TGA moves to reassure Australians on COVID-19 vaccine

pharmacy jabs: vaccine on blue

The regulator has pointed to its “extremely rigorous” approval process after reports of some deaths in elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine

The TGA has emphasised its processes for vaccine approvals are “extremely rigorous and comprehensive”, following reports of about the deaths of 30 elderly individuals in Norway who had been vaccinated with the Pfizer BioNTech vaccine.

These 30 deaths were recorded in a cohort that comprised over 40,000 elderly individuals, whom the TGA described as “very frail patients, including some who were anticipated to only have weeks or months to live”.

Norwegian authorities report that in recent years in aged care, an average of around 400 deaths typically occur each week, said the TGA.

“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,” said the TGA.

It was “promptly” advised of the Norwegian deaths and is working closely with the European Medicines Agency and Pfizer on further investigations.

Hassan Vally, Associate Professor in Epidemiology at La Trobe University, said “despite how unfortunate” the deaths were, it was important to note these 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,” said A/Prof Vally.

“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.”

Dr Abrar Chughtai, lecturer and the director of the Master of Infectious Diseases Intelligence (MIDI) program in the School of Public Health and Community Medicine at UNSW Sydney, said while the deaths may be unrelated to the vaccine, “we definitely need to be vigilant and check data from other countries”.

“Millions of doses of the same vaccine have been administered in the US, UK and some other countries, and no death is reported due to the vaccine,” said Dr Chughtai.

“We know that development of a new vaccine is generally a long process and requires multiple trials to ensure safety and efficacy. So far there is only one study on safety and efficacy of the Pfizer vaccine and, of total participants, 42% were older than 55 years of age (median age was 52 years) and around one-fifth had co-existing medical illnesses. As this vaccine may be tested on very few people over 80 years of age, more data is needed to ensure safety and efficacy in this age group.

“The government needs to ensure transparency and engage researchers and other community groups to maintain trust and avoid mixed messages.”

The TGA said it will continue to work with European regulators over the coming days to investigate the report from Norway 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.

“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,” it said.

“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.”

Australia has entered into four separate agreements for the supply of COVID-19 vaccines, if they are proved to be safe and effective. If the Pfizer/BioNTech vaccine is successful at gaining registration on the Australian Register of Therapeutic Goods, 10 million doses are expected to be available over the coming months.

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  1. Kim R

    Only one study of safety and efficacy for the Pfizer vaccine?! How do we access this study please? “Millions of doses of the same vaccine have been administered in the US, UK and some other countries, and no death is reported due to the vaccine,” said Dr Chughtai. Over 900 reports of deaths have been made with VAER They can’t be PROVEN to be directly related to the vaccine, but have they been proven to not be caused by the vaccine? Considering there has only been one study on safety and efficacy, why are we assuming that there is no evidence those deaths were caused by the vaccine when there is no study to confirm that? I don’t know how the TGA process is comprehensive and rigorously when there isn’t that much data available? Certainly not equivalent to usually years of trials and research, as the case with any other medication or vaccine gone through for approval. I’m curious what standards they are going by now. Genuinely concerned pharmacist, wondering how to explain to anti-Covid vaxxers about the ‘provisionally’ approved vaccines

    • Sheshtyn Paola

      Hi Kim,
      Thanks for your comment. Here is some information provided by the CDC:
      “Over 52 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through February 14, 2021. During this time, VAERS received 934 reports of death* (0.0018%) among people who received a COVID-19 vaccine. CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information including death certificates, autopsy, and medical records findings revealed no link with vaccination. CDC and FDA will continue to investigate reports of adverse events, including deaths, reported to VAERS.”
      *Includes only reports of death following COVID-19 vaccination in the United States.
      Hope this helps.
      Kind regards,
      Sheshtyn Paola (Journalist, AJP)

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