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At the holder’s request, the marketing authorisation for Oxford’s AstraZeneca vaccine Vaxzevria has now been withdrawn.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 This glut of vaccines has seen Sanofi and GSK’s next-generation COVID-19 booster Vidprevtyn Beta withdrawn, also at the companies’ request.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.
To join in with the discussion please make a donation to The Daily Sceptic.
Profanity and abuse will be removed and may lead to a permanent ban.
What is astonishing and beyond comprehension is that nobody will even face any prison time for the deaths, destruction and sheer misery that they knowingly unleashed via these poisonous “vaccines.”
I will never get my head around this.
Never forget. Never forgive.
Furthermore Astra zeneca, like Pfizer etc are protected from legal action because our and other Western Governments have given their failed and dangerous injections protection from legal action as a result of deaths and injury caused by the failed, forced injections, Astra Zeneca walk away and keep the in excess of 15 billions in profit, whilst we the highest taxed, and for many the forced recipients of the gene therapy have our money, taken by our Government to pay the compensation that Pharma with the colusion of Government and the opposition caused.
And there was that smug prick Nicki Campbell on Five Live talking about contaminated blood, how things were different in those days….”Drs were like Demigods back them, they have an oath”…..Words fail me!
Pfizer’s stocks tank due to the tragic death of a young boy in one of their clinical trials of a gene therapy product for muscular dystrophy;
”Stock in Pfizer dropped on Tuesday after a young boy receiving experimental gene therapy for Duchenne muscular dystrophy died during the trial.
According to STAT News,
Pfizer has yet to determine exactly what happened or how the boy diedPfizer has confirmed that the boy suffered cardiac arrest, and is pausing crossing over patients in its randomized phase 3 trial of the treatment in older boys, according to the report. The company will, for now, stop dosing patients who initially received a placebo with the gene therapy after a year.”https://www.zerohedge.com/medical/pfizer-stock-hit-after-boy-dies-gene-therapy-trial
Coincidentally the exact same thing happened in 2021, to a young man that time;
https://www.benzinga.com/general/biotech/21/12/24723532/pfizers-duchenne-gene-therapy-trial-put-on-fda-hold-after-patient-death?
I am sure that won’t be an issue with the MHRA, after all its a death facilitator don’t you know, it works with the treasury in keeping the costs of pensions and welfare down.
Professor Norman Fenton on Twitter:
‘With the formal withdrawal of the AstraZeneca vaccine it’s appropriate to remind people of this double page spread in The Times, March 2021 that hailed the AstraZeneca vaccine as 100% effective. But note the article highlighted bottom right…the article by Tom Whipple has headline:
“Academics back ‘bizarre’ claim that jabs may kill”
The online version of this article explicitly named me as one of the academics.’
https://twitter.com/profnfenton/status/1788174739002855782
I don’t need the MHRA to keep me safe.
My safety is my responsibility.
I certainly didn’t need the MHRA to enable me to look through my living room window and see NO PANDEMIC.
Nice one M A k.
I must have had my eyes shut when walking / driving during the early months / scenes (and indeed all months) of the scamdemic. I didn’t see one, let alone the hordes of people, dead or dying littering the streets and pavements of our villages, towns or cities that the MSM and government tried to hoodwink us was happening or would happen due to a deadly virus…
However, incidents of dead / dying / incapacitated people after being subjected to supposedly ’safe and effective’ jabs that were fast-tracked by the ‘enabling’ MHRA seem to be common place.
Strange, that…
I said “where is the pandemic” to this lad, the cocky bugger said the ‘pan’ in pandemic is Worldwide.
I worked within the MHRA a few years ago as the lead BA on a project to build a new data warehouse for them. I spent six months assessing their existing systems, processes and data in depth. From my experience, I have zero faith that the MHRA are anywhere near as good as they claim to be.
Their case handling system was quite weak – custom-built with evident bugs and poorly handled data. Their pharmacovigilance (PV) processes were described to us as using sophisticated signal analysis but I suspect that was inflated talk. Given the flaws in their main system, I suspect the PV process and data were similarly tainted.
We didn’t get into looking too deeply at that unfortunately because the commercial arrangement began to go awry. Scope was ballooning and they decided to be arseholes and screw us. I left the project soon after because the dispute was wearing on me – I knew the history and called out their fibs; in fact I was rather unwelcomely honest. My diplomacy wasn’t up to it so my company brought in someone more neutral. The project died a year later with neither party getting what they wanted.
Covid wasn’t the first time I’ve been unwilling to bend. I have these tendencies on occasion.
Starting April 2020 I was getting bombarded by offers of work to “have the chance to help build new decision support tools for the forefront of medical technology” (or words to that effect). I ignored the lot. I just knew I would be impossibly angry the whole time, and I had no wish to be a useful idiot.
It was no surprise to learn a few months later that almost the entire stack of NHSX’s “world-beating Test and Trace app” was…. Microsoft Excel
Take the moral high ground. There’s a lot less traffic.
I’m perfectly aware I’ll be called a conspiracy theorist in most quarters, possibly not here. But I’d like, at the minimum, for our Government to start doing some human trials in response to this piece of new research giving mRNA to lab rats.
Exposure to COVID-19 mRNA Vaccine BNT162b2 Induces Autism-Like Behaviors in Male Neonatal Rats
https://link.springer.com/article/10.1007/s11064-023-04089-2In this peer reviewed report the authors present evidence that the COVID-19 mRNA impacts the brain of rats including ‘autism-like behaviors, reduced neuronal counts, and impaired motor performance, emphasize the potential neurodevelopmental implications of the vaccine, aligning with existing literature on the roles of the WNT pathway and BDNF signaling in neurodevelopmental disorders.’
BDNF help to support survival of existing neurons, and encourages growth of new neurons and synapses. In the brain it is active in the hippocampus, cortex and basal forebrain – areas vital to learning, memory and higher thinking.
Has the vaccine been designed to make us less capable of critical thought – more compliant? All sounding very Orwellian. And certainly Dr Michael Nehls, author of The Indoctrinated Brain would agree.
A human study before the WHO rolls out mRNA technology to billions in response to the next plandemic – with potentially devastating hippocampal destruction – might be sensible.
We need alternative treatment protocols to Covid and infectious respiratory diseases – mRNA ain’t working and I’ll bet nobody wants it given what’s coming out.
Thank God for Musk and Daily Sceptic.
I understand they are now designing alternative methods to injection. Patches, inhalers etc. Easier to administer. I wouldn’t touch any of them with a barge pole.
I kind of use the analogy that “All snakes are not poisonous, but why jump into the snake pit”? ——-I prefer not to risk that a few of the snakes in there might be poisonous. It is the same with vaccines. Why take the risk? Some will say that covid is a greater risk, and I say that is for you to decide. —-I have made my decision already.
merogenomics on you tube is worth following
‘Add the MHRA’s refusal to make public data on the relationship between deaths and vaccine doses for “commercial confidentiality reasons”.’
This news suppression of vaccine-harms data is nothing new. It has been going on since New-Year 20/21, in other words right from the start of the vaccine rollout.
And not just in this country but worldwide. There has been an official determination that no data will be allowed out that besmirches the heaven-sent public perception of the covid so-called vaccines.
I’ll say it here again, with what perseverance I can muster, that, at New-Year 20/21, spates of deaths in UK care homes were flash reported in local newspapers and on local TV news, all over England, as the grim jabbers charged in to deliver the life-saving elixir to those frail elderly who, with the exception of the already moribundly ill, were the only people at any mortal risk from the supposed virus.
Many dropped dead more or less on the spot from the intense flu-like side effects of the original and rapidly pulled Pfizer jab. The news reports abruptly ceased, but over the next 3 months a total of 25,000 more than expected frail old people died in England and Wales.
Nothing about their cvd vaccination status was recorded on their death certificates, at a time when any death at all occurring within 28. days of a positive PCR test, even a traffic-accident death, was recorded as a cvd19 death.
When Dr Clare Craig and I sent an FOI to Sarah Caul at ONS, responsible at that time for deaths statistics in England and Wales, she replied that no data was available about the cvd-vaccination status of the recently deceased.
My MP in Milton Keynes, Iain Stewart, said the same, and so did the NHS.
Can you believe that? Can you believe it?
I don’t believe there can be any doubt that the news reporting of vaccine deaths in care homes in Jan-21 to Apr-21 was stopped on high political orders. The person who gave them has to answer charges of mass murder.
There was also a suspension of autopsies and coroner’s inquests.
Like Nelson’s famous quote “I see no ships” with the telescope held to his blind eye.
Plausibly deniable.
MHRA is a crooked organisation aiding and abetting the Pharma cartel . Rainer declared that they’re now “enablers” not regulatory . The last thing these fascists are interest in are the people
In Australia, the government hastily shelled out millions to develop an app that would supposedly help trace and notify covid cases/exposures. The development of an app for people to voluntarily report any potential side effects after the vaccine would have been easy to develop and show a duty of care to citizens and demonstrate the government was interested in knowing any potential side effects. This would have quickly alerted them to health issues that were above previous baselines.