The coroner’s inquest into the tragic death of Rory Nairn following immunisation with the Pfizer vaccine raises concerns that need to be addressed.
Let’s examine how events unfolded.
Pfizer’s application for the use of their Comirnaty COVID-19 mRNA vaccine in New Zealand was lodged with the medical regulator Medsafe on 3 November 2020. Approval was given on 3 February 2021 for a ‘provisional’ consent for a period of two years.
Once a new medicine has been approved by Medsafe, a monitoring process is established to identify any serious adverse reactions that may not have been picked up during limited clinical trials. Healthcare professionals and patients are encouraged to report side-effects to the Otago University based Centre for Adverse Reactions Monitoring (CARM).
For the Pfizer vaccine, all adverse events following immunisation (AEFI) – including symptoms, diseases, abnormal laboratory findings, or any other untoward development – are recorded weekly and published on the Medsafe website.
The latest available update is for the week of 22 July 2022. It shows 11,133,437 doses of the Pfizer vaccine have been administered and 62,937 adverse event notifications have been received, of which 3,452 have been deemed to be serious.
New Zealand’s Covid-19 vaccine rollout began on Friday 19 February 2021.
By late April, after 224,000 Pfizer doses had been given and 1,600 vaccine incidents had been reported, ‘myocarditis’ was included as a new safety signal: “There was one serious report of myocarditis this week. Medsafe is currently reviewing this signal and we will provide further information once the review is completed.”
Myocarditis involves the inflammation of the heart muscle and is a serious condition that, if left untreated, can be fatal. It is the same story with pericarditis, which involves the inflammation of the tissue forming a sac around the heart, and myo-pericarditis, where both the heart muscle and the sac are inflamed.
In early June, Medsafe published a “Monitoring Communication” outlining safety concerns about vaccine-induced myocarditis and asking for any new cases to be notified to CARM.
The Ministry of Health published Medsafe’s announcement on their website.
On 21 July 2021, as more cases were being reported, and similar concerns were emerging overseas, Medsafe issued an alert: “CARM has received 9 cases of myocarditis, 5 cases of pericarditis and 4 cases of myopericarditis… Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinated individuals should also seek immediate medical attention should they experience new onset of chest pain, shortness of breath, palpitations or arrhythmias.”
A memo sent that day to the Director-General of Health from Dr Ian Town, Chair of the COVID-19 Vaccine Technical Advisory Group also recommended the introduction of new restrictions including: “People aged 16-29 years receive their second dose of the vaccine at least 8 weeks after the first dose. A longer interval between doses may reduce the frequency of some side effects… Anyone who develops confirmed myocarditis and/or pericarditis after the first dose should not receive a second dose of the Pfizer COVID-19 vaccine”.
At a time when the public and the media were regularly checking the Ministry of Health’s website for more information about Covid and the vaccine, Medsafe’s crucial warning does not appear to have been published.
On 1 September 2021, Medsafe reported New Zealand’s first vaccine death in their weekly update: “Following medical assessments by CARM and Medsafe it has been determined that… 1 death was likely due to vaccine induced myocarditis (awaiting Coroner’s determination).”
The death of this woman in her 50s, appears to have occurred around the time Medsafe issued their 21 July 2021 alert. Following a request by the regulators, the Ministry of Health published a statement on their website on 30 August 2021 explaining, “The COVID-19 Vaccine Independent Safety Monitoring Board has advised the Ministry of Health to ensure that healthcare professionals and consumers remain vigilant and are aware of the signs of myocarditis and pericarditis. This advice follows the review of the death of a woman following her Pfizer vaccination.”
That directive, however, did not stop more deaths.
By the time a second myocarditis alert was issued by Medsafe on 20 December 2021 revealing 233 reports of myocarditis, pericarditis and myo-pericarditis, two people had died – the second was Rory Nairn.
With three deaths now attributed to vaccine-induced myocarditis (a third notification was made earlier this year) the six-day inquest in the Dunedin District Court into the death of the 26-year-old plumber has revealed many troubling matters.
The Court heard that Rory Nairn died at his Dunedin home on 17 November 2021, less than two weeks after receiving his first dose of the vaccine at a pharmacy. He had complained of pain after the immunisation on November 5, including fluttering in his chest, but since he hadn’t been told about the risk of myocarditis nor the symptoms to watch out for, he hadn’t sought medical help.
With his condition deteriorating, as he was getting ready to go to the hospital’s emergency department, he collapsed in the bathroom and died.
The family wants to know why he wasn’t warned about the risk of myocarditis when he was considering whether or not to take the vaccine. That question is amplified by the fact that he hadn’t wanted to be vaccinated but only did so to ensure that the wedding being planned for March wouldn’t face obstacles such as gathering limits.
The pressure to get vaccinated and a lack of information about the risks, strike at the heart of the controversy over the Pfizer vaccine.
Many New Zealanders will remember how the disaster that unfolded following the use of the new drug thalidomide in the 1960s, highlighted the need for comprehensive clinical testing before the widespread use of a new drug.
With the Covid vaccine using new mRNA genetic technology, and clinical trials that won’t be completed until 2023, concerns about the Pfizer vaccine are understandable – especially as it had received only ‘provisional’ consent.
The Medsafe website explains that provisional consent under section 23 of the Medicines Act 1981 must be renewed every two years, and it outlines the general rationale: “Provisional consent is ideally suited to medicines still undergoing clinical assessment but where it is desirable that patients have early access. It is anticipated that the medicine will be used on a restricted basis until the risks and benefits have been quantified and full consent has been granted.”
The Medicines Act, however, also gives the Minister of Health the authority to grant a provisional consent if he believes “it is desirable that the medicine be used”. That was clearly the case when the Minister approved the Pfizer application.
The decision by Prime Minister Ardern that New Zealand should become a world leader in our vaccine uptake exacerbated the problem. Instead of vaccination remaining voluntary – as she promised before the 2020 election – to all intents and purposes it became mandatory.
A multi-million-dollar campaign was unleashed urging everyone to get vaccinated. It sent a clear message that anyone who failed to do so was letting down the team of 5 million.
Jacinda Ardern divided our society into those that were vaccinated and those that weren’t – splitting families and destroying relationships in the process.
That division included those in the medical profession.
Guidance jointly issued by the Dental and Medical Councils in April stated that members were expected to get vaccinated – and convince their patients to do the same.
The Councils state that while “Patients are entitled to information that a reasonable consumer, in that consumer’s circumstances, would expect to receive”, they then warn: “It is our view that there is no place for anti-vaccination messages in professional health practice, nor any promotion of antivaccination claims including on social media and advertising by health practitioners”.
In practice, this has meant that doctors raising concerns about the vaccine – or prescribing alternative treatments that have been successfully used overseas – have been threatened with disciplinary action, including being struck off.
While the Pharmacy Council’s guidance issued in May 2021 also required members to get vaccinated, it reminded them of their professional and ethical obligation to explain “risks and benefits” when helping patients to make informed decisions: “Pharmacists have an important role to play in addressing vaccination hesitancy. While respecting an individual’s right to choose, including the right to refuse vaccination, you have an obligation to explain the risks and benefits of vaccination both for that individual and for society at large.”
The Nursing Council’s guidance to members issued in June 2021 was similar to that given to doctors – nurses were encouraged to discuss only the benefits of vaccination with the public, or they too could face disciplinary action.
At Rory Nairn’s inquest, the Court heard there was a great deal of confusion between health professionals over whether the risks associated with the vaccine – including the risk of developing myocarditis – should be discussed prior to vaccination.
With the principle of informed consent at the core of the health system, the findings of the Inquest will have important implications in the wider context of what information someone should receive before vaccination – and not just for pharmacies, but for everyone administering vaccines including doctors, nurses, and government-contracted vaccinators.
There are many questions.
Why did the Ministry of Health fail to properly inform the public about the risk of the more dangerous side effects of vaccination as soon as Medsafe issued that first alert in July?
Why haven’t the media been more proactive in raising concerns about vaccine safety?
Has political pressure to achieve the PM’s vaccination goals led to widespread coercion – resulting in New Zealanders not being adequately informed about vaccine risks?
This week’s NZCPR Guest Commentator, Waikato University’s Economics Professor John Gibson, has been monitoring the Government’s pandemic response and is now raising concerns about a worrying rise in unexpected deaths amongst vaccinated New Zealanders:
“In the last eight months there have been almost 3,000 excess deaths (which is 13% above what was expected). What is causing all of these deaths?
“The new way to count COVID-19 deaths has 1,216 deaths from COVID-19 as the underlying cause, going right back to 2020, plus 700 deaths where COVID is a contributory factor. So, in the last eight months New Zealand has had over 1,000 more people die than expected, where COVID is neither a cause nor a contributory factor. This is more than three times the annual road toll, yet there is no ‘road to zero’ advertising campaign or government strategy about these unexplained deaths…
“It is likely that some of the unexplained excess deaths are arising from the indiscriminate use of COVID-19 vaccines. It helps to recall that Pfizer documents eventually released by the FDA show that four months after the second dose, the vaccinated group in the Phase 2/3 trial had suffered 25% more all-cause deaths than the number of deaths occurring in the placebo group. Thus, more deaths due to greater use of the vaccines is consistent with results from the clinical trials.
“Moreover, there are now several studies which show that vaccine rollout – particularly of the booster doses – is associated with rising excess deaths. Examples where this pattern has been observed include Israel, Germany, and the Netherlands.”
This is a matter that must not be treated as an inconvenience by our health authorities and politicians. It is especially relevant given a Covid booster campaign is currently underway.
A precautionary approach would see the booster program paused while the scientific data is independently reviewed. It seems logical to do so given that the Government is now considering removing Covid restrictions altogether.
Please note: To register for our free weekly newsletter please click HERE.
THIS WEEK’S POLL ASKS:
*Should an investigation be carried out into the rise in unexplained excess deaths in New Zealand?
No comments:
Post a Comment