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Old 08-14-2020, 06:03 AM
  #131  
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Human challenge trails are under consideration in the US....

That could speed up phase-3 trails, since you don't have to wait weeks or months or longer for enough participants to get naturally exposed in the environment to generate sufficient data.


https://www.reuters.com/article/us-h...-idUSKCN25A1EL
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Old 08-14-2020, 06:53 AM
  #132  
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Originally Posted by rickair7777 View Post
Human challenge trails are under consideration in the US....

That could speed up phase-3 trails, since you don't have to wait weeks or months or longer for enough participants to get naturally exposed in the environment to generate sufficient data.


https://www.reuters.com/article/us-h...-idUSKCN25A1EL
Interesting it sounds like it won’t come in time though. This almost seems like they are doing Thai for future vaccines. They said it would take six month to a year to actually execute the trails. So we should know the results on this first batch but if they help get it under control they could use this for better vaccines.
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Old 08-30-2020, 07:09 AM
  #133  
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Sounds like the FDA is potentially open to emergency use authorization for vaccines after all... that IS a shortcut. They are clear that it would only happen if the risk/benefit tradeoff was appropriate. Most likely limited to select groups who are at-risk for one reason or another.

https://www.reuters.com/article/us-h...-idUSKBN25Q0G7
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Old 08-30-2020, 07:55 AM
  #134  
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Originally Posted by rickair7777 View Post
Sounds like the FDA is potentially open to emergency use authorization for vaccines after all... that IS a shortcut. They are clear that it would only happen if the risk/benefit tradeoff was appropriate. Most likely limited to select groups who are at-risk for one reason or another.

https://www.reuters.com/article/us-h...-idUSKBN25Q0G7
i would hope front line healthcare workers, first responders, and residents and staff of nursing homes only. This needs to be gotten right.
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Old 08-30-2020, 04:46 PM
  #135  
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Originally Posted by rickair7777 View Post
Sounds like the FDA is potentially open to emergency use authorization for vaccines after all... that IS a shortcut. They are clear that it would only happen if the risk/benefit tradeoff was appropriate. Most likely limited to select groups who are at-risk for one reason or another.

https://www.reuters.com/article/us-h...-idUSKBN25Q0G7
That is worrisome.
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Old 08-30-2020, 06:08 PM
  #136  
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If the phase 3 testing is complete (45,000 volunteers ?) before the end of the year, and results are good, I like the idea of the emergency approval. The testing of large quantities will have been done. The risk to someone getting the vaccine is low. All the paperwork is not complete.

I have heard 3 vaccines are in final tests, with more getting close behind them. All of them are making the vaccine in mass quantities based on the first phase being straightforward positive.

After health care workers and high risk people, I want to stand in an early line for the general public.
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Old 08-31-2020, 07:20 AM
  #137  
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Originally Posted by BlueMoon View Post
That is worrisome.
Meh. They just said they're open to it, depending on risk vs. benefit. I said back in March they might do this, because the covid was being hyped to be rather more dangerous than what it actually turned out to be. If we were dealing with a Spanish Flu scenario right now, emergency authorization would be very appropriate.

I'm pretty sure nobody (except .mil) would try to mandate use of a non-certified vaccine, would likely be optional, although health care workers who opted out might get re-assigned or something like that. Probably wouldn't be emergency-approved for the general population anyway.
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Old 08-31-2020, 07:26 AM
  #138  
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Originally Posted by rickair7777 View Post
. I said back in March they might do this, because the covid was being hyped to be rather more dangerous than what it actually turned out to be. If we were dealing with a Spanish Flu scenario right now, emergency authorization would be very appropriate.
I was beginning to think I was the only one thinking this. Back in March I was thinking this was going to be bad. Now, it’s like it was just a bad flu season.

But hey, at least 10,000 pilots are going to lose their job.
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Old 08-31-2020, 07:26 AM
  #139  
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Originally Posted by TransWorld View Post
If the phase 3 testing is complete (45,000 volunteers ?) before the end of the year, and results are good, I like the idea of the emergency approval. The testing of large quantities will have been done. The risk to someone getting the vaccine is low. All the paperwork is not complete.
If phase 3 is complete, and the data looks good they should be able to do regular approval... that's where that normally happens anyway, it just typically takes the bureaucracy a few years to get around to looking at it. But they're not going to sit on this one, I'm sure they're analyzing all the data as it comes in, updating as the trial progresses so they'll have a pretty good idea as to the final result before the trial is finished.

Originally Posted by TransWorld View Post
After health care workers and high risk people, I want to stand in an early line for the general public.
x2. I'm sick of wearing a mask.
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Old 08-31-2020, 07:40 AM
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Concerns about efficacy of Chinese and Russian viral-vector vaccines...

https://www.reuters.com/article/us-h...-idUSKBN25R19H
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