When is enough enough? Do No Harm

Currently, the Medicines and Healthcare Products Regulatory Agency (MHRA) data on Yellow Card reports of serious adverse reactions after the Covid-19 vaccine is showing over 1.5 million adverse reactions and 2,132 deaths, rising every day.

Having been stonewalled and obfuscated into oblivion by CEO Dame June Raine et al. at the MHRA, in desperation I decided to contact Professor Sir Munir Pirmohamed in his capacity as Chair of the Commission on Human Medicines (CHM), which gives the MHRA independent advice. The CHM advises Ministers on the safety and quality of medicinal products.

On 23 March 2022, I sent my first e-mail to the Professor. It read as follows:

Dear Professor Sir Munir Pirmohamed,

Please accept this request under the Freedom of Information Act. 

I am very concerned that MHRA are reporting over 1.5 million serious adverse reactions and over 2,000 deaths reported via the Yellow Card Scheme. We are aware that there is a huge underreporting of Yellow Cards, so we must expect those figures in real time to be much higher. Whilst I appreciate these figures cannot be directly attributed to the vaccine, equally, without thorough and forensic investigations we will never know. 

I have been in regular contact with MHRA CEO Dame June Raine and have diligently watched every single MHRA Board meeting. I am very concerned that a simple question is not being answered; it almost seems as though I am being stonewalled. I do hope this is not the case. I was fortunate in being able to address my question to [former British Health Secretary and now Chair of the Health and Social Care Select Committee of the House of Commons] Jeremy Hunt MP when he was holding a meeting on patient safety. I am relieved that he too takes the large number of serious adverse reactions as very concerning. 

So my question is: 

Please can you tell me what advice you will be giving the MHRA with regard to investigating these serious, life-limiting and sometimes life-ending effects? Will you be recommending a thorough investigation? If not, why not?
Also, I would appreciate your definition of ‘safe’. I note the word ‘safe’ must never be used [without qualification], according to the Association of the British Pharmaceutical Industry (ABPI). Could you explain? 

As Chairman of CHM, I would appreciate your reassurance that this is being taken very seriously, given this is a Black Triangle medication still under trial. 

I look forward to your response.

Deborah Evans
Retired SRN
PG Cert Autism

Two months later—after many reminders to and promises from Professor Pirmohamed—my determination paid off, and at last I received a four-page PDF reply in response to my original and subsequent e-mails. Initially, Professor Pirmohamed had been trying to deflect my questions to the MHRA, until I made it clear that it was from him in his capacity as Chair of the Commission on Human Medicines that I was seeking a response.

I am now in a position to set out my thoughts on his response. Below are some extracts from his reply, with my observations and comments beneath his. The original entire letter can be seen in context in a segment beginning at one hour and seven minutes into the 18 May 2022 episode of UK Column News.

There are still growing numbers of those who listened to him and his colleagues at the MHRA, who took the vaccine in good faith, and now suffer as a result. Globally, millions suffer in silence, ignored and invisible to those in power: the very authorities who inflicted an experimental injection on them with the promise that it was ‘safe’ and with the brow-beating that by subjecting themselves to it, they would keep others ‘safe’.

But at what cost? What were the risks and benefits? At the time of writing, no-one in Britain has received any compensation for a Covid vaccine injury under the Government’s previously-established Vaccine Damage Payments Scheme, despite some apparent victims having submitted claims as long as a year ago. Thus far, none of the victims, their families or loved ones have been believed or listened to. By default, their Yellow Cards appear to have been sucked into a research void, never to be seen again. Questions remain unanswered or sidestepped.


Sir Munir’s responses and my comments

Sir Munir writes:

When the Covid-19 vaccines were first authorised, we purposefully [sic—in the sense of ‘purposely’] highlighted the Yellow Card scheme, and the importance of receiving reports of suspected [italicisation in original] adverse reactions from healthcare professionals and the public. I am therefore really pleased that the public responded so positively and have sent in Yellow Cards from the start of the vaccination campaign. [...]
The number of Yellow Cards received is consistent with the numbers of reports received by the European Medicines Agency [link in original].

— DE: Suspected adverse reactions are, as the word suggests, something suspect; they ought not to be left to lie. Yet any investigation of the suspicion is conspicuous by its absence. Are all suspects eliminated before investigation? Would we release a suspect in a murder case, eliminate them from inquiries, when they have not yet been interviewed or referred for trial?

The Professor says he is ‘really pleased’ to receive notifications of injury, illness or even death. This appears to me to be a macabre choice of words. One adverse reaction is one too many.

It has been reported that the MHRA’s European Union counterpart, the EMA (an agency to which the Professor refers above), has processed over 1.7 million adverse reports related to Covid-19 vaccines. That figure accounts for 48% of all adverse reaction reports globally and drives the total up to 3.5 million. Are we to congratulate ourselves in Britain for keeping up with neighbouring countries in the injury stakes, or should we rather be horrified that we are performing as badly as they are, and be calling for an immediate stop to the rollout of all experimental medicines?

Sir Munir continues:

It is important to mention two issues regarding spontaneous adverse reaction reporting schemes, wherever they operate in the world: first, the reported cases are of suspected [italicisation in original] adverse reactions which means they are not necessarily related to or caused by the vaccine. [...] In addition, the World Health Organisation has been integrally involved in the fight against COVID-19, including monitoring the safety of vaccines.

The MHRA has put into place a proactive process to continually monitor the safety of vaccines as part of their responsibility for ensuring the safety, quality and efficacy of all medicinal products authorised in the UK. [...]

To inform its decision-making, the MHRA seeks independent expert advice from the Commission on Human Medicines (CHM).

— DE: Note the word ‘spontaneous’, referring to adverse reactions. The Merriam-Webster definition of this adjective is: “Developing or occurring without apparent external influence, force, cause or treatment.” Not, then, an apt word for things apparently contrived or manipulated; ‘spontaneous’ properly refers to natural occurrences. This would leave one to wonder whether the Professor is suggesting that any reaction reported after vaccination would definitively not be caused by this injection. If so, that would be a bold statement to make when there is no supporting evidence or data to support that statement. Currently, it would appear that the injections are still in Phase 3 clinical trials, with no data as yet available.

The Professor is correct that the WHO has been monitoring the safety of vaccines. The WHO uses the Bradford Hill criteria, a group of nine principles that can be useful in establishing epidemiologic evidence of a causal relationship between a ‘presumed cause and an observed effect’ and that have a history of use in public health research. If any of the nine principles is met, there should be an immediate stop of vaccine rollout and a full and thorough investigation. It appears that the Covid-19 vaccines satisfy all nine principles, yet they are still being promoted by the WHO. Monitoring should be ceased and stoppage effected immediately.

The MHRA would like to be seen as monitoring Covid vaccine safety; however, in reality any monitoring is not effective without discussion and decisions on what has been detected. ‘Efficacy’ and ‘effectiveness’ are two distinct nouns with different meanings: efficacy refers to the capability of achieving certain results in certain conditions, whereas efficency concerns the ability to obtain the best possible results with the minimum waste of resources. Dame June Raine is keen to point this nuance of language to audiences. 



Sir Munir continues:

The determination of whether reports of suspected adverse reactions are likely to be caused by the vaccines or are co-incidental is not only relevant to the Yellow Card system, but also for other spontaneous reporting systems worldwide, hence the importance of working collaboratively with other regulatory agencies, and learning from each other’s expertise [emphasis added]. There has been a lot of work going on globally to evaluate the safety of the vaccines.

Where careful analysis of the Yellow Card reports and subsequent investigations has shown that the COVID-19 vaccines may be potentially causing the adverse event, the product information has been updated to include details of the safety issue and any risk mitigation procedures put into place [emphasis added]. For example, when very rare cases of blood clots associated with lowered platelets [thrombocytopenia] were identified with the AstraZeneca COVID-19 vaccine, we worked with the Joint Committee for Vaccination and Immunisation (JCVI) to identify the patient population at highest risk. Similarly, when the MHRA identified the potential of vaccines to cause anaphylaxis, we liaised with experts in the field, and brought in measures to mitigate the risk, which were followed by other stringent regulators globally. Additionally, we have been continuously monitoring reports of suspected myocarditis associated with the mRNA vaccine and in the majority of cases these reactions are mild, and short-lasting [...] after COVID-19 infection, 1 in 20 developed new onset myocarditis [link in original]. We continue to monitor, with the help of expert cardiologists, any long-term effects of myocarditis associated with the mRNA vaccines, and to date, the data have been reassuring.

Regarding the issue of fatal events with a temporal association with vaccination: Irrespective of vaccination, and even before the pandemic, unfortunately over 1700 people [link in original] die every day in the UK (approximately one person every 2 minutes). Given that 92% of the UK population aged over 12 years have received a COVID-19 vaccine [emphasis added], by chance some deaths will occur in the days and weeks after vaccination. However, this does not mean these deaths was [sic] caused by the vaccine.

— DE: Here, nuancing of the use of language would appear to give those ‘monitoring’ the adverse reactions a free pass to avoid discussion of the gravity of the situation. The terms spontaneous (on this occurrence, unlike the occurrence above, the word is being used by Sir Munir in the well-established sense of ’[reported] of one’s own accord’), co-incidental and suspected lead me to believe that the language here is designed to confuse in order to remove all liability from manufacturers, regulators and governments.

It would appear that as long as the MHRA can demonstrate that it is mitigating the risks of serious adverse reactions identified, and as long as the MHRA perfunctorily types up the serious adverse reactions on its website (removing them the following week) to ‘inform’, there is actually no obligation upon it to act further. There are many who have experienced anaphylactic episodes after Covid vaccination, but despite the MHRA warning of just this adverse reaction, the advice to go for a second dose has been overwhelming.

It is a mystery to me why myocarditis would only be classified as ‘suspected’ when we are hearing of so many young people receiving a fully-fledged medical diagnosis of myocarditis after Covid vaccination. It would also appear that myocarditis after vaccination, compared to myocarditis without vaccine involvement, is an entirely different medical picture.

I am interested in the statistic of 92% of the UK population over twelve supposedly having received a Covid vaccine; this would appear to contradict the official figures, which suggest far less uptake. If the deaths in question were not caused by Covid vaccines, then—even in the absence of post-mortems and forensic examination to enable us to eliminate vaccination as a possible cause—what did cause death?



Sir Munir continues:

Most of the excess mortality over the course of the pandemic has been due to COVID-19 infection itself, and investigations to date have not implicated vaccines as a cause for the excess mortality. Indeed, mortality rates in the first 8 weeks of this year [2022] have been below the 5-year average. I should highlight the most recent investigation (dated 22nd March 2022) from the Office of National Statistics, COVID-19 vaccination and mortality in young people during the coronavirus pandemic [link in original]. The main conclusion from this independent investigation was that “There is currently no evidence of a change in the number of cardiac-related deaths or death occurring from any cause after a coronavirus (COVID-19) vaccination in young people aged 12 to 29 years in England”.

— DE: Are we to understand from this that, even without thorough and forensic investigation, we should assume that Covid-19 is responsible for strokes, myocarditis, anaphylactic shock, thrombocytopenia, spontaneous abortions, blindness, deafness and thousands of other reactions? Is the Professor really blaming this all on viral infection?

Is the weekly MHRA data from the Yellow Card scheme not enough to cause concern to anyone within our public agencies? Seemingly not: those suffering with what they believe is a result of the injection have now been corrected as, according to Professor Pirmohamed, serious adverse reactions appear to be due to long-term effects of the novel coronavirus. However, I see little evidence or references provided in Professor Pirmohamed’s reply to support this assertion.



Sir Munir continues:

Regarding the issue of safety of the vaccines in pregnancy: globally, regulators have now amassed a huge amount of data from different sources in women of childbearing potential and in pregnant women and this has shown that the COVID-19 vaccines are not associated with infertility, adverse pregnancy outcomes, or foetal malformations. These data are vitally important because pregnant women are at higher risk of severe illness and death from COVID-19 infection [emphasis added] [...] In addition, the MHRA is proactively recruiting 2500 vaccinated women through the Yellow Card Vaccine Monitor to track long term outcomes. [..]

Finally, it is important to state that many of the adverse events which have been attributed to the vaccines occur much more commonly with COVID-19 infection itself [emphasis added]. Analysis undertaken by the UK HSA [Health Security Agency, formerly Public Health England; link in original] (dated 16 Sept 2021) has shown that over 230,000 hospitalisations have been prevented in people over the age of 45 [emphasis added], while over 100,000 deaths have been prevented [emphasis added]. In November 2021, the WHO [link in original] also reported that nearly half a million lives have been saved by COVID-19 vaccination [emphasis added] in less than a year.

— DE: Despite the thalidomide scandal, and the more recent sodium valproate scandal that has affected thousands of pregnant women, children and their unborn babies, lessons do not appear to have been learned. The golden rule of medical professionals has long been that pregnant women, their unborn babies and young children should never be experimented on. End of argument.

Where is the evidence to support the statement that pregnant women are at heightened risk of severe illness and death from Covid-19 infection? There is no supporting evidence. The trials for pregnant women are not yet complete; therefore, no cast iron assurances can or should be given.

These are more bold statements—without any references to back them up—of lives ostensibly saved through vaccination and of people supposedly spared the need for hospitalisation. Where are the evidence, studies and methodology to support this version of events?



Sir Munir concludes:

In relation to comments about under-reporting of suspected adverse events, the actual rate of reporting is unknown and likely to be highly variable as it will be influenced by public awareness and seriousness of events as well as publicity around the use of the vaccines [emphasis added]. For the COVID-19 vaccines, there is a higher than normal public awareness of Yellow Card reporting and therefore the reporting rate for these products is expected to be higher. I am confident that the MHRA evaluate all aspects of the Yellow Card data including potential variability in levels of reporting for Yellow Card data as part of their ongoing monitoring procedures.

To summarise, there is intensive proactive monitoring of the safety of the COVID-19 vaccines, and if a plausible link between any adverse event and a vaccine is identified, the product information is updated, and risk mitigation procedures are put into place as appropriate.

I therefore hope these answers all the queries received. We continually monitor the benefits and risks of the vaccines in order to protect public health.

Please note that any further correspondence will be re-directed to the MHRA Customer Services.


— DE: Many peer-reviewed papers discuss major underreporting of serious adverse reactions, both historically and in the present day. Why is there a higher than normal public awareness of the MHRA’s Yellow Card reporting in the current Covid era? Might it have anything to do with reports actually having increased because of genuinely enhanced levels of injury and death?

It appears that any pharmocovigilance signals of concern received are simply fed through to the MHRA website, prompting no guidance, advice or recommendations to people to avoid further injections. How confident is Professor Pirmohamed? Is he reading the same data as the rest of us? 



In summary, it would appear that those who have suffered vaccine injury or who have lost members of their family to post-vaccine death, and who are convinced that the serious adverse reactions and deaths are linked to the vaccine, will continue to be ignored and left in the shadows unless we all increase the pressure and carry on challenging the narrative. We can do this by writing to those responsible and by encouraging those suffering to speak up if they are able.

We owe that to those who were coerced, misled, persuaded to ‘trust the science’, for those too weak to have their voices heard. The rest of us must be those voices for them. When is enough enough? Clearly, some of my questions remain unanswered:

Will there be an immediate and thorough investigation of serious adverse reactions?

What is your definition of ‘safety’?

With more experimental vaccines and genomic precision medicines coming down the line, this is not over yet; this is only just the start. Question everything, research everything. Do No Harm.