Vaccine Development Summary
#131
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
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
#132
Gets Weekends Off
Joined APC: May 2020
Posts: 484
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
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
#133
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
https://www.reuters.com/article/us-h...-idUSKBN25Q0G7
#134
Gets Weekends Off
Joined APC: May 2020
Posts: 484
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
https://www.reuters.com/article/us-h...-idUSKBN25Q0G7
#135
Gets Weekends Off
Joined APC: Feb 2007
Position: FO
Posts: 3,032
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
https://www.reuters.com/article/us-h...-idUSKBN25Q0G7
#136
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.
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.
#137
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.
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.
#138
Gets Weekends Off
Joined APC: Mar 2005
Posts: 392
But hey, at least 10,000 pilots are going to lose their job.
#139
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.
x2. I'm sick of wearing a mask.
#140
Concerns about efficacy of Chinese and Russian viral-vector vaccines...
https://www.reuters.com/article/us-h...-idUSKBN25R19H
https://www.reuters.com/article/us-h...-idUSKBN25R19H
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