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flu COVID-19 mRNA vaccine

Combination flu and COVID mRNA vaccine starting clinical trials

Pfizer and BioNTech have announced the start of a phase 1 clinical trial for a new mRNA vaccine that prevents both the flu and COVID-19. The new vaccine targets these two severe respiratory diseases with one jab.

Although during the past three years we have focused on the COVID-19 pandemic, the seasonal flu is also a dangerous disease. During the 2019-2020 flu season, the last one before COVID-19 mitigation efforts reduced the risk of flu, 390,000 Americans were hospitalized from the flu. And over 25,000 died.

So, a new mRNA vaccine (with all of its advantages to tailor the vaccine to the key antigens on the virus) that combines both flu and COVID-19 can be an effective weapon against these two diseases. In a couple of years, if all goes well, we will be able to get a season flu-COVID-19 mRNA vaccine that has been manufactured for the season’s prevalent variants of both diseases.

Let’s take a look at what we know about this new vaccine and the phase 1 clinical trial.

Read More »Combination flu and COVID mRNA vaccine starting clinical trials
Pfizer lyme disease vaccine

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

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.

Read More »Pfizer-Valneva Lyme disease vaccine to start phase 3 clinical trials
big pharma drug development

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

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.

Read More »Big Pharma drug development — it’s not as easy as everyone thinks it is
vaccine development process

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.

Read More »Vaccine development process – how it’s usually done
intercessory prayer

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

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.

Read More »Intercessory prayer in medicine — systematic reviews say it does not work
woman holding books

One vaccine clinical trial to rule them all — moving goalposts

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.

Read More »One vaccine clinical trial to rule them all — moving goalposts
laboratory test tubes

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

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.

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

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.

Read More »Drug development – explaining a complicated process, including vaccines