How to Replicate Operation Warp Speed

"It had to be a miracle. We got a miracle"

Can policy makers take lessons from the success of Operation Warp Speed (OWS)? As my colleague Arielle D’Souza has noted, “the OWS model isn’t a universal solution to pressing problems.” But can we leverage specific features of it to prevent future pandemics, or cure Alzheimer’s, or other national priorities?

On November 6th, the Institute for Progress, 1Day Sooner, and the Medical Countermeasures Coalition co-hosted a conference on Operation Warp Speed and its potential descendants. At the conference, former Secretary of the Department of Health & Human Services (HHS) Alex Azar answered these questions and more.

What You’ll Learn

• Why you can’t do a Warp Speed for Alzheimer’s

• Would money be appropriated for OWS today?

• Why HHS is a “JV” Cabinet member

Azar played a crucial role in Operation Warp Speed by overseeing the coordination and logistics of the program. He worked closely with pharmaceutical companies, government agencies, and public health officials to accelerate the development, production, and distribution of COVID-19 vaccines. He was interviewed here by Taylor Sexton, who previously served under Azar at HHS as Senior Advisor to the Assistant Secretary for Preparedness and Response.

Azar speaks during a news conference on Operation Warp Speed.

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Operation Warp Speed's success and the availability of funding was in part due to the urgency of a global crisis. Can we replicate the intensity and commitment of Operation Warp Speed in a non-emergency scenario? 

I think it's a genuine challenge. A lot of people say, “Create a Warp Speed for this, that, and the other.” We'll probably talk about some of those possible examples today, but the funding is a critical starting point. When Dr. Bob Kadlec, Peter Marks, Paul Mango and I sat down initially, I was able to say, “Take money off the table.” Since we’d spent $2 trillion on COVID relief, literally any amount of money that we would spend would have an infinite return on investment. There were effectively unlimited supplies of money when I commissioned the team originally. That's unusual. 

I remember back in the Bush Administration when we were afraid of a pandemic flu virus, and Secretary Leavitt and I created the first pandemic planning exercise in 2000, I guess it was probably 2005 when we got it kicked off. I remember going over and negotiating with Joel Kaplan and Josh Bolten to get a budget request for $7.1 billion [Bolten featured prominently in the first Statecraft interview, on PEPFAR]. That was like real money back then. And we couldn't get that through. We couldn't get that through Congress, and I was literally working with the Speaker of the House and the Majority Leader. I could not get $7.1 billion through Congress in the absence of a crisis. I have to be quite pessimistic about the ability to, on the financial side, execute something like OWS in the absence of a catastrophic, systemic-type crisis. It's just not how we work. But I think it's one of the defining features of what we need. 

We need some form of appropriated money that is accessible and available. Because I've got to tell you, if we had to go to Congress and get a new appropriation for Operation Warp Speed, it wouldn't have happened for a couple reasons.

One, my good friends at OMB would have said no, because they would have known it would become must-pass legislation that would become a Christmas tree, and therefore, a $26 billion request would have become a half-trillion dollar package of gobbledygook. And so they wouldn't have let the process start. 

Stu Simonson, who really came up with the idea for and created Project BioShield, had the idea of a permanent indefinite appropriation for medical countermeasures. Robert Byrd, the big appropriator, didn't like that being taken out of his hands, and so that got killed, and that's why with BioShield we live with the hundreds of millions of dollars that we can get every year. I think it was about $500 million a year during our time, which was so short of our targets. So I'm somewhat pessimistic, honestly. I hate to be, but I want to be realistic. 

Thinking how we would build the next Operation Warp Speed, what were the defining principles of Warp Speed? What were the strategies and structure that made it a success? 

The key to Operation Warp Speed, what made it unique was it was about execution. It wasn't about discovery.

It wasn't like, “Let's do an Operation Warp Speed to find a cure for cancer.” No. We had over a hundred vaccine targets. We knew we had a vaccineable virus, because the human body could heal itself, meaning that our body could produce antibodies sufficient to recover. If we could trick the body into believing it had COVID, you could create a vaccine. We also, on therapeutics, just from the history of dealing with monoclonal antibodies, had reason to believe that we could create artificial human response through monoclonal antibodies. It became about brute force. Could you simply make things happen faster, execute faster than ever before? 

Then you get into issues like “How do you make it work in a public-private partnership? How do you solve the incentive issues? How do you de-risk development for the pharma companies? How do you de-risk and accelerate manufacturing by pre-funding all of your commercial-scale manufacturing and committing to commercial acquisition, regardless of the state of the disease and the need for a product at the end of the day. How do you de-risk distribution by using existing distribution systems and funding all of that?” 

And, “How do you solve the human capital issue of getting the right people?” As with anything, people is policy. And getting the right people involved, the right leadership, the right structures of governance to enable, to empower, to isolate them, to give them the freedom of movement so that Gus Perna, Moncef Slaoui, etc. could have the power and freedom to do what they needed to do without political or bureaucratic interference. That's what Warp Speed was about. That's the core of it. 

When we talk about replicating it, it's keeping that aspect in mind. There are other ways to fund things, other ways to create incentive structures. We can talk about those, but Warp Speed was primarily an execution focus. 

The interagency process was a huge part of what made Operation Warp Speed a success, as well as learning the DoD culture, which was very different. Can you talk about how the command and control structure worked and how we would do that again? 

The partnership with DOD was unprecedented, and without it, Warp Speed wouldn't have happened. And frankly, I think if you hadn't had a cabinet secretary like Mark Esper as the Secretary of Defense, it wouldn't have happened. I've dealt with Secretaries of Defense over the course of my pretty long public life. Remember, HHS is the JV cabinet, okay? We're on the cusp, but we're still the JV. I gotta tell you, the notion that a Secretary of Defense takes a call from the Secretary of HHS on a weekend, a cell phone call, that's big, number one. But Mark and I were very good friends and colleagues. Number two, that he says immediately, “Whatever you need, you have the entire Department of Defense at your disposal.” 

I love Don Rumsfeld, but those words would not have come out of his mouth. This was about individual leadership. What that means for the future is, we can't build enduring systems assuming certain personalities and selfless leaders like Mark Esper will be in their roles at the time.

This is something Dr. Kadlec and I wrestled with, I don't know if we actually agreed on this point, DOD brought incredible capabilities to the table: the Defense Logistics Agency, procurement, logistics, operations, go through that lengthy list.

There's been a long-standing debate since Warp Speed: “Do you just build that at HHS so it's there at the ready?” Because HHS doesn't do those things well. It's not our wheelhouse. We have really smart scientific minds, but logistics, operations, and procurement are not the core. 

As with pharma manufacturing, it's very hard to build something and have it run without a warm base. It gets stale, the personnel don't work, idle hands are the devil's plaything, blah, blah, blah. I've always been of the mindset that you need to have a day job, and that DOD has the day job of running our military.

What you should have are systems where you can, regardless of the secretaries involved, basically pull in the DLA-type capabilities to scale when needed, as opposed to building up that infrastructure in-house at HHS and thinking that somehow it won't atrophy on the vine when it doesn't have the day job of deploying the US military around the world to keep it busy, occupied, and at a high skill level. It's a fair point of disagreement. 

The current administration, I think, has tried to insource that work within HHS. It's different from the decision I made. Not sure where Bob is on that issue. Were you with me or against me? I don't know. [Kadlec interjects, “I was with you, sir,” and the audience laughs.]

But I think that's a challenge. And I would just say for any future administration, and I don't know if this has happened, having that playbook ready for interagency collaboration and how do you merge DOD and HHS or another department as need be, that ought to happen. That playbook needs to be there because it was very interpersonal, relationship-based.

What, politically, does Project NextGen need, to be able to have bipartisan support, both on the Hill and otherwise? 

I always felt that we had complete bipartisan support. We, I was always quite careful to keep in close contact with, what's the formal name for the big four? With my four corners. Three years later, I even forget the terminology. My four corners, those are the top Democrat and Republican House and Senate appropriators. Anytime they wanted information, we were keeping them in the loop. We kept their clerks in the loop. We made sure that there was transparency. and they were fully on board, cooperative. We never had an issue. It was totally bipartisan.

That's with people like Rosa DeLauro and Patty Murray on the other side, with me on this side. Crisis brings that to the table. I don't know that you see that replicated for the same reasons as we talked about initially. 

I don't know that you see that kind of bipartisan working relationship happening outside of a crisis, in a preparedness, advanced countermeasures activity. I think you get into a lot of other issues that come up: where's money coming from? That's often the issue; it doesn't have to do with the money you're trying to spend on that particular program. It's what the pay-for is, or what the Christmas tree is that's being added to it, is where the fights often come about. Few would dispute spending money on countermeasures development. We're spending a lot of money on countermeasures, development, and capabilities. It's what comes with it. 

Shifting gears a bit, what advice would you give for the success of Project NextGen?

Please forgive me if I misunderstand elements of it, but I don't think of Project NextGen as the latest iteration of or continuation of Operation Warp Speed. Again, Operation Warp Speed was about a very defined goal, we said it publicly, which is enough vaccines for all Americans. An approved, authorized vaccine by the end of the year. It was a very clear goal structure, and we had a credible, scientific, technical reason to believe that it could be done. As Moncef said when we interviewed him for the job, literally everything that happened, had to happen right without a day's delay.

It had to be a miracle. We got a miracle. NextGen feels more like BARDA BioShield to me, in fact, because it's more of a grant than a cooperative agreement or procurement? 

That's right. There's no procurement. 

The challenge you've got there is, what's the government's right to operate in that space? Because we have a private sector that invests tens of billions of dollars in this space, both therapeutics and vaccines. Why the government? Are you solving a market failure or a market inefficiency? For instance, botulinum antitoxin. I can make you a really good case why the US government needs to fund the development of botulinum antitoxin and needs to buy and secure supplies of and be a very predictable purchaser of botulinum antitoxin, because there are not many CVS's out there that want to stock that. Okay? That's pretty easy. 

But countermeasures, therapeutics for COVID variants, nasal spray, vaccines, next-gen vaccines, next-gen diagnostics: You have to analyze that. You have to say, “Is there a commercial marketplace?” I think we've seen with some of the recent announcements out of Pfizer, for instance, that some of the antiviral markets maybe aren't as enduring and durable as we thought, but what's the commercial case that the US government needs to be involved as a guaranteed purchaser or as a funder of R&D to make that happen? Would it happen in the absence of government action? That for me is the first question. Because if it's going to happen without the US government doing it, then you should let it happen, because we will only get in the way of it. 

But if it is needed, then we have to think about what the intervention is. And the challenge with the way the BARDA system works is it's often grants. That was actually what got Dr. Bob Kadlec and me down on the path of Operation Warp Speed, was a BARDA grant of half a billion dollars to a pharmaceutical company.

Grants don't come with terms and conditions on the price of a product, the commercial delivery of a product, quantities of a product, timelines on delivery. Grants are like NIH. It's, “Here's money. You had a neat project and a neat proposal. Here's money now. God bless, we hope good things come from that.” 

it doesn't have the type of accountability of a procurement or a cooperative agreement. So I would hope as BARDA thinks about these things, that they think about, “How is it a real public-private partnership? Why are you there? What's the government's right to operate in this space? Why are you using taxpayer money? Why are you involved?” 

And then, how do you set up accountability so it's not just like NIH R01 funding, just sprinkling money about and hoping some flowers bloom. Because that often is the approach. I hope the people involved have a really good understanding of pharmaceutical development timelines and finances and incentive structures around it, because you'll just need to make sure there are no valleys of death in there. That's another thing where BARDA can play a big role: Is it at the venture stage, are you preclinical, is it at clinical, is it late stage clinical, is it at manufacturing? Where do they need a little help from BARDA and the government to be involved? 

What do you think the media got wrong about Operation Warp Speed? What do you wish the general public had known about Operation Warp Speed? 

Among policy makers, the thing I wish they would get right would be this notion that it's about execution. You hear: “We need an Operation Warp Speed for Alzheimer's.” When you tell me you have fully characterized the mechanism, what causes Alzheimer's, and what the mechanism of action is that will deal with Alzheimer's, and then it's just about brute force of going through large-scale clinical trials and manufacturing scale-up and commercial market building to make that happen, I'd say yes.

But when we're still debating, is it the amyloid hypothesis, tau tangles, or whatever else, you're still in the discovery phase. That's not the brute force execution of a Warp Speed. It's a very creditable, very important scientific and human health venture. It's just not Warp Speed. That’s me being technical about how one thinks about it. 

The thing that I worry about, from a public perspective, is they think it's replicable. With Warp Speed, truly the stars aligned. You had unbelievable people willing to give their lives like Moncef Slaoui and Carlos De Notaristefani and hundreds of others coming in from the private sector.

Government officials like Gus Perna, Bob Kadlec, Paul Mango, Matt Hepburn, Janet Woodcock. You just had the right people that, thanks be to God, were at the right place at the right time. The right Secretary of Defense. And it all worked. It all aligned. But it's not cookie cutter.

People now think, “Oh, we'll just get a vaccine in seven months for a new disease. It'll happen.” No, sorry. We were very fortunate that this all worked. and it's still making vaccines and making therapeutics especially for a novel pathogen. It’s rocket science. It is.

I worry that people underestimate that. They think that whatever else happens, “Oh, we'll just turn the spigot on again and that's what will come out.” I think they underestimate, frankly, the courage of those involved. This was really politically stupid. I looked back at the quotes, including from many of my own team, when we announced this in May 2020. One of these alleged “public health experts” was on TV saying, “This is another instance of POTUS in La La Land,” or “POTUS in Wonderland.” “This is all political, this is all dreamt up.” 

I teach at the University of Miami, and I was talking about Warp Speed and I had a woman at the end of class say, “Mr. Secretary, did you think about what would happen if all six vaccines failed?” And I stared into the outer distance, and I said, “I actually didn't.” Maybe as a leader, you have to have that supreme level of confidence that this will happen. And plus, we did our Monte Carlo probabilizations. We knew our likelihood of technical success across the molecules, but anything could have gone wrong, from supply chain to manufacturing disruption to protein replication.

Audience Questions

One thing that’s overlooked by the general public is that a lot of the luck we had was built on the foundational science over decades of discovery, both in the platforms and the antigens. How do the government and private sector continue to invest in that foundational science as well? 

Yeah, absolutely. It was decades of funding into the mRNA platform, which was totally unproven. It is a challenge to keep support up for NIH and the funding that we do for primary research. I do get nervous. 

That's part of the reason I get a bit nervous when we talk a lot about translational medicine, et cetera. I get very nervous, as you can probably guess, when I hear the government talking about trying to replicate what the private sector in biopharma does. Because they do it really well, and they aggregate huge amounts of capital and are really good at placing a diverse group of bets there. 

What they don't do is the commons, the basic primary research. That's the foundation that becomes generally applicable knowledge. It could be on physiology, target identification, even molecule target and receptor identification, target validation: all of that can open the pathways to the multibillion dollar investments. 

So I always get worried. What's NIH, about 60 billion now? Maybe more. I get worried when there's any diversion of that towards playing drug company. We need so much of that focus on the primary research that is the foundation for all of that. 

I want to go back to your characterization of HHS as the JV cabinet member. Arguably the bio-pharmaceutical industrial base in the US is a world-class, varsity player. Do we need to drill with those companies and test these sorts of speed and scale capabilities more regularly? 

Let's face it, the varsity cabinet is still Defense, State, Treasury, Justice, and, sort of, Homeland Security, the big five. But you’re right: HHS is the world's largest insurance company, the world's largest funder of primary research, the world's largest funder of epidemiology, and the largest funder of the welfare state. That's the day job.

Contingency management is important too; really, since the ‘90s, HHS has thought of itself as a national security agency. But thinking of yourself that way doesn't mean the rest of the world does. If America gets attacked, I may be sitting in coach on Southwest in the back of a plane. That's not what happens to the Secretary of Defense. 

The point you made about collaboration, how do we make public-private collaboration more enduring and more repeatable, is a really good point. Maybe DOD over-indexes on collaboration in the defense establishment. But we probably could do a lot better. The problem is at HHS, there are significant antibodies. You are the regulator of industry at FDA. You are the payer of industry at CMS. So there is a natural disinclination to be seen as too cozy. 

But for what you're talking about, that notion of exercising and validating the process of working together for creating diagnostics, therapeutics, and vaccines on a very short timeline: it has to be a two-way street. If you think you can come up with these ideas in the Humphrey Building on your own, you're fooling yourself. You're not running these businesses. You do not know how they work. You don't know their manufacturing processes. You don't understand the incentive structures internally.

They don't know how to run HHS, but you don't know how to run their biopharmaceutical company, and you've got to talk and work together. So overcoming some of that prejudice and creating more collaborating, coordinating councils and vehicles for that would be a very good thing to do. 

We used to think about bioterrorism as something that was fairly impossible because you'd have state actors. You have non-state actors now. So we've got to be able to respond to novel pathogens that can really be engineered quite easily without significant state-level capabilities. We've got to be able to do diagnostics, therapeutics, vaccines in a way that's faster, more nimble than we've ever conceived of before.

How do we think outside that box and make that happen? It ain't gonna be HHS sitting there at a whiteboard session in a conference room. It will have to be in collaboration.