by Maryanne Demasi, PhD

In December 2020, the US FDA authorised the Moderna and Pfizer mRNA covid-19 vaccines, claiming “the benefits outweighed the harms.”

Now, a group of international researchers has gone back to re-analyse the original trial data upon which that claim was made. 

A valid claim?

A pre-print study (not yet peer-reviewed) by Fraiman and colleagues contradicts the FDA’s claim that the benefits outweigh the harms of the mRNA vaccines.

In fact, the authors conclude that the vaccines are associated with an “increased risk of serious adverse events” that surpass the “risk reduction for covid-19 hospitalisation” relative to the placebo group.

The conclusion is provocative. While some have criticised the study for fuelling ‘anti-vax’ sentiment, many have welcomed the independent scrutiny of the trial data.

The researchers focused on analysing serious adverse events -- specifically, they narrowed it to serious adverse events of "special interest" which were derived from a predefined list by the Brighton Collaboration, an established framework for vaccine safety used for over two decades.

The advantage of this method is that it removes adverse events that are unlikely to be vaccine-related such as gunshot wounds and car accidents, thereby removing ‘noise’ from the analysis.

They also pooled the trial data for the two mRNA vaccines which increased the sample size and achieved higher confidence in the results (more precision). 

The upshot of the analysis was that mRNA vaccines were associated with an absolute risk increase of serious adverse events of 12.5 per 10,000 vaccinated people (95% CI 2.1 to 22.9) over placebo.

Put another way, 1 in 800 people experienced a serious adverse event following either one of the mRNA vaccines (95% CI: 437 to 4762).

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