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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‘Town Crier Championship to be held in Silence’.
Servile surrender to the new puritanism, might as well write an essay about how you would win a game of football.
5 seconds of thought = Each Town Crier takes it in turn to do his/her thing from the town hall clocktower to the Socially Distanced crowd of the great and the good down below. Simples.
I thought that one had to be just taking the piss.
… but then I woke up, and remembered the last year of the piss being constantly taken.
‘Letter to an MP from a daughter’.
Clearly the author and her mum deserve our sympathies and let’s hope they go out walking again soon.
Going off topic, the letter says that her mum recieved a second vaccination ‘several weeks ago’.
“Despite all best efforts Covid did enter the home in January taking mums best friend .”
She does not link the two.
These care homes sound just like prisons. Better to take your elderly relatives out of them and bring them home to live with you, so they can have quality lives before they die.
‘Kier Starmer has betrayed a chilling truth about lockdown.’ Jonathan Sumption.
I saw Starmer being interviewed by the BBC after his fracas with the Bath hero publican and noted that he accused Rod Humphris of denying the Pandemic which he had not.
I was sure that I could remember Starmer further accusing him of ‘*spreading misinformation*’ about the well known negative effects of lockdown but could not subsequently find the clip, perhaps removed, so did not mention it yesterday.
I am grateful to Lord Sumption for confirming my memory.
I’m afraid Sumption betrays one or two fixed misapprehensions.
“Why has Sir Keir failed to live up to his initial promise?”
What initial promise? The recent leadership election was the first in which I couldn’t see a candidate worthy of any vote.
And then :
“No sensible person disputes that there is a pandemic or that it is serious.”
Sorry – but facts are facts. It is only a ‘pandemic’ because the WHO eliminated the part of the definition that related to unusually high mortality. In terms of ‘seriousness’, judged by mortality, this is at a lower level than a third of ‘flu seasons. And this in a country that has a relatively high rate!
Yes, and below the line I also pointed out to him that all of this evil is not just murderous and wilful ignorance – there is clearly a plan (Agenda 30 etc)…and he needs to re-analyse. Lord Sumption’s use of ‘limited/trimmed argument’ reminds me a bit of someone else…..
Kev’s response was basically ” He’s entitled to have an opinion, but I profoundly disagree with his opinion. So much so, that I got Big Vern to rough him up a bit”
The last year we’ve seen politician, after politician being caught in what would normally be career ending episodes and yet, not a single one has been kicked out.
Dan Wooton in the Màil also comes down in favour of the Hero of Bath, noting how he was bullied on Good Morning Britain the following day (worth watching btw).
Dan also says
“I believe what the government is putting us through to socialise is inhumane.
On Friday night I booked to see five friends in one of those outdoor dining pods. But it was rendered completely useless because the sides had to be left open to the buffeting winds thanks to another stupid state sanction.
I deeply resent having to sit outside in the freezing cold to see a loved one”.
Good. Now you know how smokers felt after the indoor ban with Council wonks worrying publicans about what constituted a ‘covered smoking area’ or what they considered to be an ‘enclosed’ one.
Not off topic because it’s all part of the same divide and control strategy.
Not at all like being a smoker, however (I was one). Smoking genuinely affected other people other people (as I came to realize).
My point was about forcing smokers not only to go outside, fair enough, but getting petty and vindictive about how little shelter they were allowed from the elements. Non smokers were not involved.
Probably just a limited trial run to gauge reaction for the big one.
There is a designated smoking area at my small regional airport. It consists of a bus stop shelter from which the perspex walls forming the sides have been thoughtfully removed.
If not the shelter is considered an ‘enclosed working space’ since someone has to clean it once in a while.
Hahahah….loved the pic of celebrity yachts spelling out shite. Who are they appealing to…. aliens or satellites?!
It’s a satire site.
By ‘they’ I was referring to the celebrities with their yachts….message seen from above!
I keep reading reports of
many people not wearing masks in supermarkets and putting staff in danger on e-news reports.
My wife and myself go shopping in our local Sainsburys at least once a week since mask wearing became mandatory and I have seen no more than 6 people (exempt) not wearing them in all that time.
So where are all these people who go to supermarkets that don’t wear masks?
Perhaps I live in a parallel universe?
I see a far higher proportion of unmasked staff with Exempt lanyards than customers and good for them.
Risk to their health from extended wearing is much greater, as we all know.
Agreed.
Our younger son is one of them.
Tim Spector in the ZOE app disparaging Vit D. He is however focussing on it’s ability to stop people catching Covid rather that it’s proven ability to enhance the immune system, which is designed to fight infection not stop it.
Although the App has done some good I believe Spector is a ‘tame critic’. He makes it look as if he’s standing up to ‘The Science’ but when it matters he’s totally ‘on message’.
That’s my impression, too.
Never trust any app especially if its collecting medical data.
Inspiring: Celebrities Spell Out ‘We’re All In This Together’ With Their Yachts.
Photoshop on steroids. I reckon that only six different yachts are used.
“UK Cabinet Office Minister Michael Gove arrived in Israel Monday night on a fact-finding mission to see how the country is opening up from COVID-19 restrictions.
He and Jonathan Van-Tam, one of England’s deputy chief medical officers, met with Foreign Minister Gabi Ashkenazi Tuesday morning.”
Be afraid. Be very afraid – wherever the state of Israel pops up its head.
The links between Israel and the black arts of the government, Cabinet Office, ‘security’ services and international affairs in general well known and documented, usually manifesting itself in the interference of what, for shorthand is called the ‘Israel Lobby’.
Never good news for democracy and liberty.
Just one word; Rothschild.
May 6th and a habitual Tory voter?
Then do this quick test:
1. Type Conservative into your search engine
2. If you are or ever have been a Party Member, please apply some critical thinking
3. Ding, dong the conservative party is dead, long live the WEF Great Reset party!
4. Cut up your membership card and join the resistance
Just a thought; if more than 6 people meet up/if you don’t wear a face nappy/ if you don’t eat all your meals outside/ if you don’t use a gallon of hand sanitizer each and every day then “You have blood on your hands and everybody is going to die”.
Thousands of unmasked football fans gather to protest, etc and ( unless I’ve missed something) there has not been a squeak from the government, heath experts and most of all the MSM.
It has occurred to me that the ‘spreading misinformation’ comments made by that idiot Starmer may have opened a door. They were made outside of the protected bubble of Parliament hence they are subject to the laws of slander/libel. If challenged in court he would have to prove his statements were true. At the very least this would provide a public airing of the arguments on both sides, something that the Government and MSM have suppressed up to now.
I for one would chip in to a Crowdfund for this. Maybe the FSU might take a look?
To be frank, you couldn’t build a viable court case on that issue – and trying to do so would cost a fortune. It’s not slander or libel.
That’s debatable. It’s an accusation of lying from a public figure. A statement that simply isn’t true and is intended to damage the reputation of the target.
Also known as oral or spoken defamation, slander is the legal term for the act of harming a person’s reputation by telling one or more other people something that is untrue and damaging about that person. Slander can be the basis for a lawsuit and is considered a civil wrong