Health minister reassures Australians over vaccine rollout after Norway adverse reactions report
Australian authorities will examine reports of potentially adverse reactions to the Pfizer Covid-19 vaccine in Norway but the health minister said it was not yet clear whether several reported deaths were related to old age rather than the jabs.
Greg Hunt said on Sunday there was no change to the government’s vaccine rollout plans and “safety is Australia’s number one priority”.
He vowed to update the public on any details from Norway, where authorities said they could not rule out adverse reactions contributing to deaths in patients with severe underlying disease.
The Norwegian Institute of Public Health has updated its advice on vaccinating the frail elderly.
Hunt said Australians should have confidence “that we are being absolutely thorough” and have “a cautious but highly focused medical regulator who is taking into account all of the evidence from around the world”.
Although Australia’s Therapeutic Goods Administration is yet to approve the Pfizer vaccine, the government recently indicated this process should be complete by late January, paving the way for vaccinations to begin by mid to late February.
Hunt said he had spoken to the TGA on Sunday morning and asked it to seek additional information both from Pfizer and the Norwegian regulators.
“We don’t know yet whether this is 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 – that hasn’t been asserted as yet,” Hunt said.
“We’re proceeding with an abundance of caution. So there’s no change in our timeframes at this point. But the medical regulator is completely empowered, completely empowered, to make independent decisions.”
Hunt also pointed to “a heartening report” from the US Centers for Disease Control and Prevention which had reviewed about 1.8m doses of the Pfizer vaccine “with very positive results in terms of both the safety and the efficacy”. The vaccine adverse event reporting system in the US detected just 21 cases of anaphylaxis after a reported 1,893,360 first doses of the Pfizer-BioNTech vaccine were administered, the CDC report said, with 71% of these occurring within 15 minutes.
No deaths from anaphylaxis were reported after receipt of Pfizer-BioNTech vaccine, the report said.
“We were absolutely clear and we remain absolutely clear that safety is Australia’s number one priority,” Hunt said.
“So we’ll continue to follow the processes of the medical regulator because that’s going to keep Australians safe and ultimately provide confidence.”
Norwegian authorities have assessed 13 deaths reported as being potentially associated with Covid-19 vaccination.
Sigurd Hortemo, chief physician at the Norwegian Medicines Agency, said the reports suggested “that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients”.
But authorities also provided context for those reports, saying the large studies on the BioNTec/Pfizer vaccine had not included patients with unstable or acute illness – and included few participants over 85.
“In Norway we are now vaccinating the elderly and people in nursing homes with serious underlying diseases, therefore it is expected that deaths close to the time vaccination may occur,” authorities said on Friday.
“In Norway, an average of 400 people die each week in nursing homes and long-term care facilities.
“We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination (such as fever and nausea) may contribute to more serious course and fatal outcome in patients with severe underlying disease.”
Hunt said although there was no change to the rollout plans, the government would listen to advice about particular groups.
“So it’s very feasible, for example, that a medical regulator or our TGA might choose that a vaccine would apply to certain age groups or not to people in certain immune conditions. That’s something which they do routinely.”
Australia’s vaccine strategy involves starting with high-priority groups including frontline workers in the health sector, border enforcement, hotel quarantine, aged and disability care, and residents of aged and disability care.