Is the Pfizer coronavirus vaccine safe?
Health minister Greg Hunt is assuring Australians it is after it was reported that up to 30 Norwegians who had been given the vaccine had died.
“We don’t know yet whether this is a function simply of age and people who are older and sadly facing the natural loss of their life, or whether there’s any causation that hasn’t been asserted as yet,” Mr Hunt said on Sunday. “But we’re proceeding with an abundance of caution.”
Side-effects including nausea and fever might have contributed to the deaths, but Norway has been vaccinating elderly people with serious underlying diseases, and no “concrete link” between the vaccine and the fatalities has yet been proven, reports Nine.
Pfizer says there was no “signal of serious allergic reactions associated with the vaccine”.
“Pfizer will continue to work closely with the government to support their vaccine implementation plans,” it says.
ABC News reports that all the deaths occurred among patients in nursing homes and all were over the age of 80.
Australia has ordered 10 million doses of the Pfizer vaccine. Approval for the Pfizer vaccine is expected within weeks and authorities were planning to begin using it in mid-February, starting with 678,000 people, including quarantine and border workers, frontline health workers, and aged care and disability staff and residents.
Mr Hunt said he had contacted the Australian medical regulator the Therapeutic Goods Administration (TGA) requesting it seek additional information from Pfizer and the Norwegian medical regulator.
“(Foreign minister) Marise Payne will task DFAT (the Department of Foreign Affairs and Trade) to seek advice directly from the Norwegian government.
“At this point there’s no change, but we’ll follow the medical regulator’s advice,” Mr Hunt said. “We’re proceeding with an abundance of caution.”
The Pfizer or Moderna vaccines have been administered to 30,000 Norwegians since late December.
Infectious diseases specialist Associate Professor Sanjaya Senanayake told 9News the vaccine may not be responsible for the deaths in Norway.
“This could just be coincidental, that you have people with chronic health problems who just succumb to their chronic illnesses rather than due to the vaccine itself,” Prof. Senanayake said.
Aged care residents and older Australians were scheduled to be vaccinated first in Australia.
The Norwegian Medicines Agency said nine people who took the vaccination had serious side-effects, including strong discomfort and severe fever, and seven had less serious side-effects.
“The deaths were associated with fever, nausea and diarrhoea, which are relatively common short-lived effects that a number of people experience after vaccination,” a TGA spokesperson said late on Sunday.
“Indications from Norway are that these were not typical aged care residents who died but those who were very frail and had terminal conditions.
“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.”
Professor Kristine Macartney, director of the National Centre for Immunisation Research and Surveillance, told Nine that Australians should not be concerned about the reports from Norway.
“We shouldn’t at all be alarmed. We should just wait for the usual processes to occur, and any adjustments to clinical guidance or the product information will come if needed, but it’s too early to say whether that would change the program,” she said.
“As vaccines are rolled out to millions, and ultimately billions of people across the world, we will see some flags pop up, but it’s very important for people to understand that those will be really thoroughly investigated.
“I expect it to be approved and enable an Australian rollout commencing next month, including to the elderly.”
Professor Greg Dore, an infectious diseases physician and epidemiologist at the Kirby Institute, UNSW Sydney, told Nine no deaths related to the Pfizer vaccine have been reported in the US, where nearly two million doses of the Pfizer vaccine have been administered.
The US Centres for Disease Control has 4393 cases of adverse outcomes including allergic reactions and anaphylaxis.
“Data from clinical trials plus this early rollout data from other countries should be sufficient for the TGA to make an assessment of safety,” he said.
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