Norse concern

On Sunday, Australia’s Therapeutic Goods Administration (TGA) announced that in recent days it had received reports “of about 30 deaths in over 40,000 elderly individuals” that had received the Pfizer BioNTech vaccine in Norway.

The Australian Government has ordered 10 million doses of the Pfizer BioNTech vaccine, as part of its $3.3 billion commitment to COVID vaccinations in Australia and, through the COVAX Facility, more than 90 lower-income countries.

The TGA said the deaths occurred in very frail patients, “including some who were anticipated to only have weeks or months to live” and that they 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 that, because Australia has a close working relationship with European regulators, it is one of the first non-European regulators to routinely receive early notification of any possible serious adverse events with COVID-19 vaccines.

Australian COVID experts have mostly urged caution in response to the Norway news.

“As I have been repeating throughout the past 12 months, it’s really important to be measured and calm when looking at any new information that emerges as we navigate the pandemic, even when new information relates to deaths in individuals who have received a vaccine,” says La Trobe University epidemiologist Hassan Vally.

“If we step back and try and put this in perspective, despite how unfortunate this is, these deaths have occurred in a number of older, frail individuals, some of whom had terminal illnesses. All of these individuals were over the age of 80 years of age. It is unclear at this stage what exactly led to these deaths and this needs to be understood better before drawing conclusions.”

Sydney University medical ethicist Diego Silva says that, as things stand, the news shouldn’t deter Australia from using the Pfizer vaccine.

“Norway have acted in good faith within the global health community by instituting a pharmaco-surveillance system and reported findings that may be troubling,” he says.

“The key right now is to investigate the causes of those deaths and continue monitoring for all side effects with the knowledge that it is still the case that serious side effects are exceedingly rare, especially when we consider the global rollout of the Pfizer vaccine.”

Swinburne University respiratory disease expert Bruce Thompson echoes Silva’s acknowledgement of Norway’s response.

“The good thing is that the reporting of clinical findings is open and transparent, and that standard systems for the reporting of adverse events is happening,” he says.

“Whilst the deaths amongst elderly people who have been recently vaccinated is of concern, we now need to understand if the death is associated with the vaccine, or other medical issues.”