OT Coronavirus: America in chaos, News and Updates. One million Americans dead and counting

[Chris Craig]

Efficiency signifies a peak level of performance that uses the least amount of inputs to achieve the highest amount of output. Efficiency requires reducing the number of unnecessary resources used to produce a given output including personal time and energy

And after they are finished with the first iteration of the vaccine, they can go back and review and mainstream the process to create better efficiency. They cant do that as they go along. You have to have a result that works, and the steps it took to get there, to then go back and change the process to make it quicker. You can't know until you have the result which steps are unnecessary and can be removed from the equation.

 

[kjironman1]

But, that comes after you get to the result, not during. After scientists figure out the vaccine, then they look to remove the adverse effects. That is why vaccines take a while to make. You have to figure out what works against coronavirus and then test it for adverse effects, then work to remove/stabilize those effects. Then test it again. And, there are usually many adverse effects when you test it, so you have to go back and account for all of those. It is a lot of work and it takes time. It can be done in a month.

Fauchi said 18 months would be reasonable in April with very fast being a year


IF EVER!

He specifically said there was a chance no vaccine is ever produced. There is always a chance they cannot get one. Just better ways to treat it.

 

[wizenheimer]

I don’t. Neither do you.

I'm not the one arguing for the whole thing to be rushed...you are

the NY Times is reporting tonight that the trump white house, thru HHS, changed the testing guidelines for Covid published by the CDC at the end of August, and did so even though the CDC and several of the scientists there objected to the changes vigorously and said they were bad guideline. The CDC was told they weren't the final authority on testing...the white house was. Further, the reporting is there will be more changes in CDC guidelines tomorrow...again, over the objections of the CDC

this sure as hell appears to be politics corrupting processes and protocols that are based upon science and medicine. And THAT, is exactly the lesson the trump administration teaches.

https://www.nytimes.com/2020/09/17/world/covid-19-coronavirus.html?action=click&module=Top Stories&pgtype=Homepage

why in the hell would any aware person believe that trump isn't working hard to corrupt the vaccine testing process? He has corrupted and broken every thing he's touched in the last 44 months. His deadline is election day. A woman who has worked in the trump white house on the Covid task force came out today and said that trump is essentially evil and doesn't give a shit about the impact of covid on anybody but himself

from what I know, and people can correct me if I'm wrong, all these phases of trials are conducted by the drug manufacturer. There are FDA and CDC guidelines that are supposed to adhere to but how the fuck do we know that those guidelines haven't already been altered by the white house? And then, those companies are supposed to submit the data to the 'authorities' for analysis and either approval or an emergency use authorization (EUA). Anthony Fauci said tonight that in the past there was excellent transparency in the process that instills confidence. I'm hoping that's still true, but if trump is involved, and he is, there's plenty of reason for concern

and of course the big problem is that nobody trusts trump, even his supporters. An early turnout of a vaccine will be looked at with wide skepticism. That's just another way that trump has poisoned the waters.

 

[Hoopguru]

And after they are finished with the first iteration of the vaccine, they can go back and review and mainstream the process to create better efficiency. They cant do that as they go along. You have to have a result that works, and the steps it took to get there, to then go back and change the process to make it quicker. You can't know until you have the result which steps are unnecessary and can be removed from the equation.

Good points.

 

[SlyPokerDog]

Again, I am going to wait a few months after the vaccines are out and then I will talk with my doctor about which one is best for me.

I suggest everyone does something similar.

 

[tlongII]

I'm not the one arguing for the whole thing to be rushed...you are

the NY Times is reporting tonight that the trump white house, thru HHS, changed the testing guidelines for Covid published by the CDC at the end of August, and did so even though the CDC and several of the scientists there objected to the changes vigorously and said they were bad guideline. The CDC was told they weren't the final authority on testing...the white house was. Further, the reporting is there will be more changes in CDC guidelines tomorrow...again, over the objections of the CDC

this sure as hell appears to be politics corrupting processes and protocols that are based upon science and medicine. And THAT, is exactly the lesson the trump administration teaches.

https://www.nytimes.com/2020/09/17/world/covid-19-coronavirus.html?action=click&module=Top Stories&pgtype=Homepage

why in the hell would any aware person believe that trump isn't working hard to corrupt the vaccine testing process? He has corrupted and broken every thing he's touched in the last 44 months. His deadline is election day. A woman who has worked in the trump white house on the Covid task force came out today and said that trump is essentially evil and doesn't give a shit about the impact of covid on anybody but himself

from what I know, and people can correct me if I'm wrong, all these phases of trials are conducted by the drug manufacturer. There are FDA and CDC guidelines that are supposed to adhere to but how the fuck do we know that those guidelines haven't already been altered by the white house? And then, those companies are supposed to submit the data to the 'authorities' for analysis and either approval or an emergency use authorization (EUA). Anthony Fauci said tonight that in the past there was excellent transparency in the process that instills confidence. I'm hoping that's still true, but if trump is involved, and he is, there's plenty of reason for concern

and of course the big problem is that nobody trusts trump, even his supporters. An early turnout of a vaccine will be looked at with wide skepticism. That's just another way that trump has poisoned the waters.

No I’m not. I’m arguing that a vaccine will be available for at risk people by December.

 

[SlyPokerDog]

No I’m not. I’m arguing that a vaccine will be available for at risk people billionaires, politicians, and professional athletes by December.

FTFY

 

[SlyPokerDog]

 

[SlyPokerDog]

This is what happens when you cut out testing.

LOOK AT IT!

 

[tlongII]

This is what happens when you cut out testing.

LOOK AT IT!

I would eat that.

 

[crandc]

Where it was possible without a lessor result. If it is a perfect process with no room to improve the result, let it be. Think of all the steps on achieving a result and evaluate if there is a way to improve the product or process?

Yes, with more resources more staff can be hired and best equipment purchased. It's why big pharma has advantage over start-ups. But eventually you need double blind trials in thousands of people, not just numbers but diverse population, and that simply cannot be rushed.

 

[BigGameDamian]

 

[Lanny]

there is not "too much at stake" to justify getting things wrong when it comes to a vaccine. There's no good justification for shit-canning protocols that have been put in place for excellent reasons. The process has been incredibly rushed to this point, meaning that the danger of eliminating essential stages is much higher. And it's ridiculously obvious that trump and his sheeple are doing everything they can to get something out before the election. It's just as obvious they don't give a shit if the vaccine is safe, just as long as it's something trump can brag about

if you want to know how and why the phase 1, phase 2, & phase 3 trials came to be protocols, followed by efficacy and anti-body testing, followed by a set period of time to study side effects, then read up about the disaster of the first polio vaccine:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1383764/

Also, check out the history of thalidomide.

 

[Lanny]

Maybe he will get it

Pray all you want but our dream won't come true.

 

[Lanny]

And after they are finished with the first iteration of the vaccine, they can go back and review and mainstream the process to create better efficiency. They cant do that as they go along. You have to have a result that works, and the steps it took to get there, to then go back and change the process to make it quicker. You can't know until you have the result which steps are unnecessary and can be removed from the equation.

That's actually the proper paradigm for any large project development. You iterate in on the optimum solution. I learned this in software development.

 

[ABM]

 

[andalusian]

The Trump administration cut positions in China as part of it's efficiency improvement. We have all seen what that meant for early decisive action against this virus.

There is efficiency and there is lunacy. If you get to the market first but it bankrupts you because the product is defective - it is not efficiency - so any vaccine that arrives this early is to be suspect for a good reason.

 

[tlongII]

Any approval process led by a government entity, like the FDA, is subject to improvement.

 

[Chris Craig]

Any approval process led by a government entity, like the FDA, is subject to improvement.

Sure. Once they have an iteration of the vaccine that works even imperfectly, they can improve subsequent iterations to work better, have less adverse effects, etc.

But, it seems you are suggesting they improve the process before they have a workable vaccine. That isn't how it works.

 

[Hoopguru]

https://www.oregonlive.com/collegef...-featured-overstated-covid-19-statistics.html

 

[tlongII]

Sure. Once they have an iteration of the vaccine that works even imperfectly, they can improve subsequent iterations to work better, have less adverse effects, etc.

But, it seems you are suggesting they improve the process before they have a workable vaccine. That isn't how it works.

It's exactly how it works. Process improvements are made to speed the product to market without sacrificing quality.

 

[Hoopguru]

It's exactly how it works. Process improvements are made to speed the product to market without sacrificing quality.

There are gates in the process, and innovation and development are always a criteria in each gate.

 

[BigGameDamian]

https://www.nytimes.com/2020/09/17/health/coronavirus-testing-cdc.html

C.D.C. Testing Guidance Was Published Against Scientists’ Objections

A controversial guideline saying people without Covid-19 symptoms didn’t need to get tested for the virus came from H.H.S. officials and skipped the C.D.C.’s scientific review process

 

[BigGameDamian]

 

[BigGameDamian]

Very soon on CNN Trump Faces and tells more Lies to Reporters.

 

[andalusian]

Very soon on CNN Trump Faces and tells more Lies to Reporters.

This entire presidency is him trying to transition from reality tv to scripted lore

 

[BigGameDamian]

If you need to get vaccinated just go get vaccinated just like if you need a test just go get a tested. It's that easy folks!

 

[wizenheimer]

latest on the "vaccine by Nov 1" hustle by the trumpies:

* " With rising concern that Donald Trump would attempt to push out a vaccine ahead of the election, despite a lack of data on safety and efficacy, nine leading vaccine researchers and manufacturers signed a pledge earlier this month not to submit their vaccine candidates to the FDA until large-scale “Phase 3” trials have been completed. However, with Trump promising a vaccine “very soon” since the beginning of March, and the CDC shocking states by telling them to prepare for a vaccine by Nov. 1, restoring faith in the vaccine process called on many to demand that the manufacturers practice radical transparency by releasing their plans for testing.

On Thursday, two of the leading vaccine manufacturers—Moderna and Pfizer—did exactly that by releasing detailed plans for their Phase 3 testing. Moderna’s 135-page description covers how they plan to distribute vaccines among 30,000 volunteers, with results expected in November. Pfizer’s plan includes 44,000 volunteers and does not give an expected date for completion of Phase 3.

Both companies have triggers that could end the trial early, including triggers that might show the vaccine was ineffective. However, even if the trials ended in the next two months, the companies acknowledge that analysis of the data—an absolute necessity to properly assess safety, efficacy, and proper dosage—could take several months more.

All of this supports previous statements by National Institute of Allergy and Infectious Disease Director Dr. Anthony Fauci and CDC Director Robert Redfield, both of whom have said that vaccines are not likely to be available to the general public until sometime well into 2021."
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so, in other words, phase 3 trials are a long ways from being finished. Very well might not be done until at least November
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* " Moderna’s candidate vaccine involves messenger RNA enclosed in a lipid shell. It’s a form of vaccine that has never been approved before in humans. A 2017 review of the company’s efforts suggested that Moderna had “run intotroubling safety problems with its most ambitious therapy” and that in order to get its vaccine technology approved the “unicorn” biotech startup was “in need of a Hail Mary” to survive.

For Moderna, their COVID-19 vaccine is that Hail Mary. They really, really need this to work. That could lead to a company pushing too hard for success, and Moderna’s rapid release of early data from Phase 1 and 2 trials only amplified those concerns. However, the Phase 3 trial looks to be, if anything, conservative in its approach.

At this point, Moderna has already enrolled over 25,000 volunteers, 10,000 of whom have received their first dose of vaccine. The plan is to enroll 5,000 more, with half of volunteers eventually receiving an initial shot of vaccine followed by a booster, with a total dosage of 100 μg. That dosage is in the middle of the levels used in Phase 2 testing, where some patients who received a higher dose reported moderate reactions. The other half of volunteers will receive a placebo."
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* " COVID-19 infection rates among patients receiving the vaccine vs. those receiving the placebo will be compared after 53 cases of COVID-19 have been diagnosed. This point represents a potential early stopping point at which the vaccine may be found to be particularly effective or ineffective. Moderna is shooting for a minimum of 74% efficacy to consider the vaccine a success. So, if the magic number of 53 cases is reached, and more than 74% of those are among the placebo group, that could be a point where the company declares “good enough.” Likewise, if the vaccine proves less than 74% effective at that point, the trial could be suspended or halted. As was recently seen with the AstraZeneca trial of the vaccine developed at Oxford, any safety issue that pops up could also suspend or halt the trial."
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granted that I don't know much about the logistics of a trial like this, but out of 30,000 people, a 39 out of 53 infection rate among the placebo trial seems a might small sample size
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* " Pfizer, which has partnered with German tech firm BioNTech, has a similar plan overall. Their vaccine is also using a new technology based on messenger RNA, and while this is not a make-or-break moment for this large, established pharmaceutical company, there’s little doubt they want a share of the multibillion dollar pie for COVID-19, as well as the chance to fast track future mRNA vaccines using their technology, which involves a different delivery system than Moderna. Both of these companies aren’t just competing to deliver a vaccine for COVID-19: They’re hoping to open the door to a whole new approach to vaccines that could greatly extend the range of what we think of as a “vaccine.”

Pfizer plans to enroll 44,000 volunteers, also equally split between those receiving the vaccine and the placebo. And, like Moderna, they also have a number of cases that will trigger a first analysis. In Pfizer’s case, that number is 32. With a larger number of volunteers and a smaller number of cases required to trigger a possible halt, it can be argued that Pfizer is actually hurrying things along more aggressively than Moderna."
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* " Moderna’s plan also includes a timeline that suggests that first analysis of Phase 3 results is not likely before November, and may not happen until some time in late December. Final analysis before distribution of vaccine is not expected before spring of 2021.

Pfizer does not provide a detailed timeline for its plan, but it’s safe to assume it cannot possibly meet Donald Trump’s claims that a vaccine would be available as soon as October, because Pfizer is not even halfway through enrolling people for their trial. Their overall timeline is likely to be similar to that of Moderna, putting a vaccine on the street (i.e. at your local clinic) around the second quarter of 2021."
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* " Earlier this week, after Redfield once again testified to Congress that a vaccine was unlikely to be available this year and stated that a mask may be more effective than a vaccine, Trump hurried to contradict the CDC director, saying, “It’s just incorrect information.” Which is exactly the kind of statement that has half of American adults unwilling to take a COVID-19 vaccine under Trump"

https://www.dailykos.com/stories/20...-the-vaccine-manufacturers-say-not-until-2021
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those two of the leading vaccine candidates since the AstraZeneca/Oxford vaccine testing was suspended. There are others obviously, but I'm wondering how much reason there is to expect something different by those other candidates

and it's why all the predictions by trump of a vaccine by election day creates massive cynicism about the process itself if any vaccine comes out that early. This would not be about "efficiency" or any of the other lame-ass reasons for speeding the process

 

[BigGameDamian]

 

[barfo]

Again, I am going to wait a few months after the vaccines are out and then I will talk with my doctor about which one is best for me.

I suggest everyone does something similar.

I'd be happy to talk to your doctor about which vaccine is right for you. What is his name, and also I need to know a little bit about you (breed, age, whether you've had your other shots)

barfo