NON_POLITICAL China Coronavirus THREAD

[Red Squirrel]

That's the sad part about all this, all the small businesses are the ones that really suffer. The system as a whole is not designed to cater to small business at all. Just try to start any kind of business - especially food, and you will see the amount of red tape and BS you have to go through. The big chains don't have this problem. In fact if a big chain wants to establish themselves in a given city they usually get tax breaks! Meanwhile a mom and pop shop will be taxed to oblivion because they are running a business. Not just taxes, but everything else is anti business, insurance too. They will want to charge you way more because you're trying to make a living. Even vendors. As a business you want to serve pop? You need to pay up. You can't just go to the grocery store and buy it for $5/case. Everything works against you when you are trying to run a small business.

This pandemic has just reinforced just how unfriendly the system is to small business. The big business bilionaires on the other hand they are just racking in record profits. If Jeff Bezos had his way I'm sure there would be a new virus every year. Amazon is doing great right now.

 

[ultimatebob]

Let them die.

Yeah, screw 'em. Those poor folks can't afford Tesla products anyway

 

[K1052]

A mask is not the end-all-be-all of obtaining or not obtaining the virus.

Regardless, we are getting thousands and thousands of cases DAILY. But for some reason we never talk about effectively fighting the virus if obtained.

No that's a vaccine but masks are a very effective mitigation. So people should wear them. They also lower the does you encounter which is good news for people's immune systems.

 

[K1052]

No company should submit for an EUA or release their doses to the government until at least 50% of the candidate group has had the 2nd dose for two months. Political influence around this decision is unacceptable and will result in a tremendous loss of already limited confidence in what could be effective vaccines.

https://twitter.com/x/status/1313259190610268161

 

[Svnla]

In other news, super bugs are lurking in the background.

https://www.yahoo.com/news/while-world-gripped-covid-19-162427627.html

 

[Roger Wilco]

Michigan's conservative-leaning supreme court recently struck down our mask mandate as unconstitutional. This is especially idiotic considering our case numbers aren't exactly going in the right direction as we head into colder weather.

Fortunately the DHHS just stepped in and reinforced their own mask mandate.

 

[CZroe]

Michigan's conservative-leaning supreme court recently struck down our mask mandate as unconstitutional. This is especially idiotic considering our case numbers aren't exactly going in the right direction as we head into colder weather.

Fortunately the DHHS just stepped in and reinforced their own mask mandate.

Determining constitutionality has nothing to do with whether a mask mandate is idiotic or not. They can't just call the mandate "constitutional" because not wearing masks is dumb.

Much more is at stake than some flash in the pan virus when you erode checks and balances and distort constitutional powers for some momentary issue such as COVID-19.

 

[Roger Wilco]

Determining constitutionality has nothing to do with whether a mask mandate is idiotic or not. They can't just call the mandate "constitutional" because not wearing masks is dumb.

Much more is at stake than some flash in the pan virus when you erode checks and balances and distort constitutional powers for some momentary issue such as COVID-19.

I'm commenting on the timing of this decision. This seems like the worst time to be telling people they don't have to wear a mask.

If they decide that this is an overreach of power via executive order, I genuinely don't care. What I do care about is the timing of this ruling, the lives it will cost, and the danger it presents to my family.

 

[CZroe]

I'm commenting on the timing of this decision. This seems like the worst time to be telling people they don't have to wear a mask.

If they decide that this is an overreach of power via executive order, I genuinely don't care. What I do care about is the timing of this ruling, the lives it will cost, and the danger it presents to my family.

I see. I, too, would've preferred they delay the decision until after the pandemic has died down but I don't know the ins and outs of their state's Supreme Court and maybe that would have exposed them to liability.

 

[Roger Wilco]

I see. I, too, would've preferred they delay the decision until after the pandemic has died down but I don't know the ins and outs of their state's Supreme Court and maybe that would have exposed them to liability.

I am not terribly familiar with it either (although I probably should be). You could be right.

 

[K1052]

Outrageous and wrong.

https://twitter.com/x/status/1313528980742590466

 

[CZroe]

Outrageous and wrong.

https://twitter.com/x/status/1313528980742590466

I found something else in that article to be angry about:

Inglesby was one of the dozens of scientists who recently penned a letter to Pfizer asking the company to wait until at least November before it seeks approval for its vaccine.
"Their CEO is the only CEO who's been really outspoken about saying we'll know by October," said Dr. Eric Topol, executive vice president of Scripps Research, who also signed the letter.

Where is the science in pushing Pfizer back "until at least November" if the trials have completed successfully? Sounds arbitrary AF, unless you consider ulterior motives. Pfizer has no control over how fast the regulatory agencies approve of it and holding back before submitting it can only make them rush the regulatory process even more.

Phase II has already been completed. Project Warp Speed merely accelerates the regulatory side after they submit the data and request approval. Pfizer set a self-imposed October target many months ago without any government deals. No matter how many times Trump has called to check on the status and ask if they can speed it up, that was still their own self-imposed timeline. Some would say they expect the President to make calls like that to stay on top of things, so that may not be as concerning as it initially appears (damned if he does, damned if he doesn't).

Furthermore, Pfizer denies any outside influence while claiming to be "moving at the speed of science," so what business does this group have arbitrarily telling Pfizer to wait until November?

To me, it sounds like hypocritical politics or salty competition in science/medicine all while condemning that behavior in the same breath.

 

[K1052]

Where is the science in pushing Pfizer back "until at least November" if the trials have completed successfully? Sounds arbitrary AF, unless you consider ulterior motives. Pfizer has no control over how fast the regulatory agencies approve of it and holding back before submitting it can only make them rush the regulatory process even more.

Ultimately creating a vaccine for the coronavirus does not appear to be exceptionally challenging technologically. What is challenging is the political atmosphere that has fostered skepticism of the products that will emerge because of political interference and pressure on the companies which it appears Trump is personally applying. The Phase III won't be completed rather stopped if it meets an interim goal, there is a legit argument that the original FDA guidance for an EUA was insufficiently rigorous. Letting the trial go longer will improve confidence, provide more data, and hopefully provide ample evidence that the vaccine is protective from severe disease.

Phase II has already been completed. Project Warp Speed merely accelerates the regulatory side after they submit the data and request approval. Pfizer set a self-imposed October target many months ago without any government deals. No matter how many times Trump has called to check on the status and ask if they can speed it up, that was still their own self-imposed timeline. Some would say they expect the President to make calls like that to stay on top of things, so that may not be as concerning as it initially appears (damned if he does, damned if he doesn't).

He is trying to face an announcement before the election. I don't really care what Pfizer said about their timeline. They slip or are moved for good reason and the reasons the FDA has are sufficiently good IMO for the above reasons. Warp Speed is mostly about money. Money to do trials, money to develop, money to manufacture at risk.

Furthermore, Pfizer denies any outside influence while claiming to be "moving at the speed of science," so what business does this group have arbitrarily telling Pfizer to wait until November?

The additional requirements include the prevention of severe COVID. Seems worthwhile to know if the vaccine can do that.

 

[jpiniero]

There's obviously an advantage to being first. I doubt Pfizer cares about helping Trump, it's about being first.

Is Pfizer really that close? I haven't been following it too much.

 

[Brainonska511]

There's obviously an advantage to being first. I doubt Pfizer cares about helping Trump, it's about being first.

Is Pfizer really that close? I haven't been following it too much.

For these companies, it isn't just about 'being first'. They recognize that a lot of their other, extremely profitable lines, also rely on maintaining a reputation for safe and effective products. It isn't in their interest to bend the rules or take shortcuts.

And with the new FDA rule requiring a median follow-up of 2 months from the last dose of study drug and some additional data, I doubt we'll see anything approved before election day. And that's a good thing. Regulatory agencies, especially for medicines, should be grounded in reality and only approve things backed by good scientific data. If the process pushes vaccines out, it pushes them out.

 

[jpiniero]

For these companies, it isn't just about 'being first'. They recognize that a lot of their other, extremely profitable lines, also rely on maintaining a reputation for safe and effective products. It isn't in their interest to bend the rules or take shortcuts.

I'm sure that's a factor as to whether they do submit at the end of October. But being first means a lot more money.

Imagine Trump telling Pfizer's CEO that if he manages to get approval before the election that he will find a way to get the Federal Government to buy a hundred million vaccines or some crazy number. After the election, no deal.

 

[Brainonska511]

I'm sure that's a factor as to whether they do submit at the end of October. But being first means a lot more money.

Eh - there is more than enough money to go around with the vaccine project. They are already being paid to manufacture at risk, and its quite clear that a single company's product will not meet the entirety of the demand for a vaccine.

Plus, never forget that there is a lot more money to be made on every other product they sell. If they inappropriately burn their reputation on this, they'll likely see hits elsewhere in their current brands and future pipelines.

 

[jpiniero]

Eh - there is more than enough money to go around with the vaccine project. They are already being paid to manufacture at risk, and its quite clear that a single company's product will not meet the entirety of the demand for a vaccine.

Plus, never forget that there is a lot more money to be made on every other product they sell. If they inappropriately burn their reputation on this, they'll likely see hits elsewhere in their current brands and future pipelines.

I could see them thinking people will just blame Trump if things were to go bad.

 

[CZroe]

Ultimately creating a vaccine for the coronavirus does not appear to be exceptionally challenging technologically. What is challenging is the political atmosphere that has fostered skepticism of the products that will emerge because of political interference and pressure on the companies which it appears Trump is personally applying. The Phase III won't be completed rather stopped if it meets an interim goal, there is a legit argument that the original FDA guidance for an EUA was insufficiently rigorous. Letting the trial go longer will improve confidence, provide more data, and hopefully provide ample evidence that the vaccine is protective from severe disease.

Continuing longer than they need to comes at a cost too when the virus continues to spread through the population unabated. It's a balancing act for sure. There are other things they can do to improve confidence and get more data without extending the length of the trial... like increasing the size of the trial. They did that. Obviously, it's not the same data they would get from a longer trial, but it's something. Since Phase II is already completed we should be passed the need to demonstrate safety.

Even if we decrease confidence in the efficacy by rushing Phase III and the regulatory process, the risk vs. reward seems to make it worth it. So what if it's 50% effective versus 60% effective if we can roll it out months before one lands that's 60+% effective? That's still getting a vaccine earlier than we otherwise would have without significant risks.

He is trying to face an announcement before the election. I don't really care what Pfizer said about their timeline. They slip or are moved for good reason and the reasons the FDA has are sufficiently good IMO for the above reasons. Warp Speed is mostly about money. Money to do trials, money to develop, money to manufacture at risk.

If the FDA wants to add a two-month delay from the final dose of Phase III before a drug company can submit for regulatory approval then it will result in Phase III trials being truncated rather than expanded/lengthened.

The additional requirements include the prevention of severe COVID. Seems worthwhile to know if the vaccine can do that.

Which is what Phase III is supposed to determine/prove... not whatever delay we can concoct after Phase III concludes. Delaying the filing/submission of a completed trial for regulatory approval only delays the regulatory process for what is essentially a proven treatment... unless the Phase III trials show the opposite and the FDA denies it on those grounds. In that case the drug company had no business submitting for approval. We will see, but throwing up an arbitrary delay runs counter to what you want.

 

[Brainonska511]

I could see them thinking people will just blame Trump if things were to go bad.

I don't think they're that short sighted. The populace might blame Trump of something went wrong, but who do you think prescribes the drugs? Physicians. If they don't trust a company in one area, do you think they're going to prescribe their products?

The people in charge of these companies know all of this calculus. And on top of all that, these companies arent mobolithic in their internal structures. People in charge of commercial activities in these companies and the people responsible for the medical and regulatory sides are very different, with distinct motivations

 

[K1052]

I’ll address the above when I’ve had less to drink.

Somebody needs to shoot Trump’s phone into orbit because he’s tweeting about this now.

 

[Brainonska511]

Continuing longer than they need to comes at a cost too when the virus continues to spread through the population unabated. It's a balancing act for sure. There are other things they can do to improve confidence and get more data without extending the length of the trial... like increasing the size of the trial. They did that. Obviously, it's not the same data they would get from a longer trial, but it's something. Since Phase II is already completed we should be passed the need to demonstrate safety.

Safety must be demonstrated at every step of the clinical development process. Two big safety factors to come out of a large, Phase 3 trial: potential to see rare adverse events that you wouldn't see on a smaller trial, and adverse events versus some control group, so you know what's potentially drug-related and what's not. You're about to give a vaccine to millions of people - you sure as shit want to know if there is some rare adverse event to keep an eye out for.

Even if we decrease confidence in the efficacy by rushing Phase III and the regulatory process, the risk vs. reward seems to make it worth it. So what if it's 50% effective versus 60% effective if we can roll it out months before one lands that's 60+% effective? That's still getting a vaccine earlier than we otherwise would have without significant risks.

If the FDA wants to add a two-month delay from the final dose of Phase III before a drug company can submit for regulatory approval then it will result in Phase III trials being truncated rather than expanded/lengthened.

Which is what Phase III is supposed to determine/prove... not whatever delay we can concoct after Phase III concludes. Delaying the filing/submission of a completed trial for regulatory approval only delays the regulatory process for what is essentially a proven treatment... unless the Phase III trials show the opposite and the FDA denies it on those grounds. In that case the drug company had no business submitting for approval. We will see, but throwing up an arbitrary delay runs counter to what you want.

It's not a two-month delay for the sake of just delaying. It's demanding that a median number of people get followed for adverse events for 2 months post the last dose. That's a very reasonable request to monitor for rare adverse events that can have onset times in that window.

 

[jpiniero]

The other issue beyond the obvious competition angle is that it seems like people are losing interest. People may simply not bother getting the vaccine if they wait too long, esp without a real second wave.

 

[PlanetJosh]

That's the sad part about all this, all the small businesses are the ones that really suffer. The system as a whole is not designed to cater to small business at all. Just try to start any kind of business - especially food, and you will see the amount of red tape and BS you have to go through. The big chains don't have this problem. In fact if a big chain wants to establish themselves in a given city they usually get tax breaks! Meanwhile a mom and pop shop will be taxed to oblivion because they are running a business. Not just taxes, but everything else is anti business, insurance too. They will want to charge you way more because you're trying to make a living. Even vendors. As a business you want to serve pop? You need to pay up. You can't just go to the grocery store and buy it for $5/case. Everything works against you when you are trying to run a small business.

This pandemic has just reinforced just how unfriendly the system is to small business. The big business bilionaires on the other hand they are just racking in record profits. If Jeff Bezos had his way I'm sure there would be a new virus every year. Amazon is doing great right now.

Some believe most of the wealth in the country which includes businesses that succeeded greatly because of pandemic related services (like Amazon) came from oppression of minorities over the years. It may seem to many that's a political statement and should go over in the other forum. But there are some political overtones in your post and it's still here so let arguments determine the fate of my post.

 

[Brainonska511]

The other issue beyond the obvious competition angle is that it seems like people are losing interest. People may simply not bother getting the vaccine if they wait too long, esp without a real second wave.

We have 40000+ new cases per day across the country with another 700-1500 deaths per day, that is showing no signs of abating. I doubt people will lose interest in getting a vaccine, especially if it lets them get out more, send kids back to school, or even travel.