The public deserves a complete and transparent accounting of the Centers for Disease Control and Prevention’s safety monitoring, including the results of all interim reports and analyses, whether through an Freedom of Information Act request, Congressional order or some other means.
- There is a disproportionately large number of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from COVID-19 vaccines compared with other vaccines.
- There are 91x the number of deaths and 276x the number of coagulopathyevents reported after COVID-19 vaccination than after flu vaccination.
- Safety signals were found for 242 adverse events using the Centers for Disease Control and Prevention’s (CDC) methodology.
- Full transparency of CDC and U.S. Food and Drug Administration (FDA) safety monitoring is urgently needed.
On Aug. 30, the CDC Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer/BioNTech’s mRNA COVID-19 vaccine for people 16 years and older.
In comments I submitted to the committee along with my collaborators, we provided evidence of large safety signals from VAERS, using published CDC methods to analyze the data.
In this article, I describe the safety signals highlighted in our comments, which raise pressing questions about the CDC’s and FDA’s COVID vaccine safety monitoring efforts.
To begin with, there has been an unprecedented increase in the number of adverse event reports to VAERS associated with COVID-19 vaccines. The chart below shows the number of deaths for all other vaccines reported to VAERS annually since the system’s inception in 1990, compared to deaths reported for COVID-19 vaccines, from both domestic and foreign sources.
As of early September, there have been 14,506 deaths reported to VAERS for COVID-19 vaccines, compared to 8,673 for the preceding 30 years for all other vaccines. That is already more than 50 times the annual average — and we still have four months left to go until the end of the year.
It is hard to imagine how anyone can look at these numbers and not be at least a little bit concerned. Yet many people are dismissive, saying the unprecedented number of reports is due to the unprecedented number of vaccinations being administered.
I crunched the numbers, and even after taking into account the total number of vaccinations, the number of reports for COVID vaccines still towers over previous years.
See, for example, Figure 2 below, which shows the number of deaths reported per million vaccine doses from 2010-2020 and for COVID-19 vaccines. That’s nearly 40 deaths reported per million COVID vaccines versus an average of 1.6 for all other vaccines from the previous 10 years.
No matter what I did to the data, or what types of adverse events I looked at, I could not make the big jump in COVID vaccine reports go away.
So why do the CDC and FDA not seem to be concerned about this? I don’t know, but to try to answer that question, we have to take a step back to talk about VAERS and how the CDC uses it to detect safety signals.
VAERS, which is jointly administered by the CDC and FDA, is typical of all reporting systems used to monitor the safety of medicinal products. Although widely used, there are many known limitationswith this type of system. Probably the biggest is that it is passive or spontaneous, meaning it relies on the willingness of people and medical professionals to “spontaneously” submit reports. So reporting rates are low and inconsistent.