Vaccine Development Summary
09-08-2020, 09:09 AM
#161
:-)
Joined APC: Feb 2007
Posts: 7,339
Looks like the High Road on their part, to concerns about political interference in the process...
https://www.npr.org/sections/coronav...vid-19-vaccine
https://www.npr.org/sections/coronav...vid-19-vaccine
09-08-2020, 01:40 PM
#162
:-)
Joined APC: Feb 2007
Posts: 7,339
Nobody (in the west) is skipping any trials.
Right now the uncertainty in the *timeline* is phase-3, which requires that participants actually get challenged by the pathogen in the wild so they can obtain efficacy data (some efficacy data was likely acquired incidentally in phase 1 & 2). That's why they are running trials in various known hotspots around the world, to increase the opportunity to acquire data. There's still obvious uncertainty as to efficacy and safety as well, that's why they do phase-3 (and 4).
Right now the uncertainty in the *timeline* is phase-3, which requires that participants actually get challenged by the pathogen in the wild so they can obtain efficacy data (some efficacy data was likely acquired incidentally in phase 1 & 2). That's why they are running trials in various known hotspots around the world, to increase the opportunity to acquire data. There's still obvious uncertainty as to efficacy and safety as well, that's why they do phase-3 (and 4).
900 studies on HCQ, that science knew would fail, all just to prove a point, what a waste of much needed resources.
09-08-2020, 05:02 PM
#163
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
AstraZeneca vaccine study on hold...
The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”
An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.
An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.
If this were antibody dependent disease enhancement, that would be very bad...
https://www.nature.com/articles/s41586-020-2538-8
09-08-2020, 05:09 PM
#164
:-)
Joined APC: Feb 2007
Posts: 7,339
https://www.statnews.com/2020/09/08/...nt-in-the-u-k/
If this were antibody dependent disease enhancement, that would be very bad...
https://www.nature.com/articles/s41586-020-2538-8
If this were antibody dependent disease enhancement, that would be very bad...
https://www.nature.com/articles/s41586-020-2538-8
09-08-2020, 05:16 PM
#166
Gets Weekends Off
Joined APC: Mar 2015
Posts: 514
I guess. Someone in the phase three developed a rare swelling of the spinal cord, Transverse Myelitis, that is usually caused by a virus, but can also be caused by a vaccine. So it's a big deal, so I'm told, I'm just a pilot.
09-08-2020, 05:22 PM
#167
Prime Minister/Moderator
Joined APC: Jan 2006
Position: Engines Turn Or People Swim
Posts: 40,057
1 is only safety, although they will certainly look for any indications of efficacy as a matter of interest.
2 is looking also at efficacy and dosing but still with a small sample size. Efficacy may be measured more by analysis of immune response than by real world challenge data. Phase 3 is where the rubber meets the road... large numbers of participants in a double-blind real-world challenge. Also serves to screen for any rare adverse reactions which might not have occurred in small early trials. Phase 4 is ongoing safety monitoring after the pharma is approved and deployed.
09-08-2020, 05:46 PM
#168
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
One would think that both political sides could find common cause against an RNA virus causing bipartisan carnage. Apparently the other side losing has become more to be desired than everyone winning.
09-08-2020, 08:12 PM
#169
Prime Minister/Moderator
Joined APC: Jan 2006
Position: Engines Turn Or People Swim
Posts: 40,057
https://www.statnews.com/2020/09/08/...nt-in-the-u-k/
If this were antibody dependent disease enhancement, that would be very bad...
https://www.nature.com/articles/s41586-020-2538-8
If this were antibody dependent disease enhancement, that would be very bad...
https://www.nature.com/articles/s41586-020-2538-8
09-09-2020, 07:13 AM
#170
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
as well as on the clinical trials being conducted by other vaccine manufacturers.
https://pubmed.ncbi.nlm.nih.gov/9492360/
https://onlinelibrary.wiley.com/doi/...2/cyto.a.24047
https://pubmed.ncbi.nlm.nih.gov/32582200/
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