Many cynics had been predicting that good news about the Covid-19 pandemic would come out just after the election. Some very good news was released at 6.45am EST on Monday morning, 9 November – Pfizer reported that its vaccine candidate is demonstrating 90% efficacy in its Phase 3 trial.
This has been described as a “miracle”, promising “return to normalcy by spring” and even the staid conservative WHO said the vaccine “could fundamentally change the course of the pandemic”.
But what about the timing? Was the data deliberately withheld, or was this purely an innocent coincidence of timing?
Pfizer has insisted that its work is not influenced by politics and that it was “moving at the speed of science”.
The facts that Pfizer itself has shared disagree with this smug statement. We’re not looking at “the speed of science” (whatever that is), we’re looking at the decisions about when and what to report on “the science”, and we’re looking at an unexplained decision to delay the initially planned release of data.
This data was deliberately held back. We know this because Pfizer tells us so. Pfizer’s press release says, in this 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 DMC performed its first analysis on all cases.
This is a very curious set of statements, and very carefully written to say much but tell little. There are at least six puzzles.
1. When did the case count reach 32?
2. When did the case count reach 62?
3. Why was a decision made not to make the originally planned interim analysis after 32 cases?
4. Why was the FDA even involved in a discussion not to release interim results at that point?
5. What did the FDA recommend and why?
6. How long did the discussions take?
7. What were the further discussions with the FDA after reaching the 62 case number?
8. How long did those discussions take?
We can actually roughly guess at the timings from the information that was disclosed in the press release.
The Phase 3 trial commenced on 27 July. A second dose of the vaccine would have been given 21 days later, and outcomes would start to be significant seven days after that, which is 24 August.
At some point prior to today, Monday 9 November, 94 cases had been reported. Let’s say the 94 cases were reported around the middle of last week, giving a couple of days for their Data Monitoring Committee to do whatever it is they do, and then to write up a press release for distribution very early on Monday morning. Shall we say Wednesday 4 November, the day after the election? Actually, you can choose any date you like (within reason), the analysis that follows won’t change much.
So if we had 94 cases in the 72 days between 24 Aug and 4 Nov, that suggests the first 32 cases might have taken 25 days to amass. It probably took longer for the first cases to start coming in, due to the increasing virus prevalency in the last month or two, so let’s be generous and give Pfizer the benefit of the doubt, and make the gap between the 32 case planned-announcement point and the election as small as possible. Let’s double the guess of 25 days for the first 32 cases and say it took 50 days for those cases to occur.
Adding 50 days to 24 August (the date when results would start to be recorded) takes us to 13 October. On or shortly after that date is when Pfizer had earlier planned to make an announcement about how the trial was proceeding. For the three weeks between then and the election, and for almost another week afterwards, with the number of cases in their trial increasing daily at a rate of perhaps 3 new cases every day, Pfizer said nothing.
On or about 23 October, Pfizer probably reached the 62 case total and then gratuitously involved the FDA in “discussions” for a second time, 11 days before the election.
- If Pfizer had stuck to its original schedule, it could have made an announcement on/about Tuesday 13 October.
- If it had promptly announced results after reaching 62 cases, this might have been on/about Friday 23 October.
Just for the record, analysis takes minutes to do – it is as close to realtime as possible. It is as quick as changing a number in a spreadsheet and the time it then takes for the spreadsheet to recalculate. So why the unplanned delay and change of timetable?
We don’t know why the FDA needed to be involved in “discussions” at all prior to announcing interim findings. Sure, the FDA is totally involved in approving a vaccine, but that is unrelated to reporting on how a trial is progressing. The announcement from Pfizer on Monday is very vague and non-specific (there’s an enormous omission – the “confidence interval” used to assess the 90% efficacy rate) and absolutely did not require any formal sign-off by the FDA at all. It is not advice about FDA approval, it is not advice about even lodging an application with the FDA for approval, it is merely a statement of trial progress.
For reasons that are nowhere disclosed, Pfizer chose to say nothing when it had earlier planned to do so, after 32 cases. Then after 62 infections had been reported, Pfizer had discussions with the FDA for an unknown amount of time, and because we know that some short time prior to Monday, the total count of infections had grown from 62 at the start of those discussions to 94 at their conclusion, clearly this was a measurable and significant amount of time.
The original timing and plan would have been for an announcement probably a month prior to now. At the end of September, Pfizer’s CEO was predicting a result by the end of October. We don’t know if “by the end of October” means one day or one week or whatever prior to Halloween, but we do know that all those dates would have been prior to the election.
So, really – why did Pfizer delay a significantly positive announcement that could have been made prior to the election?