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.-- More...
