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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Pfizer and Moderna mRNA COVID vaccines are really vaccines – obviously

person aspirating the vaccine from the vial

Here we go again – I keep seeing the new anti-vaxxer claim that the mRNA COVID-19 vaccines from Pfizer and Moderna are not, in fact, vaccines but are either “medical devices” or “gene therapy.” I keep trying to stay up with every single myth and trope pushed by the anti-vaxxers, but I swear that there’s a new one every day.

I would really love to write about something other than COVID-19 vaccines – I’ve got a ton of articles I want to write about GMOs, supplements, and cancer that are just sitting in a virtual pile on my desk. Unfortunately, I’m very worried that the anti-vax hatred of these new vaccines will allow this pandemic to keep going. That’s why many of us keep doing the best we can to stamp out the myths.

Just to be clear, the Pfizer and Moderna COVID-19 mRNA vaccines are actually vaccines – they are biological preparations that provide active acquired immunity to an infectious disease, in this case, COVID-19. But, I’m going to have to debunk these myths.

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Experimental COVID vaccines? Another anti-vaxxer trope to be debunked

pexels-photo-5863391.jpeg

And here we go with another one of those silly anti-vaxxers tropes – the COVID-19 vaccines are experimental, and the government/Big Pharma/Bill Gates are conspiring to test the vaccine on innocent people. Nothing could be further from the truth.

The claim that the COVID-19 vaccines are experimental probably arises from the fact that most of them received anEmergency Use Authorization (EUA) in the USA and other countries. The anti-vaxxers what to use the EUA to make a strawman argument that EUA is equivalent to “a risky, experimental drug that will cause great harm to you.”

But if these anti-vaccine activists spent just a little bit of time to understand the high-quality science behind these vaccines and the Emergency Use Authorizations, they might move on to some other topic. But in case someone finds this article among all of the nonsense on the internet, looking to find out if COVID-19 vaccines are, in fact, experimental, let’s debunk that with actual facts.

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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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Myocarditis and COVID mRNA vaccines – very rare adverse event

myocarditis covid mRNA vaccines

Regulatory agencies, such as the FDA and CDC, are monitoring reports of myocarditis, a heart inflammation, after COVID-19 mRNA vaccines from Moderna and Pfizer. Although myocarditis after these vaccines are exceedingly rare, anti-vaccine activists have already jumped 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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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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Why can’t we get a cancer vaccine as fast as one for COVID-19?

cancer vaccine

I keep reading memes and other nonsense that if scientists are so smart why can’t we have a cancer vaccine as fast as we did for COVID-19? It’s not a serious question, it’s actually pejorative – it’s meant to imply that we’ve been looking for years for a cancer vaccine without success, yet we were able to get a COVID-19 vaccine within a few months, so obviously it was rushed.

Fortunately for us on the side of science, this is one of the silliest and most desperate myths being pushed by our favorite anti-vaxxers.

Busting cancer myths is one of my favorite activities – my non-statistical analysis of medical pseudoscience puts cancer slightly above vaccines on the stupidity of the tropes. Combining vaccine nonsense with cancer is right up my bailiwick. Let’s have some tearing apart this trope.

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COVID vaccine breakthrough infections – let’s do some simple math

Let’s talk about COVID-19 vaccine breakthrough infections. That is individuals who contract COVID-19 despite being fully vaccinated by the Pfizer, Moderna, or JNJ vaccines, the only ones with Emergency Use Authorizations in the USA.

This article is going to be short and, hopefully, sweet, because even though the number of COVID-19 vaccine breakthrough infections appear large, it really isn’t. It’s just simple math.

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Myocarditis and COVID vaccine – a rare event that may not be linked

COVID-19 vaccine myocarditis

Regulatory agencies across the world, including the FDA and CDC, are monitoring COVID-19 vaccine adverse events including reports of myocarditis, a heart inflammation. Of course, the anti-vaccine squad will probably jump on this to make it appear that the vaccine is 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 this adverse event is 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.

Continue reading “Myocarditis and COVID vaccine – a rare event that may not be linked”