Put simply, both the Moderna and the Pfizer vaccine trial data appeared to have a negative benefit/harm ratio. I suspected that such a finding wouldn’t find its way into a peer-reviewed journal, but as of yesterday, that’s exactly what happened. Below is one of the key findings from the paper.
Quick jargon translation, an AESI is an ‘adverse event of special interest’, which comes from a “priority list of potential adverse events of special interest relevant to COVID-19 vaccine trials.” More simply, they are serious adverse events which we should be paying very close attention to with regard to the Covid-19 vaccines.
Serious Adverse Events are defined as “death; life-threatening at the time of the event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgment.”
In the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (6.4 per 10,000 participants).
In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (2.3 per 10,000 participants).
It’s worth reading that twice. A discussion won’t happen unless we break the ice, so please do share this post. If you disagree with the paper’s findings, now’s the time to publicly show why their methods and data are incorrect.
https://philharper.substack.com/p/peer-reviewed-vaccine-trial-data