Stat News, a medical-business-technology website, has an important report laying out in detail how Pfizer adjusted its vaccine Phase III trial plan midstream, effectively delaying it until after the election by "leaving samples in storage" until the day after the election:
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.
[Pfizer's senior vice president of vaccine clinical research and development William] 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. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.
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.
I guess I can understand how, from a business standpoint, it might help Pfizer to not have the vaccine look politicized by announcing it before the election. But isn't it also politicized to delay the release until after the election? From a public health standpoint, it's a tradeoff. The delay might help increase vaccine uptake among those who would have seen a pre-election announcement as phony science calculated to help President Trump. But if delaying the vaccine news or sample analysis by a week for that purpose means the vaccine is delivered a week later, what about the health of the week's worth of people who die or get sick?
It would be interesting to know more about the "why" of this. Why did the FDA and Pfizer not stick with the original plan to announce results after 32 cases, and instead wait much longer, to 94 cases? If "Election Day" was a factor—well, President Trump's tweet on the topic was this: "As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn't have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!" Trump also said, "The @US_FDA and the Democrats didn't want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I've said all along!"
File it under "corporate America against Trump." Pfizer board of directors member Suzanne Nora Johnson donated $50,000 to the Biden Victory Fund in June 2020 and $35,500 to the Democratic National Committee on the same date, Federal Election Commission records show. Meanwhile Trump's Republican National Committee speech boasted about how "last month I took on Big Pharma." If Trump could have somehow navigated this so that the vaccine announcement came after 32 cases—in October—it might have helped make a difference in the election outcome. Votes are still being counted, and there were plenty of other factors. But the timing here is something.