We're only getting half the story with that 9 page list. You need numbers.
Ultimately, they'll claim (correctly) that the data are inconclusive. They're insufficient to show causation. That's correct. They are. So is VAERS. But neither system is designed to be. They're sentinel systems. They collect data and then, the people watching are supposed to investigate further when a signal is detected.
Pfizer's still culpable for not redoing their safety analyses. There was a question about safety, they were obliged to do a proper study that was sufficiently designed in order to get usable safety numbers. I'd go farther than that, personally. They were obliged to design that sentinel system to be transparent and usable in the first place. They damn sure didn't.
Keep in mind, all of this was still done prior to approval of Comirnaty. All of this was under EUA, all as part of a phase 3 clinical trial. Pfizer was legally obliged to report that data in full to FDA. And FDA was obliged to investigate further. FDA did a half-assed job of it, and they set it up in such a way as to allow themselves to conclude these adverse effects were rare. That's what they did with J&J's vax and TTS. That's what they did with Moderna's and the myocarditis warning. They put their thumb on the scale with their process and got the result they wanted so they could keep pushing this product. They wanted the product to succeed, so they ensured it.
We're only getting half the story with that 9 page list. You need numbers.
Ultimately, they'll claim (correctly) that the data are inconclusive. They're insufficient to show causation. That's correct. They are. So is VAERS. But neither system is designed to be. They're sentinel systems. They collect data and then, the people watching are supposed to investigate further when a signal is detected.
Pfizer's still culpable for not redoing their safety analyses. There was a question about safety, they were obliged to do a proper study that was sufficiently designed in order to get usable safety numbers. I'd go farther than that, personally. They were obliged to design that sentinel system to be transparent and usable in the first place. They damn sure didn't.
Keep in mind, all of this was still done prior to approval of Comirnaty. All of this was under EUA, all as part of a phase 3 clinical trial. Pfizer was legally obliged to report that data in full to FDA. And FDA was obliged to investigate further. FDA did a half-assed job of it, and they set it up in such a way as to allow themselves to conclude these adverse effects were rare. That's what they did with J&J's vax and TTS. That's what they did with Moderna's and the myocarditis warning. They put their thumb on the scale with their process and got the result they wanted so they could keep pushing this product. They wanted the product to succeed, so they ensured it.