Paul Offit

Vaccine development process – how it’s usually done

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process is robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).

However, the world of the COVID-19 pandemic meant that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands, maybe millions, of lives.

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., have expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the development process, along with the independent controls that make sure that all vaccines are safe and effective.

The tragic passing of the son of Nick Catone – vaccines are not responsible

This article about the tragic death of the son of Nick Catone 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On May 12, 2017, the son of retired UFC fighter Nick Catone, Nicholas Catone, by all accounts a healthy, sweet, happy, child, died in his sleep. It’s horrible to lose a child, and I want to start by extending my condolences to the family.

Sadly, I can’t stop there. His parents blame vaccines. The story is being spread in mom groups and understandably scares moms from vaccinating. But Nicholas’ tragic death is not a good reason to refuse vaccines. First, the alleged link to vaccines is extraordinarily weak. There is no good reason to blame vaccines for the boy’s tragic death. Second, even if this was linked to vaccines – and there’s no evidence of that – it’s still safer to vaccinate.

Vaccine science — why I do research better than anti-vaxxers

by Michael Simpson
2022-02-08
Climate change, Diabetes, Science, Vaccines

How many times have you read a comment from an anti-vaxxer that states, “I’ve done my vaccine science research, and it says vaccines are bad.” That comment seems to imply two things – that the anti-vaxxer believes they have done real vaccine science research, and those on the science/medicine side have not done real vaccine research.

What I’ve found is that the anti-vaxxer research into vaccine science is based on their Google University education rather than actual scientific education. Vaccine science is hard, and it cannot be done in a few hours searching for unimpressive memes.

The typical anti-vaxxer understates how hard vaccine research is while overstating their actual skills and experience in comprehending real scientific research. I suppose this is a perfect example of the Dunning-Kruger effect – a cognitive bias wherein people without a strong scientific background fail to recognize their actual ineptitude in the field and mistakenly overrate their knowledge and abilities as greater than it is.

On the other hand, I’ve done real scientific research that gives me a relatively decent background in vaccine science. And I’m going to state, without any remorse, that I am no Dr. Paul Offit, Dr. Peter Hotez, or any of the hundreds of researchers at the CDC and WHO. My background in vaccines is a result of my education, which is a lot more than a few hours on Google.

Google University is not the same as real scientific research in vaccines

I’m sure everyone has run into the type – a science denier who thinks their two hours at Google University makes them as knowledgeable as a real physician or scientist. This arrogance manifests itself in ridiculous discussions with anti-vaccine activists who claim to have “done the research,” and who believe their pseudoscientific research is more valuable than real scientific research.

This Google University education utilized by vaccine deniers, really all science deniers, can be frustrating. I frequent a couple of large Facebook groups that try to help on-the-fence anti-vaxxers understand what constitutes evidence and what doesn’t concerning vaccines. Recently, one of the anti-vaccine true believers kept saying she knew more than a nurse with a public health master’s degree. The arrogant anti-vaxxer kept claiming that she “did her research.”

Because of this absurd overvaluing of their Google University research, I want to review a handful of points that every science denier seems to use that make us laugh. All but one applies to any type of science denial, but we’re sticking with vaccines. Because we can.

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

by Michael Simpson
2021-08-12
COVID-19, JNJ, Moderna, Pfizer, Vaccines

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 an Emergency 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.

Scientific consensus – collective opinion on vaccines, evolution, climate change

In the hierarchy of scientific principles, the scientific consensus – that is, the collective opinion and judgment of scientific experts in a particular field – is an important method to separate real scientific ideas and conclusions from pseudoscience, cargo cult science, and other beliefs.

I often discuss scientific theories which “are large bodies of work that are a culmination or a composite of the products of many contributors over time and are substantiated by vast bodies of converging evidence. They unify and synchronize the scientific community’s view and approach to a particular scientific field.”

A scientific theory is not a wild and arbitrary guess, but it is built upon a foundation of scientific knowledge that itself is based on evidence accumulated from data that resulted from scientific experimentation. A scientific theory is considered to be the highest scientific principle, something that is missed by many science deniers. In addition, a scientific consensus is formed by a similar method – the accumulation of evidence.

I have written frequently about the scientific consensus because it is one of the most powerful pieces of evidence in a discussion about critical scientific issues of our day – evolution, climate change, vaccines, GMOs, and many other areas of science.

This tome has one goal – to clarify our understanding of the scientific consensus, and how we arrive at it. Through this information, maybe we all can see the power of it in determining what is real science and what are policy and cultural debates.

But the most important thing is that the scientific consensus (and theories, for that matter) are not opinions. They aren’t random thoughts pulled out of the ether. Scientific consensus is based on overwhelming scientific evidence published in respected journals.

Scientific consensus – collective opinion on vaccines, climate change, evolution

Sharyl Attkisson says science-based websites are astroturfers

by Michael Simpson
2021-05-31
15 Comments
Andrew Wakefield, Autism, Science journalism, Vaccines

Once upon a time, I was told of an article published on the website of “journalist” Sharyl Attkisson where she accused a lot of people of being astroturfers, including this old snarky feathered dinosaur. Now I admit to not being up-to-date on every cultural term that flows through the internet every day (who could?), but I had to find out more.

Well, what is an astroturfer? Supposedly, it’s a pejorative term that describes a fake grassroots effort. Astroturf is fake grass, so that’s its roots (pun intended).

I’m not really sure of the logic of placing science writers and evidence-based websites into the “astroturf” category, but she does it. It’s like the Big Lie, I guess if she keeps repeating it, people will think it’s true.

Of course, let’s not forget that if we’re going to accuse any person or group of being astroturfers, we should straightaway look at anti-vaccine groups led by Del Bigtree and Robert F. Kennedy Jr. I mean they are the epitome of astroturfers. To quote Inigo Montoya, “You keep using that word. I do not think it means what you think it means.”

Vaccine profits from Big Pharma – let’s take a closer look at this trope

by Michael Simpson
2021-03-03
7 Comments
AstraZeneca, COVID-19, JNJ, Merck, Moderna, Pfizer, Pharmaceutical, Vaccines

The old myth of the huge Big Pharma vaccine profits – it’s the subject of so many memes, tropes, and outright lies from the anti-vaccine activists. These vaccine deniers, who not only lack knowledge of science but also of basic corporate finance, believe that every Big Pharma CEO relies on vaccines for their next bonus check, which they use to buy their new Ferrari to show off to imaginary vaccine-injured children.

I am not naive – public corporations have an obligation to their shareholders and employees to maximize profits. That’s capitalism, I suppose.

But where this trope goes off the rails is when you realize that vaccine profits would be eclipsed by medical industry profits if Big Pharma simply stopped producing vaccines – mass epidemics would mean that hospitals would be filled with patients, just look at the COVID-19 pandemic. It’s ironic that the anti-vaxxers claim that Big Pharma’s greed gives us vaccines, but if they were truly greedy they’d be out of the vaccine business.

This article is not going to be as much science as I usually do – it’s going to focus on finance and accounting. Yes, I’m a finance and accounting geek as much as I am a science aficionado.

Peter Doshi discusses COVID vaccine clinical trials – once again, he’s wrong

One of the most annoying anti-vaccine activists is Peter Doshi who has decided to pontificate on COVID-19 vaccine trials. He is bothersome not because he is a noteworthy scientist or physician, he’s not, it’s because he somehow scored a position as an editor at the respected medical journal, BMJ (formerly known as the British Medical Journal).

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 here, here, 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.

Doshi occasionally uses BMJ as his personal bully pulpit to push anti-vaccine rhetoric that can lead the casual observer to think that he is some respected authority figure with vaccines. He isn’t.

Peter Doshi has just posted an anti-vaccine blog post on BMJ attacking the clinical trials for the Pfizer and Moderna COVID-19 vaccines. His opinion piece needs to be critiqued because his attacks can add to the vast number of anti-COVID-19 vaccine myths that are being spread across the internet.