Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

My question is to the Minister representing the Minister for Health and Aged Care, Senator Gallagher. In the February Senate estimates hearings Adjunct Professor Skerritt, deputy secretary, health products regulation group, made the following statement:

… there is only one regulator in the world—the USFDA … —that actually looks at individual patient data. The rest of the regulators, like us … take statistically validated analyses of patient data. If there are issues with the individual patient data, the FDA … will raise those issues. …we … do not get individual patient data.

In estimates hearings on 10 November 2022 Adjunct Professor Skerritt said:

We did check the phase 2 and phase 3 clinical trial data from Pfizer …

Minister, please confirm that the TGA simply checked what Pfizer and the FDA sent to them without checking that back to the source material, patient records—meaning they took Pfizer's word for it.

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

GALLAGHER (—) (): I thank Senator Roberts for his questio I was there, I think, at both of those hearings with Professor Skerritt, who has since retired from that role. I'll take this opportunity to acknowledge his contribution, particularly during the COVID-19 pandemic, and the role of the TGA.

On the substantive part of your question, Senator Roberts, I will go back. Obviously I wasn't in the position I'm in now when those comments were made about what was done with the phase 1 and phase 2 trials and the data that was available. My understanding of the TGA process is that they don't necessarily look at just one set of data; they are looking at a whole range of data as they're making approvals for particular vaccines. I will come back if I have anything further to add on that.

I would also say that it's very clear that the rollout of the vaccination program has saved lives and, particularly for those who are vulnerable to COVID-19, it has reduced the chance that they would pass away or have very severe disease from COVID-19. That data is well and truly established and evidence based, and you can see that in the hospitalisation data and other data that's been collected about the impact of the vaccination program. The vaccine program has been very successful, and we're very fortunate to have been in a position to have all been vaccinated against this virus over the last couple of years.

Sue Lines (President) Share this | Link to this | Hansard source

Senator Roberts, a first supplementary question?

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Minister, can you assure the Senate that the US FDA did actually check the Pfizer analysis of patient data back to the actual patient data?

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

I don't think I'm in a position, or the government is in a position, to say what the FDA did or didn't do. I can certainly see if there's any further information I can provide to Senator Roberts. I acknowledge his ongoing interest in this area. If there is further advice I can provide to assure you that very strong, thorough and rigorous processes were followed before the TGA approved any of the vaccines that were used to vaccinate against COVID-19, I will.

Sue Lines (President) Share this | Link to this | Hansard source

Senator Roberts, a second supplementary question?

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

If that is the case, Minister, why does that same data, when independent leading virologists examine it properly in a peer reviewed published paper, show that 400,000 patient records prove the vaccine was unsafe and should not have been approved? I ask you again, Minister: did our bureaucrats approve a dangerous product because they trusted Pfizer and in so doing fail to act in Australia's best interests?

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

(—) (): No. I don't think that's a correct assertion to put. I do have, and I would expect that most senators in this place would have, complete and total faith in the processes used by the TGA when they were going through the approvals for the vaccine against COVID-19. I know there are some in this place who have a different view, and I've certainly sat in estimates listening to the questions that a number of senators have asked who have a different view, but I would say the overwhelming view of senators in this place is that the TGA undertook rigorous examination in a compressed time frame because of the situation we were facing. I think it's easy to forget that we were facing a pandemic where it was predicted that we would see significant loss of life if we were not able to protect citizens. We've been, again, very fortunate to have relied on the science and to have rolled out the vaccine. The data is very clear around the impact the vaccine has had on reducing serious disease and death from COVID-19. (Time expired)