HEWITT, Dr Brian, Head of Regulatory Sciences, Pfizer Australia [by video link]

THIRU, Dr Krishan, Country Medical Director, Pfizer Australia [by video link]

Committee met at 17:03

CHAIR ( Senator Sheldon ): I now declare open this hearing of the Senate Education and Employment Legislation Committee into COVID-19 Vaccination Status (Prevention of Discrimination) Bill 2022 and the Fair Work Amendment (Prohibiting COVID-19 Vaccine Discrimination) Bill 2023. I begin by acknowledging the traditional custodians of the land on which we meet and pay my respects to their elders both past and present. I extend that respect to Aboriginal and Torres Strait Islander peoples here today. The committee will be conducting today's hearing via video conference and in person. These are public proceedings being video streamed live via the parliament's website, and a Hansard transcript is being made.

I remind all witnesses that in giving evidence to the committee they are protected by parliamentary privilege. It is unlawful for anyone to threaten or disadvantage a witness on account of evidence given to a committee. Such action may be treated by the Senate as a contempt. It is also a contempt to give false or misleading evidence. Witnesses also have a right to request to be heard in camera. If a witness objects to answering a question, they should state the ground upon which the objection is made and the committee will determine whether it will insist on an answer having regard to the ground which is claimed. If the committee determines to insist on an answer, a witness may request that the answer be given in camera. I remind committee members and witnesses who are appearing via video conference who are not speaking to please mute their microphones.

I now welcome representatives from Pfizer Australia via video conference. I understand that information on parliamentary privilege and the protection of witnesses giving evidence to Senate committees has been provided to you. I now invite you to make a short opening statement. At the conclusion of any remarks, I'll invite members of the committee to ask questions. Over to you.

Dr Thiru: Thank you, Chair. Pfizer thanks the Senate Standing Committee on Education and Employment for the opportunity to appear at the hearing today. As has been communicated to the committee previously, Pfizer believes the debate on the prevention of discrimination based on COVID-19 vaccination status, which is at the core of both the bills that are subject to inquiry by this committee, is a policy matter for government. However, with our recent experience developing, manufacturing and supplying a COVID-19 vaccine, Pfizer is happy to share details of this experience.

With approximately 80,000 employees globally and one of the most sophisticated supply chains systems in the industry, Pfizer is one of the largest biopharmaceutical companies in the world. Pfizer is proud to have had operations in Australia since 1956. We have more than 1,000 employees in Australia and operate across two commercial sites in Sydney and Melbourne. We have a manufacturing facility in Melbourne that exports to over 60 countries worldwide. Pfizer is a proven, reliable, multinational vaccine producer, supplying vaccines that prevent a multitude of diseases and infections to 175 countries even prior to the pandemic, when we manufactured more than 200 million doses of Pfizer vaccines annually. Additionally, Pfizer is one of the largest sterile injectable suppliers in the word, producing more than one billion sterile units per year.

Last year, more than one out of every six people worldwide are estimated to have used a Pfizer medicine or vaccine. As of 4 June 2023, we have delivered more than 4.6 billion COVID-19 vaccine dozes to 181 countries and territories in every region of the world. These numbers represent real people around the world who are helped by what Pfizer scientists developed and brought to patients.

At the start of 2020, as the SARS-CoV-2 virus began rapidly spreading across the globe, Pfizer and our partner BioNTech recognised the urgency and need to play a leadership role in addressing the global public health crisis. On 17 March 2020, just six days after the World Health Organization declared COVID-19 a pandemic, Pfizer signed a letter of intent with BioNTech to codevelop a potential COVID-19 vaccine. We worked to safely accelerate the development, manufacture and distribution of an mRNA based coronavirus vaccine for active immunisation to prevent COVID-19 infection. In less than a year, it received emergency use approval from the US Food and Drug Administration, the first COVID-19 vaccine to be granted such authorisation.

In addition to the public health benefit, vaccine access has also had a tremendous economic benefit in Australia. A peer reviewed paper in the scientific journal Vaccine estimated the timely rollout of COVID-19 vaccinations to have reduced the impact of the pandemic on the Australian economy, resulting in a positive incremental benefit of $181 billion, contributing to significant positive effects for tourism exports, education exports, employment and government finances.

Pfizer has confidence in the safety of our vaccine. Given the urgent public health need to develop a vaccine in a safe and responsible way, we collaborated closely with independent regulatory and health authorities around the world to conduct key activities in parallel to allow us to significantly accelerate the vaccine development without compromising safety. The independent data monitoring committee for our landmark trial did not report any serious safety concerns related to the vaccine prior to licensing. The data demonstrates the vaccine is well tolerated across the authorised indications and across all age groups. The most common side effects reported have been local reactions at the injection site.

Since its FDA authorisation in 2020, Pfizer's COVID-19 vaccine has been administered to hundreds of millions of individuals globally and continues to be vigilantly monitored through trials and post-authorisation surveillance. The vaccine has received full regulatory approval in a variety of countries, including the United States, the EU and Australia, following earlier emergency use and conditional or provisional approvals. These authorisations are based on robust and independent evaluation of the scientific data on quality, safety and efficacy, including our landmark phase 3 trial. Data from real-world studies complement the clinical trial data and provide additional evidence that the vaccine provides effective protection against severe disease.

We take all adverse events that are potentially associated with our COVID-19 vaccine very seriously. We closely monitor all such events and collect relevant information to share with global regulatory authorities. Based on ongoing safety reviews performed by Pfizer, BioNTech and health authorities, the vaccine retains a positive benefit-risk profile for the prevention of COVID-19 infections. To date, hundreds of millions of people have been vaccinated with our vaccine. Pfizer and BioNTech have invested more than US$2 billion at risk to develop our COVID-19 vaccine. Within just 13 months from December 2020—

Senator CANAVAN: Sorry to interrupt. We have very limited time. I raise a point of order. Could we have an indication of how long to go? We could, of course, table any opening statement. That opportunity is there. I am sorry to interrupt. I am mindful of the clock.

CHAIR: It would be of assistance. It saves us having to have another hearing.

Dr Thiru: There is about one minute to go. I am happy to be guided by you, Chair.

CHAIR: If you can wrap up quickly, that would be great. If you get somebody from your office to email the opening statement, we might have it in front of us as well.

Dr Thiru: We would be happy to do that. Let me close. Vaccine manufacturing is a biological production that is extraordinarily complex under any circumstances. Pfizer's COVID-19 vaccine requires 280 components and relies upon 86 suppliers located in 19 different countries. As a result, the maintenance of strong and reliable global supply chains is crucial to the ongoing production and availability of the vaccine. Fundamental to Pfizer's ability to commit the R&D investment into vaccines and treatments are pro innovation policy settings, including a strong intellectual property system. Large-scale pandemics like COVID-19 are likely to occur again. Epidemiologists forecast that the frequency and scale of future pandemics may steadily increase. As such, near-term pandemic readiness efforts are critical to respond to future pandemic and/or public health emergencies at the domestic and global level. Pfizer is proud of its collaboration we've had with the Australian government. We look forward to continuing that partnership to ensure Australia is even better prepared for future threats to public health. Pfizer hopes that its appearance at this public hearing assists the Senate committee.

CHAIR: Thank you.

Senator CANAVAN: Thank you, gentlemen, for appearing today and your evidence. Did Pfizer test whether your COVID-19 vaccine could stop or reduce the transmission of the virus before its approval and rollout in late 2020?

Dr Thiru: To bring this vaccine to patients, we were required to show that the vaccine was safe and effective in preventing illness, in preventing severe disease and in preventing hospitalisations. The primary purpose of vaccination was, and remains, to protect the person who received the vaccine.

Senator CANAVAN: I will repeat the question. I appreciate that. There hasn't been an answer to it. I might add into the record that on 3 December 2020, your CEO, Mr Albert Bourla, when asked whether vaccinated people could carry and spread the virus, responded to NBC News:

I think this is something that needs to be examined. We are not certain about that right now.

Was Mr Bourla correct that, as of 3 December 2020, Pfizer did not know whether the vaccine could stop or reduce the spread of the virus?

Dr Thiru: Senator, as with all vaccines seeking regulatory authorisation, the requirement is to demonstrate in robust clinical programs that the vaccine is safe and effective in preventing the infection and, in this case, preventing severe disease and hospitalisation.

Senator CANAVAN: Sorry to interrupt, but I have very limited time. I have five minutes. Is it a yes or no? Did you test whether transmission would be reduced or stopped before the approval of the vaccine?

Dr Thiru: Senator, we designed our clinical programs in agreement with regulatory agencies, the purpose of which was to demonstrate the vaccine was safe and effective in preventing infections.

Senator CANAVAN: We might move on to another topic. On 14 January 2021, just six weeks after Mr Bourla's statement to NBC News, the official Pfizer Twitter account tweeted:

The ability to vaccinate at speed to gain herd immunity and stop transmission is our highest priority.

What evidence did Pfizer have to make that public statement to imply that vaccination could stop transmission?

Dr Thiru: I'm not familiar with the context or the details of those comments. Let me just say that the primary purpose of vaccination, the approved product label and the regulatory approvals in Australia and around the world were to prevent infection, prevent severe disease and prevent hospitalisation. That is what our clinical trial program sought to demonstrate. That is what was demonstrated. That was the evidence that was evaluated by regulatory agencies and by health authorities. That was the strong, robust clinical evidence that led to the approvals that were received in Australia and in many other countries.

Senator CANAVAN: I will ask you to take that on notice. The question is: what evidence did Pfizer have for their statement on Twitter on 14 January 2021?

Dr Thiru: Senator, I would be happy to take that question on notice—

Senator CANAVAN: Thank you.

Dr Thiru: and come back to the committee with what information we're able to provide.

Senator CANAVAN: So on 8 June 2021, the Pfizer CEO, Mr Albert Bourla, tweeted:

… vaccination is a critical tool to help stop transmission.

What evidence did Mr Bourla have by that stage, 8 June 2021, that vaccination could stop transmission?

Dr Thiru: Senator, it has been very clearly demonstrated that the robust efficacy of Pfizer's COVID-19 vaccine has been a centrally important tool in enabling societies to open up international borders, to reduce—

Senator CANAVAN: I'm asking for the evidence. What is the evidence? Can you point me to a study that an independent scientist has done to give grounds for Mr Bourla's statement that your vaccine stopped transmission?

Dr Thiru: Senator, I'm not familiar with the context of that statement. We've complied and worked very closely with the regulatory agencies around the world to probe the evidence that they required to approve this vaccine to prevent infection and severe disease and hospitalisations.

Senator CANAVAN: I will ask you to take on notice again the evidential basis for Mr Bourla's comments on 8 June 2021.

Dr Thiru: I am happy to take that on notice.

Senator CANAVAN: Thank you. Do you still believe that your COVID vaccine is a critical tool to help stop transmission?

Dr Thiru: Absolutely. It's a critical tool in preventing, as I said earlier, infections, severe disease and hospitalisation.

Senator CANAVAN: That wasn't my question. You did say, I think, absolutely. Just to be clear on that evidence, and if I could get you to clarify it, is it Pfizer's view that your COVID vaccine is a critical tool to help stop transmission?

Dr Thiru: Sorry, I may have misheard your question. I was—

Senator CANAVAN: That is why I re-asked it. I thought you might have misinterpreted it. Is your view that your vaccine is a critical tool to help stop transmission?

Dr Thiru: Pfizer's view is that the vaccine is a critical tool in protecting the health of individuals who are vaccinated and enabling society to operate normally as it is at the moment.

Senator CANAVAN: Okay. I'm taking from that you don't think it's a critical tool to help stop transmission. You haven't repeated Mr Bourla's statement today under oath, so it doesn't sound like you're that confident in it. What I'm concerned about here is that you have a statement from your CEO that obviously has huge weight for governments around the world on their regulatory settings, saying that the COVID vaccine could stop transmission or was a critical tool to help stop transmission. Can you point me to any statements made by Pfizer officials—the Pfizer CEO, anything—that has somewhat moved away from that very strong statement of Mr Bourla in June 2021 that it is a critical tool to help stop transmission? Have you clarified the record since that time?

Dr Thiru: I am very confident that the evidence we have presented to regulatory agencies still stands and clearly demonstrates that the vaccine is safe and effective for its intended use.

Senator CANAVAN: That is not my question. I am very sorry to pull you up. I don't normally do this, but we have very limited time and you are being very shifty here. You are not answering the very clear questions.

Senator HANSON: Senator Canavan, can I just—

Senator CANAVAN: Hang on.

Senator HANSON: I would like see Dr Hewitt—

Senator CANAVAN: Can I—

Senator HANSON: I would like to see Dr Hewitt answer the question, because he is the scientist.

CHAIR: Senator Canavan has the floor. Any questions are through the chair. I do allocate time so people can have their train of questions before I allocate to others.

Senator CANAVAN: I will finish up now.

CHAIR: I will go to Senator Rennick next.

Senator CANAVAN: I'll finish with this. My point here is that, by late 2021 in this country, the Australian government and state governments imposed vaccine mandates on their own employees and required other employers to impose them on their employees. They definitely did that in part based on the evidence and advice from organisations like yours and the statements of Mr Bourla. We were constantly told by our leaders that your vaccine was necessary to stop the spread. I have pages and pages of quotes from those leaders saying that the vaccine would stop the spread. You have seen those statements. You are the head of regulatory services. You would have seen those statements. Is there any statement from Pfizer that clarified Mr Bourla's statement from June 2021 that responded to the very strong statements from premiers about your product? If not, what you are doing is effectively only reporting the good news that you have about your vaccine and not clarifying where there may be a shortcoming from your product that has led thousands of Australians to lose their jobs.

Senator ROBERTS: And livelihoods.

Senator CANAVAN: And their livelihoods. Why hasn't Pfizer clarified the record on transmission when governments have used that to mandate your product and provide you with billions of dollars of profits around the world by doing so?

Dr Hewitt: Perhaps I can make a comment. Pfizer was very clear in making an application to TGA that it sought an indication for active immunisation to prevent coronavirus disease caused by SARS-CoV-2.

Senator CANAVAN: But you said more than that. That's not what I am asking. I am asking about the public statements from your CEO. He said it was a critical tool to stop transmission. I can't find anything from him or anyone else of his employees that has moved back from that statement since, yet you won't repeat his statement on evidence today. So you obviously don't believe in it. Why haven't you clarified the public record since June 2021?

CHAIR: If you can answer that question, I will go to Senator Rennick.

Dr Hewitt: Senator, again, I can only repeat that in making an application to TGA, Pfizer sought active immunisation to prevent coronavirus disease caused by SARS-CoV-2. It was very clear in its application to the TGA.

CHAIR: Senator Rennick.

Senator RENNICK: I note that you've already stated today that the vaccine was designed to actually stop or prevent infection. This was also reiterated by your CEO, Albert Bourla, on 2 April 2021, when he posted a tweet,:

Excited to share that updated analysis from our Phase 3 study … showed that our COVID-19 vaccine was 100% effective in preventing #COVID-19 cases—

By September 2022, Australia had recorded 10 million cases of COVID despite having an adult population vaccinated to the tune of 95 per cent. Given those real-world figures in Australia, do you still stand by that statement you've just said to Senator Canavan that the vaccine was effective in preventing infection?

Dr Thiru: We strongly believe, and we reiterate, that the vaccine is safe and effective for its intended use. What changed was that the virus evolved. If we look at the clinical data from before the virus mutated into Delta, Omicron and subsequent variants, the vaccine maintained high levels of efficacy. If we look at the six-month data from the pivotal trial, efficacy for the prevention of serious—

Senator RENNICK: Sorry, I'm not referring to trials. I'm referring to the fact. I'm referring to the Omicron variant. That's a product of the nature of the vaccine. You have actually designed a vaccine that is an epitope on one spike protein and not the other 28 proteins in the vaccine. That is a design fault of yours, the fact that it can't cope with other variants. That is the nature of the way you have designed that vaccine.

Dr Thiru: Senator, I categorically reject your statement. The vaccine was carefully designed against the virus that was prevalent at the time, which was the original wild-type virus. It remained highly effective against preventing illness and preventing severe disease.

Senator RENNICK: Thank you. Can you define 'highly effective' in terms of a duration?

Dr Thiru: When the wild-type virus was prevent, efficacy of approximately or greater than 90 per cent was maintained at six months for both overall the illnesses and severe disease.

Senator RENNICK: The TGA non-clinical report on the Pfizer vaccine said that T-cells, antibodies and T-cells in monkeys declined quickly after five weeks after the second dose of the vaccine. So the best we've got here in animal studies was five weeks, 35 days, a bit over a month. Why are you saying six months when animal studies showed five weeks? In human studies, you cut them short after two months.

Dr Thiru: The human immune system doesn't rely on antibodies alone. Antibodies provide short-term protection against infection. T-cell and other immune responses, which are a bit more difficult to measure, provide longer lasting protection.

Senator RENNICK: Maybe you didn't hear what I just said. It said antibodies and T-cells declined quickly after five weeks. That's what the TGA Pfizer non-clinical report said—five weeks.

Dr Thiru: It is very difficult to measure the totality of the immune system's responses against the infection. What we need to rely on is—

Senator RENNICK: Okay. If that's the case—

CHAIR: Senator Rennick, Dr Thiru could finish his answer. Are you finished, Dr Thiru? By all means, if you have something else to say, say it. I'll then go back to Senator Rennick.

Dr Thiru: I will make one more comment. We then need to look to clinical outcomes. It's very clear that, even with the Omicron variant, with a virus that is now quite different to the original virus, efficacy against, in particular, severe disease, hospitalisation and people not surviving is maintained for significant durations.

Senator RENNICK: I'm referring to infection. For the bulk of the people, half the country was infected with COVID 10 months after. For healthy people of working age population, their risk from COVID was very low. I'm putting it into context here. These people were forced to take a vaccine that you said—you've said today—was effective in preventing infection. That is not the real-world data. The real-world data showed that almost 50 per cent of the population, despite being vaccinated twice, if not three times, caught COVID. You've just said it's very difficult to measure the duration. Are you going to retract the statement that the vaccine was effective, because you've basically contradicted yourself already?

Dr Thiru: Senator, the virus had approval for the prevention of infection, for the prevention of severe disease and the prevention of hospitalisation. Despite the fact that the virus had evolved, had mutated significantly, vaccination remained significantly effective against severe disease and hospitalisation for prolonged periods.

Senator RENNICK: I will move on. Thank you.

Dr Hewitt: May I say something? I actually reject your statement that people were forced to take the vaccine.

Senator RENNICK: We'll deal with that later. That's not your decision. That's not to do with today. According to the Pfizer non-clinical report, there were no carcinogenic tests, no genotoxicity tests, no immune toxicity tests, no interaction studies with other medicines and no longitudinal studies. I note that in regard to pregnancy and lactation, studies were conducted on rats. How can Pfizer say that the vaccine was unequivocally safe without qualifying any risks around the vaccine?

Dr Hewitt: I don't have that report in front of me so I'm afraid I can't talk to it. What I can say is that the TGA is one of the world's leading regulators.

Senator RENNICK: You can take my word for it. I'm happy to table this document. It clearly stated that a number of tests were not conducted. Those tests weren't conducted. I accept that we had a short time frame, but that doesn't remove the fact that certain risks were not analysed. You never highlighted those risks when the vaccine was rolled out.

Dr Hewitt: I disagree with that statement. The Therapeutic Goods Administration is a very thorough and very competent authority perfectly able to reach a decision based on data that it reviews.

Senator RENNICK: Initially, when the vaccine was rolled out, myocarditis and pericarditis weren't recognised side effects. Does Pfizer understand why the vaccine causes myocarditis and pericarditis? If not, how can it guarantee that it is not also injuring other organs? Can you explain why the vaccine causes myocarditis and pericarditis?

Dr Thiru: I'll take that. Based on our clinical trials and pharmacovigilance data as well as real-world evidence following the distribution now of billions of doses of vaccine, we retain strong confidence in the safety profile of the vaccine.

Senator RENNICK: Chair, I raise a point of order. I have asked whether they understand why it causes these symptoms. I know that it is a low risk. I am asking whether you understand why it causes myocarditis. I want you to explain to me why it causes myocarditis. Do you understand why it causes myocarditis?

Dr Thiru: Pfizer is aware of very rare reports of myocarditis and pericarditis that have been temporally associated with vaccination. However—

Senator RENNICK: Well, that's still ongoing for some people.

CHAIR: Senator Rennick, Dr Thiru should answer the question. Thank you, Dr Thiru.

Dr Thiru: According to public health experts and regulatory authorities around the globe, the number of reports of myocarditis remains small.

Senator RENNICK: I'm not referring to the number of reports. I want you to explain to me the mechanism of how the vaccine causes myocarditis. Do you or do you not understand the mechanism of why the vaccine causes myocarditis? It looks to me like you don't. If you don't understand it, why are you saying that the vaccine is safe without qualifying the risks?

CHAIR: Senator Rennick, I think Dr Thiru is actually about to get to that point. Whether people agree with his evidence is another question for others to make a judgement on. Dr Thiru, if you could again go to Senator Rennick's question.

Dr Thiru: All medicines, all therapeutic products and vaccines, have benefits and side effects as well. Looking at the totality of the evidence for Pfizer's COVID-19 vaccine, regulatory authorities, health authorities and experts globally, including in Australia within the department of health and the TGA, have maintained that the benefit-risk ratio—

Senator RENNICK: That's not the question I asked. I asked whether you can explain why the vaccine causes myocarditis. Yes or no?

Dr Thiru: The benefit-risk profile—

Senator RENNICK: Yes or no. You clearly don't understand the pathway, do you, because you can't explain it? I'm not referring to the cost-benefit analysis here. I'm referring to whether you understand the biochemical pathway as to why the vaccine causes damage to the heart.

Dr Thiru: Senator, I'm happy to take your question on notice and come back to the committee with whatever information we can provide. I might clarify that I was not referring to a cost-benefit analysis in my previous response. I was referring to the benefit-risk ratio. Health authorities around the globe continue to recommend the benefits of—

Senator RENNICK: This isn't the question I'm asking. Thanks, Chair.

CHAIR: Just so I can clarify as well, Dr Thiru, you have agreed to take the question on notice and give further response to that question. Is that correct?

Dr Thiru: That is correct, Chair. As I understand the question, it was about the mechanisms. We're happy to take that question on notice.

Senator ANTIC: I want to refer you to a recent study published in an Elsevier journal. It is a peer reviewed study, I believe, from late last year. I have copies here that I can tender, if you like. The cut and thrust of it, though, is that the study shows that the risks of these vaccines is greater than previously reported. It shows that, using your own publicly available data, there was one serious adverse event for every 800 vaccinations, which translates to about 1,250 serious events for every million vaccine recipients. Look at that in comparison to the rate for conventional vaccines. It is about, I think, one every one or two million. In fact, the 1976 swine flu vaccine was withdrawn after it was associated with Guillain-Barre syndrome at a rate of about one in 100,000. But this is particularly difficult when you factor in that those at the lowest risk for hospitalisation were probably at the highest risk for serious vaccine reactions. Was Pfizer aware of these matters before it was approved in Australia? Did you alert the regulator, the TGA, to these risks?

Dr Hewitt: Senator, I'm not aware of the report that you are reading or, indeed, the article from which you are quoting. Could you just repeat your question? It was very complex. I'm not sure I fully understood it.

Senator ANTIC: Well, the question is: were you aware of the one in 800 rate of return on serious adverse events and the fact that the profile of those events damaged or affected those who are the least likely to be hospitalised prior to the drug being submitted for approval? Did you make the TGA aware of those risks?

Dr Hewitt: Again, I can't speak to that. I don't have that report in front of me. One thing I would note overall is that global regulators are continually assessing the vaccine safety data in their regions. The International Coalition of Medicines Regulatory Authorities, which is a coalition of 38 medicines regulatory authorities from every region in the world, recently released a statement. That statement was endorsed by the European Medicines Agency. It confirms the safety profile of COVID-19 vaccines. The regulators stated that the evidence from more than 13 billion doses of COVID vaccines administered worldwide showed that the vaccines have a very good safety profile in all age groups.

Senator ANTIC: Our therapeutic goods association derives something in the order of 96 per cent of its budget from industry fees. What amount of funding does Pfizer provide to therapeutic goods association per annum?

Dr Hewitt: The Therapeutic Goods Administration? Senator, yes, it's user fee funded. So there are a couple of different ways in which the TGA is funded. There is a—

Senator ANTIC: The question is the dollar figure, not the rationale.

Dr Hewitt: I don't have that figure, Senator.

Senator ANTIC: You don't know that?

CHAIR: If you could take that on notice, it would be helpful.

Senator ANTIC: Thank you.

Dr Hewitt: We can.

Senator ANTIC: Another recent journal article in the European Journal of Heart Failure stipulates that the incidence and the mechanisms of myocardial injury following COVID mRNA booster vaccination was found to be more common than first thought and warranted further studies. Is Pfizer aware of this? If so, when is Pfizer going to remove this product from the market?

Dr Thiru: I might take this question. I don't have a copy of the research paper that you are referring to. It's not data that we have, so I can't comment on that specifically. What I can do is reiterate that we are aware of these very rare reports of myocarditis. We're aware that the Therapeutic Goods Administration has provided advice to vaccine administrators on how to manage that risk. We are aware that all the information available is in the approved product label. It is fully and transparently disclosed. That is a decision for individual vaccine providers to make. I might reiterate what my colleague Dr Hewitt just said. Based on the administration of over 13 billion doses of vaccine, regulatory agencies around the world have said that these vaccines remain safe in all age groups, including younger people, including people who are immune compromised and including people who have other medical conditions.

Senator ANTIC: I accept that you've been sent here to go the rope a dope like Ali and Frazier, the Thrilla in Manila, so we're not going to get proper answers out of this. I want you to answer this question. Did at any time your legal compliance teams look to the possibility that the lipid nanoparticle mRNA complexes satisfied the definitions for being properly deemed genetically modified organisms under the Australian legislation? The question is: did you examine that possibility?

Dr Hewitt: Senator, mRNA technology is not gene therapy. It does not alter human DNA.

Senator ANTIC: That is not an answer to the question. Was it examined or considered?

Dr Hewitt: Examined or considered? I'm not sure the nature of your question. Can you be more specific?

Senator ANTIC: I can't really be more specific. It was very specific. Did your legal compliance teams examine the possibility that these vaccinations satisfied the definitions for being properly deemed GMOs under the Australian legislation for the purposes of Australian legislation?

Dr Hewitt: Again, Senator, our mRNA technology is not a genetically modified organism and does not—

Senator ANTIC: So your team did not consider that?

Dr Hewitt: Pfizer consulted with the Office of the Gene Technology Regulator and sought confirmation, in fact, that our vaccine did not fall under the Gene Technology Act 2000.

Senator ANTIC: Has Pfizer notified its underwriters of the potential for future litigation as a result of claims, or will those claims be offset pursuant to an indemnity given to the Australian government?

Dr Hewitt: I can't answer that one, Senator. I'll need to take that on notice.

Senator ANTIC: Thank you.

Senator RENNICK: Chair, I raise a point of order. I have a document here from Pfizer. I'm happy to table this. They actually state that manufacturing gene therapies in particular includes transfection, a process that uses HEK cells. So they admit on their own website that gene technology includes transfection. Transfection is a part of the COVID vaccine process. I table this document just to prove that these people are contradicting their own statements.

CHAIR: Firstly, pass it up here and we'll have a look at it. Can we just be mindful that Pfizer hasn't got a copy of this document for verification.

Senator RENNICK: Okay.

CHAIR: We've only got so much time. I would very much encourage that, if there are additional questions that may relate to this matter, we send them to Pfizer following this hearing.

Senator RENNICK: Absolutely, Chair. I'm happy to do that. I remind the witnesses to please not contradict statements on your own website.

CHAIR: The committee will circulate this and send it to Pfizer. We'll now go to another senator.

Senator HANSON: Thank you, gentlemen, for coming here. A recent peer reviewed paper in the establishment scientific journal Vaccine examined Pfizer's COVID vaccine randomised phase 3 clinical trial data. It used the World Health Organization framework made for this purpose. It is the Brighton Collaboration on adverse events of special interest. The authors are world leading virologist and pharmacology experts from the UCLA, Stanford, University of Baltimore and Queensland's Bond University. The paper concluded that Pfizer's vaccine was associated with a 36 per cent increase in serious adverse events. The most common were coagulation disorders, including thrombosis, and acute cardiac injury. In every 10,000 people injected, 18 will experience a life threatening or altering medical complication. Serious adverse events from the Pfizer COVID vaccine are four times higher than any benefit from the vaccine in reduced hospitalisation. The paper said that the product should never have been approved. Would you like to respond to that, please?

Dr Thiru: Senator, again, I do not have a copy of your paper. I have not examined it. I cannot comment on it specifically. What I can say is this. This benefit-risk ratio of vaccination in all age groups in all populations continues to be strongly positive. Vaccination continues to be encouraged by health authorities globally, including in Australia. The most common adverse events that are seen are local reactions—a painful arm, some redness or swelling, some muscle aches and pains, maybe a fever or some fatigue or tiredness. We take all reports of adverse events seriously. We collect that information. We analyse that information. We communicate it to regulatory agencies such as the TGA. They've pooled that data from the safety data that they receive from other sources, be it from health care professionals, patients directly or state departments of health. Their conclusion is very consistent with conclusions of other regulatory agencies around the world. That is, that the benefit-risk ratio for vaccination remains strongly positive in all indications and all age groups for which it has been approved.

Senator HANSON: Well, I want to know your response to the reported 1,476,227 adverse event reports up to December 2022, including 32,621 deaths.

Dr Hewitt: Senator, I'm not aware of the figures or the document from which you are reading.

Senator HANSON: In Australia. You don't know? You haven't read up much on all this, have you? You knew you were going to come this inquiry, yet you haven't done anything whatsoever to respond to our questions. I think it's very poor of you to not be able to answer these questions. You are a scientist. You are from science, Dr Hewitt, and you're a country doctor, Dr Thiru. I expected to have more of an answer here because we're going through dire straits. People in Australia have had adverse side effects. You say that the injection site is the main cause of adverse side effects. What I'm reading here in your figures is pages and pages of adverse side effects. You know what most of this comes up with? Nervous system disorders. There are thousands upon thousands of people affected, be it with lethargy or headache. You've got other problems here with them. Another one that really concerns me is to do with reproductive system and breast disorders. Did you state to the TGA the impact that this drug would have on pregnant women?

Dr Thiru: Senator, firstly, I reject the premise of your question in terms of those safety findings that you have communicated. It's very important to note the difference between an adverse event that has been reported and an adverse reaction that has been actually attributed to the product. The TGA carefully analyses all of the reports that it receives and makes a determination as to whether there is a causal link to therapeutic product or not. This is not something different for vaccines. This happens with all therapeutic products. In terms of your specific question about pregnancy, all of the information that we have has been communicated to the TGA. I draw your attention to the approved product label for the product. It says that there is limited clinical trial evidence in pregnant women and that it should be the subject of an informed decision between a woman and her physician or vaccine provider. That animal data has not suggested any untoward effects on pregnancy, on foetal development, on childbirth and on postnatal development. I might add that expert groups have said this about vaccination in pregnancy. The Australian Technical Advisory Group on Immunisation has recommended that if you are pregnant, you can get vaccinated with the Pfizer vaccine at any stage of pregnancy. They have also said real-world evidence has shown that the Pfizer vaccine is safe if you are pregnant and breastfeeding. If you are pregnant and unvaccinated, you have a higher risk of severe illness from COVID-19. Your baby may also have a higher risk of premature birth. That is one group of experts.

Another group of experts, and probably the most august authority in this area, is the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. This is the peak body of obstetricians, the doctors who have spent their lives training and are specialised in the care of pregnant women. They have said that pregnant women in Australia are a priority group for COVID-19 vaccination and should be routinely offered the Pfizer vaccine Comirnaty or Moderna Spikevax at any stage of pregnancy. They have said there is no evidence of increased risk of miscarriage or teratogenic risk with mRNA or viral vaccines. It is very clear that experts who have spent their lives and are dedicated to examining this data in pregnant women have come to that conclusion.

We continue to take all reports of adverse events, whether pregnancy related or otherwise, very seriously. We work with the TGA and other regulators around the world to further characterise the vaccine. Based on the information that is available at the moment, that is the recommendation of expert authorities.

Senator HANSON: You are still on trial with this drug, aren't you? Any other drugs that are actually introduced into our society usually go through 10 years of testing. When the pandemic was announced by the World Health Organization, you said within six days you started doing trials into it. You started the vaccination, which you said came out a year later. It was passed. What trials had you done prior to that? What trials had you performed to ensure the full safety of this drug on the people of the world?

Dr Thiru: Before I hand over to my colleague Dr Hewitt, let me just correct the record. I did not say that any vaccination or clinical trial was done within six days. I said we signed—

Senator HANSON: No. I didn't say it wasn't done. You responded to the World Health Organization six days later. A year later, you produced the drug.

Dr Thiru: We signed a contract. We signed an agreement with another company BioNTech to research the vaccine. That proceeded over the year. I might ask my colleague Dr Hewitt to talk about the clinical trial program.

Dr Hewitt: Sure.

CHAIR: Dr Hewitt, just before you start answering, Senator Hanson, there's obviously an opportunity for a follow-up question after this.

Dr Hewitt: Given then urgent public health need to responsibly develop a vaccine with a favourable safety profile, we collaborated very closely with independent regulatory and health authorities around the world. That allowed us to conduct key activities in parallel to significantly accelerate vaccine development without compromising safety.

Senator HANSON: But—

Dr Hewitt: One of the reasons—

Senator HANSON: Go on.

Dr Hewitt: No, Senator. You go.

Senator HANSON: Right. This is the last question. You're both Australians. You live here. Were you in the country during COVID-19?

Dr Hewitt: Yes, Senator, I was.

Dr Thiru: Yes.

Senator HANSON: Okay. Dr Thiru, you made a comment that no-one was forced to have the vaccination. Who made the comment? Was it Dr Thiru?

Dr Hewitt: I believe I made that comment.

Senator HANSON: You made that comment. You were in Australia during COVID-19. You must have been fully aware that people—nurses, doctors—to keep their jobs were forced to have the vaccination. Do you retract your statement that they were not forced?

Dr Hewitt: No. I believe firmly that nobody was forced to have a vaccine. Mandates for vaccine requirement are determined by governments and health authorities. I believe everybody was offered an opportunity to get a vaccine or not get a vaccine. I don't believe that anybody was forced to take a vaccine.

Senator HANSON: A lot of Australians will disagree with you on that one.

Senator GROGAN: I appreciate that you have been presented with a range of extracts from reports. Are you aware of how many academic and situational reports have been published on COVID-19 since the beginning?

Dr Thiru: I'm not aware. I would imagine it would be a very large number.

Senator GROGAN: I had a quick search on Google. I got 23,500. That is an interesting point. Obviously, through that there are quite a lot of different perspectives, some of which have been fleshed out here. I understand that one of the great benefits of the mRNA technology is that you can quickly adapt the vaccine to respond to new variants. What other benefits could it present to vaccine development and medicine development in general?

Dr Thiru: Thank you, Senator. You are correct that the major benefit is that vaccines can be adapted very quickly. That is exactly what we're doing to respond to new variants that are emerging. For example, we were very quickly able to produce a BA.4 and BA.5 vaccine, which is now currently available and being used in Australia to provide protection against the Omicron variant. We are also now working on developing a vaccine against the XBB variant. There has been a request from regulatory agencies around the world for us to focus on that for our next vaccine. We've already commenced research. So processes that normally can take much longer can be now completed within some months. We can develop a new vaccine within 100 days of identifying an actual strain that we are targeting. So we are aiming to deliver that XBB variant vaccine by October in the United States and some time after that in Australia.

If we move potentially beyond vaccination, mRNA technology holds a tremendous amount of promise in other non-infectious diseases. That is whether we are talking about specific types of cancers or other autoimmune diseases, essentially where there's a protein that's missing or not functioning correctly and you can use the body's own protein factory to produce the desired protein. Potentially, it holds a lot of promise. Pfizer and many other companies are looking to see how this technology can be leveraged to address the immense unmet medical need in cancer, in autoimmune diseases as well as other infectious diseases at the moment.

Senator GROGAN: Thank you. I do have other questions. I'm going to put most of them on notice because we are tight on time. I would like to say since the workplace mandates have come into force—obviously, we are not looking at very much of that any more—Pfizer has developed an antiviral to treat COVID infection. Is that correct?

Dr Thiru: That is correct. We were proud to develop an effective antiviral agent for people who are most at risk of severe disease. Vaccination remains the primary first-line defence against severe disease or hospitalisation. There are people who are particularly at risk of a poorer outcome should they contract a COVID infection. That could be due to age—being over 50, 60 or 70 years—having chronic health conditions with heart, lung, kidney, liver disease or diabetes, being in a residential care facility or having a disability or other complex health needs. Those people can be treated early with an antiviral agent such as Paxlovid, which is Pfizer's agent. It's essentially a take home pack, a five-day course of pills similar to an antibiotic. It substantially reduces the risk of the disease progressing to severe disease that may require hospitalisation. The pivotal clinical trial that was submitted to the TGA, which led to that organisation authorising the vaccine for distribution in Australia demonstrated a 90 per cent reduction in the risk of hospitalisation and death. So that has immense potential to mitigate the burden of disease of COVID-19 that is still ever-present in our community.

Senator GROGAN: Does it provide sufficient protection for people who are hesitant or antivaccine?

Dr Thiru: I said at the start that vaccination remains the primary first line of defence against severe COVID-19 and hospitalisation. This is a second line defence or another option for people potentially who weren't able to be vaccinated. It has demonstrated that it has a substantial effect on improving or mitigating that risk of severe disease and hospitalisation.

Senator GROGAN: Thank you very much. I'll put the rest of my questions on notice.

Senator O'SULLIVAN: I have a quick question. Dr Hewitt, I looked at all the information before me, as every other Australian had the opportunity to do, to get vaccinated. I decided that getting vaccinated was the right thing for me. I am fully vaccinated. There are many Australians who, looking at that information, didn't believe the vaccination was right for them. I'm from Western Australia. In Western Australia, vaccines were mandated essentially across the entire population. There were a few exceptions. There were very few exceptions. If you wanted to go to work and earn a living and provide for your family, you had to be vaccinated. Based on your evidence, I'm staggered that was the response you gave earlier to questions in relation to whether or not people were forced to have vaccines. If you had to make a choice between paying your mortgage and putting food on the table for your family, you can hardly say that those people were not forced. They were making choices. There were plenty of people who were forced to do it. There were some in Western Australia—I've had so many who have contacted me—who had to go without because they chose not to be vaccinated. The state government forced them to be vaccinated, frankly. What do you have to say to that?

Dr Hewitt: Mandates or vaccine requirements are determined by governments and health authorities. As a company, we were not involved in the development of any government vaccine mandates.

Senator O'SULLIVAN: But they didn't have the same opportunity. You said that they had the opportunity to be vaccinated. Well, there were people who had the opportunity to not pay their mortgage and they chose to not be vaccinated.

Dr Hewitt: Is there a question there, Senator?

Senator O'SULLIVAN: Do you still stand by your original statement that you made a few minutes ago?

Dr Hewitt: The mandates for vaccine requirements are determined by governments and health authorities. I don't believe that the mandates actually forced individuals to get vaccinations.

Senator ROBERTS: Thank you, Dr Hewitt and Dr Thiru, for being here. You have repeatedly refused to provide evidence. You've dodged questions on evidence from Senator Canavan and from Senator Rennick. You have relied instead on appeals to authority and other logical fallacies, including an appeal to authority. Let's talk about one of your experts, the health minister. The former health minister in this country said, 'We're engaged in the world's largest clinical vaccination trial.' It's experimental, in his view. He was the health minister that introduced these things. Let's go to the first question. What we've seen during the COVID mismanagement and malfeasance was the largest transfer of wealth in our nation's history from we the people to big pharma via big government that lied repeatedly during the COVID mismanagement. My question is: did you ask the minister to introduce vaccine mandates for employment?

Dr Thiru: Senator, I reject the premise of your question. We have—

Senator ROBERTS: Did you or did your company ask the minister to introduce vaccine mandates for employment?

Dr Thiru: Senator, I reject your question and your accusation. We had no involvement.

Senator ROBERTS: I made no accusation, Dr Thiru. I asked you a question.

Dr Thiru: I was referring to your previous comments as well when you mischaracterised the evidence base for the vaccine. We have covered that previously. What I can confirm is that we have had not had any discussions. We have not been involved with any governments or any other organisations in relation to vaccine mandates. That is a matter for government. That is a matter for law makers. That is not a matter for Pfizer.

Senator ROBERTS: Did you ask the health department or one of their agencies for vaccine mandates?

Dr Thiru: I believe I have clearly communicated the position on that. Pfizer had no involvement and has no involvement in the imposition of vaccine mandates.

Senator ROBERTS: Did you ask anyone in or near a government or a department to ban Ivermectin?

Dr Thiru: Pfizer has had no involvement and no—

Senator ROBERTS: Thank you.

Dr Thiru: discussion in relation to Ivermectin.

Senator ROBERTS: Does the indemnity you have with the government extend to providing you with indemnity in a situation where an employee is forced by their employer to undergo vaccination and then experiences harm? If you do have indemnity, I want the proof.

Dr Thiru: Any indemnity agreements between Pfizer and the Australian government are confidential. We are not able to discuss that in this forum.

Senator ROBERTS: Why are they confidential? As a taxpayer, I paid for those injections even though I didn't take any. Why are they confidential from 26 million Australians? What are you hiding?

Dr Thiru: Indemnity agreements between the Australian government and private organisations such as Pfizer are confidential. We are not at liberty to discuss that.

Senator ROBERTS: Why are they confidential? The people who paid for these injections cannot see what they've actually bought. Why are they confidential? Why are you hiding?

Dr Thiru: Those indemnity agreements—indeed, contractual arrangements, as is always the case, between the Australian government and external parties—are confidential. I don't have any information today that might assist the committee in relation to that.

Senator ROBERTS: Did Pfizer have COVID vaccine mandates for your own employees in Australia?

Dr Thiru: At the height of the pandemic and consistent with guidance from health authorities from the New South Wales and Victorian governments, Pfizer did have a colleague vaccination program for its employees.

Senator ROBERTS: Do you still have it?

Dr Thiru: That vaccine requirement for colleague vaccination for Pfizer employees is currently present. We introduced a colleague vaccination program in the interests of protecting the health and safety of our colleagues and the communities in which we operate.

Senator ROBERTS: We've read that your vaccine mandate was using your own batch of vaccine especially imported for Pfizer which was not tested by the TGA. Is that correct?

Dr Hewitt: Pfizer undertook to import our batch of vaccines specifically for the employee vaccination program. That was so that no vaccine would be taken from government stocks. It was being delivered to clinics as needed.

Senator ROBERTS: Thank you. Did you enforce your mandate on your colleagues, your employees? Did you enforce it? Did you sack anyone or refuse to pay anyone who refused to take the injection?

Dr Thiru: We aligned with the public health guidance. We permitted accommodations or exemptions for people who had specific medical or religious reasons that they did not or could not be vaccinated. A small number of colleagues departed the company.

Senator ROBERTS: Thank you. Does your contract with the government for the supply of COVID injections include a clause that negates your indemnity in the event of Pfizer committing a crime such as fraudulent treatment of trial data?

Dr Thiru: Pfizer always abides by all of the laws and regulations of the markets in which it operates. It abides by the highest standards for clinical trials and all its operations.

Senator ROBERTS: Does your contract with the government for supply of COVID injections include a clause that negates your indemnity in the event of Pfizer committing a crime such as fraudulent treatment of trial data?

Dr Thiru: I hadn't—

Senator ROBERTS: The question is simple. What is the answer? Yes or no?

Dr Thiru: As I have mentioned previously, the contents of Pfizer's contract with the Australian government remains confidential. I don't have any information that I can provide to the committee in relation to that.

Senator ROBERTS: Is it true that Pfizer COVID-19 vaccines were developed initially as countermeasures for the American Department of Defense?

Dr Thiru: Our sole focus from the start of this pandemic has been to discover, develop and supply a safe and effective vaccine—

Senator ROBERTS: I didn't ask you about your focus. I asked you whether it is true that Pfizer's COVID-19 injections of vaccines were developed initially as countermeasures for the American Department of Defense, as experts have told us. Is it true?

Dr Thiru: The vaccine was developed to address the dire global public health emergency that became rapidly apparent in the early part of 2020. That was the only reason for which the Pfizer vaccine was developed. We're very proud of the role that the Pfizer vaccine has demonstrated clearly in protecting the health of hundreds of millions of people around the world and enabling countries, borders and societies—

Senator ROBERTS: There you go again—another appeal to authority, another appeal to consensus and an appeal to numbers. That's not what I asked. Have you had any association during the development of these vaccines with the Department of Defense?

CHAIR: Just before you answer that, Dr Thiru, there is a follow-up question after this answer.

Dr Thiru: I have no information on that. I'm happy to take it on notice. Let me confirm again that the sole purpose of developing the vaccine was to protect global public health.

Senator ROBERTS: Isn't it true that many standard steps and procedures otherwise required before receiving approval for use were omitted or circumvented entirely to achieve this accelerated time period of development that you talked about of 12 months?

Dr Hewitt: The evidence that was gathered and presented not just to the Therapeutic Goods Administration but to regulators worldwide was thorough and comprehensive. It was assessed by those regulators, who made independent decisions on the benefit-risk profile of the vaccine.

Senator ROBERTS: I notice that you have repeatedly transferred the responsibility for these injections to the TGA. Repeatedly you've done that. Did Pfizer research the long-term effects and risk profile of its COVID-19 vaccine prior to release? Long-term?

Dr Hewitt: Again, as part of an application to any regulatory authority, the data that we gather and present are used to determine whether or not the regulatory authority feels that the medicinal product may be licensed and supplied to patients.

Senator ROBERTS: Again, you have failed to answer my question. You are shifting responsibility to the TGA. I will be asking the TGA.

CHAIR: If there's another answer to that, please proceed. I don't think there was a question in that. If there are further questions, you can give them on notice. I know that Senator Payman said that she will put her questions on notice in light of the time. I know there is a quick follow-up question from Senator Antic.

Senator ANTIC: You can take this on notice if you would like. I remind you that providing correct evidence to the Australian Senate is critical. I want to know whether or not Pfizer had any communications with any Australian government department or social media company in relation to the censorship of Australians' social media posts.

Dr Thiru: Senator, I have no information in relation to your question.

Senator ANTIC: You may not, but I would like you to take that on notice.

Dr Thiru: We will take it on notice and come back to the committee with any information of relevance that we can provide.

Senator ANTIC: Thank you.

CHAIR: Thanks very much. Dr Thiru and Dr Hewitt, thank you for—

Senator CANAVAN: I have one more question.

CHAIR: If it's a quick follow-up.

Senator CANAVAN: Very quickly. I want to ask a quick question about the Doherty modelling, which was crucial in convincing Australian governments to impose mandates in late 2021. In that modelling—I'm sure you are familiar with the Doherty modelling—they concluded:

High vaccine coverage can reduce transmission and health impacts in urban and remote communities.

Was Pfizer consulted by any of the modellers that compiled the Doherty modelling report for the Australian national cabinet?

Dr Hewitt: I can't answer that question. I will need to take that on notice.

Senator CANAVAN: Take that on notice. In particular, can you take on notice whether you provided any advice to Doherty modelers around the effectiveness of your vaccine in reducing transmission?

Dr Hewitt: Noted.

Senator CANAVAN: Thank you. Thank you, Chair.

CHAIR: Thanks very much. Thank you for joining us this evening and having a robust engagement. If you have taken any questions on notice, please return the answers to the secretariat by 17 August 2023. Have a good evening. Thank you.

Dr Hewitt: Thank you, Senator.

Dr Thiru: Thank you, Senators.
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