Did vaccine safety data transparency help or hinder?
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In Australia and globally, following regulatory approval of the COVID-19 vaccines Health Authorities encouraged the public to report suspected vaccine adverse reactions directly to them, leading to an exponential increase in vaccine safety data flowing into public safety databases.
At the same time, there was unprecedented public interest in vaccine safety, which led to unprecedented public scrutiny of vaccine safety data. Unfortunately, misinformation about the safety of COVID-19 vaccines was quickly spread, fuelled by incorrect interpretation of public safety data.
Health Authority safety database contains ‘product-event pairs’, i.e., an adverse event occurred after the administration of a product. While these are useful early warning systems for potential safety issues with medicines and vaccines, this data alone cannot be used to make conclusions about product safety. Potential safety issues identified from public safety database require further detailed investigation because adverse events recorded in these systems are not necessarily causally related to the suspect product.
One claim circulated in Australia in the early days of the pandemic was that COVID vaccine increased the risk of death, which was based on reports in the TGA safety database of patients dying not long after being administered the vaccine. However, this claim did not survive scrutiny when an analysis revealed the rate of patients dying following vaccine administration was the same as the rate of death in the general population. Of course, this claim and other false claims continued to be circulated, especially on social media, which may have led to reduced vaccine uptake at a critical time during the pandemic.
Should Health Authorities continue to make medicine and vaccine safety data freely available to the public when it can be weaponised against public health? It is the authors opinion that transparency of scientific data is generally a good thing, but it certainly warrants deeper discussion in times of a public health crisis.
Indeed, after years of routine safety monitoring of the COVID-19 vaccines, the data continues to suggest they are generally safe and effective. Whether or not transparency of medicine and vaccine safety data is in the public interest, individuals should be skeptical of claims based on public safety database alone.
