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To start:
- Pfizer likely knew that Paxlovid did not work in the vaccinated, and removed them from the EPIC-SR trial
- Paxlovid was not AT ALL tested on children in both trials, but the FDA approved it for children anyway.
Introduction
You can skip this introduction and head straight into the next section if you are familiar with the Paxlovid story. Briefly, I wrote the following article on April 13, pointing out that the Internet is full of stories of Paxlovid-treated patients relapsing and having Covid re-emerge on Day 10 of their illness.
Much has happened since then (not all related to my post, of course). So much noise was made that the US government got interested!
Brian Mowrey wrote five excellent articles looking at the biomolecular mechanisms of why Paxlovid would not work and some aspects of the trial. Jessica Rose also wrote a Paxlovid article, looking at Paxlovid and bringing her highly relevant experience as a former HIV researcher. Peter Nayland Kust brought up the above story Federal Government is forced to urgently look into Paxlovid not working. Darby Shaw straight out asked, correctly, whether Paxlovid is a danger to the vaccinated. Much noise was also made on Twitter, including by yours truly, before Twitter suspended me.
Hundreds of stories are all over Twitter and Reddit. This one from yesterday 4/30/22:
Pfizer Purposely Excluded Vaccinated People from Trials. It had a Reason!
Two Pfizer trials for Paxlovid (High Risk and Standard Risk) had long lists of patients to exclude. Some, like HIV patients with complicated problems, are understandably excluded.
But why did Pfizer decide to exclude vaccinated people from the trials? That decision seems crazy since Pfizer intended to ”vaccinate the world” and have everyone vaccinated. So, considering that Pfizer knew about “breakthrough infections,” why did it decide to ban vaccinated people from both trials if it expected that most people would be vaccinated? Seems strange to exclude most people from being potential customers, no?
Well, it looks like Pfizer knew more than it disclosed. (hat tip, Dr. Buzz)
Actually, Pfizer did NOT want to exclude the vaccinated from at least one trial, EPIC-SR, from the start. In the beginning, EPIC-SR allowed vaccinated people with comorbidities. Original Epic-SR exclusion read:
Has received or is expected to receive any COVID-19 vaccine, except for participants with an underlying medical condition associated with an increased risk of developing severe illness from COVID-19. Participants with these conditions who are fully vaccinated are considered to be at lower risk of developing severe disease and are therefore considered eligible.
So, according to the above, vaccinated patients with comorbidities were considered “standard risk” and were in the trial.
However, between March 9 and April 5 of 2022, Pfizer decided to change the criteria and excluded ALL vaccinated people:
What made Pfizer change this criterion? My speculative answer is that Pfizer knew that Paxlovid did not work in the vaccinated. Having failed to hit the target when it came to vaccinated people, Pfizer decided to remove them from the trial and “move the target,” so to speak. This way, the EPIC-SR study would end up being a “success,” technically.
They removed their main target market — the vaccinated — from the trial, to make sure that the trial looks good. Then Pfizer turned around and asked the FDA to sell the drug to the very people whom they consciously excluded from the trial.
Despite intentionally removing and ignoring vaccinated people in both trials, Pfizer asked for and received FDA approval for all patients, vaccinated or not. So now, Pfizer gets $895 per treatment course and makes a lot of money. Does this treatment benefit vaccinated patients? You decide.
Paxlovid was not tested in Children; FDA Approved Paxlovid for Kids Anyway
It gets worse. Both EPIC-HR and EPIC-SR excluded children under 18.
Despite not having tested Paxlovid for kids at all in these clinical trials, FDA authorized Paxlovid for children:
I am slightly puzzled by this. I mean, surely the FDA cares for our children, right? So wouldn’t it want to ask Pfizer to at least test Paxlovid for children? Of course, it is just a few million dollars for Pfizer. Not a big deal. But testing on children was not done at all, and the FDA recommended Paxlovid for children anyway.
Mind you, Paxlovid is not a little harmless vitamin pill. It is a repackaged HIV/AIDS medication blocking certain liver functions, combined with a radically novel protease inhibitor affecting intricate intracellular processes. Who knows how Paxlovid affects growing kids going through puberty? I surely do not know, but does anyone else?
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