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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Page 2
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 3
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 4
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 5
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 6
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 7
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 8
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 9
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 10
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 11
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 12
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 13
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 14
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×
Page 15
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Page 16

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Summary Influenza viruses have the potential to disrupt the health and well-being of populations around the world. The World Health Organization (WHO) estimates that, globally, there are approximately 1 billion cases, 3–5 mil- lion of those being severe, and 290,000–650,000 influenza-related deaths each year. Although most cases are mild, seasonal influenza causes a high burden of disease globally. In addition to the direct health effects, billions of dollars of economic loss are attributed to seasonal influenza every year. Influenza viruses are ubiquitous and have a high potential to mutate and reassort, resulting in severe seasonal outbreak risks or emergent pandemic virus strains. Public and global health experts have long warned of the risks of influenza and the need for preparedness, not only for seasonal virus strains, but also for those with pandemic potential. The world’s response to the COVID-19 pandemic and prior public health emergencies of international concern, such as severe acute respira- tory syndrome (SARS), influenza A (H1N1pdm09), and Ebola virus disease, illustrate the importance of global preparedness and coordination among governments, academia, scientists, policy makers, nongovernmental orga- nizations, the private sector, and the public to address the threat of pan- demic influenza. Addressing needs of low- and middle-income countries has been particularly challenging. These health emergencies have exposed gaps in pandemic preparedness and revealed opportunities to enhance global vaccine infrastructure, manufacturing, distribution, and administration, highlighting how vaccines and their subsequent distribution are critical to help save lives. 1

2 GLOBALLY RESILIENT SUPPLY CHAINS Considering these factors, the Office of Global Affairs (OGA) of the U.S. Department of Health and Human Services (HHS) requested the Na- tional Academies of Sciences, Engineering, and Medicine (the National Academies) to undertake a study to develop recommendations to bolster global vaccine manufacturing, distribution, and supply chains for future seasonal and pandemic influenza events. In response to the request, the Committee on Addressing Issues of Vaccine Distribution and Supply Chains to Advance Pandemic and Seasonal Influenza Preparedness and Response was formed in February 2021 to examine supply chain and distribution challenges related to vaccines and vaccinations during the COVID-19 re- sponse and explore its implications for pandemic and seasonal influenza. This committee is one of four commissioned by OGA regarding vaccines: the others are addressing vaccine research and development; public health interventions and countermeasures; and global coordination, partnerships, and financing as needed components to preparing for and responding to pandemic and seasonal influenza. Vaccine manufacturing and distribution requires timely access to hun- dreds of components and resources, some of which have limited availability, particularly during a pandemic. These critical components must be defined, identified, and tracked to ensure an uninterrupted, timely, and equitable vaccine distribution. A skilled and trained workforce is also essential to the manufacture, distribution, and administration of vaccines. The committee considered these issues from both a U.S. and a global perspective, though not on a country-by-country basis. KEY FINDINGS • Since global vaccine manufacturing requires timely access to hun- dreds of items, critical components must be defined, identified, and managed for seasonal and pandemic influenza to ensure unin- terrupted, timely, equitable vaccine supply dependent on varying requirements of different vaccine platforms. • A systems approach is needed to design and develop vaccines for feasible distribution and delivery in various global contexts. There are tradeoffs between vaccine design and speed of distribution, de- livery, and administration, particularly in a pandemic. Developers and manufacturers need to consider global mass-scale production, distribution (especially in low-resource settings), and reverse logis- tics (retrieval of supplies, including unused vaccines, to redistribute or dispose of) when developing vaccines, accounting for end-to-end supply chain needs. • Financial incentives for developing vaccines with high efficacy; long-lasting immunity; ease of manufacturing, distribution, and

SUMMARY 3 administration; and broad public acceptance will help increase the demand for influenza vaccines and improve the return on invest- ment for manufacturers. Without a high level of ongoing global demand, there is little incentive for manufacturers to develop im- proved vaccines and invest in manufacturing capacity. • Guidelines need to be streamlined through harmonization of or reliance on accepted steps in the regulatory pathway(s) for seasonal influenza vaccine, including its development, approval, and release; its demonstrated safety, efficacy, and quality; and its distribution for population-wide use. • A globally distributed network for influenza vaccine manufactur- ing, including mechanisms for sustained financing, is needed to ensure equitable access to vaccines for all. • Managing the complexities of an end-to-end global influenza vac- cine manufacturing supply network requires a global entity to coordinate actions of multiple stakeholders and ensure production and distribution of numerous inputs, equipment, resources, and infrastructure. • Countries need high-quality, robust, and actionable pandemic pre- paredness plans that are periodically updated. Given the potential of pandemics to cause widespread negative health and economic effects, multiple stakeholders—including global health agencies, multilateral development banks, development financial institutions, and private-sector entities—are needed to harmonize and collabo- rate on strategies that improve regional and country preparedness. Regional structures can assist in delivering technical assistance and improving coordination and engagement. • Countries need to have access to a balanced portfolio of influenza vaccines of various platforms and administration routes, where different vaccines can be selected for different country contexts. Portfolios need to be balanced considering the tradeoff between vaccine access and the complexity of distributing and administering multiple vaccines. Better data-driven tools for supply and demand planning at local, regional, and global levels are needed. CRITICAL COMPONENTS FOR VACCINE MANUFACTURING To produce a vaccine for mass distribution, manufacturers must pro- cure adequate supplies of more than 100 different critical components— glass vials, filters of various types, tubing, stabilizing agents, disposable bags, media, resins, and other supplies—that are produced by scores of different suppliers in dozens of countries. Should the supply or delivery of one of these components fall short of demand, the entire production of a

4 GLOBALLY RESILIENT SUPPLY CHAINS vaccine can grind to a halt. In addition, global vaccine manufacturing at scale requires a highly trained workforce, skilled in the exact procedures for ongoing manufacturing of a product for use in humans. Globally dis- tributed manufacturing bases to facilitate equitable access to vaccines are needed. Expanding manufacturing capacity could be applied to any part of the production process, from components to the finished vaccine. While the United States has the needed mechanisms to obtain these critical components, there is no functional, ready-made global mechanism to define, identify, and appropriately track the availability of critical com- ponents to manufacture seasonal or pandemic influenza vaccines. Several global entities have either the authority or convening power to create such globally coordinated mechanisms, but without national and global iden- tification, forecasting, and tracking mechanisms for critical components during periods of surge demand (i.e., regional or global influenza outbreaks, epidemics, or pandemics), vaccine manufacturing to meet global needs is at high risk.  To have a meaningful public health impact during a pandemic, critical components for influenza vaccine production, including a skilled workforce and workforce trainers, need to be mobilized nearly instantly. Training for current on-site manufacturing personnel and an on-demand “reserve corps” to fill any critical workforce gaps during a pandemic is a key component to scaling up and scaling out influenza vaccine manufacturing. A standing reserve corps—composed of highly trained and experienced experts in tech- nology transfer chemistry, manufacturing, and controls, as well as quality control and assurance specialists—that can be deployed immediately will help vaccine manufacturers meet demand during a pandemic influenza response. The committee concludes that global supply and equitable access to pandemic influenza vaccines will remain uncertain and at highest risk with- out globally and regionally distributed vaccine manufacturing networks. A well-coordinated global body with an inclusive governance structure could orchestrate a globally distributed supply chain to produce influenza vaccine. The international entity with the appropriate reach to address this issue is the G20, an intergovernmental forum composed of 19 countries and the European Union. RECOMMENDATION 3-1: The G20 should constitute a Global Pan- demic Manufacturing and Supply Chain Task Force as a permanent structure, governed by a globally inclusive body, with technical respon- sibilities to ensure global pandemic influenza manufacturing and supply chain preparedness and response. The task force governance should be designed to bring together relevant U.S. and international governmen- tal agencies; industry associations, such as the International Federation of Pharmaceutical Manufacturers & Associations and the Developing

SUMMARY 5 Countries Vaccine Manufacturers Network; private philanthropic orga- nizations; and international nongovernmental organizations. RECOMMENDATION 3-1(a): The G20 should commission an inde- pendent panel of manufacturing and supply chain experts to conduct a review of the technical capabilities and governance structure of the COVAX Manufacturing Task Force to extract lessons learned, assess its suitability for pandemic influenza, and inform the design of the structure, management, and governance of the committee’s recom- mended task force. RECOMMENDATION 3-1(b): U.S. government entities, including the U.S. Department of Health and Human Services and its agencies (such as the U.S. Food and Drug Administration, the Biomedical Advanced Research and Development Authority, and the Centers for Disease Con- trol and Prevention), the U.S. Trade Representative, the U.S. Depart- ment of Commerce, the U.S. Agency for International Development, and others should work collaboratively with the committee’s recom- mended task force in specific areas and, as identified in this report, take a global leadership role in activities under the task force. RECOMMENDATION 3-2: The Office of the Secretary of the U.S. Department of Health and Human Services (HHS) and its technical agencies (including the Office of Global Affairs, the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority), in collaboration with appropriate global technical counterparts, should provide technical and resourcing sup- port to the committee’s recommended task force (see Recommendation 3-1) to develop a comprehensive pandemic preparedness and response capability framework that consists of three elements: • End-to-end visibility of critical inputs: in collaboration with the World Trade Organization, the Coalition for Epidemic Preparedness Innovations, the Developing Countries Vaccine Manufacturers Network, and the International Federation of Pharmaceutical Manufacturers & Associations, evaluate a means to define, identify, and track (e.g., through barcodes and block- chain technologies) the global real-time availability of potentially supply-constrained critical inputs necessary to manufacture vac- cines for pandemic influenza, known as the essential global com- mons list for pandemic influenza vaccine manufacturing. • Resiliency assessment and analysis: in collaboration with other U.S. agencies (including the Office of Science and Technology Policy, the U.S. Trade Representative, and the U.S. Agency for

6 GLOBALLY RESILIENT SUPPLY CHAINS International Development) provide technical and resourcing support for the committee’s recommended task force to fore- cast supply and demand of critical inputs, including workforce personnel and training needs for pandemic influenza vaccine manufacturing, and perform a resiliency assessment of the cur- rent end-to-end network to identify vulnerabilities in physical inputs, as well workforce gaps, that may impede pandemic influenza vaccine manufacturing. • Preparedness, response, and global coordination: working with the U.S. Department of State, coordinate efforts both within HHS and across other U.S. government entities to provide tech- nical and resourcing support to the committee’s recommended task force to develop technical capabilities to ensure sourcing, production, distribution, risk management, and coordination of critical components necessary for manufacturing seasonal and pandemic influenza vaccines, including capabilities to ensure globally effective preparedness and response. RECOMMENDATION 3-3: The U.S. Food and Drug Administra- tion and the regulatory arm of the World Health Organization (WHO) should evaluate the development of fast turnaround batch release (in- cluding potency and stability-indicating) assays for seasonal and pan- demic influenza vaccine manufacturing and ready global access to international reference standards and benchmark comparators (e.g., immunological reagents) for use in product analytics and clinical trials. The WHO Collaborating Centres for Influenza should facilitate the development of internationally harmonized and prioritized assays ac- ceptable to regulatory bodies. A long-term goal should be set to achieve global regulatory harmonization and convergence of the analytical standards and assays, in partnership with the International Coalition of Medicines Regulatory Authorities. RECOMMENDATION 3-4: Improving vaccine manufacturing work- force development and capacity should be prioritized by relevant global stakeholders: • Government agencies, commercial entities, nongovernmental organizations, and academic institutions with the requisite knowledge and skill sets should partner with advanced and developing vaccine manufacturers to develop vaccine manufac- turing and development technology hubs. • The U.S. Department of Health and Human Services and its technical agencies, including the Office of Global Affairs, with nongovernmental partners, such as PATH, should develop and

SUMMARY 7 implement a medical countermeasure “university” for training a vaccine manufacturing and delivery critical workforce. RECOMMENDATION 3-5: The Office of Global Affairs, in coordi- nation with other U.S. interagency stakeholders and working closely with global agencies, such as the World Health Organization, should provide technical and resourcing support to the committee’s recom- mended task force to evaluate the feasibility, structure, and sustain- ability of a globally distributed network of regional and local vaccine manufacturing capacity. DISTRIBUTION AND DELIVERY Getting vaccines into people’s arms requires carefully orchestrated global and in-country logistics. Poorly managed logistics systems can dis- rupt vaccination campaigns, lead to shortages of immunization-related supplies, and cause the overstocking of influenza vaccine, all of which can increase vaccination program costs. Transport capacity and cold chain con- siderations are primary logistical constraints in transporting vaccines from manufacturers to recipient countries and their populations. Data are critical to establishing and maintaining a well-managed influenza vaccine logistics system, but existing tools are often limited. Few countries and regions have systems in place that provide data on how many vaccine doses have been administered and where, as well as data on inventories. Effective and efficient global vaccines distribution in a pandemic relies on the existence, coordination, and successful operation of a collection of robust and responsive systems reporting real-time information. These systems include physical infrastructure for transportation, storage, distri- bution, and delivery to individuals. They also include systems that help to coordinate demand and delivery of products, as well as information on populations, vaccine coverage, safety, and effectiveness. These systems need to exist at global, regional, country, and local levels to deliver the right amount of vaccine, to the right place, at the right time, and to the right person. Vaccines designed to incorporate operational characteristics and pro- grammatic considerations improve distribution delivery efficacy, as well as vaccine acceptance by the public. Fewer doses and needle-free administra- tion may facilitate distribution and is often preferable for vaccine recipients. Countries need access to a broad portfolio of vaccines to adopt those best suited for their populations and distribution infrastructure. At the same time, focusing on simplifying logistics, improving equitable access, increas- ing immunization, and facilitating outreach is necessary to inform future pandemic preparedness and response.

8 GLOBALLY RESILIENT SUPPLY CHAINS Demand forecasting—both aggregate and disaggregate—remains a challenge for many, if not most, countries. Multiple factors affect vaccine uptake, including access, hesitancy, supply availability, and prior experience within health systems. Understanding the challenges in achieving equitable and timely coverage as well is important so that best practices can be shared. RECOMMENDATION 4-1: The U.S. Department of Health and Hu- man Services (HHS), in partnership with its counterparts in other countries and relevant global stakeholders and funders, should ensure a systems approach to the design and development of vaccines for fea- sible distribution and delivery in various global contexts and support relevant innovations. RECOMMENDATION 4-1(a): HHS, its global counterparts, and rele- vant global funders and stakeholders should encourage attention to op- erational considerations up-front when funding vaccine development. RECOMMENDATION 4-1(b): The U.S. Food and Drug Administra- tion (FDA), along with the World Health Organization (WHO), should encourage manufacturers to consider including WHO’s preferred char- acteristics in their submissions for clinical trials. The National Institutes of Health (NIH) should prioritize including these preferred character- istics in its influenza vaccine research program. RECOMMENDATION 4-1(c): HHS offices and relevant agencies, in- cluding the Assistant Secretary for Preparedness and Response and NIH, should make sustained global investments in novel vaccine end- to-end technologies, including stabilization and delivery platforms, that will improve equitable access and adaptation for vaccines to be used in various temperature settings. RECOMMENDATION 4-1(d): WHO and FDA, after issuance of a WHO emergency use listing procedure or an FDA Emergency Use Au- thorization, should require digital packaging labels during a pandemic so that changes in vaccine stability and shelf life can be immediately understood and easily accessed by end users. These labels could also serve as a verification mechanism against counterfeit vaccines. RECOMMENDATION 4-2: The World Health Organization, its part- ners, and its funders should facilitate a global vaccine portfolio rollout to ensure the development and access to a broad portfolio of influenza vaccines.

SUMMARY 9 RECOMMENDATION 4-3: The Centers for Disease Control and Pre- vention should work with the World Health Organization, Gavi, and global counterparts to commission studies in demand forecasting and demand uptake. The National Vaccine Advisory Committee should be augmented to engage in this task. RECOMMENDATION 4-4: The Centers for Disease Control and Prevention and the National Institutes of Health should support the development of better models for influenza vaccine cost-effectiveness. The U.S. Agency for International Development should support techni- cal assistance to strengthen country systems for vaccine uptake. RECOMMENDATION 4-5: The Office of Global Affairs, in partner- ship with the World Health Organization, Gavi, the United Nations Children’s Fund, and relevant global funders, should facilitate the de- velopment of global tools to help countries with better supply planning for vaccines and ancillary supplies planning, allocation, and rollout decisions, and with obtaining necessary funding for operations. FRAMEWORKS, TOOLS, AND INNOVATIONS FOR DISTRIBUTION READINESS Vaccine distribution requires preparedness on global, national, and local levels. Currently, readiness frameworks either do not exist or need im- provement in many countries. COVID-19 underscored a lack of adherence to existing national deployment and vaccination plans, and these frame- works were ill-suited to adapt for mass vaccination or to target specific groups. Engaging the private sector for planning could advance pandemic preparedness, as industries have the expertise and resources for the scale-up needed in a pandemic. Once vaccines are allocated to countries, national governments are responsible for in-country allocation, distribution, and administration. For such efforts, various tools are needed to help countries deploy new vaccines, assess country-specific vaccination campaigns, and use the vaccines received efficiently. Overall, national preparedness and deployment plans are not properly funded. Accurate costing of vaccine delivery plans would allow countries to address planning and distribution challenges.  In response to the COVID-19 pandemic, international organizations supported countries in preparing and deploying new vaccines. Because both the data systems and immunization strategies were new, the data collected has been of low quality: the tools do not collect data on a sufficiently granu- lar level to appropriately assess localized contexts. Country preparedness plan development rarely occurs at the subnational level, and data from

10 GLOBALLY RESILIENT SUPPLY CHAINS service delivery sites is often not reported in a timely manner, making the development of more localized plans challenging. Multiple innovations from vaccine development, including regulatory approvals, scaled manufacturing, and global distribution have helped bring COVID-19 vaccines to large segments of the global population. While there have been many successes, there also have been significant gaps in vaccine equity. A comprehensive review of COVID-19 response to identify lessons learned and gaps to be filled will be essential for future pandemics. RECOMMENDATION 5-1: The Office of Global Affairs, with other agencies in the U.S. Department of Health and Human Services and with the Expert Committee on Influenza of the World Health Organiza- tion, along with other global stakeholders, should periodically convene to identify the challenges in global preparedness for influenza, as well as overall preparedness for emerging pathogens, benefiting from the lessons learned from recent disease outbreaks to address global supply challenges, and support cold chain infrastructure needs across the tem- perature spectrum, as well as to plan mock drills and tabletop exercises to test these systems. The outcome of these meetings should inform national authorities on approaches and best practices to prepare and periodically update their national preparedness plans, with technical support from different agencies, so that the resulting plans are high quality, granular, relevant, and actionable. National authorities should be encouraged to engage with the private sector for pandemic prepared- ness and response. RECOMMENDATION 5-2: The World Health Organization, the Co- alition for Epidemic Preparedness Innovations, the United Nations Children’s Fund, and Gavi, along with other stakeholders and key re- gional structures, using lessons learned from the rollout of COVID-19 vaccines, should review, update, adapt, and harmonize all developed and innovative COVID-19 vaccine access tools to improve future influ- enza outbreak responses. Appropriate training curricula and tools that emphasize systems thinking and medical logistics should be included. RECOMMENDATION 5-3: The World Health Organization, working with relevant partners, such as the Coalition for Epidemic Preparedness Innovations, the United Nations Children’s Fund, and Gavi, should support the development of a global influenza vaccine supply and demand planning tool. The tool should be linked or aligned to allow real-time consolidation of relevant global data to inform manufacturing and accuracy of supply and demand status to better inform allocation and avoid wastage.

SUMMARY 11 RECOMMENDATION 5-4: An independent convening group (such as Chatham House, The Rockefeller Foundation, or The Aspen Institute) should convene a workshop for global health technical agencies—in- cluding the World Health Organization, the Coalition for Epidemic Preparedness Innovations, the United Nations Children’s Fund, and Gavi; international financial institutions, such as the World Bank and the International Monetary Fund; other development financial institu- tions; and regional organizations, such as the African Union and the Pan American Health Organization—to share updates from evaluating the tools used to respond to the COVID-19 vaccine rollout, identify current capabilities, constraints, and gaps, and aim to harmonize coun- try assessment methodologies relevant for different stakeholders. RECOMMENDATION 5-5: The United States and international agen- cies should develop mechanisms to evaluate pandemic preparedness plans and financing mechanisms to support their development, while incentivizing country compliance. Specifically: • The U.S. Congress should authorize government agencies and programs, such as the U.S. Agency for International Development and the President’s Emergency Plan for AIDS Relief, to include pandemic preparedness as an input into coun- try funding proposals for various health programs and provide financial support and technical assistance if deficiencies in pan- demic preparedness plans are uncovered. • Global institutions, including G20, the World Bank, the International Monetary Fund, and the International Finance Corporation, and regional multilateral development banks should integrate country preparedness assessments into their country economic assistance programs, such as development assistance, loans, and grants, and they should advocate for financial support. They should also identify gaps in country preparedness and develop and evaluate pandemic preparedness and response plans. RECOMMENDATION 5-6: The United States and international agen- cies (including the World Health Organization, the World Bank, and the International Monetary Fund), along with regional bodies (such as the Africa Centres for Disease Control and Prevention and the Pan American Health Organization), should support the development of regional structures with appropriate expertise to assist countries in the region to develop pandemic preparedness plans and ensure plan quality and compliance.

12 GLOBALLY RESILIENT SUPPLY CHAINS RECOMMENDATION 5-7: The G20 should ensure up-front regional engagement in a future organizational structure for the financing, pro- curement, and deployment of pandemic vaccines to ensure the inclusion of access to vaccines for their regions. RECOMMENDATION 5-8: The U.S. Department of Health and Hu- man Services should fund a comprehensive review of innovations devel- oped and deployed during the COVID-19 pandemic, carried out by an independent scientific body. The review should cover such critical areas as regulatory approval, manufacturing, global and in-country distribu- tion, delivery, and lessons learned, and it should identify innovation gaps for future pandemic preparedness and response. BARRIERS, INCENTIVES, AND INNOVATIONS FOR SUSTAINABLE MANUFACTURING The global effort to produce COVID-19 vaccines highlighted pertinent issues to sustainable manufacturing for seasonal and pandemic influenza vaccines. Rapid vaccine development led to discussions of tradeoffs in manufacturing during a pandemic with high morbidity and mortality rates: those tradeoffs involve speed, quality, safety, and transparency of the clini- cal development process. Platforms that are widespread and easy to use, such as egg-based technologies, tend to be slow and produce vaccines with lower efficacy. However, as this is the most common, globally established influenza vaccine manufacturing platform, it may also be the most reliable platform to address an influenza threat in the foreseeable future. While platforms such as mRNA have the potential to be faster than egg-based vaccines, more time is needed to fully assess the technology. In addition, mRNA vaccines have higher costs and complexities that prohibit affordable and feasible implementation in all contexts. The barriers that hinder the rapid development of novel vaccines in- clude slow and disjointed regulatory review, high risks, uncertainties, and significant legal liabilities with vaccine production for manufacturers, es- pecially for novel platforms. Because seasonal influenza vaccines have low uptake in most countries and generate relatively low rates of return on investment, especially in low- and middle-income countries, manufacturers lack significant incentives to innovate. Even in countries that have sustainable manufacturing using existing platforms, shifting to novel platforms may not be the most efficient use of resources. However, when developing manufacturing capacity in countries or regions where it does not already exist, using other vaccine platform technologies (e.g., cell-based, mRNA, or plant-based), dose-sparing ap- proaches (e.g., use of adjuvants), and alternative routes of administra-

SUMMARY 13 tion (e.g., self-administered skin patches or oral delivery) may be better. Public-sector investments are needed to ensure that novel and alternative technologies are developed for influenza pandemic responses. However, it is important to ensure that manufacturers that receive public funding will deploy their expertise during a pandemic. Mechanisms such as harmoni- zation and reliance can streamline guidelines and are critical for seasonal influenza vaccine development, demonstration of its safety and efficacy, and scale-up of manufacturing for population-based use. Similarly, global agreement requirements to release pandemic influenza vaccine is needed before an outbreak begins. Information from vaccine clinical trials needs to be entered into a readily available registry and protocols need to be made available. Expe- dited but stringent regulatory inspection and audit processes, in addition to existing national regulatory authorities for ensuring safety, efficacy, and manufacturing quality, are needed during a pandemic. This need requires creation of a new global entity of international manufacturing experts to conduct inspections. Additionally, manufactured vaccines purchased by countries need to be approved under WHO’s emergency use listing or have undergone its prequalification process to ensure quality of production at all sites. RECOMMENDATION 6-1: The World Health Organization, in col- laboration with the Coalition for Epidemic Preparedness Innovations, PATH, the U.S. Food and Drug Administration, and the Biomedical Advanced Research and Development Authority, should conduct a comparative assessment of all available and potential manufacturing technologies for influenza vaccines. Metrics for assessment should in- clude speed, complexity, scalability, flexibility to address alternative diseases, efficiency, and potential for mass production. The assessment should inform a decision-making framework for future investments that recognizes the dynamically evolving nature of technologies and tradeoffs for different platforms. RECOMMENDATION 6-2: Public funders of vaccine development for influenza viruses of pandemic potential, including the U.S. Depart- ment of Health and Human Services, should ensure that contracts and awards to biotechnology innovator grantees stipulate, in detail, their proposed mechanism to scale up production, which could include part- nership with a large proven and experienced vaccine development and manufacturing company. RECOMMENDATION 6-3(a): The G20 should provide substantial monetary and other incentives—such as intellectual property volun-

14 GLOBALLY RESILIENT SUPPLY CHAINS tary licensing, advanced market commitments, and priority review vouchers—administered through a future structure for financing, procurement, and deployment for pandemic vaccines, to develop im- proved seasonal and pandemic influenza vaccines that would increase uptake and demand, leading to sustainable manufacturing capacity investments. These incentive mechanisms should set clear expecta- tions of manufacturers to leverage their innovations to respond during pandemics. RECOMMENDATION 6-3(b): The U.S. International Development Finance Corporation and the U.S. Agency for International Develop- ment should provide concessional capital and technical assistance to manufacturers in developing countries to begin producing improved seasonal and pandemic influenza vaccines. RECOMMENDATION 6-4: The World Bank should develop a global indemnification mechanism that can be applied to all vaccines with World Health Organization emergency use listing or prequalification, regardless of the mechanism (pooled or bilateral) or financing used to procure the vaccines. RECOMMENDATION 6-5(a): The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration should investigate the barriers to public transparency of vaccine clinical trial protocols during a public health emergency and evaluate measures, including legislation, to remove these barriers. RECOMMENDATION 6-5(b): The World Health Organization should support an independent after-action review of its emergency use list- ing procedures, including learning from the COVID-19 experience, to make recommendations regarding appropriate process structure, staff- ing, and resourcing for surge capacity needed for expedited reviews during a future pandemic. RECOMMENDATION 6-5(c): The U.S. Department of Health and Human Services, along with the World Health Organization, should support the creation of a network of inspectors to conduct rapid inspec- tions of vaccine manufacturing plants during a pandemic to ensure vac- cine quality, which may include providers of assays, technical experts, and lot comparability in secondary manufacturing sites. RECOMMENDATION 6-5(d): The World Health Organization (WHO) should prioritize efforts for the creation of a treaty mechanism

SUMMARY 15 for pandemic influenza vaccine manufacturing countries whereby they agree to undergo plant inspections by independent inspectors and only export vaccines that are approved through WHO’s emergency use list- ing procedures or prequalification program.

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Influenza viruses, both seasonal and pandemic, have the potential to disrupt the health and well-being of populations around the world. The global response to the COVID-19 pandemic and prior public health emergencies of international concern illustrate the importance of global preparedness and coordination among governments, academia, scientists, policy makers, nongovernmental organizations, the private sector, and the public to address the threat of pandemic influenza. These health emergencies have revealed opportunities to enhance global vaccine infrastructure, manufacturing, distribution, and administration.

Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines outlines key findings and recommendations to bolster vaccine distribution, manufacturing, and supply chains for future seasonal and pandemic influenza events. This report addresses the challenges of manufacturing and distributing vaccines for both seasonal and pandemic influenza, highlighting the critical components of vaccine manufacturing and distribution and offering recommendations that would address gaps in the current global vaccine infrastructure.

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