Pfizer-Valneva Lyme disease vaccine to start phase 3 clinical trials

Pfizer lyme disease vaccine

We have some good news today, the Valneva Lyme disease vaccine, which will be distributed by Pfizer, is going to commence phase 3 clinical trials in the USA and Europe. For those of you who live in areas where Lyme disease is endemic, I’m sure you can’t wait.

This article will quickly review Lyme disease, the new vaccine, and how you might be able to volunteer for the clinical trials. Yes, you might be able to volunteer for the phase 3 clinical trials.

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Big Pharma drug development — it’s not as easy as everyone thinks it is

big pharma drug development

Doing what I do here, I always get the impression that many people think that Big Pharma drug development is relatively easy. Just invent a drug, test it on some people, and then call up the FDA to get approval to sell it. I know that supplement manufacturers would be so happy if they could do that.

The actual facts are that Big Pharma drug development is so expensive, complicated, time-consuming, and failure-prone that you have got to wonder why anyone would jump into this process. For some drug discoveries, people grow old waiting for final FDA approval.

The myths about Big Pharma drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias,  you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies) and does whatever it wants. But let’s look at the process of Big Pharma drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts about Big Pharma drug development.

I have written a similar article about vaccine development, but I wanted to have one that was more about all drugs, except vaccines. Vaccines, and other biological drugs, have slightly different development and regulatory pathways which are not used to bring a standard pharmaceutical to market.

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Vaccine development process – how it’s usually done

vaccine development process

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.

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Intercessory prayer in medicine — systematic reviews say it does not work

intercessory prayer

Intercessory prayer, where people pray for the health of someone in a hospital, has been studied for a while to determine whether it is effective. I keep reading that people believe it has been “proven” to work, but I have always been skeptical.

I didn’t realize that there are published studies about intercessory prayer, but I shouldn’t be surprised. There are even systematic reviews that examined the body of research — spoiler alert, there isn’t much evidence that it works.

If intercessory prayer works, I would want to rely upon that famous Carl Sagan quote — “extraordinary claims require extraordinary evidence.” The indisputable medical evidence supports real medicine, not prayers. The prayer supporters haven’t even been able to provide ordinary evidence.

So let’s take a look at some of the science supporting or refuting the effectiveness of intercessory prayer.

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One vaccine clinical trial to rule them all — moving goalposts

woman holding books

If you spend time listening to anti-vaxxers, you would hear that they would support vaccinations if there were better vaccine clinical trial design. The problem with the anti-vaxxer demand for a better vaccine clinical trial design is one of several moving targets for their denialism, relying on a form of the Argument from ignorance, claiming that if we can’t absolutely “prove” that vaccines are safe, then it must be absolutely unsafe. It’s trying.

For example, there are literally thousands of articles, (an example here and was discussed here), that provide overwhelming evidence of the safety and effectiveness of vaccines using real science, real statistics, and real hard work. The antithesis of the fake science, bogus statistics, and 2 hours of Google.

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Pfizer COVID-19 vaccine whistleblower – hand waving about clinical trials

laboratory test tubes

And here we go again – a so-called COVID-19 vaccine whistleblower makes vague claims about the Pfizer clinical trials. Predictably, the anti-vaccine world points a trembling, HPV-riddled finger at us, screaming “SHAME. SHAME. SHAME.”

Except, like a lot of these stories, the anti-vaxxers overstate anything critical about the COVID-19 vaccines, while ignoring the vast majority of evidence that support the overwhelming safety and effectiveness of these vaccines. Their confirmation bias is amazing.

Anyway, let’s take a look at this COVID-19 vaccine whistleblower and see if anything they say passes the smell test.

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Drug development – explaining a complicated process, including vaccines

Based on some of the comments I see on the internet, I think that that people believe that drug development is easy. Anyone can do it. And all you have to do is invent a drug and, voila, it’s approved and you can make billions of dollars in gold

I might be over-exaggerating, but I’ve always thought that the anti-vaccine crowd believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Drug and vaccine development is the total opposite of easy. It takes time, a lot of brilliant minds, and some luck. Sure, some worthless drugs do get approved (we’re eyeballing you Biogen), but almost every drug that fails to have a significant benefit to cost (in terms of safety and price) ratio will fail to get FDA approval.

The myths about drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias, you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies) and does whatever it wants. But let’s look at the process of drug and vaccine development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts of pharmaceutical drug development.

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Vaccine effectiveness – correcting misunderstandings about COVID-19 vaccines

vaccine effectiveness

I keep reading how people think that when a COVID-19 vaccine is reported to have 95% effectiveness it must mean that they have a 5% chance of catching COVID-19 after being vaccinated. But effectiveness doesn’t quite mean that, and I wanted to clarify.

Part of the reason this needs clarification is that until we have herd immunity against COVID-19 (along with all of the variants), it’s important to practice all of the public health measures like wearing a mask and social distancing even if you have been vaccinated.

So, this will be a little bit of mathematical analysis of vaccine effectiveness, so that you know what it means.

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Coronavirus vaccine trials – updating current studies across the world

coronavirus vaccine trials

This article about coronavirus vaccine trials will has been substantially updated and published here. Please go there for the most up-to-date information about these vaccines.

Keeping up with COVID-19 vaccine candidates has gotten out of hand, so for brevity, I’ve created a separate list of coronavirus vaccine trials. The interest in clinical trials for a new COVID-19  vaccine is unprecedented, so I thought this might be the best way to keep loyal readers up-to-date.

Recently, the World Health Organization (WHO) has listed over 140 vaccine candidates, which is amazing, but it is way too difficult to tell which ones have any chance of actually becoming a real product.

Right now, there are 16 vaccine candidates in clinical trials – this article will analyze these coronavirus vaccine trials. Of course, this number changes from week-to-week, so who knows what it will be the next time I update this article!

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Coronavirus vaccine clinical trials – keeping up with everything out there

coronavirus vaccine clinical trials

This article about coronavirus vaccine clinical trials will be regularly updated as new clinical trials are registered or early results are published about an ongoing trial. Again, this article will focus on coronavirus clinical trials – treatments and diagnostic tests are outside of the scope of this article.

Keeping up with COVID-19 vaccine candidates has gotten out of hand, so for brevity, I’ve created a separate list of coronavirus vaccine clinical trials. The interest in clinical trials for a new vaccine is unprecedented, so I thought this might be the best way to keep loyal readers up-to-date.

Recently, the World Health Organization (WHO) has listed over 110 vaccine candidates, which is amazing, but it is way too difficult to tell which ones have any chance of actually becoming a real product.

Right now, there are numerous vaccine candidates in clinical trials – this article will analyze these coronavirus vaccine clinical trials.

Continue reading “Coronavirus vaccine clinical trials – keeping up with everything out there”