Never before have new vaccines been developed, tested and rolled out to millions in less than a year.
So when there’s news of a potential problem — like the deaths of frail, elderly people in Norway — how do we make sense of it?
In case you missed it, Norwegian health officials yesterday reported a small number of deaths among older people who received the Pfizer-BioNTech COVID-19 vaccine and suffered side effects.
While the Norwegian Medicines Agency is now investigating the deaths — estimated to be about 30 — the regulator and Australian authorities have been quick to play down any serious safety concerns.
“This group of people who had these adverse effects, and unfortunately some died, were very, very old and frail,” Professor Brendan Murphy, secretary of the Department of Health, told ABC News Breakfast.
“It’s not clear whether the vaccine — how directly related to the deaths it was.”
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All the people who died were in nursing homes and all were over the age of 80.
Doctors in Norway are now being instructed to carefully consider whether to vaccinate people who are very frail or at the end of life, but otherwise the rollout of the Pfizer jab is continuing as planned.
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Read moreAre rare side effects to be expected?
Vaccines undergo rigorous safety checks before they’re approved for use.
Clinical trials lasting several months have been conducted in around 40,000 people for most of the COVID-19 vaccines. But these only tell us about side effects in the people selected for the trials.
Rare side effects usually only emerge after a vaccine or drug has been released in the real world and tested on millions of people.
In the US, where more than 11 million people have received at least one dose of the vaccine, health authorities are beginning to see rare instances of severe (though treatable) allergic reactions to some of the COVID-19 vaccines.
They’re also investigating the case of a doctor who developed an unusual blood disorder shortly after receiving the Pfizer jab, and later died. It’s not yet known whether the COVID jab is linked to his illness.
Rare but serious side effects are why regulators and health authorities continue to closely monitor vaccines once they’ve been approved for use.
We’re likely to see more potential scares as COVID-19 vaccines are rolled out more widely. But that doesn’t mean we should be alarmed.
Separating coincidence from cause
When investigating adverse events related to vaccination, regulators have to separate coincidence from true vaccine side effects — and then decide what to do.
They do this by looking for similar reports from the millions of people already immunised to see whether there are emerging patterns.
Space to play or pause, M to mute, left and right arrows to seek, up and down arrows for volume. Brendan Murphy says he’s not unduly concerned by reports of adverse effects from the Pfizer vaccine.
In Norway, approximately 400 people die in an ordinary week in nursing homes. It’s not yet clear whether the reported deaths following COVID-19 vaccination are simply a function of age and declining health, or whether the vaccine may have played a role.
According to Australia’s Therapeutic Goods Administration, the deaths were associated with fever, nausea and diarrhoea, which are “relatively common short-lived effects” some people experience after vaccination.
“It is not expected that these common adverse reactions following immunisation will be of significance in the vast majority of individuals vaccinated with the Pfizer BioNTech vaccine,” a TGA spokesperson said.
So far, the problem in the frail elderly doesn’t seem to be widespread — but it may be that other countries aren’t vaccinating terminally ill people at scale.
If regulators find there is a real risk to this group, they might be excluded from some vaccines, in the same way authorities advise people with certain severe allergies to avoid vaccination
In the US, the story of the doctor’s death is troubling. But his condition is so rare that it should be readily noticed and reported if it’s happening elsewhere.
So far, it doesn’t seem to be. But it’s just the kind of side effect that does worry authorities, because unlike severe allergic reactions or impacts on the elderly, it may be impossible to avoid, even if it’s extremely rare.
More information to come
For those of us watching from the sidelines, it’s important to sit back and wait.
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Many of these reports are likely to end up being coincidental, rather than directly caused by the vaccine.
And with huge amounts of data available in real time, serious problems should be able to be sorted out at high speed.
Professor Catherine Bennett, chair in epidemiology at Deakin University, told ABC News earlier today that people should be reassured they won’t be offered the vaccine in Australia if it’s not safe.
“We have a very good regulatory process here … we’ve been able to wait for all safety data to come in from the phase 3 [advanced] trials and now have the benefit of learning from the experience in those countries rolling out the vaccine,” she said.
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