They want booster approval based on studies covering about 300 people – with no control arms. BUT IT GETS BETTER. They tested it in 12 (yes, 12!) people over 65.
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.
As in NONE.
Which makes total sense – why test the booster in people who actually need it because they’re at high risk from the ro? Nothing good can come of that.
So that’s our trial design.
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.
“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.”
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?
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