Australia is gearing up to roll out the first round of coronavirus vaccines, expected to be administered in February. But following the deaths of older people in Norway, government bodies and public health watchdogs have been put on high alert.
According to reports coming out of Norway, 30 older people living with existing health conditions and diseases have died following the receipt of the Pfizer and BioNTech COVID-19 vaccine. Following the roll out of over 40,000 inoculations, those who died reportedly experienced known side effects, which in these cases proved to be fatal.
According to a statement released by the Therapeutic Goods Administration, “The deaths were associated with fever, nausea and diarrhoea, which are relatively common short-lived effects that a number of people experience after vaccination. 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.”
It is believed that when they experienced these side effects, their underlying pre existing conditions worsened, resulting in their deaths.
According to Bloomberg, Norway has made the decision to suggest that the very old or terminally ill skip the vaccine, saying that it may be too risky.
The Norwegian Institute of Public Health said that “for those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant.”
Acting Prime Minister, Michael McCormack has made statements reassuring the public that the roll out of vaccines in Australia will be safe, saying that once inoculation begins in Australia, it will be “swift but safe.”
“I spoke to Greg Hunt the Health Minister this morning, who has asked the Therapeutic Goods Administration to run a deep rollout of drugs and medicines in Australia, and they will ask the Norwegian authorities and they will also ask the Pfizer company for their answers in response to what has happened,” he told Sunrise on Sunday morning.
“It is also why we have not put all of our eggs in one basket. We have other options, of course, with AstraZeneca, as well as Novavax.
“We have enough doses to roll out across the nation free-of-charge and to also provide a vaccine from February for Pacific Islanders as well. So, throughout the year, we are going to ensure that the vaccine is swift but safe.”
“That is absolute paramount, it will be safe,” Mr McCormack added.
While these deaths have been cause for concern, the Australian government has pressed that they will not negatively affect the way that Australia is testing and monitoring the progress of the vaccines around the world.
“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,” said the Therapeutic Goods Administration.
“The TGA’s processes for vaccine approvals is extremely rigorous and comprehensive. The TGA is evaluating all of 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.”
Federal Health Minister Greg Hunt has also said that should any more information come to light, the public will be duly informed.
“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.”
He also made note of the ongoing success of the Pfizer vaccine in the US, where more than 1.8 million people have had it administered with “very positive results” of the vaccine’s safety and efficacy.
While Pfizer and BioNTech is currently the most administered vaccine, Australia has an agreement for only 10 million doses. The majority of Australians are set to receive either the AstraZeneca vaccine, with 53 million doses ordered, or the Novavax vaccine, which is still in the clinical trial stage, but of which Australia has ordered 51 million doses.
“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. For any approved vaccines, the existing extensive Australia-wide vaccine and medicine safety monitoring system will immediately be scaled up to include the new vaccine,” said the Therapeutic Goods Administration.
