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COVID Crisis Post 39: Vaccine Trial Ethics.

First, politics aside because this has nothing to do with politics:

Trump is mentally ill.

I originally was going to joke about this, but I just can't. He is the President. People listen to and trust his ideas even IF he says he is not a doctor. His press conference was dangerous. He is dangerous.

So much so that Reckitt Benckiser, the British company who produces Lysol and Dettol, had to issue this statement today:

“As a global leader in health and hygiene products, we must be clear that under no circumstance should our disinfectant products be administered into the human body (through injection, ingestion or any other route).”

Why in the living fuck does a company in the modern age have to issue such a statement?? They did so because they could see the danger in his comments.

Also, William Bryan, the science and technology adviser to the Department of Homeland Security, stated government research found sunlight, heat, and humidity were effective in killing the virus.

However, the government's research has NOT been verified or released for review to any independent experts. And there have been outbreaks in countries where it was both warm and humid so the environmental factor is not one we should depend on. So take all of this with a massive heap of salt.

To repeat: using "tremendous" light and disinfecting yourself with bleach as possible COVID-19 cures are both incredibly stupid ideas. Even if he did not specifically say "do this".

Ugh. Moving on.

A concerning comment regarding development of a vaccine for COVID-19:

There are human trials that have been started for a number of potential vaccines. This to me is both incredible and worrisome.

Typically, animal trials are undertaken first to ensure both adequate efficacy (high levels of antibody, protects against the virus in question) AND safety (low risk for both serious side effects and development of ADE) before humans become involved. And this can, obviously, take a while.

But in pandemics, the time line gets more easily shifted. And I question the ethics of this.

Shortcuts are being taken where safety may not be demonstrated in animals prior to proceeding to human trials; some of these trials are being run concurrently in fact. The animals may show high antibody levels and no immediate harm, so the trials are being moved on to humans. If the animal at any point shows the vaccine does not protect against illness or if it causes significant harm, the human trials would be stopped.

But I am concerned for the subjects in these trials.

Obviously these people volunteered to be subjects in these trials, but it still makes me very uneasy. And if this vaccine proves to be disastrous, do we really want to add fuel to the fire for those against vaccines?

Maybe this will all end up being much ado about nothing. But in the race to develop a vaccine, are we taking risks we should not be taking to save MAYBE a few months in terms of development?

Because even though human trials are underway, a vaccine will not be available to the general public anytime soon.

The volunteers need to be followed for at least a year to ensure there are no adverse events or reactions related to the vaccine itself, even if efficacy is proven. If there is any adverse event, the trials are stopped and the developers go back to square one.

So the earliest we could have a vaccine is still 12-18 months at the MINIMUM. And realize that even that timeframe would be truly unprecedented.

As a point of reference, the fastest vaccine EVER produced was the mumps vaccine. And that took 4 years to develop. Yes, that was 53 years ago so the development may have taken longer, but humans are still humans so the safety and efficacy trials still have to be completed. So we will see.

I had a bunch of interesting, and worrisome, things I wanted to talk about today regarding COVID-19 itself. But I had to say my peace about what occurred yesterday.

People may be angry at Dr. Brix for not standing up and refuting the absurdity of Trump's comments right off the bat, but I believe she recognizes she can do more to protect us by continuing to be in her position rather than be fired. I have not been a big fan of hers throughout the pandemic, but I think she did the right thing in this regard.

Again, these are my opinions and am happy to discuss any disagreements privately; please do not use this as a forum for politics.

My only agenda is to inform and educate while maintaining a strict oath of ethics towards those who choose to read my posts because it IS a choice.

I have maintained this oath of ethics since the day I ever received my first short white coat.

And I guess I am just too old and set in my ways to change.

Sorry, not sorry.

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