TGA approves Pfizer vaccine as safe in older adults, despite deaths

Australia’s Therapeutic Goods Association (TGA) has further investigated the Pfizer COVID-19 vaccine in the wake of 30 Norwegian deaths among the elderly and found there are no specific risks for older Australians.

The TGA received reports on 14 January of about 30 deaths in more than 40,000 elderly individuals in Norway, who were vaccinated with the Pfizer vaccine, and worked closely with the European Medicines Agency (EMA) and Pfizer to investigate the matter further.

The 30 deaths recorded in Norway were among very frail patients, including some who were anticipated to only have week or months to live.

The deaths were associated with fever, nausea and diarrhoea, which are relatively common short-lived effects that a number of people experience after vaccination. The TGA explained that it is not expected that these common adverse reactions following immunisation will be of significance in the vast majority of individuals who receive the Pfizer vaccination.

A recent meeting of the EMA’s risk assessment committee concluded that there was no specific safety concern, and no causal link between the vaccination and the deaths.

The EMA’s COVID safety update stated that “no specific safety concern has been identified for vaccine use in frail elderly individuals” as a result of their investigations and the benefit to the community of using the vaccine continues to outweigh any risks.

“In many cases concerning individuals above 65 years of age, progression of (multiple) pre-existing diseases seemed to be a plausible explanation for death. In some individuals, palliative care had already been initiated before vaccination,” the report said of the 30 deaths recorded in Norway.

Before the vaccine received authorisation in Europe, its safety was carefully assessed through large clinical trials across age groups including participants that were 75 years of age or older.

The TGA also explained that wider discussions with regulators in North America and the UK had all reached a similar verdict, allowing them to conclude that there was no specific risk of elderly patients receiving the Pfizer vaccination.

The TGA provided provisional approval to the Pfizer vaccine on 24 January, which means that elderly patients can receive this vaccine and there is no cap on the upper age limit.

The product information for health care professionals contains the following advice: “The data for use in the frail elderly (>85 years) is limited … the potential benefits of vaccination versus the potential risk and clinical impact of even relatively mild systemic adverse events in the frail elderly should be carefully assessed on a case-by-case basis.”

Australia’s vaccine strategy says aged care residents will be in phase 1a, the very first priority group for jabs. Those aged 70 and above will be in phase 1b.

The regulator said it would “continue to monitor the safety of COVID-19 vaccines as they are rolled out in Australia and internationally”.

“For all approved COVID-19 vaccines, the existing extensive Australia-wide vaccine and medicine safety monitoring system is being scaled up to include the new vaccine.”

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Written by Ben

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