Four years ago, Pfizer froze its vax trial until the day after election

Almost nobody is aware of one the most shocking and perhaps consequential events in recent election history.

On October 27, 2020, Pfizer made an earnings call to Wall Street analysts, at which Pfizer CEO Albert Bourla had long implied that he’d announce the results of the pharmaceutical giant’s vastly anticipated covid vaccine trial.

But Bourla, who’d been under intense pressure from Democrats Joe Biden and Kamala Harris to not deliver good news about Donald Trump’s Operation WarpSpeed before the November 3, 2020 election, did not make any such announcement until after the election.

A couple of weeks later, we learned that, in fact, Bourla had ordered all processing in the world-historical clinical trial shut down until the day after the election.

From my November 11, 2020 column in Taki’s Magazine:

By Any Means Necessary

… Consider another example that emerged only this week: how the public announcement of the blockbuster result from the Pfizer-BioNTech COVID-19 vaccine test was delayed until after Election Day.

The best coronavirus strategy that any president could come up with has always been to be president when vaccines start rolling out. Thus Trump long claimed that a vaccine would succeed real soon now, while Democrats downplayed that idea and spread fear, uncertainty, and doubt about vaccines.

Back on Nov. 1, The New York Times news section gloated:

Welcome to November. For Trump, the October Surprise Never Came.

Trump’s hope that an economic recovery, a Covid vaccine or a Biden scandal could shake up the race faded with the last light of October.

By Shane Goldmacher and Adam Nagourney

President Trump began the fall campaign rooting for, and trying to orchestrate, a last-minute surprise that would vault him ahead of Joseph R. Biden Jr. A coronavirus vaccine….

I’m not easily shockable, but I found it eyebrow-raising to discover that the November Surprise, Monday’s [November 9, 2020] announcement by the Pfizer-BioNTech team that their new vaccine was spectacularly effective (over 90 percent), likely could have been made a week earlier, which would have given Trump a late October Surprise.

… Matthew Herper’s [November 9] article on StatNews points out that we now know Pfizer chose in October to deviate substantially from its published clinical protocol for conducting the vaccine trial:

…it also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.

Months ago, Pfizer released its 137-page scientific protocol for how it would test its vaccine on 44,000 volunteers, half of whom would get the treatment and the other half the placebo. As StatNews summarizes:

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.

Additional interim analyses were slated to be performed after 62, 92, and 120 cases, with the final analysis after 164.

The FDA had set a cutoff of 50 percent effectiveness being required for approval: A vaccine would have to reduce the number of cases in a population at least from, say, one million to a half million.

The annual flu vaccine usually has only around a 50 percent effectiveness, while measles vaccines run at 97 percent efficacy, which is why we don’t have measles epidemics anymore (so long as most people get their kids vaccinated).

It is remarkable that if in the first 32 cases in the vaccine trial, 26 or more afflict people in the placebo arm, researchers can say with a high degree of confidence (over 98.6 percent) that the vaccine will be at least 50 percent efficacious. But that’s how the math works out.

Similarly, if 47 of the first 62 cases or 67 of the first 92 cases show up among the unfortunates who got the placebo, then the vaccine has at least a 98.6 percent chance of ultimately meeting the 50 percent threshold. (See page 103 of the protocol.) …

Pfizer hired five experts to form an independent board to review the blinded trial data and deliver the statistical verdict.

StatNews writes that the aggressive schedule of Pfizer, which appeared to be the only consortium with a chance to deliver an update on efficacy before the election, was heavily criticized [by Democrats] on safety grounds:

That study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people.

That line of critique concerns safety, not efficacy.

The vaccine clinical trials looked into two separate issues: efficacy vs. safety. If efficacy was not achieved, then the safety question became moot. But if efficacy was discovered, then the trial would go on to see if the vaccine was safe enough for global rollout.

The vaccine still hasn’t been in use long enough [in the clinical trial] to meet the safety criteria. Yet it apparently did meet Pfizer’s published efficacy criteria before the election, but they just didn’t tell us that until this week.

Note that with vaccines, efficacy (how well the vaccine protects you from the disease) is a separate issue from safety (how well you are protected from the vaccine). Pfizer claims that the vaccine has proven very safe so far in its trial, but it won’t file for FDA approval until the second half of November when it expects to have two months of safety data on a sufficient number of volunteers.

StatNews offers a timeline of the announcement of its effectiveness:

The story of how the data have been analyzed seems to include no small amount of drama…. 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.

In other words, the companies skipped both the first (32 cases) and second (62 cases) scheduled interim analyses and only did the third (92 cases). But then it turned out that the vaccine was so effective (over 90 percent) that the first 32-case analysis likely would have been sufficient after all.

[William] Gruber [Pfizer’s senior vice president of vaccine clinical research and development] 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.

That’s pretty wild: The firms had their labs stop processing cases and just put the samples in cold storage. They stopped the count. They ran out the election clock.

Pfizer froze the world’s most important clinical trial from late October, when they had been hinting they would make an efficacy announcement, until the day after the election in Early November. They literally froze the specimens coming in daily from trial participants in a deep freeze in their lab until the day after the Wednesday after the election. They then announced the good news five days later on Monday, November 9 after the media had declared Biden the winner on Saturday, November 7. Team Biden was notified of the glad tidings on Sunday, November 8, but the President, that loser, had to wait until everybody else heard on Monday morning.

The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday.

Perhaps coincidentally (or perhaps not), last Wednesday was the day after the election. As one cynic suggested: They didn’t choose a sample size for when to report, they chose a date.

So, it appears that Monday’s announcement perhaps could have been made before the election.

My best guess is that if Pfizer and the FDA had not secretly changed their plan but had instead stuck to the publicly announced protocol, they would have announced successful efficacy results on the morning of Monday, November 2. That would have given Trump a full day to boast of his vaccine success. Would that have flipped the three narrowest states, leading to an electoral college tied of 269-269?

Who knows? But that hardly seems implausible.

But the corporations weren’t in the mood to follow their own protocol and Trump’s FDA let them get away with stalling on telling voters and investors what had been achieved.

From a political and financial standpoint, the firms likely made the self-interested right decision to delay. Even giant pharmaceutical companies don’t want to wind up on blacklists for vengeance by Democrats. But from a scientific and ethical perspective, it was highly questionable.

… The media is constantly accusing Trump of “authoritarianism,” but for a notorious authoritarian, Trump sure does get pushed around and stabbed in the back a lot, even by his own hirelings.

Then, a year and a half later I reviewed Pfizer CEO Albert Bourla’s memoir on the vax race to find out his personal explanation for his decision to secretly delay reporting results until after the 2020 election. From Taki’s Magazine:

The Missing Piece
Steve Sailer
March 23, 2022

Dr. Albert Bourla, CEO of pharmaceutical giant Pfizer, has published a new memoir entitled Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible. 

While the revolutionary mRNA vaccine from Pfizer-BioNTech has not turned out to be as much of a [covid] panacea as hoped, for people at risk (e.g., older and/or fatter, like most of us) it remains effective at reducing the odds of dying or being ventilated due to Covid. …

I read Bourla’s Moonshot carefully in the hope of finally hearing a horse’s-mouth explanation of his curious decision in what he calls “the most important trial in the world” to shut down laboratory processing of samples from late October 2020 until the day after the election. This extraordinary freeze may well have denied Donald Trump his much-feared “October Surprise” upon which his vaccine-centric pandemic and reelection strategies hinged.

… It’s hard to remember at this point, but in 2020, Trump was the pro-vaccine candidate, while Biden and Harris were spreading fear, uncertainty, and doubt. Democrats were up in arms that Dr. Bourla had long been forecasting that Pfizer’s giant clinical trial would produce a public announcement of the vaccine’s efficacy by the end of October 2020.

Thus, many Wall Street analysts expected Pfizer to announce its trial results during Bourla’s Oct. 27 earnings call. But that didn’t happen as Pfizer secretly stopped work on the trial until Wednesday, Nov. 4, by which point it had blown past its published protocols’ first, second, and even third checkpoints.

Six days after the election, Pfizer announced that its vaccine was more than 90 percent efficacious. If not for its unannounced hiatus, it’s likely Pfizer would have made the same announcement a week earlier, the day before the election, allowing Trump to spend the last 24 hours boasting of the success of his big bet on vaccines.

Would that have changed the political outcome?

Perhaps.

If 0.13 percent of the electorate in Georgia switched from Biden to Trump at the last moment, 0.16 percent in Arizona, and 0.32 percent in Wisconsin, Biden and Trump would have tied 269–269 in the Electoral College.

The conclusion would then have gone to the House of Representatives where under a section of the Constitution never used before, each state’s delegation would get one vote. By my count, the GOP had the majority in 27 states. So, Trump would have won.

Of course, immense pressures would have been exerted on Republican Representatives—ideology, blackmail, bribery, riot, insurrection, and perhaps a coup—to break ranks and elect Biden. So, we’ll never know.

But close reading of Bourla’s reticent book can give us some clues about the political pressures the Pfizer CEO was under to freeze the count until after the election….

His executives quickly brought him a timetable far faster than normal that would deliver clinical trial results within a mere eighteen months:

“It is not good enough,” I told the teams. “We must have it by this October.”… A week later, the team came back to me with a genius plan that, if successful, would bring us results by the end of October 2020.

Bourla became personally associated with his October deadline:

I had been telling everyone that the vaccine could come by October 2020, but it turned out that very few people besides me were expecting this really to happen.

Bourla feels his main contribution was infusing all his underlings with his need for speed:

Not everyone felt at ease with this at the beginning…. Pretty soon, though, the team’s passion to cross the line as fast as possible with a vaccine before October 2020 replaced hesitation…. Looking back, I think this attitude—Time is life—was the most important success factor for this project…. I didn’t ask people to do it in eight years. I asked them to do it in eight months.

Why did Bourla insist on October? As many Democrats worried, was he trying to deliver Trump an October Surprise? This Oct. 22, 2020, Vanity Fair article about how insanely anti-vax Democrats were in the fall of 2020 is eye-opening.

Was Bourla a Trump stooge as many Democrats implied that fall? I looked up on Open Secrets Bourla’s campaign contributions over the past decade. They seem conventional for a New York executive: $105,900 to Republican candidates and political action committees, $36,600 to Democratic candidates. None of his contributions were to presidential nominees. His giving makes him seem less like a partisan ideologue than like the standard CEO trying to help elect tax-cutting Republicans while maintaining an open door with enough Democrats.

… Bourla’s situation was tricky:

If [Pfizer’s vaccine] was approved before the elections, some might think that this was the result of the political pressure from the White House. If it was approved after the elections, others might think that this was the result of the political pressure from the Biden campaign.

Keep in mind that there are multiple elements that went into the FDA’s emergency-use approval of Pfizer’s vaccine on Dec. 11, 2020: Pfizer’s efficacy announcement of Nov. 9, the rather slapdash safety data submitted on Nov. 17 once two months of side-effects data were available on half the volunteers, and the esoteric manufacturing process review.

Of the three, the key event politically was the announcement of efficacy, which was delayed until the Monday after the election by the lab shutdown.

I looked forward to reading Bourla’s own account of what must have been an agonizing choice for him to put his clinical trial on ice until post-election. But instead, his narrative suddenly leaps forward without explanation to two days after the election, ignoring the crucial period in which he decided not to meet his goal of an October declaration.

After Pfizer’s big post-election announcement,

In the meantime, I started receiving news that President Trump was extremely dissatisfied with Pfizer and me personally because the results had come after the November 3 election. He was forming an opinion that this was done on purpose to hurt him and that if we’d wanted, we could have had the results before the elections.

Well, indeed, Bourla could have had the results before the election, but he put his clinical trial on hold.

The same sources were telling me that Health and Human Services Secretary Azar was thinking the same and was among the people who kept feeding the president’s anger. ....

At this point, I expected Bourla to offer an explanation of exactly why his obsession with October hadn’t panned out, but why the president was wrong to worry about dirty work at the crossroads. After all, over the past sixteen months I’ve heard many rationalizations hypothesized for Pfizer putting the trial on ice, so I was wondering which the CEO would go with.

But instead, Bourla changes the subject. In his entire book, his bizarre hiatus is never mentioned and never explained.

I wouldn’t be surprised if his lawyers told him to just shut up about it. Pfizer’s stock dropped after he failed to announce vaccine results in late October, so those who sold before Nov. 9 may have a claim against him.

At least two Pfizer stock analysts issued downbeat recommendations on Pfizer stock in late October on the grounds that if the clinical trial were going well, Bourla would have announced data like he’d been promising. Indeed, Pfizer’s stock drifted down when efficacy was not declared in the original time frame, in part because no explanation was given to anybody before the election other than FDA insiders that Pfizer was not following their published protocol for commercial-political reasons.

Still, under Bourla’s adept leadership, Pfizer managed to thread the needle, announcing more than 90 percent efficacy on Nov. 9, thus not outraging the Democrats by reporting before the election but still beating Moderna by a week. Bourla’s decision-making process during these politically fraught weeks deserves its own Harvard Business School case study. I am impressed by how he managed to navigate between Scylla (announcing in time to help Trump) and Charybdis (losing the race to Moderna).

From a normal ethical standpoint, secretly shutting down lab processing in the world’s most important clinical trial is obviously dubious.

However, from the standpoint of the [new] higher morality of denying Trump an October Surprise, it’s saintly….

Of course, by delaying Pfizer’s announcement from the day before the election to the week after, the vaccines were effectively converted in the Narrative from Republican to Democrat vaccines.

The Biden Administration then went hog wild on vaccine policy. For example, there’d been no testing of whether the vaccine provided “sterilizing immunity” (i.e., halting transmission of infections). Biden, assuming the vaccine did provide sterilizing immunity despite the lack of evidence, imposed vaccine mandates and used them to fire stubborn people in the military and the like.

In the end, the vaccines didn’t provide much if any sterilizing immunity, plus their time of highest efficacy was short, and the germs kept evolving into new variants.

On the other hand, the vaccines were pretty effective at reducing the death rate among those most at risk, such as the old or fat. Many Trump supporters, ignoring his repeated endorsement of the vaccines he’d helped rush to market and never having heard of the events described in this post, decided that mRNA vaccines were a Democratic plot, which led to higher death rates among Republican voters, many of whom are old and/or fat.