Vaccine Development Summary
09-09-2020, 07:30 AM
#171
Prime Minister/Moderator
Joined APC: Jan 2006
Position: Engines Turn Or People Swim
Posts: 40,057
Clearly, random events don’t stop because you are in a study. Of more concern to me though was this comment:
as well as the fact that some veterinary coronaviruses apparently never made it to market because of antibody dependent enhancement issues.
https://pubmed.ncbi.nlm.nih.gov/9492360/
https://onlinelibrary.wiley.com/doi/...2/cyto.a.24047
https://pubmed.ncbi.nlm.nih.gov/32582200/
as well as the fact that some veterinary coronaviruses apparently never made it to market because of antibody dependent enhancement issues.
https://pubmed.ncbi.nlm.nih.gov/9492360/
https://onlinelibrary.wiley.com/doi/...2/cyto.a.24047
https://pubmed.ncbi.nlm.nih.gov/32582200/
It's a double-blind study... a participant who got the placebo might have gotten sick from anything (including covid itself).
09-09-2020, 08:12 AM
#172
Gets Weekends Off
Joined APC: Nov 2019
Posts: 1,256
https://www.statnews.com/2020/09/09/...witter_organic
The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.
09-09-2020, 08:32 AM
#173
Gets Weekends Off
Joined APC: Nov 2016
Posts: 303
Hard to see how they would all be involved in some conspiracy to hurt Trump.
09-09-2020, 08:32 AM
#174
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
Negative. Not an institutional review board on the planet would permit a protocol where you continued to conceal the treatment/control status of someone who did develop a significant problem from the physicians treating that patient and not a researcher anywhere would shut down a major study because of a putative complication in a participant who received only the placebo.
As you point out yourself, people get sick all the time.
09-09-2020, 09:06 AM
#175
:-)
Joined APC: Feb 2007
Posts: 7,339
AstraZeneca uses the US as its profit tax shelter, it's actually very easy to see. In fact, it was expected to happen. Also, you haven't heard about the other stoppages have you, the media is selectively covering what is in their interests.
09-09-2020, 10:00 AM
#176
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.
So what happens is that you shut down giving anyone else the immunization while you have a big conclave on the ethics and morality of going on, all while intensively looking at everybody (immunized and control) for anything related to transverse myelitis. If, after a legally defensible interval, no new cases of transverse myelitis occur in the treated group (or you find one in the control group) you can then press on with an updated informed consent letter that specifically identifies the potential (but yet unproven) risk of transverse myelitis as a consequence of immunization.
And all your competitors pretty much have to do the same.
Acute transverse myelitis (TM) is a rare acquired neuro-immune spinal cord disorder that can present with the rapid onset of weakness, sensory alterations, and bowel or bladder dysfunction. TM can occur as an independent entity, usually as a postinfectious complication, but TM also exists on a continuum of neuro-inflammatory disorders that includes acute disseminated encephalomyelitis, multiple sclerosis, neuromyelitis optica spectrum disorder, and acute flaccid myelitis.ETIOLOGY
Immunopathogenesis — The immunopathogenesis of TM is varied and reflects the rather diverse spectrum of this disease from idiopathic to disease-associated myelitis (see 'Associated and causative conditions' below). Traditionally, the majority of TM cases were thought to be characterized by perivascular infiltration by monocytes and lymphocytes in the lesion [1]. Axonal degeneration was also reported [1]. Pathologic heterogeneity and the involvement of both gray and white matter suggest that TM is not a pure demyelinating disorder but rather a mixed inflammatory disorder that affects neurons, axons, and oligodendrocytes and myelin. TM has been reported after vaccination [2,3], and autopsy reports have described lymphocytic infiltration with demyelination and axonal loss [4]. Although these case reports describe TM in association with vaccination, causation has not been established based on the timing and sequence of events alone
Immunopathogenesis — The immunopathogenesis of TM is varied and reflects the rather diverse spectrum of this disease from idiopathic to disease-associated myelitis (see 'Associated and causative conditions' below). Traditionally, the majority of TM cases were thought to be characterized by perivascular infiltration by monocytes and lymphocytes in the lesion [1]. Axonal degeneration was also reported [1]. Pathologic heterogeneity and the involvement of both gray and white matter suggest that TM is not a pure demyelinating disorder but rather a mixed inflammatory disorder that affects neurons, axons, and oligodendrocytes and myelin. TM has been reported after vaccination [2,3], and autopsy reports have described lymphocytic infiltration with demyelination and axonal loss [4]. Although these case reports describe TM in association with vaccination, causation has not been established based on the timing and sequence of events alone
Last edited by Excargodog; 09-09-2020 at 10:10 AM.
09-09-2020, 10:07 AM
#177
Gets Weekends Off
Joined APC: Nov 2019
Posts: 1,256
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.
So what happens is that you shut down giving anyone else the immunization while you have a big conclave on the ethics and morality of going on, all while intensively looking at everybody (immunized and control) for anything related to transverse myelitis. If, after a legally defensible interval, no new cases of transverse myelitis occur in the treated group (or you find one in the control group) you can then press on with an updated informed consent letter that specifically identifies the potential (but yet unproven) risk of transverse myelitis as a consequence of immunization.
And all your competitors pretty much have to do the same.
So what happens is that you shut down giving anyone else the immunization while you have a big conclave on the ethics and morality of going on, all while intensively looking at everybody (immunized and control) for anything related to transverse myelitis. If, after a legally defensible interval, no new cases of transverse myelitis occur in the treated group (or you find one in the control group) you can then press on with an updated informed consent letter that specifically identifies the potential (but yet unproven) risk of transverse myelitis as a consequence of immunization.
And all your competitors pretty much have to do the same.
09-09-2020, 10:14 AM
#178
Perennial Reserve
Joined APC: Jan 2018
Posts: 12,120
09-09-2020, 10:19 AM
#179
Prime Minister/Moderator
Joined APC: Jan 2006
Position: Engines Turn Or People Swim
Posts: 40,057
Negative. Not an institutional review board on the planet would permit a protocol where you continued to conceal the treatment/control status of someone who did develop a significant problem from the physicians treating that patient and not a researcher anywhere would shut down a major study because of a putative complication in a participant who received only the placebo.
If that's what happened I imagine we should know within a day or so.
09-09-2020, 10:22 AM
#180
Prime Minister/Moderator
Joined APC: Jan 2006
Position: Engines Turn Or People Swim
Posts: 40,057
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