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Epidemiologist reveals how the Moderna and Pfizer COVID-19 vaccine trials grossly exaggerated the usefulness of the injection and represents the “Worst Miscalculation in Human History.” Dr. Ron Brown, PhD. ⁽⁰⁵⁾ Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials – medicina – Feb 2021

From the Conclusion: “A critical appraisal of phase III clinical trial data for the Pfizer/BioNTech vaccine BNT162b2 and Moderna vaccine mRNA-1273 shows that absolute risk reduction measures are very much lower than the reported relative risk reduction measures. Yet, the manufacturers failed to report absolute risk reduction measures in publicly released documents.

As well, the U.S FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273 vaccines for emergency use. Such examples of outcome reporting bias mislead and distort the public’s interpretation of COVID-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.” ⁽⁰⁶⁾Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials – PDF

An interview between Trial Site News & the Author of the paper, Dr. Ron Brown communicates what the paper means. ⁽⁰⁷⁾Dr. Ron Brown Discusses Outcome Reporting Bias in COVID-19 mRNA Clinical Trials | Interview – TrialSiteNews – 10 Apr 2021

Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows:
relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016;
absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000.

For the Moderna vaccine mRNA-1273, the appraisal shows:
relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004;
absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000.

Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures.

Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy.

Source: Abstract: Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials ⁽⁰⁸⁾ Abstract: Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials

The New England Journal of Medicine ⁽⁰⁹⁾Maintaining Safety with SARS-CoV-2 Vaccines | CDC – Pfizer ⁽¹⁰⁾ACIP Evidence to Recommendations for Use of Pfizer-BioNTech COVID-19 Vaccine under an Emergency Use Authorization CDC – Moderna ⁽¹¹⁾Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Moderna COVID-19 Vaccine.

Why Relative Risks are Misleading

This video (not about vaccines) explains why reporting “just relative risks” without including “absolute risks” is misleading. ⁽¹²⁾Relative vs Absolute risks: Why Relative Risks Are Misleading, and How To Communicate Absolute Risks

He mentions a tool at the end of the video, called the !RealRisk tool by the University of Cambridge ⁽¹³⁾RealRisk – University of Cambridge RealRisk works with any study which investigates the link between a risk factor or intervention and an outcome of interest, which also reports one of the following: a relative risk (RR), hazard ratio (HR), … Click for full citation I played around with it by plugging in the data from the clinical trial, and it concurred that out of 100 people, the absolute risk reduction is about 1 in 100. I interpret that as meaning that out of 100 people who take the vaccine, only 1 would have reduced serious COVID symptoms? But if you plug in the reported “relative risk” data of 95.1%; with the “90-97% confidence level” (that they stated in the clinical trial outcomes), the data magically makes the vaccines look “miraculously very favourable” (suddenly 67 out of 100 wouldn’t develop serious COVID symptoms). Huge difference and something we probably should be informed about before taking a risk with experimental vaccines on a global scale, especially true because of the suppressed COVID-19 vaccine-victims data ⁽¹⁴⁾Vaccine Victims Silenced – do we want to risk blood clots and permanent vaccine damage for a ‘1%’ potential ‘protection’?

Now – before I get carried away with any uneducated assumptions I might be making – I don’t trust my own data interpretation because this is not my field – I’m just a person trying desperately to understand what all things COVID means, and there’s nothing worse than “people like me who don’t understand the data, coming to conclusions about data they don’t understand” – so I’m looking for more of those who “do understand what this means” who can reliably explain it.

There are ‘letters to the editor‘ querying the Pfizer trial data. Excerpts below: ⁽¹⁸⁾Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine – To the Editor

In their article, however, questionable results are reported in Table 3. In each trial group, the sum of the number of cases across age groups (9 in the vaccine group and 186 in the placebo group) does not equal the overall number of cases (8 and 162, respectively). The reasons for the discrepancy are not clearly explained in the article.  ⁽¹⁹⁾Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine – To the Editor

To the Editor – Jean-Noel Vergnes, D.M.D., Ph.D.

(Table 3 is listed in this post under ‘side effects’)

The percentage of Covid-19–positive patients in whom severe illness developed was (9 of 162 patients) in the placebo group and (1 of 8 patients) in the vaccine group. Thus, the preliminary data do not appear to support the conclusion that this vaccine offers protection against severe Covid-19 illness or alleviate the theoretical concern over vaccine-mediated disease enhancement, given that the percentage of Covid-19–positive patients in whom severe illness developed was significantly higher in the vaccine group than in the placebo group. ⁽²⁰⁾Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine – To the Editor

To the Editor – Xiang Wang, Pharm.D.

Response by the Authors:

We would like to clarify that it is not appropriate to use the proportion of Covid-19–positive patients in whom severe disease developed to assess vaccine protection against severe Covid-19. Protection against severe illness is an integrated effect of reducing the chance that any Covid-19 symptom will develop and reducing the risk that severe symptoms will develop after infection. The estimation of vaccine efficacy against severe illness should be based on the incidence of severe illness in the total study population. ⁽²¹⁾Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine – Response by Authors

Response by the authors

Does that sound right to you?

Dr.Been says reporting Relative Risk data is not misleading:

Dr. Been takes a different approach to whether the “Relative Risk” data is misleading – he pretty much says it’s not: ⁽²³⁾ Absolute Risk Reduction vs Relative Risk Reduction ⁽²⁴⁾ Chapter 18 Relative risk, relative and absolute risk reduction, number needed to treat and confidence intervals ⁽²⁵⁾ Common pitfalls in statistical analysis: Absolute risk reduction, relative risk reduction, and number needed to treat

From the comments on the video which are mostly thanking him for explaining it, and, although grateful for the explanation of how ‘relative risk’ is calculated, most do not agree with leaving out the absolute risk data, and bring up the following points:

“The Math”

Another video explains “the math” behind the reports of 95% efficacy for the Pfizer vaccine: ⁽²⁶⁾Pfizer Vaccine Efficacy Explained – Coronavirus News – YouTube – F.Perry Wilson, MD, 19 Nov 2020

Of which he explains that 22,000 were in each group (Vaccine vs Placebo). That 8 ‘got sick’ in the vaccine group and 162 ‘got sick’ in the placebo group, and how that calculates to a 95% efficacy.

Wait… only 5 people hospitalized?

Am I the only one that watched this video whose first thought was… wait a second. 44,000 people, only 170 got sick, and only 5 people got severe-covid?

When the media broadcasts the 95% efficacy number, which is only a “relative risk” number based on those in the study that didn’t get covid, they fail to mention that almost all of the people in the study didn’t get covid, and that they are basing a 95% efficacy number on just 5 people getting severe covid. They ARE being deceptive if they don’t include the actual numbers, because people are making a risky decision based on 5 people who got severe-covid.

The media is the ‘trusted-source’ for the ‘non-researchers’ to get their information. Most ‘normal everyday people’ are going to actually interpret that headline to think that having the vaccine will give them 95% protection against getting severe COVID, but you cannot translate 5 people out to the whole world. (This kind of conversation is ‘normal’- People read/watch the news & literally only take in the headlines and parrot it to others as fact – without understanding what it means).

Now I need to know what they determine “sick” to be in the trials. What is ‘sick’? Sick as in “requires medical intervention sick”, or sick as in “I’m going to take the day off work”, or sick as in “I have a bit of a headache/sniffle”? (How do they determine exactly what COVID-19 symptoms look like when they are so similar to the flu – how do they “determine” that data exactly, blood clots and lung failure? or “feeling a bit unwell”. How do they know the difference between COVID & the normal flu?

Update (next day) 21 Jun 2021: Found the ‘what determines “sick” data’ for Pfizer ⁽²⁷⁾Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (I’m still annoyed that I have to dig for this), I’m also finding discrepancies in the numbers which has added further confusion, making me wonder if these are completely different trials or whether hundreds of people were dropped from the end-result – if anyone understands why, please reach out – but this is another reason if you are creating these ‘explainer videos’ to include links to the specific trials you are ‘explaining’:

“Sick” data

The first primary end point was the efficacy of BNT162b2 against confirmed Covid-19 with onset at least 7 days after the second dose in participants who had been without serologic or virologic evidence of SARS-CoV-2 infection up to 7 days after the second dose;

The second primary end point was efficacy in participants with and participants without evidence of prior infection.

Confirmed Covid-19 was defined according to the Food and Drug Administration (FDA) criteria as the presence of at least one of the following symptoms:

• fever
• new or increased cough
• new or increased shortness of breath
• chills
• new or increased muscle pain
• new loss of taste or smell
• sore throat
• diarrhea
• vomiting

• combined with a respiratory specimen obtained during the symptomatic period or within 4 days before or after it that was positive for SARS-CoV-2 by nucleic acid amplification–based testing, either at the central laboratory or at a local testing facility (using a protocol-defined acceptable test).

Major secondary end points included the efficacy of BNT162b2 against severe Covid-19. Severe Covid-19 is defined by the FDA as confirmed Covid-19 with one of the following additional features:

• Clinical signs at rest that are indicative of severe systemic illness;
• Respiratory failure;
• Evidence of shock;
• Significant acute renal, hepatic, or neurologic dysfunction;
• Admission to an intensive care unit;
• or Death.

Did they use PCR tests – what was the cycle threshold used for each person tested? How can you determine 95% efficacy from only 8 people getting ‘sick’ when it seems the majority of people are not getting ‘sick’ across the entire trial and you haven’t mentioned whether any of the others were ‘positive’ or not – were only those ‘with symptoms’ tested?

Update (next day) June 21st 2021, Answer: ⁽²⁸⁾Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Ok, what is this protocol-defined acceptable test please? Since this is a big debate from the beginning of the entire COVID-19 pandemic as to the accuracy of the various tests and whether they should even be used or relied upon.

And in the Moderna trial ⁽²⁹⁾Peer-reviewed report on Moderna COVID-19 vaccine publishes Data from Phase 3 clinical trial confirm vaccine is effective which had over 30,000 volunteers, 196 had ‘symptomatic covid-19’ (‘at least 14 days after they received their second shot’*), 185 from the placebo. Of which, 10 people were hospitalized (1 vaccinated, 9 placebo)

Can I ask what happens to those who got covid less than 14 days after receiving the first or second jab? Enquiring minds would like to know – me – I would like to know. I found first jab info (below) but still want to know about ‘less than 14 days’ after first shot – is that data deleted, counted, included somewhere? (Is that the reason why there are discrepancies with the numbers?)

Anyway, we have 30,420 + 44,000 phase 3 trial participants, and 461 (236+225) + 170 who ‘got sick’, and out of 74,420 people, we only have 10 + 5 hospitalizations? I feel like I’m taking crazy pills here – but how are we justifying vaccines out to ——————- THE ENTIRE GLOBE ——————- based on this? How is it front-page news to encourage ‘everyone’ to get vaccinated, based on data like this? What am I not seeing here, because this is not enough proof that the vaccines are extremely effective?

You’re basically telling the world that its 95% effective at preventing severe covid, on 170 + 236 symptomatic cases of which only 15 people (placebo+vaccinated) got severe covid (and almost 75k who didn’t even get covid). This is ‘roll the dice’ numbers – not proof of anything, right? 15 people – are you kidding me. Am I also biased myself because I was in a group of 75k people who had adverse affects from the covid vaccines of which there was post after post of heart-breaking stories of deaths of loved ones, ICU trips, strokes, paralysis, bell’s palsy, etc. and severe adverse injuries from the vaccines themselves?

What ‘side effects’ did those in the vaccine group get in comparison to the ‘placebo’ group?
Why do I… as a ‘lay person’, have to look up and download trial data to find out this information – why are you not including this when you present the data?

Where’s the table that shows the blood clots, hives, swelling, neurological issues, tremors & uncontrollable shaking, facial numbness, burning sensations, myocarditis, erythromelalgia, bell’s palsy, spinal cord inflammation, disorientation, loss of memory, brain fog, aggression, night terrors, loss of vision, complete hearing loss, mouth sores, respiration issues, cardiovascular issues, muscle fatigue, menstrual irregularities, spontaneous miscarriages, multi-system organ failure, strokes, and more that are reported elsewhere? ⁽³⁰⁾Covid Vaccine Side Effects ⁽³¹⁾COVID-19 AstraZeneca Vaccine Analysis UK ⁽³²⁾UK spontaneous reports received between 09/12/20 and 02/06/21 for mRNA Pfizer/BioNTech vaccine

I’m saying this because the vaccine(s) safety data should be reported along with the absolute risk – people need to know – before they hold their arms out – exactly what their chance of getting covid is (and it seems that it’s not very high at all in a lot of places), the likelihood of getting ‘severe’ covid (extremely low in these trials), and what risks they are taking by having a vaccine they may not even need (shrugged-off/downplayed/censored), and whether it’s even safe one way or another. We need you to stop pushing the vaccines when the safety data of the vaccines themselves are obscured, and the numbers getting severe covid in these trials – placebo or not – are so very low, so they shouldn’t be used as proof these vaccinations are worth the risk of the adverse affects of the vaccines themselves. (If you’re inflating the numbers to assume that ‘everyone is going to get severe covid’ if they get covid at all, as a determining factor in this vaccine push).

Update (next day) 21 Jun 2021: Found the “Pfizer” adverse effects data’ ⁽³³⁾Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine – (will seek Moderna data next & update – Ok update: cannot locate Moderna phase 3 trial results because the official trial 3 page ⁽³⁴⁾A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 has no results posted yet, and there is only that preliminary review ⁽³⁵⁾Peer-reviewed report on Moderna COVID-19 vaccine publishes Data from Phase 3 clinical trial confirm vaccine is effective that doesn’t include the data, and the Moderna site ⁽³⁶⁾Clinical Trial Results – Moderna Phase 3 itself which only has a summary, please correct me if I’m wrong of if you have located the data:

Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3)

More vaccine recipients than placebo recipients reported any adverse event or a related adverse event. 

64 vaccine recipients (and 6 placebo recipients) reported lymphadenopathy.

4 related serious adverse events were reported among vaccine recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).

2 vaccine recipients died (one from arteriosclerosis, one from cardiac arrest)

4 placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction).

No deaths were considered by the investigators to be related to the vaccine or placebo.

No Covid-19–associated deaths were observed.

Report says: “About 50% of participants receiving mRNA-1273 experienced moderate-to-severe side effects — such as fatigue, muscle aches, joint pain and headache”. ⁽³⁸⁾Peer-reviewed report on Moderna COVID-19 vaccine publishes Data from Phase 3 clinical trial confirm vaccine is effective Does this feel like it’s being deliberately down-played to anyone else? Half the people got ‘moderate to severe side effects’, but they only mention the moderate-sounding-ones that wouldn’t be listed as ‘severe’ in anyone’s determination, so what are the ‘severe’ ones they are leaving out of this report? I’m annoyed with the ‘peer-review’ process too – (since it’s anonymous and you can never find out who did the review and what links they have to the authors/vaccines).

Please – all of you – who are trying to prove something one way or another with your “this is how it works” explainer videos & reports – stop fucking around with these kinds of ‘basic/unsubstantial’ explanations and give us the actual data we need to determine the risks. You need to stop focusing on that bullshit 95% number – because if it’s based on the trial data above, then it’s based on “air” -this pie-in-the-sky 95% number is based on an assumption that not only will ‘everyone get covid’, but that “everyone” who gets COVID will get “SEVERE covid” which we already know not to be true, but their trials also re-validate that considering only 15 people had severe COVID symptoms.

And when they get vaccinated, not only are any severe adverse reactions to the vaccines obscured, they still have to be quarantined and wear masks, because they can still “spread the disease”. Clearly – that 95% number is a publicity stunt / headline-grabbing marketing ploy at best. You need to go into way more detail when presenting data that is meant to explain the true efficacy and true risk:

What is the actual risk of getting “severe” covid
vs the risk of adverse side effects of the vaccine(s)
vs the risk of potential permanent damage (either way).

If you leave out the other ‘risk factors’, or what the terms mean, you are the reason we don’t trust the biased data to begin with. I don’t know exactly what we should be knowing, but I expect those who are data-mining to understand/explain the risks, should have some kind of data that looks a little more like this:

Data I’d like to see compared:

“Fake” Table – this is the kind of information you need to give us to make an ‘informed decision’ about the risks.

…and after you have all that data, then you have something that you can use to explain it to the rest of us why you think it’s worth injecting something so new into our most vulnerable and without any known data for long-term issues – on our children! Do I want to play Russian roulette with the ‘other’ risks that you are deliberately omitting from your research, for a 1/100 chance that ‘if’ I get COVID, I ‘might’ avoid severe COVID? Especially when there are way less risky treatments available should ‘severe covid’ be a reality.

See also: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us  BMJ 2020;371:m4037 ⁽³⁹⁾Will covid-19 vaccines save lives? Current trials aren’t designed to tell us

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