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Booster trial data (12 participants)
jecornel
Member Posts: 9,727
in Tug Tavern
This is reported by a former New York Times investigative reporter who has been banned from Twitter for publishing government data that the vaccine is ineffective (the government data is public data but Twitter didn't like it)
Link to study: https://www.fda.gov/media/152176/download
Alex Bereson: http://www.alexberenson.com/ (reporter)
The FDA just released its briefing book for Pfizer’s request for a third dose of Comirnaty (or is that BNT162b2? No matter! It’s approved either way, sorta).
It is every bit the mess we all expected.
Let’s go to the highlights:
Pfizer basically hasn’t bothered to test the booster AT ALL in the people actually at risk - it conducted a single “Phase 1” trial that covered 12 people over 65. The main Phase 2/3 booster trial (beware efforts to cover multiple “phases” of drug research at once, you want it bad you get it bad) included no one over 55.
No one.
As in NONE.
Which makes total sense - why test the booster in people who actually need it because they’re at high risk? Nothing good can come of that.
So that’s our trial design.
Now safety:
Of the 300 people who received the booster, one had a heart attack two months later. No worries, Pfizer concluded it wasn’t related. Yay!
Five percent of recipients had enlarged lymph nodes.
How about effectiveness?
Well, we don’t have enough data - or any data, really - telling us how well the booster will work.
But the FDA made Pfizer go back and review its data from the pivotal clinical trial from last year. Pfizer compared people who received the vaccine with those who received the placebo and THEN the vaccine (the best we can do at this point, since Pfizer blew up the trial by giving placebo subjects the vaccine, double-yay!)
Pfizer concluded that your annual risk of getting Covid-19 IF YOU ARE VACCINATED is about 7 percent.
Further:
“An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2 at the start of the analysis period.”
Oh.
But don’t worry, Uncle Joe already told you you can get your booster on September 20. If it’s good enough for our fearless leader, it should be good enough for the FDA, amirite?
SCIENCE!
SOURCE: https://www.fda.gov/media/152176/download
6.4. FDA review of clinical data from Study C4591001 6.4.1. Design Study C4591001 is ongoing. The study was initially designed to evaluate two vaccine candidates and several dosages in healthy adults in the United States (Phase 1), of which 24 participants (n=12 per age group: 18-55 years and 65-85 years) received a 2-dose primary series of BNT162b2 (30 µg); the study population included healthy men and women and excluded participants at high risk of SARS-CoV-2 infection or with serological evidence of prior or current SARS-CoV-2 infection.
Link to study: https://www.fda.gov/media/152176/download
Alex Bereson: http://www.alexberenson.com/ (reporter)
The FDA just released its briefing book for Pfizer’s request for a third dose of Comirnaty (or is that BNT162b2? No matter! It’s approved either way, sorta).
It is every bit the mess we all expected.
Let’s go to the highlights:
Pfizer basically hasn’t bothered to test the booster AT ALL in the people actually at risk - it conducted a single “Phase 1” trial that covered 12 people over 65. The main Phase 2/3 booster trial (beware efforts to cover multiple “phases” of drug research at once, you want it bad you get it bad) included no one over 55.
No one.
As in NONE.
Which makes total sense - why test the booster in people who actually need it because they’re at high risk? Nothing good can come of that.
So that’s our trial design.
Now safety:
Of the 300 people who received the booster, one had a heart attack two months later. No worries, Pfizer concluded it wasn’t related. Yay!
Five percent of recipients had enlarged lymph nodes.
How about effectiveness?
Well, we don’t have enough data - or any data, really - telling us how well the booster will work.
But the FDA made Pfizer go back and review its data from the pivotal clinical trial from last year. Pfizer compared people who received the vaccine with those who received the placebo and THEN the vaccine (the best we can do at this point, since Pfizer blew up the trial by giving placebo subjects the vaccine, double-yay!)
Pfizer concluded that your annual risk of getting Covid-19 IF YOU ARE VACCINATED is about 7 percent.
Further:
“An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2 at the start of the analysis period.”
Oh.
But don’t worry, Uncle Joe already told you you can get your booster on September 20. If it’s good enough for our fearless leader, it should be good enough for the FDA, amirite?
SCIENCE!
SOURCE: https://www.fda.gov/media/152176/download
6.4. FDA review of clinical data from Study C4591001 6.4.1. Design Study C4591001 is ongoing. The study was initially designed to evaluate two vaccine candidates and several dosages in healthy adults in the United States (Phase 1), of which 24 participants (n=12 per age group: 18-55 years and 65-85 years) received a 2-dose primary series of BNT162b2 (30 µg); the study population included healthy men and women and excluded participants at high risk of SARS-CoV-2 infection or with serological evidence of prior or current SARS-CoV-2 infection.