On Wednesday, Moderna executives Dr. Jane Leong, Vice President, Medical Affairs, Dr. Chris Clarke, Director, Scientific Leadership, and Dr. Rachel Dawson, Executive Director, Medical Affairs – Respiratory Vaccines faced intense scrutiny during their appearance before the Australian Senate’s ‘Education and Employment Legislation Committee.’
Leading the scrutiny was Senator Alex Antic, who took particular issue with the reported adverse effects of the pharmaceutical company’s experimental COVID-19 vaccines.
Citing a study from the leading publisher of some of the most well-respected science journals in the world, Elsevier, Senator Antic claimed serious adverse reactions to Moderna’s vaccine were occurring at a rate of 1 in 800 vaccinated individuals.
He then questioned Dr. Clarke on whether Moderna acknowledges this rate and how it compares to the reaction rates of traditional vaccines like those for influenza.
“Now, according to your own clinical trial data, do you accept that that is the rate? And if not, how does your overall rate of serious adverse events compare with routine traditional vaccine products such as flu vaccines and the like?” Sen. Antic asked.
Dr. Clarke admitted to being unaware of the referenced study, which led to an escalation in the senator’s questioning. Antic emphasized the importance of Moderna’s awareness of such studies, expressing his disbelief that the executives did not seem informed of such a significant report.
“So I’m not aware of the report to which you’re referring,” said Dr. Clarke.
“This is the report of a prominent medical journal. You’re not aware of that?… Do you think you should be aware of that?” Sen. Antic asked.
“The frustration of this process, is if you were here, we could provide you with that. But I mean, this has been widely reported. You are a manufacturer of vaccines. I find it difficult to think that you wouldn’t be aware of this report,” Antic added.
While Dr. Clarke assured that Moderna performs routine screenings of scientific literature for adverse event reports as part of their pharmacovigilance activities, he did not provide specific rates of adverse reactions to Moderna’s vaccine.
This lack of information sparked criticism from Senator Antic, who deemed it “extraordinary” that Moderna’s representative could not provide these crucial statistics during a Senate hearing.
“One thing I can say is that as a company we have as part of our pharmacovigilance activities, we do routine screens of the literature to look particularly for publications that include adverse events. We do review those publications and those adverse events and we do include them into our global pharmacovigilance database,” said Clarke.
“So what is Moderna’s overall rate of serious adverse events and how does that compare with routine vaccinations,” Antic asked.
“I don’t have the actual rate of adverse events,” Clarke responded.
“You don’t have the rates of adverse events in front of you?” Antic asked.
“What I can tell you is that the rates of serious adverse events in our very large randomised controlled trials was actually in a similar range to what was observed in the placebo,” said Clarke.
“You can’t tell me the rates of serious adverse events. You realize you’ve come to a Senate hearing today for the purposes of exactly that question and you can’t tell me the rates of serious adverse reactions to your product, which I find extraordinary,” said a visibly upset Sen. Antic.
Despite the lack of specific rates, Dr. Clarke pointed to the Therapeutic Goods Administration (TGA) website, which he said reports 1.2 million adverse event reports.
“Not asking about the TGA, I’m asking about Moderna. You must have that information. You are a multinational company, you’re before a Senate inquiry and you cannot tell me the rates of serious advert. I mean, that’s quite extraordinary what you’re telling me,” said Antic.
The senator asked the other executives if they can provide it but he just received silence. Dr. Clarke assured the committee that the information could be provided later and reiterated that their clinical trials showed no significant safety concerns.
The tense interaction ended with Senator Antic suggesting that the committee was wasting its time, as he expected more precise information from Moderna’s representatives.
In a Twitter post, Sen. Antic wrote, “During last night’s Senate hearing into our COVID 19 Vaccine Discrimination Bill representatives from Moderna couldn’t provide the numbers of serious adverse reactions from their COVID mRNA injection. I was so stunned I literally dropped my pen!”
During last night’s Senate hearing into our COVID 19 Vaccine Discrimination Bill representatives from Moderna couldn’t provide the numbers of serious adverse reactions from their COVID mRNA injection.
I was so stunned I literally dropped my pen!
Watch below: pic.twitter.com/P4COBxWk7w
— Senator Alex Antic (@SenatorAntic) August 4, 2023