Do we Cancel Everything? You still Travelling??

[birdguy 3,943]

Alan, I an not enrolled in any social media sites like twitter or facebook or the like.  The closest I get to that sort of thing are flightsim forums that I have not been banned from and personal e-mails.  I have an iPhone but I do not text.  I just use it as a phone.  I like GPS feature too.

Noel

[HiFlyer 9,359]

Kinda scary study for those interested, and a news article condensing the findings in a more comfortable format for general readers.

Places without social distancing have 35 times more potential coronavirus spread, study finds

Strong Social Distancing Measures In The United States Reduced The COVID-19 Growth Rate

 

[MartinRex007 390]

A nice short summary of what steps a vaccine goes through in order to get approved.

Martin

There are four phases and a preclinical phase in drug and vaccine development. Preclinical trials are done in animals, and in vitro, it is to determine toxicity, including reproductive and developmental toxicity, carcinogenicity, pharmacokinetics, and pharmacodynamics. In some cases, this can take more than 10 years to determine.

At the end of the studies, researchers review the findings and determine if the drug/vaccine should move forward to human trials.⁹ The review team consists of a project manager, medical officer, statistician, pharmacologist, pharmacokineticist, chemist, and microbiologist. Only 10% of drugs/vaccines make it past this stage of research.

• Phase 1 clinical trials last several months and recruits anywhere from 20 to 100 participants. This phase of the trial evaluates pharmacokinetics and tolerability in humans. This is usually studied in single and repeat doses and evaluates any organ toxicity that could lead to renal or hepatic impairment. The goal is to limit risk and maximize the benefits by finding the proper dose. Around 70% of drugs/vaccines that complete this phase will go on to phase 2 clinical trials.¹⁰
• Phase 2 clinical trials last several months to two years and recruit several hundred participants. In this phase, researchers are evaluating the efficacy and side effects. This phase of the trial is not large enough to determine if the drug/vaccine will be beneficial. That is why yet another phase is necessary. Around 33% of the drugs/vaccines will move on to the next phase.¹⁰
• Phase 3 clinical trials last one to four years and recruits between 300 and 3,000 participants. The purpose of this phase is to determine efficacy and monitor for adverse effects. Due to the length and size of these studies, the results are more likely to show any long-term adverse effects of the drug/vaccine. Around 25-30% of the drugs/vaccines will move on to the next phase.¹⁰
• Phase 4 clinical trials are also referred to as post-marketing surveillance. This phase is conducted after the drug/vaccine has been FDA approved and marketed to the general public. This includes several thousand participants. This part of the clinical trial is to continue to evaluate safety and efficacy. There is no time frame, and it is continuous monitoring.¹⁰

https://www.todaysrdh.com/coronavirus-the-current-science-behind-sars-cov-2-and-how-it-impacts-dentistry/

[Alan_A 1,650]

@MartinRex007 - That's an excellent summary.

Just to amplify it, Dr. Katelyn Jetelina, the University of Texas epidemiologist I link to from time to time, posted this the other day specifically about vaccine development. 

An excerpt:

Quote

Now, if we want a vaccine to come out by winter, the problem is time. On average, it takes 10 years to develop a vaccine. The fastest vaccine every created took 4 years (mumps).

[In the Moderna mRNA-1273 vaccine trial, w]e were already able to shed off around 2.5 years by skipping the academic research (step 1). We used data on SARS and MERS to fast track vaccine development, since this virus is from the same family. Also, scientists didn’t have to find money to support this research. Speeding up Phase I-III is not so easy. Only 10% of vaccines are ultimately approved (37% fail in Phase I; 70% fail in Phase II; and 40% fail in Phase III). And then there’s manufacturing and distributing for 331 million Americans…

Bottom line…patience. It's a good thing for vaccines to take time. We do not want to sacrifice safety for public or political pressure.

In other words, even a very accelerated development process will take longer than we'd like.

[Alan_A 1,650]

2 hours ago, birdguy said:

Alan, I an not enrolled in any social media sites like twitter or facebook or the like. 

No need - you can follow the list through the Talking Points Memo website at the page I linked to.  I checked, and it updates in real time, so it's as good as following it directly on Twitter. Really a good set of sources.

[HiFlyer 9,359]

1 minute ago, Alan_A said:

@MartinRex007 - That's an excellent summary.

Just to amplify it, Dr. Katelyn Jetelina, the University of Texas epidemiologist I link to from time to time, posted this the other day specifically about vaccine development. 

An excerpt:

In other words, even a very accelerated development process will take longer than we'd like.

I'm not so sure.........

Especially with the stock market dancing in the streets about encouraging news from this Moderna vaccine trial, I could easily see the administration ignoring normal safeguards and rushing stuff out to the public in a crazy short period......

[Alan_A 1,650]

3 minutes ago, HiFlyer said:

ignoring normal safeguards and rushing stuff out to the public in a crazy short period

Could happen, but thankfully as trials move forward they usually involve multiple sites with lots of independent researchers, so it's hard to change that process.

The trial process has been accelerated in the past - sometimes for the good.  Fauci worked with the HIV activist community, and the FDA joined in, to streamline drug trials (by allowing the use of surrogate markers like CD4 protein counts as clinical endpoints, instead of waiting until you could measure viral load directly) and to expand access (by allowing the sickest patients to take drugs still in trial under two expanded access protocols - the FDA created the Investigational New Drug application and Fauci proposed the parallel track protocol).  There's some interesting background on that history here.

A rushed vaccine, on the other hand, would not be a good thing.

 

[HiFlyer 9,359]

2 minutes ago, Alan_A said:

A rushed vaccine, on the other hand, would not be a good thing.

I did not think it would be. In fact, I hope practicalities of development slow things down to a pace that comports with rational science rather than political.... stuff.

[Alan_A 1,650]

Just now, HiFlyer said:

I hope practicalities of development slow things down to a pace that comports with rational science

We can only hope.

[n4gix 4,947]

On ‎5‎/‎17‎/‎2020 at 4:45 PM, Alan_A said:

Agreed.  It's not a study, just an incident, and there are too many unknowns.

The best comment I read on the first link was this bit of snark:

Quote

The Abbot test has a 49% false positive rate and a 51% false negative rate. It was developed at The Heisenberg Center for Applied Uncertainty. /s

6 hours ago, birdguy said:

If local conditions change and warrant me wearing a mask I will do so.

Noel, I have only one question for you to consider: Can you with absolute, one hundred percent certainty guarantee that you are not infected already, or might become infected sometime?

If not, then how would you feel finding out that you had been infected and had been spreading it around to others unknowingly?

That is, after all, the main purpose of wearing a mask: to protect others!

[W2DR 1,860]

7 hours ago, birdguy said:

Reader, it's not a matter of resisting what you are told.  It's a matter of making a judgement call based on conditions on the ground where you are located at the present time.  I don't feel the need to wear mask in my community AT THIS TIME.  Neither do most of the people here.  Where I to relocate to a community that had hundreds of cases I would surely wear a mask.  

This is not a case 'if I wear a mask then everyone should wear a mask'.  

If local conditions change and warrant me wearing a mask I will do so.

Noel

Have you been tested? If not, how do you know you're not asymptomatic? And even if you tested negative that doesn't mean you won't be positive tomorrow.The purpose of the mask is not to protect you. It's to be sure you don't infect others. I don't think you understand the underlying issues here......

[MartinRex007 390]

There is a term used in the Social Sciences and Economics called Free-Riding, basically it means there are people who benefit from the sacrifices/inconvenience  of others without having to make those same scarifies themselves. Let's use a hypothetical,  In this case an individual chooses to not wear a mask because there are very few cases where he/she lives, however  the reason there are so few  cases is because other people from around the country have wore a mask that helped keep the virus cases low where this person lives. This person benefits but does not make the same sacrifice/inconvenience  that others have had to make. This is known as Free-Riding.

Now having said that I suspect all of us in one form or another are guilty of Free-Riding  at one time or another. Just another way of looking at this!

Martin

Edited May 19, 2020 by MartinRex007

[HiFlyer 9,359]

45 minutes ago, MartinRex007 said:

Now having said that I suspect all of us in one form or another are guilty of Free-Riding  at one time or another. Just another way of looking at this!

The article I linked to a while back regarding Games Theory as applied to this Pandemic covered a lot of ground on Free-Riding.

[MartinRex007 390]

8 minutes ago, HiFlyer said:

covered a lot of ground on Free-Riding.

I'll go back and take a look, thanks!

[HiFlyer 9,359]

1 minute ago, MartinRex007 said:

I'll go back and take a look, thanks!

Actually, after that post, I continued to look into the subject  and did find another interesting article. It's a slightly older one, but it's amazing how accurately it portrays the current Dynamics.

Honestly, it makes me a bit sad. Human selfishness is so predictable. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7124076/