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The spectacularly timed Pfizer vaccine announcement

Why did the company’s discussions with the FDA result in the 32-case interim analysis being dropped?

November 9, 2020

12:18 PM

9 November 2020

12:18 PM

Cockburn is not normally one for the conspiracy theories, preferring as he does to believe in cock-up, accident and coincidence.

But conspiracy theories are the bread and butter of 21st century politics. Many Trump fans, for instance, will be poring over today’s Pfizer and BioNTech announcement of the first set of results from their Phase 3 COVID-19 vaccine trial, and wondering what might have happened if only the announcement had come a week earlier. ‘The timing of this is pretty amazing. Nothing nefarious about the timing of this at all right? 🙄’ tweeted celebrated immunologist Donald Trump Jr. Yes, you may be paranoid, but that doesn’t mean they’re not lying to you.

How many citizens would have changed their vote if they had seen, a few days before the election, President Trump standing with the Pfizer CEO and announcing: ‘My fellow Americans, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. America is great again. COVID-19 is now the loser’?


And anyone reading the details in the Pfizer and BioNTech announcement on their website might have paused on the following part: ‘After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the Data Monitoring Committee performed its first analysis on all cases.’

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So, the very suspicious among Team Trump might wonder, why did the discussions with the FDA result in the 32-case interim analysis being dropped? And who from the FDA led the discussions? And what was the cause for the delay between hitting the 62 cases and the interim readout at 94 cases? Did the election play a part?

Cockburn makes no judgment. He asked Pfizer’s press office what the cause for the delay was. A Pfizer spokesperson said ‘After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.’

But don’t expect that to stop the theories spreading like a highly infectious virus…


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