Vaccine News

[Merge]

I’ve already answered your questions. They have immediate and guaranteed distribution coordiordinated and paid for by Warp Speed. Even though there is demand, the cost and effort to do all of that is considerable. Pharma Economics 101.

Red tape is not political when a drug is fast tracked in the system. You obviously have no idea how clinical trials, EUA’s, etc. work.

So their research is farther along because distribution is guaranteed and coordinated? But Pfizer is doing their own distribution and not using the government.

Operation Warp Speed's Logistics Chief Weighs In On Vaccine Progress

Gen. Gustave Perna says as soon as the FDA deems a vaccine safe and effective, his team is ready to coordinate deployment of tens of millions of doses as early as next month.

www.npr.org

So there goes that theory...

I think ows is good, but it does seem odd that you’re just making stuff up about the impact to Pfizer specifically.

But you are right in that I don’t have an understanding of clinical trials etc... and that is why I was my first question was "Are there other regulatory hurdles that were cleared to help Pfizer?" Maybe just focus on the stuff that is true instead of making up other stuff that is demonstrably false.

 

[Merge]

Trump mentioned at the debate he was working with J&J and Pfizer by name. I find it odd with all the fact checking nobody called him out on that from anything I’ve seen. Then Pfizer comes up with a vaccine, Trump had nothing to do with it.

We have a purchase order with Pfizer so will will have the vaccine in the US as early as possible. I think that's a good thing. Administration should get credit for that as well as any measures that were taken to speed up regulatory hurdles to get the vaccine to the public as fast as possible (safely, of course)

 

[Pirata]

Pfizer funded their own development without OWS money.
They will also fund manufacturing.

Pfizer will receive $1.95 billion for distribution.

"Not every deal, however, included that kind of up-front investment. “We have never taken any money from the US government, or from anyone,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, told the New York Times. The $1.95 billion in its agreement will only be paid out when the government takes delivery of the vaccines, after they are authorized for emergency use by the Food and Drug Administration (FDA). "

Why we know so little about Pfizer’s vaccine deal with the US

The terms of Pfizer's agreement with the US for its vaccine are largely invisible to the public.

qz.com

 

[SHUHoopsFan]

We have a purchase order with Pfizer so will will have the vaccine in the US as early as possible. I think that's a good thing. Administration should get credit for that as well as any measures that were taken to speed up regulatory hurdles to get the vaccine to the public as fast as possible (safely, of course)

With everything you just said, I don't get the excitement around more government bodies with the new administration. Get rid of the hurdles. They get in the way of helping the American people.

 

[HALL85]

So their research is farther along because distribution is guaranteed and coordinated? But Pfizer is doing their own distribution and not using the government.

Operation Warp Speed's Logistics Chief Weighs In On Vaccine Progress

Gen. Gustave Perna says as soon as the FDA deems a vaccine safe and effective, his team is ready to coordinate deployment of tens of millions of doses as early as next month.

www.npr.org

So there goes that theory...

I think ows is good, but it does seem odd that you’re just making stuff up about the impact to Pfizer specifically.

But you are right in that I don’t have an understanding of clinical trials etc... and that is why I was my first question was "Are there other regulatory hurdles that were cleared to help Pfizer?" Maybe just focus on the stuff that is true instead of making up other stuff that is demonstrably false.

What are you talking about? I've refuted every one of your points. I haven't made one thing up. Just because you don't know what you're talking about, it's not my job to educate you.

 

[Section112]

My family is in Pharma and medical research. My brother runs a huge part of Merck and my sister, cousins and uncles are all in R&D. They all told me to buy Pfizer stock a while ago even though I have it as my Dad worked there in the 50s and 60s. They all said what the government has done to fast track the FDA approval process will be like printing money for Pfizer. Pharma invests billions in R&D and usually the payback is a minimum of 5-6 years if the drug or vaccine is approved (at about only a 10-15% success rate). Warp Speed cut through all of that and made the R&D spend an easy decision because they had confidence in the Messenger RNA vaccine and had a guarantee payout if it was successful and an immediate payback unheard of in Pharma (6 years to less than one year). Warp Speed had everything to do with it if you have any understanding of the process whether they guaranteed the money or not. They paved the way for Pharma to make these investments.

This is looking like a terrific case study on how Govt can partner with private industry to get a solid result and it was a good deal because the US Govt did not guarantee payment unless they delivered. A solid deal all around.

 

[HALL85]

My family is in Pharma and medical research. My brother runs a huge part of Merck and my sister, cousins and uncles are all in R&D. They all told me to buy Pfizer stock a while ago even though I have it as my Dad worked there in the 50s and 60s. They all said what the government has done to fast track the FDA approval process will be like printing money for Pfizer. Pharma invests billions in R&D and usually the payback is a minimum of 5-6 years if the drug or vaccine is approved (at about only a 10-15% success rate). Warp Speed cut through all of that and made the R&D spend an easy decision because they had confidence in the Messenger RNA vaccine and had a guarantee payout if it was successful and an immediate payback unheard of in Pharma (6 years to less than one year). Warp Speed had everything to do with it if you have any understanding of the process whether they guaranteed the money or not. They paved the way for Pharma to make these investments.

This is looking like a terrific case study on how Govt can partner with private industry to get a solid result and it was a good deal because the US Govt did not guarantee payment unless they delivered. A solid deal all around.

mic drop....

 

[Merge]

What are you talking about? I've refuted every one of your points. I haven't made one thing up. Just because you don't know what you're talking about, it's not my job to educate you.

What I'm talking about is your response to hoopsfan when you said...

The answer is yes. Operation warp speed included funding to organizations that were creating therapies or vaccines. In order to fast track them to the market. In the case of vaccines investments were made to start up manufacturing in parallel to the clinical trials. In essence warp speed providing an insurance policy to these companies.

So yes, Trump and his administration get credit for this.

Pfizer did not receive funding related to development or manufacturing.
Those are not the reasons why Pfizer is where they are today.

 

[Merge]

My family is in Pharma and medical research. My brother runs a huge part of Merck and my sister, cousins and uncles are all in R&D. They all told me to buy Pfizer stock a while ago even though I have it as my Dad worked there in the 50s and 60s. They all said what the government has done to fast track the FDA approval process will be like printing money for Pfizer. Pharma invests billions in R&D and usually the payback is a minimum of 5-6 years if the drug or vaccine is approved (at about only a 10-15% success rate). Warp Speed cut through all of that and made the R&D spend an easy decision because they had confidence in the Messenger RNA vaccine and had a guarantee payout if it was successful and an immediate payback unheard of in Pharma (6 years to less than one year). Warp Speed had everything to do with it if you have any understanding of the process whether they guaranteed the money or not. They paved the way for Pharma to make these investments.

This is looking like a terrific case study on how Govt can partner with private industry to get a solid result and it was a good deal because the US Govt did not guarantee payment unless they delivered. A solid deal all around.

Thank you. I am not arguing against it at all or arguing against where to give credit. Just trying to understand how it changed where we are today.

My main question was related to that Pfizer has something they believe in back in July and agree to provide it to the US. What changed between July and November which made this faster than it otherwise would have been?

Again, I think ows was beneficial. Not arguing that point at all.

 

[HALL85]

What I'm talking about is your response to hoopsfan when you said...



Pfizer did not receive funding related to development or manufacturing.
Those are not the reasons why Pfizer is where they are today.

They got a guarantee of $2 billion!!! What don't you get about that? Surely, you can't be that dumb.

If you don't get Section112's post, there is no hope for you.

 

[Merge]

They got a guarantee of $2 billion!!! What don't you get about that? Surely, you can't be that dumb.

If you don't get Section112's post, there is no hope for you.

So Pfizer would not be as far along in their research without a promise of $2 billion?

 

[Pirata]

The details of the individual OWS deals are not known.

I wager that the path Pfizer took was a money/risk decision based on the proposed terms of the deal. They elected to pay their own R&D and manufacturing and get guaranteed Gov dollars on the final distribution. Unless we have the details of that deal, we will never know why they went that route.

Arguing that OWS did not contribute to a faster result is largely based on Trump hatred. Not surprising though.

 

[Pirata]

So Pfizer would not be as far along in their research without a promise of $2 billion?

The premise is "yes", albeit it is a premise. 112's post supports that. I believe it is reasonable to consider that Pfizer redirected resources to accelerate the process based on the financial opportunity that OWS provided.

I would argue that they were also motivated by the good of the country but I think it naïve to think that was the sole motivator.

 

[Merge]

The details of the individual OWS deals are not known.

I wager that the path Pfizer took was a money/risk decision based on the proposed terms of the deal. They elected to pay their own R&D and manufacturing and get guaranteed Gov dollars on the final distribution. Unless we have the details of that deal, we will never know why they went that route.

Arguing that OWS did not contribute to a faster result is largely based on Trump hatred. Not surprising though.

I don't disagree with that. I am not blindly saying that ows did not contribute, I was just asking for the context of how it did. I think people blindly making stuff up to support the idea that it helped are just as bad as those who are blindly saying it didn't.

 

[HALL85]

So Pfizer would not be as far along in their research without a promise of $2 billion?

Research is only one aspect of making the vaccine available. Clearly Pfizer and their German company they were collaborating with were very far along on the research piece of it. That’s not what the money was meant for. It was meant to scale production and get it to market faster.

 

[Merge]

The premise is "yes", albeit it is a premise. 112's post supports that. I believe it is reasonable to consider that Pfizer redirected resources to accelerate the process based on the financial opportunity that OWS provided.

I would argue that they were also motivated by the good of the country but I think it naïve to think that was the sole motivator.

But at the same time, we would all agree that the first successful vaccine has enormous potential for the company that makes it, right? Would Pfizer really be slower without a promise of $2 billion? I don't quite follow the logic there.

 

[HALL85]

But at the same time, we would all agree that the first successful vaccine has enormous potential for the company that makes it, right? Would Pfizer really be slower without a promise of $2 billion? I don't quite follow the logic there.

Yes

 

[Merge]

Research is only one aspect of making the vaccine available. Clearly Pfizer and their German company they were collaborating with were very far along on the research piece of it. That’s not what the money was meant for. It was meant to scale production and get it to market faster.

So Pfizer would be in the same spot today in relation to the results of their trial.
Could have saved a lot of posts here if that was your original response to SHUHoopsFan.

 

[Merge]

Yes

Big supporter of Bernie's phara prize plan?

Text of S. 627 (113th): Medical Innovation Prize Fund Act (Introduced version) - GovTrack.us

Text of S. 627 (113th): Medical Innovation Prize Fund Act as of Mar 20, 2013 (Introduced version). S. 627 (113th): Medical Innovation Prize Fund Act

www.govtrack.us

 

[HALL85]

So Pfizer would be in the same spot today in relation to the results of their trial.
Could have saved a lot of posts here if that was your original response to SHUHoopsFan.

No, we could’ve saved a lot of posts if you just were able to comprehend what has been posted. Must be tough for you.

If this was business as usual, Pfizer would not be in the same place. OWS fast tracked the approval process.

One of the main aspects of 0WS was to incentivize organizations to do things in parallel versus in a linear manner to speed the process. I would also suggest that the price per dose that 0WS is guaranteeing is likely higher than what Pfizer would have gotten by doing everything themselves.

 

[Pirata]

But at the same time, we would all agree that the first successful vaccine has enormous potential for the company that makes it, right? Would Pfizer really be slower without a promise of $2 billion? I don't quite follow the logic there.

I agree about the potential. What we do not know is what other "enormous" potential Pfizer was already working on and what the value/risk/reward of those are.

It's possible they would be in the same place but my guess is the fast tracking and $ incentives helped to accelerate it. By what amount is purely anyone's guess.

Trump deserves his share of the credit. He rapidly steered HHS and DOD together to put a program in place to accelerate the delivery of a vaccine. It is exactly what you want the POTUS to do in this kind of situation. He does not deserve all the credit. There are plenty of people and entities that should share in it. However, to say Trump had nothing to do with it, is not reasonable. That being said, I don't expect nor am I waiting for the MSM or anyone with left/liberal/democratic tendencies to do anything different.

At the end of the day, I don't care who gets credit. I am thankful we are making strong progress on the vaccine.

 

[Merge]

I agree about the potential. What we do not know is what other "enormous" potential Pfizer was already working on and what the value/risk/reward of those are.

It's possible they would be in the same place but my guess is the fast tracking and $ incentives helped to accelerate it. By what amount is purely anyone's guess.

Trump deserves his share of the credit. He rapidly steered HHS and DOD together to put a program in place to accelerate the delivery of a vaccine. It is exactly what you want the POTUS to do in this kind of situation. He does not deserve all the credit. There are plenty of people and entities that should share in it. However, to say Trump had nothing to do with it, is not reasonable. That being said, I don't expect nor am I waiting for the MSM or anyone with left/liberal/democratic tendencies to do anything different.

At the end of the day, I don't care who gets credit. I am thankful we are making strong progress on the vaccine.

I don't take issue with anything you're posting. It's a reasonable view.

Looking at Pfizer's timeline, they finished phase 2 and started on phase 3 in July around the time when they signed the agreement. The FDA said they need 2 months of follow up post vaccination for phase 3 trials. So August they administer the two shots, and September and October they monitor participants and report in November. Is that 2 months shorter than normal because of OWS? If so, I think that would be the strongest argument about the impact of OWS.

 

[Section112]

I don't take issue with anything you're posting. It's a reasonable view.

Looking at Pfizer's timeline, they finished phase 2 and started on phase 3 in July around the time when they signed the agreement. The FDA said they need 2 months of follow up post vaccination for phase 3 trials. So August they administer the two shots, and September and October they monitor participants and report in November. Is that 2 months shorter than normal because of OWS? If so, I think that would be the strongest argument about the impact of OWS.

It's like 5-10 years faster than normal. Some vaccines take up to 15 years to perfect. This is crazy stuff for the industry. And the FDA usually takes years to pore over the data. OWS has cut through so much of that making Pharma companies ROI decision to spend so much and move resources off other projects easy not to mention the good press they will get. Hopefully the vaccine is in fact effective and safe as medicine has never moved this quickly. OWS played a significant part of that along with the great work of the researchers and docs and don't forget the study patients that signed up to be part of the test. If this was not so politicized it would be a fantastic case study of how government can work with the private sector to get things done much faster and that help society.

 

[Hallsome]

I’ve already answered your questions. They have immediate and guaranteed distribution coordiordinated and paid for by Warp Speed. Even though there is demand, the cost and effort to do all of that is considerable. Pharma Economics 101.

Red tape is not political when a drug is fast tracked in the system. You obviously have no idea how clinical trials, EUA’s, etc. work.

They don’t understand business, certainly not this one. Why bother explaining?

 

[Hallsome]

I don't take issue with anything you're posting. It's a reasonable view.

Looking at Pfizer's timeline, they finished phase 2 and started on phase 3 in July around the time when they signed the agreement. The FDA said they need 2 months of follow up post vaccination for phase 3 trials. So August they administer the two shots, and September and October they monitor participants and report in November. Is that 2 months shorter than normal because of OWS? If so, I think that would be the strongest argument about the impact of OWS.

112 and 85 and Pirata have explained this 10 times, each explanation consistent with the other. in one response you allege that one is saying things “demonstably false” but this reasonable. Can someone explain fast tracking approvals and the advantages of the 2bill and tailored government support for the 30th time please?

 

[HALL85]

112 and 85 and Pirata have explained this 10 times, each explanation consistent with the other. in one response you allege that one is saying things “demonstably false” but this reasonable. Can someone explain fast tracking approvals and the advantages of the 2bill and tailored government support for the 30th time please?

LOL...He doesn’t do math
well...completing Phase 1, 2 & 3 clinical trials in 9 months vs 5-7 years. Most people can figure that out.

 

[Merge]

LOL...He doesn’t do math
well...completing Phase 1, 2 & 3 clinical trials in 9 months vs 5-7 years. Most people can figure that out.

They were halfway done with phase 1/2 when OWS started though.

Only asked how OWS Made Pfizer work faster and you made stuff up to support it.

I didn’t say OWS didn’t make it faster, I just asked how.

 

[HALL85]

They were halfway done with phase 1/2 when OWS started though.

Only asked how OWS Made Pfizer work faster and you made stuff up to support it.

I didn’t say OWS didn’t make it faster, I just asked how.

And several of us told you...but....

 

[Hallsome]

And several of us told you...but....

Maybe we can debate what the word several means? Geeze, we all need some pirates hoops-pirates are primed for fun

 

[Pirata]

I didn’t say OWS didn’t make it faster, I just asked how.

In a previous post you had stated that OWS had a 1 to 2 month impact.

I think 112 gave a credible post suggesting that your estimate was a tad conservative.

 

[Merge]

In a previous post you had stated that OWS had a 1 to 2 month impact.

I think 112 gave a credible post suggesting that your estimate was a tad conservative.

That’s not what I said.

The FDA said they need two months of post treatment data to see if there were any negative side effects. I asked if that 2 month window was shorter because of OWS. Like is it normally 6 months or a year? What does the FDA require as far as having enough safety data for a new vaccine under normal circumstances?

I don’t really see a purchase order as being the thing that speeds this up. Pfizer has agreements with other countries as well. How much credit do we give to Canada for the development of the vaccine?

Are we giving Obama credit for the H1N1 vaccine because the government placed an order before stage 3 trials were finished? Went from stage 1 to approved by the FDA in like 6 months.

Now I wasn’t trying to take credit away at all. I wasn’t saying Trump doesn’t deserve credit. i was just trying to understand what the mechanisms were which made Pfizer get this done faster. Speeding through regulatory hurdles would absolutely be enough. I was just trying to understand how that worked.

 

[Pirata]

If you have ever thought about going into sales, don't.

 

[Merge]

Am I misquoting you?

Context can get lost over text. I will clarify.

When I said “is that 2 months”.. I am referencing the 2 months the FDA required.

The FDA said they need 2 months of follow up post vaccination for phase 3 trials. So August they administer the two shots, and September and October they monitor participants and report in November. Is that 2 months shorter tha

I’m not asking if things were sped up by 2 months. I’m asking if 2 months required is shorter than normal.

 

[Merge]

If you have ever thought about going into sales, don't.

Zing... always going for internet points. Rather childish, but not unexpected.

 

[NYShoreGuy]

The scientists who developed the Pfizer/BioNTech Covid-19 vaccine are a Turkish-German power couple | CNN

Scientists Ugur Sahin and Ozlem Tureci have dedicated their lives to the field of oncology and infectious diseases, and spent years pioneering personalized immunotherapy treatments for cancer.

www.cnn.com

 

[Pirata]

Zing... always going for internet points. Rather childish, but not unexpected.

Not really.

You replied to a short straightforward post with War and Peace. You have the traits of a quintessential wonk and "smartest guy in the room" syndrome. You have an incurable "last word" affliction. It gets old. Your last cycle of posts exposes your neurosis.

You can't see the gestalt. You can't see the forest because of those pesky trees.

Those are not good traits for business, especially if you you want to do large deals.

Just looking out for you buddy.

But then again, like the kid in the locker room we whipped with our towels, you are fun to bat around every now and them.

 

[Merge]

Not really.

You replied to a short straightforward post with War and Peace. You have the traits of a quintessential wonk and "smartest guy in the room" syndrome. You have an incurable "last word" affliction. It gets old. Your last cycle of posts exposes your neurosis.

You can't see the gestalt. You can't see the forest because of those pesky trees.

Those are not good traits for business, especially if you you want to do large deals.

Just looking out for you buddy.

LOL... now this board is for business deals? Good lord.

All this nonsense is because I tried asking what the mechanisms were within OWS which made Pfizer get a vaccine faster?

Never said it didn’t. Just asked how.
You’re earlier answer was it probably did but we won’t know the extent was reasonable and I’m in the same boat.
Yet you take more issue with my take than those who offered a more definite “yes”? Ok buddy...

But then again, like the kid in the locker room we whipped with our towels, you are fun to bat around every now and them.

Ew.

 

[Pirata]

Like Jewel sang.....breathe...just breathe.....

 

[SHUHoopsFan]

Like Jewel sang.....breathe...just breathe.....

Faith Hill. I'm not forgetting Faith Hill laying dow, rolling around on the bed in a white sheet any time soon.

 

[Merge]

Faith Hill. I'm not forgetting Faith Hill laying dow, rolling around on the bed in a white sheet any time soon.

Careful. He doesn't like when people question incorrect statements.