Vaccine Development Summary
09-09-2020, 10:23 AM
#181
Prime Minister/Moderator
Joined APC: Jan 2006
Position: Engines Turn Or People Swim
Posts: 40,057
09-09-2020, 10:29 AM
#182
Prime Minister/Moderator
Joined APC: Jan 2006
Position: Engines Turn Or People Swim
Posts: 40,057
And the problem with this is what the biostatisticians call ‘sparse data’. The annual incidence of transverse myelitis ranges from 1.34 to 4.60 cases per million, so in a population of 15,000 research subjects observed over 6 months the statistical EXPECTATION is only maybe 0.002 case. So already you have had a severe occurrence at 500 times the statistical expectation. But transverse myelitis DOES OCCUR sporadically (1400 cases a year in the US), and it certainly COULD be simple coincidence. You simply don’t have the data yet to tell you if that one case is statistically significant or not.
MS however is common enough (especially in women), that can also be a cause.
My guess, based on previous precedent with this condition, is there will be some analysis and hand-wringing and then they'll proceed with the trials. A small but vibrant anti-vax cottage industry will revolve around this for decades, discreetly fueled by plaintiff's attorneys hoping to "prime the pump" of potential future jurors.
If it pops up again in phase-3, it might be game over for this particular candidate. If it pops up in phase-4 that will have to be considered in the context of how large the phase-4 cohort is at the time... it could literally number in the billions before very long. In that case, you'd actually expect a few more cases. You'd also expect a few cohort members to die in plane crashes, but they probably won't blame that on the vaccine.
Last edited by rickair7777; 09-09-2020 at 10:39 AM.
09-09-2020, 10:51 AM
#183
Gets Weekends Off
Joined APC: Nov 2016
Posts: 303
I personally can not in anyway believe a 60,000 person company with $25,000,0000 in revenue last year, that is publicly traded and based in the UK, is in a conspiracy with one of the best and oldest universities in the world, and who after getting 65 million Euro in support from the British government to fund this vaccine, would all be conspiring together just to hurt Trump. It’s just to big and too many people with no skin in the game.
To say nothing of the fact that 1 billion in funding for this vaccine is from the US government’s Operation Warp Speed, an operation headed by various agencies in Trump’s executive branch, including people he directly appointed, so if anything was fishy, the guy writing the checks is going to look at this very close. (Meaning you would expect the US government to want answers to any and all questions they may have, rightfully so)
So for this to be a conspiracy against Trump, a major multi-national publicly traded company, along with a nearly 1000 year old “Ivy League of England” type school, the British Government, along with the Department of Defense and Department of Health and Human Services would have to turn a blind eye to it - are all in it to hurt Trump?
(And how much help a vaccine getting approved one week before vs one week after the election is probably debatable seeing how polorized we are and how many voters on both sides are 100% locked in today regardless)
I am not going to convince you this is nothing more than how vaccine trials work, nor will you convince I that a conspiracy on this scale and size could even be possible. It is my fault for engaging in the drift so I will end it with we agree to disagree.
09-09-2020, 11:52 AM
#184
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
PART 56 -- INSTITUTIONAL REVIEW BOARDS
Subpart A--General Provisions
Sec. 56.103 Circumstances in which IRB review is required.(a) Except as provided in 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part
Subpart A--General Provisions
Sec. 56.103 Circumstances in which IRB review is required.(a) Except as provided in 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part
Last edited by Excargodog; 09-09-2020 at 12:27 PM.
09-09-2020, 12:01 PM
#185
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
09-09-2020, 12:37 PM
#186
:-)
Joined APC: Feb 2007
Posts: 7,339
Look in the interest of preventing thread drift, I will just say this and leave it be after.
I personally can not in anyway believe a 60,000 person company with $25,000,0000 in revenue last year, that is publicly traded and based in the UK, is in a conspiracy with one of the best and oldest universities in the world, and who after getting 65 million Euro in support from the British government to fund this vaccine, would all be conspiring together just to hurt Trump. It’s just to big and too many people with no skin in the game.
To say nothing of the fact that 1 billion in funding for this vaccine is from the US government’s Operation Warp Speed, an operation headed by various agencies in Trump’s executive branch, including people he directly appointed, so if anything was fishy, the guy writing the checks is going to look at this very close. (Meaning you would expect the US government to want answers to any and all questions they may have, rightfully so)
So for this to be a conspiracy against Trump, a major multi-national publicly traded company, along with a nearly 1000 year old “Ivy League of England” type school, the British Government, along with the Department of Defense and Department of Health and Human Services would have to turn a blind eye to it - are all in it to hurt Trump?
(And how much help a vaccine getting approved one week before vs one week after the election is probably debatable seeing how polorized we are and how many voters on both sides are 100% locked in today regardless)
I am not going to convince you this is nothing more than how vaccine trials work, nor will you convince I that a conspiracy on this scale and size could even be possible. It is my fault for engaging in the drift so I will end it with we agree to disagree.
I personally can not in anyway believe a 60,000 person company with $25,000,0000 in revenue last year, that is publicly traded and based in the UK, is in a conspiracy with one of the best and oldest universities in the world, and who after getting 65 million Euro in support from the British government to fund this vaccine, would all be conspiring together just to hurt Trump. It’s just to big and too many people with no skin in the game.
To say nothing of the fact that 1 billion in funding for this vaccine is from the US government’s Operation Warp Speed, an operation headed by various agencies in Trump’s executive branch, including people he directly appointed, so if anything was fishy, the guy writing the checks is going to look at this very close. (Meaning you would expect the US government to want answers to any and all questions they may have, rightfully so)
So for this to be a conspiracy against Trump, a major multi-national publicly traded company, along with a nearly 1000 year old “Ivy League of England” type school, the British Government, along with the Department of Defense and Department of Health and Human Services would have to turn a blind eye to it - are all in it to hurt Trump?
(And how much help a vaccine getting approved one week before vs one week after the election is probably debatable seeing how polorized we are and how many voters on both sides are 100% locked in today regardless)
I am not going to convince you this is nothing more than how vaccine trials work, nor will you convince I that a conspiracy on this scale and size could even be possible. It is my fault for engaging in the drift so I will end it with we agree to disagree.
09-10-2020, 09:09 AM
#187
The NeverEnding Story
Joined APC: Sep 2005
Posts: 7,609
I know three people participating in the Pfizer Stage III trial; all had VERY temporary and mild symptoms a couple days after the injection (sub-101 fever, soreness, etc) like other vaccines have...but nothing worse than an influenza or tetanus shot.
09-10-2020, 09:52 AM
#188
:-)
Joined APC: Feb 2007
Posts: 7,339
09-11-2020, 08:19 AM
#189
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
The episode that triggered the halt is the second time a person taking part in the AstraZeneca study developed neurological symptoms, leading to a pause in research.
According to a participant information sheet dated July 12 that was posted on the ISRCTN clinical-trial registry, one volunteer in AstraZeneca’s U.K. trial had developed symptoms of transverse myelitis. The posting said the cause was being investigated.
An August update of the information sheet removed the reference to transverse myelitis and said the participant developed neurological symptoms that caused the study to be paused, and that the volunteer was later diagnosed with what was described as “an unrelated neurological illness.”
“There was a brief trial pause in July while a safety review took place after one volunteer was confirmed to have an undiagnosed case of multiple sclerosis,” Meixell, the AstraZeneca spokeswoman, said. She said that the independent panel monitoring the trial concluded the diagnosis was unrelated to the vaccine.
According to a participant information sheet dated July 12 that was posted on the ISRCTN clinical-trial registry, one volunteer in AstraZeneca’s U.K. trial had developed symptoms of transverse myelitis. The posting said the cause was being investigated.
An August update of the information sheet removed the reference to transverse myelitis and said the participant developed neurological symptoms that caused the study to be paused, and that the volunteer was later diagnosed with what was described as “an unrelated neurological illness.”
“There was a brief trial pause in July while a safety review took place after one volunteer was confirmed to have an undiagnosed case of multiple sclerosis,” Meixell, the AstraZeneca spokeswoman, said. She said that the independent panel monitoring the trial concluded the diagnosis was unrelated to the vaccine.
09-11-2020, 11:04 AM
#190
Prime Minister/Moderator
Joined APC: Jan 2006
Position: Engines Turn Or People Swim
Posts: 40,057
30,000 participants?
If you had zero MS cases in that, you'd probably need to evaluate the drug in question as a possible vaccine for MS itself.
MS is very common, as those things go. Probably more common than covid fatality in low-risk people.
If you had zero MS cases in that, you'd probably need to evaluate the drug in question as a possible vaccine for MS itself.
MS is very common, as those things go. Probably more common than covid fatality in low-risk people.
Thread
Thread Starter
Forum
Replies
Last Post
