Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate
By MATTHEW HERPER @matthewherper NOVEMBER 9, 2020
… The first analysis was to occur after 32 volunteers — both those who received the vaccine and those on placebo — had contracted Covid-19. If fewer than six volunteers in the group who received the vaccine had developed Covid-19, the companies would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of Covid-19 — individuals with at least one symptom and a positive test result — had been reported. …
That study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people.
In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.
Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday.
Interesting choice of data to resume testing of cases. Was there anything in particular scheduled for last Tuesday? It seems like last Tuesday was a big day, but I can’t remember why. I’m sure, though, it was in all the papers at the time.
When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.
So the original plan was to make a public announcement after 32 cases, but instead they stopped doing simple lab tests until the day after Election Day, at which point they had 94 cases, almost triple what the protocol had said they needed for making a public announcement.
This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.
So, I’m not crazy, StatNews sees it too.
Basically, this says that Pfizer had the physical evidence in their labs in October that their vaccine had met the hurdle of success, but chose, with the agreement of the FDA, not to physically process the samples until the day after Election Day.
Am I nuts to read this as saying that Pfizer and the FDA conspired to alter the agreed-upon plan, which would have required a public announcement of the vaccine’s success before the election, and instead Pfizer refused to even process the crucial samples during the last days before the election to delay having to make a public announcement until after the election? And that this ploy may well have cost Trump the election?
For a notorious authoritarian, Trump sure gets pushed around and stabbed in the back even by his own hirelings a lot.[Comment at Unz.com]