But there has been very little scrutiny of that claim by the media, and I couldn’t find an instance where international agencies actually quantified what they meant by the term “rare” or provided a scientific source.
The authors, Joseph Fraiman et al., found that serious adverse events (SAE)—i.e., adverse events that require hospitalization—were elevated in the vaccine arm by an alarming rate—1 additional SAE for every 556 people vaccinated with Pfizer’s mRNA vaccine.
Therefore, I asked eight drug regulators and public health agencies to answer a simple question: What’s the official calculated rate of SAEs believed to be caused by Pfizer’s mRNA vaccine, and what’s the evidence?
What Is the Official SAE Rate?
Not a single agency could cite the SAE rate of Pfizer’s vaccine. Most directed me to pharmacovigilance data, which they all emphasized doesn’t establish causation.The Australian TGA, for example, referred me to the spontaneous reporting system but warned, “It is not possible to meaningfully use these data to calculate the true incidence of adverse events due to the limitations of spontaneous reporting systems.”
Both the German regulator (PEI) and European CDC referred me to the European Medicines Agency (EMA) which, according to its own report, saw no increase at all in SAEs.
“SAEs occurred at a low frequency in both vaccinated and the placebo group at 0.6 percent,” the EMA stated.
The UK regulator MHRA went so far as to state that it “does not make estimations of a serious adverse event (SAE) rate, or a rate for adverse reactions considered to be causally related for any medicinal product.”
The U.S. FDA, on the other hand, conceded that SAEs after mRNA vaccination have “indeed been higher than that of influenza vaccines” but suggested that it was justified because “the severity and impact of covid-19 on public health have been significantly higher than those of seasonal influenza.”
Expert Response
In response to the criticism, Fraiman, an emergency doctor and lead author on the reanalysis said, “To be honest, I’m not that surprised that agencies have not determined the rate of SAEs. Once these agencies approve a drug, there’s no incentive for them to monitor harms.”He said it’s hypocritical for health agencies to tell people that serious harms of the COVID-19 vaccines are rare when they haven’t even determined the SAE rate themselves.
“These noble lies may get people vaccinated in the short term, but you’re creating decades or generations of distrust when it’s revealed that they have been misleading the public.”
Dick Bijl, a physician and epidemiologist based in the Netherlands, agreed.
“It goes to show how corrupted these agencies are,“ he said. ”There is no transparency, especially since regulators are largely funded by the drug industry.”
Bijl said it’s vital to know the rate of SAEs for the vaccines.
“You must be able to do a harm-benefit analysis, to allow people to give fully informed consent, especially in young people at low risk of serious COVID or those who have natural immunity,” he said.
Bijl said the mainstream media has allowed these agencies to make false claims about the safety of vaccines without interrogating the facts.
“The rise of alternative media is strongly related to the lies being told by the legacy media, which just repeats government narratives and industry marketing. In the Netherlands, there is a lot of discussion about the distrust in public messaging,” he said.
