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.