In a letter last week responding to a Freedom of Information Act (FOIA) request, the Centers for Disease Control and Prevention (CDC) admitted that it did not monitor the COVID-19 vaccine’s safety signals as it had promised to do.
A safety signal is information about an adverse event which “signals” that investigation is required. In its Vaccine Adverse Events Reporting System Standard Operating Procedure (VAERS SOP) updated on January 29, 2021, the CDC promised to monitor safety signals by calculating what is called proportional reporting ratios (PRR).
A PRR compares the proportion of a reported adverse event from one drug to the same reported adverse event from another drug; in this case, the COVID-19 vaccine.
“PRR will be used at CDC for potential signal detection,” promised the CDC in the SOP documents.
A PRR is a basic, standard method for pharmacovigilance and monitoring the safety signal of any drug, including vaccines.
But in response to a FOIA request submitted by the legal team at Children’s Health Defense at the request of researcher Dr. Josh Guetzkow, the CDC admitted it had not calculated any PRRs.
“In regards to Item 2, program staff within the Immunization and Safety Office inform me that no PRRs were conducted by CDC,” wrote CDC FOIA Officer Roger Andoh.
That’s why the CDC has been able to adamantly insist that the vaccines are “safe and effective” and have no safety signals: 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,” writes Dr. Guetzkow in his Substack newsletter. “Maybe they think it’s OK if you do it with your fingers crossed behind your back.”
Furthermore, the FOIA response letter also revealed that while the CDC had promised to produce eight tables of data weekly related to the vaccine’s adverse events, it did not produce many of the tables promised, including a weekly list of the top 25 most frequently reported adverse events, comparisons between vaccine manufacturers, and a list of autoimmune disorders.
Though adverse event reports began flooding in mid-December 2020 just after the vaccine was introduced, the CDC did not begin monitoring them until April.
In other words, whatever little monitoring was actually performed by the CDC was done months after the vaccine rollout.
“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,” continued Dr. Guetzkow. “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.”
Moreover, the CDC appears to be unsure of how to even assess a safety signal. In the letter, the CDC describes “signal assessment” as “assessed that a causal association exists between the vaccine and both TTS and myocarditis.” But in its SOP, “signal assessment” actually refers to a litany of analyses following a reported adverse event.
The CDC was granted just under $8 billion for its 2021 budget. But with supplemental funding, the CDC was actually granted a total of $34.239 billion for the year.
“What are they doing with all that money?” asked Dr. Guetzkow. “One thing we now know for sure: they aren’t using it to monitor vaccine safety as promised.”