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At the holder’s request, the marketing authorisation for Oxford’s AstraZeneca vaccine Vaxzevria has now been withdrawn.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 This glut of vaccines has seen Sanofi and GSK’s next-generation COVID-19 booster Vidprevtyn Beta withdrawn, also at the companies’ request.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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