How to Replicate the Success of Operation Warp Speed
Summary
Operation Warp Speed (OWS) was a public-private partnership that produced COVID-19 vaccines in the unprecedented timeline of less than one year. This unique success among typical government research and development (R&D) programs is attributed to OWS’s strong public-private partnerships, effective coordination, and command leadership structure. Policy entrepreneurs, leaders of federal agencies, and issue advocates will benefit from understanding what policy interventions were used and how they can be replicated. Those looking to replicate this success should evaluate the stakeholder landscape and state of the fundamental science before designing a portfolio of policy mechanisms.
Challenge and Opportunity
Development of a vaccine to protect against COVID-19 began when China first shared the genetic sequence in January 2020. In May, the Trump Administration announced OWS to dramatically accelerate development and distribution. Through the concerted efforts of federal agencies and private entities, a vaccine was ready for the public in January 2021, beating the previous record for vaccine development by about three years. OWS released over 63 million doses within one year, and to date more than 613 million doses have been administered in the United States. By many accounts, OWS was the most effective government-led R&D effort in a generation.
Policy entrepreneurs, leaders of federal agencies, and issue advocates are interested in replicating similarly rapid R&D to solve problems such as climate change and domestic manufacturing. But not all challenges are suited for the OWS treatment. Replicating its success requires an understanding of the unique factors that made OWS possible, which are addressed in Recommendation 1. With this understanding, the mechanisms described in Recommendation 2 can be valuable interventions when used in a portfolio or individually.
Plan of Action
Recommendation 1. Assess whether (1) the majority of existing stakeholders agree on an urgent and specific goal and (2) the fundamental research is already established.
Criteria 1. The majority of stakeholders—including relevant portions of the public, federal leaders, and private partners—agree on an urgent and specific goal.
The OWS approach is most appropriate for major national challenges that are self-evidently important and urgent. Experts in different aspects of the problem space, including agency leaders, should assess the problem to set ambitious and time-bound goals. For example, OWS was conceptualized in April and announced in May, and had the specific goal of distributing 300 million vaccine doses by January.
Leaders should begin by assessing the stakeholder landscape, including relevant portions of the public, other federal leaders, and private partners. This assessment must include adoption forecasts that consider the political, regulatory, and behavioral contexts. Community engagement—at this stage and throughout the process—should inform goal-setting and program strategy. Achieving ambitious goals will require commitment from multiple federal agencies and the presidential administration. At this stage, understanding the private sector is helpful, but these stakeholders can be motivated further with mechanisms discussed later. Throughout the program, leaders must communicate the timeline and standards for success with expert communities and the public.
| Example Challenge: Building Capability for Domestic Rare Earth Element Extraction and Processing |
| Rare earth elements (REEs) have unique properties that make them valuable across many sectors, including consumer electronics manufacturing, renewable and nonrenewable energy generation, and scientific research. The U.S. relies heavily on China for the extraction and processing of REEs, and the U.S. Geological Survey reports that 78% of our REEs were imported from China from 2017-2020. Disruption to this supply chain, particularly in the case of export controls enacted by China as foreign policy, would significantly disrupt the production of consumer electronics and energy generation equipment critical to the U.S. economy. Export controls on REEs would create an urgent national problem, making it suitable for an OWS-like effort to build capacity for domestic extraction and processing. |
Criteria 2. Fundamental research is already established, and the goal requires R&D to advance for a specific use case at scale.
Efforts modeled after OWS should require fundamental research to advance or scale into a product. For example, two of the four vaccine platforms selected for development in OWS were mRNA and replication-defective live vector platforms, which had been extensively studied despite never being used in FDA-licensed vaccines. Research was advanced enough to give leaders confidence to bet on these platforms as candidates for a COVID-19 vaccine. To mitigate risk, two more-established platforms were also selected.
Technology readiness levels (TRLs) are maturity level assessments of technologies for government acquisition. This framework can be used to assess whether a candidate technology should be scaled with an OWS-like approach. A TRL of at least five means the technology was successfully demonstrated in a laboratory environment as part of an integrated or partially integrated system. In evaluating and selecting candidate technologies, risk is unavoidable, but decisions should be made based on existing science, data, and demonstrated capabilities.
| Example Challenge: Scaling Desalination to Meet Changing Water Demand |
| Increases in efficiency and conservation efforts have largely kept the U.S.’s total water use flat since the 1980s, but drought and climate variability are challenging our water systems. Desalination, a well-understood process to turn seawater into freshwater, could help address our changing water supply. However, all current desalination technologies applied in the U.S. are energy intensive and may negatively impact coastal ecosystems. Advanced desalination technologies—such as membrane distillation, advanced pretreatment, and advanced membrane cleaning, all of which are at technology readiness levels of 5–6—would reduce the total carbon footprint of a desalination plant. An OWS for desalination could increase the footprint of efficient and low-carbon desalination plants by speeding up development and commercialization of advanced technologies. |
Recommendation 2: Design a program with mechanisms most needed to achieve the goal: (1) establish a leadership team across federal agencies, (2) coordinate federal agencies and the private sector, (3) activate latent private-sector capacities for labor and manufacturing, (4) shape markets with demand-pull mechanisms, and (5) reduce risk with diversity and redundancy.
Design a program using a combination of the mechanisms below, informed by the stakeholder and technology assessment. The organization of R&D, manufacturing, and deployment should follow an agile methodology in which more risk than normal is accepted. The program framework should include criteria for success at the end of each sprint. During OWS, vaccine candidates were advanced to the next stage based on the preclinical or early-stage clinical trial data on efficacy; the potential to meet large-scale clinical trial benchmarks; and criteria for efficient manufacturing.
Mechanism 1: Establish a leadership team across federal agencies
Establish an integrated command structure co-led by a chief scientific or technical advisor and a chief operating officer, a small oversight board, and leadership from federal agencies. The team should commit to operate as a single cohesive unit despite individual affiliations. Since many agencies have limited experience in collaborating on program operations, a chief operating officer with private-sector experience can help coordinate and manage agency biases. Ideally, the team should have decision-making authority and report directly to the president. Leaders should thoughtfully delegate tasks, give appropriate credit for success, hold themselves and others accountable, and empower others to act.
The OWS team was led by personnel from the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the vaccine industry. It included several HHS offices at different stages: 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). This structure combined expertise in science and manufacturing with the power and resources of the DOD. The team assigned clear roles to agencies and offices to establish a chain of command.
| Example Challenge: Managing Wildland Fire with Uncrewed Aerial Systems (UAS) |
| Wildland fire is a natural and normal ecological process, but the changing climate and our policy responses are causing more frequent, intense, and destructive fires. Reducing harm requires real-time monitoring of fires with better detection technology and modernized equipment such as UAS. Wildfire management is a complex policy and regulatory landscape with functions spanning multiple federal, state, and local entities. Several interagency coordination bodies exist, including the National Wildfire Coordinating Group, Wildland Fire Leadership Council, and the Wildland Fire Mitigation and Management Commission, but much of these efforts are consensus-based coordination models. The status quo and historical biases against agencies have created silos of effort and prevent technology from scaling to the level required. An OWS for wildland fire UAS would establish a public-private partnership led by experienced leaders from federal agencies, state and local agencies, and the private sector to advance this technology development. The team would motivate commitment to the challenge across government, academia, nonprofits, and the private sector to deliver technology that meets ambitious goals. Appropriate teams across agencies would be empowered to refocus their efforts during the duration of the challenge. |
Mechanism 2: Coordinate federal agencies and the private sector
Coordinate agencies and the private sector on R&D, manufacturing, and distribution, and assign responsibilities based on core capabilities rather than political or financial considerations. Identify efficiency improvements by mapping processes across the program. This may include accelerating regulatory approval by facilitating communication between the private sector and regulators or by speeding up agency operations. Certain regulations may be suspended entirely if the risks are considered acceptable relative to the urgency of the goal. Coordinators should identify processes that can occur in parallel rather than sequentially. Leaders can work with industry so that operations occur under minimal conditions to ensure worker and product safety.
The OWS team worked with the FDA to compress traditional approval timelines by simultaneously running certain steps of the clinical trial process. This allowed manufacturers to begin industrial-scale vaccine production before full demonstration of efficacy and safety. The team continuously sent data to FDA while they completed regulatory procedures in active communication with vaccine companies. Direct lines of communication permitted parallel work streams that significantly reduced the normal vaccine approval timeline.
| Example Challenge: Public Transportation and Interstate Rail |
| Much of the infrastructure across the United States needs expensive repairs, but the U.S. has some of the highest infrastructure construction costs for its GDP and longest construction times. A major contributor to costs and time is the approval process with extensive documentation, such as preparing an environmental impact study to comply with the National Environmental Policy Act. An OWS-like coordinating body could identify key pieces of national infrastructure eligible for support, particularly for near-end-of-lifespan infrastructure or major transportation arteries. Reducing regulatory burden for selected projects could be achieved by coordinating regulatory approval in close collaboration with the Department of Transportation, the Environmental Protection Agency, and state agencies. The program would need to identify and set a precedent for differentiating between expeditable regulations and key regulations, such as structural reviews, that could serve as bottlenecks. |
Mechanism 3: Activate latent private-sector capacities for labor and manufacturing
Activate private-sector capabilities for production, supply chain management, deployment infrastructure, and workforce. Minimize physical infrastructure requirements, establish contracts with companies that have existing infrastructure, and fund construction to expand facilities where necessary. Coordinate with the Department of State to expedite visa approval for foreign talent and borrow personnel from other agencies to fill key roles temporarily. Train staff quickly with boot camps or accelerators. Efforts to build morale and ensure commitment are critical, as staff may need to work holidays or perform higher than normally expected. Map supply chains, identify critical components, and coordinate supply. Critical supply chain nodes should be managed by a technical expert in close partnership with suppliers. Use the Defense Production Act sparingly to require providers to prioritize contracts for procurement, import, and delivery of equipment and supplies. Map the distribution chain from the manufacturer to the endpoint, actively coordinate each step, and anticipate points of failure.
During OWS, the Army Corps of Engineers oversaw construction projects to expand vaccine manufacturing capacity. Expedited visa approval brought in key technicians and engineers for installing, testing, and certifying equipment. Sixteen DOD staff also served in temporary quality-control positions at manufacturing sites. The program established partnerships between manufacturers and the government to address supply chain challenges. Experts from BARDA worked with the private sector to create a list of critical supplies. With this supply chain mapping, the DOD placed prioritized ratings on 18 contracts using the Defense Production Act. OWS also coordinated with DOD and U.S. Customs to expedite supply import. OWS leveraged existing clinics at pharmacies across the country and shipped vaccines in packages that included all supplies needed for administration, including masks, syringes, bandages, and paper record cards.
| Example Challenge: EV Charging Network |
| Electric vehicles (EVs) are becoming increasingly popular due to high gas prices and lower EV prices, stimulated by tax credits for both automakers and consumers in the Inflation Reduction Act. Replacing internal combustion engine vehicles with EVs is aligned with our current climate commitments and reduces overall carbon emissions, even when the vehicles are charged with energy from nonrenewable sources. Studies suggest that current public charging infrastructure has too few functional chargers to meet the demand of EVs currently on the road. Reliable and available public chargers are needed to increase public confidence in EVs as practical replacements for gas vehicles. Leveraging latent private-sector capacity could include expanding the operations of existing charger manufacturers, coordinating the deployment and installation of charging stations and requisite infrastructure, and building a skilled workforce to repair and maintain this new infrastructure. In February 2023 the Biden Administration announced actions to expand charger availability through partnerships with over 15 companies. |
Mechanism 4: Shape markets with demand-pull mechanisms
Use contracts and demand-pull mechanisms to create demand and minimize risks for private partners. Other Transaction Authority can also be used to procure capabilities quickly by bypassing elements of the Federal Acquisition Regulation. The types of demand-pull mechanisms available to agencies are:
- Volume guarantees: Commits the buyer (i.e., a federal agency) to purchase a minimum quantity of an existing product at a set price from multiple vendors.
- Advance purchase agreements: Establishes a contract between a single buyer and a single supplier in which the buyer provides advance funding for resources to manufacture a product or provide a service.
- Advance market commitments: Engages multiple suppliers or producers to produce a product or service by providing advance funds.
- Prize competitions: Solicits the development of creative solutions for a particular, well-defined problem from a wide range of actors, including individuals, companies, academic teams, and more, and rewards them with a cash prize.
- Challenge-based acquisitions: Solicits creative solutions for a well-defined problem and rewards success by purchasing the solution.
- Milestone payments: Provide a series of payments contingent on achieving defined objectives through the contract timeline.
HHS used demand-pull mechanisms to develop the vaccine candidates during OWS. This included funding large-scale manufacturing and committing to purchase successful vaccines. HHS made up to $483 million in support available for Phase 1 trials of Moderna’s mRNA candidate vaccine. This agreement was increased by $472 million for late-stage clinical development and Phase 3 clinical trials. Several months later, HHS committed up to $1.5 billion for Moderna’s large-scale manufacturing and delivery efforts. Ultimately the U.S. government owned the resulting 100 million doses of vaccines and reserved the option to acquire more. Similar agreements were created with other manufacturers, leading to three vaccine candidates receiving FDA emergency use authorization.
| Example Challenge: Space Debris |
| Low-earth orbit includes dead satellites and other debris that pose risks for existing and future space infrastructure. Increased interest in commercialization of low-earth orbit will exacerbate a debris count that is already considered unstable. Since national space policy generally requires some degree of engagement with commercial providers, the U.S. would need to include the industry in this effort. The cost of active space debris removal, satellite decommissioning and recycling, and other cleanup activities are largely unknown, which dissuades novel business ventures. Nevertheless, large debris objects that pose the greatest collision risks need to be prioritized for decommission. Demand-pull mechanisms could be used to create a market for sustained space debris mitigation, such as an advanced market commitment for the removal of large debris items. Commitments for removal could be paired with a study across the DOD and NASA to identify large, high-priority items for removal. Another mechanism that could be considered is fixed milestone payments, which NASA has used in past partnerships with commercial partners, most notably SpaceX, to develop commercial orbital transportation systems. |
Mechanism 5: Reduce risk with diversity and redundancy
Engage multiple private partners on the same goal to enable competition and minimize the risk of overall program failure. Since resources are not infinite, the program should incorporate evidence-based decision-making with strict criteria and a rubric. A rubric and clear criteria also ensure fair competition and avoid creating a single national champion.
During OWS, four vaccine platform technologies were considered for development: mRNA, replication-defective live-vector, recombinant-subunit-adjuvanted protein, and attenuated replicating live-vector. The first two had never been used in FDA-licensed vaccines but showed promise, while the second two were established in FDA-licensed vaccines. Following a risk assessment, six vaccine candidates using three of the four platforms were advanced. Redundancy was incorporated in two dimensions: three different vaccine platforms and two separate candidates. The manufacturing strategy also included redundancy, as several companies were awarded contracts to produce needles and syringes. Diversifying sources for common vaccination supplies reduced the overall risk of failure at each node in the supply chain.
| Example Challenge: Alternative Battery Technology |
| Building infrastructure to capture energy from renewable sources requires long-term energy storage to manage the variability of renewable energy generation. Lithium-ion batteries, commonly used in consumer electronics and electric vehicles, are a potential candidate, since research and development has driven significant cost declines since the technology’s introduction in the 1990s. However, performance declines when storing energy over long periods, and the extraction of critical minerals is still relatively expensive and harmful to the environment. The limitations of lithium-ion batteries could be addressed by investing in several promising alternative battery technologies that use cheaper materials such as sodium, sulfur, and iron. This portfolio approach will enable competition and increase the chance that at least one option is successful. |
Conclusion
Operation Warp Speed was a historic accomplishment on the level of the Manhattan Project and the Apollo program, but the unique approach is not appropriate for every challenge. The methods and mechanisms are best suited for challenges in which stakeholders agree on an urgent and specific goal, and the goal requires scaling a technology with established fundamental research. Nonetheless, the individual mechanisms of OWS can effectively address smaller challenges. Those looking to replicate the success of OWS should deeply evaluate the stakeholder and technology landscape to determine which mechanisms are required or feasible.
Acknowledgments
This memo was developed from notes on presentations, panel discussions, and breakout conversations at the Operation Warp Speed 2.0 Conference, hosted on November 17, 2022, by the Federation of American Scientists, 1Day Sooner, and the Institute for Progress to recount the success of OWS and consider future applications of the mechanisms. The attendees included leadership from the original OWS team, agency leaders, Congressional staffers, researchers, and vaccine industry leaders. Thank you to Michael A. Fisher, FAS senior fellow, who contributed significantly to the development of this memo through January 2023. Thank you to the following FAS staff for additional contributions: Dan Correa, chief executive officer; Jamie Graybeal, director, Defense Budgeting Project (through September 2022); Sruthi Katakam, Scoville Peace Fellow; Vijay Iyer, program associate, science policy; Kai Etheridge, intern (through August 2022).
The OWS approach is unlikely to succeed for challenges that are too broad or too politically polarizing. For example, curing cancer: While a cure is incredibly urgent and the goal is unifying, too many variations of cancer exist and they include several unique research and development challenges. Climate change is another example: particular climate challenges may be too politically polarizing to motivate the commitment required.
No topic is immune to politicization, but some issues have existing political biases that will hinder application of the mechanisms. Challenges with bipartisan agreement and public support should be prioritized, but politicization can be managed with a comprehensive understanding of the stakeholder landscape.
The pandemic created an emergency environment that likely motivated behavior change at agencies, but OWS demonstrated that better agency coordination is possible.
In addition to using processes like stakeholder mapping, the leadership team must include experts across the problem space that are deeply familiar with key stakeholder groups and existing power dynamics. The problem space includes impacted portions of the public; federal agencies and offices; the administration; state, local, Tribal, and territorial governments; and private partners.
OWS socialized the vaccination effort through HHS’s Office of Intergovernmental and External Affairs, which established communication with hospitals, healthcare providers, nursing homes, community health centers, health insurance companies, and more. HHS also worked with state, local, Tribal, and territorial partners, as well as organizations representing minority populations, to address health disparities and ensure equity in vaccination efforts. Despite this, OWS leaders expressed that better communication with expert communities was needed, as the public was confused by contradictory statements from experts who were unaware of the program details.
Future efforts should create channels for bottom-up communication from state, local, Tribal, and territorial governments to federal partners. Encouraging feedback through community engagement can help inform distribution strategies and ensure adoption of the solution. Formalized data-sharing protocols may also help gain buy-in and confidence from relevant expert communities.
Possibly, but it would require more coordination and alignment between the countries involved. This could include applying the mechanisms within existing international institutions to achieve existing goals. The mechanisms could apply with revisions, such as coordination among national delegations and nongovernmental organizations, activating nongovernmental capacity, and creating geopolitical incentives for adoption.
The team included HHS Secretary Alex Azar; Secretary of Defense Mark Esper; Dr. Moncef Slaoui, former head of vaccines at GlaxoSmithKline; and General Gustave F. Perna, former commanding general of U.S. Army Materiel Command. This core team combined scientific and technical expertise with military and logistical backgrounds. Dr. Slaoui’s familiarity with the pharmaceutical industry and the vaccine development process allowed OWS to develop realistic goals and benchmarks for its work. This connection was also critical in forging robust public-private partnerships with the vaccine companies.
It depends on the challenge. Determining which mechanism to use for a particular project requires a deep understanding of the particular R&D, manufacturing, supply chain landscapes to diagnose the market gaps. For example, if manufacturing process technologies are needed, prize competitions or challenge-based acquisitions may be most effective. If manufacturing volume must increase, volume guarantees or advance purchase agreements may be more appropriate. Advance market commitments or milestone payments can motivate industry to increase efficiency. OWS used a combination of volume guarantees and advance market commitments to fund the development of vaccine candidates and secure supply.
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