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How will the issues reported in Norway Pfizer rollout impact Australia's vaccine strategy?


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Why Norway's reports of deaths in Pfizer vaccine recipients will help the TGA assess the drug


Key points:

  • Australian health authorities will use information about deaths in elderly Norwegian Pfizer vaccine recipients as part of their assessment of the drug
  • The Therapeutic Goods Administration has not yet approved the vaccine in Australia and will recommend how it should be administered
  • Experts say Australia is in an advantageous position, buying itself time to analyse the results and determine the best course of action



The Australian Government is reviewing information from Pfizer to determine any impact on "vaccination of the frail".(Reuters: Andreas Gebert)


Reports out of Norway that up to 30 "frail patients" have died after receiving the Pfizer COVID-19 vaccine will ultimately help Australian health authorities determine the best way to safely administer the drug, experts say.


Norwegian health authorities sparked concerns when they announced "common adverse reactions" to the vaccine "may have contributed to a fatal outcome" among the elderly nursing home residents.


The Pfizer vaccine is yet to be approved by Australia's drug regulator, the Therapeutic Goods Administration (TGA).


A TGA approval would recommend how, or if, the Pfizer vaccine should be administered to Australians over the age of 85.


Epidemiologist Hassan Vally says "every single bit of information we can gather" will be factored into the evaluation of the medicine, and into Australia's vaccine strategy.

"It could be as simple as the fact that the more frail, older people may need to get a different vaccine that's a bit gentler, or there may be some alteration in the way the vaccines are administered," Dr Vally said.

"This is the advantage we have.


"We can see these results and adjust our strategy to get the best possible results for Australians."


According to the TGA, the Government has now received information from Pfizer and is reviewing it "to determine any impact this may have on the vaccination of the frail aged in Australia".


Infectious disease expert from ANU, Professor Sanjaya Senanayake, said moving the very vulnerable group to the AstraZeneca vaccine was one option.


"One way around it, and hopefully we don't have to do it, if people over 85 in nursing homes were vulnerable to the effects of the vaccine, then you could use another vaccine — the AstraZeneca vaccine," he said.


"I would want to hear what the Norwegian authorities said, and if they find no association whatsoever, then there would be no need for that, but if they have some concern, then yes that would be something we would have to consider."


Professor Senanayake said it was important to wait for the TGA decision on the Pfizer vaccine.


"It is still unclear what happened in Norway, but it's more likely the deaths are due to chronic medical conditions rather than the vaccine itself," he said.


"If the UK, US and Israel were all reporting problems, then alarm bells would be going off.


"Because our vaccine regulators are very careful and the Government has been very open, we should have faith in whatever advice comes out of our regulatory authorities."

Norway news part of 'phase four results'

With low community transmission of COVID-19, experts said Australia had bought itself time to analyse what was happening in other countries using the Pfizer drug in mass vaccination programs.


The so-called "phase four results" will allow Australian health authorities to collect data about the vaccine after it has been deployed in the community to learn more about the best way to use it.

"We've already got millions of data points from the people that have received the Pfizer vaccine in the rollouts in the US, and other countries," Dr Vally said.


He said the development in Norway was important to consider, but the vaccine had already "been safely administered to millions of people".

"On the surface, it's not something you want to hear, but we have to look at the full picture and we have to understand some of the nuance of what has occurred and also what's happened around the world," Dr Vally said.


Professor Senanayake said there had not been a "disproportionate number of unexpected deaths in older people" in vaccination programs across the Northern Hemisphere.

"In Germany, they have given 800,000 vaccines so far [with] 10 deaths in ill, frail people," he said.

"German authorities said these were very unwell people, some in palliation [or end of life care]."


The Australian Government has asked Pfizer for more information about the German deaths.

'This is a very, very particular sub-group'

Older people were "well represented" in the Pfizer vaccine trials, according to Professor Senanayake.

"If you look at the phase three Pfizer data, we know that 41 per cent of participants were aged between 56 to 85 years old," he said.

"In the data they (Pfizer) released there wasn't a disproportionate number of deaths in the older age group."


The experts said it was important to look at the reports out of Norway "very scientifically".

"These aren't just vulnerable people, these are people who are over 80 years of age," Dr Vally said.

"They were incredibly frail and my understanding is that some of them had terminal illnesses ... this is a very, very particular sub-group."


Professor Senanayake said common side effects of the vaccine may have caused an "irreversible spiral" in the Norway patients.

"An older person, [who was] very infirm, who was teetering on the edge where their heart, lung or kidneys were not working very well, if they got very bad pain or nausea or very bad fatigue, that may be enough to just tip them over in an irreversible spiral downwards," he said.

"That's one possibility that authorities would be looking into, but in terms of the vaccine directly causing a heart attack or stroke, that would be unusual."


The experts said Australians should expect more reports from different countries already rolling out the vaccine, but that this is simply part of the process.

"As sad as it is that these people have died, from a broader population health perspective, we really just need to step back and understand as much as we can from this," Dr Vally said.


"Some very loud voices have been critical of the TGA for not having approved the vaccines already, saying we should have already started rolling them out.

"We have a bit of extra time and we can take on all of the information and we know how rigorous and how thorough the TGA is in terms of its regulatory process, so you can be assured all of this will be factored in."



Source: Why Norway's reports of deaths in Pfizer vaccine recipients will help the TGA assess the drug

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