Sunday, March 17, 2024

Vaccines for COVID-19: Censorship or Misrepresentation of the Data - Part 2

 In their rebuttal to Springer Nature Research Integrity Support over the decision to retract their paper "COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign"...



...the authors state emphatically that the eight claims made in support of retraction are "false, misleading, and unsupported by evidence." In my previous post I argued in support of one of the claims, number 2 for Figure 5, showing how they were misleading in showing the data comparing adverse effects from the influenza vaccine when compared to the COVID-19 vaccine.

That was misleading, this next one is just downright inexcusable for an author who has an MPH as well as assert that they have an "understanding of epidemiological principles, methods and procedures, [and] how to place quantitative analyses in context.

I have the MPH but I don't claim to have the understanding that they claim to have. Again, I may be wrong here, but I'll show my work as to why I think they are incorrect and the claim for retraction is valid.

Claim Number 3: "Kersjes claim: The article states that the Pfizer COVID-19 vaccine saved two lives and caused 27 deaths per 100,000 vaccinations, and the Moderna vaccine saved 3.9 lives and caused 10.8 deaths per 100,000 vaccinations, though there does not appear to be convincing evidence for this claim."

The authors state "The calculation of number of lives saved per 100K vaccinations was in fact based on generous assumptions of benefit, utilizing data from the relatively healthy population recruited for the Pfizer trial. It was also based on conservative assumptions of risk based on the Fenton analysis of UK Yellow Card data."

The paper states:
It is imperative to carefully weigh all potential risks associated with the COVID-19 mRNA products. Should substantial harms be linked to their use, the perceived “reward” conveyed by the NNV would necessitate a re-appraisal. For example, assuming an NNV of 119 and an IFR of 0.23% (both conservative estimates), approximately 52,000 vaccinations would be needed to prevent one COVID-19-related death. Thus, for the BNT162b2 injection, a generous estimate would be two lives saved from COVID-19 for every 100,000 courses of the biological. Given the evidence of trial misconduct and data integrity problems (see next section), we conjecture that this estimate is an “upper bound”, and therefore the true benefit is likely to be much lower. Regarding potential harms, assuming 30% false-positive reports and a moderate under-reporting factor of 21, we calculate a risk of 27 deaths per 100,000 doses of BNT162b2. Thus, applying these reasonable, conservative assumptions, the estimated harms of the COVID-19 mRNA vaccines greatly outweigh the rewards: for every life saved, there were nearly 14 times more deaths caused by the modified mRNA injections (for details, see Appendix 2).
The authors contend that for every 100,000 doses of the vaccine, 27 will die because of the vaccine and only 2 out of those 100,000 vaccinated will be saved from COVID-19.

This was "clearly explained and delineated in Appendix 2." 
Thus, comparing the benefits to harms, at least 5 times more lives are lost than saved by the full course of Pfizer mRNA vaccinations.

At the time of the writing of their paper, there was, and still is, data collected by numerous reputable sources that would show this calculation to be wrong. That is, it does not match what we see. Even if the authors want to claim that actual deaths are kept from us, it would be difficult to accept that all these different government bodies who collect data were all in on keeping the data from us.

March 27, 2023 the UK Office for National Statistics writes

Several studies have reported associations between coronavirus (COVID-19) vaccination and risk of cardiac diseases, especially in young people; we assessed the impact of COVID-19 vaccination and positive SARS-CoV-2 tests on the risk of cardiac and all-cause mortality in young people (aged 12 to 29 years) in England using a self-controlled case series design.

There was no significant increase in cardiac or all-cause mortality in the 12 weeks following COVID-19 vaccination compared with more than 12 weeks after any dose for the study population as a whole.

They did find:

 According to the statistical model, 11 out of the 15 cardiac deaths in young women that occurred within 12 weeks of a first dose of a non-mRNA vaccine were likely to be linked to the vaccine; this corresponds to 6 cardiac-related deaths per 100,000 females vaccinated with at least a first dose of a non-mRNA vaccine.

Only females and only females within this age group based on reports of elevated risk of cardiac disease in young people. 


The CDC writes:

To assess mortality not associated with COVID-19 (non–COVID-19 mortality) after COVID-19 vaccination in a general population setting, a cohort study was conducted during December 2020–July 2021 among approximately 11 million persons enrolled in seven Vaccine Safety Datalink (VSD) sites.§ After standardizing mortality rates by age and sex, this study found that COVID-19 vaccine recipients had lower non–COVID-19 mortality than did unvaccinated persons. After adjusting for demographic characteristics and VSD site, this study found that adjusted relative risk (aRR) of non–COVID-19 mortality for the Pfizer-BioNTech vaccine was 0.41 (95% confidence interval [CI] = 0.38–0.44) after dose 1 and 0.34 (95% CI = 0.33–0.36) after dose 2. The aRRs of non–COVID-19 mortality for the Moderna vaccine were 0.34 (95% CI = 0.32–0.37) after dose 1 and 0.31 (95% CI = 0.30–0.33) after dose 2. The aRR after receipt of the Janssen vaccine was 0.54 (95% CI = 0.49–0.59).

Concluding: 

There is no increased risk for mortality among COVID-19 vaccine recipients. This finding reinforces the safety profile of currently approved COVID-19 vaccines in the United States.


The Lancet, June 2022, in a paper titled "Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe" writes:

During the study period, 298 792 852 doses of mRNA vaccines were administered in the USA. VAERS processed 340 522 reports: 313 499 (92·1%) were non-serious, 22 527 (6·6%) were serious (non-death), and 4496 (1·3%) were deaths. The following tables breakdown what they found:


 

These three credible sources all show a very different risk outcome "of 27 deaths per 100,000 doses of BNT162b2." Reality shows us differently and that reality had to have been known to the authors since they are very clear on how their paper was extensively cited paper with 293 references (average paper has 30)"

That deals with the deaths they state as a risk of getting the vaccination. They also make a claim that "for the BNT162b2 injection, a generous estimate would be two lives saved from COVID-19 for every 100,000 courses of the biological."

This means - if I am reading it correctly - that their risk calculation projects only two lives saved per vaccinated individual. This means that for all intents and purposes the vaccine does nothing to save lives. Which means that we should see the roughly same amount of deaths from COVID-19 between those vaccinated and those not vaccinated. The author's write "approximately 52,000 vaccinations would be needed to prevent one COVID-19-related death."

That's their conclusion in glorious black and white pixels.

What does the data they had available to them show? Do we see the same results between vaccination and those not vaccinated. Let's do a Google search...  

Here is what the CDC reports:

Among persons aged ≥12 years, a total of 21,296,326 COVID-19 cases and 115,078 associated deaths were reported...from 24 U.S. jurisdictions....During all periods, average weekly age-standardized incidence and mortality were consistently higher among unvaccinated persons (ranges = 216.1–1,256.0 and 1.6–15.8, respectively) than among monovalent-only vaccine recipients (ranges = 86.4–487.7 and 0.3–1.4, respectively)...

If the authors of the retracted paper were correct, we would not see a weekly mortality that is lower for the vaccinated cohort (0.3–1.4) then the unvaccinated cohort (1.6–15.8). Once again, reality says something very different then the risk of lives saved they calculate and use to support their contention that the vaccine must be stopped.

The following was easily found data which shows that lives saved by the vaccine is considerable - or to use one of their words 'significant.' 

From the Washington State Department of Health (December 2023)


Scientific American (June 7, 2022):


Arizona Department of Health Services (6/7/2023)


When the authors write in their 2024 paper:

Thus, applying these reasonable, conservative assumptions, the estimated harms of the COVID-19 mRNA vaccines greatly outweigh the rewards: for every life saved, there were nearly 14 times more deaths caused by the modified mRNA injections (for details, see Appendix 2).

 They were either not being honest when they wrote this because they should have done a tiny modicum of research to see if their claim that their "reasonable, conservative assumptions [about] the estimated harms of the COVID-19 mRNA vaccines" actually matched reality, or they just don't care if the facts don't align with their feelings.

I am flabbergasted and dumbfounded as to how seven advanced degreed people and an " following an intensive review process that lasted several months and included multiple editors and reviewers," allowed this easily verifiable 'assumption' to get through. This alone should have thrown the paper into the rubbish bin.

Just because you do math and call it an 'assumption' does not excuse it from having to stand up to a tiny bit of credibility. It is another swing and a miss by those who don't like vaccines to scientifically prove why they are correct in their fear and dislike of this vaccine and/or all vaccines in general.

There is no censorship here. No violation of the Committee on Publication Ethics, No false, misleading, and unsupported by evidence claims by the Journal. Nothing arbitrary and capricious by Mr. Kersjes. This is a paper that makes claims that do not match reality, a reality that was available to all seven of the authors. Discounting all the research from all different parts of the globe by all different types of scientists, from many varied entities because it does not fit the conclusion you want - "a global moratorium on the modified mRNA products" - is bad science and they should be ashamed.

Their call for a moratorium "until all relevant questions pertaining to causality, residual DNA, and aberrant protein production are answered" is disingenuous because they will never allow their minds to be changed no matter what evidence they are shown.

Point goes to Mr. Kersjes, the retraction is warranted.

Note: I am becoming more and more convinced that peer reviewed is nothing more than a you scratch my back, I'll scratch yours. 



Friday, March 15, 2024

Vaccines for COVID-19: Censorship or Misrepresentation of the Data - Part 1

It has been a while since I wrote in this blog. Figured I should post this because I want to understand what is being said, claimed, and argued about in a YouTube video I just watched.

This showed up in my YouTube recommendations:



Never hear of her, but she's an MD and was apparently duped by some paper on something (spoiler alert: no she was not!).

"I reviewed a paper about Covid-19 on this channel that's been retracted..."

Well that's worth a listen to.

I may write about what she said, but what I want to do first is understand what the retraction is all about. Let me take a look at the link she provides...


Yeah, so after listening to her video and wondering why she does not really address the Journal's issues with the paper and instead goes over the paper and its findings, I can see where her opinions on the validity of the Editor's reasoning for the retraction are coming from.

And this is confirmed by reading the comments all supporting the same vaccines are bad and they want to cover it up group think. I want to keep an open mind on this, as with any claims made by researchers. However, I - WE - need to go where the data takes us, not where we want it to take us to fit our 'feelings' on the topic. 

Let's get into the weeds about this claim of censorship through retraction.

The paper [being retracted] called for a halt in COVID-19 mass vaccination based on a valid evaluation of the evidence. It topped >330,000 views/reads/downloads in a month as compared to an average Cureus-promoted paper which has only ~2700 in a year.

Right there we have one of those logical fallacies we read about. The fact that the paper was viewed 330,000 times means nothing in terms of its validity of its findings and conclusion. The article doubles down on this by stating:

A rating of >9.2 is considered “excellent” and “groundbreaking” appropriately characterizing this extensively cited paper with 293 references (average paper has 30

References cited are just references cited. It's how they are used to support the claims of the paper that matter. The article then goes on to make the argument that if the paper was not rejected during the peer review process "Once published, it is a violation of the Committee on Publication Ethics (COPE) Guidelines to retract paper without adequate justification."

The censorship claim, it appears, is that there is not adequate justification to retract it and the publication is just outright wrong in their reasons to do so. This is something I was hoping that Dr. Boz was going to address on why she was duped, or. more importantly for her - why she was not - that the paper stands as valid and the retraction is unjustified.

Because she did not, I now have to for myself, because I want to make sure that how I 'feel' about this is sound. I know how she feels about it, how her audience feels about it, and how the authors and Courageous Discourse feels about it. What I want to understand better is should I feel the same and be moved to consider the authors of the paper's claims as valid even though I hate the logical fallacies used and their claims of 'Censorship!" and "Violation!"

The issue with the retraction starts with a letter to the authors by Tim Kersjes, the Journal's Research Integrity Advisor.


Courageous Discourse includes their rebuttal to Mr. Kersjes letter, writing:

The statements made by Kersjes are false, misleading, and unsupported by evidence. Several claims were also arbitrary and capricious. Most of the statements appear to be adapted, either directly or indirectly, from the numerous comments made by the well-known vaccine industry social media trolls, Jonathan Laxton and Matthew Dopler...

 This response is an entertain read if you like drama and childish name calling. Entertaining, but distracting from the question of are the eight statements made by Kersjes "false, misleading, unsupported by evidence," and/or "arbitrary and capricious?"

I may decide to write about all eight of them, but that takes a bit of research for me to understand if the claims are indeed unfounded. For now, I want to focus on two of them.

Let us look at Kersjes (No. 2) claim:  We find that the article appears to be misrepresenting VAERs data...

“Based on a query of the MedDRA code ‘Autoimmune disorder’ in the Vaccine Adverse Events Reporting System (VAERS), there was an 803% increase in autoimmune disorders per million doses administered when comparing the administration of Influenza vaccines from 2018 to 2020 with COVID-19 vaccinations from 2021 to 2023 (Figure 5) [173]. This represents an immense safety signal.”  All eight reviewers agreed with this wording and interpretation.

Notice the "803% increase" and then "This represents an immense safety signal."

I have made this comment before. Numbers used to convey how you want the public to see your findings is disingenuous because it is done purposefully to support the claim the authors want to see. 803% is not a false statement. And the term "immense" is subjective as all get out because the authors did not define what they mean by immense.

Is it immense because its an 803% increase or is it immense in terms of the number of people impacted by autoimmune disorders once they receive the vaccine? Context matters here. I have a very difficult time giving a pass to anyone who wants the research published. The authors new what they wanted that 803% to convey and they knew that the peer reviewers could find no fault with it because its a factual number. They should have taken issue with the term 'immense' but because they did not, the authors an claim it was appropriate.

Context...

What does an 803% increase actually mean?

 


The devil is in the details. If person A makes $10.00 per hour and receive a raise up to $20.00 per hour that's a 100% increase. If person B makes $100.00 per hour and gets a 100% increase they now make $200.00 per hour.

Both received a 100% raise, which one got the bigger impact? Context matters here.

When you look at their 803% graph, you see that autoimmune disorders (adverse effects [AE]) for the influenza vaccine was 0.1 per million doses. If I am reading this correctly, this means that will be one AE for every 10 million doses.

The COVID-19 vaccine showed 10 AEs for every 10 million doses.

There is an increase here, but I am unsure if  'immense' was the appropriate word to use to describe it.

Context...

Claim No. 2 for Figure 5 seems valid. Point goes to Mr. Kersjes for retraction. Figure 7 does not present the same type of misleading statements as Figure 5. There is also research to be found that shows a spike in heart issues for teenage boys. If that spike is reason to halt COVID-19 mass vaccination is debatable so reporting it to support their claim - in my opinion - is not, by itself, false or misleading. 

Now on to Part 2.