Federal Health Minister Greg Hunt has asked the Therapeutic Goods Administration (TGA) to seek further information on the Pfizer vaccine, following a Norwegian report about the risks of its administration.
The TGA on Sunday afternoon confirmed it is working closely with the European Medicines Agency and Pfizer to investigate vaccine risks flagged by the Norwegian government.
“The TGA is evaluating all of the scientific and clinical information provided by the vaccine’s sponsor, Pfizer, as well as other available evidence … prior to making a regulatory decision,” the TGA said in a statement.
Media reports out of Norway have flagged six more elderly patients who were given the vaccine died after being inoculated, bringing the total to 29.
The patients are all 75 and over, with 13 deaths already fully assessed and another 16 under review.
“Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition,” a statement from the Norwegian Medicines Agency said.
The TGA said the reported deaths were recorded among very frail patients, including some who were anticipated to only have months to live before taking the vaccine.
“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 elderly or terminally ill should be potentially included in the product information for the Pfizer BioNTech vaccine.
“We have been in contact with the Foreign Minister, and Marise Payne will task DFAT to seek advice directly from the Norwegian government,” Mr Hunt told reporters on Sunday.
“In addition, I‘ve briefed both the Acting Prime Minister and the Prime Minister’s Office today. So as further information is available, we’ll share that with the Australian public.”
Earlier, Mr Hunt confirmed the federal government had removed all hot spots in Australia following only one confirmed case through community transmission in the past couple of days.
“There are no remaining hotspot definitions,” Mr Hunt said.
“Of course, inevitably, there will be days of new cases. There will be days where there may be a requirement for Commonwealth hotspot definition to be reintroduced. But they‘ll be done on the basis of that, and cases.”