If you compare the concept of “Safety Integrity Level” (search for that term if you like), with the “safe and effective” mantra that has been used recently, you’ll see that medicine is really a foreign country, compared with the rest of industry.
“First do no harm”, should never be forgotten. If the cure is worse than the disease….
“Oh, we are dreadfully sorry. We did not notice the danger signals because we were swamped with danger signals.“
Nick is too polite, we all know the pharmaceutical funded MHRA did exactly what they were paid to do.
Exactly..
Blindfold themselves? Is that what you mean? I certainly think so.
What is also very concerning is that they are putting these products into all our animals, farmed and pet.
Either I have missed something or I don’t see why a large number of Covid yellow cards should prevent proper analysis. The reports are presumable stored in a database (data warehouse) and multi variance analysis is done as a matter of course.
in very simple terms, if there are typically (say) 100 reports a year for condition or treatment “X” then 100 or 1000 Covid reports per month, week or day does not prevent proper supervision.
it seems to me MHRA is yet another expensive Quango that just doesn’t work.
Am I missing something?
Where is common sense?
If side-effect reporting for any drug overwhelms the system, surely the first response should be to halt the use of this drug whilst you work out what is going on, rather than continuing its use whilst you work out what is going on?
That was always the way.. but not with the clot shot..
It appears they still haven’t worked out cause and effect! It is too politically damaging for too many people. However lies usually come out in the end, and they will, and have here!