Down to earth facts about the USA vaccines

[shunyadragon]

History simply cannot be changed.

True, so what? Failure to respond. Again . . .

Joey never said so concerning vaccines. The vaccines did not come out of the Trump administration any more than the flu vaccines came out of the Obama Administration The vaccines came out of good sound medical science, and the hard work of the scientists of the companies developing the vaccines. This is an ongoing project for over 100 years and will continue.

[rogue06]

It takes years to develop safe vaccines - No, it has taken many years to develop the technology to develop safe vaccines. Under Obama the flu pandemic vaccines were safely developed in less than a year. Yes, some vaccines have taken a number of years to develop, but the "Medical Protocols for developing and approving vaccines for safe use remains the same for all vaccines.

If they typically can be developed rapidly, then why was the MSM and the experts they brought on mocking Trump for saying we could develop a vaccine by the end of 2020? National Geographic declared that achieving a vaccine within "a year to 18 months" would be absolutely unprecedented. USA Today informed us that "despite medical researchers’ progress, the vaccine was more than a year away." According to NBC "Fact check: Coronavirus vaccine could come this year, Trump says. Experts say he needs a 'miracle' to be right." And on CNN you had Jim Acosta saying about a 12-18 month timeline that "Many health experts aren’t so sure it’s achievable" to which Chris "Fredo" Cuomo disparaged, "So if we say they can’t really get this vaccine, the science is questionable, now we’re the Negative Nancys? Oh, look at that Acosta, always trying to kill our optimism."

So were they lying? Was it a case of bad mouthing the likelihood because they saw it as their duty to do so because, well OMB and anything he says must be a lie?

[Maranatha]

If they typically can be developed rapidly, then why was the MSM and the experts they brought on mocking Trump for saying we could develop a vaccine by the end of 2020? National Geographic declared that achieving a vaccine within "a year to 18 months" would be absolutely unprecedented. USA Today informed us that "despite medical researchers’ progress, the vaccine was more than a year away." According to NBC "Fact check: Coronavirus vaccine could come this year, Trump says. Experts say he needs a 'miracle' to be right." And on CNN you had saying about a 12-18 month timeline that "Many health experts aren’t so sure it’s achievable" to which Chris "Fredo" Cuomo disparaged, "So if we say they can’t really get this vaccine, the science is questionable, now we’re the Negative Nancys? Oh, look at that Acosta, always trying to kill our optimism."

So were they lying? Was it a case of bad mouthing the likelihood because they saw it as their duty to do so because, well OMB and anything he says must be a lie?

Nice. You said things that needed said, but I am way too lazy to remind someone about recent history they remember but ignore.

[shunyadragon]

If they typically can be developed rapidly, then why was the MSM and the experts they brought on mocking Trump for saying we could develop a vaccine by the end of 2020? National Geographic declared that achieving a vaccine within "a year to 18 months" would be absolutely unprecedented. USA Today informed us that "despite medical researchers’ progress, the vaccine was more than a year away." According to NBC "Fact check: Coronavirus vaccine could come this year, Trump says. Experts say he needs a 'miracle' to be right." And on CNN you had saying about a 12-18 month timeline that "Many health experts aren’t so sure it’s achievable" to which Chris "Fredo" Cuomo disparaged, "So if we say they can’t really get this vaccine, the science is questionable, now we’re the Negative Nancys? Oh, look at that Acosta, always trying to kill our optimism."

So were they lying? Was it a case of bad mouthing the likelihood because they saw it as their duty to do so because, well OMB and anything he says must be a lie?

Selective citations incomplete. .

First, Careful with 'We' Trump did was not involved with developing the vaccines. Trump's problem was he was ranting and raving to get the vaccines developed and approved, before the election. Maybe MSM not reliable first sources, but the experts in the medical field did not specifically claim this. There were different views as to when the vaccines could be developed. The important point is despite pressure from the Whitehouse the medical authorities and vaccine developers would NOT prematurely commit to when the vaccines would be developed and approved for use, and rejected Trump's pressure to have the vaccines approved before the election..

The scientists that develop vaccines speak

Source: [URL="https://www.pfizer.com/science"

OUR SCIENCE[/URL]/ An Open Letter from Pfizer Chairman and CEO Albert Bourla]


October 16, 2020As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.

There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.

To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas.

As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates. As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial. Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage. In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us.

A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use.

The second requirement is to prove that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are set high. In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.

And finally, if we achieve a positive efficacy readout and a robust safety profile, the last requirement will be the submission of manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced. Pfizer has been investing at risk since the early days of the pandemic to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached.

So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.

The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.

In the meantime, I hope you and your loved ones are staying safe and well.

OUR SCIENCE/ An Open Letter from Pfizer Chairman and CEO Albert Bourla
October 16, 2020As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.

There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.

To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas.

As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates. As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial. Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage. In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us.

A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use.

The second requirement is to prove that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are set high. In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.

And finally, if we achieve a positive efficacy readout and a robust safety profile, the last requirement will be the submission of manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced. Pfizer has been investing at risk since the early days of the pandemic to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached.

So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.

The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.

In the meantime, I hope you and your loved ones are staying safe and well.

© Copyright Original Source

[shunyadragon]

Again

Source: https://www.nytimes.com/2020/09/30/health/pfizer-covid-vaccine.html

All Eyes Are on Pfizer as Trump Pushes for Vaccine by October


Despite slim chances that its vaccine will be ready by October, Pfizer has big incentives to hint that it might be.



n media appearances and talks with investors, Pfizer’s chief executive nearly always mentions a word that is so politically perilous, most of his competitors shy away from it: October.

“Right now, our model — our best case — predicts that we will have an answer by the end of October,” the chief executive, Dr. Albert Bourla, told the “Today” show earlier this month. In other interviews, he has said he expected a “conclusive readout” by then, with an application for emergency authorization that could be filed “immediately.”

Dr. Bourla’s statements have put his company squarely in the sights of President Trump, who has made no secret of his desire for positive vaccine news to boost his chances on Election Day, Nov. 3. “We’re going to have a vaccine very soon. Maybe even before a very special date,” Mr. Trump said recently.

And yet by all other accounts, the idea that it will be ready in October is far-fetched. Even if the vaccine shows promising signs in clinical trials — still a big if — the company will not have collected enough data by then to say with any statistical confidence that it is safe and effective.

© Copyright Original Source

[rogue06]

Selective citations incomplete. .

First, Careful with 'We' Trump did was not involved with developing the vaccines. Trump's problem was he was ranting and raving to get the vaccines developed and approved, before the election. Maybe MSM not reliable first sources, but the experts in the medical field did not specifically claim this. There were different views as to when the vaccines could be developed. The important point is despite pressure from the Whitehouse the medical authorities and vaccine developers would NOT prematurely commit to when the vaccines would be developed and approved for use, and rejected Trump's pressure to have the vaccines approved before the election..

The scientists that develop vaccines speak

Source: [URL="https://www.pfizer.com/science"

OUR SCIENCE[/URL]/ An Open Letter from Pfizer Chairman and CEO Albert Bourla]


October 16, 2020As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.

There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.

To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas.

As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates. As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial. Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage. In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us.

A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use.

The second requirement is to prove that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are set high. In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.

And finally, if we achieve a positive efficacy readout and a robust safety profile, the last requirement will be the submission of manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced. Pfizer has been investing at risk since the early days of the pandemic to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached.

So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.

The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.

In the meantime, I hope you and your loved ones are staying safe and well.

OUR SCIENCE/ An Open Letter from Pfizer Chairman and CEO Albert Bourla
October 16, 2020As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.

There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.

To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas.

As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates. As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial. Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage. In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us.

A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use.

The second requirement is to prove that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are set high. In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.

And finally, if we achieve a positive efficacy readout and a robust safety profile, the last requirement will be the submission of manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced. Pfizer has been investing at risk since the early days of the pandemic to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached.

So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.

The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.

In the meantime, I hope you and your loved ones are staying safe and well.

© Copyright Original Source

None of which explains why they (and there were others) mocked and scoffed at the idea.

[shunyadragon]

None of which explains why they (and there were others) mocked and scoffed at the idea.

Anybody and claim and mock whatever they chose. I go straight to the most reliable academic sources, the professionals and academics that are developing the vaccines. Early in the pandemic there were many variable estimates from on to fifteen years, because the corona virus that causes COVID-19 was new and described as a 'novel' virus..

[Cow Poke]

Ya know, these "public service" threads would be so much more enjoyable if they didn't have to start out with a "See, I TOLD YOU OMB!"

[shunyadragon]

Example of anti-science attitudes among conservatives is the anti=mask and anti social distancing attitude. The facts that masks and social distancing reduce the spread of COVID-19 is good sound down to earth science,

[shunyadragon]

Ya know, these "public service" threads would be so much more enjoyable if they didn't have to start out with a "See, I TOLD YOU OMB!"

What does OMB have to with this thread?

[Cow Poke]

What does OMB have to with this thread?

They way YOU made it the GLARING HEADLINE

glaring headline.jpg