Australian experts comment on deaths in Norway

Norway has reported several deaths and some side effects in elderly people vaccinated with the Pfizer BioNTech vaccine.

From more than 40,000 elderly individuals vaccinated in Norway, the Australian Therapeutic Goods Administration (TGA) has received reports of about 30 deaths and some side effects. The deaths were recorded among very frail patients, including some who were anticipated to only have weeks or months to live. Norwegian authorities report that an average of about 400 deaths typically occur each week in aged care.

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.

The TGA is working closely with the European Medicines Agency (of which Norway is a member) and Pfizer on further investigations. Because of Australia’s close working relationship with European regulators, the TGA is one of the first non-European regulators to routinely receive early notification of any possible serious adverse events with COVID-19 vaccines.

The TGA has said it 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.

Dean of the School of Health Sciences at Swinburne University Professor Bruce Thompson said that while the news is concerning and needs close monitoring, we need to be very careful about making comment without all the necessary information.

“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,” Professor Thompson said.

“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.”

Dr Diego Silva from the University of Sydney School of Public Health added, “The deaths of the Norwegians over the age of 80 should sadden us, but should not deter us from the Pfizer vaccine as things currently stand.

“Norway ha[s] acted in good faith within the global health community by instituting a pharmaco-surveillance system and reported findings that may be troubling.

“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.

“We require medical due diligence while continuing to reassure and foster public trust in the vaccine. It is not the time to panic nor withdraw the vaccine from circulation,” he said.

Associate Professor in Epidemiology at La Trobe University Hassan Vally reiterated the importance of remaining measured and calm when looking at any new information that emerges as we navigate the pandemic.

“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,” Associate Professor Vally said.

“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.

“What can be said is that all new information we obtain as the vaccine is delivered throughout the world needs to be examined closely and be used to inform how we implement our vaccination strategy. This information, along with any new information that comes to hand, will be examined closely by regulators in Australia to fully understand if there are any implications for us.

“It may be that this leads to a refining of the advice that the Pfizer vaccine not be used for those who are really frail, or that this decision is made on a case-by-case basis by medical professionals.

“What we can take some comfort from is that millions of people have safely received the Pfizer vaccine throughout the world.”

The TGA has assured that 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.

Image credit: ©stock.adobe.com/au/Yakobchuk Olena