COVID vaccine restrictions possible following elderly deaths in Norway

Australians over 80 may not be given the Pfizer/BioNTech COVID vaccine, after a number of deaths in frail elderly people occurred post-vaccination in Norway.
 
Australia’s vaccine regulator has flagged possible new restrictions if the link is confirmed, after 29 aged care residents aged over 80 reportedly died following a vaccination drive of 40,000 older Norwegians using the mRNA vaccine, the only one currently available in that country.  
 
But GPs and top vaccine hesitancy experts have called for calm, given there is at present no causal link between the vaccine and the deaths, other than occurring close together in time.
 
Australia’s Therapeutic Goods Administration (TGA), which is currently deciding whether to authorise the vaccine candidate, said in a statement that it does not expect that the common adverse reactions following immunisation will be ‘of significance’ in the vast majority of people.
 
‘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.
 
Australia has an agreement to purchase 10 million doses of the Pfizer/BioNTech vaccine candidate, which is slated to be administered in residential aged care facilities as soon as next month during phase 1a of the Federal Government’s vaccine roadmap.

Close to 7 million doses of the same vaccine have been administered in the COVID-ravaged United States, but so far similar concerns have not been raised. 
 
Vaccine hesitancy expert and University of Sydney Professor Julie Leask told newsGP that there is a question mark over whether the vaccine had actually caused the deaths, given the age and vulnerability of the demographic.
 
‘At present there is no evidence the vaccine has caused these deaths,’ she said. ‘There is a temporal association which needs to be investigated. A report like this from Norway without filtering and sensemaking will undoubtedly scare people.
 
‘Antivaccine activists will of course take any issues around the program and exaggerate and amplify safety and efficacy concerns. They’re ready and waiting to do that. We need to focus on the majority of the population, not the minority, with good proactive communication so others don’t fill that gap.
 
Professor Leask says as the vaccines had been given to cohorts of people who are older and have chronic diseases, it ‘stands to reason’ that there would be higher rates of deaths and other illnesses.
 
‘At this point, it’s important to do an epidemiological investigation to determine if there is an association,’ she said.
 
‘The Therapeutic Goods Administration will look very closely at this.
 
‘GPs can be assured that Australia has some of the best vaccine safety and reporting systems in the world, and that we have the capacity to monitor actively for adverse events following COVID, as well as making assessments of the risk/benefit profile of the vaccine.’


Australia has an agreement to buy 10 million doses of the Pfizer/BioNTech vaccine. (Image: AAP) 

UNSW biosecurity expert Professor Raina McInytre told the Australian Financial Review serious reactions are not common in vaccines approved by regulators.
 
‘You can get events that are [temporally] associated with a vaccine but that doesn’t mean it’s caused by vaccination,’ she said.
 
Despite these reassurances, the news may make it harder for public health officials running vaccination campaigns this year, if it undercuts confidence.
 
If the Norwegian deaths prove to be linked to the vaccine, they would represent a death rate of 0.08% of those vaccinated – vastly lower than COVID’s average infection fatality rate in the over 80 cohort, which is 8.9%.
 
The deaths were associated with fever, nausea and diarrhoea – relatively common side effects after vaccination, which are very rarely dangerous in younger people.
 
Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), also told the British Medical Journal that the connection is not definite as yet.
 
‘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,’ he said.
 
‘We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.’
 
He later told the ABC that if there was a very short expected lifespan or if patients were terminally ill, vaccination should be reconsidered.
 
In a statement, Pfizer noted Norwegian authorities had 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. All reported deaths will be thoroughly evaluated by NOMA to determine if these incidents are related to the vaccine,’ the company stated.
 
The TGA also noted the deaths took place amongst a cohort including some expected to only have weeks or months to live, and moved to reassure the public that their approval process for vaccines is ‘extremely comprehensive and rigorous’.
 
‘A vaccine will only be approved for use if it is demonstrated to be safe and effective in clinical trials and if the manufacturer can show it can be produced in a high quality, consistent and controlled manner,’ the TGA stated.
 
The regulator’s comments have been backed by GP and Smartvax founder Dr Alan Leeb, who told newsGP the TGA will scrutinise the news closely.
 
He said the possible link is puzzling given the US and other countries have already administered millions of doses of the same vaccine, without similar reports of deaths.
 
‘This vaccine has been rolled out in many different countries and this is the first we’ve heard of [deaths],’ he said.
 
‘You would expect some adverse reactions, but this is an elderly population and some were terminal.
 
‘Is this just a single cluster? We just need more information. One thing is for sure – the TGA will be looking at this really closely. We should be reassured by the fact that the TGA is efficient and diligent with this type of analysis. They will be right onto it.’

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