Serious adverse events from Pfizer's mRNA vaccine are not "rare"

Despite repeatedly claiming that serious harms of Pfizer’s mRNA vaccine are RARE, an investigation found no drug regulator could quantify the rate. Experts say it's "hypocritical."

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 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 conceded 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.”

Joe Fraiman, emergency doctor, New Orleans, Louisiana

Fraiman said it’s hypocritical for health agencies to tell people that serious harms of the covid vaccines are rare, when they have not even determined the SAE rate themselves.

“It’s very dangerous not to be honest with the public,” said Fraiman, who recently called for the mRNA vaccines to be suspended.

“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,” added Fraiman.

Dick Bijl, a physician and epidemiologist based in the Netherlands, agreed.  “It goes to show how corrupted these agencies are. There is no transparency, especially since regulators are largely funded by the drug industry.”

Dick Bijl, physician and past President of the International Society of Drug Bulletins

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.”

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,” said Bijl.

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