Swerd

Swerd

Audioholic Warlord
They are taking a risk by manufacturing the vaccines before it is even proven Effective and SAFE.
That's always been true for drug manufacturers. They must have enough supply of newly approved drugs ready to sell the day after the FDA grants them a license to sell. They have to take that risk.

Many vaccines that have been around a while are made by more than one manufacturer. I see no reason why a vaccine directed against SARS-CoV-2 should be any different. More than one type of vaccine is insurance that we all get immunized.

It is highly possible that more than one dose of a vaccine will be needed. If, for example, a primary dose and one booster dose are needed, then twice the number of doses will be needed. That will be determined only by the long term results of wide scale vaccination.
 
AcuDefTechGuy

AcuDefTechGuy

Audioholic Jedi
That's always been true for drug manufacturers. They must have enough supply of newly approved drugs ready to sell the day after the FDA grants them a license to sell. They have to take that risk.
You mean they might start production toward the end of the human trials when they have clear evidence that the drug is both Effective and Safe?

If they have the final conclusive results and the only thing left is waiting for the final approval from the FDA.
 
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M

Mr._Clark

Audioholic Samurai
Pretty easy to do when the people are disciplined and there are less than 9 million of them.
The Wall Street Journal ran an article about how German factories stayed open without causing the virus to spread. The companies there were very proactive and put procedures in place to test workers and minimize spread of the virus in the workplaces.

In this country it seems like we wait for the government to tell us what to do, then we whine and complain about it when the government does tell us what to do (I realize that's a huge generalization that's not true for everyone).

>>>MULFINGEN, Germany—When much of Europe’s economy shut down in mid-March, business kept right on going at Ebm-papst Group, a fan and motor manufacturer based near Germany’s Black Forest.

Throughout the six-week national lockdown that now is gradually being lifted, the family-owned company kept its domestic factories running at 80% of normal capacity, said Chief Executive Officer Stefan Brandl.

Social distancing, ubiquitous face masks, in-house Covid-19 tests and contact-tracing when employees fell ill helped the company keep its plants open. Just 15 of its 6,700 employees in Germany have contracted the virus, the company said.<<<


If the article is behind a pay wall you can sign up for a very cheap trial subscription, but it requires providing a credit card and authorization for automatic renewal after the trial subscription ends. They do not make it easy to cancel (e.g. you cannot do it online) and you have to call them during their normal business hours before the trial period ends and wait until an actual human answers. This can take a while.
 
D

Danzilla31

Audioholic Spartan
The Wall Street Journal ran an article about how German factories stayed open without causing the virus to spread. The companies there were very proactive and put procedures in place to test workers and minimize spread of the virus in the workplaces.

In this country it seems like we wait for the government to tell us what to do, then we whine and complain about it when the government does tell us what to do (I realize that's a huge generalization that's not true for everyone).

>>>MULFINGEN, Germany—When much of Europe’s economy shut down in mid-March, business kept right on going at Ebm-papst Group, a fan and motor manufacturer based near Germany’s Black Forest.

Throughout the six-week national lockdown that now is gradually being lifted, the family-owned company kept its domestic factories running at 80% of normal capacity, said Chief Executive Officer Stefan Brandl.

Social distancing, ubiquitous face masks, in-house Covid-19 tests and contact-tracing when employees fell ill helped the company keep its plants open. Just 15 of its 6,700 employees in Germany have contracted the virus, the company said.<<<


If the article is behind a pay wall you can sign up for a very cheap trial subscription, but it requires providing a credit card and authorization for automatic renewal after the trial subscription ends. They do not make it easy to cancel (e.g. you cannot do it online) and you have to call them during their normal business hours before the trial period ends and wait until an actual human answers. This can take a while.
Thanks for just putting the info out there interesting stuff
 
Mikado463

Mikado463

Audioholic Spartan
while a lot of what is written here is already known, it's a quick read for those interested ..........

 
Swerd

Swerd

Audioholic Warlord
You mean they might start production toward the end of the human trials when they have clear evidence that the drug is both Effective and Safe?
One of the biggest expenses in drug manufacturing is sterile packaging, putting the vaccine material into individual vials while under sterile conditions. The rest of the manufacturing is done in large scale, bulk processing. The bulk vaccine can be stored cold or frozen, and after it's clear that the clinical data looks good, sterile vialing can be done.
 
davidscott

davidscott

Audioholic Spartan
2 White House insiders were tested positive today. No one is immune. I really hope this state by state reopening does not undo the good that supposedly has already been done. But if I was unemployed and broke Id probably want to go back to work myself. Tough choices going forward. :(
 
Swerd

Swerd

Audioholic Warlord
You mean they might start production toward the end of the human trials when they have clear evidence that the drug is both Effective and Safe?
There are more reasons why drug companies must have production up & running long before final FDA approval.

First, they must be able to produce the vaccine, or other drug, that will be used during the clinical trials. It must be made in the same facilities that will be used later if the drug is approved for commercial use.

And before that, they must demonstrate they can successfully produce their drug by making three production runs on a size scale needed for their phase III clinical trials. The results of those runs can be used for animal tests or stability studies, but cannot be used in clinical trials. Data gathered during these production runs must be presented to the FDA as part of the overall approval process.

So yes, large scale manufacturing must be up and running long before final approval.

Imagine if other industries, such as car or airplane manufacturing, had to do the same. Boeing would have had to submit convincing data to the aviation equivalent of the FDA (the FAA doesn't come close) that their 737 Max airliner was both safe and effective. And they would have to do it with a sample of mass produced airplanes, not a hand-made prototype.

The IT industry would have to abandon beta testing as a part of it's software development process.

And I wouldn't know where to begin if I tried to apply this thinking to the coal or petroleum industry.
 
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Swerd

Swerd

Audioholic Warlord
Johnson & Johnson, in an effort to produce a billion vaccine doses, is gearing up four smallish biotech manufacturing plants around the world. These contract plants will be the manufacturing development plants for the clinical trials. One of them, Emergent BioSolutions, is ~50 miles up I-95 from where I live.

Emergent BioSolutions 1.png


Emergent BioSolutions 2.png


The Biomedical Advanced Research and Development Authority (BARDA) is channeling nearly half a billion dollars in emergency funds to Johnson & Johnson to develop a vaccine. BARDA also is providing hundreds of millions of dollars for vaccine efforts by Sanofi, the large French drug company, and Moderna, a biotech company in Massachusetts teaming with a Swiss company for vaccine manufacturing.

It's going to take large scale international coordination to make enough vaccine. This job isn't for rookies or amateurs.

I excerpted this from part of a Washington Post article,
 
D

Danzilla31

Audioholic Spartan
2 White House insiders were tested positive today. No one is immune. I really hope this state by state reopening does not undo the good that supposedly has already been done. But if I was unemployed and broke Id probably want to go back to work myself. Tough choices going forward. :(
Honestly there is a very good chance it is being massively undertested in the states it's already out there way more then we could probably ever realize.

Some testing for antobodies in the population awhile back had the testers thinking it's being underreported by a factor of 50 to 80 times. It's important to note that those tests have some error rates but they said even with those error rates that they are accurate enough to tell us it's being underreported.

What that means is we have to smartly open back up. Because as you correctly pointed out there is no way we can continue to support 30 million unemployed and rising long term the virus is here to stay we are no longer in containment we are in mitigation unfortunately were going to have to learn to coexist with the virus for know don't really have an option at this point.

Like you said Im praying that the reopenings go well we are more educated though then we were in March we know masks distancing and hygiene protocols are effective I have faith we can make it work
 
mtrycrafts

mtrycrafts

Seriously, I have no life.
[
...

And I wouldn't know where to begin if I tried to apply this thinking to the coal or petroleum industry.
May be very simple. There would not be such industry around. ;):)
 
M

Mr._Clark

Audioholic Samurai
I'm guessing a lot of people saw this already, but here's a pessimistic take on the situation by Dr. Michael Osterholm:

>>>Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the initial wave of outbreaks in cities such as New York City, where one in five people have been infected, represent a fraction of the illness and death yet to come.

"This damn virus is going to keep going until it infects everybody it possibly can," Osterholm said Monday during a meeting with the USA TODAY Editorial Board. "It surely won’t slow down until it hits 60 to 70%" of the population, the number that would create herd immunity and halt the spread of the virus. . . .

"It’s the big peak that’s really going to do us in," he said. "As much pain, suffering, death and economic disruption we’ve had, there’s been 5 to 20% of the people infected, ... That’s a long ways to get to 60 to 70%." . . .

Osterholm said only an effective vaccine can slow the virus before a large enough segment of the population becomes infected and develops some level of immunity. Even if a vaccine works, Osterholm said, it's unknown whether it would be durable enough to confer long-lasting protection from SARS CoV-2, the virus that causes COVID-19.<<<

 
M

Mr._Clark

Audioholic Samurai
The results of the MLB antibody testing has also made the news recently. Some aspects are potentially good news:

>>>Researchers revealed Sunday that 70% of those who tested positive for COVID-19 antibodies — a sign of previous infection — reported no symptoms, bolstering the idea that the disease is more prevalent than one would guess based on those who appear sick.

“It’s sometimes a very deadly disease, but it’s most often asymptomatic or mild, especially in this kind of relatively healthy population,” Dr. Jay Bhattacharya, a Stanford professor who ran the study, said on a conference call with reporters. “What we learned from this study is, nationwide, the range of clinical presentations include a substantial amount of people who are infected with the disease but have very few symptoms and don’t proceed to the viral pneumonia.”<<<

It would be interesting to track this group to see how many (if any) who showed no symptoms later developed symptoms.

The low infection rate strikes me as being bad news, especially if Dr. Osterholm is correct:

>>>The study found antibodies in just 0.7% of subjects, about 40 people after researchers accounted for false positive and false negative rates. That was lower than Bhattacharya expected but still seven times the rate of infection based on confirmed COVID-19 cases.<<<

 
TLS Guy

TLS Guy

Seriously, I have no life.
Honestly there is a very good chance it is being massively undertested in the states it's already out there way more then we could probably ever realize.

Some testing for antobodies in the population awhile back had the testers thinking it's being underreported by a factor of 50 to 80 times. It's important to note that those tests have some error rates but they said even with those error rates that they are accurate enough to tell us it's being underreported.

What that means is we have to smartly open back up. Because as you correctly pointed out there is no way we can continue to support 30 million unemployed and rising long term the virus is here to stay we are no longer in containment we are in mitigation unfortunately were going to have to learn to coexist with the virus for know don't really have an option at this point.

Like you said Im praying that the reopenings go well we are more educated though then we were in March we know masks distancing and hygiene protocols are effective I have faith we can make it work
WHO does not agree with you. You are banking on herd immunity. This is well debunked now. Estimates of 100% unreported or silent are drastically over optimistic. There is good evidence now showing it is not greater than 10% and almost certainly less. So mortality per 1000 population data is useless and worse miss leading and fueling idiots. We now are getting a better handle in the infection case fatality rate and its 1.3% That is appalling. 40% of these deaths are in younger age groups.

Now we have late effects from vasculitis in children and now young adults. No one knows where this will lead.

Another not widely talked about, but of even greater import is the burden of care. This illness is actually not mild for most but severe for most. In numerous cases not severe enough to go to hospital recovery is very slow to non existent in many healthy younger and formerly athletic adults. There are now increasing reports of people who used to run or bike and now can't even though they have so called recovered two months ago. There has been no time to devote to this to find out why. However increasingly my medical colleagues are worried about a legacy of chronic illness. Are we going to have a generation of people carting around oxygen tanks in ten years or so. I hope not, but we easily could, if this virus is casing permanent lung damage, which it may be. We will only find this out later.

My ND colleagues tell me the clotting problem is appalling. Two cases in Fargo are interesting and highlight the problem. A young athletic man of 32 presented with a stroke but was otherwise perfectly well. Despite testing negative for Covid 19 they followed the Covid 19 clotting protocol. On his third PCR test, he tested positive. So he had a serious problem before he was shedding enough virus to be detected. He is making a good recovery.

Next case. A previously healthy 25 year old worker, presented with Covid 19 and had rapid decline and had to go on the ventilator. He had numerous clotting issues from the outset, involving heart, brain and kidneys. He had one cardiac arrest. He is vented and on dialysis. He is not expected to survive.

As of last week there were 17 vented patients in the Covid 19 unit at Sandford Health Fargo. They have lost two patients in the ICU previously with one recovery so far. Most of those 17 in the ICU last Wednesday will either not survive are be compromised.

So one of the worst legacies of this crisis may well turn out to be be a dreadful burden of chronic care for large numbers of people severely and permanently damaged by this ghastly virus.

My advice to everyone is to do everything in your power to avoid getting this virus and hope the misery is ended by a vaccine. That is I fear the best outcome we can hope for.

So anyone who thinks it OK to go to Church, a concert, bar or restaurant or any place you don't actually have to before we have a vaccine is misguided.
 
D

Danzilla31

Audioholic Spartan
WHO does not agree with you. You are banking on herd immunity. This is well debunked now. Estimates of 100% unreported or silent are drastically over optimistic. There is good evidence now showing it is not greater than 10% and almost certainly less. So mortality per 1000 population data is useless and worse miss leading and fueling idiots. We now are getting a better handle in the infection case fatality rate and its 1.3% That is appalling. 40% of these deaths are in younger age groups.

Now we have late effects from vasculitis in children and now young adults. No one knows where this will lead.

Another not widely talked about, but of even greater import is the burden of care. This illness is actually not mild for most but severe for most. In numerous cases not severe enough to go to hospital recovery is very slow to non existent in many healthy younger and formerly athletic adults. There are now increasing reports of people who used to run or bike and now can't even though they have so called recovered two months ago. There has been no time to devote to this to find out why. However increasingly my medical colleagues are worried about a legacy of chronic illness. Are we going to have a generation of people carting around oxygen tanks in ten years or so. I hope not, but we easily could, if this virus is casing permanent lung damage, which it may be. We will only find this out later.

My ND colleagues tell me the clotting problem is appalling. Two cases in Fargo are interesting and highlight the problem. A young athletic man of 32 presented with a stroke but was otherwise perfectly well. Despite testing negative for Covid 19 they followed the Covid 19 clotting protocol. On his third PCR test, he tested positive. So he had a serious problem before he was shedding enough virus to be detected. He is making a good recovery.

Next case. A previously healthy 25 year old worker, presented with Covid 19 and had rapid decline and had to go on the ventilator. He had numerous clotting issues from the outset, involving heart, brain and kidneys. He had one cardiac arrest. He is vented and on dialysis. He is not expected to survive.

As of last week there were 17 vented patients in the Covid 19 unit at Sandford Health Fargo. They have lost two patients in the ICU previously with one recovery so far. Most of those 17 in the ICU last Wednesday will either not survive are be compromised.

So one of the worst legacies of this crisis may well turn out to be be a dreadful burden of chronic care for large numbers of people severely and permanently damaged by this ghastly virus.

My advice to everyone is to do everything in your power to avoid getting this virus and hope the misery is ended by a vaccine. That is I fear the best outcome we can hope for.

So anyone who thinks it OK to go to Church, a concert, bar or restaurant or any place you don't actually have to before we have a vaccine is misguided.
Actually I'm not banking on herd immunity. There is real debate amongst scientists what that even means. There not even sure how much or how long you have immunity once you get past clearing it the first time

What I am banking on is REALITY. Sports can't reopen mass gatherings won't happen and most people with the rightful concern of this virus and with the depression coming will limit there activity anyway combine with proper procedures such as social distancing face masks hand washing will slow it enough that we can learn to live through it

I'm banking on enough of the economy restarts to keep our Medical facilities open and ALL vital medical procedures can get done

Because our hospitals are going BANKRUPT in this country waiting for COVID
 
highfigh

highfigh

Seriously, I have no life.
So anyone who thinks it OK to go to Church, a concert, bar or restaurant or any place you don't actually have to before we have a vaccine is misguided.
South Korea had opened some of their clubs last week and now, they're closed- apparently, a pinhead who was COVID positive went to three different clubs and has infected a good number of people. I have seen ads for FLIR thermal cameras that are meant to be used for scanning people as they approach a building entrance- I think that should be required, privacy concerns aside; there's no expectation of privacy in a public space and these cameras don't log any identity.
 
D

Danzilla31

Audioholic Spartan
WHO does not agree with you. You are banking on herd immunity. This is well debunked now. Estimates of 100% unreported or silent are drastically over optimistic. There is good evidence now showing it is not greater than 10% and almost certainly less. So mortality per 1000 population data is useless and worse miss leading and fueling idiots. We now are getting a better handle in the infection case fatality rate and its 1.3% That is appalling. 40% of these deaths are in younger age groups.

Now we have late effects from vasculitis in children and now young adults. No one knows where this will lead.

Another not widely talked about, but of even greater import is the burden of care. This illness is actually not mild for most but severe for most. In numerous cases not severe enough to go to hospital recovery is very slow to non existent in many healthy younger and formerly athletic adults. There are now increasing reports of people who used to run or bike and now can't even though they have so called recovered two months ago. There has been no time to devote to this to find out why. However increasingly my medical colleagues are worried about a legacy of chronic illness. Are we going to have a generation of people carting around oxygen tanks in ten years or so. I hope not, but we easily could, if this virus is casing permanent lung damage, which it may be. We will only find this out later.

My ND colleagues tell me the clotting problem is appalling. Two cases in Fargo are interesting and highlight the problem. A young athletic man of 32 presented with a stroke but was otherwise perfectly well. Despite testing negative for Covid 19 they followed the Covid 19 clotting protocol. On his third PCR test, he tested positive. So he had a serious problem before he was shedding enough virus to be detected. He is making a good recovery.

Next case. A previously healthy 25 year old worker, presented with Covid 19 and had rapid decline and had to go on the ventilator. He had numerous clotting issues from the outset, involving heart, brain and kidneys. He had one cardiac arrest. He is vented and on dialysis. He is not expected to survive.

As of last week there were 17 vented patients in the Covid 19 unit at Sandford Health Fargo. They have lost two patients in the ICU previously with one recovery so far. Most of those 17 in the ICU last Wednesday will either not survive are be compromised.

So one of the worst legacies of this crisis may well turn out to be be a dreadful burden of chronic care for large numbers of people severely and permanently damaged by this ghastly virus.

My advice to everyone is to do everything in your power to avoid getting this virus and hope the misery is ended by a vaccine. That is I fear the best outcome we can hope for.

So anyone who thinks it OK to go to Church, a concert, bar or restaurant or any place you don't actually have to before we have a vaccine is misguided.
You remind me of a part off the movie Jurrasic park where Jeff Goldblum tells the scientists just because you could you never stopped to think if you should.

Lockdown was necessary to slow the spread

But it is not SUSTAINABLE long term

For someone who is so intelligent I can't understand why you and other providers simply can't stomach the big picture?

The big picture is India has 1.5 million cases of tuberculosis already going untreated

The big picture is diseases scientists thought we'd gained the upper hand on while ravage the poor across the world especially when we can no longer afford vaccines for then to the poor of the world

The big picture is the WHO has already estimated 125 million across the world will die of starvation due to the lockdowns in place now that will increase if continued

The big picture is that it could take years to develop a vaccine and if even done it may not be completely effective especially if we can't fully develop herd immunity which is partly why you develop vaccines in the first place

The big picture is 75000 Americans are already projected to commit suicide from this and that's just here not even worldwide

The big picture is many more will die from violence and child abuse and domestic violence and war and this will increase child abuse

The big picture is our medical system will collapse well before COVID can overrun us The lives lost from that will be a lot of people aren't getting there dialysis done chemotherapy treatments are being delayed elective procedures that actually will became life threatening if not eventually done will be delayed

The big picture is we our already experiencing disruptions to our food supply chain

The big picture is we will have massive inflation that will cripple our children and grandchildres ability to make any type of living at all

The big picture is lockdowns will not stop a virus that is this contagious through high numbers of asymptomatic carriers and it will make it almost impossible to contact trace and whenever we do lift lockdowns it will spread lockdowns don't stop the spread you either pay the cost of this virus now or you pay it later but either way you will pay.

The big picture is if our medical system crashes we will die from this on our streets and at home anybody want that

You get the picture Doc? I am on your side and I am empathetic to your concerns are you empathetic to the other side of the equation

Because the harsh reality is even with the additional problems this virus presents which everything you stated HAS NOT BEEN CONCLUSIVELY PROVEN THROUGH SCIENTIFIC STUDIES to be linked to the virus YET more will die from what I've spoken about above then will ever die from this virus even with its complications

Don't you care about them Doc? Because I do

I'm not saying your wrong to be worried about the virus

I'm saying that I question your approach to REALISTICALLY get through it. There has to be a better way to protect the highly vulnerable and protect the lives lost from economic collapse

There is morality on both sides of the argument there is no safe option there is no easy option we are going to have to compromise somewhere Doc why do you refuse to see that?
 
D

Danzilla31

Audioholic Spartan
South Korea had opened some of their clubs last week and now, they're closed- apparently, a pinhead who was COVID positive went to three different clubs and has infected a good number of people. I have seen ads for FLIR thermal cameras that are meant to be used for scanning people as they approach a building entrance- I think that should be required, privacy concerns aside; there's no expectation of privacy in a public space and these cameras don't log any identity.
for the record I think opening clubs and such is really foolish at this stage you wont see me any where near one

In fact even when people start getting out I will still stay at home mostly because I have to work closely with high risk populations

So I have a responsibility to self isolate until we reopen parts of the economy to make things bearable and sustainable I really just want to open up enough to keep society functionable and hospitals able to make a living

The rest can wait a bit

Even so my family is not allowed back and if the economy reopens without a hitch I will still have to self isolate for a bit because I'm high risk with where I have to work

Good point on the club situation it's something wonder like you said if they can make that work since privacy won't be compromised
 
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