One of the Pfizer documents that has garnered a lot of interest carries the title “Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-Feb-2021”. The file is called 5.3.6-postmarketing-experience for those that want to follow along. In this document, there is an appendix that contains nine pages of “adverse events of special interest”. The sheer number of listed events was enough for many to label this document a “smoking gun”. Is it the bombshell it was made out to be? Let’s go to the document to find out. One final note, this report was intended to be confidential which makes its findings more credible in my opinion.
Introduction
The first relevant thing to note is that the Pfizer vaccine is classified as a class of drug known as a Biologic. In fact, all vaccines fall into this broad category along with many other drugs. From the FDA website: “Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.” Another COVID-related treatment, monoclonal antibodies, would also fall into this category. I note this only to prevent confusion.
This document was prepared at the request of the FDA as a supplement to previous monthly reports. Basically, FDA asked Pfizer for a comprehensive report of reported adverse events and they also wanted to know the plans Pfizer had to continue monitoring for adverse events moving forward.
Methods
The first thing to note is which adverse events they are looking at. In their assessment, they are looking at everything reported to Pfizer, reported to public health authorities (i.e. the Vaccine Adverse Event Reporting System, VAERS), published in the literature, or reported as part of the clinical trial. The note that they include all reported events regardless of whether they were judged to be related to the vaccine. To their credit, they note that because adverse event reporting is voluntary there is no way to know the rate of underreporting. Voluntary reporting systems are useful in detecting disease signals but comparisons between agents, even between vaccines, are difficult. For example, clinicians may be more vigilant for adverse events related to the COVID vaccines because they are new and weren’t yet fully approved. On the flip side, the politicization of the vaccines may lead to decreased reporting in some clinicians due to a lack of belief that an event could be connected to a recent vaccine administration. These factors are why numerical adverse event comparisons to other vaccines such as the yearly flu vaccines are likely flawed.
Moving on, the report notes that reported adverse events may not be related to the vaccine but instead to other factors. This is why it is so important to do a longer randomized trial than was performed. Only by comparing a random group who got the vaccine to those that got a placebo can you see if certain events are more common in the vaccine group. This comparison was lost after EUA approval because the groups were told what they received, and the placebo group was able to get vaccinated.
Finally, the report notes that due to the volume of adverse event reports they are not able to process all of them each month. Pfizer notes that they rapidly process serious events but that those viewed as non-serious may be delayed up to 90 days. There are objective measures used to classify an event as “serious” including but not limited to: an event that requires hospitalization, an event that results in disability, death, etc. They noted that they are hiring people to handle the high volume of reported events.
Results
In the first 3 months, there were 42,086 reports (60% reported by healthcare professionals) involving 158,893 events. This reveals that most of the reports likely involved more than 1 adverse event per patient. This isn’t surprising given that even “flu-like symptoms” is a collection of symptoms that can include fever, muscle aches, headache, nausea, vomiting, malaise, etc. Each of these would be reported as its own adverse event. In the table at the top of page 7, the most important section is the outcomes section. In this, you can see that 1,223 of the events were fatal and that of those that recovered, 520 had residual symptoms. There is a huge number of unknowns in this category which is surprising given that case outcomes are a key part of adverse event reporting. I suspect that these may largely be events reported by non-medical professionals as those individuals may not realize which parts of the reporting are important.
Figure 1 shows you which organ systems were affected by both serious and non-serious adverse events. By far the largest number is in “general disorders” which would include things like fatigue. It also appears that this grouping includes reactions at the site of vaccination based on the table description on the preceding page.
Table 2 gives you a more specific breakdown of symptoms reported in >2 percent of cases. These are generally what would fall under “flu-like symptoms”. I’ll provide a few definitions: pyrexia = fever, asthenia=global weakness/lack of energy, hypoesthesia=numbness, dyspnea=shortness of breath, pruritis=itching, and urticaria=hives. One interesting reported adverse event is COVID-19, which just goes to show that not all of the reported adverse events can be directly related to the vaccine as there is no way that the vaccine itself could directly cause COVID-19.
Table 3, to me, is the most important so far. In this table, they note the known risk of anaphylaxis (a serious allergic reaction) which is a risk with almost everything people are exposed to. Then they note that there is a potential risk that the vaccine could make the disease resulting from infection with the SARS-CoV-2 virus worse. This was one of the concerns that many expressed based on experience with prior SARS outbreaks. Thankfully that has not proven to be a problem as of now. The final section is where I find the most issues. They note that they do not know the risks with pregnancy or lactation, safety in kids <12, or overall effectiveness (see my discussion of the Pfizer vaccine paper for the difference between effectiveness and efficacy). These 3 things were known to public health officials and despite that knowledge, they said the vaccines were both safe and effective. There was no equivocating. There was no “to the best of our knowledge”. Public health officials had a duty to provide clear and accurate information to the public regarding what was and wasn’t known. In my opinion, they failed.
Tables 4-6 go through the reported cases relating to table 3. The pregnancy table is interesting but without knowing how many pregnant women received a vaccination, there is no way of knowing if the rate of miscarriage is higher than what would be expected.
Now we get to the parts that garnered so much attention. Table 7 relates to the 9-page appendix of “Adverse Events of Special Interest”. This table actually gives you the details regarding each grouping of adverse events including the ages of those affected, who reported them, severity, and the number of specific events. At the bottom of each section, there is a note as to whether the listed events raised new safety concerns. The one that caught my eye was related to facial paralysis (such as Bell’s Palsy). They note that an analysis of the risk of Bell’s Palsy will occur once the primary study is unblinded in April 2021.
Discussion/Summary and Conclusion
The report finishes by restating the pharmacovigilance process. They note that they did not uncover any new risks in this analysis that weren’t previously known. The authors conclude that the data continues to show a favorable risk/benefit analysis for the Pfizer vaccine. I think that globally they were correct in this. The problem is that public health officials stated that this was true for essentially everyone, with rare exceptions. The problem is that nowhere is there a consideration of baseline risk of serious infection in the individual.
Appendix
The appendix of this report is what got a lot of attention. It is 9 pages of scary-sounding medical diagnoses. Is it a smoking gun? I don’t think so. If you look at any pharmacovigilance document or any full application for FDA approval you will see a long list of scary reported side effects. This list is no different. Essentially, it is anything that a person suffered from or was diagnosed with after receiving the Pfizer vaccine. Some of these things were without a doubt caused by the vaccine but most of them probably weren’t.
My Conclusions
This release got a ton of attention and with good reason. Seeing a list of adverse events that long is jarring. However, if you know anything about how these things are reported and documented, you will realize that it is not a surprise. Pointing this out has not been popular with some. I was even blocked by one prominent libertarian podcaster over it (my decision to use the word “ignorant” may have contributed to that decision).
This vaccine is remarkable in the number of VAERS reports entered. However, it is also remarkable the number of doses that were administered in a short period of time. The questions regarding efficacy proved to be prescient, as we see it wane more rapidly with each booster dose and new variant.
I do think that the awareness of data like this is useful. Adverse event documents exist for many of the drugs people take, even those available over the counter. There is no such thing as a perfectly safe medication. I am glad that many are waking up to that fact.