Vaccine adverse events and the TGA's role in monitoring them - is it failing the Australian public?

TGA  Database of Adverse Event Notifications (DAEN) is where all suspected side effect reports following vaccination are collated in collaboration with state level databases like SAEFVIC in Victoria. It is commonly reported in the media by politicians, epidemiologists, CHOs etc that all adverse events post vaccination are monitored by the TGA. However, the reality is that the TGA depends on health practitioners and the general public to report them. I quote from the TGA website: 

"The TGA encourages health professionals and consumers to report suspected side effects following immunisation with COVID-19 vaccines. Every report is valuable and contributes to our safety monitoring."

The TGA claims to collect data of adverse events presenting after the administration of any medication irrespective of causality being established. This is good practice and a requirement in any data set that is to be used for statistical inference purposes - to ascertain if there is an increased level of presentation in the target population as opposed to the general population. There is a small caveat though - the TGA can only collect data that is reported to it! The department of health has ample resources to collect data of all such events through the GP and hospital network simply by requiring medical practitioners to do so, in particular relating to adverse events post administration of covid19 vaccines. However, it has hitherto not done so, and therefore the TGA dataset is incomplete. 

The following personal experiences vouch for the fact that reporting is not taken as a serious responsibility by health professionals.

    a) a GP at myhealth Doncaster observed that there is no directive to do so and she hasn't reported any (only relatively minor) side effects she had come across.

    b) Terry White Pharmacy responded by asking me to Google how to report myself if I needed to, when I inquired why I haven't received a questionnaire after they administered the Spikevax. ie. if it is because they failed to register my details on some system that sends out the questionnaire. Incidentally, they charged Medicare $135.45 to administer the vaccine.

    c) Box Hill Hospital, where a family was admitted on the 7th day post vaccination, before continuing to experience ongoing symptoms for 6-8weeks, has dodged the simple question as to whether they reported this incident, and thus in all probability hasn't.

    d) A cardiologist in the family who claims to have diagnosed at least 2 myocarditis cases is not sure if anyone reported them.

In a setting where statistics is not comprehensive, "medical advice" and opinions coming from health professionals about phenomena "science cannot explain" do not necessarily have a scientific basis merely because they are coming from health professionals. Many doctors seem to be very hesitant to establish a correlation between vaccination and symptoms that have not been previously associated with vaccines. The lack of a proper statistics exacerbates this problem exponentially, and sadly many "medical professionals" who are in charge will not have had sufficient training in statistics to appreciate this problem.

In this context, the public health messaging assuring the TGA monitors all adverse events, is manifestly misleading and untrue, in my opinion. I have requested clarification on this from the TGA, the Department of Health, and most recently Minister Greg Hunt's office. I am yet to hear back from any party (3 months and counting).

- Chandi de Silva, PhD Applied Mathematics (Bioinformatics and Epidemiology)