CDC Admits It Never Monitored VAERS for COVID Vaccine Safety Signals

The Defender ^ | 06/21/22 | Josh Guetzkow, Ph.D.

[george76]

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).

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.

And it only began monitoring in early April 2021, even though reports from COVID-19 vaccines had been flooding VAERS since mid-December of the previous year.

To be clear, VAERS is not the only database the CDC uses to monitor COVID-19 vaccine safety.

For example, the CDC sponsored several studies of COVID-19 safety using the Vaccine Safety Datalink (VSD), which is comprised of millions of medical records from HMO’s across several states.

Those studies do not raise many safety concerns. However, they make many questionable methodological choices.

To give one example, a major safety study based on VSD data published in September 2021, in “JAMA,” compares adverse event rates that occur within 1-21 days of vaccination to the rate of occurrence from 22 to 42 days after vaccination.

It makes no comparison between vaccinated and unvaccinated individuals, or before vaccination versus after in the same individuals.

Moreover, the VSD is far from infallible, having failed initially to detect the increase in myocarditis rates.

In contrast, although calculating PRR’s is a blunt pharmacovigilance tool and far from perfect, it nevertheless has the advantage of being straightforward and difficult to manipulate with statistical sleight of hand.

PRRs are one of the oldest, most basic and most well-established tools of pharmacovigilance. The calculations are so straightforward that the CDC automated it several years ago, so it could have been done at the press of a button.

It simply beggars belief that the CDC failed to do this simple calculation. Even now, a paper published by CDC staff in March on the safety of the mRNA COVID-19 vaccines remains purely descriptive with no PRR calculation.

Meanwhile, a study published by a researcher not affiliated with the CDC in February in “Frontiers in Public Health” analyzes VAERS and EudraVigilance data using a method similar to PRRs, revealing clear and concerning safety signals.

And while it is true that VAERS is not the only database the CDC can use to monitor COVID-19 vaccine safety, it is of critical importance because it can reveal signals much faster than any other method — if anybody cares to look for them.

It remains to be seen if the FDA was properly monitoring VAERS. That will be the subject of a future FOIA request.

But even if it was, it doesn’t change the fact that the CDC completely failed in its promise to monitor VAERS for safety signals.

[glorgau]

It’s a case of being willfully, even criminally, blind. People inside the CDC knew better than to be looking for contra-indicators to the prevailing instructions.

[Flick Lives]

This is the sort of maneuvering underhanded bureaucrats do to create “plausible deniability”.

[heavy metal]

please pick up the courtesy phone...

[FamiliarFace]

This whole CoVid vaccine stuff has been a disaster.

[eyeamok]

NUREMBERG II, Some good rope

[Tunehead54]

Bump to PC & ALL!

[Pontiac]

A whole lotta people need to go to jail.

The entire response to COVID was a conspiracy to defraud the American People.

Billions of dollars were siphoned from the tax payers to the medical industry

COVID was the source of fear necessary to force people into compliance

[Political Junkie Too]

Since you found this interesting press release on VAERS, I'm interested in your opinion on something...

The CDC says: "... VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also referred to as “safety signals.” If a possible safety signal is found in VAERS, further analysis is performed with other safety systems..."

If, by the CDC's own admission, VAERS is set up as a first alert system that "signals" the need for follow-up analysis on other "complementary systems," does it bother you that the CDC has refused to use their own primary system "intended to monitoring safety after vaccines are licensed or authorized for use?"

Does it bother you that it took at FOIA request to find this out?

-PJ

[Sioux-san]

A few things to keep in mind about VAERS. The Vaccine Manufacturers were threatening to stop production in AMerica due to all the lawsuits. They made a deal with the Reagan Administration and Congress to be exempt from these lawsuits in perpetuity, and a special ‘Fund’ of taxpayer dollars would be set up for adjudicating complaints and provide compensation if warranted, which is rare for this tribunal. Reagan allegedly asked why they couldn’t make a “Safe Vaccine” and was told: Not Possible.

A condition of this liability exemption was for a reporting system to be set up for Vaccine Adverse Events. ANyone is permitted to make a VAERS report online and by mail. The form clearly states the penalties you would suffer for making a false report.

I analyze the VAERS data every week for the entire US and for Michigan where I live. You can get Event detail with specifics (husband had vxx today, went to bed and never woke up) or quite detailed on miscarriages, young people repeatedly receiving boosters even though sick enough to be hospitalized after the first one. The Events provide age group, sex, state/territory, Vxx Mfgr, type of event by seriousness, date reported, date received by CDC, date of vaccination, lot #, dose, and specifics on where you got the vxx. Also you can describe in detail what happened and that is what will show up on the CDC VAERS report.

STudies have been done that show what is reported to VAERS is a fraction of what is actually going on, and that is why the CDC bloviates about the “unreliability” of this system they set up as a PROTECTION RACKET under “plausible deniability”

Very hard to get outraged when you don’t know the truth, and your trusted doctor is sworn to secrecy or lose his/her license, and HOspitals lose their Covid bonus. Citizens of Tennessee, Kentucky, and Michigan, don’t you wonder why your states are in the top 5 for Covid Vx deaths.

There’s still no approved test for Covid, just 500+ eua’s, The Govt. is still counting every “positive” as a New Case. Plenty of people did and still are dying from the lethal Covid Treatment Protocol: Ventilators, deadly anti-viral drugs, and now the Jabs. Miscarriages and dead babies, but the doctors still want you to get the Jab if you’re pregnant. Wow. The toll of the Fearmongering is a whole other matter.

[Sioux-san]

I forgot to mention that almost 715,000 Adverse Events have been reported to VAERS for Covid inoculates. Almost 10,000 deaths, 12,000 life threatening, 13,000+ with permanent disability, and nearly 52,000 hospitalized in the last 15 months for the 50 States+DC. From the beginning of the reporting (Dec2020) through April 2021, VAERS had almost 3,000 deaths reported. No one noticed that?

[combat_boots]

Worse.

No one in power cares

[Sioux-san]

Those in charge are quite pleased with how easy this was to accomplish. Hopefully FJB will not command such cooperation in the future.

[Political Junkie Too]

What you posted is interesting, but the point is that the CDC's own help page on VAERS brags about its front-line signaling of concerns requiring deeper analysis, and yet doesn't use it in actual practice.

Either the CDC is lying about its effectiveness as a go-to-first tool, or the CDC knows that VAERS has data quality issues and is using the existence of VAERS to give the medical community and the public the illusion that the CDC is monitoring for "signals" of deeper issues with the drugs that they approved just to appease the public.

I'd like to know which one it is, because it seems like what it is not is the signaling tool that the CDC said it uses to proactively look for problems. If the medical community comes to believe that VAERS is a smokescreen for the CDC, then they will stop putting in the effort to enter what they see on the ground in the hospitals and clinics, which would be a de facto vote of no-confidence in the CDC.

-PJ

[entropy12]

715k adverse effects out of 270 million jabbed?
That computes 99.75% not reporting adverse effects.

[teeman8r]

for a disease that has a less than 1% mortality rate...

[Seeing More Clearly Now]

If the plan was to destroy the social contract and trust from within, they did a great job. Who, but an automaton, still trusts any of the agencies of the government after this fiasco fueled by the production of mass fear.

[Pelham]

“Does it bother you that it took at FOIA request to find this out?”

Have you seen any proof that that is true?

[gitmo]

The Center for Deception and Control

[Political Junkie Too]

Have you seen any proof that that is true?

I've seen this article. Are you accusing the Children's Health Defense of lying about the CDC? Are you accusing the CDC of lying to the Children's Health Defense organization?

The CDC says:

Program staff within the Immunization and Safety Office inform me that no PRRs were conducted by CDC.

Furthermore, there are many medical publications (including this one from the FDA: Data Mining at FDA) that discuss using the Proportional Reporting Ratio (PRR) method to analyze the FDA's FAERS (FDA Adverse Event Reporting System).

It's clear that the FDA has known for a long time about the PRR method of analyzing their FAERS system. This means that the CDC was also familiar with how to use the same analysis method on their VAERS (Vaccine Adverse Event Reporting System). The CDC admitted in their FOIA response that they have not done PRR analysis on their VAERS system, so yes I have seen proof -- the CDC itself admitted it in the letter I attached above.

Do you find it curious that the FDA does PRR analysis on their FAERS system, but the CDC won't do PRR analysis on their VAERS system?

Do you think they don't want to know the answers, so they're not willing to do the same analysis on the VAERS system that is done on the FAERS system?

I've given you the proof that you asked for. Now do you wish to answer the questions, or are you just going to deflect again?

-PJ