Previously undisclosed documents expose dosing errors, disputed safety records and ethics violations at one of Pfizer’s largest Covid-19 vaccine trial sites.
Has anyone ever established why Site 4444 was created to get thousands of participants through the military hospital before the cut off date, knowing that their data wouldn't contribute meaningfully to the final analysis?
These new documents don't explain why a small 'virtual' site was established at the same hospital - except that the system crashed at one point and they had to create a "sub-centre" and seperate IDs. I didn't find anything unusual about it in ANMAT's inspection reports.
According to the docs, Silvia Margalejo Raffin, president of the hospital's ethics committee (CIREC), wrote, “Regarding the query about the changes in participant IDs from 1231 to 4444, this was because the system crashed due to the number of participants, and they had to create a sub-centre to generate the codes.” (translated from Spanish)
Yeah, it's possible they had a few software errors when they (most likely) erased completely a large chunk of subjects data from the database - a good part of them recruited on the same day than Augusto Roux.
Reading your article reminded me of something I'd heard previously – that the Pfizer COVID-19 vaccine used in the original clinical trials was manufactured differently from the vaccine subsequently distributed to the wider community.
I've just been exploring this with AI, which confirms the change from ‘Process 1’ to ‘Process 2’, including reported differences in mRNA integrity.
This isn't my area of knowledge, but it raises a question for me – to what extent were the original trial findings on safety and efficacy applicable to the commercially manufactured vaccine administered to the wider population?
Yes, that's right. The original vaccine formulation used in the clinical trials was manufactured using Process 1. But when production was scaled up to billions of doses, the manufacturer switched to Process 2. As I recall, the Process 2 product was tested in only about 250 participants before being rolled out to the wider population.
The lesson I take from this experience is that no one should trust the government or their bureaucracies. They will promise medical and financial support if you are injured but it will renage and there will be no feasible way to force them to honor their promises.
Great reporting. Yet more scary information about cover ups to protect money and reputation
Have they no conscience?
Many thanks Maryanne
I assume that’s a rhetorical question 🤭
Indeed!
Naughty, Naughty....Very Naughty 😵💫
Has anyone ever established why Site 4444 was created to get thousands of participants through the military hospital before the cut off date, knowing that their data wouldn't contribute meaningfully to the final analysis?
https://threadreaderapp.com/thread/1523617233255436289.html
These new documents don't explain why a small 'virtual' site was established at the same hospital - except that the system crashed at one point and they had to create a "sub-centre" and seperate IDs. I didn't find anything unusual about it in ANMAT's inspection reports.
Pfizer had a contractual limit to the number of subjects they were allowed to enroll in Argentina.
It's likely that they created 4444 when 1231 reached that margin.
According to the docs, Silvia Margalejo Raffin, president of the hospital's ethics committee (CIREC), wrote, “Regarding the query about the changes in participant IDs from 1231 to 4444, this was because the system crashed due to the number of participants, and they had to create a sub-centre to generate the codes.” (translated from Spanish)
Yeah, it's possible they had a few software errors when they (most likely) erased completely a large chunk of subjects data from the database - a good part of them recruited on the same day than Augusto Roux.
https://blog.openvaet.info/p/pfizerbiontech-c4591001-trial-the
Thanks for this investigation, Maryanne.
Reading your article reminded me of something I'd heard previously – that the Pfizer COVID-19 vaccine used in the original clinical trials was manufactured differently from the vaccine subsequently distributed to the wider community.
I've just been exploring this with AI, which confirms the change from ‘Process 1’ to ‘Process 2’, including reported differences in mRNA integrity.
This isn't my area of knowledge, but it raises a question for me – to what extent were the original trial findings on safety and efficacy applicable to the commercially manufactured vaccine administered to the wider population?
Yes, that's right. The original vaccine formulation used in the clinical trials was manufactured using Process 1. But when production was scaled up to billions of doses, the manufacturer switched to Process 2. As I recall, the Process 2 product was tested in only about 250 participants before being rolled out to the wider population.
I wrote about this a few years ago. https://blog.maryannedemasi.com/p/researchers-alarmed-to-find-dna-contamination
Thanks for the link to your earlier article Maryanne.
And where was 'valid voluntary informed consent' in all this? It was nowhere, particularly under coercion and mandates...
Unfortunately, you know the answer to that all too well.
The lesson I take from this experience is that no one should trust the government or their bureaucracies. They will promise medical and financial support if you are injured but it will renage and there will be no feasible way to force them to honor their promises.
Excellent, thank you yet again for your tireless work.
You may find a few points discussed here of interest regarding site 1231 / 4444.
https://amidwesterndoctor.substack.com/p/the-fraud-that-launched-the-mrna?utm_source=share&utm_medium=android&r=1ltk77
I just emailed TSTrials urging them to sack Dr Polack for unethical and dishonest conduct.
You can contact them at www.tstrials.com