Poll: White House orders FDA chief to authorize Pfizer-BioNTech vaccine Friday (today) or submit his resignation

[BoomerD]

"i would rather die than get a fever for 2 hours" is what i read.... UK has approved, the FDA panel has recommended approval. finish the process and approve if it's worthy.

This is how this new tech works, it teaches your body to make the spike protine, your body makes it and then you form an immune response, just like forming an immune response to the real thing, without the death/organ/ vascular damage of the real virus.


you really are in the camp of " if it happened under trump i wont take it" or " the government is trying to control my brains with this shot"?? which one is it?

How about, "I'm in the camp where I'll take a vaccine that's been properly tested and not rushed to market."

Hell, with everything going on, I even got a flu shot this week...something I almost NEVER do.

 

[ch33zw1z]

Well isn't that just great. FDA was going to approve it today or tomorrow anyway. So Trump has to fuck it up by corruptly pressuring them to do something they were going to do anyway, which means lots of people will be suspicious that the vaccine was approved because of corrupt politics rather than good science. Nice going.

Pretty much this.

 

[Brainonska511]

How about, "I'm in the camp where I'll take a vaccine that's been properly tested and not rushed to market."

Some people say this, but they never articulate a standard. 40k were enrolled in a phase 3 trial, there was a minimum of 2 months of safety follow-up, the data is both available from the meeting materials and published in NEJM.

 

[Jhhnn]

Well isn't that just great. FDA was going to approve it today or tomorrow anyway. So Trump has to fuck it up by corruptly pressuring them to do something they were going to do anyway, which means lots of people will be suspicious that the vaccine was approved because of corrupt politics rather than good science. Nice going.

Were I a superstitious person I'd believe that Trump is a manifestation of Satan.

 

[BoomerD]

Some people say this, but they never articulate a standard. 40k were enrolled in a phase 3 trial, there was a minimum of 2 months of safety follow-up, the data is both available from the meeting materials and published in NEJM.

What's the normal standard for new vaccine testing? I realize the normal "years of clinical trials and animal testing isn't really gonna work here...it's more of an emergent need...but this just feels rushed...time will tell. I posted above anout one subject's experience. Herm made light of "just a fever," but the temperature she reported is getting close to being dangerous. (Any temp over 103.something is considered dangerous)

 

[Brainonska511]

What's the normal standard for new vaccine testing? I realize the normal "years of clinical trials and animal testing isn't really gonna work here...it's more of an emergent need...but this just feels rushed...time will tell. I posted above anout one subject's experience. Herm made light of "just a fever," but the temperature she reported is getting close to being dangerous. (Any temp over 103.something is considered dangerous)

The standard is to run a Phase I trial to identify any major safety issues in a small population, and identify the appropriate dose to use in later trials, as well as gather data about potential efficacy. Phase II is an extension of Phase I - enroll more patients, check for any new safety issues at the determined Phase II dose (from the Phase I trial) in a broader population, as well as more rigourously look at efficacy. The last step is to identify an appropriate clinical trial efficacy endpoint, then enroll tens of thousands in a Phase III placebo-controlled trial where patients are randomized to either vaccine or placebo, and then monitor safety and for events triggering the primary endpoint. Safety follow-up will often run for 2+ years, but due to the nature of vaccines, almost all adverse events of interest will occur temporally close to the vaccination date(s).

The standard has been followed. Timelines have been compressed due to the fact that there is a pandemic, but I wouldn't say that dangerous shortcuts have been taken.

As for the incidence of adverse events, that data is reported - you're welcome to take a look at it:
NEJM publication: https://www.nejm.org/doi/10.1056/NEJMoa2034577
FDA advisory committee meeting and materials (including the data - see the briefing document PDFs at the bottom of the page): https://www.fda.gov/advisory-commit...0-2020-meeting-announcement#event-information

Your one post about a single subject's experience is not representative of the trial data. We also know how to control temporary fevers - you could pop a Tylenol if you had a fever.

Anyway, there is no risk-free vaccine. If there was no pandemic or serious risk of coming down with COVID-19, it would be pretty stupid from a risk-benefit standpoint to take the vaccine, since it would be all risk and practically 0 benefit. But there is a pandemic, with a virus that seems to cause long-term damage in some that survive, so the risk-benefit profile has shifted greatly in favor of the vaccine, even if a small percentage have a fever

 

[Zorba]

The standard is to run a Phase I trial to identify any major safety issues in a small population, and identify the appropriate dose to use in later trials, as well as gather data about potential efficacy. Phase II is an extension of Phase I - enroll more patients, check for any new safety issues at the determined Phase II dose (from the Phase I trial) in a broader population, as well as more rigourously look at efficacy. The last step is to identify an appropriate clinical trial efficacy endpoint, then enroll tens of thousands in a Phase III placebo-controlled trial where patients are randomized to either vaccine or placebo, and then monitor safety and for events triggering the primary endpoint. Safety follow-up will often run for 2+ years, but due to the nature of vaccines, almost all adverse events of interest will occur temporally close to the vaccination date(s).

The standard has been followed. Timelines have been compressed due to the fact that there is a pandemic, but I wouldn't say that dangerous shortcuts have been taken.

As for the incidence of adverse events, that data is reported - you're welcome to take a look at it:
NEJM publication: https://www.nejm.org/doi/10.1056/NEJMoa2034577
FDA advisory committee meeting and materials (including the data - see the briefing document PDFs at the bottom of the page): https://www.fda.gov/advisory-commit...0-2020-meeting-announcement#event-information

Your one post about a single subject's experience is not representative of the trial data. We also know how to control temporary fevers - you could pop a Tylenol if you had a fever.

Anyway, there is no risk-free vaccine. If there was no pandemic or serious risk of coming down with COVID-19, it would be pretty stupid from a risk-benefit standpoint to take the vaccine, since it would be all risk and practically 0 benefit. But there is a pandemic, with a virus that seems to cause long-term damage in some that survive, so the risk-benefit profile has shifted greatly in favor of the vaccine, even if a small percentage have a fever

I believe these phase 3 trials are way larger than normal too, so there is way more safety data than normal. They made them so large so more people (gross quantity) would get sick sooner, so the effectiveness could be determined sooner.

 

[sandorski]

The Algorithm :

Fake News + Democratic Hoax + Wuhan Flu + Media Hoax + Bill Gates Vaccine + Microchips + Just the Flu + TrumpCine!;

The Trumper:

No Errors.

 

[Brainonska511]

I believe these phase 3 trials are way larger than normal too, so there is way more safety data than normal. They made them so large so more people (gross quantity) would get sick sooner, so the effectiveness could be determined sooner.

I think it depends on the vaccine. I know that some vaccine trials have enrolled large numbers like this (rotovirus comes to mind), and you see 10k+ enrollment in some cardiovascular disease trials.

You're on the right track with regards to patient numbers, but it wasn't so much that people would get sick sooner, but that you'd have more statistical power to see a real difference between two groups, even if only a small number ultimately got sick. Fewer enrolled people would mean you need more sickness events to see a difference between the arms. Though, it is certainly true that more people being enrolled means more chances someone gets sick. And as you pointed out, another benefit is having safety data on a large number of people, which is especially important for something you're looking to give a large chunk of the population.

 

[Zorba]

I think it depends on the vaccine. I know that some vaccine trials have enrolled large numbers like this (rotovirus comes to mind), and you see 10k+ enrollment in some cardiovascular disease trials.

You're on the right track with regards to patient numbers, but it wasn't so much that people would get sick sooner, but that you'd have more statistical power to see a real difference between two groups, even if only a small number ultimately got sick. Fewer enrolled people would mean you need more sickness events to see a difference between the arms. Though, it is certainly true that more people being enrolled means more chances someone gets sick. And as you pointed out, another benefit is having safety data on a large number of people, which is especially important for something you're looking to give a large chunk of the population.

Yeah, that is what I meant. The same percentage of people getting sick resulted in a higher gross number of sick people. So you can get strong statistically significant results sooner.

 

[Ajay]

I appreciate polls @HomerJS ; but at this point, in P&N, I think almost all of the republicans have been so severely chastised that they avoid this forum like the plague. Hell, before Trump, I did too, even after I switched to the Dem side. Just FWIW.