How can a vaccine that was once actively promoted by the Government and celebrated with knighthoods, standing ovations and even Barbie dolls rapidly lose its credibility? Although the company claims it’s due to commercial reasons, early indications of potentially harmful side-effects were overlooked, resulting in significant costs to patients and its ultimate downfall.
At the holder’s request, the marketing authorisation for Oxford’s AstraZeneca vaccine Vaxzevria has now been withdrawn. The withdrawal is effective May 7th 2024 and is for the EU, the beginning of a worldwide withdrawal.
The company has announced that it is withdrawing a vaccine due to a “surplus of available updated vaccines”. However, the AstraZeneca vaccine has come under scrutiny for potentially dangerous side effects. AstraZeneca recently admitted that the vaccine, in rare cases, causes Thrombosis with Thrombocytopenia Syndrome, which has been linked to at least 81 deaths in the U.K.
To some extent, the commercial decision could be seen as a reasonable explanation. The market has been saturated with SARS-CoV-2 vaccines. By 2022, 42 vaccines had entered phase III clinical trials designed to test efficacy in humans; 17 vaccines had to be abandoned due to problems, and 22 were authorised for use. This glut of vaccines has seen Sanofi and GSK’s next-generation COVID-19 booster Vidprevtyn Beta withdrawn, also at the companies’ request.
In 2022, Pascal Soriot, the CEO of AstraZeneca, announced that his company would not be in the vaccine business for the long haul. Production delays and the vaccine’s short half-life issues have added to their problems. Although it’s a practical decision that safeguards the company’s reputation and limits its losses, much of what passed might have been avoided if the signals of harm had been acted upon.
The speed at which the vaccines were developed and tested was unprecedented. But has the haste meant necessary steps in accruing the evidence were omitted?
For example, followers of the Cominarty series know that Pfizer and BioNTech did not carry out carcinogenicity studies before submitting their product for emergency approval. The regulators let them get away with this.
The vaccine’s vehicle nanoparticles go everywhere in the body instead of being concentrated in one place (the injection site).
Before entering the market, the AstraZeneca vaccine similarly lacked carcinogenicity and even genotoxicity studies.
At the outset, the trials that led to approval were too small to detect rare harms. A simple rule of thumb is that you need three times as many subjects to observe an outcome in a trial when you assume that the adverse event of interest does not normally occur without the vaccine. So if a rare event happens in 1 in 10,000, you need at least 30,000 people in the trial to detect it. Such rare events matter when you decide to give a drug to millions of people. An event that might have seemed innocuous suddenly becomes widescale when you deliver the intervention to tens of millions.
This explains why Bell’s Palsy, a rare autoimmune condition, suddenly became extremely frequent in ophthalmologists’ clinics.
The lack of detection during the trials means the regulatory bodies should have been hyper-vigilant in the post-marketing phase to detect severe problems.
Substantial problems with underreporting of adverse drug reactions hinder the ability to detect signals and assign causation. In July 2023, we warned MPs that the Yellow Card system should come with a warning.
The U.K. regulator MHRA says it takes all reports of fatal outcomes in patients who have received a COVID-19 vaccine very seriously and reviews every report carefully. However, it does not attempt to assess or compare the safety of different vaccines. This occurs because the system uses inadequate reporting to prevent any analysis. MHRA does not hold any data on the metabolism of the modified RNA.
Neither has it a clue about the biodistribution of spike protein concentration of apparently pretty much all licensed Covid vaccines.
It does not have a clue as to the extent of serious harm underreporting, which could be as high as 98% or more. That makes any post-registration assessment of the incidence of harms complete nonsense.
This is what MHRA told a member of the public:
The MHRA does not hold an estimate of the degree of underreporting to the Yellow Card scheme, nor an estimate of the actual number of deaths and adverse events likely to be related to the COVID-19 vaccines.
Add the MHRA’s refusal to make public data on the relationship between deaths and vaccine doses for “commercial confidentiality reasons”.
You have the description of a system that is broken beyond repair. The MHRA famously described itself as a “facilitator”, but of what, we wonder?
Systems across other countries are better at identifying adverse reactions to vaccines. Health authorities in Denmark, Norway and Iceland suspended the use of AstraZeneca’s COVID-19 vaccine in March 2021 following reports of blood clots. On April 7th, the U.K. JCVI advised the AstraZeneca vaccine should be restricted to people aged 30 and over because of the risk of blood clots.
Yet, at the same time, the MHRA was “not recommending age restrictions in COVID-19 AstraZeneca vaccine use”. The MHRA’s scientific review of U.K. reports of blood clots with lowered platelets concluded the evidence of a link with AstraZeneca’s vaccine was stronger, but more work was still needed. On May 7th, Britain restricted AstraZeneca to people aged over 40. However, within a week, Norway permanently removed AstraZeneca from its vaccine programme, and several countries followed suit.
The Telegraph was among the first to imply a causal link between the vaccine and blood clots. The regulator’s dismissive response was unacceptable: a senior official at the MHRA warned that the newspaper “would be banned from future briefings and press notices if we did not soften the news”.
Ultimately, safety is what defines effective medical intervention. The Hippocratic school says, “Practice two things in your dealings with disease: either help or do not harm the patient”. No interventions should be immune from interrogation – questions must be raised and not dismissed. It’s at the heart of the evidence-based approach.
The MHRA’s approach to patient safety requires a radical overhaul. MPs are right when they say the MHRA’s failure to flag Covid vaccine side-effects must be investigated. The pervasive problem requires legislative changes regarding who is mandated to report adverse reactions and changes to how the MHRA is funded. The U.K. regulator has badly let down those who suffered the most severe of consequences.
No intervention should come with protected status. Past problems and the withdrawal of the Oxford AstraZeneca vaccine mean we must remain vigilant.
Dr. Carl Heneghan is the Oxford Professor of Evidence Based Medicine and Dr. Tom Jefferson is an epidemiologist based in Rome who works with Professor Heneghan on the Cochrane Collaboration. This article was first published on their Substack, Trust The Evidence, which you can subscribe to here.
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$cientism. No data, no common sense supports the cult of Klimat. Money and power is all they have.
I was reading a history of the middle to late Bronze age and going over Isaiah the 8th century prophet astronomer. You want climate change? Go back to 1500 BC and 750 BC. Land turned upside down. Empires, states destroyed. Volcanoes, ash, lava en masse. Endless earthquakes. Global catastrophes. Massive floods. Rifts in the ocean appear – one stretches 2 x around the globe. Sun blotted out. Rotation and tilt changed. Number of days increased. Dead everywhere. Global. Every culture has the same story. The civilised became nomadic. Massive swings in temps including in 1500 BC an ice age in the north. Unending precipitation. But what do we know about it today? Nothing.
The cult vomits the Billions of years with not much happening. Oh but today the rounding error 0.04% plant food, and our 5% of it, from the non-existent fossil fuel (hydrogen-carbon liquid has nothing to do with a f*ing fossil) is the end of the world. Horseshit all of it. We are clueless. People can’t even tell me how coal seams form. Or why gold is littered only at the surface.
This theory has been around long enough for the earlier predictions to have been tested against actual climate data and the models refined so that their output matches the observations. This is how I was taught that scientific knowledge (as opposed to speculation) progresses.
All I see is continuing divergence between prediction and reality, and a lot of very nasty shouting at people who point out this inconvenient fact, followed swiftly by changes to the historical record.
Saturation: is this the fellah?
https://arxiv.org/pdf/2006.03098.pdf
No one wants to silence other people on issues such as black holes or evolution and all other matters of science. It is only politicised issues where you get claims of “settled science” or “all scientists agree” etc. because no one is trying to reorganise the global economy and gain control over the worlds wealth and resources based on what might or might not be true regarding black holes or evolution. But more and more government are playing a bigger and bigger role in shaping the outcome of scientific research and inquiry on hugely politicised issues like climate, where the symbiotic relationship that has always existed between governments and scientists is clearer than ever before. Climate change “science” is almost entirely funded by government, and I often hear that “deniers” of climate change simply want to protect the agenda of fossil fuel company’s. But hold it right there.——What makes those people think that governments don’t have an agenda? Ofcourse they do. It is UN agenda of Sustainable Development. If there is no evidence that dangerous changes are happening or will happen because of our CO2 emissions then that whole political agenda collapses. ——That cannot be allowed to happen. The urge to micro manage very aspect of people’s lives depends on the “science”. But there is a very big difference between “science” and “official science”. One is the genuine search for truth and the other is the excuse for public policy.
Not quite true, sadly, though you’re right that a large factor is politicisation, but sometimes that is from the scientific community itself, and not just from governments.
Scientists and other academics have been cancelled or even sacked, on many occasions, for raising doubts about the adequacy of Neodarwinian mutation/natural selection as the sole engine of evolution. And it began way back when the Modern Synthesis guys took over the professorships and journals back in the 1920s and 1930s and started elbowing out the formerly dominant Structuralists, Orthogenesists and Saltationists. It worked so well that most people now don’t even realise that Darwinism was in deep scientific trouble from the end of the nineteenth century until the 1920s.
Now, Schools, universities, media people and governments all have a lot of money and jobs invested in keeping the paradigm’s wheels on. Hence all dissenters, even atheists, will find themselves labelled as “anti-science Creationists” in exactly the same way as others are “Far-right Transphobes or “Anti-vaxxers.”
But that’s not a unique case – for years it was hard to make your way in cosmology if you disputed string-theory, and even now the community wants an even bigger multi-billion dollar collider rather than admit that the theory is junk. And remember how governments want to look “sciency” by investing in multi-national projects like the Big Collider.
Likewise, the linear-non-threshold model of damage from radiation, PM2.5 and a host of other politically-hot potatoes arose from Herman Muller’s use of his academic and political clout to make it a scientific axiom and suppress evidence that contradicted it. Once more, there is much vested interest in regulating all these “toxins,” not to mention talking up the Armageddon view of nuclear war to maximise public paranoia and so control geopolitics.
My main point is that science’s self-promoting myth of objectivity and self-correction, which hides an all-too-human reality, makes it extremely vulnerable to being corrupted by government money, and used to awe the public into compliance with largely political projects like climate-change, COVID, and the rest of it.
Sensible reply, and I take your point about politicised aspects of other bits of science going on, but Climate Change has to be the Mother of all Politicised scientific issues, which in reality isn’t only about science. It is also an economic, moral and social issue.
Changing you mind
the old Spanish Proverb says;
”A wise man changes his mind, a fool never will”
Of course, in our world changing your mind on things, be they mRNA vaccines or climate change; challenges so much power, money and vested interests that it is not an easy thing to do. To challenge climate change thinking is akin to challenging Christianity in the time of the Spanish Inquisition and will be met with something of a similar reaction. And so my thanks to Chris and those like him who persist in pointing out that the climate change Emperor is actually naked.
Everything pointing towards negative efficacy of the jib jabs and more hospitalizations if you’ve had one or more. Obviously not safe but they’re certainly ”effective” at something.
https://twitter.com/_aussie17/status/1666657074607198208
Computer models are garbage. There is no empirical evidence of man-made global warming, all such predictions are based on computer models.
Note that TCR range is much narrower than ECS and narrowed significantly from CMIP 1 to CMIP 5 (although it broadened a little with CMIP 6). ECS is a strange concept anyway. There is never going to be a stable equilibrium with double CO2.
In the end this is like saying the science behind smoking and cancer drug is not settled because there are such a wide range of predictions as to how long a smoker will go without getting cancer.
And in today’s other news….
If Climate Science is about being able to accurately predict future global temperatures then this science is not settled. The wide range of predictions from the various models evidences this fact.
Yep but we can see what smoking does to lungs. Your analogy is a poor one. PS There have been times with 20 times as much CO2 in the atmosphere with no runaway global warming taking place and current levels are historically very low. If you know the correct amount of CO2 that should be in your ideal planet please let us know.
Why are governments basing their policy on climate prediction models, which have not once given accurate results? I think climate modellers aiming for accuracy are no better than medieval wizards trying to find ways of turning base metal into gold. Proper scientists know that humankind cannot know or evaluate all the factors that control our climate. They also know CO2, the gas essential for life, and currently consisting of 0.042% of our atmosphere, cannot be a main influence controlling our climate. Only scientists financed by organisations benefitting from net-zero, politicians making loads of money or gaining power by talking rubbish about it, or idiots believe this rubbish. I hope soon many more idiots start to realise their stupidity, and we stop our politicians from aiming to cripple every aspect of our life which is the effective objective of net-zero.