Don’t fall for the Nirvana fallacy – COVID vaccines are safe and effective

glass blur government health

I bet you’ve read that the new COVID-19 vaccines are not 100% perfect, so employing the Nirvana fallacy, must be avoided. That’s just not how one should look at medical data – whether examining vaccine safety and effectiveness or the usefulness of chemotherapy in treating cancer.

No medical procedure is perfectly safe or perfectly effective. Physicians and scientists never make those kinds of claims. In evidence-based medicine, benefits are weighed against risks based upon peer-reviewed published data.

I always like to say that when a physician reduces a fracture of the arm or leg, there is a small, but statistically significant chance of dying from something like a clot forming that goes to the heart or lungs. However, if you don’t reduce the fracture, there is a might higher chance of dying or permanent disability. Yet, I doubt that anyone would refuse the procedure despite the inherent risk.

Unfortunately, the bad math of the anti-vaccine world means that any risk that is not absolute 0% is rounded up to 100%, and vaccine effectiveness that is not absolutely 100% is rounded down to 0%. Yet, I’m sure if they had a broken arm, they would have the fracture reduced immediately.

This article is going to take a look at the Nirvana fallacy and how it relates to the acceptance of the COVID-19 vaccines.

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Anti-vaxxers misuse VAERS against COVID-19 vaccines – bad science

COVID-19 vaccines VAERS

Recently, a poorly written pre-print article uses VAERS “data” to show that the COVID-19 vaccines cause myocarditis in children 12-17 years old. Although we do have some data that the COVID-19 mRNA vaccines may be linked to myocarditis in some age groups.

I, and many others, have frequently criticized the use of VAERS, and I will do it again in this article, so just hang on. It cannot be used for anything by gross observations, and it certainly cannot be used as the basis for an article that condemns a vaccine.

So, let’s once again go down the rabbit hole of misusing VAERS to evaluate the safety of COVID-19 vaccines.

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Adverse events surveillance after 11.8 million COVID mRNA vaccine doses

adverse events COVID-19 vaccine

A paper was just published that reviewed adverse events after 11.8 million COVID-19 mRNA vaccine doses were administered in the USA. Because it is the topic of discussion these days, I felt it was important to review this paper.

Even though anti-vaxxers love to claim excess adverse events after people receive the COVID-19 mRNA vaccine, there are excellent methods that the CDC has developed to monitor these issues in vaccines, and this new paper looks at one of them.

The news is good, in case you’re wondering.

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Gardasil researcher Diane Harper is pro-HPV vaccine – shocking, right?

Gardasil researcher diane harper

Anti-vaxxers love their false authorities, so they invoke Gardasil researcher Diane Harper, MD as the authority of choice with regard to HPV vaccines. Obukhanych is truly a false authority, but Dr. Harper is much more complicated. She actually is an authority for HPV vaccines, but not in the way that the anti-vaccine world would like you to believe.

Because vaccine deniers lack any scientific evidence supporting their unfounded beliefs about vaccines, they tend to rely upon unscientific information like anecdotes, logical fallacies, misinterpretation of data, or false authorities to support their case about the lack of safety of vaccines.

The so-called “lead Gardasil researcher,” Diane Harper, a former “consultant” to Merck and GSK, had some responsibilities in the clinical trials for their HPV vaccines. But the claims about whether Dr. Harper supports or dislikes those vaccines are substantially more complicated than what the anti-vaccine zealots would like to claim about her.

Amusingly, every few months the social media haunts of the anti-vaccine crowd explode with claims that Dr. Diane Harper, lead Gardasil researcher, hates HPV vaccines.

Let’s take a look at the story and see what we find.

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Vaccines mandates, religion, and the law – Cait Corrigan edition

vaccines mandates

This article about vaccines mandates, religion, and the law was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

As vaccines mandates spread around the United States in response to the virus, there is naturally those who are unhappy. Committed anti-vaccine activists are, unsurprisingly, less happy than most, and driven to express their unhappiness in a variety of forums and a variety of ways including employing religion.

In one example, a relative newcomer on the anti-vaccine scene, student Cait Corrigan, has written a complaint to her former college, challenging their vaccines mandate, after she was removed from their Facebook group for offering to help people game exemptions based on religion.

By itself, this is not particularly important; the complaint is unlikely to go very far, and the college’s legal advisor would likely be able to point to the college’s authorities its many flaws (and the one point that the complaint is right about, and that the college should correct). But the complaint provides an opportunity to examine several arguments anti-vaccine activists make in other forums and address the way anti-vaccine activists build arguments.

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America’s Frontline Doctors anti-vaccine affidavit – expert analysis

America's Frontline doctors affidavit

This article, about America’s Frontline Doctors anonymous anti-vaccine affidavit, was written by Kelsey S Hollenback, a Ph.D. student in Systems & Information Engineering at the Center for Risk Management of Engineering Systems, Department of Engineering Systems and Environment, School of Engineering and Applied Sciences, University of Virginia.

On reviewing America’s Frontline Doctors anonymous affidavit, part of a recent lawsuit over the COVID-19 vaccines, my first and most important takeaway is that, while Jane Doe apparently wishes to assert that she has discovered excess mortality associated with COVID-19 vaccines, what she describes in her affidavit bears absolutely no resemblance to how to conduct an actual such analysis.  Not even a little bit.

My second takeaway, which almost doesn’t matter given the first, is that, insofar as it’s possible to determine the methodology she used from the extremely limited description provided, that methodology is…flawed. 

Flawed in what ways? It counted more deaths associated with a COVID-19 vaccine than there are total deaths recorded in VAERS. It doesn’t account for differences between the CMS patient population and the general population. Depending on what criteria Jane Doe used to query the CMS claims database, she may have pulled patients receiving any vaccine, not just the COVID-19 vaccine; she may have pulled only patients receiving Moderna, or only Pfizer, or only Johnson & Johnson; she may have failed to pull patients receiving a no-cost or government-provided vaccine; and/or she may have oversampled patients at higher risk generally for all-cause mortality.

My third and final takeaway is that, while America’s Frontline Doctors affidavit does not in any way describe either a valid method for identifying excess mortality associated with the COVID-19 vaccine, doesn’t do anything at all to establish causality, and certainly doesn’t expose any cover-up, it does possibly reveal a serious HIPAA violation.

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VAERS is not the best method to evaluate vaccine adverse events

VAERS

The Vaccine Adverse Event Reporting System (VAERS) is one of the systems employed by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to monitor vaccine safety. VAERS is a post-marketing surveillance program, collecting information about adverse events (including death) that occur after the administration of vaccines to ascertain whether the risk-benefit ratio is high enough to justify the continued use of any particular vaccine.

VAERS, the Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment Network (CISA) are the major tools used by the CDC and FDA to monitor vaccine safety. These are powerful tools that contradict the trope from anti-vaccine activists that regulatory agencies do not monitor vaccine safety – they do.

This article will review how VAERS works along with its strengths and limitations. However, one thing we will focus on how dumpster diving into the VAERS database without context is a very bad use of statistics.

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RETRACTED – COVID vaccine causes two deaths for every three deaths prevented

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The anti-COVID-19 vaccine crowd thought they had a gotcha with a new paper published that seemed to claim that the vaccine causes two deaths for every three cases of COVID-19 that it prevents. Predictably, this paper became “evidence” for refusing the vaccine.

Except for one little problem. The paper is, from a scientific perspective, pure garbage. And it caused a huge kerfuffle at the “journal” that published the article. Yeah, I put journal in scare quotes because I’d argue it really isn’t much of a journal.

Nevertheless, let’s take a quick look at this paper and the subsequent uproar at the “journal”.

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COVID vaccine during pregnancy – uptake lagging in the USA

close up photo of pregnant woman in white dress holding her stomach

The CDC strongly recommends the COVID vaccine during pregnancy to protect the health of the mother and the developing fetus. The CDC stated that there are “no safety concerns” among women in their third trimester and for their newborn babies.

Despite the claims of COVID-19 deniers everywhere, the disease is dangerous and can cause both short- and long-term harm to anyone, and that means pregnant persons and their newborn babies. That’s why the COVID-19 vaccine is so important.

Unfortunately, recent data from the CDC shows that COVID-19 vaccine uptake during pregnancy has lagged badly. There are a lot of reasons for this, as you might guess.

Let’s take a look at what the CDC is reporting and why pregnant persons should get the COVID-19 vaccine.

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COVID-19 vaccines and myocarditis – what are the facts

medical stethoscope and mask composed with red foiled chocolate hearts

Regulatory agencies, such as the FDA and CDC, are monitoring reports of myocarditis, a heart inflammation, after COVID-19 vaccines. Although if there is a link, it is exceedingly rare, anti-vaccine activists have already on this issue to make it appear that COVID-19 vaccines are dangerous.

My job is to look at this data and give you a scientific analysis of the observations and whether they are actually related to the vaccine.

Like with reports of other conditions, such as blood clots, after receiving COVID-19 vaccines, we need to examine whether myocarditis is actually related to the vaccine or just random events in which the incidence is no different than what would be predicted in a similar group of unvaccinated people. And if it is linked, we need to look at the potential risk and compare it to the risks of COVID-19 itself.

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