Operation Warp Speed (OWS) was launched on May 15, 2020 with the goal of accelerating “the testing, supply, development, and distribution of safe and effective vaccines, therapeutics, and diagnostics to counter Covid-19.” The largely untold story of how OWS was miraculously able to create vaccines in just a few months is a triumph of public health policy. It saved countless lives. But it is also a triumph and validation of industrial policy.
OWS offers insights into what is required to rebuild American industrial capabilities more generally. Investing in only basic scientific research, which is the traditional strategy of the United States, is not sufficient. Conventional fiscal or monetary policy is no longer working effectively to foster domestic productivity growth or to prevent deindustrialization. OWS-type interventions offer an entirely new repertoire of economic policies that could be a blueprint for industrial strategy going forward. OWS shows how the United States can reimagine and leapfrog existing manufacturing paradigms to dominate the technologies of the future.
Background: RED DAWN
The pandemic preparedness community realized fairly early in 2020 that the novel coronavirus posed a severe threat. News about the virus kept going from bad to worse. It was originally hoped that it would be like H1N1 (swine flu), which was highly contagious, but not lethal. Instead, as was becoming clear, the novel coronavirus was highly contagious and often lethal, too; it wasn’t comparable to just a bad case of the flu.
These discussions among public health experts can be found in the so-called Red Dawn emails. (The name “Red Dawn” comes from the 1984 movie about Americans fighting Soviet invaders.) “The chatter is that WHO and CDC are behind the curve. Any way you cut it, this is going to be bad,” Dr. Carter Mecher, a senior medical adviser at Veterans Affairs, wrote on January 28, 2020. On February 20, he warned in another email that the outbreak of Covid-19 on cruise ships was “a preview of what will happen when this virus makes its way to the US healthcare system, not to mention institutionalized high-risk populations in the US, like nursing homes. I’m not sure that folks understand what is just over the horizon.”
When Covid-19 did hit the United States, something akin to a Manhattan Project for vaccines was required in response. The idea for OWS itself came from Dr. Robert Kadlec, assistant secretary for preparedness and response (ASPR) at HHS, who had read the Red Dawn emails and created a coronavirus task force. Also deserving credit is Dr. Peter Marks, director of the center at the FDA that regulates biological products, who similarly saw the need for an accelerated vaccine development program. Marks gave Warp Speed its name — he is a Star Trek fan.
In April 2020, Kadlec and Marks wrote a proposal for HHS secretary Alex Azar, who in turn took it to Jared Kushner and others in the White House, who were enthusiastic. President Trump supported it and signed off on it. Azar brought in the DoD as well. Azar, Kushner, and others then made two hiring decisions that were crucial to Warp Speed’s success, recruiting Moncief Slaoui, a pharma executive, and Gustave F. Perna, a general, as its leaders
THE SCALE-UP PROBLEM
Dr. Matthew Hepburn, Col. (Ret.), joined Warp Speed on day one as the DoD lead for vaccine development. He had previously served as the director of medical preparedness on the White House National Security Staff in the Obama administration, and had also been a DARPA program manager. Hepburn, who was part of the Red Dawn email chain, remembers, “many people I trusted were freaking out about Covid-19 so I was fired up to join. The beauty of Warp Speed was the focus on speed. I wanted to accomplish the impossible. But even I thought the vaccine goals were outrageous.”
Typically, the process to bring a new vaccine to market takes ten years or more, if it can be accomplished at all. With OWS, the goal was to do that in just a few months. The private sector played a key role in OWS, but to claim OWS’s success was simply the product of the market is as absurd as arguing that the Manhattan Project was fundamentally a free market exercise (though it too involved private companies). It is also ridiculous to think that the handful of industrial policies which the U.S. economics establishment deems acceptable — better infrastructure, more education, the right tax incentives, clusters, “broadband for all” — could on their own have achieved what Warp Speed did, and in just a few months.
The specific economic problem plaguing America that a Warp Speed – style program solves for — aside from a pandemic of course — is the scale-up problem. This refers to America’s inability to develop and manufacture at scale the technologies that are invented in the United States. Outside of software, technologies don’t scale here; instead, they are typically manufactured abroad.
In fact, there is a long list of advanced technologies created in the United States that America no longer manufactures or even has the capability to manufacture. The problem is acute for hardware startups. There are few financial mechanisms in the United States to domestically scale up advanced manufacturing start-ups, in contrast to the direct subsidies and infant industry protection policies used by East Asian countries.
Vaccine technology is a case in point. Underlying the seemingly overnight success of OWS was the fact that the United States had already made huge advances in vaccines. Much of the technology had been pushed forward by DARPA, the renowned DoD research agency. As is typically the case in the United States, however, these breakthroughs were languishing when it came to widespread manufacturing and market implementation at scale. OWS changed that.
Dr. Hepburn says, “There were a lot of fundamental principle and tactical approaches that our government incorporated into Warp Speed. Warp Speed was inspired by DARPA but with a focus on scaling and implementation. OWS was DARPA at scale.” Hence to fully understand OWS, it is important to start with DARPA.
DARPA
The Defense Advanced Research Projects Agency, or DARPA, was established in response to the Soviets’ 1957 launch of Sputnik with a mission “to make pivotal investments in breakthrough technologies for national security.” The transformative technologies that have come out of DARPA include ARPANET (the precursor to the internet), drones, the F-1 engine that powered the Saturn V rockets used in the Apollo missions, portable GPS, voice-technology recognition software, flat-panel displays and self-driving cars.
Dr. Dan Wattendorf arrived at DARPA’s biological technologies office in April 2010 from the National Institutes of Health (NIH), where he had worked on the Human Genome Project. He is a geneticist who is also interested in industrial innovation, and new genetic approaches to vaccine manufacturing.
Wattendorf felt investments in lipid-based mRNA delivery systems could lead to effective vaccines for humans, though manufacturing such vaccines had not been widely attempted nor were there any clinical human trials. What made the new approach appealing to DARPA is that it could produce vaccines very quickly, critical to DARPA’s defense mission of reducing the risks of exposure to new pathogens and bioterrorism faced by military personnel. The old biological manufacturing process using chicken eggs to grow the pathogen would simply take too long to effectively respond to these threats.
Wattendorf went to DARPA’s director for funding to investigate further. “A fundamental part of the initial pitch was the speed and the rapidity of the scale-up in using mRNA for vaccines,” he says. In the summer of 2010 he started his mRNA vaccine work.
In 2013, DARPA made a $25 million grant to the recently founded biotech firm Moderna Therapeutics to “advance promising antibody producing drug candidates into preclinical testing and human clinical trials.” The company would make vaccines using mRNA technology (notice the last three letters in Moderna’s name).
As a result of DARPA’s support for mRNA vaccine technology, as well as other mRNA vaccine research conducted independently across the world, Operation Warp Speed had a proven vaccine platform to turn to when it needed to push a rapid response to the Covid-19 pandemic.
Wattendorf has a measured take: “DARPA’s early investments de-risked the technical problem. But they didn’t solve the fundamental capital shift we needed,” Wattendorf says.
This was ultimately provided by Warp Speed. Wattendorf adds, “as much as OWS was a success, reactive emergency funding is not a predictive way to plan.”
DEVELOPING AND MANUFACTURING VACCINES
Before OWS was officially formed, the urgent problem facing the United States was the need to provide more Covid-19 tests. Admiral Brett P. Giroir, MD, assistant secretary of HHS, took on the role of coordinating Covid-19 diagnostic testing in March 2020. He explains some of the challenges facing the United States: “We didn’t have a stockpile of tests or basic materials, and very little domestic manufacturing capacity.”
A greater limitation, though, was the CDC’s mission and culture. He said, “The CDC was insular and academic. It was not built for a rapidly emerging, potentially catastrophic health threat. It was used to creating tests in the thousands, such as for detecting anthrax, not in the millions.” He further argued that the CDC had almost no history of partnering with the commercial sector, and completely missed the importance of engaging with it.
Admiral Giroir implemented private-public partnerships to scale the manufacturing of tests. The government invested billions of dollars to build domestic test manufacturing capacity. By June 2020, the United States was testing five hundred thousand people daily.
When it came to vaccines, core to OWS’s acceleration strategy was to run vaccine development processes in parallel rather than sequentially. Almost from the outset, OWS took on the unprecedented financial risk of funding and scaling up manufacturing efforts while the vaccine candidates were still in clinical trials.
To choose from over a hundred vaccine candidates, OWS used “down select,” according to Hepburn, meaning whittling down the list using objective criteria. “The goal was never to try to pick one type of vaccine technology, let alone one company, but instead to keep the portfolio diverse. This was very deliberate given the many unknowns,” he said. Vaccine candidates had to use one of the three platform technologies deemed most promising. In the end, three vaccine platforms, and two companies per platform, were targeted: (1) mRNA: Moderna, Pfizer/BioNTech; (2) replication-defective live-vector platform: AstraZeneca, Janssen; (3) recombinant-subunit-adjuvanted protein: Novavax, Sanofi/GSK.
OWS’s acceleration and compression of the vaccine pipeline paid off. The process typically takes ten years or more. Two Covid-19 vaccines, Pfizer-BioNTech’s, followed by Moderna’s, received emergency use authorization from the FDA in December 2020.
Dr. Michael Callahan, an infectious disease specialist at Massachusetts General Hospital and Harvard Medical School, explained just how radical these results were. “Warp Speed has transformed the investment and R&D cycle for public health using biotechnology,” Callahan said. “No one is going back to the eleven-year development cycle.”
What happened at rollout?
When it came time for the rollout of the new vaccines, the United States stumbled slightly. It was not the most successful country in the world at vaccinating its population on a percentage basis, though it was still among the top performers, and the leader on an absolute basis.
The rollout had two components: (1) distribution and (2) administering shots in the arm. OWS, broadly defined, oversaw distribution. In contrast, the states ran the administration side, meaning delivering shots in the arm.
Initially, OWS considered having the Department of Defense rather than the states handle vaccination administration. In the end, the states, with the CDC’s endorsement, would administer the vaccines as they requested. But the states were not able to execute on time. They blamed poor communications and coordination from the federal government, but never themselves.
The distinction between vaccine distribution and administration is not widely known, though it was never hidden, and the problems with the vaccine rollout remain a highly charged topic. But the rollout rapidly improved with time, particularly in certain states.
This acrimony surrounding the rollout was typical of the atmosphere in the US during the pandemic. The standard narrative is the pandemic exposed the failures of America. Operation Warp Speed provides a different narrative. Rather than relying on endless authoritarian lockdowns, the US created multiple vaccines. (And parts of China are now in lockdown again).
Operation Warp Speed demonstrated American competence and that should give Americans confidence.
Editor’s note: A longer version of this article was originally published in American Affairs Journal. You can read that piece here.
David Adler is author of the monograph The New Economics of Liquidity and Financial Frictions and coeditor of the forthcoming anthology The Productivity Puzzle, both published by the CFA Institute Research Foundation. He is also an adviser on industrial strategy at the Common Good Foundation (UK).