Peer Reviewed: Vaccine trial data shows a negative benefit to harm ratio

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.

To find this data, investigators used four months of trial data submitted to regulators before the vaccines were put on the market. They gathered the data from journals, and data published by both Health Canada and the FDA. They created a blinded table of serious adverse events recorded in each trial and then had blinded investigators go through that table and determine if those serious adverse events were actually “AESIs”, which I defined above.

Headlines are never easy to write, but the core finding of this paper is important and needs to be clearly understood. Obfuscation and editorialisation will start bubbling up immediately, so I think it’s important to be clear about what the findings of the paper suggest; trial data showed that mRNA vaccines appear to have a negative benefit/harm ratio. The limitations of the paper are worth reading in full, but a quick summary would be that we need patient-level data to create a clearer picture of the benefit/harm comparisons. The limitations “can lead to bias both directions, further complicating interpretation.”

The paper was published in volume 40, issue 35 of the Vaccine journal, with an impact score of 4.1, and an acceptance rate of 32%. One of the authors of the paper is Peter Doshi, an associate editor of the British Medical Journal. A little over a month ago, he put his name to a pre-print of the paper, which I reported on, suggesting it would never find its way through peer review, and yet here we are. The reason I think Doshi is important is that it’s not easy (though it should be) for people in his position to put their heads above the parapet on this issue. Courage is contagious.

Other key findings from the paper:

• There was a 16% higher risk of serious adverse events in mRNA vaccine recipients than in placebo recipients

• There was a 43% higher risk of serious adverse events of special interest in mRNA vaccine recipients

• mRNA vaccines are associated with more harm than initially estimated at the time of emergency authorization.

• Authors call for a formal risk-benefit analysis of the mRNA vaccines to take place

• The authors suggest that we’ll need trial participant data in order to complete this task

• Authors encourage third-party replication of their study, with access to complete SAE case narratives.

• The risks may be substantially less in some groups compared to others. Thus, knowing the actual demographics of those who experienced an increase in serious AESI in the vaccine group is necessary for a proper harm-benefit analysis

Comments are open. For the record, I absolutely hate having to write this. I am just of the view that if independents don’t try to kindle a discussion, it will simply never happen. As ever, comments, shares, and subscriptions all help to keep the Digger going.

UPDATE:
Clarified the definition of AESI