The Trump administration is organizing a Manhattan Project-style effort to drastically cut the time needed to develop a coronavirus vaccine, with a goal of making enough doses for most Americans by year’s end.
Called “Operation Warp Speed,” the program will pull together private pharmaceutical companies, government agencies and the military to try to cut the development time for a vaccine by as much as eight months, according to two people familiar with the matter.
Vaccine development is typically slow and high risk. The project’s goal is to cut out the slow part, the people said. Operation Warp Speed will use government resources to quickly test the world’s most promising experimental vaccines in animals, then launch coordinated human clinical trials to winnow down the candidates.
The project will cost billions of dollars, one of the people said. And it will almost certainly result in significant waste by making inoculations at scale before knowing if they’ll be safe and effective — meaning that vaccines that fail will be useless. But it could mean having doses of vaccine available for the American public by the end of this year, instead of by next summer.
The parallel development and manufacture of vaccines seems, well, innovative to me, and in a good way. Since the alternative to a vaccine is ruin, the project really shouldn’t be descibed as “wasteful.” From the HHS FAQ, “Fact Sheet: Explaining Operation Warp Speed“:
What’s the goal?
Operation Warp Speed’s goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures)…..
Who’s working on Operation Warp Speed?
OWS is a partnership among components of the Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD). OWS engages with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA.
In this post, I’ll pull out and comment upon the salient points of Florko’s article, focusing on institutional issues. Then I’ll do a recap of the politics of OWS, which have centered on the stock holdings of HHS Secretary Alex Azar’s Chief Advisor. (A focus on institutional issues means that general discussion of vaccine efficacy and safety is out of scope, along with other issues like the choice of OWS participants, the vaccine approval process, manufacturer liability, or delivery dates and the political implications thereof. Here is a good round-up of reactions to Florko’s scoop.)
Here is Florko’s key takeaway:
The labyrinthine chart, dated July 30, shows that roughly 60 military officials — including at least four generals — are involved in the leadership of Operation Warp Speed, many of whom have never worked in health care or vaccine development. Just 29 of the roughly 90 leaders on the chart aren’t employed by the Department of Defense; most of them work for the Department of Health and Human Services and its subagencies.
Now, to be fair, given that OWS is a public-private partnership, the scientists are employed by the pharmaceutical companies, and so don’t appear on the org chart. In addition, 600 HHS officials do not appear on the org chart. Nevertheless, the military presence is dominant:
One senior federal health official told STAT he was struck by the presence of soldiers in military uniforms walking around the health department’s headquarters in downtown Washington, and said that recently he has seen more than 100 officials in the corridors wearing “Desert Storm fatigues.”
And then there are (or are not) agencies. The FDA is not on the org chart at all, necessarily so:
The Food and Drug Administration is also largely absent from the organizational chart, though that is by design. Most FDA officials are barred from participating formally in Operation Warp Speed over concerns that their involvement would conflict with their mission to impartially review eventual vaccine applications. The one major exception is Janet Woodcock, who took a temporary leave as head of FDA’s drug center to lead the initiative’s efforts on therapeutics.
The organizational chart also underscores which agencies are not as closely involved in the leadership of the effort: namely, the Centers for Disease Control and Prevention, which took a leading role in coordinating vaccine distribution for other past pandemics, like the H1N1 pandemic of 2009.
So why the dominance of the military? One reason is logistics. The Iraq War, after all, albeit from a strategic and indeed a warfighting standpoint a complete debacle, was nevertheless a logistical triumph, beginning with prepositioning materiel in the run-up to the war. Florko writes:
Though HHS Secretary Alex Azar and Defense Secretary Mark Esper are at the top [of the org chart], the two key leaders are [Moncef] Slaoui, the formal civilian leader of the project [of whom more below], and Gen. Gustave Perna, the military lead who is the chief operating officer for Operation Warp Speed.
[Perna] is a four-star Army general who previously managed virtually all of the Army’s logistics. He was even inducted into the Army’s own logistics hall of fame. He most recently served as head of Army Materiel Command, a sprawling job that handles virtually all of the Army’s equipment. The organization’s slogan is: “If a Soldier shoots it, drives it, flies it, wears it, communicates with it, or eats it — AMC provides it.”
Military officials contend that the U.S. Army excels at complex challenges — like distributing vaccines that might need to be transported at subzero temperatures.
“You know the old joke about, ‘You and what army,’ right?” said Andrew Hunter, a Defense Department expert at a Washington think tank, the Center for Strategic and International Studies. “They routinely do things that are more complex, even than this vaccine job, all the time.”
“There are quite honestly certain logistical elements of this that the CDC has never, ever been asked to do, and why not bring the best logisticians in the world into the equation?” Mango said.
However, I would urge that there is a second reason: Trust. The military is one of the few remaining trusted public institutions in America. From Gallup:
If, when it comes time to deliver the vaccine, which will be a massive and visible public effort, it’s hard to imagine a better public relations vehicle than the military. (That may not say much about the state of our body politic, but that is where we are.) Go down Gallup’s list, and you will see there is no alternative. Small business, though trusted “a great deal” (39%), is structurally incapable of delivering vaccines; the military (40%) is. From there, there’s an 18-point drop to the medical system (22%). The only alternative I can think of is Amazon (a large technology company, 14%).
There’s a good deal more information in Florko’s article, with some concrete examples of how OWS is working with the vendors, but especially about personnel, who seem competent (indeed, I have to say that Florko occasionally verges on beat sweetening).
The executive, Moncef Slaoui, is the top scientist on Operation Warp Speed, the administration’s effort to develop a coronavirus vaccine in record time. Federal law requires government officials to disclose their personal finances and divest any holdings relating to their work, but Slaoui said he wouldn’t take the job under those conditions. So the administration said it’s treating him as a contractor. Contractors aren’t bound by the same ethics rules but also aren’t supposed to wield as much authority as full employees.
Slaoui agreed to sell stock worth $12 million and resign from the board of Moderna, the developer of a leading potential vaccine. But Slaoui insisted on keeping his roughly $10 million stake in his former company, GlaxoSmithKline, another contender in the Operation Warp Speed vaccine race. “I won’t leave those shares because that’s my retirement,” he has said.
Q: Have you discussed with the administration the possibility of saying, ‘Let’s not ask [the FDA] for an EUA [Emergency Use Authorization] until after 3 November?’ Let’s just clear that off the deck right now, because there’s so much worry of an October surprise and something being pushed before 3 November. It’s not going to make a difference to the pandemic if there’s a vaccine on 2 November or 4 November.
A: I have to say, maybe even despite my personal political views, that I don’t think that’s right, because 1000 people die every day [from COVID-19]. If a vaccine [had evidence of safety and efficacy] on 25 October, it should be [requested] on 25 October. If it’s 17 November, it should be 17 November. If it’s 31 December, it should be 31 December.
It needs to be absolutely shielded from the politics. I cannot control what people say. The president says things, other people will say things. Trust me, there will be no EUA filed if it’s not right.
Q: You also have a history of being politically active. As a university student in Belgium, you were politically active. It’s in your blood: Your father, who resisted the French occupation of Morocco, was politically active. For you to now say there’s nothing political about Operation Warp Speed? Politics is all over this. And I wonder how you deal with political decisions that you disagree with.
A: I would immediately resign if there is undue interference in this process.
Q: If you see an EUA push you don’t believe in, you’re out?
A: I’m out. I have to say there has been absolutely no interference. Despite my past, which is still my present, I am still the same person with the same values. The pandemic is much bigger than that. Before being a political person with convictions, humanity has always been my objective.
Warren said lawmakers need to strengthen federal ethics laws “to root out this kind of corruption.”
“It should pass the Coronavirus Oversight Recovery Ethics Act, which is a bill that I introduced in order to prohibit conflicts of interest in the federal Covid-19 response. And the first person to be fired should be Dr. Slaoui,” the Massachusetts senator said at a Senate Appropriations subcommittee hearing.
I’ve made a big fortune out of the game, and I’m gettin’ richer every day, but I’ve not gone in for dishonest graft – blackmailin’ gamblers, saloonkeepers, disorderly people, etc. – and neither has any of the men who have made big fortunes in politics.
There’s an honest graft, and I’m an example of how it works. I might sum up the whole thing by sayin’: “.”
Just let me explain by examples. My party’s in power in the city, and it’s goin’ to undertake a lot of public improvements. Well, I’m tipped off, say, that they’re going to layout a new park at a certain place. I see my opportunity and I take it. I go to that place and I buy up all the land I can in the neighborhood. Then the board of this or that makes its plan public, and there is a rush to get my land, which nobody cared particular for before.
Ain’t it perfectly honest to charge a good price and make a profit on my investment and foresight? of course, it is. Well, that’s honest graft.
Now, nobody is suggesting Slaoui is going even as far as Plunkett’s “honest graft.” (Hero Fauci, who ramped Gilead’s stock, is another matter entirely, and it’s odd, or not, that Warren didn’t go after him.) If the “public improvements” get built, did “honest graft” matter so very much? Given the givens? And if a safe and effective vaccine is developed — and the country and its people saved from ruin — does the stock that Slaoui held onto matter so very much?
* * *
There’s little I can say in conclusion, except I’m surprised to see that OWS doesn’t seem to be shambolic, amazingly enough. I certainly hope I’m proved right! Frankly, I’ve got a bias toward action on Covid-19, so for all my qualms about Big Pharma and the military, it’s hard to see what else could have been done, given the givens.
 However, from Paul Mango, HHS’ deputy chief of staff for policy: “We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.” That may or may not conform to the HHS FAQ, which says that “Operation Warp Speed’s goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021.” That is, “having” a vaccine is not the same as “having initial doses available,” a month is October 28, but two months is November 28.
 From (sorry) Wikipedia: “Slaoui spent thirty years working at GSK. During his time there, Slaoui oversaw the development of numerous vaccines, including Cervarix to prevent cervical cancer, Rotarix to prevent gastroenteritis in children, and an Ebola vaccine. He also spent 27 years researching on a malaria vaccine, Mosquirix, that was approved by the European Medicines Agency in 2015 and touted as the first in the world.” If one must have someone from Big Pharma at the helm, Slaoui seems better than the norm; recall that Big Pharms is not enthusiastic about manufacturing vaccines, because they’re not profitable enough.
 Like, say, private property. Yes, I know honest graft is rent!