I have been a member of the audience listening to the bimonthly Medicines and Healthcare products Regulatory Agency (MHRA) board meetings for some time. The MHRA's directors are a self-congratulatory bunch who seem to believe that their many conflicts of interest are not of any concern, that the public's trust in them has grown by leaps and bounds, and that they are doing a good job—even though they have an ongoing shortage of staff.
Any member of the public who signs up to attend the MHRA board meeting via Eventbrite can send in a question, but it must relate to the agenda. As a public participant in the MHRA’s March 2023 board meeting, I pointed out that my question was related to the "Agency Performance" item on the agenda, which was the subject of MHRA CEO Dame June Raine's presentation. This was my question:
Why, in one of the MHRA's most important regulatory activities, pharmacovigilance—especially over a period of two years of multiple injections given to millions of people—has there been a reduction or curtailment of:
- Rapid Cycle Analysis
- Ecological Analysis
- Target Active Monitoring
- Yellow Card Monitoring
- Listings of Freedom of Information (FoI) requests and responses?
I heard from the MHRA five days before the meeting to say that they were going to use my question and asking me to complete and sign a form, as they wanted me to ask my question live on air. After reading the form, I was rather concerned—and sent it back, on the advice of a solicitor, with the following lines crossed through:
- These media and content files may be altered or edited in any way the MHRA finds appropriate.
- These media or content may be used to depict an imaginary person.
Therefore, I was interested to see that the recording of my question was left intact when the MHRA, after its customary delay, released the recording of the board meeting.
My opportunity to ask the MHRA a question
When the day of the meeting came, starting at 10 am, I was only contacted at 11:45, as questions were to be asked at the end. I felt very prepared, because I had all the information I needed in front of me. Although I’m used to being on screen, I was quite worried, as I never thought they would want to answer this question, so I was wary of what they had in store for me.
After I had asked my question, Stephen Lightfoot, Chair of the MHRA, handed the floor to Dr Alison Cave, Chief Safety Officer, who opened her laptop and gave her prepared answer, which I will dissect in a moment.
Once she had finished, the Chair asked whether this answer had provided the information that I sought. While Dr Cave had been talking, there was so much misinformation in her response that my head was spinning, so I decided to throw the MHRA's own Yellow Card data back at them.
I therefore commented that many people have concerns regarding the fact that the MHRA’s reporting system shows one serious adverse effect (SAE) for every 426 doses, and that I wanted more information on this. The Chair responded by stating he thought we shouldn't use the meeting as an opportunity to talk around all the specific details. So, when can you? I felt shut down, and I soon disappeared from the screen.
Even though I didn't get a satisfactory answer, I at least asked the questions, which lets the MHRA know that I and many others are aware and want proper answers. We are not going to accept everything the MHRA says, as we know that the pharmacovigilance for which it bears responsibility is not being done properly.
I found it to be quite a draining experience. I hope there are questions asked as to why the MHRA didn't do any due diligence on me to see what my mindset was likely to be. I have made the assumption that they didn’t, because they allowed me to voice my question in public. They are blinded by being utterly convinced and certain that what they are doing as enablers (instead of regulators), a term of which they are proud, is right.
Alison Cave was given time to prepare her answer prior to the meeting and made sure to include all the set MHRA terminology, thus propagating the MHRA narrative. Unfortunately, I was not permitted the chance to challenge her response.
Dr Cave's answer
Below, in italics, is my analysis of Alison Cave's answer, in which bold emphasis is added. Although Alison Cave's answer is given as indented quotations for ease of reading, the below is a restatement of her words and not verbatim.
- Alison Cave uses the word "robust" to describe the four-stranded strategy for monitoring. "Robust" is defined as strong and healthy, strongly formed or constructed. It is a word associated with heath: vigorous health. She is following June Raine's use of the word.
—I refer you to: Doctors for Covid Ethics: Regulation or Racket? UK Drug Regulator Never Inspected the Pfizer Vaccine Study Data (8.9.21).
In a Freedom Of Information (FoI) request, it was explained that the ABPI Code of Practice Cl 6.4 for Pharma states that the word “safe” cannot be used without qualification. However, the MHRA continues to use the word "safe". It was Alison Cave herself who had responded to this FoI:
"Patient safety is our highest priority. The Covid–19 vaccines [. . .] were approved after a rigorous review of the safety, quality and effectiveness of the vaccines by the MHRA and the CHM. The MHRA concluded that the Covid–19 vaccines were safe and effective, and the benefits of the vaccines outweigh any risks."
—There has been a much higher number of the MHRA's Yellow Card Reports for the Covid–19 vaccines than the total for all conventional vaccines over the last 50 years. This fact alone is a red flag. The reporting rate is accepted as being under 10% of the actual number of incidents.
- Alison Cave talks of sourcing additional data through extensive engagement with academia and the international regulatory network.
—Both of these sets of institutions are captured and funded by Big Pharma. The MHRA never mentions the victims of the Accident & Emergency reports from British hospitals, as they have not engaged with nor investigated any of these people or their families for further information. All Western regulators' databases (MHRA, VAERS, TGA, EUDRA) are showing the same magnitude of serious adverse effects (SAEs).
The MHRA's Target Active Monitoring programme was stopped after seven months, and that was fifteen months ago. Why?
V-Safe data was recently released by US court order through an action by ICAN, representing the findings of ten million Americans signed up to the FDA's app to report any reactions to the vaccines. That data shows that 25% were incapacitated the day after vaccination and 7–8% ended up going to hospital Emergency Room. Was the MHRA afraid of what the system showed in the short time for which it ran?
- After two years, and on the advice of the Commission on Human Medicines (CHM), the MHRA is moving to "as required" publishing rather than publishing a regular narrative report—because of the "very stable safety profile of the vaccines".
—We know that Coroner's courts have certified Covid–19 vaccine death on 59 certificates so far. Other vaccines have been withdrawn on the strength of fewer than 50 death reports, irrespective of how many doses were given. The MHRA's Yellow Card system shows over 2,300 fatalities linked to these vaccines so far. The evidence suggests that there can be a reaction up to seven months after vaccination.
- Alison Cave emphasised that the “robust” monitoring and surveillance of any Covid–19 vaccines that are under deployment will continue.
—There are major concerns that the excess deaths which have started to rise since mid-2021 have affected many people aged under 60 (a shift from the average age of death from Covid in 2020, which was higher than average life expectancy at 82.4 years). This is a global pattern and is most pronounced in countries with high vaccination rates. It needs to be recognised that these patterns of serious adverse effects (SAEs) linked to the Covid–19 vaccines are being seen all over the world.
- Alison Cave also states that the full range of tools is still available to the MHRA if the agency sees any changes of concern in the safety profile of the vaccines.
—She does not define how the MHRA would recognise what a safety concern would be. 58% of all deaths and serious adverse effects are listed under AstraZeneca vaccines, which have now been quietly stopped—but who made this decision? Two billion doses of the AstraZeneca Covid–19 vaccine have been supplied to 170 countries. More than 80% of those in India who took an injection were given the AstraZeneca vaccine.
- The suspected adverse reactions are published on the recently-launched Interactive Analysis Print (IAP), which allows anyone interested to look at these reports.
—I will point out that the IAP makes the following statements on each report:
- The existence of an adverse reaction report does not necessarily mean that the vaccine has caused the reaction.
- Sometimes, reactions can be part of the condition being treated rather than being caused by the vaccine.
- Many factors have to be considered when assessing whether a vaccine has caused a reported adverse reaction.
- It is important to note that most people receive vaccinations without having any serious side effects.
- The MHRA acknowledges that there has been a gap in the publication of FoI responses. The MHRA is reviewing its resource requirement so it can deliver on FoI commitments.
—Strangely enough, FoI response publication by the MHRA was due to resume the very week when I wrote this article. The MHRA is short-staffed and new people recruited tend to be inexperienced, as has been confirmed over previous board meetings held in public. The answer to FoI 22/262 stated that the MHRA "do not hold a process for investigation of individual Yellow Card reports as it is the role of the coroner to determine likely cause of death on a case by case basis. It is not the role of the MHRA to adjudicate on individual events as we assess the body of evidence as a whole".
I have already stated that Coroners have certified 59 deaths as being due to Covid vaccination. So the MHRA patently does not assess many cases—but what about the other 2,300 fatalities? With fewer than 10% of serious adverse effects getting reported, this could amount to 23,000 British fatalities that no-one is investigating.
Unsatisfactory
When asked if I was satisfied with Dr Cave's reply, I responded by referring to the MHRA's own Yellow Card data from 12 Feb 2023:
I took the last data point: one serious adverse event in 426 doses.
It was at this point, as mentioned above, that Stephen Lightfoot, Chair of the MHRA, stopped me, interjecting, "This is not an opportunity to talk around all the specific details". Yet he did afford Alison Cave the opportunity to talk and respond to my specific point, which was:
Firstly, the MHRA didn't state that the "one serious adverse event in 426 doses" figure is incorrect. This is a rate that is based on published Yellow Card Reports and which therefore must be accepted by the MHRA.
Secondly, what other platform is there to ask questions of the MHRA?
Alison Cave responded by saying that every single adverse event is investigated, considered, and analysed extremely carefully. (In what follows, my post-meeting analysis of her response is again given in italics.)
—But the investigation does not include contacting the affected person or, in the case of a death, the family.
She refers to the narrative report and points out the huge attention to detail and careful analysis of every single report.
—But what about the lack of staff? How can the MHRA square its vaunted attention to detail with its acknowledged lack of experienced staff?
She states that it is incredibly important that the MHRA reassure the public and maintain the trust of the public in its vaccine surveillance.
—But perhaps the MHRA should ask someone who has completed a Yellow Card Report how satisfied they are with the system. In the US Vaccine Adverse Event Reporting System (VAERS), once the investigation on the injured is registered, they are allocated an incidence number. Many in the UK who submit a Yellow Card Report never hear anything further; they have effectively disappeared in the system.
She then refers to the huge effort over the last two years to assure the public that the MHRA understands the safety profile of the vaccines and asserts that "the benefit/risk [consideration] of those vaccines remains positive”.
—But where is the MHRA's data to confirm the benefit of the vaccines? We know that Covid vaccines do not stop infection, transmission, hospitalisation, or death. The conditional licences granted for these injections state that temporary authorisation grants permission for the medicine to be used for active immunisation of individuals aged 18 years and older, for the prevention of coronavirus disease 2019 (Covid–19). But this is not true. Have the manufacturers been breaking the licence agreement?
Undue influence
At this point, I should refer to the House of Commons Select Committee investigation The Influence of the Pharmaceutical Industry, Fourth Report 2004–05 Volume 1. The Committee expressed the following concerns.
1. Pharmaceutical funding leads the MHRA 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.
2. The MHRA:
[. . .] failed to adequately scrutinise licensing data, and its post-marketing surveillance is inadequate.
3. There is a need for transparency:
Greater transparency is also fundamental to the medicines regulatory system. There has to be better public access to materials considered by the MHRA prior to licensing.
Causality
My second piece of information throws light on Causality, regarding which the MHRA, especially in response to FoI requests, continually states:
An adverse drug reaction or a fatal outcome does not mean that the vaccine was the cause of SAEs [serious adverse effects] or death.
The WHO accepts the Bradford-Hill Criteria as confirmation of causation if at least five of the criteria are met. These vaccines meet all the criteria. This is confirmed in the presentation Understanding 'Vaccine' Causation by Dr Jessica Rose, Dr Peter McCullough and others.
Dr Rose explains that the WHO uses a ten-criterion list, the Bradford Hill criteria, to prove causality. She goes through all ten criteria and provides evidence accordingly.
Strength
- Efficacy data for Moderna shows SAE [serious adverse effects] at 83 (vaccine):31(placebo); this is highly significant.
- Plotting Pfizer doses administered versus disability reports to VAERS gives a very high correlation coefficient: R = 0.99.
- Plotted fully-vaccinated (Own World Data) versus adverse effects (VAERS) January 2021–2022: R = 0.94. It is reproducible and consistent.
Consistency
- Looking at whether the vaccines cause adverse drug reactions (ADRs). All three main regulatory agencies (FDA, EUDRA, MHRA) are all seeing in excess of one million reports since January 2021.
- This has never happened before within a year.
Specificity
Looking at specific healthy populations (all by 30.8.21—CDC data):
- Athletes: 183 professionals and coaches collapsed—108 dead. Background rate: five per year.
- Children and myocarditis. Background rate: one in 100,000; 12–15 = 116 in 100,000; 16-–7 = 120 in 100,000; 18–24 = 134 in 100,000.
Temporality
The cause occurs before the consequence, and if there is a shorter timeframe, the case is stronger.
- Clot formation = 50% within 48 hours.
- Anaphylaxis = 87% within 24 hours; 92% within 48 hours.
- Anaphylaxis Children 5–11 = 73% within 24 hours; 84% within 48 hours.
Biological Gradient
Dose-response relationship:
- Myocarditis (inflammation of the heart muscle), by age group and dose, children, especially 15-year-old boys: see four-times higher reporting rate.
- Accumulation effect of shots by the second dose. More given, and a shorter time between doses, shows the cumulative effect of dose.
Plausibility
Biological plausibility:
- Spike protein has clearly been pronounced cytotoxic.
- Encasing NLPs (nanolipoprotein particles), especially their cationic fats, are highly toxic to cells; to the membrane on entering and once inside.
- Modifications: two prolines are substituted; uridines replaced by pseudo-uridines.
- Lipid and spike protein stays around for a long time.
Coherence
Does it make sense that A (vaccines) can cause B (adverse effects)?
- There are 10,910 codes for VAERS serious adverse effects for Covid vaccine products.
- Bell’s palsy: 2016—220, almost nothing; 2021—over 10,000 cases. This is backed up by case reports.
- Bell's palsy occurs at a 2.7-times higher rate in the Moderna drug arm of the [FDA] clinical trial.
Experiment
RCTs can be done, but adverse event data collection can also be used as evidence.
- VAERS adverse effects, 2021: Non-Covid = 2,631; Covid = 798,460.
- VAERS deaths, 2021: Non-Covid = 36; Covid = 12,635.
Many studies have shown strong indicators of signal dangers: strong indicators of immune deficiencies, auto-immunities, cancers, hyper-inflammation in some populations.
Analogy
Has this happened in history before?
- VAERS showed the link between intussusception and the Rotavirus vaccine, which was pulled in 1999.
- Acute encephalopathy (permanent brain injury) and MMR vaccine; injuries seen more in boys under 18 months old.
Reversibility
If the shots are stopped, will the adverse drug reactions (ADRs) stop?
- Dysregulation and dysfunction of the immune system will show through, but we do not know in whom.
- We will not know if they are unsafe until we stop giving them. If there are long-term serious adverse effects, the adverse effect reporting will continue to rise, despite a halt in the rollout.
- A low estimate of the under-reporting to VAERS would entail calculating an actual figure 31 times as high! (Because of the low reporting, you would have to multiply this by 31 to get an actual figure).
My question is:
If the WHO used these same criteria, they only used five. Why is the MHRA not admitting the likelihood, or even the possibility, of the cause-effect relationship?
Remember, when patients are reported as unvaccinated in the data, they can still be vaccinated, but they have not crossed the two-week mark, at which it is claimed that the vaccines become “effective”. Yet many serious adverse effects occur within 48 hours, including death.
Pharmacovigilance is a very important concept: it is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects. This applies equally before and after approval (and these Covid products have yet to be approved) and to maintaining the diligence and pharmacovigilance throughout the lifecycle of the product.
If causation is suspected, which in this case amply met (as it appears to be very clear-cut), then it is of utmost relevance and importance to inform the public. If the MHRA is willingly withholding safety data from the public and knows there is a problem with the safety profile of Covid jabs, and if it continues to permit the administration of those products, it is guilty of malfeasance.
My final observation on causality is this: it is easier to disprove causality than to prove it. Nevertheless, the onus is on the manufacturers to prove that there is no causal effect here.
A boiled-down graphic version of Dr Rose's Evidence of Causation follows.
Conclusion
I have taken great interest in the MHRA, which is responsible for the pharmacovigilance of the Covid–19 vaccines, a brand-new experimental technology. I am particularly interested in the recording of information surrounding these liability-free vaccines. As a member of the public, I have a substantial interest in reviewing the monitoring of these vaccines by the MHRA, introduced via an untested, accelerated review process.
I stepped forward to ask the MHRA an important and intelligent question on air. I believe that their answers are uninformed, and therefore, that they are not telling the public the truth. This occasions a lack of trust in their ability to protect the public from harmful substances.
Lack of trust of the MHRA develops because of its duplicitous and disingenuous behaviour, demonstrated at its board meetings and appearances on other platforms.
I believe that the MHRA has demonstrated malfeasance in public office.
Part 2 is here.
Main image: Number 10 on Flickr, licence CC BY-NC-ND 2.0
