CDC Admits It Never Monitored VAERS for COVID Vaccine Safety Signals
by Josh Guetzkow, Ph.D., Childrens Health Defense:
In response to a Freedom of Information Request submitted by Children’s Health Defense, the Centers for Disease Control and Prevention last week admitted it never analyzed the Vaccine Adverse Event Reporting System for safety signals for COVID-19 vaccines.
In a stunning development, the Centers for Disease Control and Prevention (CDC) last week admitted — despite assurances to the contrary — the agency never analyzed the Vaccine Adverse Event Reporting System (VAERS) for safety signals for COVID-19 vaccines.
The admission was revealed in response to a Freedom of Information Act (FOIA) request submitted by Children’s Health Defense (CHD).
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In September 2021, I published an article in The Defender in which I used the CDC’s published methodology to analyze VAERS for safety signals from COVID-19 vaccines.
The signals were loud and clear, leading me to wonder “why is nobody listening?”
Instead, I should have asked, “Is anybody even looking for them?”
After that article was published, I urged CHD’s legal team to submit a FOIA request to the CDC about its VAERS monitoring activities.
Since CDC officials stated publicly that “COVID-19 vaccine safety monitoring is the most robust in U.S. history,” I had assumed that at the very least, CDC officials were monitoring VAERS using the methods they described in a briefing document posted on the CDC website in January 2021 (and updated in February 2022, with minor changes).
I was wrong.
The lynchpin of their safety monitoring was to mine VAERS data for safety signals by calculating what are known as proportional reporting ratios (PRR’s).
This is a method of comparing the proportion of different types of adverse events reported for a new vaccine to the proportion of those events reported for an older, established vaccine.
If the new vaccine shows a significantly higher reporting rate of a particular adverse event relative to the old one, it counts as a safety signal that should then trigger a more thorough investigation.
The briefing document states, “CDC will perform PRR data mining on a weekly basis or as needed.”
And yet, in the agency’s response to the FOIA request, it wrote that “no PRRs were conducted by CDC. Furthermore, data mining is outside of the agency’s purview.”
The agency suggested contacting the U.S. Food and Drug Administration (FDA), which was supposed to perform a different type of data mining, according to the briefing document.
CDC officials repeatedly claimed they have not seen safety signals in VAERS.
For example, on April 27, 2021, CDC Director Dr. Rochelle Walensky stated the CDC did not see any signals related to heart inflammation.
But a PRR calculation I did using the number of myo/pericarditis reports listed in the first table produced by the CDC obtained via the FOIA request reveals clear and unambiguous safety signals relative to the comparator vaccines mentioned in the briefing document (i.e., flu vaccines, FLUAD and Shingrix).
The table is dated April 2, 2021, almost four weeks before she made those remarks.
In fact, among the 15 adverse events for adults included in that week’s tabulations, PRRs I calculated also show loud-and-clear safety signals for acute myocardial infarction, anaphylaxis, appendicitis, Bell’s palsy, coagulopathy, multisystem inflammatory syndrome in adults (MIS-A), stroke and death.
The actual monitoring the CDC did diverges from the one promised in the briefing document in other ways.
For example, the CDC never created tables of the top 25 adverse events reported in the previous week, tables comparing different vaccine manufacturers, or tables of auto-immune diseases.