TGA reduces timeframe for publishing adverse event reports

With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our IT systems, the Therapeutic Goods Administration (TGA) is making reports for medicines and vaccines publicly available more quickly.

The changes will reduce the time between adverse event reports being accepted into our database and published on the Database of Adverse Event Notifications - medicines (DAEN) from 90 days to 14 days.

These changes align with the TGA's Digital Transformation project which over the coming couple of years will digitise, transform and modernise our business systems and infrastructure and allow for greater transparency. The shorter time period for making adverse event reports available to the public is also consistent with other international regulators.

Reports will now be made public prior to in depth TGA analysis of the data to check for patterns of adverse events that may or may not indicate a safety issue (signal detection). If we identify a safety signal, we investigate and communicate any important safety information to the public.

We encourage reporting of adverse events even if people are uncertain whether it is related to a medicine or vaccine. Therefore, publication of an adverse event report does not necessarily mean that it is related to the medicine or vaccine. There might be no relationship between the adverse event and the medicine or vaccine - it may be a coincidence that the adverse event occurred when the medicine or vaccine was taken.

Since 2012 TGA has made de-identified reports of suspected side effects (also known as adverse events) publicly available in the DAEN 90 days after they are accepted. From 18 August 2021 this information will be released 14 days after reports are accepted.

Following the change, more than 30,000 additional reports will be visible in DAEN, reflecting the availability of more recent reports combined with the rate of reporting for COVID-19 vaccine adverse events arising from the millions of COVID-19 vaccines administered in Australia over a short period of time.

The COVID-19 pandemic and roll-out of COVID-19 vaccines has increased public awareness of and interest in adverse event reporting. TGA has been publishing a weekly report for several months that provides information about the latest findings of our safety monitoring of COVID-19 vaccines.