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NZ myocarditis death had probable link to Pfizer vaccine
But a recent real-world study on the vaccine’s safety – the largest undertaken to date – has found people are four times more likely to develop the condition if they become infected with COVID-19.
New large-scale research into Pfizer’s safety has found the risk of developing myocarditis is four times more prevalent in unvaccinated individuals who contract the virus. (Image: AAP)
A woman in New Zealand who developed myocarditis after receiving the Pfizer COVID vaccine has died.
In a statement issued on Monday, the country’s Ministry of Health said the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB), responsible for reviewing fatal outcomes following vaccination, considers the death was due to myocarditis, which is known to be a rare side effect of the mRNA vaccine.
‘The CV-ISMB considers that the circumstances of this death are consistent with what is known about myocarditis and the Pfizer vaccine,’ the statement reads.
However, the independent board did note that there were other medical issues occurring at the same time ‘which may have influenced the outcome following vaccination’.
The case has since been referred to the coroner, who will determine the cause of death.
While New Zealand’s Centre for Adverse Reactions Monitoring (CARM) has received reports of other deaths in recently vaccinated individuals, this is the first case that has been linked to a COVID-19 vaccine out of 3,337,075 administered doses.
In Australia, where more than 8.2 million doses of Pfizer have been administered, the Therapeutic Goods Administration (TGA) noted in its most recent COVID vaccine safety report that it has received 235 reports of suspected myocarditis and/or pericarditis out of 8.2 million doses of Pfizer (2.8 per 100,000). No deaths linked to the vaccine have been reported.
Meanwhile, the largest real-world study into Pfizer’s safety, published in the New England Journal of Medicine, found the risk of developing myocarditis to be four times higher in unvaccinated individuals who contract COVID-19.
Involving 884,828 vaccinated and 884,828 unvaccinated individuals aged 16 and over, myocarditis was rarely associated with the vaccine, with 2.7 cases per 100,000 compared to 11 cases per 100,000 unvaccinated and infected individuals.
In contrast to the relatively small number of adverse effects associated with the vaccine, high rates of multiple serious adverse events were associated with COVID infection among unvaccinated patients, including:
- cardiac arrhythmias (a 3.8-fold increase; 166 excess cases per 100,000 infected patients)
- kidney damage (14.8-fold increase; 125 excess cases per 100,000)
- pericarditis (5.4-fold increase; 11 excess cases per 100,000)
- pulmonary embolism (12.1-fold increase; 62 excess cases per 100,000)
- deep vein thrombosis (3.8-fold increase; 43 excess cases per 100,000)
- myocardial infarction (4.5-fold increase; 25 excess cases per 100,000)
- stroke (2.1-fold increase; 14 excess cases per 100,000).
Professor Ben Reis from Boston Children’s Hospital and Harvard Medical School said the research provides ‘reliable information on vaccine safety’ that he hopes will be helpful to people who have not yet decided about vaccination against COVID-19.
‘Those who have hesitated until now to get vaccinated due to concerns about very rare side effects – such as myocarditis – should be aware that the risks for this very same side effect are actually higher among unvaccinated infected individuals,’ he said.
The CV-ISMB has advised the New Zealand health ministry to ensure healthcare professionals and recipients of the vaccine ‘remain vigilant and are aware of the signs of myocarditis and pericarditis’. These can include:
- new-onset chest pain
- shortness of breath
- an abnormal heartbeat.
‘It’s important that anyone who experiences these symptoms in the first few days after vaccination seeks medical attention promptly,’ the Ministry of Health’s statement reads.
‘The benefits of vaccination with the Pfizer COVID-19 vaccine continue to greatly outweigh the risk of both COVID-19 infection and vaccine side effects, including myocarditis.’
CV-ISMB Chair Dr John Tait said the board is committed to ensuring the outcomes of the investigation into the woman’s death are widely available ‘for others to learn from’.
‘The findings will be published to increase the scientific knowledge about vaccine-induced myocarditis,’ he said.
‘The Pfizer vaccine is highly effective in protecting against serious illness and death from COVID-19, and we remain confident about using it.’
The woman’s death has reaffirmed the importance of Australia’s no-fault COVID-19 Vaccine Claim Scheme, for which the RACGP strongly advocated.
Finalised on 28 August, the scheme will come into effect from 6 September, ensuring anyone who experiences a serious ‘proven adverse reaction’ to a vaccine delivered through a government-approved program has rapid access to compensation.
‘Serious and life-threatening side effects are very rare, but it is important that we provide a safety net to support those affected,’ Federal Health Minister Greg Hunt said.
‘It also ensures that health professionals administering vaccines will be able to continue with their crucial role in the vaccine rollout with assurance that the claims scheme will offer them protection.’
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