New FOIA Release Shows CDC Lied About Its VAERS Safety Monitoring Efforts
They never found any safety signals, because they didn't look for them
Back in September, I published an article in CHD’s The Defender, where I showed the alarming and unambiguous safety signals coming from the Vaccine Adverse Events Reporting System (VAERS), using the CDC’s own published methodology. In that article, I wondered out loud why, if the safety signals were so blaringly obvious, nobody was doing anything. Was anybody listening?
Well, it turns out the CDC wasn’t even looking for safety signals! They said they were going to use the most basic, standard pharmacovigilance method by calculating what are called proportional reporting ratios (PRR’s) to monitor VAERS (see the article linked above for more details). But it turns out they didn’t. And then they turned around and said they weren’t seeing any safety signals in VAERS. They forgot to mention that they weren’t looking for any.
They took a page from the pharma playbook: don’t look for safety problems, then claim that absence of evidence is evidence of absence. Maybe they think it’s OK if you do it with your fingers crossed behind your back.
Let’s rewind a bit. See, in late January of 2021, the CDC released a briefing document outlining the agency’s standard operating procedures (SOP) for ongoing monitoring of VAERS for safety signals from COVID-19 vaccines. The document describes the analyses that the VAERS team at the CDC’s own Immunization Safety Office was going to conduct in their “unprecedented” effort to monitor the safety of the new COVID-19 vaccines. This included a plan to produce weekly tables of the incidence of about forty different adverse events. They would also engage in data mining using PRRs and create tables with the results (you can read the document at the link above for more details - see esp. sections 2.2-2.5):
At my request, the amazing legal team at CHD submitted a FOIA request to CDC asking for:
Copies of the weekly tables they said they would produce from Feb 1-Sept. 30, 2021.
Copies of all tables, analyses and reports generated in connection with ‘Signal Detection Analyses’ as described in sections 2.3 and 2.5 of the SOP document, also from Feb 1-Sept. 30.
Well guess what? In their response letter they state that “no PRRs were conducted by CDC” and that “data mining is outside of the agency’s purview” even though their own SOP document from January stated they would do data mining.
The response letter goes on to say that the agency has “conducted ‘signal assessment’ as described in section 2.5 (i.e. assessed that a causal association exists between the vaccine and both TTS and myocarditis), that assessment involved no formal records.”
So then what kind of records did it involve? People chatting about all the vaccine injuries over drinks after work? The CDC’s budget in 2021 was over $8 billion dollars, but they received other supplemental funding for a total budget of over $34 billion. What are they doing with all that money? One thing we now know for sure: they aren’t using it to monitor vaccine safety as promised. They told us the data monitoring they were doing was rigorous and unprecedented. They said they were going to use the most rudimentary pharmacovigilance tool, PRRs, to monitor safety. They lied.
Furthermore, although their response letter defines ‘signal assessment’ as finding a causal connection, it actually refers to all follow-up analyses done following a safety signal, as described in the SOP document:
But wait, there’s more! The depths of the CDC’s safety monitoring failure doesn’t stop there. We requested the weekly tables they promised to produce beginning Feb 1, 2021, since the SOP document was dated Jan. 29. But the first table they supplied us with is dated April 2. That means they only started “monitoring” VAERS more than 3 months after the vaccines were deployed in mid-December. So much for VAERS being used as an early warning system!
They also said they were going to produce no less than 8 different tables every week. You can see the list in section 2.2.2 in the SOP document pages 15-16. It includes:
Table 1. All reports following COVID-19 vaccines by severity and selected manufacturer/brand name
Table 2. Top 25 most frequently reported AEs
Table 3. Reports of the following AESIs after vaccination with COVID-19 vaccines, stratified by age group (ages <18 years, 18–49 years, 50–64 years, 75–84, years, 85+ years, unreported):
• Death • COVID-19 Disease • Guillain Barre Syndrome (GBS) • Seizure • Stroke • Narcolepsy/Cataplexy • Anaphylaxis • Acute Myocardial Infarction • Myopericarditis • Coagulopathy • Transverse Myelitis • Multisystemic Inflammatory Syndrome in Adults (MIS-A)
Table 4. Reporting trends of the following AESIs after vaccination with COVID-19 vaccines, stratified by age group (<12 months, 12–35 months, 36–59 months, 5–11 years, 12–20 years, >20 years, unreported):
• Kawasaki Disease • Multisystem Inflammatory Syndrome in Children (MIS-C)
Table 5. Reporting trends of VACCINATION DURING PREGNANCY following vaccination with COVID-19 vaccines stratified by age group (ages <18 years, 18–29 years, 30–39 years, 40–49 years, ≥50 years, unreported)
Table 6. Reporting trends of Autoimmune Disorders by System Organ Class following vaccination with COVID-19 vaccines by age group (ages <18 years, 18–49 years, 50–64 years, 65–74 years, 75+ years, unreported)
Table 7. Reporting trends of AESIs to monitor but not abstract (Table 2, p. 8), following vaccination with COVID-19 vaccines by age group (ages <18 years, 18–49 years, 50–64 years, 75–84, years, 85+ years, unreported).
Table 8. Vaccination errors
How many of these did they actually produce? Turns out, their weekly reports include 2 tables:
One table that lists the number of deaths reported, serious non-death reports, non-serious reports and all reports by state. A second table that reports the data listed above for tables 3-5 by age. Missing is a table with AE’s broken down by manufacturer; they don’t have table 2 at all; the age groups promised for table 4 are completely different (with the lowest age range being 0-17 years); and the information promised in tables 6 and above is non-existent — including no information on auto-immune diseases. But, hey, according to the FDA’s VRBPAC, they are as safe as ordinary childhood vaccines. I mean, VAERS isn’t showing any safety signals, right?
But there is still more digging to do. The CDC response letter and the SOP document say the FDA did do data mining. So we will be filing a FOIA with FDA for that information as well. We are also going to try to get the informal signal detection/assessment documents/e-mails they have.
People who are willing to defend the CDC’s negligence will tell you that PRR’s are outmoded and that the CDC is now using more sophisticated methods using other data sources such as the Vaccine Safety Datalink (VSD), as discussed in the documents here. That is true, they farmed out their pharmacovigilance duties to external researchers. Picking apart those other studies to show their weaknesses is beyond the scope of this article, but you can be certain that they all have huge methodological weaknesses.
All of that is irrelevant to the key point: they stated they were going to calculate PRRs. They even say it in their revised SOP document dated Feb 2, 2022. They didn’t. VAERS is supposed to be the early warning system, our first line of defense. It takes more time to analyze VSD even using their ‘Rapid Cycle Analysis’ (RCA), and it is far from perfect — it completely failed to capture the myocarditis signal. And the tables they generated using VAERS reports are essentially meaningless from a pharmacovigilance perspective without doing any kind of disproportionality analysis such as calculating PRRs.
[UPDATE: On April 27, 2021, CDC Director Walensky stated that the CDC did not see any signals related to heart inflammation. But I did a PRR calculation using the number of myopericarditis reports listed in the first table produced by the CDC obtained via the FOIA request. It reveals clear and unambiguous safety signals relative to the comparator vaccines mentioned in the briefing document (i.e., flu vaccines, FLUAD and Shingrix). That 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, other 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.]
You can see all the tables the CDC provided in response to the FOIA request here:
Here is the original FOIA request:
And here is their response letter: