Why Did Pfizer Delay Their Vaccine Announcement So Long?

Pfizer announced what seems to be very positive news about its Covid-19 vaccine candidate today.

 

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?

6 thoughts on “Why Did Pfizer Delay Their Vaccine Announcement So Long?”

  1. lifegotinteresting

    Perhaps all of the pressure the Trump Administration put on Big Pharma to reduce the horrendous
    US drug prices had them wishing (and working) for a change in leadership?

  2. I’d guess they didn’t want to be dragged into the political mess and be accused of helping either candidate. For what it’s worth, I think they made the right decision. Had they come out before the election, the validity of the info would have been questioned as politically motivated.

    1. David Rowell – Seattle, WA, USA – New Zealander now living in the United States.

      I disagree.

      In late September, their CEO promised an announcement by the end of October. Had he forgotten there was an election on 3 November? Sticking to their originally implied (an announcement after 32 cases) and subsequently confirmed (by their CEO) schedule would have been fair and consistent. Delaying it – that is where the political motivation surely can be found.

      You talk about “helping either candidate”. Not so. Their delay helped only one candidate. One candidate was promising good news by the election, the other candidate was not. By reneging on their promise, Pfizer made one candidate look bad and validated the other candidate’s criticisms.

  3. The assumptions on the date math need to be explored further.

    “Phase 3 trial commenced on 27 July” Normally that means the process of getting trial participates identified, screened and ready for the vaccine starts. It takes time to get 40,000 people identified.

    Plus the 20,000 initial shots and the 20,000 additional shots needed to be manufactured. They may have been by 27 July or it may have taken a little time for that. (I’ll assume getting 2X20,000 saline shots is easy).

    Then there is the logistics of actually administering 40,000 shots across who knows how many sites. Assuming this was a double blind test (neither the patient nor the doctor monitoring the patient know if they got the trial drug or salt water), there is a level of logistics of getting 40K serialized vials to the administration site (and again 3 weeks later). There is no practical way all 40K shots were given on 27 July. Optimistic reality would be 1-2 weeks.

    All of the above says the likely dates computed are too optimistic.

    1. David Rowell – Seattle, WA, USA – New Zealander now living in the United States.

      I believe they already had vaccine manufactured (two different types actually). But I allowed for the slow start and ramp up by doubling the time it would take to get to 32 results.

      I happily accept I may be wrong in my guesses (as may you). I’ll simply point you to the quote, above, from the CEO in late September, promising an announcement by the end of October. That seems to over-ride both our calculations, although it is entirely consistent with mine.

  4. Whereas the Pfizer announcement appears to have been timed for some preferential impact on the election (nothing here should be surprising in such a polarized high-stakes environment), the CEO has claimed his ‘victor’s crown’ for altruism: “Today is a great day for science and humanity.”

    However, the following Epoch Times report indicates another very human motivation: pure greed.
    https://www.theepochtimes.com/pfizer-ceo-sold-5-6-million-worth-of-stock-on-day-vaccine-announcement-sent-shares-soaring_3576056.html?utm_source=CCPVirusNewsletter&utm_medium=email&utm_campaign=2020-11-13

    Regarding the potential for election influence, many unusual circumstances have tipped outcomes in key battleground states and cannot be clearly dismissed except by clearly biased media outlets. Since all humans are inherently biased (and often hidden/denied, even from our own consciousness), the Pfizer timing carries all the markings of clever calculation for a desired spin on election results. As you identified in your reply to Carol Baker, “Pfizer made one candidate look bad and validated the other candidate’s criticisms.” Sure looks like a duck to me also; maybe most of the media has duck-blindness?

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