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by zaroth 2055 days ago
No, there is no citation needed. They didn’t discover this data all in the last week.

There is some incremental work that was done toward confirming this result and typing this press release in the last week.

It’s not like they waited till last week to collect the data. They have ongoing surveillance of their entire study population.

3 comments

In a double-blind, phase 3 trial only one group has on-going data access: the independent group conducting the study. No one else, including patients, doctors, and the business, has any knowledge of the results until they are "unsealed". That continues to be true throughout the entire trial even if preliminary results are unsealed at different points.
Precisely. They have seen 94 infections total so far, based on the statistics that’s likely to be almost entirely in the control group. Those infections are reported as they come in, so for example, perhaps last week there were 87 infections. The study ends once they hit ~150 infections, based on their sample size that will give them the confidence intervals they need to finalize.

So the difference between announcing preliminary results last week versus this week was their own internal decision on timing.

They did wait until last week to collect the data. Wednesday, in fact.
They intentionally kept the samples frozen in their lab until the day after the election. The most important vaccine in the 21st century, and they kept the samples on ice? That's incredible.
Ok, I have to partially take that back. According the Pfizer they intentionally did not confirm the data until last Wednesday.

> 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.

> 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. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.

Discussions between the agency and the companies concluded, and testing began this past Wednesday.

https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pf...