Australian authorities will investigate reports of possible adverse reactions to the Pfizer Covid-19 vaccine in Norway, but the health minister said it was not yet clear whether several deaths reported were related to age rather than the jabs.
Greg Hunt said on Sunday there was no change to the government’s vaccine deployments and “safety is Australia’s top priority ‘.
He promised to keep the public informed of the details of 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 the confidence ‘that we are absolutely thorough’ and ‘have a careful but very focused medical regulator that takes into account all the evidence from around the world’.
Although the Australian Therapeutic Goods Administration has yet to approve the Pfizer vaccine, the government recently indicated that this process should be completed by the end of January, paving the way for vaccination from mid to late February.
Hunt said he spoke to the TGA on Sunday morning and asked that he seek additional information from Pfizer and Norwegian regulators.
“We still do not know if it is a function of age and people who are older and unhappy with the natural loss of life and if there is any cause – which has not yet been claimed,” Hunt said.
“We continue with an abundance of caution. So there is no change in our time frames at this point. But the medical regulator is completely empowered to make independent decisions. ”
Hunt also pointed to a ‘pleasant report’ from the US Centers for Disease Control and Prevention, which estimated approximately 1.8 million doses of the Pfizer vaccine ‘with very positive results in terms of safety and efficacy’.
The adverse event reporting system in the US detected only 21 cases of anaphylaxis after a first dose of the Pfizer BioNTech vaccine was administered by 1893 360, according to the CDC report, with 71% of these within 15 minutes.
No deaths due to anaphylaxis were reported after receiving the Pfizer-BioNTech vaccine, the report said.
“We have been absolutely clear and we remain absolutely clear that safety is Australia’s top priority,” Hunt said.
“We will therefore continue to follow the processes of the medical regulator, as this will keep Australians safe and ultimately provide confidence.”
Norwegian authorities have assessed 13 deaths reported as possibly associated with Covid-19 vaccination.
Sigurd Hortemo, chief physician at the Norwegian Medicines Agency, said the reports suggested that ‘general adverse reactions to mRNA vaccines, such as fever and nausea, could contribute to a fatal outcome in some debilitated patients’.
However, the authorities also provided context for the reports, saying that the large studies on the BioNTec / Pfizer vaccine did not include patients with unstable or acute diseases – and that few participants were older than 85.
“In Norway, we are now vaccinating the elderly and people in nursing homes with serious underlying diseases. Therefore, deaths near the vaccination are expected to occur,” authorities said on Friday.
“In Norway, an average of 400 people die every week in nursing homes and long-term care institutions.
“We cannot rule out that adverse reactions to the vaccine that occur within the first few days after vaccination (such as fever and nausea) may contribute to a severe course and fatal outcome in patients with severe underlying disease.”
Hunt said while there is no change to the implementation plans, the government will listen to advice on specific groups.
‘It is therefore very feasible that a medical regulator or our TGA can choose that a vaccine applies to certain age groups or not to people in certain immune conditions. This is something they do regularly. ”
Australia’s vaccine strategy involves launching high-priority groups, including frontline workers in the health sector, border enforcement, hotel quarantine, aged care and disability care, and residents of elderly care and disability care.