The number of Kiwis who've died after getting a COVID-19 vaccine jab is actually "less than the expected number" by chance, New Zealand's medical safety authority says.
The first death here likely to have been a direct result of a dose of the Pfizer-BioNTech vaccine was reported on Monday, a woman in her 50s who died about a month ago.
"All the evidence" is the cause was myocarditis - inflammation of the heart muscle - "probably due to the vaccine", COVID-19 Vaccine Independent Safety Monitoring Board chair John Tait told The AM Show on Tuesday.
He said she had "a couple of other things that may potentially have affected this, but we can't really comment on that as it's still under the jurisdiction of the coroner. But when we weighed up all the evidence, we felt that the myocarditis was probably due to the vaccine."'
The death made headlines worldwide, including on BBC News in the UK, Bloomberg in the US and the international wire service Reuters. But that could be seen as evidence of how rare deaths linked to the Pfizer vaccine have been.
Since the start of the vaccine rollout, 26 deaths following doses of the Pfizer vaccine have been reported to Medsafe. Medsafe says people "some people will experience new illnesses or die from a pre-existing condition shortly after vaccination… by chance", and part of its monitoring involves comparing the number of deaths in those who receive doses to the rest of the population "to determine if there are any specific trends or patterns that might indicate a vaccine safety concern".
"To date, the observed number of deaths reported after vaccination is actually less than the expected number of deaths," according to Medsafe's latest vaccine safety report, published last week and covering all deaths and adverse reactions up to August 7.
Nearly half the deaths - 12 - were of people aged 80 or over. Ten in their 60s and 70s, four between 30 and 59, and none were under 30.
"The benefit of the vaccination far outweighs any risk of getting COVID or of getting an adverse outcome from the vaccine," said Dr Tait.
Myocarditis is fairly rare on its own, with only about 100 cases a year in New Zealand according to Medsafe. A recent Israeli study found the risk of myocarditis following a dose of the Pfizer vaccine is 2.7 in 100,000 - that's just 0.0027 percent. The risk of myocarditis following infection with the SARS-CoV-2 virus which causes COVID-19 is about four times that in the unvaccinated, the study found.
"Coronavirus infection - but not vaccination - was also associated with greatly increased risk of pericarditis, arrhythmias, heart attacks, strokes, pulmonary embolism, deep-vein thrombosis, acute kidney damage, and others," the Clalit Research Institute, which carried out the research, said in a statement.
In the US, after 363 million doses there had been just under 7000 deaths reported. "Reports of adverse events... following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem," according to the Centers for Disease Control website. But around 2.8 million people die in the US every year. In the past 18 months, more than 600,000 of them have succumbed to COVID-19.
Only a few deaths have been linked to COVID-19 vaccines in the US, and none to the Pfizer jab being used in New Zealand. Some recent deaths linked to the similar mRNA vaccine made by Moderna in Japan have been blamed on contamination, not the vaccine formulation itself.
A paper published in the British Medical Journal in May linked 10 deaths "of frail elderly people" in nursing homes in Norway to the vaccine, but no direct causal link was found, except that "common adverse reactions may have contributed to a more serious course of their disease".
"The benefits far outweigh the very small risks," said James Ussher, a microbiology and vaccine scientist from the University of Otago.
"This is a very unfortunate and rare case, and one of the first instances of a vaccine myocarditis death associated with the mRNA vaccines worldwide, despite hundreds of millions of doses having been administered. It is extremely sad and unfortunate, but it is rare."
He said US data has shown fully vaccinated people are 25 times less likely to end up in hospital or die from COVID-19, and are eight times less likely to be infected in the first place.
"Myocarditis is an uncommon complication of COVID, a rare complication, but the risks are four times greater... than with the vaccine. That's quite aside from all the other risks that we know about with COVID - such as respiratory failure requiring ventilation and leading to death, and also all the clotting issues associated with COVID. The risks if you develop COVID are many times greater."
So far more than 5 billion doses of COVID-19 vaccines have been administered worldwide, with just a handful of linked deaths. Official counts show more than 4.5 million people have died of the disease itself, with the true figure likely much higher.