COMMONWEALTH OF AUSTRALIA

SENATE

EDUCATION AND EMPLOYMENT LEGISLATION COMMITTEE

These hearings have been the subject of worldwide news and and so we bring you these edited highlights. For those who have followed it, they mark an historic turning point in the debate.

This is the questioning from Queensland Senator Gerard Rennick.

There were two representatives from Pfizer.

HEWITT, Dr Brian, Head of Regulatory Sciences, Pfizer Australia [by video link]
THIRU, Dr Krishan, Country Medical Director, Pfizer Australia [by video link]

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.

Highly Effective

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 Tcells 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.

Studies Conducted on Rats

Senator RENNICK: 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 Therapeutic Goods Administration 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.

Myocarditis and Pericarditis

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 temporarily
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.