Data on real-world use of COVID-19 vaccines approved in Australia provides reassurance about their safety in older people. There is also encouraging new data on the effectiveness of the vaccines in older people.

So far, more than 300 million people have received these vaccines worldwide.Reported suspected side effects have been consistent with those observed during clinical trials.

Extensive vaccine experience has found no safety concerns in older people.

The Therapeutic Goods Administration (TGA) continues to review data from Australia and overseas relating to the safety and effectiveness of COVID-19 vaccines in older adults. Our monitoring has not detected any new safety signals in relation to COVID-19 vaccines to date.

The approved Product Information does not include an upper age limit for the use of either of the two vaccines currently registered in Australia. The decision to vaccinate an older person should be made on a case-by-case basis with consideration of the potential risks and benefits for the individual.

Reviews of safety data by international medicines regulators in countries with extensive COVID-19 vaccine experience have found no new safety concerns from use of the vaccines in older people.

• The European Medicines Agency (pdf,163kb) found no specific safety concern for vaccine use in frail elderly people in its review of worldwide safety data and reports of suspected side effects in Europe for the Pfizer/BioNTech vaccine, Comirnaty. This review included an assessment of reports of death following vaccination in elderly people in Norway.
• The United Kingdom (UK) Medicines and Healthcare products Regulatory Agency found that the overall safety experience with the Pfizer/BioNTech and AstraZeneca COVID-19 vaccines is so far as expected from clinical trials. Review of individual reports and patterns of reporting of cases with a fatal outcome does not suggest that the vaccines played a role in deaths reported in the UK.
• The United States (US) Centers for Disease Control and Prevention found that most reports of adverse events to the US Vaccine Adverse Event Reporting System (VAERS) were of non-serious events. An analysis of deaths in aged care facilities found no unexpected pattern that might suggest a causal relationship with vaccination.

The TGA has encouraged health professionals and consumers to report suspected side effects and significant events following vaccination to contribute to our safety monitoring. Our assessment of these reports aims to determine whether these events could have been caused by the vaccine or are coincidental and would have occurred irrespective of vaccination. We review individual reports of significant events and look for patterns of reports that may indicate a safety issue that needs further investigation. We perform statistical analyses to determine whether there are more events occurring than the expected background rate of events in the population.

Many people vaccinated so far in Australia have been older, with pre-existing medical conditions. Older age and underlying illnesses make it more likely that coincidental adverse events, including deaths, will occur.

The TGA has received some reports in which an older Australian died after receiving the COVID-19 vaccine. None of these deaths are thought to be caused by vaccination. The TGA is reviewing these reports together with the relevant state and territory health departments. This process includes considering the individual's health status and medical history at the time of vaccination, and where possible involves the individual's health professionals.

We continually review and analyse adverse event data, and assess safety information submitted by the pharmaceutical companies supplying the vaccines. If we identify a new safety concern related to the COVID-19 vaccines, we will publish a safety alert as soon as possible.

Promising UK real-world data on vaccine effectiveness in older adults

Two as-yet unpublished studies of vaccine effectiveness in the early months of the vaccine roll-out in England and Scotland indicate the vaccines decrease symptomatic infections and hospitalisations in older people.

Results of two studies of the real-world effectiveness of the Pfizer/BioNTech and AstraZeneca COVID-19 vaccines in the United Kingdom have recently been made available. These studies have not yet been peer-reviewed and published in a journal but are available as 'preprints'.

Public Health England examined the number of symptomatic infections, hospitalisations and deaths in individuals aged over 70 years between October 2020 and February 2021. People who were vaccinated with a single dose of either the Pfizer/BioNTech vaccine or the AstraZeneca vaccine had a 60-70% lower risk of symptomatic SARS-CoV2 infection, at 28 days after vaccination, than people who were not vaccinated. People who were vaccinated and did experience symptomatic SARS-CoV2 infection had a 40% lower risk of being hospitalised within 14 days of a positive test than those who were not vaccinated.

In Scotland (pdf,910kb), a single dose of any COVID-19 vaccine prevented 85-94% of COVID-19 related hospitalisation at 28-34 days after vaccination. In people aged over 80 years, those who were vaccinated with either the Pfizer or the AstraZeneca vaccine had an 80% lower risk of hospitalisation for COVID-19 than those who were not vaccinated.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.