Vaccine Passports and Compensation

IF THERE’S ONE VIDEO YOU WATCH FROM SENATE ESTIMATES MAKE IT THIS ONE.

I questioned the Government about vaccines, the indemnities it has provided to vaccine manufacturers and whether the government actually has a plan to stop restrictive lockdowns. These are common sense questions about liability and informed consent, let’s see if the tech-censors agree.

Also see part 2 to these questions here: https://www.malcolmrobertsqld.com.au/informed-consent-and-vaccine-passports-department-of-health-part-2/

Transcript

Thank you. Senator Roberts.

[Malcolm Roberts] Thank you, Chair. And thank you for appearing today. Many Australians have heard that getting vaccinated does not stop us from getting COVID, and that if we do get it we could still infect other people. Is that true?

– Yes – I guess Dr. Kelly onto that.

[Malcolm Roberts] Thank you. What is the risk of being infected by a vaccinated person with COVID compared to an unvaccinated person with COVID?

So, just repeat the question.

[Malcolm Roberts] What is the risk of being infected by a vaccinated person who has COVID compared with an unvaccinated person with COVID?

Well, it’s lower. I’m not sure I can give you an exact amount. I think Professor Murphy earlier talked about the issue and also Senator Colbeck, about the issue of transmission and how the vaccine affects that. We’re getting more information, and it seems like there is a definite influence on transmission, decreasing transmission somewhere between 30 and 60% less likely.

[Malcolm Roberts] Is that a mass figure or is that if you had COVID and you were vaccinated compared with if you had COVID and weren’t vaccinated, would I have the same risk or lesser risk?

You would have a much lower risk, but it’s not zero.

[Malcolm Roberts] Okay, thank you. What decrease in transmission of infection would stop restrictions such as lockdowns, masks, and social distancing?

So, that’s a matter that we’ve been charged by national cabinet way as in Australian Health Protection Principal Committee of which I chair, by the national cabinet to look at. And so, it’s a matter for the national cabinet. There will be, there’s a series of papers that we’re preparing exactly to answer those questions. Some have been produced already and presented and there’ll be more in the coming meetings.

[Malcolm Roberts] Thank you. How many times and how often would each of us need to be injected for the vaccine to be effective and for each time, for how long does the effect last?

So, as I mentioned earlier in the hearing, very good protection from one dose of vaccine, either the AstraZeneca or Pfizer particularly in relation to severe infection, but also to symptomatic infection, and to a lesser extent asymptomatic infection. So, that’s a single dose. The second dose is important for both of those vaccines. And most of the vaccines that are currently being used around the world require two doses to give a longer effect and a more deep effect, if you like, in terms of protection. I think it’s very important that Australia knows that this is the start of our vaccine programme. It will almost certainly not be the end. There will be a need for boosters into the future particularly in relation to the variants of concern of which there are four now that have been designated by the World Health Organisation. And some of those we already know do affect the vaccine efficacy. So, it’s likely we will need to have boosters into the future. How long the two dose effect works is still, we don’t know. We know it’s at least six months because that’s the studies of, been looking at it for six months. It’s almost certainly longer than that for the original strain, but the variance of concern adds another complexity to it.

[Malcolm Roberts] Can you guarantee Australians that all the vaccines you have obtained are 100% safe?

I can’t say that they were 100% safe, Senator, no.

[Malcolm Roberts] I do appreciate your honesty. How many years will it be before we know the long-term and intergenerational effects of these vaccines that only have provisional approval?

I might ask my colleague from the TGA to come up to answer that one.

John Skerritt, Deputy Secretary, Health Products Regulation, also responsible for the TGA. So, TGA, unlike the U.S. and the UK, for example, did a provisional approval of a vaccines as opposed to an emergency use authorization. The reason why it is a provisional approval is because we don’t have, for example, as Professor Kelly has just said, information on the duration of protection from these vaccines. And we require that the companies to give us that sort of information in the coming years. I mean, no one has those answers now. There’s some encouraging results, but as Professor Kelly has said, it’s likely that further vaccinations will be required. As part of the approval of any medicine or vaccine, big companies together with us are involved in very extensive safety monitoring. And we publish the results of the safety monitoring of that vaccine every week including mild or 24 hour adverse events, right through to those that might be much more serious and require hospitalisation. And no medicine or vaccine is without adverse events, but on balance, the number of adverse events, especially serious adverse events for these vaccines are comparatively low. The overwhelming majority of people vaccinated from them at worst suffer the 24 or 48 hours sore arm or tiredness, fatigue, et cetera.

[Malcolm Roberts] So, thank you. It’s a very comprehensive response. So, to summarise, we don’t know yet, but you’re relying upon company, the vaccine makers, to feed you back information as time moves on.

No, information on safety comes from a wide range of sources. It comes from the states and territories. For GP vaccination agreements, the GPs make an undertaking to also report any adverse events. The companies are legally bound to report adverse events not only in Australia, but also globally. And of course we share, and in fact at nine, 10 o’clock tonight we’ll be having one of our regular fortnightly video conferences. We share information on adverse events with all the major regulators globally. So, and the final sources from a medical scientific literature. So, while the companies have this legal requirement to report, it’s only one of a number of inputs to understanding adverse events. And many of our adverse event reports come directly from doctors or even individuals. Any individual can report an adverse event directly to us.

[Malcolm Roberts] Thank you, moving onto another topic away from vaccines for a minute, the vaccine only has provisional approval. Is it true that provisional approval is only possible where there are no approved pharmaceutical treatments available?

The provisional approval is possible where there is not a similar treatment available in that, for that group of patients. And so, if there’d been an approved vaccine, but say it had been on the market for several years, fully approved, then it wouldn’t have been possible to provisionally approve a vaccine, but at the time of the submissions of those vaccines, and indeed we have provisionally designated the Novavax vaccine as well and the Johnson & Johnson or Janssen vaccine, it is possible to provisionally designate and potentially provisionally approve those vaccines.

[Malcolm Roberts] Thank you. Ivermectin is an antiviral that’s been proven safe in 3.6 billion human doses over 60 years. It’s now demonstrating success in treating COVID internationally, including in certain Indian states that are performing far better than the other states without it. Last time you were here, sorry Dr. Murphy and, Professor Murphy and Professor Kelly, you acknowledged that cures and preventatives are a fundamental and complimentary part of a virus management strategy. What is your timeline for the assessment and use of Ivermectin in light of the emerging evidence and it’s historical setting.

Senator, we have not received a submission for Ivermectin for the treatment of COVID. I have had a number of people write to me and say, “Why haven’t you folks approved?” We can’t make a medicine submission to ourselves for regulatory approval. There’s no provision in law for us because it requires a legal sponsor. But we have said to people if you come with a dossier of information we will review it as a priority. Now, if you go to the broader community including the company that is the main originator company that is a sponsor of Ivermectin, they do not believe that the overwhelming balance of evidence actually supports that Ivermectin being effective in the prophylaxis or prevention or the treatment of COVID. However, our doctors and scientists would look at that evidence with open eyes. And so, it is open for any sponsor to put an application in for Ivermectin to the TGA for regulatory approval.

[Malcolm Roberts] Thank you. Moving back to the vaccine, the government has provided an indemnity to vaccine suppliers, as I understand it, and multinational pharmaceutical companies who have caused harm in the past. What is the nature of the indemnities that government has provided, and are they full indemnities?

Yeah, just give me a moment. Sorry, Senator, going to a wholly different part of my folder.

[Malcolm Roberts] You’ve got a lot on your plate.

So, just to go to your question, I understand it. You’re wanting to know exactly the nature of the indemnities provided, obviously–

[Malcolm Roberts] That the government has provided to the vaccine manufacturers and suppliers.

So, in the first instance to say that the actual detail of the indemnities is part of the Commercial in Confidence contracts, but I can provide you some information about the nature of what’s provided. So, we’ve agreed to certain indemnities with the COVID-19 vaccine suppliers. They’re contained in commercially confidential contracts. The indemnities are designed to operate if there are problems with the flow on from the vaccines themselves, as opposed to the manner of administration and so on, they don’t cover that. Details of the agreement are Commercial in Confidence, but nothing in any of the contractual agreements from individual companies would stop individuals from seeking to litigate should an individual seek to do so in the future.

[Malcolm Roberts] Sorry, could you repeat that again, please.

So, the actual detail of the indemnity, it relates to the nature of the vaccine itself as opposed to the manner of administration or any other issue to do with how it’s transported and so on. But it is absolutely the case that nothing in the indemnities prevents an individual from taking an action against the manufacturer or against anybody, if there’s an issue that arises from the impact of the vaccine. So, the summary of the arrangements are that they ensure that manufacturers have the significant indemnity in place to allow them to come into the marketplace and provide the protection, but they don’t prevent any action being taken by an individual who might be affected by a vaccine.

[Malcolm Roberts] So, what would they be? Why would they need an indemnity if they, they can still be sued? I don’t understand that. I’m not a lawyer, but.

I was once, but it’s a long time ago.

[Malcolm Roberts] You could say, I’m honest with you. Now, we’ve got lawyers as good friends. We’ve got good friends.

So, no one’s saying I’m . It’s to do with the relationship between the government and the company.

[Malcolm Roberts] What is the nature of that relationship?

Well, those are the things that are confidential in the contracts. You’d appreciate in order to get these vaccines into Australia so that we have access to them, there are strict requirements in the way the contracts are done with the companies and confidentiality. And the nature of the indemnities are part of that confidentiality.

[Malcolm Roberts] In the event of an injury or death from the vaccine, who pays compensation?

Not a question I can answer in the abstract. It would depend on the circumstances and so on and how the legal process would go on. As I say, the indemnities with manufacturers relate only to the flow on from the vaccine itself. So, in the event that negligence happens in any mechanism then it could be actionable against the person who had done the negligence, but there’s no simple answer to who pays compensation ’cause compensation would have to be found to be payable and attributable to someone and so on.

[Malcolm Roberts] So, it’d be pretty challenging, Ms. Edwards, for an individual to sue that they’ve just lost their spouse or their son or daughter, because, I’ll just go through some of the settlements in the past or some of the fines. Pfizer has paid the second largest pharmaceutical settlement in history, $2.3 billion in 2009, off-label promotion and kickbacks plus US$ 430 million in 2004 for off-label promotion. AstraZeneca has paid US$ 520 million in 2010 off-label promotion and kickbacks and US$ 355 million in 2003 for Medicare fraud. Johnson & Johnson has paid US$ 2.2 billion in 2013 for off label promotion and kickbacks plus millions in Australia last year for defective pelvic mesh implants. It’d be a pretty brave person that would hope to get anything out of this if they tried to sue any of these companies. These guys have a history of dodging.

Well, I’m not aware of any of the instances you’re referring to, but clearly there have been instances in which action has been taken against these companies.

[Malcolm Roberts] Are these companies appropriate to be entered into an agreement in this way? I mean, look at the history.

So, the Australian government and Australian consumers have the advantage of pharmaceutical products produced by companies such as these and many others. Obviously, enormously important to the health of Australians that they have access to medicines, including vaccines. We rely heavily on the scientific advice from the CMO, from the TGA and from experts as to what is the appropriate vaccine to be approved and used in the country. And those are the vaccines which we have purchased and are administering.

[Malcolm Roberts] I’m going–

[Member] Senator Roberts…

Senator, I think that perhaps I might throw this in In relation to this. The approvals for the vaccines have been based on a considerable amount of data. The approvals haven’t been provided lightly. And we have had the advantage of the visibility of the application of the vaccines in a number of other jurisdictions. It’s an important question that you ask, I think. And so, it’s not a company reputational issue, it’s actually the data that supports the application of the vaccines that is assessed by not only our regulatory authorities, but also the regulatory authorities in other jurisdictions. And also the fact that, as has already been indicated, there is a lot of discussion between those authorities in relation to that data. So, it’s interrogated as a part of the approval process not only in this jurisdiction, but in others, and I might…

[Malcolm Roberts] I understand it’s, perhaps you could also include reference to this Doctors Skerritt that some of the overseas nations that are using these vaccines have suspended their use.

Well, there’s several questions. I’ll return to suspension of use although it’s been relatively limited in countries like Norway. But to talk about those fines for the companies, I should clarify that it’s a consequence of one of the things that personally I hope Australia never follows. And this is the U.S. widespread advertising directly to the public of prescription medicines. And it is legal and extremely commonplace. You only have to have the TV on for five minutes in your hotel room to see an advertisement for prescription medicine in the United states. And however, it is tempting for some of these companies. And they’ve been found with major fines from court cases when they push for sorts of conditions, what we call the indications for which a medicine is approved. So, a medicine may be approved for certain sorts of arthritis and their marketing people think it’s a great idea to talk about arthritis in general, and that’s where they get these multi hundred million dollar fines. So, if you go into those cases in the U.S. it’s not about them providing defective vaccines or cheating with their quality data or cheating with their clinical data. Almost all those cases come down to inappropriate promotion because of the, I guess the temptation the United States systems offers of allowing to advertise prescription medicines directly to the public. Now, thank God we don’t have that system in this country.

[Malcolm Roberts] That’s still a matter of ethics, though, isn’t it? That the companies are pushing that, it’s their marketing people they are employing.

It’s their marketing people, and of course, we could mention many well-known Australian corporations who have also had challenges with marketing, including of telecommunication services. Now, we also —

[Malcolm Roberts] But they also go to the essence of integrity of the company?

But in Australia, we do look closely at promotion, including to doctors. So, recently we fined a particular company over $300,000 for what we concluded was inappropriate promotion of opiates to doctors. This wasn’t of a general public, but it was still inappropriate in our view. So, we will take action if we believe promotion of a product is inappropriate. Now, talking about companies in countries that have suspended vaccines, there were a number of short term suspensions of vaccines. For example, when some deaths in aged care were reported very early in the new year, they were then lifted off after further investigation where it was found that sadly people die in aged care. And the death rates were not all that different from the expected death rates. There were then short term changes, suspensions in some countries after the initial clotting cases were found AstraZeneca. In most countries, although Norway, for example, was an exception, most countries have re-introduced those vaccines, but like Australia, many of them have age recommendations. And those ages vary between countries.

[Malcolm Roberts] Thank you.

Senator Roberts, you’ve just run out of time. So, if you’ve got one more question.

[Malcolm Roberts] Okay. After the TGA had already provisionally approved the AstraZeneca vaccine, Minister Hunt said of the vaccines quote – “The world is engaged in the largest clinical trial, the largest global vaccination trial ever”. Australians later died of blood clots due to the vaccine, a side effect that was not known prior to provisional approval. Why should Australians be the lab rats of a drug trial?

So, the word trial really, I mean, the treatment of COVID. And none of us has a crystal ball, where we’ll end up, whether it’s opening the borders or changes to the way we live our lives in a year or two is probably one of the biggest societal trials we’ve had since World War II. So, it’s true to say that because we don’t know whether vaccines are 100%, 90%, 80%, 70, 50, 60 in preventing transmission because we don’t know about the duration of protection, all those things. It is a trial in the sense that anything is new. So, that was a context. If you look at the wider context in which the Minister made those comments. Now, on the issue of benefit versus risk, every medicine or vaccine has significant risks. There’s been many dozen deaths due to Panadol in this country. And yet, if we didn’t have that drug for the relief of simple fever and so forth, there’d be a lot of people suffering. And so, every medicine has its benefits and its risks. Now, because the clotting thing is very rare, even though the trials were extremely large as trials go, 20, 30,000 people, and there’s been another 30,000 people on a follow-up trial of the AstraZeneca. Those numbers were still too low, but you would predict something would be seen 10 in a million times. And so, that’s why the clotting thing was not picked up.

[Malcolm Roberts] Isn’t there still something really big, outstanding though and that is that these are an RNA vaccine?

[Professor John] No, the AstraZeneca vaccine–

[Malcolm Roberts] Some of them, sorry, are RNA. How long before we know the intergenerational effects?

[Professor John] There’s no evidence at all from animal or human studies that the RNA vaccines, if you’re talking about them, incorporate into the genetic material of human beings. They wouldn’t have been approved for regulatory approval and that includes by much bigger regulators such as the FDA, if these bits of mRNA incorporated into the human genetic material. In fact, medicines that incorporate into human genetic material and are inherited are currently not permitted in most major countries, including Australia.

[Malcolm Roberts] So, what you’re saying is that it is okay to have a few deaths?

I’m saying that every medicine or vaccine is assessed both before it goes onto the market and once it’s on the market based on benefit and risk. And in Australia, we’ve had, sadly, one death. We’ve had a number of cases of this clotting syndrome, but the really encouraging thing is that many of our cases seem to be milder than in our countries. And that’s because of such widespread awareness. These cases are picked up early, they’re put in hospitals, even if it’s minor clotting, and the really good news is that, the overwhelming majority of those people were already out of hospital.

[Malcolm Roberts] Thank you, Chair.