I have stated elsewhere that it seemed to me that PFE deliberately delayed their vaccine results until after the election, in order to aid Biden’s chances, and in addition, gave him valuable material non-public information that he could have used to cash in on the news of the vaccine’s excellent results ahead of the public.
This post outlines that story and the primary sources so you can judge for yourself. The short version, basically -
- PFE lied and contradicted their prior disclosure policies in order to delay reporting great vaccine news until after the election,
- PFE told only Biden’s campaign hugely important market moving information ahead of the public, and
- PFE went out of their way to disclaim association with Warp Speed
if this wasn’t a 8-9 figure payoff plus throwing a marginal election to Biden, I don’t know what was. Now comes the long version…
How Pfizer helped Biden and his campaign by deliberately delaying their vaccine results until after the election and then providing extremely valuable material non-public information to Biden’s campaign in advance of their public release
As you know, the pandemic has been the primary focus of 2020 and one of the top two issues for most US voters for deciding their vote this November. Pfizer was very early to start the covid vaccine testing and trials (starting late April), and hence they were, barring possible setbacks which did not materialize in practice, expected to be first to announce their vaccine results. Clearly the effectiveness of this potential vaccine to restore normalcy to our lives, our economies, and our governments could not be understated, and as such would have major impacts on both voting decisions and the stock market.
In that context, let’s look at some background on Pfizer’s vaccine trial and how it was planned and supposed to go.
It was a double blind, placebo controlled trial so half got the vaccine and half got something that looked like a vaccine and all of them were followed to see which group ended up with more symptomatic covid cases. The results would be periodically reviewed by an outside Data Monitoring Committee to judge if things were going so well (or so badly) that intervention in the normal course of the trial was merited.
“Three blinded case reviewers (medically qualified Pfizer staff members) will review all potential COVID-19 illness events”
“During Phase 2/3, 4 IA’s [Interim Analyses] were planned to be performed by an unblinded statistical team after accrual of at least 32, 62, 92, and 120 cases” (pg 111)
The statistical threshold for the first interim results with 32 cases was >77% effectiveness, ie 6 or fewer of the 32 cases coming from the vaccine group, with decreasing thresholds to prove effectiveness in subsequent interim reviews due to the better confidence and statistics from the larger groups. One somewhat counter-intuitive aspect of this trial design is that the longer you wait for the fixed number of cases to arise, the better the chances the vaccine is working (since for a perfect vaccine, half the people can’t get it).
Let’s look at what the Pfizer and especially their CEO has been saying about likely timing for when we could expect to see these trial results. As you can see, the early information coming out of the company suggested October was the most likely time for this “first look” at the interim results.
Aug 24th - article - “For Pfizer, the first look could occur as early as September, when there are 32 cases of the disease in the study.”
Sept 8 - predicts that Pfizer “will have an answer [on safety and efficacy] by the end of October,” but adds that that does not mean actual distribution of a vaccine.
Sept 15 - presentation - “Continuous monitoring is performed by Pfizer’s qualified personnel by reviewing individual and aggregate data on a blinded basis. Weekly review of unblinded data is performed by an external, independent Data Monitoring Committee (DMC)”
Sept 17th - article - “Pfizer’s plan does not appear to estimate when its results could be available. Its chief executive has said repeatedly that the company hopes to have an answer as early as October.”
Oct 1st - “after consulting with our scientists, … we could have vaccine data ready to submit to the FDA by end of the third quarter, in October, and hopefully a hundred million doses delivered by the end of the year.”
Now that October as arrived, we get more specific details and the CEO is often speaking on the status of the trial. With the background of the frantic election rhetoric and the press talking up a lack trust in the Trump administration Warp Speed process, we hear this from the CEO:
Oct 16 - “given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines… This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial… a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial… In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us.”
So they expect to provide the first interim results promptly after they occur, regardless of the outcome. All very reasonable and in the spirit of openness and scientific research. However, a mere ten days later and a week before the election, there’s a marked difference in tone from the CEO:
Oct 27th - earnings call - “As we reiterated in an open letter, we may know whether or not the vaccine demonstrates efficacy soon. In case of a conclusive readout, positive or negative, we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within 1 week from the time we know. I can say today that the Data Monitoring Committee has not been unblinded to efficacy data nor has it conducted any interim efficacy analyses to date. But I want to be clear that after today’s earnings call, we do not intend to speak publicly about interim analyses until we have a conclusive readout from the Data Monitoring Committee.
So you can tell from change in tone and the legal language (no further public comments) that they are no longer following their previous policies of transparency and candor, but instead will be hiding their results until they feel like disclosing them, which will be at least a week. Anyone remember something that was going to happen in exactly one week after that call on Oct 27th? November 3rd - vaguely rings a bell.
So all they said as of Oct 27th, with lots of weaselly language, was that the DMC had not yet conducted its first review. Why could that have been? Naively, you might think this was because they did not yet have 32 cases, so there was nothing to review, but that’s not what they said. Could they have had good results at that stage, and not reported them? Quite possibly, since as we know now with much higher confidence, the vaccine appears to be about 95% effective, so the odds were quite good that at the 32 person checkpoint, they would have exceeded the 77% threshold for halting and announcing success. We also know that as of around the weekend of Nov 1st or perhaps a bit later, the DMC began their up to a week long analysis of 94 cases that were reported from the company to the DMC, and subsequently they reported to the company on Sun Nov 8th that it had passed the 2nd (62 case minimum) interim analysis by a wide margin. Given these trials had been going on and some 30,000+ people had been living their lives and occasionally getting covid, are we to believe there were less than 32 cases as of Oct 27th and yet just 4-12 days later there were suddenly 94 cases, and increase of at least 63 cases? In several months barely anyone gets sick and in just that week across the election, at least twice as many as in the whole trial to date get sick? The odds are astronomical. My bet is they did hit the 32 case threshold during mid October just like they expected, and issued the previous highly misleading statement making it sound like that hadn’t happened yet.
Later we find out that Pfizer had been sandbagging the results to push this good news until after the election. What happened to the first interim analysis? The updated trial protocol stated
“However, for operational reasons, the first planned IA was not performed.”
while their eventual success press release would state:
“After discussion with U.S. regulators, Pfizer and BioNTech said they recently elected to drop the 32-case threshold and conduct the first analysis at a minimum of 62 cases.”
A very interesting decision. Rather than report with in a day or two, as they had promised two weeks earlier, they not only chose to not conduct this first look at all, but they also did not tell anyone about it either, at least not the public or their investors. It would have been much more in keeping with standard procedure to conduct the review, report the results, and then say something like “out of an abundance of caution, we will not proceed to request FDA authorization until at least the 2nd interim review confirms these preliminary results”. But then the wrong person might have won the election, you know, the one who wants to keep drug prices down with a US “most favored nation” approach that would severely cramp big pharma profitability by preventing their pricing practices where they charge the US the highest costs for drugs, the EU less, and other countries much much less. The other one is happy to keep Medicare paying at least the OECD average price, which is considerably higher.
Now why might the DMC not have done this analysis? Remember the way the trial works, it’s administered by Pfizer who does all the testing and monitoring of the trial participants, and they regularly report any cases to the DMC. But around the time they hit the first checkpoint and were in “discussions” over what excuse they would use to not analyze it, they stopped running covid tests on their trial patients!
“While Pfizer conducted those negotiations, it paused testing of participant samples for the virus, said Gruber. By the time Pfizer had made the changes in the trial plan and restarted virus testing a few days ago, some 94 cases had occurred, far more than the trial needed to meet the new threshold.”
Take the samples, just don’t bother to check if they had gotten sick. That sure doesn’t sound like any clinical trial I’ve ever heard of. “Don’t test, don’t tell.” So finally when they did get the good news from the DMC on Sunday after, Nov 8th, the weekend when the mainstream press had declared the election over (even if various recounts and legal challenges persisted), Pfizer was suddenly in a hurry to selectively share the good news.
“Pfizer raced to verify the data, which were still blinded to almost everyone at the company beside a few statisticians. Early on Sunday afternoon, an independent data monitoring committee met in a closed video session to review the results for the first time. Afterward, the panel brought Gruber, Sahin and other company representatives onto the call and told them the vaccine had easily achieved its efficacy goal.”
They would tell the world at 6:45am Monday, Nov 9th, and the market reaction was understandably ecstatic.
Speaking not telling, almost an hour later around 7:30am Monday, the President would enthuse by tweet over the news “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!”
https://mobile.twitt…778096151203843 [since expunged by Twitter]
A senior White House aide told RealClearPolitics that the administration only learned of the vaccine from news reports. “[Pfizer] intentionally didn’t look at the data when originally planned,” the source told RCP. “And it likely would have been announced in October if they did look at it as originally planned.”
Meanwhile, some political animals are more equal than others:
article “Biden said in a statement that he was informed by his public health advisers on Sunday evening [Nov 8th] about drugmaker Pfizer’s analysis that its coronavirus vaccine is more than 90 percent effective.”
What possible reason could there have been for Pfizer to inform ex-Vice President Biden’s staff about this material non-public information Sunday evening, well in advance of the official press release first thing Monday morning? Recall that nothing was going to be done for 2-3 more weeks due to the FDA’s safety monitoring period running until late November anyway, and any state or federal government preparations for vaccine rollout and logistics had begun back in September, not that Biden was in charge of any of that at this point.
From the Oct 27th earnings call - “For Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide 2 months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November.”
Biden’s team came up with a nice press release by that morning, celebrating the effort but cautioning on mask use, but that’s hardly a good reason and was over two hours later so I’m sure someone could have dashed that out or had it prepared and ready to touch up and release. Meanwhile, in the stock market, nearly $1B in profits were made by those trading S&P futures in the premarket starting Sunday evening through the announcement of the news (around 230k ES contracts or $40B worth of trading volume), not counting other futures and equity markets.
As a side note, I will also point out as not-yet-elected officials, the Biden campaign and their family members in any event are not subject the congressional insider trading rules of the STOCK act, so they would neither have to disclose nor would it have been illegal for them all to personally trade on the material non-public information PFE so generously gave them in advance of the public. As long as they didn’t trade PFE stock, they were totally in the clear. I bet it was a busy night and a great morning for Hunter’s hedge fund with all that Chinese money backing it, as well as key members of the Biden family personally.
So in addition to their lying about disclosure and highly misleading description of the eventual clinical trial process, what else was Pfizer doing? For one thing, they were denying that they were participants in Trump’s Warp Speed vaccine development program. An odd technical point to make on such a momentous day that Monday morning, splitting hairs over whether they took research funding (no) or very large, generous government vaccine orders (yes).
But Dr. Jansen sought to distance the company from Operation Warp Speed and presidential politics, noting that the company — unlike the other vaccine front-runners — did not take any federal money to help pay for research and development. “We were never part of the Warp Speed,” she said. “We have never taken any money from the U.S. government, or from anyone.” She said she learned of the results from the outside panel of experts shortly after 1 p.m. on Sunday.
Well, except for that $2B contract that has options to go to $10B, but hey, that was only signed back in July so I’m sure she just forgot.
“Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA). The U.S. government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.”
I mean, when you’re taking $2B worth of government money from Warp Speed, that does sound a bit like participation to me, and they are in line for another $10B in total if they provide the 500M doses they are discussing providing to the US. Pfizer’s immediate denial of Warp Speed participation was subsequently “walked back”, but the important part was the headlines saying it had nothing to do with Trump’s vaccine effort, even if that was a lie.
This page has been updated to clarify Jansen’s comments following further details from a Pfizer spokesperson. The spokesperson clarified that its vaccine is linked to Operation Warp speed, though its research and development has not taken funding from the federal government.
some of us remember that the President Elect used to be the Senator from MNBA and had no ethical qualms about taking lobbying funds via a payoff to his son, and this looks to be yet another such situation only with hugely higher stakes. This time it’s not “unethical” that comes to mind, but rather “corrupt” and “illegitimate”.
If you have questions or alternative interpretations or insight into the events in question, I’m happy to hear them.