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Very old and frail Australians may be excluded from receiving Pfizer’s coronavirus vaccine following the deaths of almost 30 aged care residents in Norway after receiving the jab.
In a potential setback to Australia’s plans to include the elderly in the initial vaccine rollout, Australia’s medicines safety regulator is urgently seeking patient data from European officials as well as the American pharmaceutical giant.
However, the deaths are unlikely to delay the Therapeutic Goods Administration’s overall approval for the use of the Pfizer vaccine in Australia, according to the Morrison government and medical experts.
Both Pfizer and Norwegian officials emphasised that the risks were very low and they were not alarmed, although the Norwegian Medicines Agency’s chief physician, Sigurd Hortemo, said the reports suggested common side effects to mRNA vaccines such as fever and nausea “may have contributed to a fatal outcome in some frail patients”.
A total of 29 people, all aged over 75, have died out of more than 42,000 vaccinations dispensed, prompting Norwegian health chiefs to update advice to doctors to consider whether or not to give the vaccine to very frail or terminally ill patients.
In a statement, the TGA said among those who died were people who had only weeks or months to live.
The deaths were associated with fever, nausea and diarrhoea, relatively common short-lived side effects that 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,” the TGA said.
“We will continue to work with European regulators over the coming days to investigate this report and determine whether specific warnings about risks of vaccination in the very frail elderly or terminally ill should be potentially included in the product information for the Pfizer BioNTech vaccine, which will be made available to all doctors and vaccinators.”
Mr Hunt said safety was the government’s top priority in any vaccine that was approved.
“There is no change in our time frames at this point but the medical regulator is completely empowered to make independent decisions,” he said.
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