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Last week during an Australian Senate committee hearing, Pfizer and Moderna executives were grilled under oath about covid-19 vaccine policies and vaccine safety.
Tensions were high during the public hearing, which was live-streamed via the parliamentary website.
Senators fired questions at Pfizer and Moderna executives who responded by dodging questions and refusing to take accountability for their failures.
To complicate matters, the drug company executives did not attend the hearing in-person, only via video link allowing them to plead ignorance about the studies that were presented during the inquiry.
At the commencement, the Chair warned the witnesses against giving “false or misleading evidence” and after opening statements by Pfizer and Moderna, the floor was opened to questions.
Stopping transmission
Senator Matt Canavan began question time and was laser-focused on the issue of viral transmission.
“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,” asked Canavan pointedly.
Pfizer Australia’s medical director Krishan Thiru was evasive.
“To bring this vaccine to patients we were required to show that the vaccine was safe and effective…The primary purpose of vaccination was, and remains, to protect the person who received the vaccine,” said Thiru.
Canavan reminded him that Pfizer’s own CEO Anthony Bourla told a reporter on NBC news on Dec 3, 2020, that it was “not certain” if vaccinated people could catch and spread the virus, but Thiru kept repeating the mantra, “the vaccine is safe and effective.”
Canavan persisted, citing Pfizer’s official tweet on Jan 14, 2023, stating its highest priority was its “ability to vaccinate at speed to gain herd immunity and stop transmission,” and then on June 8, 2021, Bourla tweeted, “the vaccine was a critical tool to help stop transmission.”
“What evidence did Pfizer have to make that public statement to imply that vaccination could stop transmission?” asked Canavan.
Thiru pleaded ignorance saying he was not familiar with the context of the tweets and took the question on notice (to respond later in writing).
Canavan explained that federal and state governments had imposed vaccine mandates based on the evidence and advice from the manufacturers that claimed the vaccines could “stop the spread.”
Canavan also pointed to the Doherty Modelling report submitted to national cabinet in Nov 2021 that underpinned the government’s decision to impose mandates in late 2021, but again, Pfizer could not confirm whether it was consulted about the modelling.
Hewitt said, “I can’t answer that question” and took it on notice.
Moderna Executive Director of Medical Affairs for Respiratory Vaccines Rachel Dawson, said that in the phase III pivotal trials of 2020, its mRNA vaccine showed that it could reduce symptomatic infection, and that it could “make an important contribution to reducing viral transmission.”
Dawson cited real world data demonstrating that the spread of the virus was reduced in households among vaccinated individuals and that they had a “lower viral load.”
But to this day, the US regulator says the ability of Moderna’s mRNA vaccine to reduce transmission remains unproven. “While it is hoped this will be the case, the scientific community does not yet know if Spikevax will reduce such transmission,” states the FDA.
Canavan said Moderna’s evidence, “just doesn’t seem to stack up”.
“Politicians told us it will stop the spread. Clearly that hasn’t happened. Do you have a simple explanation for why very high rates of vaccination, higher than anyone expected (90%) in this country, has clearly not stopped the spread of coronavirus,” asked Canavan.
But Moderna avoided the question on transmission, presumably because it would undermine the entire argument that vaccine mandates “keep others safe,” and instead, referred to its scripted statement that “the goal of vaccination is to prevent severe infection in hospitals.”
Preventing infection
Senator Gerard Rennick then proceeded to challenge Pfizer on its claim that the vaccine was “100% effective at preventing covid-19 cases,” a statement that Bourla tweeted on April 2, 2021.
Rennick proceeded to explain why the statement was implausible.
“By September 2022, Australia had recorded 10 million cases of COVID despite having an adult population vaccinated to the tune of 95% so given those real world figures in Australia, do you still stand by that statement?” said Rennick.
But Thiru responded repeatedly, “we strongly believe, and we reiterate, that the vaccine is safe and effective for its intended use” saying that Pfizer’s vaccine remained highly effective prior to the emergence of variants.
When Rennick asked Pfizer for its definition of “highly effective” in terms of duration, Thiru responded saying, “When the wild-type virus was prevalent, efficacy of approximately or greater than 90% was maintained at six months for illness and severe disease.”
But regulatory filings clearly show Pfizer had strong evidence by April 2021 that its vaccine’s efficacy waned, and withheld the data from the public for months.
Claiming that vaccine efficacy was 90% after six months following vaccination is misleading because that figure is largely driven by the first couple months of the trial when there was still a placebo group. Had people stayed in the trial for the whole duration of the 6 months, the average overall, would have been lower.
Lack of studies
Senator Rennick proceeded to read out the TGA’s non-clinical report listing all the safety studies in animals that were not carried out prior to testing in humans.
Despite assurances that “no corners were cut,” there were no carcinogenic tests, genotoxicity tests, immunotoxicity tests, duration studies, interaction studies with other medicines, and the list went on.
Again, Thiru predictably answered, “I don’t have that report in front of me, so I’m afraid I can’t talk to that.”
When Rennick asked directly if any studies were omitted or circumvented entirely to achieve the accelerated time frame for vaccine development, Pfizer objected saying its process was “thorough and comprehensive”.
Safety problems
Senator Rennick asked if Pfizer had determined the mechanism for why its vaccine could cause myocarditis and pericarditis, but Thiru was defiant saying that Pfizer had “strong confidence in the safety profile” of its vaccine.
Rennick would not let up. “I want you to explain to me why it causes myocarditis,’ he asked several times.
Thiru conceded that Pfizer was aware of “very rare” reports of myocarditis and pericarditis temporally associated with vaccination, but could not explain the mechanism, instead opting to take the question on notice again.
Senator Alex Antic challenged Pfizer on the Fraiman re-analysis, which found one additional SAE for every 800 people vaccinated with an mRNA vaccine, but his attempts hit a brick wall.
Senator Pauline Hansen chimed in, noting the Fraiman re-analysis found a “36% 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,” said Hansen.
Again, Thiru pleaded ignorance. “I do not have a copy of your paper. I have not examined it,” he said, “the benefit risk ratio for vaccination remains strongly positive in all indications, all age groups for which it has been approved.”
Senator Hansen became visually frustrated.
“You haven’t read up on all of this, have you?” she said angrily, “You’ve come to this inquiry and 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.”
When it was Moderna’s turn to respond to the Fraiman re-analysis, they too, said they were not aware of it.
Senator Antic asked Moderna what its overall rate of SAEs was for its mRNA vaccine and how that compared to routine vaccination.
But Moderna’s director of Scientific Leadership Chris Clarke said, “I don’t have the actual rates of adverse events,” as he shuffled through the papers on his desk.
Antic was staggered by the response, “You’re before a Senate inquiry and you cannot tell me the rates of serious adverse events? I mean, it’s quite extraordinary.”
Moderna took the question on notice and said that in the clinical trials they “observed no safety concerns.”
Indemnity agreements
Senator Malcolm Roberts asked for details of the indemnity agreement between Pfizer and the Australian government.
Specifically, Roberts asked if there was any clause in the agreement that indemnified Pfizer in the situation where an employee is mandated by their employer to undergo vaccination and then experiences harm.
“Senator, any indemnity agreements between Pfizer and the Australian Government are confidential, and we’re not able to discuss that in this forum,” responded Thiru.
Roberts fired back, “What have you got to hide?”
He also asked if there was any clause in the agreement that negates Pfizer’s indemnity in the event Pfizer is found to have committed fraud in the trial, as alleged by whistle-blower Brook Jackson in 2021.
“My question is simple. What is the answer? Yes or no?” asked Roberts. But Pfizer insisted “the contents of Pfizer’s contract with the Australian Government remains confidential.”
Senator Malcolm Roberts summed up his thoughts.
“You have repeatedly refused to provide evidence and dodged questions from Senators Rennick and Antic. You have relied instead on appeals to authority, and other logical fallacies.”
Covid vaccine in pregnancy
Senator Hansen confronted Pfizer with questions about the safety of its vaccine in pregnant and breastfeeding women.
Thiru did concede that there is limited clinical trial evidence in pregnant women, but said that peak bodies such as the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) supported use of the vaccine.
“[RANZCOG] have said pregnant women in Australia are a priority group for covid-19 vaccination and should be routinely offered the Pfizer vaccine (Comirnaty) or Moderna (Spikevax) vaccines 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.”
Forced vaccination
One of the most egregious moments of the hearing was when Pfizer’s Head of Regulatory Affairs Brian Hewitt, piped up and said no-one in Australia was ever “forced” to be vaccinated.
Senator Hansen took exception to the comment and asked if Hewitt would retract his statement.
Hewitt held his position saying, “No. I believe firmly that nobody was forced to have a vaccine.”
“A lot of Australians will disagree with you on that one,” retorted Senator Hansen.
Senator Matt O’Sullivan was incredulous. He said that in his state of Western Australia, there were mandates across the board, with “very, very few exceptions.”
“If you wanted to go to work, and earn a living and provide for your family, you had to be vaccinated. I am staggered that that was your response to questions in relation to whether or not people were forced to have vaccines,” said O’Sullivan.
Many of O’Sullivan’s constituents had to go without income because the state government was “forcing” them to be vaccinated against their will.
Hewitt looked down to read a pre-prepared answer, much to the dismay of listeners.
“Senator, mandates, and vaccine requirements are determined by governments. As a company we were not involved in any government vaccine mandates. I don’t believe the mandates actually forced individuals to get vaccinated.”
Pfizer did confirm that it enforced a vaccine mandate within its own company and that it had imported a special batch of covid-19 vaccines for its employees. Why the special batch? “So that no vaccine would be taken from government stocks,” said Hewitt.
Thiru also said there were some exemptions for medical or religious reasons and that “a small number of colleagues departed the company,” presumably because they did not comply with the mandate.
Moderna, on the other hand, distanced itself from commenting on vaccine mandates.
Moderna’s Vice President of Medical Affairs Jane Leong said, “We do not have a view on decisions taken by public health agencies or governments in relation to vaccine mandates. This is purely a matter for policymakers.”
At the finish line, Pfizer and Moderna executives managed to expertly dodge questions, they couldn’t recall their own rate of SAEs, they wouldn’t admit that covid vaccines cannot stop transmission, and they refused to divulge details of their indemnity agreements with the government.
Responses to questions on notice are due Aug 17, 2023.
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