Australian authorities are seeking more information about one of the COVID-19 vaccines set to be used locally, following a warning from officials in Norway.
Key points:
There have been a small number of deaths among older people in Norway who received the Pfizer-BioNTech vaccine and suffered side effects.
The Norwegian Medicines Agency last week reported a total of 29 people had experienced side effects, including 13 who died.
All the deaths occurred among patients in nursing homes and all were over the age of 80.
Doctors in the Scandinavian country are now being instructed to “carefully consider” who should be vaccinated.
Australia has ordered 10 million doses of the Pfizer vaccine.
Federal Health Minister Greg Hunt said he had “immediately sought” more details.
“I have been in contact with the Australian medical regulator, the [Therapeutic Goods Administration] TGA, this morning and requested that they seek additional information, both from the company, but also from the Norwegian medical regulator,” he said.
“[Foreign Minister] Marise Payne will task [the Department of Foreign Affairs and Trade] DFAT to seek advice directly from the Norwegian Government.
“We’re proceeding with an abundance of caution.”
More than 30,000 people have received the first shot of the Pfizer or Moderna coronavirus vaccines in Norway since the end of December.
The country’s medical regulator listed fever and nausea as side effects that may have led to the deaths of some frail patients.
In its report, the Norwegian Medicines Agency said that 21 women and eight men had experienced side effects.
“We are not alarmed by this,” the agency’s medical director Steinar Madsen told local broadcaster NRK.
“It is quite clear that these vaccines have very little risk, with a small exception for the frailest patients,” he said.
“Doctors must now carefully consider who should be vaccinated.
“Those who are very frail and at the very end of life can be vaccinated after an individual assessment.”
Beside those who died, the agency said nine had serious side effects, including strong discomfort and severe fever, and seven had less serious side effects.
Earlier last week, a separate Norwegian government health agency said: “Any side effects of the vaccine will be outweighed by a reduced risk of becoming seriously ill with COVID-19 for elderly, frail people.”
In Australia, the Pfizer product is expected to be approved before the AstraZeneca-Oxford University vaccine.
Mr Hunt said rollout timeframes had not changed in light of the Norwegian reports, with priority groups expected to be inoculated from next month.
“We don’t know yet whether [these deaths are] a function simply of age, and people who are older and sadly facing the natural loss of their life, or whether there’s any causation,” he said.
Australia’s medicines regulator, the Therapeutic Goods Administration, downplayed concerns later on Sunday.
“The deaths were associated with fever, nausea and diarrhoea, which are relatively common short-lived effects that a number of people experience after vaccination,” a spokesperson said.
“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.”
But the TGA said it would consider whether to include specific warnings for very frail elderly people, or people with terminal illnesses.
The Pfizer jab has a reported efficacy of 95 per cent.