Introduction
Operation Warp Speed (OWS) has joined the ranks of innovative American government efforts, like the Manhattan Project and the Apollo program, that addressed the most complex science and technology challenges of their times. Their names have become shorthand for ambitious government programs with outsize, real-world effects.
As a result, policymakers have begun to call for the OWS model to be applied elsewhere: “A Warp Speed, but for Alzheimer’s,” for example. But OWS’s success relied on a particular environment that informed a particular program design. An OWS model can’t be used for every situation; indeed, for most problems, an OWS model wouldn’t pass a cost-benefit test.
At the same time, OWS’s essential features can be applied to many more federal endeavors. Using OWS leader Paul Mango’s recent book Warp Speed: Inside the Operation That Beat COVID, the Critics, and the Odds, along with interviews of OWS staff, we can tease apart features of OWS that were specific to the COVID-19 situation and features which can be universalized.
Like Apollo and the Manhattan Project, the OWS model isn’t a universal solution to pressing problems. Specific characteristics allowed OWS to succeed, and identifying them will help policymakers understand what tools to use when.
How did OWS work?
Strictly speaking, OWS was a public-private partnership that resulted in the deployment of two vaccines (Moderna and Pfizer-BioNTech) across the United States in 2020, along with the Johnson & Johnson vaccine in 2021. Between December 2020 and May 2021, it’s estimated that OWS saved the lives of 140,000 Americans (along with $1.8 trillion in economic benefits). It’s worth highlighting just how well OWS worked from a cost-benefit perspective: between 2020 and 2021, COVID-19 resulted in a $26 billion loss a day. By contrast, OWS cost around $13 billion, or around 12 hours worth of COVID-19 daily costs.
The Unique Features of OWS
An Emergency Environment
OWS’s agility stemmed largely from the crisis environment of the pandemic, which let it effectively cut through red tape. Logistical parts of the OWS response relied on Emergency Support Functions (ESFs), preplanned structures which articulate interagency response coordination during disasters. For example, ESF 8 was activated early in the pandemic, and helped multiple federal agencies coordinate public health and medical services support.
Although the OWS board involved a range of staff from the White House and multiple executive branches, the team met regularly with and reported directly to Senior Advisor to the President Jared Kushner, who in turn reported directly to President Trump. The board was authorized to make decisions without White House clearance, avoiding standard bureaucratic channels.
The level of White House support that allowed the OWS team to make quick decisions usually only occurs during periods of emergency. Additionally, the level of both professional and personal commitment from industry, government, and the military likely could not be sustained outside of a crisis environment.
Military Logistics
General Gustave Perna, previously the Army’s Deputy Chief of Staff, led the OWS team’s approach to logistics, incorporating a military approach to work through anticipated implementation challenges, map out responsibilities, and build in redundancy at every level. To streamline operations, tasks were categorized into vaccine development, manufacturing, or distribution challenges. The team invoked the Defense Production Act to allocate key equipment such as tubing, bioreactors, and syringes.
While therapeutic candidates were still in clinical trials, the OWS team mapped out each step of the expected manufacturing chain, along with its potential failure points. The Army Corps of Engineers deployed to expand manufacturing sites. Logistical challenges like mailing vaccine vials were also tested repeatedly ahead of time. Mapping out timelines and responsibilities built in much-needed redundancy, minimizing operational risk.
Manufacturing in Parallel
Since OWS optimized for a tight timeframe, it used a parallel task structure: manufacturing tasks typically executed in series were performed simultaneously. For example, the OWS team began equipping factories for mass production before clinical trials of different vaccine candidates were even completed. The team also developed specialized packaging and operationalized neighborhood vaccination sites at the same time. Additionally, the OWS team negotiated parallel orders (or purchase commitments) with six different industry partners. Taking on additional redundancy costs enabled the U.S. government to execute at greater speed in an emergency environment.
What is the Operation Warp Speed model?
The above elements were relatively specific to the particular problem posed by COVID-19. But which pieces of OWS can be used by the federal government for other challenges? Four features of the OWS model stand out: identifying a clear commercialization goal, an acceptance of federal investment risk to solve market failures by using market-shaping mechanisms, a whole-of-government strategy and coordination effort, and a willingness to streamline regulations. Factors like parallel manufacturing and military logistical chains were essential to the pandemic response, but may not be necessary in a future “Warp Speed for X.”
1. A Clear Commercialization Goal
OWS was created with an explicit target that was measurable and verifiable: develop at least one safe and effective COVID-19 vaccine that could be manufactured at scale and distributed across the country by the end of 2020. That clear commercialization goal made partnerships with the private sector radically simpler. With advance purchase agreements in place, industry partners focused on vaccine development while the U.S. government (principally through HHS and DoD) focused on providing intense logistical support for manufacturing and distribution challenges.
Additionally, this commercialization strategy didn’t involve much novel or experimental research; rather, it relied on industry’s existing technology. While COVID-19 accelerated mRNA technology and resulted in the first approved mRNA vaccines, research and development of mRNA therapeutics had been maturing since the late 1980s, and the SARS-CoV-2 sequence had been made publicly available on January 10th, 2020. mRNA vectors had already been used in animals successfully before OWS.
Through OWS, the U.S. government approached its public-private partnerships not as simply a subsidizer, but as an active partner, creating a market for industry’s mRNA technology and producing a vaccine against COVID-19 in record time. The pre-existing target product allowed the U.S. government to provide clarity on the specific requirements and timeframe industry needed to meet.
For many of the problems one would like to use an OWS model to solve, a clear commercialization goal simply doesn’t exist. The deliverable from private industry is underspecified, would require a major scientific advance, or could simply look like a wide variety of things. In any of these cases, OWS will be an unhelpful comparison. Instead, policymakers should use the tools of OWS on problems where the ask from government to the private sector is explicit, narrowly bounded, and achievable without major scientific breakthroughs.
2. Use Market-Shaping Mechanisms
To demonstrate its sustained commitment, the U.S. government used a range of financial incentives that reduced the private sector’s investment risk. OWS harnessed the R&D strengths of industry by supporting six different vaccine candidates across three vaccine platforms — mRNA (Moderna and Pfizer/BioNTech), replication-defective live-vector (AstraZeneca and Johnson & Johnson), and recombinant-subunit-adjuvanted protein (Novavax and Sanofi/GSK).
Other than with Pfizer, OWS signed pre-purchase contracts that committed to purchasing vaccines from pharmaceutical companies, even if those vaccines later didn’t receive Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA). In the case of Moderna, OWS provided additional funding, as it was unable to assume the same risks as its larger competitors. Without the guarantees offered by OWS, the private sector would have been slower to make the investments required to develop, manufacture, and distribute vaccines for all Americans. Advanced purchase agreements reassured these companies of a guaranteed market before trials were able to produce vaccine safety and efficacy data.
For another OWS style public-private partnership in the future, the U.S. government should be a flexible partner with industry, rather than taking on the role of a typical risk-averse subsidizer. The needs of one industry partner may be very different from those of the next. Policymakers should also consider what deliverables it can help private companies produce simply by committing to providing a market for them, whether through pre-purchase agreements or other vehicles like milestone payments or innovation prizes.
3. Whole-of-Government Strategy
OWS required a level of targeted coordination across government agencies and between government and industry that is rare in non-crisis environments. To clarify interagency communication, the OWS team built a clear organizational hierarchy with channels for constant communication to address implementation challenges.
The core OWS team worked to ensure it did not function as a task force made up of individuals from other agencies, but as a cohesive and integrated group. In this spirit, OWS leaders discouraged team members from invoking their original agency affiliation in meetings.
OWS was organized into Product Coordination Teams (PCTs), each composed of a team leader and specialists from industry, manufacturing, and government agencies. An OWS innovation, PCTs were formed to address industry needs immediately without having to run an interagency process for each need. Each OWS therapy and vaccine had a corresponding PCT working with its developing company throughout the development, testing, and distribution stages of the product. Apart from the FDA, every U.S. government agency had to inform a PCT leader before interacting with a manufacturer, simplifying information flows.
PCTs maintained constant internal communication throughout the day. Daily check-ins and conference calls allowed PCTs to get clarification and secure clearances, rather than waiting on inbox responses and approvals.
Another unique feature of OWS was its “persons in plants” model. OWS deployed officers from the Army, Biomedical Advanced Research and Development Authority (BARDA), and National Institutes of Health (NIH) to manufacturing plants across the country. These “persons in plants” provided the OWS PCTs with constant updates of challenges on the ground. Where possible, an OWS 2.0 should implement this kind of on-the-ground operational support, while recognizing that it may be too expensive to justify outside of an emergency environment.
When the issue touches multiple agency jurisdictions, regulatory coordination is especially important. Consider, for instance, the issues that have stemmed from the lack of coordination in the creation of a pan-variant COVID-19 vaccine to date. The funders of the FastGrants program have cataloged the roadblocks delaying a vaccine until at least 2024:
“These groups need to run primate trials, then run human clinical trials, and then ramp manufacturing and distribution… We’ve observed that they’re frequently tripped up by stupid things outside of their control, any one of which may hold their work back by months. One group’s monkeys have been delayed by US Customs, which will push the start of their primate trial back ‘till September…”
When an emergency strikes, an OWS-style model needs to be able to incentivize coordination and prioritization across many different federal agencies, which suggests it would benefit from being structured as a mission-oriented group rather than an interagency task force. Someone needs the authority to tell Customs to expedite the monkeys, even if doing so would be outside normal protocol.
4. Streamline Regulation
To reduce bureaucratic barriers that could slow down vaccine manufacturing and deployment, OWS instituted a coordinated effort to effectively meet regulatory requirements in a time sensitive manner without compromising safety standards.
The FDA issued guidance in accordance with the Public Health Service Act, allowing concurrent and combined trial phases and, in some cases, preclinical animal studies while conducting human trials. Typically, animal studies are conducted before clinical trials to assess efficacy and safety, and an intervention is eligible for FDA approval only once all human trial phases have concluded. To streamline the process, this structure was condensed. For example, Phase III trials were initiated during phase I trials to determine efficacy in an ongoing pandemic.
Additionally, review of Phase II trial data for OWS vaccines was heavily prioritized. In traditional FDA review between Phase II and Phase III trials, therapeutics can be backlogged up to six months before receiving an FDA green light. For OWS vaccines, this timeline was expedited to around three weeks.
When selecting vaccine and therapeutic candidates, OWS chose products with the highest potential of receiving an EUA. Independently, the FDA issued EUAs based on Phase III trial data to distribute and use unapproved OWS vaccines. Even when companies secured EUAs, they still continued clinical trials. EUAs allowed safe and efficacious vaccines to be manufactured and deployed quickly, and ultimately save lives during an emergency.
Additional measures OWS took to streamline vaccine development included preparing for Phase III trials once companies filed Investigational New Drug (IND) applications with the FDA, recruiting large population sizes for Phase III trials, and stockpiling doses of vaccine before FDA approval to be deployed immediately after approval was received.
OWS’s overall regulation strategy relied on identifying the most time-consuming red tape and procedural barriers, and encouraging increased communication between companies and regulators. For another Warp Speed-like endeavor, the challenge will be to identify and remove the equivalent barriers in a different field. Examples could include purely procedural regulations like NEPA, which mandates an arduous process without demanding particular outcomes.
What could be the next Operation Warp Speed?
The U.S. government does not typically address challenges at “warp speed,” but from its inception OWS was a temporary crisis model. Although the team almost chose the name “Manhattan Project II,” the name Operation Warp Speed reflects the program’s emphasis on speed and innovation, while also evoking the military influence that was central to this approach. Through OWS, the U.S. government used aggressive financial and regulatory commitments to reduce private sector uncertainty that allowed mature research to be commercialized faster.
But the OWS model is not appropriate for every challenge. An OWS approach wouldn’t necessarily accelerate the development of novel consumer products, such as smartphones or electric vehicles, where it’s not clear in advance what consumers want or need. By contrast, for problems like carbon capture, where a verifiable amount of carbon must be pulled out of the atmosphere, an OWS model may be more valuable.
An OWS approach also needs to be applied to problems with positive spillovers that lack adequate market incentives. OWS’s timely distribution of COVID-19 vaccines benefited not just the person receiving them, but other individuals who were then less likely to become infected themselves. But federal purchase commitments were essential to de-risk vaccine development by companies that did not know in advance if their vaccines would work.
In short, OWS offers policymakers an example of remarkable public-private partnership success. An OWS model could jumpstart a universal coronavirus or flu vaccine, or the building of a resilient electrical grid. It’s a model for an ambitious government program that needs to be harnessed effectively to meet our next great science and technology challenges.
