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Australia's COVID-19 vaccine safety monitoring system

9 February 2021

A comprehensive system is in place to capture reports of adverse events following COVID-19 vaccination, through:

Vaccine safety monitoring

The TGA, like other regulatory agencies around the world, continues to monitor the safety of vaccines and medicines after they are approved to contribute to a better understanding of their safety profile.

The TGA is the Government body responsible for ensuring that medicines and vaccines supplied in Australia continue to meet the required standards of safety, effectiveness and quality for their intended use. The TGA also has oversight of sponsors of vaccines and medicines who are legally responsible for monitoring the safety, quality and effectiveness of their products.

The existing safety monitoring system for vaccines involves:

  • reviewing and analysing reports of suspected side effects (also known as adverse events) submitted by health professionals and consumers
  • requiring pharmaceutical companies to have risk management plans for the vaccines they supply
  • proactively reviewing medical literature and other potential sources of new safety information
  • working with international regulators to assess significant side effects detected overseas
  • working with state and territory health departments and clinical experts to ensure a coordinated approach.

Pharmaceutical companies also have legal obligations to monitor, collect, manage and report on safety data, known collectively as their 'pharmacovigilance responsibilities'.

Collecting COVID-19 vaccine adverse events

We are enhancing reporting of adverse events following immunisation to help strengthen the vaccine safety monitoring system for COVID-19 vaccines. As described in the COVID-19 Vaccine Safety Monitoring Plan we are encouraging and facilitating reporting of adverse events by consumers and health professionals, including by:

  • working with state and territory health departments providing vaccinations in phase 1a and beyond to strengthen existing IT systems for reporting of adverse events to the TGA
  • requiring medical practices selected for phase 1b and community pharmacies selected for participation in phase 2 of the roll out of the COVID vaccine to commit to "facilitating support and care in cases of potential adverse events and (to) provide real-time reporting of any adverse events to the TGA and relevant state government departments...".
  • encouraging adverse event reporting by incorporating information and education in COVID-19 vaccine rollout materials, such as training modules for nurses, checklists for aged care providers, and patient and healthcare professional leaflets and consent forms. Materials prepared for specific populations, including Culturally and Linguistically Diverse (CALD) and Aboriginal and Torres Strait Islander communities will include information on how to report adverse events.

Active surveillance

Some people who receive COVID-19 vaccines (or their carers) will be sent follow-up SMS messages with a survey to ask if they have experienced any potential side effects. Replying to the survey means you are contributing to vaccine safety monitoring in Australia. The Australian Government routinely runs this type of 'active surveillance' using SMS messaging through the AusVaxSafety surveillance system to monitor the safety of vaccines in Australia. Further information is on the AusVaxSafety website.

Active surveillance complements the TGA's routine collection of spontaneous (unsolicited) reports of suspected side effects. While our existing safety monitoring system effectively identifies potential safety signals, active surveillance strengthens this capability and helps support the safe and effective use of new COVID-19 vaccines.

Learn more about how you can report suspected side effects associated with a COVID-19 vaccine.