Coronavirus: Watchdog on alert as Norway probes Pfizer jab deaths
Svein Andersen, a 67 year-old resident of Ellingsrud home was the first in Norway to receive the Pfizer-Biontech COVID-19 vaccine by nurse Maria Golding in Oslo, Norway, on December 27. Picture: AFP
The Therapeutic Goods Administration is considering whether warnings should be included in product information for doctors on the risks of providing the vaccine to very frail or terminally ill people
The TGA is working with the European Medicines Agency to determine whether the 30 deaths were caused by the Pfizer vaccine, although Norway’s medical regulator says a clear link is yet to be established.
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The government says there is “no change” to that timeframe.
The Norwegian deaths — all patients who had weeks or months to live — were associated with fever, nausea and diarrhoea. These are relatively common short-lived effects of vaccination and not harmful in younger, fitter people.
The TGA says as the deaths are investigated, it will determine whether warnings should be included in product information for the Pfizer-BioNTech vaccine, to be made available to all doctors and vaccinators. “The TGA’s processes for vaccine approvals is extremely rigorous and comprehensive,” it said in a statement.
“The TGA is evaluating all the scientific and clinical information provided by the vaccine’s sponsor, Pfizer, as well as other available evidence, including from international experience with emergency use of the vaccine, prior to making a regulatory decision.”
The government has been under pressure to roll out the Pfizer vaccine quickly after several overseas countries granted approval for its emergency use, but given Australia’s low COVID-19 case numbers, it stood firm in insisting that the TGA go through a thorough review process of the vaccine, including examining overseas post-release data.
The medical director of the Norwegian Medicines Agency, Steinar Madsen, said health authorities there were not alarmed at the 30 deaths that occurred among 40,000 people who have received the Pfizer jab. Norway has prioritised the immunisation of residents in nursing homes.
Empty bottles of Pfizer-BioNTech COVID-19 vaccine. Picture: Getty
“It may be a coincidence, but we aren’t sure,” Dr Madsen told the British Medical Journal. “There is no certain connection between these deaths and the vaccine.
“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.
“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. We are asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it.”
German authorities are investigating the deaths of 10 elderly people after receiving the Pfizer jab.
Federal Health Minister Greg Hunt said further information would be shared with the public once it came to hand.
“This is exactly why as a nation we have been absolutely clear ... and we remain absolutely clear that safety is Australia’s No 1 priority,’’ he said.
“And so we’ll continue to follow the processes of the medical regulator because that’s going to keep Australians safe and ultimately provide confidence.”
Mr Hunt noted the US Centres for Disease Control and Prevention had released a “heartening” report examining the administration of the Pfizer vaccine in 1.8 million people that found “very positive results” about the jab’s safety and efficacy.
Australia has an agreement with Pfizer for 10 million doses of the vaccine. It also has orders for 53 million doses of AstraZeneca’s vaccine and 51 million doses of Novavax’s candidate, which is still in clinical trials.
The Pfizer vaccine was found to be safe during clinical trials, but has been associated with adverse reactions in people who suffer anaphylaxis.
Nigel Crawford, the director of SAEFVIC, the central reporting service in Victoria for significant adverse events following vaccination, said Australia had strong processes in place including pre-screening of patients.
“That’s one of the strengths of the Australian system,” Professor Crawford said. “A particular vaccine may be contraindicated in some cases.”
Associate professor of medicine at the Australian National University Sanjaya Senanayake said while Australia was swiftly moving towards a vaccine rollout, having extra data available to consider after overseas countries approved vaccines for emergency use was beneficial.
“I think it has been good that Australia, while we’ve got a plan to have an immunisation program rolled out soon, that we did wait that period just to see what is happening when millions of doses are given to people of varying demographics throughout the world,” Professor Senanayake said.
“With the phase three Pfizer trials, which involved tens of thousands of people, about 41 per cent of people included in the trial were between 56 and 85, so they had a reasonable representation of older people. And we certainly didn’t get any alarm bells from them.”
The Pfizer vaccine has been approved for emergency use in Britain and some European countries, as well as in the US and Israel, among other nations. Israel has already vaccinated 20 per cent of its population with the Pfizer jab and is sharing its data with the company.
Pfizer released a statement saying it would co-operate with medical regulators in investigating the causes of the deaths.
“Pfizer and BioNTech are aware of reported deaths following administration of BNT162b2,” the statement said. “We are working with NOMA to gather relevant information. Our thoughts are with bereaved families.”
Svein Andersen, a 67 year-old resident of Ellingsrud home was the first in Norway to receive the Pfizer-Biontech COVID-19 vaccine by nurse Maria Golding in Oslo, Norway, on December 27. Picture: AFP- NATASHA ROBINSON
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The Therapeutic Goods Administration is considering whether warnings should be included in product information for doctors on the risks of providing the vaccine to very frail or terminally ill people
The TGA is working with the European Medicines Agency to determine whether the 30 deaths were caused by the Pfizer vaccine, although Norway’s medical regulator says a clear link is yet to be established.
READ NEXT
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The government says there is “no change” to that timeframe.
The Norwegian deaths — all patients who had weeks or months to live — were associated with fever, nausea and diarrhoea. These are relatively common short-lived effects of vaccination and not harmful in younger, fitter people.
The TGA says as the deaths are investigated, it will determine whether warnings should be included in product information for the Pfizer-BioNTech vaccine, to be made available to all doctors and vaccinators. “The TGA’s processes for vaccine approvals is extremely rigorous and comprehensive,” it said in a statement.
“The TGA is evaluating all the scientific and clinical information provided by the vaccine’s sponsor, Pfizer, as well as other available evidence, including from international experience with emergency use of the vaccine, prior to making a regulatory decision.”
The government has been under pressure to roll out the Pfizer vaccine quickly after several overseas countries granted approval for its emergency use, but given Australia’s low COVID-19 case numbers, it stood firm in insisting that the TGA go through a thorough review process of the vaccine, including examining overseas post-release data.
The medical director of the Norwegian Medicines Agency, Steinar Madsen, said health authorities there were not alarmed at the 30 deaths that occurred among 40,000 people who have received the Pfizer jab. Norway has prioritised the immunisation of residents in nursing homes.
Empty bottles of Pfizer-BioNTech COVID-19 vaccine. Picture: Getty“It may be a coincidence, but we aren’t sure,” Dr Madsen told the British Medical Journal. “There is no certain connection between these deaths and the vaccine.
“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.
“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. We are asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it.”
German authorities are investigating the deaths of 10 elderly people after receiving the Pfizer jab.
Federal Health Minister Greg Hunt said further information would be shared with the public once it came to hand.
“This is exactly why as a nation we have been absolutely clear ... and we remain absolutely clear that safety is Australia’s No 1 priority,’’ he said.
“And so we’ll continue to follow the processes of the medical regulator because that’s going to keep Australians safe and ultimately provide confidence.”
Mr Hunt noted the US Centres for Disease Control and Prevention had released a “heartening” report examining the administration of the Pfizer vaccine in 1.8 million people that found “very positive results” about the jab’s safety and efficacy.
Australia has an agreement with Pfizer for 10 million doses of the vaccine. It also has orders for 53 million doses of AstraZeneca’s vaccine and 51 million doses of Novavax’s candidate, which is still in clinical trials.
The Pfizer vaccine was found to be safe during clinical trials, but has been associated with adverse reactions in people who suffer anaphylaxis.
Nigel Crawford, the director of SAEFVIC, the central reporting service in Victoria for significant adverse events following vaccination, said Australia had strong processes in place including pre-screening of patients.
“That’s one of the strengths of the Australian system,” Professor Crawford said. “A particular vaccine may be contraindicated in some cases.”
Associate professor of medicine at the Australian National University Sanjaya Senanayake said while Australia was swiftly moving towards a vaccine rollout, having extra data available to consider after overseas countries approved vaccines for emergency use was beneficial.
“I think it has been good that Australia, while we’ve got a plan to have an immunisation program rolled out soon, that we did wait that period just to see what is happening when millions of doses are given to people of varying demographics throughout the world,” Professor Senanayake said.
“With the phase three Pfizer trials, which involved tens of thousands of people, about 41 per cent of people included in the trial were between 56 and 85, so they had a reasonable representation of older people. And we certainly didn’t get any alarm bells from them.”
The Pfizer vaccine has been approved for emergency use in Britain and some European countries, as well as in the US and Israel, among other nations. Israel has already vaccinated 20 per cent of its population with the Pfizer jab and is sharing its data with the company.
Pfizer released a statement saying it would co-operate with medical regulators in investigating the causes of the deaths.
“Pfizer and BioNTech are aware of reported deaths following administration of BNT162b2,” the statement said. “We are working with NOMA to gather relevant information. Our thoughts are with bereaved families.”
