Dr. Andrew Bostom, a long time academic, former NIH funded scientist, and generally a very smart guy was just suspended from Twitter (again) for this tweet. I’m not a pediatrician and don’t ordinarily read research that leads to approvals for vaccines. I figure some smart people who have the best interest of the health of kids are looking over all of this and making the decisions for all of us. So ordinarily, I’d be skeptical of Dr. Bostom’s claims, but
Thank you Dr. Koka for your trenchant commentary. I took particular interest in the FDA briefing document to its ad-com in respect of Pfizer's study in 5-11s which led to the EUA. I can't understand why the FDA took seriously the kind of study that Pfizer did. As you know, the study was way too small to show any reduction in deaths--and there were no deaths in either the placebo or vaccine arm of the study. It was also way too small to show any reduction in hospital admissions--and there were no admissions on either arm. The whole exercise rested on antibody titers, even though the FDA and Pfizer agreed there was no established antibody correlate of protection. So the trick became immunobridging. The 5-11s, which I'll call Group A, were bridged to a 16-25s, Group B, but so far as I can tell, no there had been no statistically significant showing of clinical benefit in Group B, but only in a larger group of which Group B was part, that being all the 16 and ups including the middle-aged and the elderly in Pfizer's one big study, which we might call Group C. So follow the bouncing ball: C to B to A. It seems to me Pfizer couldn't even reach its surmise about clinical efficacy except by this double inference. Right? Has any vaccine ever before been authorized on such data? There was no emergency among healthy kids. If Pfizer wanted to show benefit across all kids, it could have done the trial right--enroll a quarter of a million kids. Better, as kids with co-morbidities can be at risk, Pfizer could have done a trial in, say, kids who are immunocompromised, kids who are morbidly obese, etc. In such targeted trials, the populations would have been "enriched," and perhaps then benefit could have clearly demonstrated.
Still unvaxed. Still locked out of Twitter. I suspect the opioid crisis is repeating itself (govt and pharma collusion w/ big tech included this time) and that people have been harmed/killed by the relentless, unhinged, desperate desire to make these shots look safe and effective (they aren’t). Will we learn this time not to blindly trust what the “experts” claim?
Thank you Dr. Koka for your trenchant commentary. I took particular interest in the FDA briefing document to its ad-com in respect of Pfizer's study in 5-11s which led to the EUA. I can't understand why the FDA took seriously the kind of study that Pfizer did. As you know, the study was way too small to show any reduction in deaths--and there were no deaths in either the placebo or vaccine arm of the study. It was also way too small to show any reduction in hospital admissions--and there were no admissions on either arm. The whole exercise rested on antibody titers, even though the FDA and Pfizer agreed there was no established antibody correlate of protection. So the trick became immunobridging. The 5-11s, which I'll call Group A, were bridged to a 16-25s, Group B, but so far as I can tell, no there had been no statistically significant showing of clinical benefit in Group B, but only in a larger group of which Group B was part, that being all the 16 and ups including the middle-aged and the elderly in Pfizer's one big study, which we might call Group C. So follow the bouncing ball: C to B to A. It seems to me Pfizer couldn't even reach its surmise about clinical efficacy except by this double inference. Right? Has any vaccine ever before been authorized on such data? There was no emergency among healthy kids. If Pfizer wanted to show benefit across all kids, it could have done the trial right--enroll a quarter of a million kids. Better, as kids with co-morbidities can be at risk, Pfizer could have done a trial in, say, kids who are immunocompromised, kids who are morbidly obese, etc. In such targeted trials, the populations would have been "enriched," and perhaps then benefit could have clearly demonstrated.
Still unvaxed. Still locked out of Twitter. I suspect the opioid crisis is repeating itself (govt and pharma collusion w/ big tech included this time) and that people have been harmed/killed by the relentless, unhinged, desperate desire to make these shots look safe and effective (they aren’t). Will we learn this time not to blindly trust what the “experts” claim?