Alex Berenson Sep 15502252
The FDA just released its briefing book for Pfizerâs request for a third dose of Comirnaty (or is that BNT162b2? No matter! Itâs approved either way, sorta).
It is every bit the mess we all expected. Letâs go to the highlights:
Pfizer basically hasnât bothered to test the booster AT ALL in the people actually at risk - it conducted a single âPhase 1â trial that covered 12 people over 65. The main Phase 2/3 booster trial (beware efforts to cover multiple âphasesâ 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 theyâre at high risk? Nothing good can come of that. So thatâs 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 wasnât related. Yay! Five percent of recipients had enlarged lymph nodes. How about effectiveness? Well, we donât 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: âAn 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.â Oh. But donât worry, Uncle Joe already told you you can get your booster on September 20. If itâs good enough for our fearless leader, it should be good enough for the FDA, amirite? SCIENCE! SOURCE: https://www.fda.gov/media/152176/download
Direct Link to PDF Report: