Pfizer/BioNTech COVID vaccine approved for use in older Australians

While the Pfizer/BioNTech vaccine had already been approved for use on 25 January, reports of around 30 deaths among more than 40,000 older Norwegian people who received the vaccine prompted the Therapeutic Goods Administration (TGA) to further investigate its suitability for that cohort.
 
But the regulator has determined that older patients can receive the mRNA vaccine, with no cap on the upper age limit.
 
‘The TGA was advised promptly of the Norwegian deaths and has worked closely with the European Medicines Agency [EMA] and Pfizer on further investigations,’ a TGA release stated.
 
‘The case reports were discussed at a recent meeting of the EMA Pharmacovigilance Risk Assessment Committee, which concluded that there was not a specific safety concern, and no causal link between vaccination and deaths could be established.
 
‘The TGA therefore has concluded that there is no specific risk of vaccination with the Pfizer/BioNTech COVID-19 vaccine in elderly patients.’
 
Broader discussions with regulators in North America, the UK and Europe reportedly reached a similar conclusion, while the EMA’s COVID-19 vaccine safety update contains further information that helped the TGA form its decision.
 
However, the product information for healthcare professionals cautions that the data for use in frail people who are 85 years and older 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,’ it states.
 
All of the Norwegian deaths were recorded among very frail patients, including some who were anticipated to only have weeks or months to live, but the TGA has said it will continue to monitor the safety of COVID-19 vaccines as they are rolled out in Australia and internationally.
 
News of the positive finding could help increase confidence in the vaccine, with a recent Ipsos survey showing three in four Australians (76%) are willing to receive COVID-19 vaccine when one becomes available.
 
Less than half (44%) ‘strongly agreed’ that they would choose to receive a vaccine once it becomes available, while 32% ‘somewhat agreed’.
 
Forty per cent of Australians said they would choose to get one ‘immediately’ if given the option, while a further 16% said they would seek to get vaccinated within a month.
 
Only 10% said they would not get vaccinated once the rollout begins, and 14% also expressed some reservations.
 
The global survey of 14,500 people across 17 countries showed vaccine confidence had increased most in countries that have already begun their COVID vaccination programs.
 
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coronavirus COVID-19 elderly Pfizer/BioNTech TGA vaccination vaccine