A New Zealand woman has died after suffering from a condition which is a rare side-effect of the Pfizer Covid-19 vaccine, the Ministry of Health has announced.
Following the death of the woman from myocarditis and pericarditis the Covid-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) has advised the Ministry of Health to ensure healthcare professionals and consumers remain vigilant and are aware of the signs of the condition and pericarditis which was a similar condition.
Myocarditis - an inflammation of the heart muscle - is a rare side-effect of the Pfizer Covid-19 vaccine.
Director-General of Health Dr Ashley Bloomfield said the vaccine was safe and myocarditis was a "very rare" and previously known side-effect from the vaccine.
Asked about vaccine hesitancy in light of the vaccine-related death, Bloomfield recognised it would be a worry for some, but reassured people that there was plenty of evidence the vaccine was safe and myocarditis was rare.
Associate Professor James Ussher, from the University of Otago's Department of Microbiology and Immunology, said the death was dreadfully sad, but emphasised the benefits of the vaccine far outweighed the risks.
It represented one of the first deaths from myocarditis linked to an mRNA vaccine, Prof Usher said.
"Hundreds of millions of doses of the Pfizer and Moderna vaccines have been administered globally.
"To date, the vast majority of cases of myocarditis following vaccination with the Pfizer or Moderna vaccines have been mild, with resolution of both symptoms and inflammation with anti-inflammatories."
"The benefits of vaccination against SARS-CoV-2 far outweigh the risks, with recent data from the United States showing a massive 25-fold reduction in the risk of hospitalisation and death from Covid-19 in vaccinated individuals."
The case has been referred to the Coroner and the cause of death has not yet been determined.
The CV-ISMB considered that the myocarditis was probably due to vaccination. The CV-ISMB noted there were other medical issues occurring at the same time which may have influenced the outcome following vaccination.
Further details would not be released while the Coroner investigated the death.
The ministry said this was the first case in New Zealand where a death in the days following vaccination has been linked to the Pfizer vaccine.
While the Centre for Adverse Reactions Monitoring had received other reports of deaths in someone recently vaccinated, none were considered related to vaccination.
CV-ISMB chairman Dr John Tait said it was important to thoroughly investigate significant and serious adverse events related to vaccination.
“We want to ensure that the outcomes from this investigation are widely available for others to learn from. The findings will be published to increase the scientific knowledge about vaccine-induced myocarditis," Dr Tait said
Symptoms of myocarditis can include new onset chest pain, shortness of breath and an abnormal heartbeat. It was important that anyone who experiences these symptoms in the first few days after vaccination sought medical attention promptly.
“The Pfizer vaccine is highly effective in protecting against serious illness and death from Covid-19, and we remain confident about using it in New Zealand,” says Dr John Tait.
In New Zealand, adverse events following vaccinations are reported to the Centre for Adverse Reactions Monitoring (CARM).
All cases with a fatal outcome are referred to the CV-ISMB for review. CARM provides as much information on the case as possible for the clinical experts on the CV-ISMB to help them in their consideration of whether there was a link to vaccination.
Last month Medsafe issued a safety alert on myocarditis to raise awareness of this recently identified side effect to the Pfizer vaccine. The CV-ISMB considers that the circumstances of this death are consistent with what is known about myocarditis and the Pfizer vaccine.
Myocarditis
Myocarditis is an inflammation of the heart muscle wall. There are many possible causes of myocarditis, but the most common cause is a viral infection.
Pericarditis is included in Medsafe’s safety alert as it is sometimes hard to distinguish between myocarditis and pericarditis, and they may occur together.
There have been cases of myocarditis (and pericarditis) reported internationally and 32 (including cases of pericarditis) in New Zealand by people who have received the Pfizer Covid-19 vaccine up to August 24.
A reported adverse event does not necessarily imply that it was caused by the vaccine
Most cases reported internationally have been mild, and the patient has recovered with normal treatment.
To date the rate is highest in young men but can occur in people of all ages after the first or second dose. The estimated rate is 23 cases per million in 12- to 39-year-olds according to the CDC in the USA.
An Israeli study of 250,000 vaccinated adults compared the risk of myocarditis following vaccination with the risk of myocarditis following infection from Covid-19.
- Those who were vaccinated with the Pfizer vaccine had an increased risk of developing myocarditis by a factor of 3.
- Covid-19 infection, however, increased the risk of myocarditis by a factor of 18.
- Covid-19 infection also increases the risk of several other serious conditions.
