Sorry but Serious Harms from the Vaccine are Not Rare
By: Maryanne Demasi
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Drug regulators and public health agencies have saturated the airways with claims that serious harms following covid vaccination are “rare.”
But there has been very little scrutiny of that claim by the media, and I could not find an instance where international agencies actually quantified what they meant by the term “rare” or provided a scientific source.
The best evidence so far has been a study published in one of vaccinology’s most prestigious journals, where independent researchers reanalysed the original trial data for the mRNA vaccines.
The authors, Fraiman et al, found that serious adverse events (SAEs) – i.e. adverse events that require hospitalisation – were elevated in the vaccine arm by an alarming rate – 1 additional SAE for every 556 people vaccinated with Pfizer’s mRNA vaccine.
According to a scale used by drug regulators, SAEs occurring at a rate of 1 in 556 is categorised as “uncommon,” but far more common than what the public has been told.
Therefore, I asked eight drug regulators and public health agencies to answer a simple question: what is the official calculated rate of SAEs believed to be caused by Pfizer’s mRNA vaccine, and what is the evidence?
The agencies were the FDA, TGA, MHRA, HC, PEI, CDC, ECDC and EMA.
The outcome was startling.
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 emphasised does not 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 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%.”
The UK regulator MHRA went so far as to state 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 US FDA, on the other hand, did concede that SAEs after mRNA vaccination have “indeed been higher than that of influenza vaccines,” but suggested it was justified because “the severity and impact of covid-19 on public health have been significantly higher than those of seasonal influenza.”
Despite analysing at the same dataset as Fraiman, the FDA said it “disagrees with the conclusions” of the Fraiman analysis. The agency did not give specifics on the areas of disagreement, nor did it provide its own rate of SAEs.
Expert response
In response to the criticism, Joe Fraiman, 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.”
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1 in 556 SAEs x how many shots? They say the total for all worldwide is 5.5 billion. Is Pfizer 1/3 of them? The numbers of harmed is staggering. The fact that we have heard almost nothing about this is alarming and unacceptable.