[BostonCard]

https://www.cnn.com/2020/08/10/health/co...index.html

I wish this weren't framed vis a vis whether the results will be back before the election.  I always thought a 2020 result was ambitious, but was hoping we would have something we could give to people at high risk.  Of course, Moderna is not the only shot on goal, and maybe the AZ/Oxford or BioNTech/Pfizer collaborations will get an answer more quickly.

I will also note that enrollments always start out slow and ramp up, so what Moderna is experiencing is not unusual.

BC

[BostonCard]

https://www.cnn.com/2020/08/10/health/co...index.html

I wish this weren't framed vis a vis whether the results will be back before the election.  I always thought a 2020 result was ambitious, but was hoping we would have something we could give to people at high risk.  Of course, Moderna is not the only shot on goal, and maybe the AZ/Oxford or BioNTech/Pfizer collaborations will get an answer more quickly.

I will also note that enrollments always start out slow and ramp up, so what Moderna is experiencing is not unusual.

BC

[BostonCard]

https://www.cnn.com/2020/08/10/health/co...index.html



I wish this weren't framed vis a vis whether the results will be back before the election.  I always thought a 2020 result was ambitious, but was hoping we would have something we could give to people at high risk.  Of course, Moderna is not the only shot on goal, and maybe the AZ/Oxford or BioNTech/Pfizer collaborations will get an answer more quickly.



I will also note that enrollments always start out slow and ramp up, so what Moderna is experiencing is not unusual.



BC

What a great headline.  CNN is garbage.

Perhaps CNN was onto something.

https://www.fiercebiotech.com/biotech/tr...ine-report

(sorry I didn't link to the original FT article, but it's behind a paywall and I don't have access).

President Donald Trump is considering fast-tracking the authorization of AstraZeneca’s COVID-19 vaccine to ensure a jab is available in time for the November election, according to the Financial Times. The mooted plan is to allow AstraZeneca to gain emergency use authorization (EUA) on the basis of a 10,000-subject U.K. clinical trial.

I sincerely hope we get a safe and effective vaccine as soon as possible.  I think generally, pushing all levers to move quickly in vaccine development has been the one aspect of the response to the pandemic for which Trump deserves praise.  But the potential for all this to turn sideways in order to meet an artificial deadline is substantial.  And rushing a vaccine to market that later is found to have safety concerns could cause lasting damage to the country's perception of vaccines.  Unfortunately, those might not be seen until well after the election.

BC

[BostonCard]

https://www.cnn.com/2020/08/10/health/co...index.html



I wish this weren't framed vis a vis whether the results will be back before the election.  I always thought a 2020 result was ambitious, but was hoping we would have something we could give to people at high risk.  Of course, Moderna is not the only shot on goal, and maybe the AZ/Oxford or BioNTech/Pfizer collaborations will get an answer more quickly.



I will also note that enrollments always start out slow and ramp up, so what Moderna is experiencing is not unusual.



BC

What a great headline.  CNN is garbage.

Perhaps CNN was onto something.

https://www.fiercebiotech.com/biotech/tr...ine-report

(sorry I didn't link to the original FT article, but it's behind a paywall and I don't have access).

President Donald Trump is considering fast-tracking the authorization of AstraZeneca’s COVID-19 vaccine to ensure a jab is available in time for the November election, according to the Financial Times. The mooted plan is to allow AstraZeneca to gain emergency use authorization (EUA) on the basis of a 10,000-subject U.K. clinical trial.

I sincerely hope we get a safe and effective vaccine as soon as possible.  I think generally, pushing all levers to move quickly in vaccine development has been the one aspect of the response to the pandemic for which Trump deserves praise.  But the potential for all this to turn sideways in order to meet an artificial deadline is substantial.  And rushing a vaccine to market that later is found to have safety concerns could cause lasting damage to the country's perception of vaccines.  Unfortunately, those might not be seen until well after the election.

BC

[Goose]

I sincerely hope we get a safe and effective vaccine as soon as possible.  I think generally, pushing all levers to move quickly in vaccine development has been the one aspect of the response to the pandemic for which Trump deserves praise.  But the potential for all this to turn sideways in order to meet an artificial deadline is substantial.  And rushing a vaccine to market that later is found to have safety concerns could cause lasting damage to the country's perception of vaccines.  Unfortunately, those might not be seen until well after the election.


BC

Totally agree. Additionally, a safe but ineffective (relatively, none is perfect) vaccine could have very negative consequences as well. We need to know what we are getting well enough to make decisions regarding reopening. That is one reason that Trump's public comments about the FDA approvals (or lack thereof) are so troubling. Other Presidents have attempted to influence the FDA, contrary to what has been said elsewhere on this board. However, it was always done via back channels and via third parties. How much success these attempts had is not knowable, because officially they never happened. By doing it in public, and by saying "good" or "bad" regarding FDA actions, at best Trump undermines the public perception of the FDA's objectivity. At worst, he actually coerces the FDA into doing things they wouldn't otherwise do. So far I think the FDA is still functioning objectively. Let's hope it stays that way.

[Goose]

I sincerely hope we get a safe and effective vaccine as soon as possible.  I think generally, pushing all levers to move quickly in vaccine development has been the one aspect of the response to the pandemic for which Trump deserves praise.  But the potential for all this to turn sideways in order to meet an artificial deadline is substantial.  And rushing a vaccine to market that later is found to have safety concerns could cause lasting damage to the country's perception of vaccines.  Unfortunately, those might not be seen until well after the election.


BC

Totally agree. Additionally, a safe but ineffective (relatively, none is perfect) vaccine could have very negative consequences as well. We need to know what we are getting well enough to make decisions regarding reopening. That is one reason that Trump's public comments about the FDA approvals (or lack thereof) are so troubling. Other Presidents have attempted to influence the FDA, contrary to what has been said elsewhere on this board. However, it was always done via back channels and via third parties. How much success these attempts had is not knowable, because officially they never happened. By doing it in public, and by saying "good" or "bad" regarding FDA actions, at best Trump undermines the public perception of the FDA's objectivity. At worst, he actually coerces the FDA into doing things they wouldn't otherwise do. So far I think the FDA is still functioning objectively. Let's hope it stays that way.

[BostonCard]

https://www.fiercepharma.com/pharma/pfiz...ew-analyst

The Pfizer/BioNTech vaccine is halfway enrolled through its clinical trial, and at least one person's back-of-the-envelope calculation is that they could get some early data by the end of September.

Mizuho Securities analyst Vamil Divan figures that vaccine timeline can only benefit Pfizer. If the company is already halfway to its goal of recruiting 30,000 patients in the mRNA vaccine trial, he figured, the company should “reach full enrollment by end of next month,” Divan wrote in a note sent to investors Thursday. That means the first dataset should be released in mid-September, potentially at an investor event the company has scheduled for that time.

It looks like they are probably going to have an iDMC take a look at an interim cut of the data (otherwise, how do you reconcile reaching full enrollment by the end of "next month" with an analysis in mid-September).  If so, it would be a misnomer to say that the "first dataset should be released".  What I think would happen is that a committee of experts would view the data.  Let's say at that point there are 20,000 patients enrolled (10K in each arm), and in the study there have been 25 events (given that there are about 40,000 new COVID diagnoses a day, the probability that someone is diagnosed with COVID is about 1 in 8000, so right now we are probably seeing an average of 2 patients enrolled in the trial getting COVID-19 a day.  So, it would be reasonable to expect about 40 cases by mid-September when the iDMC happens.  If you saw 90% efficacy such that the infection rate was 0.40% (40 in 10,000) in the placebo group and 0.04% (4 in 10,000) in the treated group, the iDMC could conclude there is overwhelming evidence of efficacy and submission for an EUA would be warranted.  On the other hand, if the vaccine efficacy were more like 60%, the p-value would be < 0.05, but the lower bound of the confidence interval would be about 22%, in which case the iDMC would probably say to continue the trial until it reaches its endpoint.

BC

[BostonCard]

https://www.fiercepharma.com/pharma/pfiz...ew-analyst

The Pfizer/BioNTech vaccine is halfway enrolled through its clinical trial, and at least one person's back-of-the-envelope calculation is that they could get some early data by the end of September.

Mizuho Securities analyst Vamil Divan figures that vaccine timeline can only benefit Pfizer. If the company is already halfway to its goal of recruiting 30,000 patients in the mRNA vaccine trial, he figured, the company should “reach full enrollment by end of next month,” Divan wrote in a note sent to investors Thursday. That means the first dataset should be released in mid-September, potentially at an investor event the company has scheduled for that time.

It looks like they are probably going to have an iDMC take a look at an interim cut of the data (otherwise, how do you reconcile reaching full enrollment by the end of "next month" with an analysis in mid-September).  If so, it would be a misnomer to say that the "first dataset should be released".  What I think would happen is that a committee of experts would view the data.  Let's say at that point there are 20,000 patients enrolled (10K in each arm), and in the study there have been 25 events (given that there are about 40,000 new COVID diagnoses a day, the probability that someone is diagnosed with COVID is about 1 in 8000, so right now we are probably seeing an average of 2 patients enrolled in the trial getting COVID-19 a day.  So, it would be reasonable to expect about 40 cases by mid-September when the iDMC happens.  If you saw 90% efficacy such that the infection rate was 0.40% (40 in 10,000) in the placebo group and 0.04% (4 in 10,000) in the treated group, the iDMC could conclude there is overwhelming evidence of efficacy and submission for an EUA would be warranted.  On the other hand, if the vaccine efficacy were more like 60%, the p-value would be < 0.05, but the lower bound of the confidence interval would be about 22%, in which case the iDMC would probably say to continue the trial until it reaches its endpoint.

BC

[teejers1]

https://www.fiercepharma.com/pharma/pfiz...ew-analyst

The Pfizer/BioNTech vaccine is halfway enrolled through its clinical trial, and at least one person's back-of-the-envelope calculation is that they could get some early data by the end of September.

Mizuho Securities analyst Vamil Divan figures that vaccine timeline can only benefit Pfizer. If the company is already halfway to its goal of recruiting 30,000 patients in the mRNA vaccine trial, he figured, the company should “reach full enrollment by end of next month,” Divan wrote in a note sent to investors Thursday. That means the first dataset should be released in mid-September, potentially at an investor event the company has scheduled for that time.

It looks like they are probably going to have an iDMC take a look at an interim cut of the data (otherwise, how do you reconcile reaching full enrollment by the end of "next month" with an analysis in mid-September).  If so, it would be a misnomer to say that the "first dataset should be released".  What I think would happen is that a committee of experts would view the data.  Let's say at that point there are 20,000 patients enrolled (10K in each arm), and in the study there have been 25 events (given that there are about 40,000 new COVID diagnoses a day, the probability that someone is diagnosed with COVID is about 1 in 8000, so right now we are probably seeing an average of 2 patients enrolled in the trial getting COVID-19 a day.  So, it would be reasonable to expect about 40 cases by mid-September when the iDMC happens.  If you saw 90% efficacy such that the infection rate was 0.40% (40 in 10,000) in the placebo group and 0.04% (4 in 10,000) in the treated group, the iDMC could conclude there is overwhelming evidence of efficacy and submission for an EUA would be warranted.  On the other hand, if the vaccine efficacy were more like 60%, the p-value would be < 0.05, but the lower bound of the confidence interval would be about 22%, in which case the iDMC would probably say to continue the trial until it reaches its endpoint.

BC

Wait . . . I thought we were all set on the vaccine front thanks to Russia.  You mean that's not the case?
Dang . . .

[teejers1]

https://www.fiercepharma.com/pharma/pfiz...ew-analyst

The Pfizer/BioNTech vaccine is halfway enrolled through its clinical trial, and at least one person's back-of-the-envelope calculation is that they could get some early data by the end of September.

Mizuho Securities analyst Vamil Divan figures that vaccine timeline can only benefit Pfizer. If the company is already halfway to its goal of recruiting 30,000 patients in the mRNA vaccine trial, he figured, the company should “reach full enrollment by end of next month,” Divan wrote in a note sent to investors Thursday. That means the first dataset should be released in mid-September, potentially at an investor event the company has scheduled for that time.

It looks like they are probably going to have an iDMC take a look at an interim cut of the data (otherwise, how do you reconcile reaching full enrollment by the end of "next month" with an analysis in mid-September).  If so, it would be a misnomer to say that the "first dataset should be released".  What I think would happen is that a committee of experts would view the data.  Let's say at that point there are 20,000 patients enrolled (10K in each arm), and in the study there have been 25 events (given that there are about 40,000 new COVID diagnoses a day, the probability that someone is diagnosed with COVID is about 1 in 8000, so right now we are probably seeing an average of 2 patients enrolled in the trial getting COVID-19 a day.  So, it would be reasonable to expect about 40 cases by mid-September when the iDMC happens.  If you saw 90% efficacy such that the infection rate was 0.40% (40 in 10,000) in the placebo group and 0.04% (4 in 10,000) in the treated group, the iDMC could conclude there is overwhelming evidence of efficacy and submission for an EUA would be warranted.  On the other hand, if the vaccine efficacy were more like 60%, the p-value would be < 0.05, but the lower bound of the confidence interval would be about 22%, in which case the iDMC would probably say to continue the trial until it reaches its endpoint.

BC

Wait . . . I thought we were all set on the vaccine front thanks to Russia.  You mean that's not the case?
Dang . . .

[dabigv13]

Apparently the two vaccines quickest out the gates, the mRNA vaccines of Pfizer and Moderna, both require freezing, the Pfizer one at apparently -94 F (this is something I dont think most hospitals have much of, more of a research lab type thing), and Moderna's -4,, which a standard fridge with freezer can do, but again, not something that most medical offices would have a lot of space for either.

Most vaccines are stable at room temp or refridgerated. This will definitely complicate administration and distribution.

https://www.marketwatch.com/story/modern...2020-08-27

[dabigv13]

Apparently the two vaccines quickest out the gates, the mRNA vaccines of Pfizer and Moderna, both require freezing, the Pfizer one at apparently -94 F (this is something I dont think most hospitals have much of, more of a research lab type thing), and Moderna's -4,, which a standard fridge with freezer can do, but again, not something that most medical offices would have a lot of space for either.

Most vaccines are stable at room temp or refridgerated. This will definitely complicate administration and distribution.

https://www.marketwatch.com/story/modern...2020-08-27