State medicines watchdogs find 'no causal link' between vaccine and boy's tragic death

Inquest Analysis: Joseph McGinty (14) died three weeks post Pfizer vaccine

Continuing to focus on the evidence presented at the inquest into the death of Joseph McGinty (14) of The Valley, Achill Island, Co Mayo, this Substack article takes an in-depth look at letters and statements presented by three state bodies responsible for public health and vaccine safety analysis in Ireland.

Previous articles dealing with the Health Products Regulatory Authority (HPRA), National Immunisation Advisory Committee (NIAC) and Chief Medical Officer (CMO) and their involvement in this coroner’s inquest are available here and here.

Back in April at a preliminary hearing, Coroner for the Mayo district Patrick O’Connor requested Anne Tobin, HPRA Pharmacovigilance Manager, (NIAC) Chairperson Karina Butler and Chief Medical Officer (CMO) Dr. Breda Smyth to attend the inquiry. Dr Smyth replaced former CMO Dr Tony Holohan in June 2022.

HPRA

In her reply letter to the Coroner, HPRA Director of Human Products Monitoring Sinead Curran wrote:

“Based on correspondence to date, my understanding is that attendance at the inquest is not foreseen. However should you have any queries or require further clarification or assistance in advance, please do not hesitate to contact me.”

In her statement, which was read in as evidence to the court, Ms Curran informed the inquest that a suspected adverse reaction report was filed with EudraVigilance, the database for adverse events under the European Medicines Agency (EMA) in relation to Joseph McGinty (with details anonymised).

“In November 2022 the HPRA first became aware of this case through media reports on the Inquest. The HPRA subsequently engaged with the Coroner and the information provided in response has been recorded as a suspect adverse reaction (ie side effect)…in line with the HPRA’s obligations,” the statement notes.

Having studied the pathological findings, the HPRA found that ‘based on the available safety data assessed for this vaccine to date’ no causal association to the Pfizer vaccine has been established.

“Based on information currently available to the HPRA on this case, the pathological findings commented upon in autopsy reports with regard to the fatal outcome include Addison’s Disease, Addisonian crisis and encephalitis. I can confirm that based on the available safety data assessed for this vaccine to date, that a causal association has not been established to be at least reasonably possible between these medical conditions and Comirnaty (Pfizer covid vaccine) and as such they are not reflected in the official EU product information as known adverse reactions,” Ms Curran wrote in her report.

“The HPRA will assess any further information that becomes available for this case, in accordance with ongoing *pharmacovigilance requirements,” Ms Curran wrote.

(*Pharmacovigilance includes all activities related to the detection, assessment, understanding and prevention of adverse effects and other possible drug-related problems.)

Ms Curran went on to explain that individual reports of suspected adverse reactions ‘are typically not sufficient to confirm a causal association and must be considered together with the totality of available data to reach an evidence bases conclusion.’

Case Report of Interest: Immunohistochemistry staining

The process of immunohistochemistry staining takes tissue from the heart or brain or any affected organ and differentiates between spike protein produced by covid 19 (the disease) and the spike protein induced by a covid 19 vaccine.

The following case report is based on the autopsy of a 76 year old male where encephalopathy was proven to be vaccine linked through immunohistochemistry staining.

The case report is technical, but illustrates clearly how specific protocols at autopsy can distinguish between vaccine induced spike protein and that produced by covid 19. Furthermore, the report not only proves a link between gene based covid 19 vaccines and encephalitis but points out that these findings corroborate previous reports of encephalitis cause by the vaccine.

The report states:

“Histopathological analyses of the brain uncovered previously unsuspected findings, including acute vasculitis (predominantly lymphocytic) as well as multifocal necrotizing encephalitis of unknown etiology with pronounced inflammation including glial and lymphocytic reaction. In the heart, signs of chronic cardiomyopathy as well as mild acute lympho-histiocytic myocarditis and vasculitis were present. Although there was no history of COVID-19 for this patient, immunohistochemistry for SARS-CoV-2 antigens (spike and nucleocapsid proteins) was performed. Surprisingly, only spike protein but no nucleocapsid protein could be detected within the foci of inflammation in both the brain and the heart, particularly in the endothelial cells of small blood vessels. Since no nucleocapsid protein could be detected, the presence of spike protein must be ascribed to vaccination rather than to viral infection. The findings corroborate previous reports of encephalitis and myocarditis caused by gene-based COVID-19 vaccines.”

Is it not important that Ms Curran, in her role as Director of Human Products Monitoring for the HPRA, be aware of

a) this immunohistochemistry staining test protocol and

b) evidential links via autopsy linking encephalitis to covid vaccination?

This Substack has written to Ms Curran via email to let her know these protocols exist.

NIAC

In it’s correspondence ahead of Joseph McGinty’s inquest, NIAC informed the Coroner that Prof Karina Butler has retired from her position as Chair of the organisation - the first this Substack heard of this development, which has not been reported in any main media outlets.

Prior to her retirement, NIAC Chief Prof Karina Butler wrote in response to a letter from the Coroner that set out the timeline between Joseph McGinty’s first Pfizer vaccination and his death (24 days.)

The Coroner provided the provisional cause of death as established by Consultant Pathologist at Mayo University Hospital Dr Fadel Bennani (massive brain oedema due to viral encephalitis) and the provisional post-mortem diagnosis from Dr Michael McDermott (profound adrenal pathology due to Addison’s Disease.)

In response, Dr Butler noted that a number of reports linking covid vaccinations with encephalitis have been published, but since none of the cases Dr Butler examined have an established ‘causal relationship’, Prof Butler found the link between the vaccine and Joseph’s untimely death to be ‘unlikely.’

“A number of reports of encephalitis temporally associated with covid 19 vaccination have been published including some cases of autoimmune encephalitis. However, while the temporal association promoted the reporting of these cases a causal relationship has not been established,” Prof Butler wrote.

What attempts to establish whether a causal relationship exists has NIAC made? Should that not be a matter of absolute priority given that NIAC recommend these products to infants as young as six months old?

“Within the US Voluntary Adverse Event Reporting System several adverse event reports relating to encephalitis are found, generally in older individuals with underlying co-morbidities. Such events are reported because they happen after vaccination. That they are reported does not necessarily mean the vaccine caused the event. Further investigation and analysis are required to determine whether the temporal relationship to vaccination is just coincidental or causal. Factors taken into consideration include the timing of the event, likelihood of other explanations, possible contribution of other conditions or medications, and whether the frequency of the vent in those vaccinated exceeds that expected due to the background prevalence of the condition,” Prof Butler wrote.

What further investigation and analysis is NIAC doing?

I’ve highlighted in bold the line that should set the public on edge regarding Prof Butler’s explanation. A state body doing it’s job properly would be working hard to analyse whether the vaccine caused the event.

“In summary, while there are published reports of encephalitis occurring following the covid 19 vaccination no causal relationship has been established. On an individual basis the possibility of an extremely rare adverse reaction to a vaccine is always difficult to definitively exclude. Given the experience with the Pfizer vaccine Cominarty, the number of doses administered, the data from clinical trials and post marketing surveillance, this makes it unlikely that the vaccination was causally implicated in the untimely death of Master McGinty,” Prof Butler wrote.

Ultimately, in her correspondence, the former NIAC Chief claims it is ‘unlikely’ the Pfizer vaccine caused Joseph’s untimely death.

Would a more vigilant approach be useful, given that, conditions the vaccine is now known to cause - myocarditis and pericarditis - only made it onto the HSE’s official list of adverse reactions after it was updated in March 2022, long after the Irish population had received two doses? (as outlined by this reporter here)

Readers should also note that the HSE describes these conditions as ‘very rare’ yet, this Swiss study published earlier this month found that one in 35 healthcare workers showed signs of heart damage after the Moderna vaccine.

Read news coverage of the Swiss study from three days ago here and on Steve Kirsch’s Substack, nine months ago, here.

CMO

Chief Medical Officer Prof Breda Smyth replaced Dr Tony Holohan as CMO in June 2022.

In her response to Coroner Pat O’Connor’s queries, Chief Medical Officer Prof Breda Smyth said it would not be appropriate to send a staff member from her office, ‘given the sensitivities.’

The CMO further stated that the HPRA is the competent national authority on vaccine safety and the administration of vaccines was conducted under the stewardship of the HSE.

“Dear Mr O’Connor

While I appreciate the particular sensitivities and challenges surrounding this inquest, in particular with regard to establishing whether or not vaccination was a contribtory facto on Mr McGinty’s unfortunate death or was correlative to it, I do not believe that attendance of a staff member from my office would either assist you in your enquiries or be appropriate, given the sensitivities involved,” the CMO wrote.

Prof Smyth notes that vaccine safety is a matter for the HPRA and the administration of vaccines in relation to covid 19 was ‘conducted under the stewardship of the HSE’ and as such, the value of sending a staff member from the Chief Medical Office is ‘not clear.’

Readers can peruse the letter below:

Letter from CMO Prof Breda Smyth to Coroner Patrick O’Connor re Joseph McGinty inquest.

This could be classified as a curious response to a Coroner’s request to attend the inquest into the death of a 14 year old boy, given the role former CMO Dr Tony Holohan played throughout the Irish state’s response to the arrival of covid 19. Note Prof Smyth’s job description in her biography as outlined by the government’s Department of Health information page.

According to gov.ie the CMO position holds:

“Responsibility for provision of strategic leadership and evidence-based analysis and expert medical advice to the department, government, broader health system and regulatory and professional bodies; Developing policy and legislation across the domains of Public Health, Leading the response to Pandemics an Public Health Emergencies of International Concern, Leading strategic Public Health Reform for the Irish Health System, Leading the development and co-ordination of Healthy Ireland Policy.”

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I realise that readers have plenty of questions about the coroner’s court, how it works, what verdicts may apply and why this case is important. At the moment this Substack is serving a dual purpose - to report the evidence accurately for the medical and legal community and to keep the public informed. The case is hugely significant, given this Coroner’s commitment to exploring all evidence available to him along two different avenues; the lack of diagnosis of Addison’s Disease and whether Joseph’s covid vaccine played a role in his rapid deterioration and subsequent death.

I am aware that many find this evidence difficult to process, not least because the final reality is that a family have lost their much loved youngest son and baby brother.

There is still the Pfizer evidence to sift through, which I plan to tackle in my next article, before I complete a final round up of what I believe are the key points of evidence to emerge from this inquiry to date.

Coroner Patrick O’Connor has asked that the three legal teams involved in the case have their final submissions on suitable verdicts and recommendations ready by August 11.

The inquest resumes again on August 21 for the delivery of a verdict.

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Warm thanks to those that continue to support my work, it is much appreciated.

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Multiple previous articles are available on this topic throughout this Substack eg:

here

here

here

report from the opening of preliminary hearings into the inquiry from Nov 2022