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.
挑战和机会
开发以防止Covid-19的疫苗的开发始于中国于2020年1月首次分享遗传序列。5月，特朗普政府宣布OWS极大地加速发展和分布。通过联邦机构和私人实体的一致努力，一种疫苗在2021年1月为公众准备，击败了该疫苗previous recordfor 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建议1。With this understanding, the mechanisms described in建议2can be valuable interventions when used in a portfolio or individually.
Plan of Action
建议1.评估（1）现有的大多数利益相关者是否就紧急目标和特定目标达成共识，以及（2）已经建立了基础研究。
标准1.大多数利益相关者（包括公共，联邦领导人和私人合作伙伴的相关部分）都以紧急而具体的目标为基础。
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 |
| 稀土元素（REES）具有独特的特性，使它们在许多领域都有价值，包括消费电子制造，可再生和不可再生能源的产生以及科学研究。美国严重依靠中国来提取和处理里斯U.S. Geological Survey reportsthat 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（TRL）是政府获取技术的成熟度评估。该框架可用于评估是否应采用类似ORW的方法来缩放候选技术。至少有五个的TRL意味着该技术在实验室环境中成功证明了，这是综合或部分集成系统的一部分。在评估和选择候选技术时，风险是不可避免的，但应根据现有科学，数据和证明的能力做出决定。
| 示例挑战：扩展淡化以满足不断变化的水需求 |
| Increases in efficiency and conservation efforts have largely kept the自1980年代以来，美国的用水量平坦，但是干旱和气候变化正在挑战我们的水系统。淡化，这是将海水变成淡水的良好理解的过程，可以帮助解决我们不断变化的供水。但是，在美国应用的所有当前使用淡化技术都是能源密集型的，可能会对沿海生态系统产生负面影响。先进的海水淡化技术 - 例如膜蒸馏，高级预处理和先进的膜清洁，所有这些都在技术准备水平为5-6- 将减少海水淡化厂的总碳足迹。淡化的OWS可以通过加快高级技术的开发和商业化来增加高效和低碳防淡化植物的占地面积。 |
建议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 anagile methodology其中接受的风险比正常人多。程序框架应包括在每个冲刺结束时成功的标准。在OWS期间，根据临床前或早期临床试验数据，候选疫苗的候选物被提高到下一阶段。满足大规模临床试验基准的潜力；和有效制造的标准。
机制1：在联邦机构建立领导团队
建立一个集成的命令结构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.
OWS团队由卫生与公共服务部（HHS），国防部（DOD）和疫苗行业的人员领导。其中包括several HHS offices at different stages：疾病控制与预防中心（CDC），食品药品监督管理局（FDA），美国国立卫生研究院（NIH）和生物医学高级研究与发展局（Barda）。这种结构将科学和制造业的专业知识与国防部的力量和资源结合在一起。该团队将明确的角色分配给机构和办公室，以建立一系列指挥链。
| 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国家野火协调小组，，，，Wildland Fire Leadership Council和荒地消防和管理委员会，但其中许多努力是基于共识的协调模型。现状和针对机构的历史偏见创造了努力孤岛，并防止技术扩展到所需的水平。Wildland Fire UAS的OWS将建立由联邦机构，州和地方机构以及私营部门的经验丰富的领导人领导的公私伙伴关系，以推动这一技术发展。该团队将激励人们对跨政府，学术界，非营利组织和私营部门的挑战的承诺，以实现实现雄心勃勃的目标的技术。跨机构的适当团队将有权在挑战期间重新调整他们的努力。 |
机制2：协调联邦机构和私营部门
协调机构和私营部门在研发，制造业和分配方面，并根据核心能力而不是政治或财务考虑分配责任。通过绘制整个程序中的过程来确定效率提高。这可能包括通过促进私营部门与监管机构之间的沟通或加快代理商运营来加速监管部门的批准。如果相对于目标的紧迫性，认为风险被认为可以接受，则可能会完全暂停某些法规。协调员应识别可以并行而不是顺序发生的过程。领导者可以与行业合作，以便在最小的条件下进行操作，以确保工人和产品安全。
OWS团队与FDA合作压缩传统批准时间表by simultaneously running certain steps of the clinical trial process. This allowed manufacturers to begin工业规模的疫苗生产在充分展示功效和安全性之前。团队在完成与疫苗公司积极沟通的监管程序时不断将数据发送给FDA。直接的沟通线允许并行工作流，从而大大减少了正常疫苗批准时间表。
| 示例挑战：公共交通和州际铁路 |
| Much of the infrastructure across the United States needs expensive repairs, but the U.S. has some of the最高基础设施建设成本用于GDP和最长的施工时间。成本和时间的主要贡献者是批准过程，并提供了广泛的文档，例如准备环境影响研究以遵守《国家环境政策法》。像OWS一样的协调机构可以识别有资格获得支持的国家基础设施的关键部分，特别是对于近端的少数基础设施或主要的运输动脉。可以通过与运输部，环境保护署和州机构密切合作协调监管机构批准来减轻选定项目的监管负担。该计划将需要识别并为区分持续的法规和关键法规（例如结构性评论）来确定并设定一个先例，这些法规可以用作瓶颈。 |
机制3：激活劳动力和制造业的潜在私营部门能力
激活生产，供应链管理，部署基础设施和劳动力的私营部门能力。最大程度地减少物理基础设施要求，与现有基础设施的公司建立合同，并在必要时进行资金建设以扩展设施。与国务院协调加快签证批准外国人才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国防生产法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.
在OWS期间，陆军工程兵团监督建筑项目以扩大疫苗制造能力。加快签证批准带来了关键的技术人员和工程师，用于安装，测试和认证设备。16名国防部员工还在制造地点担任临时质量控制职位。该程序established partnerships制造商和政府之间的地址s 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当前的气候承诺并减少了整体碳排放，even when the vehicles are charged with energy from nonrenewable sources。Studies suggest that current public charging infrastructure has功能充电器太少满足目前在路上的电动汽车的需求。需要可靠且可用的公共充电器，以增加对电动汽车的公共信心，作为汽油汽车的实际替代者。利用潜在私营部门的能力可能包括扩大现有充电器制造商的运营，协调充电站的部署和安装以及必要的基础设施，以及建立熟练的劳动力以维修和维护这一新的基础设施。2023年2月拜登政府宣布的行动通过与15多家公司的合作伙伴关系来扩大充电器可用性。 |
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 ofdemand-pull mechanismsavailable to agencies are:
- Volume guarantees：承诺买方（即联邦机构）以固定价格从多家供应商那里购买最低数量的现有产品。
- Advance purchase agreements：建立单个买家与单个供应商之间的合同，在该供应商中，买方为制造产品或提供服务提供了预先资助的资金。
- 提前市场承诺：Engages multiple suppliers or producers to produce a product or service by providing advance funds.
- Prize competitions：从各种各样的演员，包括个人，公司，学术团队等方面的特定，定义明确的问题来开发创造性解决方案，并通过现金奖励奖励他们。
- 基于挑战的收购：Solicits creative solutions for a well-defined problem and rewards success by purchasing the solution.
- 里程碑付款：通过合同时间表提供一系列付款，以实现定义的目标。
美国卫生和公众服务部需求拉动型机制开发使用真空吸尘器cine candidates during OWS. This included funding large-scale manufacturing and committing to purchase successful vaccines.HHS made up to $483 millionin 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创建协议与其他制造商,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先进的市场承诺去除大碎屑物品。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商用轨道运输系统。 |
机制5：减少多样性和冗余的风险
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.
在OWS期间，四个疫苗平台技术被考虑用于开发：mRNA，复制缺陷的活载体，重组 - 亚基辅助蛋白，并减弱复制活载体。前两种从未在FDA许可的疫苗中使用，但显示出希望，而第二两个则在FDA许可的疫苗中建立。经过风险评估后，提出了使用四个平台中三个候选疫苗的候选者。冗余在两个维度中纳入了：三个不同的疫苗平台和两个独立的候选者。制造策略还包括冗余，因为授予了几家公司contractsto 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 |
| 从任建设基础设施来获取能源ewable 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 drivensignificant cost declines自1990年代介绍该技术以来。但是，在长时间存储能量时性能会下降，而临界矿物的提取仍然相对昂贵，并且harmful to the environment。锂离子电池的局限性可以通过投资几种有前途的替代电池技术，这些技术使用较便宜的材料，例如钠，硫和铁。这种投资组合方法将使竞争能够竞争，并增加至少一种选择成功的机会。 |
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.
致谢
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,1天早和进度研究所叙述OWS的成功并考虑该机制的未来应用。与会者包括原始OWS团队，代理商领导者，国会工作人员，研究人员和疫苗行业领导者的领导。感谢FAS高级研究员迈克尔·费舍尔（Michael A. Fisher），他在2023年1月之前为这份备忘录的制定做出了巨大贡献。感谢以下FAS员工的其他贡献：首席执行官Dan Correa；国防预算项目主任杰米·格雷贝尔（Jamie Graybeal）（截至2022年9月）；Sruthi Katakam，斯科维尔和平研究员；维杰·艾耶（Vijay Iyer），科学政策计划助理；凯·埃瑟里奇（Kai Etheridge），实习生（至2022年8月）。
OWS的方法不太可能成功，因为挑战过于广泛或政治上两极分化。例如，治愈癌症：虽然治愈非常紧迫，并且目标是统一，但存在太多的癌症变化，其中包括一些独特的研发挑战。气候变化是另一个例子：特定的气候挑战在政治上可能过时，无法激发所需的承诺。
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.
除了使用诸如利益相关者映射之类的流程外，领导团队还必须在问题领域中包括对关键利益相关者群体和现有权力动态非常熟悉的专家。问题空间包括受影响的公众；联邦机构和办公室；政府；州，地方，部落和领土政府；和私人合作伙伴。
OWSsocializedthe 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.
可能，但这可能需要在相关国家之间进行更多的协调和一致。这可能包括应用现有国际机构中的机制以实现现有目标。这些机制可能适用于修订，例如国家代表团和非政府组织之间的协调，激活非政府的能力，并创造地缘政治激励措施。
Theteam包括HHS秘书Alex Azar；国防部长马克·埃斯珀（Mark Esper）；Moncef Slaoui博士，前葛兰素史克疫苗的负责人；前美国陆军司令部总司令古斯塔夫·佩纳将军。这个核心团队将科学和技术专长与军事和后勤背景相结合。Slaoui博士对制药行业和疫苗开发过程的熟悉，使OWS可以为其工作开发现实的目标和基准。这种联系对于与疫苗公司建立强大的公私合作伙伴关系也至关重要。
这取决于挑战。确定用于特定项目的哪种机制需要深入了解特定的研发，制造，供应链景观，以诊断市场差距。例如，如果需要制造过程技术，则最有效的是奖品竞赛或基于挑战的收购。如果必须增加制造量，则可能会更合适的批量保证或提前购买协议。提前的市场承诺或里程碑付款可以激发行业提高效率。OWS结合了数量保证和提高市场承诺的结合，以资助候选疫苗的开发和确保供应。
太空经济是巨大的，但其最大的挑战之一是微小的：太空碎片。
The U.S. would need 65,000 miles of pipeline to achieve net-zero emissions by 2050. Here’s how the Biden Administration can expanding the use of low-emission, composite materials to support a net-zero vision.
氨基酸是必不可少的，但对于大规模生物生产而言是昂贵的投入。联邦资金可以激励可扩展的产量，将这些成本减少一半。
Investing in oxygen as a utility through on-demand infrastructure can improve access and mortality rates globally. Healthcare experts propose how an international coalition led by USAID can transform the medical oxygen marketplaces of low- and middle-income countries to ensure every patient has the oxygen they need.