Greg Hunt has urged calm after reports that a number of elderly Norwegians died after being given the Pfizer COVID vaccine, just weeks before Australians are due to receive that jab.
“We’re proceeding with an abundance of caution,” the Health Minister said on Sunday.
“Confidence is absolutely critical, but confidence comes from the Australian people knowing that we have the best medical regulator in the world, in my view, and that we have the best processes in the world, in my view.”
‘Very frail’ vaccine recipients die in Norway
The Norwegian Medicines Agency (NoMA) reported on Friday that 29 people in Norway had suffered side effects after having the vaccine, including 13 deaths.
By Sunday, Bloomberg had reported that the agency was aware of “another 16 deaths that are currently being assessed”.
Of people experiencing side effects, 25 of the 29 were people aged 70 or above.
Another four were in the age bracket of under 69.
Norwegian officials said the deaths were limited to “very frail patients with very serious disease”, and some are being investigated with a focus on whether associated conditions like fever, nausea, and diarrhoea were contributing factors.
Australia’s Therapeutic Goods Administration said the deaths included people “who were anticipated to only have weeks or months to live”.
But with Australia just weeks away from beginning vaccinations with the Pfizer jab – with nursing home residents and critical health workers the first in line to be inoculated – federal officials are seeking urgent information from Norway.
“We have immediately sought, and I have been in contact with the Australian medical regulator, the TGA, this morning and requested that they seek additional information both from the company but also from the Norwegian medical regulator,” Mr Hunt said.
“As further information is available, we’ll share that with the Australian public.”
He said Foreign Minister Marise Payne also tasked the Department of Foreign Affairs and Trade to seek advice directly from the Norwegian government.
It comes after a week that included questions over the AstraZeneca vaccine’s efficacy, and confusion about the Novavax vaccine’s possible production onshore in Australia.
TGA may make Pfizer ruling
Australia’s Therapeutic Goods Administration is still yet to officially approve the Pfizer vaccine, but is expected to do so before the end of January.
Vaccinations under stage 1a of Australia’s rollout are expected to begin in “mid to late February”, once the TGA approves the vaccine and a series of batch tests are performed on the Pfizer supplies that arrive from overseas.
Mr Hunt said the Norway news had made “no change in our timeframes at this point”, but the TGA may make further decisions on Pfizer.
“It’s very feasible, for example, that a medical regulator, or our TGA, might choose that a vaccine would apply in certain age groups or not to people in certain immune conditions,” he said.
Australia has secured 10 million doses of the Pfizer vaccine, enough for five million people.
Those supplies are to be distributed through 50 Pfizer “hubs” at hospitals nationwide.
After the initial rollout to the elderly and high-risk workers, the wider Australian population is expected to receive doses of the AstraZeneca vaccine, of which the government has secured nearly 54 million doses.
Pfizer said in a statement it was working with NoMA to gather more information.
“Norwegian authorities have prioritised the immunisation of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some of whom are terminally ill. NOMA confirm the number of incidents so far is not alarming, and in line with expectations,” the company said.
“Our immediate thoughts are with the bereaved families.”
The TGA said it was “not expected” that such reactions would be seen “in the vast majority of individuals” given the Pfizer vaccine.
“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,” the TGA said.
What’s happening in Norway?
Following the results, Norwegian officials have updated their vaccination guide, giving more advice to doctors on how to approach giving jabs to the elderly.
But health officials in the country are downplaying the risks posed to the wider community.
“The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients,” said Sigurd Hortemo, chief physician at the Norwegian Medicines Agency (NoMA).
NoMA said Norway was only vaccinating the elderly and people in nursing homes with serious underlying diseases, so “therefore it is expected that deaths close to the time vaccination may occur”.
Another NoMA expert, medical director Steinar Madsen, said the agency was “not alarmed by this” and that the vaccines have “very little risk, with a small exception for the frailest patients”.
Dr Madsen told the British Medical Journal that the deaths “may be a coincidence, but we aren’t sure”.
“There is no certain connection between these deaths and the vaccine,” he said.
“There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly.”
Pfizer vaccine ‘very safe’: CDC
A study from the US Centres for Disease Control and Prevention (CDC) found that allergic reactions from the Pfizer vaccine were “rare”.
As of December 23, more than 1.89 million doses of the Pfizer vaccine had been administered in the US, with only 175 cases identified as having a potential allergic reaction afterwards.
Of those, just 21 “were determined to be anaphylaxis”, a rate of 11 per million doses.
The CDC said that figure of 21 cases included 17 people with a history of allergies, and seven with a history of anaphylaxis. All of those people recovered.
“Of course, we all would hope that any vaccine would have zero adverse events, but even at 11 cases per million doses administered, it’s a very safe vaccine,” said Nancy Messonnier, the director of the CDC’s National Centre for Immunisation and Respiratory Diseases, said after the study’s release.
On Sunday, Mr Hunt referred to that CDC study as “a heartening report” and having “very positive results in terms of both the safety and the efficacy” of the Pfizer vaccine.