Australia has asked Pfizer for “additional information” about its vaccine after reports from Norway suggesting the jab was too risky for the very old or terminally ill.
Health Minister Greg Hunt said the government had “immediately sought” more information from Pfizer and the Norway medical regulator regarding the report about “possible consequences of the Pfizer vaccine”.
The Norway report does not suggest younger people under the age of 75 should not take the vaccine.
“We have been in contact with the Foreign Minister, and Marise Payne will task DFAT to seek advice directly from the Norwegian governmentIn addition,” Mr Hunt said.
“As further information is available, we’ll share that with the Australian public.”
Mr Hunt said at the same time there had been “heartening” news from the Centers for Disease Control in the United States, with “very positive results” from its review of 1.8 million doses of the Pfizer vaccine “in terms of both the safety and the efficacy”.
“But this is exactly why, as a nation, we have been absolutely clear ... that safety is Australia’s number one priority,” he said.
“So, we’ll continue to follow the processes of the medical regulator, because that’s going to keep Australians safe and ultimately provide confidence.”
https://www.heraldsun.com.au/corona...d/news-story/3001459f81446632aa9cb11fca2c55f8 (paywalled)
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Further detail:
Natasha Robinson
The Australian
January 17, 2020
The Federal government is urgently seeking more information from Norway after health authorities in the Scandinavian nation reported multiple deaths in patients over 80 who received the Pfizer COVID-19 vaccine.
Australia’s medical regulator the Therapeutic Goods Administration says it has received reports of about 30 deaths among 40,000 elderly individuals vaccinated in Norway with the Pfizer-BioNTech vaccine in recent weeks.
“The deaths were recorded among very frail patients, including some who were anticipated to only have weeks or months to live,” the TGA said in a statement.
Norway has adjusted its advice on the Pfizer vaccine following the deaths of the patients. But it says there is very little risk associated with the vaccine other than for those who are extremely frail.
The deaths were associated with fever, nausea and diarrhoea, which are relatively common short-lived effects that a number of people experience after vaccination. The TGA said it is not expected that these common adverse reactions following immunisation will be of significance in the vast majority of individuals vaccinated with the Pfizer BioNTech vaccine.
The Norwegian regulator says there are typically around 4,000 deaths in aged care every week. “It may be a coincidence, but we aren’t sure,” Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told The British Medical Journal. “There is no certain connection between these deaths and the vaccine.”
More than 20 000 doses of the vaccine have been administered over the past few weeks in Norway. NOMA has investigated 13 of the deaths in the elderly so far and concluded that common adverse reactions of mRNA vaccines, such as fever, nausea, and diarrhoea, may have contributed to fatal outcomes in some of the frail patients, the BMJ reported.
Federal health Minister Greg Hunt has asked the Therapeutic Goods Administration to seek more information on the deaths from the Norwegian medical regulator. Foreign Minister Marise Payne will also task the Department of Foreign Affairs and Trade with seeking advice directly from the Norwegian government.
The Pfizer vaccine was the first COVID-19 vaccine to be approved by medical regulators in a host of countries. The TGA is currently assessing its safety and efficacy data and has previously stated it expects to approve the vaccine in late January.
Australia has a pre-purchase agreement with Pfizer for 10 million doses of the vaccine, which was due to be given to five million Australians from late February. Health workers, the elderly and the vulnerable were to be first in line to receive the jab.
Mr Hunt said safety was the number one priority of the government and the medical regulator.
“I have been in contact with 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.”
“But this is exactly why as a nation we have been absolutely clear from the Prime Minister and myself and the chief medical regulator, the head of the Therapeutic Goods Administration John Skerrit …..we have been absolutely clear and we remain absolutely clear that safety is Australia’s number one priority.
“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.”
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 all the relevant 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. All reported deaths will be thoroughly evaluated by NOMA to determine if these incidents are related to the vaccine. The Norwegian government will also consider adjusting their vaccination instructions to take the patients’ health into more consideration.
“Our immediate thoughts are with the bereaved families.”
Mr Hunt said at the same time as the Norwegian reports, the Centre for Disease Control in the United States had issued a “heartening” report about the Pfizer vaccine.
“Also at the same time what we have seen is a heartening report from the CDC which has reviewed approximately 1.8 million doses of the same vaccine with very positive results in terms of both safety and the efficacy,” Mr Hunt said.
The government has been under pressure to roll out the Pfizer vaccine quickly after several overseas countries granted approval for its emergency use. But it stood firm in insisting that the TGA go through a thorough review process of the vaccine. The government has emphasised that in holding off until the vaccine can be fully assessed, Australia has the benefit of examining post-release data on the vaccine from other nations who have approved it.
