The questions that got me blocked by the Australian Government's Therapeutic Goods Administration (TGA)

TGA knew where I was going with my line of questioning. They had to shut me up.

On 8 December 2021, the Australian Government's Therapeutic Goods Administration TGA announced the “provisional approval” of booster dose of Moderna's COVID-19 Vaccine (SPIKEVAX) for individuals aged 18 and above. The TGA claimed that this decision was made following “careful evaluation of available data supporting safety and efficacy.” The TGA also claimed that the decision to approve the booster dose of the vaccine was informed by “expert advice from the Advisory Committee on Vaccines, an independent committee with scientific, technical and consumer representation,”

Pretty big claims, eh?

In relation to this, I contacted the TGA with a series of questions. They responded to my queries by blocking me. I reckon the TGA figured where I was heading with my line of questioning and knew that they would land in hot water no matter how they chose to answer my questions. So, they had to shut me up.

I will produce the questions verbatim below. You be the judge of the quality of questions that I raised and speculate why the TGA had to shut me up. Remember that this was on 8 December 2021 when vaccine harm was not yet a part of mainstream discussion.

Dear Therapeutic Goods Administration - TGA,

1. Please list the names of those committee members.

2. Please detail their conflict of interests (their university/research institution being funded by pharma or pharma affiliate or an another entity funded by these, IS a conflict even if that funding does not directly pay the member's salary).

3. Please disclose the minutes of these meetings.

4. WHAT parameters defined safety?

5. WHAT parameters defined efficacy?

6. WHAT limits were set for these parameters?

7. WHAT were the end points for the safety trials?

8. WHAT were the end points for the efficacy trials?

9. Please provide the Risk-Benefit analysis.

10. Did you consider alternative approaches to attain the goal of this booster program? If yes, then, what are they? If not, then, why not?

11. Did you do the Risk-Benefit analysis using ACTUAL DATA from the past 2 years or did you use modelling?

12. If you used modelling instead of actual data, then, why?

13. In either case, did you simply use the data specific to USA or did you do an Australia-specific analysis?

14. In either case, kindly provide the complete Risk-Benefit analysis which was used to make the decision to approve a booster dose of the Moderna COVID-19 vaccine, SPIKEVAX, for individuals 18 years and older.

15. What were the inclusion & exclusion criteria of the trials?

16. What was the rationale behind these inclusion & exclusion criteria in the trials?

17. Does the provisional approval of the biological product extend to those population groups which meet the exclusion criteria of the trials? Explain the rationale behind this decision.

18. For how long were participants followed up for routine monitoring, and adverse events?

19. List the severe adverse events of clinical significance which were monitored.

20. For how long were these clinically significant severe adverse events monitored?

21. Did you rely merely on passive surveillance of clinically significant severe adverse events? Or did you also conduct proactive active surveillance?

22. Did you look for subclinical myocarditis, subclinical pericarditis, subclinical clotting factors?

23. Prior to beginning the trials, did you conduct any tests to obtain/measure any basic health parameters? If so, what were they? What is the rationale behind selecting each parameter? If not, then why not?

24. What causal attribution algorithm did you use for evaluating Adverse Events Following Immunisation (AEFI)?

25. As a pharmaceutical regulatory body under the Australian government, how do you meet your obligations pertaining to timely identification and response to Safety Signals?

26. Do you have any additional measures in place for timely identification and response to Safety Signals particularly in the context of mass administering these biologicals to the population? If yes, what are they? If not, then why not?

27. Do you have any additional measures in place for timely identification and response to Safety Signals particularly in the context that these biologicals only have a provisional approval and clinical trials are still ongoing? If yes, what are they? If not, then why not?

28. Have you identified any special population groups for Safety Signal monitoring? If yes, then, what are those groups? What was the rationale behind selecting these groups? If not, then, why not?

29. Do you have any additional measures in place for timely identification and response to Safety Signals in special groups of population? If yes, then, what are those measures? If not, then, why not?

30. Have you arranged for post-rollout surveillance of adverse events?

31. What procedures do you have in place for the public to have access to your post-rollout surveillance of this particular biological product and this particular dose?

I look forward to your responses to the above questions.

I thank you in advance for taking your time 🙏

N.B: "you" in the above questions refer to both the TGA & the sponsor of the biological product.

….And I was blocked. That was my first and last communication with the TGA. What do you think?

Adding in retrospect on 19Oct2024: If this or any of my previous work was useful to you, kindly consider supporting my work by buying me some coffees. Many thanks!

— The Solitary Reaper