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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COVID-19 vaccine liability – new information after FDA approval

small judge gavel placed on table near folders

This article about COVID-19 vaccine liability 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.

A number of questions have come up around COVID-19 vaccine liability. I previously addressed the general framework for liability. In this article, I will try to outline how individuals may be liable for potential harm from COVID-19 vaccines especially in light of the recent FDA approval of the Pfizer vaccine.

Also, this short post addresses a bit of misinformation that appears to have come up from anti-vaccine sources.

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Peter Doshi and FDA approval of Pfizer COVID vaccine – what now?

Doshi Pfizer COVID vaccine

Once again, the anti-vaccine shill, Peter Doshi, uses his BMJ blog to complain about the recent Pfizer/BioNTech COVID-19 vaccine approval by the US FDA. I’ve already seen anti-vaccine activists use this as a “peer-reviewed paper that shows that the vaccine is dangerous.” First, it is not peer-reviewed, it is a blog post no different than the one I’m writing right now. Second, it’s an opinion piece, he’s not showing any original or even secondary research to support his wild claims.

BMJ is not a hotbed of anti-vaccine pseudoscience, except for the presence of Peter Doshi. For example, they published a series of articles, written by Brian Deer, about Andrew Wakefield’s despicable deceit, you can read about it herehere, and here. Deer has also written a powerful book about Wakefield’s fraud. I wonder what Mr. Deer thinks of Peter Doshi as an editor at the acclaimed medical journal.

Even though anyone with the least bit of scientific expertise understands that whatever Peter Doshi says about the Pfizer COVID-19 vaccine FDA approval is nonsense, I will endeavor to take apart his ridiculous claims.

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FDA approval of Pfizer COVID vaccine – why did it take so long?

FDA approval pfizer COVID-19 vaccine

One of the questions I keep seeing is why did it take so long for FDA approval of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty? The answer is complicated, but the basic issue is that the FDA is very conservative in approving drugs – I bet that will surprise everyone.

I’m going to delve into a couple of issues with the FDA and its approval of the Pfizer COVID-19 vaccine. Even though some people argue that it took too long to go from the Emergency Use Authorization (EUA) to full approval, it was, in fact, fairly rapid. Remember, clinical trials only commenced maybe 15 months ago, so this is warp speed compared to the usual vaccine timeline that may be nearly 10 years.

Many of us thought that it would take up to three years before we had COVID-19 vaccines available – I’m willing to eat humble pie on blowing that prediction, but it’s amazing what happens when governments, scientists, and pharmaceutical companies can do when they are all focused on a common goal. Not for nothing, but why can’t we do the same thing with climate change – a lot more of us are at risk of that than COVID-19, but I’ll leave that for another day.

Let’s take a brief look at why some of you are wondering why it took so long for the FDA approval of the Pfizer COVID-19 vaccine.

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Pfizer COVID vaccine received full FDA approval – expect new mandates

pfizer COVID-19 vaccine FDA

Today, 23 August 2021, the Pfizer/BioNTech COVID-19 mRNA vaccine received full FDA approval for individuals 16 years and older. This should stop the claim by anti-vaxxers claimed that these vaccines were “experimental,” because they had an  Emergency Use Authorization (EUA) in the USA and other countries, despite the fact that the EUAs required just as rigorous analysis as a typical New Drug Application.

Let’s examine what this Pfizer COVID-19 vaccine FDA approval means practically.

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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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COVID vaccines effectiveness against new Delta variant

COVID vaccines effectiveness Delta

With the spread of the Delta variant (known as B.1.617.2 by the CDC) from India, scientists have been concerned about the effectiveness of COVID vaccines against it. The good news is that the Pfizer and AstraZeneca vaccines seem to fairly effective against this new variant of SARS-CoV-2 virus.

Let’s take a look at the paper that describes the effectiveness of the vaccines against the COVID-19 Delta variant.

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