In estimates I asked the Department of Health what processes it uses to monitor the performance of the TGA.
I asked this because an early autopsy recommended that Sarcoid patients get an echocardiogram before getting the vaccine. This was based on an examination that showed the vaccine killed this particular patient.
As you know the TGA don’t even solicit autopsy reports, which is bad enough in terms of recognising deaths, but it’s even worse when you consider that the coroners may be giving advice that is being overlooked by the TGA.
This is clearly what happened with the COVID jab that has caused tens of thousands of heart issues. Had the TGA actually read the autopsy reports these injuries may have been avoided.
There is no doubt the TGA is negligent in causing injury and death.
The same should be said of the Health Minister Greg Hunt who was also warned of these injuries by myself and did nothing about it.
Community Affairs Legislation Committee
26/02/2025
Estimates
HEALTH AND AGED CARE PORTFOLIO
Department of Health and Aged Care
Senator RENNICK: Let’s follow up on processes, then. I have a copy of the autopsy that I have given you in the past. This autopsy has recommendations. You have said in the past that you don’t solicit autopsies. This comes back to processes. This was the recommendation of the coroner: ‘A possible therapeutic implication of this case might be that sarcoid patients receive an echocardiogram prior to the Pfizer mRNA COVID vaccination to detect cardiac involvement or that alternative vaccination types are considered.’ This particular person died in July 2021.
Mr Comley : I want to check with the chair. I am going to take your guidance. I think it is item output 1.8. Chair, do you want to handle it here in the cross-portfolio matters or handle it in that section of the agenda?
CHAIR: If that’s where it legitimately belongs. We do have quite a few hours, so I can pop you on the list for that, Senator Rennick.
Senator RENNICK: Okay. I won’t be long. I have pretty much just one other question.
CHAIR: It is just so I have the right officials for you.
Senator RENNICK: The reason I want to connect the TGA to the health department, Mr Comley, is that it is very important that there is oversight by the health department of the TGA. While I accept that these questions will also be directed to the TGA later tonight, I want to see that the health department is actually doing its job in reviewing the processes undertaken by the TGA. That is why I am bringing it up now. I want you to demonstrate what you have just said. You say that you have processes that demonstrate a duty of care, yet here we have an autopsy report early on in the rollout of the vaccine. Forget the fact that you didn’t even solicit this autopsy report and you didn’t report on it. I am talking about the recommendation. It was that sarcoid patients get an echocardiogram before getting the vaccine. We know that thousands, if not tens of thousands, of people got myocarditis and pericarditis et cetera. This is an example, in my view, of how the TGA didn’t follow up or didn’t have proper processes in place to get feedback from doctors who performed autopsies in relation to deaths related to the vaccine. What are you going to do, as the head of the health department—you are on almost $1 million a year to do that—to make sure that the TGA does their job in examining feedback from people injured by medications in general? It doesn’t matter whether it is the vaccine.
Mr Comley : I will ask Professor Lawler to comment on this and the interaction. Obviously the TGA is part of the health department. It is effectively a group within the health department. I oversee that in the same way I oversee other parts of the department. It is also the case with the TGA that there is specific legislation that gives them certain powers. In those cases, it actually would not be appropriate for me to exercise those decisions. I will ask Professor Lawler to expand a bit on how we handle that distinction between the TGA and the department.
Prof. Lawler : As we’ve discussed previously in this place, Senator, the TGA, as the secretary highlights, is a structural unit within the department. I appreciate the attempt to tie the TGA to the department. The TGA is tied to the department. As the secretary highlights, we operate under statute. That gives us certain powers but also certain obligations. We discussed the autopsy report previously. There are some recommendations within that. The process we follow to approve vaccines is to maintain a robust pharmacovigilance program, which, as I have stated previously, has meant that the COVID vaccines have been the most scrutinised medicines that have been rolled out in the country. The way in which we respond to that, including the incorporation of autopsy reports and investigation through vaccine safety investigation groups, is probably, with your agreement, Chair, discussed best under outcome 1.8. It does not go to the structure of the department; it goes to the outcome under which the TGA sits.
Senator RENNICK: I will leave it at that.
