Coronavirus

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Hokahey
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Re: Coronavirus

#851 Post by Hokahey » Tue Nov 17, 2020 12:20 pm

mockbee wrote:
Tue Nov 17, 2020 12:13 pm
Who said anything about outright "lies"....?

The process, as currently being implemented, stinks to high hell. That's it. :noclue:

Efficacy is in serious jeopardy, due to the proce$$$$$$$$es currently in place. :idea:
Based on what exactly? I'm not even sure what you're arguing here. Is the FDA also in on this? How deep does this conspiracy go?

But before you answer, do you understand that vaccine company does not collect the efficacy data? Yes or no.

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Re: Coronavirus

#852 Post by mockbee » Tue Nov 17, 2020 12:30 pm

Hokahey wrote:
Tue Nov 17, 2020 12:20 pm
mockbee wrote:
Tue Nov 17, 2020 12:13 pm
Who said anything about outright "lies"....?

The process, as currently being implemented, stinks to high hell. That's it. :noclue:

Efficacy is in serious jeopardy, due to the proce$$$$$$$$es currently in place. :idea:
Based on what exactly? I'm not even sure what you're arguing here. Is the FDA also in on this? How deep does this conspiracy go?

But before you answer, do you understand that vaccine company does not collect the efficacy data? Yes or no.
No conspiracy involved. :noclue:
Just combine rosy projections, warp speed timeframes, $$$$ (like serious, serious $$$$) and general ineptitude (surely you don't think there is zero ineptitude out there....?) and that's the recipe for our current crap cake batter being put in the oven....nothing hidden in this recipe, all known factors.
(see panda and chaos above for specifics.....)
:noclue:

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Re: Coronavirus

#853 Post by Hokahey » Tue Nov 17, 2020 12:37 pm

mockbee wrote:
Tue Nov 17, 2020 12:30 pm
Hokahey wrote:
Tue Nov 17, 2020 12:20 pm
mockbee wrote:
Tue Nov 17, 2020 12:13 pm
Who said anything about outright "lies"....?

The process, as currently being implemented, stinks to high hell. That's it. :noclue:

Efficacy is in serious jeopardy, due to the proce$$$$$$$$es currently in place. :idea:
Based on what exactly? I'm not even sure what you're arguing here. Is the FDA also in on this? How deep does this conspiracy go?

But before you answer, do you understand that vaccine company does not collect the efficacy data? Yes or no.
No conspiracy involved. :noclue:
Just combine rosy projections, warp speed timeframes, $$$$ (like serious, serious $$$$) and general ineptitude (surely you don't think there is zero ineptitude out there....?) and that's the recipe for our current crap cake batter being put in the oven....nothing hidden in this recipe, all known factors.
(see panda and chaos above for specifics.....)
:noclue:
I have clearly disputed those "specifics."

It sounds like your entire argument is now ineptitude. I'm not sure who in this process are supposed to be the inept ones, and what the impact is on their piece. But I can see a lot of these arguments are not well informed and are beginning to sound like vAcCiNeS cAuSe AuTiSm

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Re: Coronavirus

#854 Post by kv » Tue Nov 17, 2020 12:54 pm

Hoka...look at his avatar

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chaos
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Re: Coronavirus

#855 Post by chaos » Tue Nov 17, 2020 1:01 pm

Hokahey wrote:
Tue Nov 17, 2020 12:37 pm

I have clearly disputed those "specifics."
Really? Where? You think the vaccines are going to work based on a total of 55K people who have gotten doses two different vaccines, where one showed protection for a seven day study period.

No one has seen the actual trial data. The process has been accelerated, and is moving down the road to being fast tracked based on minimal preliminary data.

Oh and this if from the Pfizer website regarding the only public information that is available:
Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists.
Last edited by chaos on Tue Nov 17, 2020 1:17 pm, edited 4 times in total.

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Re: Coronavirus

#856 Post by mockbee » Tue Nov 17, 2020 1:05 pm

kv wrote:
Tue Nov 17, 2020 12:54 pm
Hoka...look at his avatar
You only wish you were me..... :pat:
Re: Who is going to win the election - Nov 3, 2020 - Biden or Trump.....?

#28 Post by kv » Tue Nov 03, 2020 11:06 pm

So gimmie that tinhat gif cut to size pls ty :banghead:

:lol:
:wave:



:cool:

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Re: Coronavirus

#857 Post by Hokahey » Tue Nov 17, 2020 2:00 pm

chaos wrote:
Tue Nov 17, 2020 1:01 pm
Hokahey wrote:
Tue Nov 17, 2020 12:37 pm

I have clearly disputed those "specifics."
Really? Where? You think the vaccines are going to work based on a total of 55K people who have gotten doses two different vaccines, where one showed protection for a seven day study period.

No one has seen the actual trial data. The process has been accelerated, and is moving down the road to being fast tracked based on minimal preliminary data.

Oh and this if from the Pfizer website regarding the only public information that is available:
Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists.
Since you're just ranting, let's do this. You tell me how this data is "minimal" compared to traditional vaccine tracking.

You're making assertions, you get to back them.

Hint: you're wrong. About a lot.

The acceleration was in research and development, and not waiting a typical extremely cautious full 2 years for safety data. That said, the overwhelming majority of any safety side effects develop within 6 weeks (at the far, far end) of any vaccine. And yet, they will go 8 weeks before the independent board confirms final safety data because regulators asked them to go 2 months.

Yes, this is the initial data set. But it is data set from (for the millionth fucking time) AN INDEPENDENT BOARD.

It has been tested across a population of people most experts deem more than appropriate. And actually, across more of a population (and a diverse one at that) than was required!

I have read numerous reactions from infectious disease EXPERTS that are thus far thrilled with information we have so far. There would have to be a significant increase in the population of the vaccinated test subjects contracting covid over the last week for this data to trend more negative. Even then, the likelihood of dropping below the required 50-60% efficacy for FDA approval is basically 0.

Unlike most Americans, I'm going to trust the doctors and scientists that have dedicated their lives to this. The CEOs can't manipulate the data. They don't control it.

So sit back, shut up, and let the experts tell you what's happening.

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Re: Coronavirus

#858 Post by kv » Tue Nov 17, 2020 2:07 pm

You are such a dick :hehe:

clickie
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Re: Coronavirus

#859 Post by clickie » Tue Nov 17, 2020 2:14 pm

So what company do I buy stock in to capitalize on this pandemic?

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Re: Coronavirus

#860 Post by Hokahey » Tue Nov 17, 2020 3:00 pm

clickie wrote:
Tue Nov 17, 2020 2:14 pm
So what company do I buy stock in to capitalize on this pandemic?
Most market experts believe the current stock prices for the major vaccine developer already have positive vaccine data baked in, hence some being sold off right now.

Other than that, pick an industry that's going to rebound when people are comfortable being in groups again.

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Re: Coronavirus

#861 Post by Hokahey » Tue Nov 17, 2020 3:01 pm

kv wrote:
Tue Nov 17, 2020 2:07 pm
You are such a dick :hehe:
I learned it from watching you dad.

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chaos
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Re: Coronavirus

#862 Post by chaos » Tue Nov 17, 2020 3:03 pm

Jesus Christ Hoka. I don't know how to teach you how to fucking read. Start with getting a dictionary.

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Re: Coronavirus

#863 Post by Hokahey » Tue Nov 17, 2020 5:27 pm

chaos wrote:
Tue Nov 17, 2020 3:03 pm
Jesus Christ Hoka. I don't know how to teach you how to fucking read. Start with getting a dictionary.
Bud, I do nothing but read. All day e'ry day. Which is why your posts look like such nonsense.

I'm sick of ignorance being argued as fact. Sick. Of. It.

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Re: Coronavirus

#864 Post by mockbee » Tue Nov 17, 2020 6:38 pm

guysmiley wrote:
Mon Nov 16, 2020 11:37 pm
:bigrin:
That guy totally reminded me of AP Calculus in HS.
The teacher would write out all assignments by hand and give us photocopies for assigments and used this special projector that transposed his handwriting during class to a screen (this was early 90s, so wasn't digital and wasn't overhead projector (he hated those things, too hot and didn't like the "wet" pens... :lol:) He was ahead of his time, but still old fashioned.... :hehe:
I loved that guy. :cool:

Thanks for that..... :thumb:

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Re: Coronavirus

#865 Post by Pandemonium » Wed Nov 18, 2020 10:17 pm

clickie wrote:
Tue Nov 17, 2020 2:14 pm
So what company do I buy stock in to capitalize on this pandemic?
Funeral parlors.

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Re: Coronavirus

#866 Post by mockbee » Wed Nov 18, 2020 10:31 pm

clickie wrote:
Tue Nov 17, 2020 2:14 pm
So what company do I buy stock in to capitalize on this pandemic?
Facepalm gifs

:noclue:
:dunce:


Image

Image

Image

Image

Image

Image

Image

Image


:lol:

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Artemis
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Re: Coronavirus

#867 Post by Artemis » Fri Nov 20, 2020 4:03 pm

Lockdown in Toronto starting Monday.

Not as severe as the spring. Schools and daycares will still be open but most other things will be closed. Limits on gatherings indoors and out. Restaurants going back to pick up and delivery only. Gyms, personal care services(hair salons) closed. Weddings and funerals limited to 10 people.

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Re: Coronavirus

#868 Post by mockbee » Fri Nov 20, 2020 4:18 pm

Yesterday our governor said, do not gather for Thanksgiving. No more than 2 households can gather, and it must be fewer than 6 people. The state has decreed that those who “knowingly” violate the order would face a Class C misdemeanor charge, which carries the potential for a $1,250 fine, jail time or both.

A prosecutor could also reduce any criminal citation to a non-criminal violation with a lower fine. The Oregon Health Authority, meanwhile, could pursue civil penalties which carry a maximum fine of $500 a day for prolonged violations.

To add insult to injury I opened the mail yesterday evening and was notified that the Governor signed an order last week that I MUST go to the DEQ by December in order to do an emissions test. I was supposed to go in April when cases were minuscule compared to now, but was banned at that time. So, I will be at the DEQ, along with everyone else in the state who were required to delay, this Thanksgiving instead of gathering with family getting an emissions test.
The bureaucratic ineptitude is okay in my mind....just the emphatic hypocrisy from Elected Officials is what really bothers me. :banghead:


Oh, also, in my state they are averaging 4,000 COVID tests a day..... :essence: .....that is pathetic but is significantly up from previous months/weeks.

Here is what is going on in other states with similar populations:

In Kentucky (same population):
45,000 people were tested each day.....45,000 is average for them the last several months.

In Louisiana (same population):
23,000 people were tested each day...average over last couple months

In Alabama (everyone likes to make fun of Alabama...... for some reason...?)
9,500 people were tested each day....double Oregon testing.....

In Oklahoma (Trump won by 66% of the vote...so they don't believe in COVID, right?)
19,000 people were tested each day, average.....

:hs:

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Re: Coronavirus

#869 Post by mockbee » Fri Nov 20, 2020 4:28 pm

mockbee wrote:
Thu Feb 27, 2020 8:06 am
So media/stocks etc going bonkers....

I think there is going to be a period of time where everyone in the US is going to be asked to stay home. A 2 week viral holiday.... :noclue: :drink:

Just reviewing some initial pages on this thread...

2 week holiday.................?!!!!!!!!!!!!! ...................... HA! :lolol:


Try 9 months and counting.....getting worse. :drink:

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Hype
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Re: Coronavirus

#870 Post by Hype » Mon Nov 23, 2020 7:29 am

mockbee wrote:
Fri Nov 20, 2020 4:28 pm
mockbee wrote:
Thu Feb 27, 2020 8:06 am
So media/stocks etc going bonkers....

I think there is going to be a period of time where everyone in the US is going to be asked to stay home. A 2 week viral holiday.... :noclue: :drink:

Just reviewing some initial pages on this thread...

2 week holiday.................?!!!!!!!!!!!!! ...................... HA! :lolol:


Try 9 months and counting.....getting worse. :drink:
I calculated the numbers for an infection rate with an r0 value of 2 on Page 4, I think. I said:
Week 32: 43046883 people.
The first documented cases appeared around January 22nd (Week 4 of 2020)
So if the rate stayed stable, I'd expect we had at least 43 million documented infections by Week 36, which was Aug 31-Sept 6.

According to Worldometers, the world hit 43 million recorded infections somewhere between Oct 22 and Oct 26. So it seems we managed to slow the spread slightly, but not much. And looking at the charts, this second wave has actually increased the rate of spread. (We're nearing 60 million now.)

This suggests that prevention efforts have done very little, if anything, except buy hospitals time (except where they have been overwhelmed).

For all the talk of 21st century public health advances, we seem to be stuck using primitive, brutal controls (like lockdowns) until a vaccine rollout to a sufficiently large number of people has taken effect. Canadian officials are saying for us that means at least another full year of distancing and control measures. :no:

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Re: Coronavirus

#871 Post by Hype » Mon Nov 23, 2020 8:41 am

chaos wrote:
Tue Nov 17, 2020 1:01 pm
Hokahey wrote:
Tue Nov 17, 2020 12:37 pm

I have clearly disputed those "specifics."
Really? Where? You think the vaccines are going to work based on a total of 55K people who have gotten doses two different vaccines, where one showed protection for a seven day study period.

No one has seen the actual trial data. The process has been accelerated, and is moving down the road to being fast tracked based on minimal preliminary data.

Oh and this if from the Pfizer website regarding the only public information that is available:
Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists.
So, I know some peeps in pharmacovigilance/drug safety, and I can tell you with absolute certainty that the requirements for FDA approval are stringent. They will see the data. Companies are required to report directly to the FDA ALL adverse events (SAEs) during clinical trials, BEFORE it's established whether or not the AE was caused by the drug. In fact, there's a strict timeline for that reporting, and trials are stopped if certain thresholds for AEs are crossed. By the time a drug has reached in-human clinical trials, it has already passed multiple animal safety and efficacy trials. There is absolutely a team of people (always overseen by MDs) reporting literally every recorded headache, rash, soreness, eye-twitch experienced by the people in these trials.

One of the reasons why the process can be accelerated at all is that there had been existing work done on a SARS vaccine back during that pandemic in the early 2000s. Vaccines are not introducing active molecules into your system the way that other drugs do. They're usually introducing either a dead or attenuated virus, or some sort of modified protein, with the aim of prompting the appropriate immune response. This is, in some ways, far safer than other drugs where you're introducing a molecule that has some very potent chemical interaction (like, say, chelation). It's especially safer since we have a long history of developing and observing the use of the vaccine substrates, etc. (see, e.g., https://www.who.int/biologicals/vaccine ... trates/en/)

So, the main question is simply efficacy. Safety concerns are far, far easier to manage, and you'd know as soon as there's any major concern, because you'd see reports of a trial stoppage.

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Re: Coronavirus

#872 Post by mockbee » Mon Nov 23, 2020 9:26 am

The FDA, (along with, of course, WHO, etc) are no gold standard.

Even NIH has grave doubts about the expedited/politicized process currently in place. :noclue:
The FDA memo outlining the EUA for convalescent plasma cites just two randomized controlled trials, both of which were stopped early — one because it failed to recruit enough participants and the other because they found that the patients that were receiving plasma already had high levels of antibodies. Both found little to no benefit from the treatment, but they remain some of the best-constructed studies.

The memo also cites a handful of observational and retrospective studies as the basis for its decision. It was one of these retrospective studies that served as the basis for the White House’s boldest claim about the effectiveness of convalescent plasma to treat Covid-19.

During the August 23 press conference, Hahn reported that convalescent plasma would yield a 35 percent improvement in the survival rate of Covid-19 patients.

“A 35 percent improvement in survival is a pretty substantial clinical benefit,” said Hahn during a Sunday press conference. “What that means is, if the data continue to pan out, if 100 people are sick with Covid-19, 35 would have been saved with the administration of plasma.”

"A 35 percent improvement in survival is a pretty substantial clinical benefit," FDA Commissioner @SteveFDA said in relation to the convalescent plasma emergency use authorization issued today. pic.twitter.com/Dd97vLSZeL
— U.S. FDA (@US_FDA) August 23, 2020

But other researchers said that Hahn’s 35 percent improvement in survival claim was wildly misleading. It came from a retrospective preprint study that hasn’t undergone peer review, so some of the methods and findings may have flaws that would ordinarily be caught in the review process.

“For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy,” Walid Gellad, of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told the New York Times.


The study doesn’t compare patients who received convalescent plasma to patients who received a placebo, either. Rather, it compares patients who received plasma early versus those who received it later in their course of treatment.

Even within that comparison, the results showed that the seven-day mortality rate was 11.9 percent in patients who received plasma four days or more after they were diagnosed with Covid-19, while those who received plasma three days after diagnosis had a mortality rate of 8.7 percent. In other words, getting plasma to Covid-19 patients one day earlier reduced the absolute mortality by 3.2 percent.

And when the researchers compared the doses of convalescent plasma, they found that those that received the low dose had a seven-day mortality rate of 13.7 percent while those that received the high dose had a rate of 8.9 percent. That’s a only 4.8 percent improvement in absolute terms, but a 35 percent change in relative terms. It’s progress, but not the massive leap forward that Hahn and other officials made it sound like.

Faust pointed out that this retrospective study only sampled patients who were sick enough to go to the hospital. Out of those, the patients studied were only the ones who received convalescent plasma, were under the age of 80, and who did not receive mechanical ventilation.

“This big ‘breakthrough’ that they say is a 35 percent reduction in mortality, this is a subset of a subset of a subset in a retrospective study which has not been confirmed with a trial,” he said. “There’s nothing wrong with the study itself for what it is; what’s wrong is to rely on it to say that there’s been a breakthrough.”

On August 24, Hahn acknowledged, after much criticism, that he overplayed his hand. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” he wrote.

But for some researchers, it was not enough. A few responded on Twitter that they wanted a more forceful retraction of the claim and other statements Hahn made during the press conference.

You need to correct the 35 lives saved per 100 sick with covid-19 so people understand that was absolutely wrong, Steve. That there is no evidence to support that. That there is no evidence at this juncture to support *any* survival benefit. That we need RCTs.
— Eric Topol (@EricTopol) August 25, 2020
https://www.vox.com/2020/8/24/21399007 ... ephen-hahn
You're right, maybe people getting these highly expedited vaccines don't keel over or have serious complications, but certainly close to a trillion dollars of resources should go through proper channels and critical testing and proven scientific studies should not be sidelined in the name of "saving lives"....?

I blame Trump and Biden (repubs and dems) for politicizing this shit. All politicians have utterly failed in this recovery response effort.

I also don't think the US can/could really be able to respond in any different way than it did. If Biden was president we would have ALL been wearing masks since March just because he said so??? I don't think so. That's not America.
Also Europe should be doing great, if that were the case, and they are not..... :scared:

Maybe if we were all a mostly monolithic culture who lived on an isolated island like New Zealand, we would have this under control..... :noclue:

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Re: Coronavirus

#873 Post by Hype » Mon Nov 23, 2020 9:32 am

mockbee wrote:
Mon Nov 23, 2020 9:26 am
The FDA, (along with, of course, WHO, etc) are no gold standard.

Even NIH has grave doubts about the expedited/politicized process currently in place. :noclue:
The FDA memo outlining the EUA for convalescent plasma cites just two randomized controlled trials, both of which were stopped early — one because it failed to recruit enough participants and the other because they found that the patients that were receiving plasma already had high levels of antibodies. Both found little to no benefit from the treatment, but they remain some of the best-constructed studies.

The memo also cites a handful of observational and retrospective studies as the basis for its decision. It was one of these retrospective studies that served as the basis for the White House’s boldest claim about the effectiveness of convalescent plasma to treat Covid-19.

During the August 23 press conference, Hahn reported that convalescent plasma would yield a 35 percent improvement in the survival rate of Covid-19 patients.

“A 35 percent improvement in survival is a pretty substantial clinical benefit,” said Hahn during a Sunday press conference. “What that means is, if the data continue to pan out, if 100 people are sick with Covid-19, 35 would have been saved with the administration of plasma.”

"A 35 percent improvement in survival is a pretty substantial clinical benefit," FDA Commissioner @SteveFDA said in relation to the convalescent plasma emergency use authorization issued today. pic.twitter.com/Dd97vLSZeL
— U.S. FDA (@US_FDA) August 23, 2020

But other researchers said that Hahn’s 35 percent improvement in survival claim was wildly misleading. It came from a retrospective preprint study that hasn’t undergone peer review, so some of the methods and findings may have flaws that would ordinarily be caught in the review process.

“For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy,” Walid Gellad, of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told the New York Times.


The study doesn’t compare patients who received convalescent plasma to patients who received a placebo, either. Rather, it compares patients who received plasma early versus those who received it later in their course of treatment.

Even within that comparison, the results showed that the seven-day mortality rate was 11.9 percent in patients who received plasma four days or more after they were diagnosed with Covid-19, while those who received plasma three days after diagnosis had a mortality rate of 8.7 percent. In other words, getting plasma to Covid-19 patients one day earlier reduced the absolute mortality by 3.2 percent.

And when the researchers compared the doses of convalescent plasma, they found that those that received the low dose had a seven-day mortality rate of 13.7 percent while those that received the high dose had a rate of 8.9 percent. That’s a only 4.8 percent improvement in absolute terms, but a 35 percent change in relative terms. It’s progress, but not the massive leap forward that Hahn and other officials made it sound like.

Faust pointed out that this retrospective study only sampled patients who were sick enough to go to the hospital. Out of those, the patients studied were only the ones who received convalescent plasma, were under the age of 80, and who did not receive mechanical ventilation.

“This big ‘breakthrough’ that they say is a 35 percent reduction in mortality, this is a subset of a subset of a subset in a retrospective study which has not been confirmed with a trial,” he said. “There’s nothing wrong with the study itself for what it is; what’s wrong is to rely on it to say that there’s been a breakthrough.”

On August 24, Hahn acknowledged, after much criticism, that he overplayed his hand. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” he wrote.

But for some researchers, it was not enough. A few responded on Twitter that they wanted a more forceful retraction of the claim and other statements Hahn made during the press conference.

You need to correct the 35 lives saved per 100 sick with covid-19 so people understand that was absolutely wrong, Steve. That there is no evidence to support that. That there is no evidence at this juncture to support *any* survival benefit. That we need RCTs.
— Eric Topol (@EricTopol) August 25, 2020
https://www.vox.com/2020/8/24/21399007 ... ephen-hahn
You're right, maybe people getting these highly expedited vaccines don't keel over or have serious complications, but certainly close to a trillion dollars of resources should go through proper channels and critical testing and proven scientific studies should not be sidelined in the name of "saving lives"....?

I blame Trump and Biden (repubs and dems) for politicizing this shit. All politicians have utterly failed in this recovery response effort.

I also don't think the US can/could really be able to respond in any different way than it did. If Biden was president we would have ALL been wearing masks since March just because he said so??? I don't think so. That's not America.
Also Europe should be doing great, if that were the case, and they are not..... :scared:

Maybe if we were all a mostly monolithic culture who lived on an isolated island like New Zealand, we would have this under control..... :noclue:
Convalescent plasma is not a vaccine. It's a treatment for people who already have COVID-19. The accelerated vaccine schedules are a completely different issue from needing immediate treatments for dying people.

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mockbee
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Re: Coronavirus

#874 Post by mockbee » Mon Nov 23, 2020 10:41 am

Hype wrote:
Mon Nov 23, 2020 9:32 am


Convalescent plasma is not a vaccine. It's a treatment for people who already have COVID-19. The accelerated vaccine schedules are a completely different issue from needing immediate treatments for dying people.
Yeah, we'll see what happens. Looks like we'll know FDAs initial take, and whether they heed all advisory committee concerns, in the middle of December.

Surely it would be a miracle if there were no concerns or additional questions...... :noclue:


Pfizer Applies for Emergency F.D.A. Approval for Covid-19 Vaccine
ImageA large team of regulators at the agency will take about three weeks to review an application spanning thousands of pages.
Pfizer and its partner BioNTech announced this week that the vaccine was 95 percent effective and that it worked well in older people and in preventing severe Covid-19.



By Noah Weiland and Katie Thomas

Published Nov. 20, 2020Updated Nov. 22, 2020

The drug maker Pfizer said on Friday that it had submitted an application to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use, setting in motion an accelerated regulatory process that could allow the first Americans to get a vaccine by the middle of December.

Pfizer and its German partner, BioNTech, announced Wednesday that the vaccine was safe and 95 percent effective, and that it also worked well in older people and in preventing severe Covid-19.

Another front-runner, Moderna, said on Monday that its vaccine, which uses similar technology, was 94.5 percent effective and that the company also expected to apply soon for emergency authorization.

The two vaccines use a synthetic version of coronavirus genetic material, called mRNA, to program a person’s cells to churn out many copies of a fragment of the virus.

An emergency authorization would allow limited groups of Americans to get the vaccines before the F.D.A. has completed the typical monthslong approval process,
but agency officials have made clear through new guidelines that their bar for emergency authorization will be high.

In a video message Friday, Pfizer’s chief executive, Dr. Albert Bourla, called it a “historic day,” and said: “It is with great pride and joy — and even a little relief — that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the F.D.A.’s hands.”


Both of the companies’ vaccine candidates began large human trials on the same day, July 27, leading the pack of six vaccines the federal government has invested in through its crash vaccine development program, Operation Warp Speed.

If the two vaccines are authorized for emergency use, federal and company officials have said there could be enough doses to immunize about 20 million Americans before the end of the year, a group that would most likely include health care workers and nursing home residents. There are an estimated 17 million to 20 million health care workers in the United States, and about a million people living in nursing homes.

After lowering expectations for how many millions of vaccines they can produce this year, the companies expect to ramp up their manufacturing early next year. Like with other kinds of vaccines, mass producing them for the coronavirus has proved to be a complex and delicate process requiring sterile conditions and precise control of temperature and humidity. The mRNA technology has also never been commercially manufactured. If other vaccines are also authorized, hundreds of millions of doses could be available by the spring, according to federal officials.

Both Pfizer and Moderna have arranged deals with the government so that the vaccines will be free to Americans and distributed according to plans worked out between the federal government and the states. CVS and Walgreens also have federal deals to begin immunizing nursing home residents. On Tuesday, Alex M. Azar II, the secretary of the Department of Health and Human Services, said that 99 percent of the country’s nursing homes had signed up to be part of the program.

Regulators at the F.D.A. plan to take about three weeks to review Pfizer’s vaccine before an outside panel of experts meets to review the application the second week of December. That meeting has been scheduled for Dec. 10.

The agency typically, though not always, follows the advice of its advisory committees. If committee members reach a consensus about the effectiveness of Pfizer’s vaccine, the company could receive emergency clearance by mid-December.

Because Moderna is also on the verge of submitting its vaccine for review, the outside panel could review the company’s vaccine soon after Pfizer’s.

Pfizer said on Friday that the company has begun regulatory submissions in Australia, Canada, Europe, Japan and Britain, and that it plans to apply in other countries “in the immediate future.”

Inside the F.D.A., Pfizer’s application will be reviewed by the agency’s Center for Biologics Evaluation and Research, which has organized large teams of medical and compliance officers, epidemiologists and statisticians to dig into thousands of pages of data about the safety and effectiveness for each vaccine, as well as information on how companies plan to safely and consistently manufacture large batches of the product.

The process could take longer if the reviewers come across errors, or if they need to ask for additional data. Regulators expect the manufacturing data to spur intense deliberation, as companies have scrambled to turn over that information in time.

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Hype
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Re: Coronavirus

#875 Post by Hype » Tue Nov 24, 2020 8:18 am

It's so weird for me to see people googling/reading articles about this kind of thing and trying to piece it all together, because I've seen medical safety from the inside for a decade. These articles are simplifying what actually happens and not giving a real sense of what is actually involved. It usually takes a long time because there are so many people, procedures, and regulations involved. Speeding up the process isn't arbitrary. They're following the same sort of thing they use for compassionate use authorizations and so on, and all of that still has to be reviewed by MDs.

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