Untested – the mass-produced covid vaccines that skipped clinical trials
DR CLARE CRAIG
WHAT IF the vaccine you received had not been in a clinical trial? For millions of people worldwide, this is precisely what happened when they unknowingly received a covid vaccine manufactured using a process where the end product had never been trialled in humans. This manufacturing shift resulted in significantly higher rates of adverse reactions – 13 times more in some cases – representing a regulatory failure with profound implications for public trust and safety. Yet, the UK Covid-19 Inquiry tasked with investigating these critical decisions has avoided addressing this issue, which lies at the heart of the controversy on regulatory failure.
Imagine a chef perfecting a recipe in a small kitchen, only to mass-produce it in a factory using different ingredients and techniques. In December 2020, the UK’s drug regulator, MHRA, gave a temporary authorisation to a mass-manufactured vaccine (Process 2 or P2) without requiring human trial data. Available safety and efficacy data were based solely on Process 1 (P1), the small-scale clinical trial method. MHRA relied on lab-based‘comparability’ studies to justify the switch, but these assessments failed to account for potential risks posed by even minor manufacturing changes.
This article delves into how the critical manufacturing switch occurred, why it went largely unchallenged, and implications for public health, safety, and regulatory accountability.
Crucial difference between P1 and P2
Even small changes in manufacturing can significantly affect a final product’s safety and effectiveness. Pfizer/BioNTech gave the public a different product to the one tested in clinical trials; it was a ‘bait and switch’. The industry uses the phrase ‘the process is the product’ because of wide variation in the end product can result from small changes in the manufacturing process.
Process 1 (P1) was used to produce vaccine administered in clinical trials. This small-scale, lab-controlled method relied on purified materials to create DNA and mRNA, ensuring minimal risk of contamination. MHRA relied on safety and efficacy data exclusively from P1-manufactured vaccines.
Process 2 (P2) by contrast, was designed for large-scale vaccine production. This method involved growing DNA templates in vats of E. coli bacteria – a faster but riskier approach that can introduce contaminants such as bacterial DNA fragments and endotoxins, substances that can trigger a vast range of pathology.
When mass manufactured batches were first given to humans, on 8th December 2020 in the UK, MHRA had seen no trial data of these products. The data they had seen analysed in the regulatory submission was up to the cutoff on 14th November 2020 and there was no data on P2. MHRA authorised a P2 batch (EJ0553), on December 2, 2020, based solely on laboratory-based ‘comparability assessments’ between P1 and P2; there was no human testing. MHRA justified making this decision based only on these comparability studies, by claiming there had been ‘full-scale validation’ of the manufacturing process, but this was focused entirely on quality and quantity of RNA.
MHRA also failed to ensure that the public was informed of this massive unknown and the potential risks involved. Informed consent would have been possible if there had been more honesty about uncertainties. Instead, the public was subjected to a barrage of ‘safe and effective’, including from the regulator themselves – the MHRA itself sets the terms for the advertising and promotion of medicines and effectively prohibited any caveats on the ‘safe and effective’ mantra.
Avoiding the Hard Questions
On January 22, Dr June Raine, the then CEO of MHRA, was questioned under oath about MHRA’s testing of covid vaccines. The convoluted way the question was phrased allowed for an evasive response. It is no wonder the inquiry failed to properly discuss this issue, as it would expose a monumental failing on the part of the regulator.
The question that should have been asked is, ‘Was the product given to the public manufactured using the same process as the product given in the trial?’ The answer to that would have been ‘no’.
Instead, Raine was asked about the difference between batches tested by MHRA and batches given to the public. MHRA did do limited testing of batches from the mass manufacturing process, but that is not the issue which is that there was no clinical trial of the P2 product used for the vaccination of the public!
The question, at 25:35 minutes:
‘Some have suggested that the batches, which were delivered to the United Kingdom for use amongst its population, […] were batches that were produced by a different manufacturing process […] as had been tested by the MHRA. So, bluntly, the suggestion has been made [that] you tested and authorised and certified a certain number of vaccines made by manufacturing process A, and then the manufacturers actually delivered vaccines to the British population produced as a result of a different manufacturing process, and one, by inference, which had not been tested.’
Raine replied,‘My understanding is that the manufacturing process would have been the same.’
Note that that Hugo Keith KC deliberately refers to process A and B to distinguish the manufacturing of different batches. This was a further obfuscation as Pfizer/BioNTech always refer to the clinical trial manufacturing as Process 1 and the mass production as Process 2.
When Ruth O’Rafferty of Scottish Vaccine Injury Group was questioned earlier in the week, her attempts to raise the issues (at 32:37 minutes) were quickly shut down with a claim that there was no time to discuss these topics in such detail. The failure to address these issues is because what happened is nothing like what should have happened. The regulator was relying on evidence that was entirely inadequate to demonstrate a sound safety case for the vaccines.
What should have happened
MHRA should have insisted on comprehensive data showing that conclusions drawn about P1 were comparable to P2 based on what happened in humans. For the purposes of this article, we shall leave aside the fact that the harm from P1 was not fully disclosed to MHRA and, even then, the risk of a serious adverse event of special interest (which were conditions identified in advance as being worth watching for) was 1 in 800 for Pfizer and Moderna combined and 1 in 990 for Pfizer.
Pfizer did set out a plan for a direct comparison between Process 1 and Process 2 products, but said it should be ‘post-approval’because of the‘urgency of the current pandemic’. Pfizer’s clinical trial aimed to compare P2 in 250 participants per lot. However, this comparison was abandoned on February 9, 2021. Only 252 people were given P2 as their first and second dose. Despite this, P2 products with known manufacturing differences were distributed to millions worldwide.
In September 2022, the trial was terminated. Pfizer said that‘given the number now administered worldwide, the originally planned comparison of manufacturing processes is no longer warranted.’ The trial records say that the FDA and EMA agreed to early completion of this trial having ‘removed the objective to describe the safety and immunogenicity of prophylactic BNT162b2 […] produced by manufacturing “Process 1” or “Process 2” because of the volume of BNT162b2 now distributed and administered globally using manufacturing “Process 2,” making this comparison unwarranted’.MHRA have stated, ‘this process comparison was not conducted as part of the formal documentation within the protocol amendment.’
Results comparing the 252 given P2 against those given P1 doses have never been disclosed. However, even without a control group, differences between Process 2 lots were stark, with the EU processing plant having twice as many adverse reactions as USA sites, 10.4 per cent vs 5.5 per cent.
Figure 1: Comparison of Adverse Events by Manufacturing Site for Process 2 (P2) Vaccines (mostly given as dose 3), December 2020–March 2021
This figure shows percentage of adverse events reported among individuals who received P2 vaccines, broken down by manufacturing site. The EU manufacturing site showed a significantly higher adverse reaction rate (10.4 per cent) compared to the USA site (5.5 per cent), illustrating inconsistencies in vaccine quality across production facilities.
December 2020 to March 2021
The first batch given in UK was EJ0553. On November 27, 2020, Commission on Human Medicines (CHM) said of the first two batches (which had been rejected by the MHRA labs*), ‘it is not currently feasible to compare these two batches to those given to subjects in clinical trials.’ That evening, these dud duo batches were switched for two alternative batches and then a third was added. They reconvened a meeting on the next morning. One of these contained visible particulate matter, and one had RNA that was the wrong size. The batch with floaters in it was the infamous EJ0553 – the first batch used in the UK.
The CHM feared they were not getting the best quality batches, and that ‘it may be the case that the batches the FDA are evaluating are further along the development lifecycle than those allocated for the UK.’ Later, their worst fears were realised. The company said the EJ0553 vial had failed to meet their own acceptance quality limit based on visual inspection. They did not know the ratio of lipids to RNA nor the overall potency (the measure of how much spike was likely to be produced). The minutes say,‘The company further explained that these particles did not alter the concentration of the drug product and they did not think this would have an impact on safety and efficacy of the product. However, as these were rejected vials [italics mine], they did not perform a potency test on these rejected vials.’The company explained that ‘the appearance of these lipid-associated particles increases at the end of the filling line’.Nucleic acids clump and lipid nanoparticles float; both could result in a higher concentration of product in the last batches to be filled.
The batches they were first offered may have been worse than these, but that does not excuse using these ones. The CMH minutes said that variable potency testing ‘makes interpretation of the available data difficult’. They noted that the potency test would be passed if between 30 and 100 per cent of cells produced spike, saying: ‘The limits for in vitro cell expression were also wide being set at 30 per cent or above. This could lead to large differences across batches.’ They added, ‘a concern was raised that if the product has less than 50 per cent RNA integrity, it may suggest that half of the product is not what it was laid out to be.’ However, they then declared it reassuring that ‘the later developmental batches have a higher level of RNA integrity that is more comparable with the earlier clinical batches.’
The focus throughout seemed to be a concern that junk vials might not have the same efficacy. There was minimal discussion on safety even though they had seen no data comparing these P2 products with P1.
The defence for using these vials was that they ‘were not understood to be associated with a change in concentration of RNA containing LNPs’.That claim did not appear to be based on data, nor should it have provided any reassurance regarding safety, which depends on factors beyond the concentration of the active ingredient.
Three days later, Lord Bethell signed a temporary use authorisation. EJ0553 became the template for all subsequent UK Pfizer batches, despite the absence of clinical safety data for P2. On 21st December, the EMA gave a conditional authorisation for Comirnaty (the brand name) and MHRA authorised for use in the UK both batches from the ‘dud duo’, EE8492 and EE8493, which were rejected in November. A later trial showed the true nature of EJ0553 was indeed very different to P1.
Evidence emerges
As P2 was used and people were affected, MHRA should have been alarmed by the signals. From the first day of rollout, doses of EJ0553 coincided with three cases of anaphylaxis among 400 initial recipients, affecting those with a clinical history of anaphylaxis. By March 2021, breast screening programs noted 11 per cent of dose 1 recipients and 16 per cent of dose 2 recipients exhibited lymphadenopathy, a ‘swelling of lymph nodes’ that ‘usually settles within a few days’ – a dramatic increase compared to the trial’s P1 product rate of 0.4 per cent. Adjustments to breast screening protocols were required to avoid false cancer diagnoses.
In April 2021, Pfizer submitted evidence showing significantly higher rates of adverse reactions among clinical trial participants who received P2 (see Figure 2). These participants were originally part of the placebo group and had not previously received the P1 vaccine used during the initial clinical trial. Following the temporary authorizations, most participants in the placebo group were promptly vaccinated with the P2 product, making medium- and long-term safety analysis impossible. Despite the stark increase in adverse reactions among these individuals, Pfizer dismissed the findings, stating that the excess reactions wereas expected.
Figure 2: Adverse Reactions in P1 vs. P2 Recipients in Clinical Trials, Pre- and Post-Unblinding This figure presents data from Pfizer’s FDA submission, comparing adverse reactions between individuals who received P1 vaccines during the blinded trial phase (roughly around December 2020) (Table 60) and those who were given P2 vaccines as a third dose after two placebo doses up to March 2021 (Table 65). Adverse reaction rates were notably higher in the P2 group, despite the relatively short follow-up.
Despite this, MHRA did not re-evaluate the trial findings in light of this, nor did they respond to signals in Yellow Card reporting. Furthermore, they ignored a disproportionately high rate of adverse events in women given P2 compared to near-equal rates in those given P1 in clinical trials. Pfizer’s June 2021 Periodic Safety Update Report (figure 3) detailed this stark gender disparity. This was reinforced by Lareb’s finding that 48 women and 19 men experienced prolonged lymphadenopathy.
Figure 3: Gender Disparity in Adverse Reactions: P1 vs. P2 Vaccines This table highlights a stark gender disparity in adverse reaction rates between clinical trial data (P1) and real-world data (P2). While P1 showed higher adverse reactions in males (middle column), P2 data from real-world administration revealed significantly higher rates in females (first column), suggesting a fundamental difference in the reactogenicity of P2 vaccines.
In September 2021, MHRA was first presented with trial data on P2. This was not data regarding the 252 participants given it as dose 1 and 2, but was on just 306 trial participants who received P2 as a booster. Both the original batch from the UK rollout and one of the batches rejected outright by USA and UK were two of the three batches (EJ0553 and EE8493) used in Pfizer’s booster trial. The recipients of these P2 boosters had a 5.2% lymphadenopathy rate. In comparison this was 4.3 per cent for those receiving P2 in the adolescent trial and 0.4 per cent for P1. These findings indicate a 10- to 13-fold increase in reactogenicity. Did they act? No. They said nothing until December, then on Christmas Eve 2021, they added this fact as a footnote to a table saying that ‘a higher frequency of lymphadenopathy (5.2% vs 0.4%) was observed in participants receiving a booster dose (third dose) compared to participants receiving 2 doses’. This statement misleadingly framed reactogenicity as booster-related rather than acknowledging its roots in the P2 manufacturing process. Lymphadenopathy was just as common with dose 1 when P2 was given. In reality, 85 per cent of lymphadenopathy cases occurred after the first two doses, with some persisting beyond six months. The difference was not the dose; it was because P2 was given.
The elevated rate of lymphadenopathy and other adverse events is indicative of a marked inflammatory process likely linked to P2 manufacturing processes. Contaminants such as endotoxins or residual plasmid DNA may contribute to these signals. It could be something else or a combination of factors – the exact cause is as yet unproven. Unlike largely endotoxin-free P1 batches, risk of endotoxin in P2 using E. coli to produce key materials is higher.
Conclusion
MHRA’s failure to address differences between P1 and P2 in their safety analysis undermined public trust. Millions of people received a product with a 13-fold higher reactogenicity than P1. Key safety signals – such as lymphadenopathy, gender disparities, and reactogenicity – were overlooked, raising serious questions about regulatory accountability. These decisions have had lasting consequences, from deaths and injury to denial of high adverse reaction rates and widespread public confusion and concern. It is long past time for an overhaul of our regulator, MHRA.
* N.B. These first two batches were called EE8492 or CTM12 and EE8493 or CTM13 and had also been rejected for emergency use in the USA on 20th November 2020.The rejection was because of ‘differences in applied label’.
This article (Untested – the mass-produced covid vaccines that skipped clinical trials) was created and published by Conservative Woman and is republished here under “Fair Use” with attribution to the author Dr. Clare Craig
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‘The most disgraceful period of recent history’ – MPs savage the MHRA
SALLY BECK
ON Thursday January 16, Conservative MP Esther McVey led a backbench debate in the Commons criticising our drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
She highlighted the MHRA’s historical failings in investigating harmful drugs, its abysmal record regulating covid vaccines, its lack of transparency, fatal conflicts of interest, its failed Yellow Card early warning system and its intimidation of journalists.
She then lambasted the organisation, established in 2003, for ignoring covid vaccine safety signals which she said caused unnecessary injury and death, and for taking four years to publish minutes from a meeting with the Commission on Human Medicines (CHM) that discussed covid vaccine benefits versus risk. ‘Full of redactions’, it left readers with ‘more questions than answers’. The MHRA had removed the CHM minutes from its website by the weekend. One can only hope to reinstate the redactions.
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In July 2020, Baroness Cumberlege published a report, led by the Independent Medicines and Medical Devices Safety Review (IMMDS), into the MHRA which described the organisation as ‘disjointed, siloed, unresponsive, and defensive’. Nothing has changed, as highlighted in this important debate. The good news is that the House recognised ‘that the Medicines and Healthcare Products Regulatory Agency continues to need substantial reform’.
The Hansard transcript stretches to 25 pages with 13,000 words, so here are the edited highlights.
ESTHER McVEY (Tatton) (Con)
This House notes that the yellow card system for reporting suspected adverse drug reactions is failing, with no process for following up on serious or fatal reactions and conflicts of interest, with 75 per cent of the MHRA’s funding being derived from industry fees. It also notes the MHRA’s delayed response to reports of myocarditis, pericarditis and vaccine-induced thrombotic thrombocytopaenia following covid-19 vaccination, despite action from regulators in other countries; and calls on the Government to fully implement the recommendations in the IMMDS Review and to acknowledge the harm done to patients and the financial burden on the healthcare system as a result of the MHRA’s widespread regulatory failures.
Alarm bells rang for many of us when, in March 2022, Dame June Raine, the chief executive of the MHRA, boasted of the agency’s transition from watchdog to enabler. Twenty years ago, the Health Committee report The Influence of the Pharmaceutical Industry found that the MHRA was unusual in being one of the few European agencies ‘funded entirely by fees derived from services to industry’.
Not much has changed since, with the MHRA continuing to gain 75 per cent of its funding from the pharmaceutical industry. In this context, the agency’s transition from watchdog to enabler does little to quell suspicions of conflicts and the implications that has for patient safety.
One of the most worrying issues is the MHRA’s mismanagement of the yellow card system. The reporting scheme should be a valuable source of information about possible harms, and act as an early warning system, but there is gross under-reporting to it. As the IMMDS’s 2020 review put it, the system is ‘too complex and too diffuse to allow early signal detection’.
Under-reporting is a big problem [only 10 per cent of reactions reported] because it makes it difficult to spot safety signals and assign causation. That then translates into unnecessary harm or death, with devastating side effects from treatment going unnoticed for years, months or even decades.
In 2021, the MHRA reacted slowly to strong signals that there was a serious problem with the AstraZeneca vaccine causing an autoimmune condition called vaccine-induced thrombotic thrombocytopenia. Denmark and other European countries suspended the vaccine for all age groups on 11 March 2021. The MHRA, by contrast, only started to restrict the vaccine in some age groups nearly two months later, on 7 May – yet there was a signal in the yellow card reports as early as 8 February. How many people were needlessly exposed to a risk?
It is worth noting what happened when the Daily Telegraph reported on the potential causal link between the AstraZeneca vaccine and blood clots in March 2021. The journalist who wrote the story received a threatening call from the MHRA warning that the Telegraph would be banned from future briefings and press notices if it did not soften the news.
The system does not work. We know from freedom of information requests that the MHRA does not have a process for investigating and following up individual yellow card reports. We know that the retrieval of follow-up information from the yellow card database still requires manual extraction and that only 54 per cent of deaths reported as possibly linked to exposure to one of the covid-19 vaccines were followed up by the MHRA. That is extremely worrying or, as Matt Hancock infamously described it in a 2021 WhatsApp message, ‘shonky’. The chief medical officer, Chris Whitty, replied to that message by saying that the system ‘needs to get better’.
In the Commission on Human Medicines meeting on 18 November 2020, the expert working group asks if Pfizer was ‘required to respond to the 36 questions asked by MHRA’. In response, the MHRA confirmed that ‘there is no formal obligation to reply’. Why is there no formal obligation to reply? Surely it is essential, when making such an important decision as to whether to allow a new vaccine to be rolled out to the nation, to have those replies. The minutes do not specify the 36 questions. Indeed, they do not appear to have been mentioned again.
I asked a written question last week to see whether, in the spirit of openness and transparency, the MHRA would publish those questions, and any answers received from Pfizer. The response was that the MHRA does not intend to publish those questions or any subsequent responses. Why not? Is this not a matter of public interest? Those issues were not resolved before the MHRA gave the green light to start the vaccination of the nation.
Particularly worrying is the issue of lymphopenia, where blood does not have enough white blood cells, [lymphocytes are white blood cells crucial to the immune system] which was reported in phase 1 of the trials and then went away – not because they fixed the problem, but because testing for the condition was not conducted in phases 2 or 3.
GRAHAM STRINGER (Blackley and Middleton South) (Lab)
One of the things we should remember is that the MHRA and the whole of the health industry are swimming in a sea of pharmaceutical sharks. Pharmaceutical companies produce some extraordinarily wonderful products that keep us safe, but they also produce huge profits, and sometimes they get their products on to the markets by telling lies, or certainly by sins of omission.
DANNY KRUGER (East Wiltshire) (Con)
The vaccines were developed at a frantic rate. The Government managed to act at great speed, largely because they bypassed Whitehall. But significant questions remain, about whether the vaccines are genuinely safe and effective.
It is right that people ask questions about the data on excess deaths and wonder if there is a connection with the vaccine. Ultimately, there is only one way to answer that question: to have the data. However, we do not have access to that data. The Government hold it and, extraordinarily, they have made it available to the pharmaceutical companies that produce the vaccines, but not to researchers – individual-level death data that shows who was dosed with what vaccines and which of them died.
The UK Health Security Agency has admitted that the data exists, but has refused to release it, almost unbelievably, because of the risk to the mental health of the relatives of the dead. That begs the question, does the data show a link between the vaccines and those deaths?
We have a genuine problem with the regulation of the medical industry and of medical products. I very much welcome the appointment of R. F. Kennedy to the role of Health Secretary in the United States. He will shake things up over there. Perhaps the Minister can be our own RFK over here and bring some genuine transparency to the health system.
SHARON HODGSON (Washington and Gateshead South) (Lab)
The MHRA needs urgent and substantial reform. One area is the need for mandatory reporting of adverse events to the yellow card by healthcare professionals. Contrary to responses I received when I asked questions on the topic in the House, which argue that the current system works, it does not. It is broken. The current voluntary system, which doctors enjoy, enabling them to choose whether to log side effects and complications to the MHRA yellow card, is simply unacceptable. This voluntary system has led to many adverse events going unreported. The system must be made mandatory, but that fix alone will not work if the data is there but is not used.
RUPERT LOWE (Great Yarmouth) (Reform)
The biggest challenge in the MHRA’s history was the covid response, and it failed. It enabled the biggest assault on civil liberties and economic prosperity in my lifetime, which was lockdown – the greatest scandal of them all. It was, quite simply, the most disgraceful period of recent history. The MHRA’s insistence on vaccines for all enabled lockdown restrictions to continue for as long as they did. It must take part responsibility for the consequences: vast NHS backlogs, mental health issues rife, soaring alcohol-related deaths, obesity booming, children’s development wrecked, long-term illnesses mounting, increased substance abuse, domestic violence on the rise, unnoticed child neglect, fathers missing the birth of their children and elderly loved ones left to rot and die alone. We were not even allowed to mourn the dead properly. The wicked list is endless.
None of it was based on any science, and certainly not the vaccination of almost the entire population – including, disgracefully, young children. This was a hideous dereliction of duty by the MHRA. It was not just children it forced the covid vaccination on, but tens of millions of people who had absolutely no need for it whatsoever.
The question is: who regulates the regulator? Who protects against regulatory capture? How did the MHRA allow politicians, celebrities and even its own agency to describe these vaccines as safe and effective, when yellow card data clearly showed it is not universally safe and certainly not universally effective?
KARIN SMYTH – Labour Minister for Secondary Care
The MHRA plays a vital role in fulfilling the Government’s health mission: balancing its responsibilities to maintain product safety and championing innovation. I will be clear about the role of an enabler. It is about enabling innovative products to reach patients without compromising patient safety and without unnecessary delay.
On supporting safety, the MHRA recognises the need constantly to seek to improve its safety monitoring systems to deliver better results for people. Recent improvements include implementing the new Safety Connect IT system, following recommendations from the Cumberlege Review. This IT system will improve the efficiency of reporting and processing of yellow card reports, much of which we have heard about today, supporting the prompt identification and assessment of new safety concerns.
This article (‘The most disgraceful period of recent history’ – MPs savage the MHRA) was created and published by Conservative Woman and is republished here under “Fair Use” with attribution to the author Sally Beck
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Reporting a Fatal Event to the Yellow Card System
A sorry saga of delay and impediment
TRUST THE EVIDENCE
This post was written by one of our readers who would like to remain anonymous. The facts are as reported.
I reported the death of a dear friend to the MHRA’s Yellow Card Scheme back in March 2021. She had become immediately unwell following her first COVID-19 vaccination, a pain at the injection site spreading across her chest and leading to a minor heart attack nine days later. Eight days after that, she was dead.
A full 10 months elapsed before the MHRA finally got back in touch to request more details. I had assumed they were busy following up on my report, so I didn’t think to chase them.
I answered the questions as best I could. We didn’t know which vaccine brand or batch number had been administered, but the Yellow Card Service Team assured me they would contact our friend’s GP surgery and obtain those details. Once they had them, they said they would update me.
Weeks, then months, went by. I chased via email, and on 12 April 2022, over a year since my original report, I was told they had sent a letter to the GP surgery. I waited a few more weeks before contacting them again for an update. This time, I was told:
27 April 2022
Unfortunately, the letter has not been posted out from the office yet. When someone from theteam is next in the office it will be sent out. Please accept our apologies for the delay. If furtherinformation is received, we will be in contact.
I was astonished. Why was the Yellow Card Service Team not working in the office? This was clearly hampering their ability to respond to and thoroughly investigate suspected adverse event reports. What could be more important, at a time when extraordinary efforts were being made to induce even children as young as 5 to “grab a jab”?
I urged the Yellow Card Service Team to phone or email the GP surgery instead to speed up their investigations. To which I was told:
6 May 2022
We usually follow up on cases via email, however as only a postal address was provided wehave written to the GP and are awaiting a response.
I supplied the GP surgery’s full postal address, website, and phone number over a month before. An email address was just one click away. Were they being willfully obtuse? Or did this illustrate the MHRA’s wholly careless approach to monitoring the safety of brand-new drugs rolled out to millions?
The automatic reply from the Yellow Card mailbox said that if I was unsatisfied with the handling of my case, I could contact the Service Team Manager, Faiza Farooq. In June 2022, when my further emails and phone calls were unsuccessful, I decided to do just that. Much to my amazement, I heard from Faiza within five minutes.
14 June 2022
Thank you for your email. I will discuss this with my colleagues in the assessment team and getback to you.
And then… nothing. More weeks and months passed. I periodically emailed but to no avail. At the beginning of October 2022, I phoned the MHRA. I was told the Benefit-Risk Team was looking into my case and should have an update within days. They did not provide an update.
I even contacted my friend’s GP surgery to see if they would tell me which vaccine and batch number our friend was given. They couldn’t. They also said they hadn’t received any correspondence on the matter, but in the MHRA’s defence, this turned out to be untrue.
I had the idea of submitting a Subject Access Request (SAR) to find out what data and information was being held on me, my adverse drug reaction report and efforts (if any) made by the MHRA to investigate my report. I submitted this on 16 December 2022.
Their reply on 30 January 2023 (two weeks after their response was due) was revealing.
Firstly, the MHRA had incorrectly logged the age of our deceased friend on their system. Not a great start. More importantly, the SAR revealed the Yellow Card Team’s lacklustre attempts to investigate my report. They had only tried to contact the GP surgery twice – once by letter (in April 2022, after I had started to make a fuss) and once by email (11 October 2022, after further urging by me to do so). An email referred to someone’s intention to call the GP surgery, but as far as I can tell, it didn’t happen. Entirely missing was any attempt to contact the hospital where our friend was taken following the heart attack.
I decided to rattle more cages. After all, I’d come this far. Armed with the knowledge that they had indeed been approached, I contacted the GP surgery again. Finally, complete GP records were made available to the Yellow Card Team. After two years of trying, I finally learnt that our friend had been given AstraZeneca, batch AB0002.
I contacted the hospital and requested that complete records be sent; I was doing the MHRA’s job for them. Naturally, the hospital initially said that I would need to obtain our (deceased) friend’s written permission to proceed.
I wrote to the MHRA Chief Safety Officer, Dr Alison Cave. In the March 2023 board meeting, I was surprised to hear Cave claim that “every single serious adverse event to a vaccine is interrogated and analysed extremely carefully” and that there is ”huge attention to detail and careful analysis of every single report that comes through.”
I sent her an account of my experience and urged her to reflect on the issues I raised. She defensively replied two months later, “Our follow-up procedures are robust, and we will further enhance our ability to extract this information in the future.” She also told me about their “proactive strategy” for monitoring the COVID-19 vaccines and that “I consider that we have fulfilled our responsibilities set out under this strategy.”You can read Dr Cave’s response by downloading the letter below.
I exchanged a few emails with the Director of Nursing at the hospital where our friend had been treated. She was helpful (if slow) and kept me updated as the wheels of MHRA pharmacovigilance slowly creaked into life. Three more months went by. Then the Director of Nursing emailed to say that a verbal discussion had occurred with Phil Tregunno, MHRA Deputy Director of Patient Safety Monitoring, no less. Two years and 3 months after the original Yellow Card was submitted, something vaguely resembling the ‘analysis’ of my report was finally happening.
Two things stood out from the details I was sent: firstly, the case was discussed verbally, with no records (including scans) being sent via email. Secondly, the MHRA usually requests details of concurrent medication and medical history at the time of administration and not post-administration. I assume that means they aren’t interested in any symptoms experienced after administration, which seems absurd.
This saga had a few more minor twists and turns, but you get the gist. I will just mention that the GP records show our deceased friend was invited back via text for a second jab six weeks after the first one, which potentially killed her. You couldn’t make it up.
I can only conclude that the MHRA is hopelessly inept or willfully blind. I suspect both. The Yellow Card system is supposed to “rigorously” and “continuously” “monitor information on suspected safety concerns” – ready to sound the alarm as an early warning system at the first sign of a problem. It seems pretty clear they aren’t doing even a basic evaluation of suspected lethal side effects. I’d bet my experience is not a one-off.
I wrote to a doctor with cardiac expertise to get his take on what happened to our friend. He wrote back: “It sounds more than likely the vaccine may have triggered myocarditis and led to her death. But you are never going to be able to prove this. The system is big and powerful and wants no vaccine-related deaths to mess up the vaccines are wonderful narrative. I think you will only drive yourself nuts looking for answers here.”
I don’t think I’ve driven myself nuts quite yet, but I have accepted that we will never know for sure whether the COVID-19 vaccine killed our friend or whether the timing was simply a coincidence. There were no hugs or kisses the last time we were together because she wanted to be sensible and maintain ‘social distancing’. I think about that often. Do those who work for the MHRA ever spare a thought for the real human beings at the other end of a yellow card report? I doubt it.
Our friend was previously healthy and not on any other medication, so when she became immediately unwell after receiving a COVID-19 vaccine and died 17 days later, the least I would expect is that such a report would be adequately and thoroughly investigated as a matter of urgency. The fact that it was not is disturbing. The MHRA’s bombastic and repeated claims about what a good job they are doing could not sound more hollow.
This mess needs sorting out, but who in government has the power and the inclination to do it? From where I’m sitting, I see no one who fits that bill.
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The Liberty Beacon Project is now expanding at a near exponential rate, and for this we are grateful and excited! But we must also be practical. For 7 years we have not asked for any donations, and have built this project with our own funds as we grew. We are now experiencing ever increasing growing pains due to the large number of websites and projects we represent. So we have just installed donation buttons on our websites and ask that you consider this when you visit them. Nothing is too small. We thank you for all your support and your considerations … (TLB)
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