The Health Advisory and Recovery Team (HART), an expert group of medics, clinicians, scientists and academics, has published an article reminding the U.K. drug regulator, the MHRA, that it initially set out a solid plan of how it would monitor the safety of the Covid vaccines it had approved for emergency use. It asks what happened to that plan and all the vaccine safety reports promised under it.
The article starts by setting out the ways in which the MHRA has fallen short in its duty to regulate the vaccines.
The U.K. drug regulator, the MHRA, did not carry out the toxicity, biodistribution and pharmacokinetics studies that are required of new drugs because of the political pressure to approve. However, nearly two years have passed since then and the MHRA has not set a deadline for the pharmaceutical companies to provide these data. The MHRA allowed the treatments to be presented as vaccines like any other when they are a novel class of agents, never before approved for human use despite the technology being around for decades (mostly because they have been dangerous and ineffective in previous human trials).
The trials should have remained placebo controlled and ongoing for two to five years minimum in order to establish an understanding of their safety. Authorisations were based on two months of safety data in healthy people and the MHRA allowed the pharmaceutical companies to vaccinate the placebo control group such that further safety data could not be collected.
Approvals for children were unethical when the trial data did not show evidence of a benefit from the drug to the children themselves when there was already good evidence of short term safety issues and when long term safety data was inevitably unavailable. Approving for younger children after the arrival of Omicron was even less defensible.
The MHRA failed to notice that the total mortality in the trial was higher in the vaccination group than the placebo group, showing no evidence of an overall mortality benefit, and the serious adverse reactions were much higher in the vaccination group such that one in 800 participants were hospitalised for a non-Covid condition, which far outweighed the small reduction in Covid hospitalisations.
Dame June Raine, the head of the U.K. drug regulator the MHRA, appeared to take a unilateral decision to change its role. She said “the Covid pandemic has catalysed the transformation of the regulator from a watchdog to an enabler.”
The regulator receives 86% of its funding from industry fees. In 2005, the House of Commons’ health committee expressed concerns regarding the U.K. drug regulator that pharmaceutical funding could lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies”. Do we want a regulator which sees itself as an enabler of pharmaceutical companies?
At the outset, the MHRA set out an excellent plan for safety monitoring of the Covid vaccines which was required because of the minimal safety data from trials and the planned extensive rollout. It described this as a four part system of “proactive vigilance… to rapidly detect, confirm, characterise and quantify any new risks that were not detected in clinical trials”.
The four parts were:
1. Have doctors report concerns to the Yellow Card system
2. Actively analyse GP data on a weekly basis to look for increases in any suspected condition
3. Proactively survey to follow up a sample of people after vaccination
4. Academic studies of large medical databasesThe only publications from the MHRA in the last two years on safety have been the Yellow Card reports and even these do not divulge the number of people affected or the seriousness of the reports.
Where are these weekly analyses of GP data, proactive surveys of the vaccinated and academic studies of large medical databases? We’re approaching two years into the rollout – where are all these promised reports? And why is no one apart from HART and a smattering of others asking these questions?
Worth reading in full.
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Once the MHRA described themselves as enablers, they essentially became the marketing department for the companies making the drugs. GPs are their sales force.
As MHRA receive 86% of their funding from the pharmaceutical industry they are simply doing exactly what they are paid to do. The notion that this regulator has any interest in the safety of big pharma products or protecting the public from them – is delusional.
A better description than “enablers” for drug regulatory bodies around the world would be “enforcers”.
Australia’s TGA is 96 percent funded by industry.
Makes your MHRA at only 86 percent seem positively uncompromised.
Can anybody competent at sums advise if the following is correct?
96% is four percent short of 100.
86% is fourteen percent short of 100.
Therefore this proves that the MHRA is publicly funded by a factor of 350% greater than the ATG.
(14 ÷ 4 = 3.5)
If this is a load of cobblers, have a laugh
It’s NOT a load of cobblers. It’s the opposite: It IS a load of cobblers.
In simple terms….
For every £100 the MHRA receives in funding £86 comes from big pharma
The biggest red flag to me was the agreement allowing the manufacturers of the gunk to avoid liability.
Summed up exquisitely by that cartoon of the victim just about to be jabbed enquiring somewhat anxiously, “Does it provide immunity?” and the nurse, as she inserts the needle, responding, “Only for the manufacturer”.
At present, there appear to be discrepancies of related data, depending on which organisation you deal with – such as the output of the ONS and the UKHSA, according to John Campbell via his YT entry of 18/10.
Here’s his link: https://www.youtube.com/watch?v=kzLlSXsqrxc&list=WL&index=4
Least said, soonest mended. That’s also what I say to myself when I think about putting myself in the hands of a profit driven doctor.
The Daily Sceptic is a proper rogues gallery today. First Stephane Bancel and now this woman.
Please watch the video, there is so much packed into this it’s difficult to digest in one sitting. In short she:
A must-watch.
Is there a link please?
Apologies, if I had followed the link in the HART document I would have answered my own question!
I tried to watch all of Raine’s presentation but gave up around 75% of the way through; before I was physically sick.
Her sanctimonious, humble little me approach is typical of an individual speaking to her college and boasting about what a wonderful education she got from these surroundings. Such boasting would, of course, go down very well with such a friendly audience. Hence all the sycophantic laughter at her ‘bon mots’.
It seems she spent 7 years in academia, a BA in physiology, followed by a MSc in pharmacology from Somerville and then a MB Ch from Oxford Medical School. But she didn’t seem to use any of this expensively gathered education in helping out patients. Perhaps she decided to use her time raising her children and nursing her sick husband?
So how the hell does an individual with all this extensive medical knowledge allow a totally new injectable product to be called a “vaccine” and be passed through the regulatory process (see the earlier posts by Dr John Flack) faster than 5H1T off a shovel?
Political pressure is the only answer, political pressure from a bunch of ignorant politicians who were spooked by the idiotic forecasts from the numptie Ferguson and his grossly inaccurate models.
I just loved her quotes: “Independence is key to public trust”, “we keep people alive” and especially “we hold things up”. The last quote is how the MHRA usually works, without kowtowing to political pressure.
The MHRA has recently taken over 3 years to approve the reclassification of a locally applied oestrogen product from prescription only to pharmacy supply, in spite of over 30 years use of the prescription product in the UK. Why this massive delay? Because their ‘expert advisor’ wanted the product to have extensive warnings placed on the product as if it were an HRT product taken systemically. A year’s dosage of this topical product contains as much oestrogen as one single HRT tablet.
So, 3 years to approve a known, safe product vs 6 months to approve an unknown new medical product?? And she said “we could only find out about side effects in clinical practice” when she knew that all the side effects were being ignored. The woman is a witch and should be prosecuted for manslaughter at least
I remember watching this vid months ago and my conclusions then are no different now. If we ever get June Raine in court she would be wasting her money in employing defence lawyers because there is barely one sentence in this whole dreadful, sanctimonious lecture that does not condemn her on numerous counts, not least of which is crimes against humanity.
Well said, HP, I’ll look forward to that day!
Thanks Aethelred.
The lack of any active monitoring of the safety and effectiveness of the vaccines is negligence on a massive scale. There is no excuse for this — it is standard practice for normal drugs/treatments (‘phase iv studies’) and quite why it wasn’t done for the Covid vaccines is beyond me.
We could have done long term prospective matched cohort trials right from the start, and even if the earliest opportunities were missed, we could have done them for later roll-outs (lower ages and for later doses).
Do you really believe there hasn’t been active monitoring?
I don’t believe that, I never did. I bet pfisser and murderna know exactly what their poison does and why. The fact that they won’t publish these data or even acknowledge their existence merely lays the ground for future fraud trials and whole-sale stripping of liability. I really am surprised by lawyers being so slow off the mark – this is going to be the bonanza to end all bonanzas. Angry citizens are going to dream up punitive settlements that will exceed pfisser’s worst nightmares. Courts and politicians will allow the liability shield to be thrown aside, someone is going to have to pay the price and the politicians are going to make damn sure it isn’t them.
Have some data….
https://phmpt.org/pfizers-documents/
Sorry, what exactly is that data? Is that what the court ordered Pfizer must release? If it is, I think that’s just the documents that Pfizer released to the FDA to get their poison licensed, but doesn’t actually include the raw trial data. Someone can correct me if I’m wrong.
I can believe governments have not been monitoring it, because they would rather not know, but I cannot believe that people like Chris Whitty don’t know very well what they should be doing but are not. Evil.
“I bet pfisser and murderna know exactly what their poison does and why.”
I have been posting this on here for months. These gunk injections have been brewed to a recipe (s) – kill immediately, kill in the short term, the medium term and the long term.
The immediate and short term are playing out as planned. The medium and long term? Awaiting results. Let us not be frightened to face the reality of depopulation because it damn well is happening. As planned!
“why it wasn’t done for the Covid vaccines is beyond me”
Folly and evil, same as what was responsible for the rest of covid crap.
I have to second what other commentors already wrote (or hinted at): That this wasn’t/ isn’t being monitored seems very unlikely to me because if the outcome had (as everyone expected) been positive for this kind of medication, that would have been a huge and politically very convenient PR boost. Which suggests that it was monitored but the outcome was anything but. Hence, the attempt to bury this by claiming it was never done.
June Raine says in the video above: “We’re very close to the Ghanaian situation and we exchange safety signals with Ghana, with Nigeria, Ethiopia, South Africa and Kenya – every week we’re looking at signals just to condition that local decision-making and confidence in benefit / risk.”
There’s that conditioning word again. Africa: ker-ching.
At the end she quotes from A Tale of Two Cities. She doesn’t quite understand what superlative means and I think this reveals rather a lot.
The blood starts boiling when I watch this homesy, mumsy woman with her little side jokes talking about the jab as safe and effective. She reminds me of that character from The Handmaid’s Tale – Aunt Lydia – so completely and utterly deluded on her mission that brooks no other narrative, no other truth or point of view than the one she believes in. Getting all her numbers and graphs in order, little joke, audience laughs…. It makes me hopping mad to know all the vaccine injured are out there – real people who had futures, work, families, hobbies, sports and son who all did the thing they were led to believe they had to do to protect granny or their work colleagues. People who are now in constant pain. Raine needs to go to these people’s homes and meet them and talk with them. She needs a rude awakening and as for that ‘build back better’ moment, is she so completely and utterly lost and co-opted that it’s all a big joke to her? It’s her relative normalcy that gets me – I just don’t get it with her.
The banality of evil.
Yep. You beat me to it Chris.