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, not jabs.
Greg Hunt said on Sunday that there was no change in the government’s vaccine distribution plans and “safety is Australia’s number one priority”.
He promised to update the public on any details from Norway, where officials said they could not rule out adverse reactions that contribute to deaths in patients with severe underlying disease.
The Norwegian Institute of Public Health has updated its advice on vaccinating frail elderly people.
Hunt said Australians should have confidence “that we are being absolutely meticulous” and have “a cautious but highly focused medical regulator who is taking into account all the evidence from around the world”.
Although the Australian Therapeutic Products Administration has not yet approved the Pfizer vaccine, the government recently indicated that this process should be completed in late January, paving the way for vaccinations to begin in mid-February.
Hunt said he had spoken to TGA on Sunday morning and asked for additional information from both Pfizer and Norwegian regulators.
“We do not yet know if this is simply a function of age and older people and sadly experiencing the natural loss of their lives or if there is a cause – which has not yet been stated,” said Hunt.
“We are proceeding with great caution. Therefore, there is no change in our deadlines at this time. But the medical regulator is fully qualified, fully qualified to make independent decisions ”.
Hunt also pointed to “an encouraging report” from the United States Centers for Disease Control and Prevention, which reviewed about 1.8 million doses of the Pfizer vaccine “with very positive results in terms of safety and effectiveness.”
The US vaccine adverse event reporting system detected only 21 cases of anaphylaxis after administering 1,893,360 first doses of the Pfizer-BioNTech vaccine, the CDC report said, with 71% of those cases occurring within 15 minutes.
No deaths from anaphylaxis were reported after receiving the Pfizer-BioNTech vaccine, the report said.
“We were absolutely clear and we remain absolutely clear that security is Australia’s number one priority,” said Hunt.
“Therefore, we will continue to follow the medical regulator’s processes because it will keep Australians safe and, ultimately, provide confidence.”
Norwegian authorities assessed 13 deaths reported as potentially associated with vaccination against Covid-19.
Sigurd Hortemo, chief physician at the Norwegian Medicines Agency, said the reports suggested “that the adverse reactions common to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some fragile patients.”
But the authorities also provided context for these reports, saying that the large studies on the BioNTec / Pfizer vaccine did not include patients with unstable or acute illness – and included few participants over 85 years old.
“In Norway, we are vaccinating the elderly and people in nursing homes with serious underlying illnesses, so it is expected that deaths near the time of vaccination can occur,” officials 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 that occur in the first days after vaccination (such as fever and nausea) can contribute to a more serious course and fatal outcome in patients with severe underlying disease.”
Hunt said that while there have been no changes to deployment plans, the government would listen to advice on specific groups.
“Therefore, it is very feasible, for example, for a medical regulator or our TGA to choose whether a vaccine applies to certain age groups or not to people with certain immunological conditions. This is something they do routinely. “
Australia’s vaccination strategy involves starting with high-priority groups, including frontline workers in the health sector, border enforcement, hotel quarantine, care for the elderly and disabled, and elderly and disabled residents.