The Missing Piece

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 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. A new CDC report finds that two doses eight months ago were 79 percent efficacious against the recent Omicron variant. Add a booster shot and efficacy is back up to an impressive 94 percent.

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.

“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.”

On Nov. 1, 2020, The New York Times published a “news” article exulting:

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.

But the public wasn’t told until after the election that something very strange delayed Pfizer’s triumphant vaccine announcement until Nov. 9, 2020. As Matthew Herper of Stat reported after interviewing William Gruber, Pfizer’s senior VP of vaccine clinical research:

Gruber said that Pfizer and BioNTech had decided in late October…to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage…. 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.

As I pointed out in this column on Nov. 11, 2020, Bourla’s choice in late October to stop counting whether Pfizer had reached the point at which its published protocol required it to go public with news of the vaccine’s efficacy may have swung the election.

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.

Bourla’s memoir of Pfizer’s mad dash to deliver a vaccine is well-written in the time-tested style of airport books like Moneyball bought by frequent fliers looking for a diverting narrative that includes career self-improvement tips.

The day before a March 2, 2020, Covid meeting with Trump over the new pandemic, Bourla and his head researcher decided to deemphasize their development of therapeutics in favor of vaccines. (Ironically, two years later, Pfizer’s new Covid therapeutic Paxlovid is often prescribed to anti-vaxxers due to their higher risk of dying.)

Bourla’s executives then quickly decided they wanted to partner with the German firm BioNTech, a pioneer in mRNA technology. Bourla was surprised, but went along with the consensus. He quickly reached an agreement with BioNTech to share profits fifty-fifty, with the smaller company providing the vaccine and Pfizer running the trial, most government approvals, marketing, and manufacturing and distributing of billions of doses. If BioNTech’s radical new type of vaccine flopped, Pfizer would be out a couple of billion dollars. But, Bourla admits, Pfizer is so rich that $2 billion wasn’t a bet-the-company wager.

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.

My guess is that Bourla was mainly thinking: Winter is coming. There’d be another bad Covid wave in the winter of 2020–2021. (Which there was.) But he can be criticized for not anticipating that October 2020 would be an insanely politicized month.

Also, Moderna was racing to get to market with virtually the same technology as Pfizer. Whichever firm announced an efficacious vaccine first would make its brand name supreme. Toward the end of his memoir, Bourla boasts that after his pronouncement:

Our own research showed that our favorability surged. Our overall trust saw significant gains, breaking away from the pack in the industry…. Pfizer entered pop culture, becoming a frequent subject of both praise and humor on Saturday Night LiveAdAge wrote that, “Pfizer has been, far and away, the big winner in vaccine brand popularity.”

As it turns out, the Trump administration kept Moderna from announcing its own blockbuster success before the election due to its commitment to diversity. The Wall Street Journal reported:

Rival Moderna, which took funding from a division of the U.S. Department of Health and Human Services, suffered a three-week delay in completing its own mRNA trial after federal officials there asked the company to slow down enrollment to boost the racial and ethnic diversity of study subjects.

As we all know, Race Does Not Exist. Except in Covid vaccine trials, where it’s all-important.

Due to the Trump-administration-imposed three-week diversity delay, Moderna delivered its own good news on Nov. 16, thirteen days after the election.

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. A few days later, I received a call from Vice President Pence. Knowing the atmosphere in the White House, I was afraid that he was calling me to complain about it. But no. In a great demonstration of class, he called to congratulate me and thank me for what we’d done for this country and the entire world, to use his words. He didn’t even mention anything else. I was very impressed by the man. President Trump never called me, either to thank Pfizer or to complain.

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 higher morality of denying Trump an October Surprise, it’s saintly.

From a shareholder wealth maximization standpoint, I’d criticize Bourlas only for not realizing earlier how rabid the front-running Democrats and the media were to deny Trump any sort of vaccine October Surprise.

From an ethical standpoint, however…



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