Was the Pfizer/BioNTech vaccine clinical trial a bait-and-switch?
There were >44,000 people in the trial, but only ~250 of them were given doses made with a new manufacturing method ('process 2') that was used to make enough doses to sell around the world.
To our knowledge, the safety and efficacy comparison they planned to do with those 250 subjects has never been published and has not been released in the FOIA'd documents that Pfizer submitted to the FDA. Was the comparison ever done? Where are the results?
@RetsefL and I explore the importance of this comparison and the potential impact of variability in the the production process of COVID-19 mRNA vaccines on efficacy and safety in a newly published rapid response in the @bmj_latest.
bmj.com/content/378/bm…
Keep in mind that one of the major changes in the new production process was using bacterial cDNA to upscale production of mRNA. @Kevin_McKernan's analysis of vaccine vials found unacceptably high levels of leftover bacterial DNA.
rebelnews.com/genomics_exper…
Pfizer's 6-month report to the FDA doesn't include the process 2 comparison, but it does show a significantly higher serious adverse event rate in placebo subjects after they were given the vaccine compared to the original vaccine group, "as expected." Why was it expected?
We know from FOIA'd documents that about 70% of the trial sites received new batches with distinct Pfizer lot numbers after Nov. 19. Were these intended for the crossover placebo subjects? Were they different than the doses given to the original treatment group? And if so, how?
In addition, a recent Danish study found significant variability in the rate of serious adverse events across 52 different lots of Comirnaty. onlinelibrary.wiley.com/doi/10.1111/ec…
Taken together, evidence from trial documents and existing research underscores the need to better understand the potential impact of variability in the production process of COVID-19 mRNA vaccines on efficacy and safety.
I forgot to add: The two process 2 lots sent to 8 trial sites were also given to the public. There are 1,149 reports in VAERS for these lots, including 307 serious adverse events and 23 deaths.
Somebody asked if study C4591017 was the process 2 comparison trial:
It isn't though it does compare 5 (unidentified) lots & found a 2x rate of subjects experiencing at least one AE and AEs judged related to the vaccine in one of the lots & SAE variation. clinicaltrialsregister.eu/ctr-search/tri…
This thread is also highly relevant to manufacturing standards and batch toxicity:
Somebody asked if study C4591017 was the process 2 comparison trial:
It isn't though it does compare 5 (unidentified) lots & found a 2x rate of subjects experiencing at least one AE and AEs judged related to the vaccine in one lot & variation in SAEs. clinicaltrialsregister.eu/ctr-search/tri…
In case it isn't clear, the 2 production processes were radically different and yielded different quality products! You can't just test it on 250 people and say it's all the same. They could not be assumed to be bio-similar, like name-brand and generic.
This article has excellent coverage of this issue. It also points out the fact that the manufacturer was never required to test process 2 jabs on lab animals. Or at least we've never seen results of such tests.
conservativewoman.co.uk/how-hancock-an…
Genomics expert, professor @P_J_Buckhaults U of South Carolina, testifies on the potential risks of the DNA contamination he found in vials of mRNA vaccine entirely that was entirely due to the switch to process 2.
However I suspect that the endotoxin contamination is likely a bigger problem, both because it is probably a major factor in many adverse events and because it is basically impossible to purify. For more on endotoxin risks:
geoffpain.substack.com
See this thread for a further update showing that Pfizer/BioNTech never did the planned study comparing process 2 v 1 for safety and immunogenicity:
A professor and expert in cancer genetics at U of South Carolina testifies on risks posed by process 2 jabs due to the plasmid DNA contamination:
And a transcript of his interview with Maryanne Demasi:
maryannedemasi.substack.com/p/exclusive-an…
@reSeeIt
save thread
Great talk by @hedleyrees discussing the intricacies and challenges of biologic drug manufacturing:
rumble.com/v3fqujk-challe…
A clip from my discussion with @drdrew
Full interview here, starting at 3:30:
About this. We now know that EJ0553 was not part of the process 2 substudy. It was part of the adolescent trial and was likely given to the crossover placebo group.
Here is a discussion MIT Prof. @RetsefL and I had with Prof. of Global Health at SDU @StabellBenn and @TracyBethHoeg M.D. about the lack of proper testing of the Pfizer/BioNTech vaccine.
For some new info on variability across lots from Pfizer's own study, see this thread:
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