The TGA and the Morrison Government have failed to exercise duty of care towards vaccine approvals. Double Comirnaty vaccination has been approved for children despite evidence clearly showing a seven fold increase in serious harm between the first and second doses.

Transcript

[Malcolm] Thank you, Mr. President. My question is to the minister representing the Minister for Health, Senator Colbeck. The British Medical Journal has published an article revealing the company that conducted part of the phase three trials of Pfizer’s Comirnaty COVID vaccine. Covering 25,000 people, falsified data, unblinded patients, employed inadequately trained staff, and was slow to follow up on adverse events. Minister, the Morrison-Joyce government failed to conduct an Australian trial of the Pfizer vaccine. And instead, simply took Pfizer’s word for it. Was this a failure in your duty of care to the Australian people?

The minister representing the Minister of Health, Senator Colbeck.

[Richard] Thank you, Mr. President. Senator. I can’t agree with the statement that you make as a question Senator Roberts at all through, through you president. The Australian government took, undertook a comprehensive assessment of each and every vaccine that is being used in this country to ensure Australians had the confidence. That we had a safe and efficacious vaccine for utilisation in the pandemic. And Mr. President, I think the results speak for themselves. If you look at the circumstances in respect of what’s occurred in aged care this year, compared to last year, the impact is profound. Mr. President, it is very clear that we took all steps to ensure that the vaccines that are being used in this country was safe and that they worked. We, we took evidence and advice, yes, from the companies we received the data that they used in their trials, appropriately. But we also had the advantage of being able to use data from other jurisdictions around the world. And we’ve remained in close contact with those agencies that consider vaccines to ensure that they are safe to use. Mr. President. Can I say to all Australians who are still contemplating whether or not they should get a vaccine. Please be assured that our public health system and our authorities, the Therapeutic Goods Administration, recognised as one of the best in the world, has done the, the, the, yes Senator Reynolds, amazing work. To ensure that we have access, Australians have access, anyone living in this country, wants a vaccine has access to a safe and efficacious vaccine

Minister, your time has expired. Senator Roberts, a supplementary question.

Thank you. Prior to the TGA’s approval of Comirnaty vaccine, Steve Anderson, the Director of the US Centre for Biologics Evaluation and Research released data detailing potential Comirnaty adverse outcomes, including Guillain-Barré syndrome, acute myocarditis, auto immune disease, and death. This is exactly what’s happened. In approving Pfizer’s Comirnaty injections, did the TGA fail in it’s duty of care to the Australian people?

Minister.

Thank you, Mr. President. No, it did not. I couldn’t be any firmer than that. And as I indicated in my answer to the primary question, the Therapeutic Goods Administration has considered all data in relation to the vaccine. And in fact, it continues to monitor the data in relation to the vaccines. We’ve, we’ve been extremely open with respect to that. We’ve published reporting on the outcomes of the vaccination programme here in Australia. We’ve published data in relation to adverse reactions, to the vaccines of all types. Mr. President. So I reject any assertion that the TGA has failed in its duty at all. No, it has not. I could not be any firmer, President. We have one of the best and we should be proud of the fact that we have one of the best therapeutic goods assessment, organisations in the world.

Your time has expired. Senator Roberts, a second supplementary question.

Thank you. Latest data from America’s CDC indicates that children aged 12 to 17 are likely to experience mmyocarditis and related conditions at the rate of 9.5 cases per million vaccinations. Yet after the second vaccination, that rate rises sevenfold from 9.5 to 66.7. In approving two doses of Pfizer Comirnaty for our children without testing, are the Minister for Health Greg Hunt and Professor Skerritt at the TGA, risking our children’s lives, health and future.

Minister

There’s a very simple answer to that question, President, it’s no. As I’ve said in my previous answer, the TGA continues to monitor all of the data, not just from Australia, but from around the world, in relation to the impact and the utilisation of the vaccines. Particularly those that we have to be administered here in Australia. We continue to monitor all of the data so that we have the most up-to-date information and that we can continue to assure Australians that the vaccines that they are taking are both safe and efficacious. And all of the data and the advice, continues to demonstrate that Mr. President. Are there contrary indications in relation to the vaccines? Yes, there are. We published the data so that we’re open with that. But we need to make sure that Australians have confidence that the vaccines we have access to a safe and efficacious.

Time has expired.