VAERS does not show causation between vaccines and adverse events

VAERS causation

Anti-vaxxers love to use the Vaccine Adverse Events Reporting System (VAERS) to make claims about causation between vaccines and some (or all) adverse events. They have doubled down on dumpster diving into VAERS during the COVID-19 pandemic, producing outright falsehoods and misinformation about the COVID-19 vaccines.

But VAERS is not the way to determine causation. In fact, it’s not even a good way to determine correlation. At the very best, VAERS contains observational information that functions as a safety signal for the FDA and CDC, who have the resources and epidemiologists who can use other methods to determine if there is a correlation, and possible causation, between a vaccine and an adverse event.

It’s ironic that most of the so-called “VAERS data” used by the anti-vaccine activists are analyzed by amateurs, who have never taken an epidemiology or statistics course. Good research into vaccine adverse effects requires much better data than is found in VAERS.

Let’s take a look at VAERS, correlation, and causation. It’s much harder than you think.

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Vaccine adverse effects may be in our heads — a systematic review and meta-analysis

Vaccine adverse effects are a point of contention with anti-vaccine activists. They always seem to overstate their frequency and claim that it’s much more frequent than reported. On the other hand, many of us on the science side agree that the number of adverse events is vastly overstated, especially in the Vaccine Adverse Events Reporting System (VAERS), which is not a very good system for tracking these things.

Well, a new systematic review and meta-analysis, published in a respected journal, indicates that many reports of adverse effects in the COVID-19 vaccine clinical trials can be attributed to the placebo effect. As I like doing, let’s review this new paper.

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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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Vaccine adverse events are very rare – vast benefits outweigh risks

shoenfeld

Like all medical procedures, devices, and pharmaceuticals, vaccines are not perfect – there are rare vaccine adverse events. What matters is that the benefits, not only medically but also economically, outweigh any risks. As far ask I know, no perfect medical procedures, devices, or pharmaceuticals, none, that are perfectly safe or perfectly effective. Sometimes the ratio is small.

For example, there are chemotherapy drugs that only add a few months to a patient’s life, usually with substantial side effects to the medication. Yet, if you ask a patient whether it was worth it, to spend just a few extra months with their children and loved ones, the value becomes nearly incalculable.

But mostly, the FDA and other regulatory agencies demand that new products and procedures must meet or exceed the safety, and meet or exceed the financial and health benefits of currently acceptable versions. Actually, the FDA examines a lot more than that.

They check the packaging, shelf life, instructions, manufacturing practices, and so much more, it would take a book to explain it (and there probably are several). It may not be a perfect process, but it’s better than what we had 100 years ago, and it continues to improve every single day. People tend towards a form of confirmation bias where they remember where a drug may have been found to be dangerous (the best example is Vioxx).

But they forget about the millions of medications and devices that save lives or measurably improve the standard of living. 

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Vaccine adverse events are rare – vast benefits outweigh small risks

vaccine adverse events

Like all medical procedures, devices, and pharmaceuticals, vaccines are not perfect – there are rare vaccine adverse events. What matters is that the benefits, not only medically but also economically, outweigh any risks. As far ask I know, no perfect medical procedures, devices or pharmaceuticals, none, that are perfectly safe or perfectly effective. Sometimes the ratio is small. For example, there are chemotherapy drugs that only add a few months to a patient’s life, usually with substantial side effects to the medication.

Yet, if you ask a patient whether it was worth it, to spend just a few extra months with their children and loved ones, the value becomes nearly incalculable. But mostly, the FDA and other regulatory agencies demand that new products and procedures must meet or exceed the safety, and meet or exceed the financial and health benefits of currently acceptable versions. Actually, the FDA examines a lot more than that. They check the packaging, shelf life, instructions, manufacturing practices, and so much more, it would take a book to explain it (and there probably are several). It may not be a perfect process, but it’s better than what we had 100 years ago, and it continues to improve every single day. People tend towards a form of confirmation bias where they remember where a drug may or may not have been found to be dangerous (best example is Vioxx).

But they forget about the millions of medications and devices that save lives or measurably improve the standard of living.  Continue reading “Vaccine adverse events are rare – vast benefits outweigh small risks”

Chickenpox and shingles – same virus, different vaccines

chickenpox and shingles

There are a lot of nuanced facts and evidence about vaccines. The so-called “pro-vaccine” crowd looks at the body of evidence, then concludes that it saves children’s lives by stopping vaccine-preventable diseases. The “anti-vaccine” side seems to rely on anecdotes, cherry picking bad studies published in really bad journals, and read anti-science websites, just to support their preconceived conclusions. And now there is a lot of junk science with respect to chickenpox and shingles, much of which we need to refute and debunk.

One of the enduring myths of the antivaccine cult is that chickenpox vaccine will increase the rate of shingles, especially in older adults. A published article examines chickenpox and shingles vaccines – and like everything in science, it’s the nuanced data that makes the story. Not the headlines.

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