So we know that all the claims of efficacy were based on PCR positives only. How do we know if all the PCR testing undertaken at Pearl River was from subjects with symptoms suggestive of Covid? If a positive test comes from an asymptomatic individual, then that would not be evidence of a reduction in symptomatic illness. So we need to kn…
So we know that all the claims of efficacy were based on PCR positives only. How do we know if all the PCR testing undertaken at Pearl River was from subjects with symptoms suggestive of Covid? If a positive test comes from an asymptomatic individual, then that would not be evidence of a reduction in symptomatic illness. So we need to know if all the PCR testing they conducted was from symptomatic subjects.
Conversely, they report 3410 cases where there were indeed symptoms suggestive of Covid infection, but apparently no PCR confirmation. Why not? Did the dog eat the results?
The claims of efficacy were based on 81 positive PCR's for treatment and 873 positive PCR's for placebo. For a total 951 positives. Yet we have the other 3410 suspected cases with no result!
I'm not sure if the actual primary endpoint was reduction in symptomatic illness or reduction in PCR positives. Because they are not the same thing. Reduction in symptomatic illness might be clinically meaningful. But reduction in PCR positives is not clinically meaningful.
In any event, it's all a complete mess....
Incidentally in the Moderna trial; as far as toxicity goes, there were 16.5% solicited systemic Grade 3 or Grade 4 SAE's in the vax group, as opposed to 3.7% in placebo. Any SAE's graded 3-5 are serious. "Grade 3 events are serious and interfere with a person’s ability to do basic things like eat or get dressed. Grade 3 events may also require medical intervention. Grade 4 events are usually severe enough to require hospitalization." (Grade 5 is death, of course.)
It's hard to imagine that you could ethically administer to many millions of well people (often via the employment of coercion) a medical intervention that, in the clinical trial, resulted in 16.5% serious systemic adverse events. How can anyone describe serious adverse events as 'very rare', when in that Moderna trial they occurred at an incidence of 16.5%!
Whereas the EUA , I think, was granted on the basis of an IA after an even shorter study period.
Sorry for that error.
Did you note the SAE's Grade 3 or 4 (therefore 'serious' as opposed to mild or moderate) in the vaccine arm of the Moderna trial? 16.5% or 1 in 6.
For me, it's the most damning data point I've seen in any of the trials. And in a rational or ethical world, just that one stat would have precluded authorisation of any kind....
Yeah that's bad although I've mostly focused on Pfizer because that is the one we have more information from, and of course because we know they are convicted frauds. The way they got around the 16% grade 3+ AE is to claim that most of those quickly resolved. Of course there is no corroboration of that.
Which means they really had a 170-subjects study, not a 44000 study, and those 170 were not even randomly selected, but cherry-picked out of a dataset that vastly attested no effect (in the advertized sense) to the product?
I am severely injured from 1 shot of moderna. It’s been over 2 years for me. My life is ruined. How do I find this data on the moderna vaccine? Can you show me the source? Thanks
Hi there. The datapoint I cited, is shown on the video of the Moderna presentation to the FDA, which led shortly after to the granting of their EUA. The committee in attendance obviously should have stopped right there and asked the Moderna rep to explain that figure. Which they failed to do (and they all moved swiftly on to the next slide).
At the 5hr 26min mark (towards the bottom of the slide):-
So we know that all the claims of efficacy were based on PCR positives only. How do we know if all the PCR testing undertaken at Pearl River was from subjects with symptoms suggestive of Covid? If a positive test comes from an asymptomatic individual, then that would not be evidence of a reduction in symptomatic illness. So we need to know if all the PCR testing they conducted was from symptomatic subjects.
Conversely, they report 3410 cases where there were indeed symptoms suggestive of Covid infection, but apparently no PCR confirmation. Why not? Did the dog eat the results?
The claims of efficacy were based on 81 positive PCR's for treatment and 873 positive PCR's for placebo. For a total 951 positives. Yet we have the other 3410 suspected cases with no result!
I'm not sure if the actual primary endpoint was reduction in symptomatic illness or reduction in PCR positives. Because they are not the same thing. Reduction in symptomatic illness might be clinically meaningful. But reduction in PCR positives is not clinically meaningful.
In any event, it's all a complete mess....
Incidentally in the Moderna trial; as far as toxicity goes, there were 16.5% solicited systemic Grade 3 or Grade 4 SAE's in the vax group, as opposed to 3.7% in placebo. Any SAE's graded 3-5 are serious. "Grade 3 events are serious and interfere with a person’s ability to do basic things like eat or get dressed. Grade 3 events may also require medical intervention. Grade 4 events are usually severe enough to require hospitalization." (Grade 5 is death, of course.)
It's hard to imagine that you could ethically administer to many millions of well people (often via the employment of coercion) a medical intervention that, in the clinical trial, resulted in 16.5% serious systemic adverse events. How can anyone describe serious adverse events as 'very rare', when in that Moderna trial they occurred at an incidence of 16.5%!
No actually the result was based on 162 vs 8 positives
Yes, I inadvertently quoted the figures from the later interim analysis done at 6 months.
As reported here:-
https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full.pdf
Whereas the EUA , I think, was granted on the basis of an IA after an even shorter study period.
Sorry for that error.
Did you note the SAE's Grade 3 or 4 (therefore 'serious' as opposed to mild or moderate) in the vaccine arm of the Moderna trial? 16.5% or 1 in 6.
For me, it's the most damning data point I've seen in any of the trials. And in a rational or ethical world, just that one stat would have precluded authorisation of any kind....
Yeah that's bad although I've mostly focused on Pfizer because that is the one we have more information from, and of course because we know they are convicted frauds. The way they got around the 16% grade 3+ AE is to claim that most of those quickly resolved. Of course there is no corroboration of that.
Which means they really had a 170-subjects study, not a 44000 study, and those 170 were not even randomly selected, but cherry-picked out of a dataset that vastly attested no effect (in the advertized sense) to the product?
I am severely injured from 1 shot of moderna. It’s been over 2 years for me. My life is ruined. How do I find this data on the moderna vaccine? Can you show me the source? Thanks
There is a Moderna VRBPAC submission one week later... Filename on FDA website should be VRBPAC-12.17.20-Meeting-Briefing-Document-Sponsor_Moderna.pdf
Hi there. The datapoint I cited, is shown on the video of the Moderna presentation to the FDA, which led shortly after to the granting of their EUA. The committee in attendance obviously should have stopped right there and asked the Moderna rep to explain that figure. Which they failed to do (and they all moved swiftly on to the next slide).
At the 5hr 26min mark (towards the bottom of the slide):-
https://youtu.be/mQPMNmvZgi8?t=19579
Above SAE incidence is reported on the corresponding Moderna vid at the 5hr 26 min mark:-
https://youtu.be/mQPMNmvZgi8?t=19581