There has been a bit of a stir lately concerning the posting at the beginning of this month of a pre-print (not yet peer reviewed) article entitled “Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials”.
Words like “bombshell study” have been used to describe the findings. That sounds pretty significant, and certainly got my attention. With BMJ Senior Editor Dr. Peter Doshi as the senior author, could be! Dr. Doshi has a well earned reputation for telling inconvenient truths. So, let’s take a look.
Here are the headline results from the abstract:
Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8), respectively.
Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9).
The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).
And the abstract discussion section:
“The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes such as hospitalization or death.”
The headlines look pretty serious at first glance. But the discussion section should alert us that the authors are being cautious. The authors are not signaling “pants on fire” findings.
What is really going on here? To understand this, a good place to start is this wonderfully clear and accurate summary of the initial Pfizer trial results from the Canadian COVID Care Alliance (posting which is apparently the sin that got me kicked off of Twitter and Linked-In last December, resulting in my becoming disconnected from about 600,000 followers).
You can also find a PDF summary of this analysis and findings here.
The bottom line is that the Pfizer Phase 3 trial which was used by NIAID, FDA and CDC to justify the emergency use authorization is pretty much a junk clinical trial which was inappropriately halted long before it even got close to meeting the intended follow up period, did not provide a sufficiently long follow up analysis of vaccination-associated adverse events, and in which the control group was intentionally eliminated. This resulted in basically erasing any opportunity to ever get to the bottom of what the major true risks of the Pfizer mRNA inoculations were. In terms of more minor risks, the study was not powered (not big enough) to evaluate those.
Into the breach, an intrepid group of (mostly) senior academic researchers have stepped forward. The expression “fools rush in where angels fear to tread” comes to mind, in that it has become extremely risky for any academic to question the approved vaccine narrative. But bravely this decidedly un-foolish group has stepped forward.
To my reading, the approach that they have taken with this analysis and report has been to make a good faith effort to perform the analysis of the Phase 3 clinical trials (those are supposed to be the “big, final” clinical trials prior to licensure of a product) which should have been performed by Moderna and Pfizer. Basically, the analysis that the FDA should have done themselves, and also should have forced Moderna and Pfizer to do. If White House Chief of Staff Mark Meadows had not put pressure on the FDA, perhaps it would have done the right thing. But it apparently caved and did not do it’s job, and here we are.
Herein lies the rub. The FDA not only did not do its job, but neither FDA nor Moderna nor Pfizer will release the primary data, which means that no-one else can do it either. As the authors of this recent analysis note in their discussion:
A systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups. Full transparency of the COVID-19 vaccine clinical trial data is needed to properly evaluate these questions. Unfortunately, well over a year after widespread use of COVID-19 vaccines, participant level data remain inaccessible.
Doshi and colleagues have repeatedly called for full disclosure in two prior publications, to no avail. So unless the data are included in the court mandated data release, the analysis which they perform in the current pre-print report may be as good as we are going to get. For further on this, please see
Tanveer S, Rowhani-Farid A, Hong K, Jefferson T, Doshi P. Transparency of COVID-19 vaccine trials: decisions without data. BMJ Evid Based Med [Internet]. 2021 Aug 9
Doshi P, Godlee F, Abbasi K. Covid-19 vaccines and treatments: we must have raw data, now. BMJ [Internet]. 2022 Jan 19;376:o102.
As Dr. Doshi and colleagues appropriately note,
“In 2013, the US and European industry trade organisations endorsed a joint statement on clinical trial data sharing, making a series of commitments that ‘recognise the importance of sharing clinical trial data in the interest of patients, healthcare and the economy”6 In 2015, the US Institute of Medicine similarly endorsed benefits of sharing clinical trial data, emphasising that ‘verification and replication of investigators’ claims’ were essential to the scientific process, and noting the numerous benefits to stakeholders ‘including payers of healthcare as well as patients, their physicians and researchers.’”
But if wishes were horses, beggars would ride. Pfizer and Moderna and the FDA clearly have no intention of heeding the pleas of the Senior Editor of the British Medical Journal, unless forced to do so by the US courts, and even then they will drag their heels for as long as possible. I can’t imagine why <sarcasm>.