Serious A*****e E***ts of Special Interest Following m**A V******tion in Randomized Trials
Jun 22, 2022 23:10:54 #
A redo report
Here are the headline results from the abstract:
P****r and M*****a m**A C****-** v*****es were associated with an increased risk of serious a*****e e***ts of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 v******ted over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8), respectively.
Combined, the m**A v*****es were associated with an absolute risk increase of serious a*****e e***ts of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9).
The excess risk of serious a*****e e***ts of special interest surpassed the risk reduction for C****-** hospitalization relative to the placebo group in both P****r and M*****a trials (2.3 and 6.4 per 10,000 participants, respectively).
And the abstract discussion section:
“The excess risk of serious a*****e e***ts found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious C****-** outcomes such as hospitalization or death.”
The headlines look pretty serious at first glance. But the discussion section should alert us that the authors are being cautious. The authors are not signaling “pants on fire” findings.
What is really going on here? To understand this, a good place to start is this wonderfully clear and accurate summary of the initial P****r trial results from the Canadian C***D Care Alliance (posting which is apparently the sin that got me kicked off of Twitter and Linked-In last December, resulting in my becoming disconnected from about 600,000 followers).
The bottom line is that the P****r Phase 3 trial which was used by NIAID, FDA and CDC to justify the e*******y use a***********n is pretty much a junk clinical trial which was inappropriately halted long before it even got close to meeting the intended follow up period, did not provide a sufficiently long follow up analysis of v******tion-associated a*****e e***ts, and in which the control group was intentionally eliminated. This resulted in basically erasing any opportunity to ever get to the bottom of what the major true risks of the P****r m**A inoculations were. In terms of more minor risks, the study was not powered (not big enough) to evaluate those.
Into the breach, an intrepid group of (mostly) senior academic researchers have stepped forward. The expression “fools rush in where angels fear to tread” comes to mind, in that it has become extremely risky for any academic to question the approved v*****e narrative. But bravely this decidedly un-foolish group has stepped forward.
To my reading, the approach that they have taken with this analysis and report has been to make a good faith effort to perform the analysis of the Phase 3 clinical trials (those are supposed to be the “big, final” clinical trials prior to licensure of a product) which should have been performed by M*****a and P****r. Basically, the analysis that the FDA should have done themselves, and also should have forced M*****a and P****r to do. If White House Chief of Staff Mark Meadows had not put pressure on the FDA, perhaps it would have done the right thing. But it apparently caved and did not do it’s job, and here we are.
Herein lies the rub. The FDA not only did not do its job, but neither FDA nor M*****a nor P****r will release the primary data, which means that no-one else can do it either. As the authors of this recent analysis note in their discussion: A systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups. Full t***sparency of the C****-** v*****e clinical trial data is needed to properly evaluate these questions. Unfortunately, well over a year after widespread use of C****-** v*****es, participant level data remain inaccessible.
More for those thinking this is f**e news.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239
Here are the headline results from the abstract:
P****r and M*****a m**A C****-** v*****es were associated with an increased risk of serious a*****e e***ts of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 v******ted over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8), respectively.
Combined, the m**A v*****es were associated with an absolute risk increase of serious a*****e e***ts of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9).
The excess risk of serious a*****e e***ts of special interest surpassed the risk reduction for C****-** hospitalization relative to the placebo group in both P****r and M*****a trials (2.3 and 6.4 per 10,000 participants, respectively).
And the abstract discussion section:
“The excess risk of serious a*****e e***ts found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious C****-** outcomes such as hospitalization or death.”
The headlines look pretty serious at first glance. But the discussion section should alert us that the authors are being cautious. The authors are not signaling “pants on fire” findings.
What is really going on here? To understand this, a good place to start is this wonderfully clear and accurate summary of the initial P****r trial results from the Canadian C***D Care Alliance (posting which is apparently the sin that got me kicked off of Twitter and Linked-In last December, resulting in my becoming disconnected from about 600,000 followers).
The bottom line is that the P****r Phase 3 trial which was used by NIAID, FDA and CDC to justify the e*******y use a***********n is pretty much a junk clinical trial which was inappropriately halted long before it even got close to meeting the intended follow up period, did not provide a sufficiently long follow up analysis of v******tion-associated a*****e e***ts, and in which the control group was intentionally eliminated. This resulted in basically erasing any opportunity to ever get to the bottom of what the major true risks of the P****r m**A inoculations were. In terms of more minor risks, the study was not powered (not big enough) to evaluate those.
Into the breach, an intrepid group of (mostly) senior academic researchers have stepped forward. The expression “fools rush in where angels fear to tread” comes to mind, in that it has become extremely risky for any academic to question the approved v*****e narrative. But bravely this decidedly un-foolish group has stepped forward.
To my reading, the approach that they have taken with this analysis and report has been to make a good faith effort to perform the analysis of the Phase 3 clinical trials (those are supposed to be the “big, final” clinical trials prior to licensure of a product) which should have been performed by M*****a and P****r. Basically, the analysis that the FDA should have done themselves, and also should have forced M*****a and P****r to do. If White House Chief of Staff Mark Meadows had not put pressure on the FDA, perhaps it would have done the right thing. But it apparently caved and did not do it’s job, and here we are.
Herein lies the rub. The FDA not only did not do its job, but neither FDA nor M*****a nor P****r will release the primary data, which means that no-one else can do it either. As the authors of this recent analysis note in their discussion: A systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups. Full t***sparency of the C****-** v*****e clinical trial data is needed to properly evaluate these questions. Unfortunately, well over a year after widespread use of C****-** v*****es, participant level data remain inaccessible.
More for those thinking this is f**e news.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239
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