5

Frameworks, Tools, and Innovations for Distribution Readiness

Vaccine distribution requires preparedness on global, national, and local levels. Once vaccines are allocated to countries, national governments are responsible for in-country allocation, distribution, and administration. As a result, there is a need for various tools to help countries plan and deploy new vaccines and assess country-specific readiness to conduct a successful vaccination campaign and efficiently use the vaccines received. Each of the tools available to assess country preparedness has strengths and weaknesses in design and application.

The chapter presents the committee’s review and analysis of several major country assessment tools relevant to pandemic preparedness, including those that evolved from the COVID-19 response. We first review three initiatives: the Immunization Agenda 2030; ACT-Accelerator and COVAX, which was launched in 2020;¹ and national immunization technical advisory groups. We then discuss tools and frameworks for global vaccination, tools for country preparedness, and our overall assessment.

Table 5-1 summarizes the recommendations in this chapter, delineated by the U.S. and regional or global actors identified for their implementation.

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¹ ACT-Accelerator is the short name for the Access to COVID-19 Tools Accelerator, which in turn is known as ACT-A. COVAX is the acronym for COVID-19 Vaccines Global Access; for details, see fn. 9 in Chapter 2.

TABLE 5-1 Summary of Recommendations and Relevant Actors on Frameworks, Tools, and Innovations for Distribution Readiness

INITIATIVES

Immunization Agenda 2030

Developing targets for global immunization coverage is critical to advancing health goals. The Global Vaccine Action Plan (GVAP), in effect from 2011 to 2020, was a framework by the World Health Organization (WHO) intended to increase vaccine accessibility, particularly for novel vaccine introduction (WHO, 2013). GVAP called for renewed focus on supply chain and logistics management, including improvement of cold chain capacity, minimizing waste, and establishing information systems to track

vaccine supply. It also promoted sustainable financing for supply, working to increase support from global donors and improve vaccine markets (WHO, 2013, 2019). GVAP incorporated preexisting goals established by the World Health Assembly, such as eradicating polio and eliminating measles and tetanus in high-risk regions (WHO, 2013). In addition, this framework aimed to reduce inequalities in vaccine coverage on the basis of age, gender, disability, and geographic location. Despite progress in expanding immunization coverage, GVAP failed to meet its targets by 2020. Measles cases, while they initially decreased, rebounded in all WHO regions, and coverage for vaccines, such as three doses of diphtheria-tetanus-pertussis, has plateaued (WHO, 2021c).

In response to the need for continued improved immunization coverage, the Immunization Agenda 2030 (IA2030) was established in 2020. This framework, initially led by WHO, was co-developed by stakeholders, including member states and immunization entities (WHO, 2020c). The IA2030 framework is founded on the vision of maximizing global benefits from vaccination and sets a more ambitious global vision and strategy for vaccines and immunization for the decade 2021–2030 than did GVAP. IA2030 focuses on “immunization programs,” which is a more comprehensive term than the commonly used “routine immunizations.” Unlike routine immunization platforms, the concept of an immunization program includes “catch-up” vaccinations and accounts for variability in the intensity of vaccination efforts over time. IA2030 continues supporting GVAP initiatives while building on them (WHO, 2020c).

IA2030 is composed of four primary operational elements: technical planning for regional and national strategies, mechanisms to ensure ownership and accountability, a monitoring and evaluation framework, and a communication and advocacy strategy. It has three primary goals: “1) reduce morbidity and mortality from vaccine-preventable diseases, 2) increas[e] equitable access and use of new and existing vaccines, and 3) strengthen immunisation within primary health care and contribut[e] to universal health coverage” (WHO, 2020c, p. 4). IA2030 follows a global-level partnership model for the operational elements. Operational planning, monitoring and evaluation, and ownership and accountability will each be conducted at country, regional, and global levels. Learnings and assessments from each level will inform other levels and elements. These assessments will be collectively assessed to inform strategies for communications and advocacy (WHO, 2020c).

The new IA2030 program shows promise for advancing immunization coverage and filling in gaps remaining from previous frameworks. The focus on coordination among stakeholders from country to global levels provides an advanced model for reaching global health goals that are fitted to regional contexts. In addition, the focus on pandemic preparedness

and response provides a good platform to build upon and support this vision and framework. IA2030 is focusing its efforts initially on responding to COVID-19 and prioritizes equitable global distribution of vaccines to meet this need. IA2030 meets a significant challenge as it launches during COVID-19, but it represents an advancement in planning for collaborative vaccine access, especially as it focuses on country ownership and equity. It is important to ensure that lessons learned from COVID-19 vaccine deployment and response are captured to inform and strengthen equitable immunization programs and highlight the need for global immunization coordination in response to pandemics.

ACT-Accelerator and COVAX

In anticipation of a need for equitable global distribution of COVID-19 vaccines, ACT-Accelerator (ACT-A) was launched in April 2020. Through a consortium of global partners that includes Gavi, The Vaccine Alliance, UNICEF, and WHO, ACT-A is composed of three pillars (vaccines, diagnostics, and therapeutics) and a health systems connector. COVAX, the vaccine pillar of ACT-A, was designed to procure and distribute vaccine doses to countries that may not otherwise be able to access them (WHO, 2020a). COVAX engaged every country and economy to establish agreements for more than 1.4 billion doses of various COVID-19 vaccines for global distribution in 2021 (WHO, 2021f). In addition, COVAX facilitated the adoption of global tools and electronic logistics information systems to accommodate COVID-19 vaccines and related commodities (WHO, 2021b). This multilateral vaccine procurement mechanism was established with intent to provide equitable and timely global access to COVID-19 vaccines that meet international standards for safety and efficacy. COVAX represents the most significant effort to date for global vaccine allocation and procurement for a pandemic event (Usher, 2021).

While ACT-A was able to establish a successful platform in many respects, the fact that it was created reactively after the emergence of COVID-19 is reflected in its shortcomings. Not all pillars of the initiative have been equally successful, and a coherent, strategic, inclusive, and fully funded framework has not yet been achieved (Usher, 2021). Despite significant global investment, there is a remaining funding deficit of $16.8 billion in 2021 (WHO, 2021a). ACT-A is seen by some countries and civic organizations as supply driven and not sufficiently inclusive, with large donor countries and institutions having an asymmetrical influence on decision making (Usher, 2021). COVAX was initially intended to be a mechanism that procured vaccines through self-financing and providing financial aid. However, high-income nations engaged in bilateral deals

directly with manufacturers to secure doses of vaccine early in the process, leaving fewer vaccines for distribution in low- and middle-income countries (LMICs) (Phelan et al., 2020). As a result, vaccine distribution has been less equitable, and vaccine rollout occurred in two different ways. Countries that procured their own vaccines, primarily high-income countries, had experience with in-country vaccine distribution and used their own tools for logistical considerations. Despite these systems, however, these countries still experienced challenges with distribution for mass vaccination at the scale needed for COVID-19. LMICs, in contrast, have historically been supported by international actors and the United Nations, which have managed and produced the tools used for distribution. As noted above, COVAX anticipates that it will have procured 1.4 billion vaccine doses by the end of 2021 (WHO, 2021f), although this is less than the initial goal of 2.2 billion delivered doses (Berkley, 2021). Achieving further vaccination coverage will require additional financial support and dose sharing from countries that have already advanced vaccination programs (Hatchett et al., 2021). Despite the challenges, COVAX marks a significant effort toward achieving vaccine equity (Berkley, 2021).

An established system to accelerate vaccine research and development and achieve equitable access is vital to pandemic response and the delivery of essential supplies. ACT-A provides a valuable model. Lessons drawn from both its strengths and weaknesses can guide the establishment of a permanent platform that can stand in readiness for any future pandemic. The committee believes that a comprehensive review of the achievements, financing, and governance of ACT-A would be a valuable step to develop a more robust and fit mechanism for an extended purpose. Issues that need to be addressed include access, equity, and allocation, in addition to a shortage in operational funding for supporting extra cold chain capacity, vaccine rollout, and associated supplies.

The COVAX framework can be further improved to develop a more sustainable model for equitable vaccine allocation. COVAX was developed rapidly in response to the COVID-19 pandemic. Bolstering a preparedness structure during a non-pandemic period could allow systems to be strengthened to better address future threats, establishing a system that is proactive rather than reactive. Ongoing activity could allow it to establish a more stable financing mechanism. Establishment of a more permanent entity could therefore address some shortcomings of ACT-A and facilitate the long-term stability of COVAX. The findings of this committee corroborate those of the 2021 report of Independent Panel for Pandemic Preparedness and Response (IPPPR), which outlined several recommendations and “lessons learned” from COVID-19. Based on extensive review of literature and interviews with stakeholders, the IPPPR report highlights

the ACT-A funding gap, calling on G7 countries² to supply 60 percent of the remaining funds needed. IPPPR also calls on high-income countries to support COVAX with additional doses, acknowledging that equitable vaccine access is a primary means of protecting against further pandemic spread (IPPPR, 2021).

National Immunization Technical Advisory Groups

In order to implement successful vaccination campaigns, countries are encouraged to develop a national immunization technical advisory group (NITAG) to guide policy development. NITAGs are composed of “multidisciplinary national experts who provide independent, evidence-informed vaccine policy recommendations to national health authorities” (Ba-Nguz et al., 2019). Their role is to set the vaccination strategy, introduce new vaccines, and manage operational costs. While high-income countries have significant experience in developing these strategies, many LMICs require additional support. To guide NITAG development, WHO has developed indicators to assess NITAG functionality and identify areas of needed support. In addition, WHO has developed a self-assessment tool for a country to use to determine performance in data review and other technical capacities (Ba-Nguz et al., 2019). Recognizing the global importance of influenza vaccination, the Partnership for Influenza Vaccine Introduction (PIVI) was formed in 2013. This public–private partnership supports NITAGs in strengthening policy review to establish an evidence base for influenza vaccine introduction. From 2013 to 2018, PIVI partnered with 17 countries, leading to sustained and increased support for influenza vaccine introduction. An increase in influenza vaccination in these countries suggests PIVI as a suitable model for building country-level self-reliance in building influenza vaccination coverage (Bresee et al., 2019).

Overall, NITAGs are successful in developing technical assistance and building capacity for preparedness in partner countries. However, NITAGs need to promote sustainability of vaccination programs to a greater degree and build capacity for vaccines that are approved for emergency use. There are still gaps with insufficient funding for NITAGs and limited access to external technical resources (Ba-Nguz et al., 2019). WHO, the Centers for Disease Control and Prevention, and other entities have provided technical assistance to NITAGs by supporting research studies to establish an evidence base for decision making. NITAGs also receive technical support in establishing policy and initiating programs (Ba-Nguz et al., 2019). How-

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² The Group of Seven is an intergovernmental political forum of Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States.

ever, remaining gaps reveal that the approach to technical support often focuses on individual issues, rather than addressing the system as a whole.

The committee agrees that technical support should ensure a systems approach. Such an approach includes supporting medical logistics and workforce training to ensure that essential components of the supply chain are not being developed in silos, but can be connected together. Although NITAGs are recommended to contain an array of professional expertise (Duclos, 2010), they primarily have expertise with pediatrics. Previous studies suggest that successful childhood vaccination programs do not necessarily translate to programs for adults. In 2016, WHO adopted the joint external evaluation tool to support countries in the endeavor to identify existing gaps in their health systems and preparedness (Bell et al., 2017; WHO, 2018a). This tool uses traditional indicators of vaccination coverage, which are generally reflective of pediatric immunization. Although it provides valuable insight and encourages collaborative assessment, shortcomings have been revealed by implementation in emergency scenarios. Recent studies have shown that there is no correlation between scores on the joint external evaluation tool and readiness to deploy COVID-19 vaccine. Therefore, strong pediatric immunization programs may not be a reliable indicator for proficient vaccination among adults or in emergency situations (World Bank, 2021b). Significant investment needs to be directed at expanding the scope of expertise within NITAGs for general immunization programs.

A lack of functional expertise is another challenge that many NITAGs face. Not all are efficient, which can be due to a lack of access to data for producing evidence-based practice. NITAGs in different regions may have similar needs for data, especially at a larger scale (Ba-Nguz et al., 2019). However, because they operate independently, efforts to conduct analyses are likely duplicative. Creating regional NITAGs could facilitate harmonization of data analysis efforts and limit redundant efforts, saving time and resources for country-specific activities. The committee considered options for expanding the scope of NITAGs beyond pediatric vaccines by either creating a parallel immunization plan or expanding current platforms. Developing an entirely new platform would require significant expenditure, so using existing NITAG platforms would likely be more sustainable and cost-effective. These existing platforms can provide a basis for vaccination, but reaching all populations in LMICs remains challenging.

Pandemics require a significant diversion of resources, including workforce and supply chain capacity, leaving non-pandemic routine and emergency health services vulnerable (Bell et al., 2017; World Bank, 2021b). Overall, NITAGs are a key partner for country implementation of the IA2030 agenda and can be strengthened by integrating technical expertise and methodologies to support the growing demand of response to pandemics.

TOOLS AND FRAMEWORKS FOR GLOBAL VACCINATION

The WHO emergency use listing procedure is a special procedure for unlicensed vaccines, therapeutics, and diagnostic tools to be assessed and made publicly available in the event of a public health emergency. Manufacturers submit products for this approval to WHO regulatory authorities; the products can be approved after meeting criteria based on evidence of safety and efficacy. In order to be considered for this listing, the products must be developed for an immediate and life-threatening emergency for which no existing product is available (WHO, 2021e). This process assists UN procurement agencies and member states in determining the acceptability of using specific products based on an essential, available set of quality, safety, efficacy, and performance data. Emergency approvals from other stringent regulatory standards, such as an Emergency Use Authorization from the U.S. Food and Drug Administration, can be recognized by WHO, facilitating expedited emergency listing approval (WHO, 2020b). Recently, these approvals have been applied to vaccines for Ebola and COVID-19, resulting in global availability of vaccines before the process for full authorization has been completed.

This entire procedure has improved greatly in recent years to expedite vaccine approvals and distribution (CEPI, 2021; WHO, 2021e). While succeeding in making needed products available, WHO’s emergency use listings can only be activated during an outbreak. There are no emergency listing mechanisms that can be implemented before the WHO formally declares a public health emergency of international concern (PHEIC). Similarly, an emergency use listing is terminated when the PHEIC ends (Thiel et al., 2021). The need for greater regulatory harmonization is another gap that has been revealed by the COVID-19 pandemic (Hotez et al., 2021): see Chapter 6 for more information on the vaccine regulatory ecosystem and opportunities for further improvement.

Cold chains have proved to be a persistent bottleneck in global vaccine distribution. As detailed in Chapter 4, cold chains require significant costly infrastructure and energy inputs to meet vaccine temperature requirements from manufacturing to point of administration (Ashok et al., 2017; Bangura et al., 2020). Similarly, data systems are required to properly assess the amount of vaccine available and the associated storage and transportation requirements. WHO developed the cold chain gap analysis tool to be used on a national level to support vaccine inventory management (WHO and UNICEF, 2021). Similarly, Gavi, UNICEF, and other partners established a cold chain equipment optimization platform in recognition of the challenges that cold chain coverage presents. This platform has boosted cold chain equipment capacity in Gavi-eligible countries (UNICEF Supply Division, 2019; WHO and UNICEF, 2021). Gavi initiated a program to supplement

this platform, designed to incentivize markets to make cold chain equipment and services available and affordable (Gavi, 2019). While useful for many routine immunizations, this tool provides guidance only for vaccines whose cold chains require standard refrigeration temperatures of 2°–8°C; it does not provide guidance for ultra-cold storage. While “only 0.2% of vaccines procured for COVAX require sub-zero temperatures” (Sustainable Energy for All, 2021), cold chains are broadly recognized as a bottleneck in low-resource settings, even at standard refrigeration temperatures. Better tools are needed to help decision makers understand cold chain equipment and tradeoffs when upgrading cold chain systems. Expanding cold chain equipment will be necessary to facilitate equitable global vaccine distribution (Sustainable Energy for All, 2021).

The WHO Expanded Program on Immunization (EPI) is a broad strategy that has led to drastically increased vaccination coverage in children in LMICs. Initiated in 1974, EPI provides a framework to expand immunization for diseases of global significance, including polio, measles, and tuberculosis. Since its inception, EPI standards have experienced “near global adoption,” although national vaccination rates still vary (Hoest et al., 2017). EPI has proved instrumental in increasing global pediatric vaccination coverage, and it is estimated to prevent 2–3 million deaths annually in children (Hoest et al., 2017). Though successful, this program and its associated tools are designed for pediatric immunizations and do not capture the complexity needed for a pandemic vaccine rollout. Most LMICs only have experience with this framework, not with mass vaccination for adults. Pandemic vaccinations generally aim to cover 70 percent of the population. As seen from COVID-19, pandemic events can cause significant disruption to existing immunization routines. Lockdown policies have resulted in declining vaccination rates, including in areas that have seen previous improvement (Hamid et al., 2020). The pandemic has revealed that additional measures are needed both to maintain and increase vaccination coverage during a public health emergency. The EPI platforms would require significant adaptation to be suitable for a pandemic situation.

Each of these tools demonstrate that there is a need for well-funded planning activities, including facility-level, user-friendly tools that facilitate quality data collection and analysis and tracing to provide greater understanding of supply chain limitations—ideally, before an outbreak. These tools need to take into consideration the additional pressure staff are facing and lack of resources at service delivery level due the competing and overwhelming health situation during outbreaks. COVID-19 has revealed gaps in plans for vaccination and management. Overall, national preparedness and deployment plans are not properly funded. Many of these plans need to be updated and be informed from the current gaps identified during rollout of the COVID-19 vaccine. These plans must account for operational costs,

which are a significant gap. Every level of health systems needs support, including waste management and infrastructure. Accurate costing of vaccine delivery plans will assist countries in addressing challenges in vaccination planning and vaccine delivery.

TOOLS FOR COUNTRY PANDEMIC PREPAREDNESS

National Plans

On receipt of vaccines from COVAX, countries are responsible for in-country deployment and allocation. To ensure that nations are prepared to efficiently deploy vaccines, countries are encouraged to develop a national deployment and vaccination plan. These plans assess country-level preparedness and resource availability to implement vaccine rollout. WHO has developed guidance and toolkits for country development of these plans. One of these tools is the vaccine introduction readiness assessment tool, which “supports countries to 1) assess programme readiness to introduce COVID-19 vaccines; 2) identify gaps and prioritize actions for enhanced readiness; and 3) identify opportunities for financial support” (WHO, 2021b, para. 4). This assessment tool provides a high-level overview of readiness for vaccine introduction related to the cold chain (WHO and UNICEF, 2021).

Also in the suite of national deployment and vaccination plan tools is the COVID-19 vaccine introduction and deployment costing tool: it provides a structured and comprehensive estimation of incremental operational and selected capital costs of introducing and deploying COVID-19 vaccines. Such estimation is essential for resource mobilization, budgeting, and delivery strategy refinement and optimization. The suite of tools allows countries to examine key inputs and processes necessary for successful deployment of vaccines (World Bank, 2021b). These tools also provide insight into complex supply chain components and demonstrate the integration of these capacities. However, instead of relying on such plans, many countries continue to use top-down approaches to assess country readiness that are based on global cost estimates. While these methodologies are faster and less expensive, they do not capture the granular level of detail afforded by the vaccine introduction readiness assessment tool and the COVID-19 vaccine introduction and deployment costing tool (World Bank, 2021b). The tools afforded by the national deployment and vaccination plans are effective in highlighting gaps, but there are few incentives to comply with these guidelines. Local-level planning for vaccine delivery to health centers should also be accounted for to prevent gaps in last-mile efforts. Regarding both

preparedness and response, there is a global need for more comprehensive country readiness frameworks.

As evident during the 2009 H1N1 pandemic, many countries do not have readiness frameworks. Countries that do not have any national vaccine production capacity often experience limited vaccine access, complications with vaccine licensing, and delivery challenges. This lack of vaccine deployment plans led to delayed vaccine deployment in many nations during the H1N1 pandemic of 2009 (Ghiga et al., 2021). A 2018 study found that only 58 percent of surveyed countries had a national deployment and vaccination plan. This lack reveals a global vulnerability in preparedness and vaccine deployment (Ghiga et al., 2021). Introducing additional vaccines into a national immunization schedule is a challenge, as the addition of an extra vaccine can further strain already limited supply chains. Among countries that do have frameworks, they generally need improvements. For example, detailed assessment is not available at the level of granularity needed within countries. A comprehensive national system of assessment and readiness at all levels of granularity is needed to inform readiness for a mass disaster including infectious disease outbreak. Information from these frameworks will inform preparation of pandemic response plans providing more accurate and granular data. National deployment and vaccination plans are generally informed by the limited, well-established immunization programs for children, which were ill-suited to adapt to the scale of mass vaccination, as well as novelty of the target group.

The committee finds that a shared theme among many of these tools and frameworks is that they are centralized in multilateral institutions, primarily WHO and UNICEF. While these institutions provide valuable guidance and technical support, there is insufficient compliance with established pandemic preparedness plans. Global agencies like WHO expect countries to have preparedness plans; however, countries are sovereign and cannot be forced into compliance. Mechanisms to incentivize and facilitate compliance need to be developed. Updating the plans to address a variety of medical countermeasures and facilitating early involvement in supporting research and development for new medical countermeasures could be a means of facilitating better country engagement. Furthermore, in some countries, the leaders are unaware of many of the available WHO tools. There is a need to develop methods to increase awareness and to understand the challenges countries face during outbreaks with a lack of resources and competing priorities. Tools and written documents need to be clear and user friendly and be able to facilitate information capture from the facility level to the national level to inform decision making. In addition, there is a need for global harmonization and streamlining of the tools so as not to add confusion.

The committee discussed decentralization as a proposed means of increasing national and local involvement, thereby facilitating greater degrees of ownership and compliance. Regionalizing implementation structures can lead to more sustainable efforts that are maintained on a local level. Ultimately, this process is intended to increase local accountability to the populations that are being served. In the health services sector, decentralization of policy making has been shown to better match resources to local needs. However, there is a limit to effectiveness in decentralization. Higher-level decision-making processes may be less effective when made on an individual level. However, for decisions that directly affect a nation or region, decentralization can be a useful tool to facilitate engagement of diverse stakeholders and encourage ownership and compliance with institutional goals (Mitchell and Bossert, 2010).

As decision-making power is decentralized, it is important that efforts on different levels are harmonized to avoid duplication. There is a need for better and early alignment between global, regional, and national initiatives to support the interdependence needed for reaching the common global objective of pandemic preparedness. Currently, there is little harmonization. For example, during the COVID-19 pandemic, regions obtained vaccines from a variety of sources with little coordination. Many African countries received vaccines from COVAX, but also from the African Vaccine Acquisition Trust of the African Union, in addition to some bilateral arrangements (World Bank, 2021a). Better-aligned vaccine procurement could lead to improved demand consolidation, better funding, and better manufacturing supply chain visibility, which could ultimately improve access. Decentralization is a potential means of increasing country and regional ownership of deployment plans and increasing willingness to comply, but it must be balanced with harmonization. Regional partners, such as the Pan American Health Organization and the African Union, could be engaged to a greater degree to develop plans and frameworks that are tailored to regional or national structures. Technical assistance embedded in such regional structures is also needed.

Multilateral governance structures, in addition to holding centralized decision-making power, tend to work in silos. For pandemic response, WHO and UNICEF primarily provide technical assistance for vaccination programs, while Gavi contributes to financing. Though these institutions and structures such as ACT-A have been developed for pandemic preparedness, there is still no single, integrated global governance structure for pandemic vaccines. The disjointed response to COVID-19 has revealed gaps in health care systems at a global level. The governance system is fragmented and does not facilitate equitable global distribution of resources, such as vaccines, that is needed on a level to combat a pandemic (The Lancet, 2020). This is

evident from the remaining significant funding gap in ACT-A (IPPPR, 2021), as well as the failure to deploy vaccines equitably (The Lancet, 2020).

The COVID-19 pandemic and the new IA2030 framework have catalyzed the development of new tools with promise for further improvements. New tools have been introduced to facilitate data collection, but the quality of data input is a key struggle that compromises the quality of the plan. Limited data availability, especially for disease surveillance, has hindered global collaboration on data sharing and establishing alert systems for pandemic preparedness. IPPPR has called for a redesign of surveillance and alert systems at global, national, and regional levels (IPPPR, 2021). Although COVAX tools were developed by international actors during the pandemic to quickly support countries to prepare to use and deploy new vaccines through new immunization delivery platforms during an outbreak, gaps remain in data sharing and communication. Limited data on global production capacity and the fragility of the global supply chain for medical goods has presented challenges for coordination and distribution of needed goods (GPMB, 2020). Data granularity is also connected to this issue. The committee finds that many of these tools only exist at a country level and need to be built out at subnational and regional levels in order to capture more detail and account for varying needs within countries and foster regional collaborations. Countries also need to be empowered in the tool development process.

Funding effective national pandemic preparedness and response plans is a significant burden; operational costs are often not taken into account at the beginning of the plan development process. The introduction of COVID-19 vaccines is a heavy burden on LMICs. The cost to roll out this new vaccine has been approximately 20 percent of the annual preCOVID-19 health budget of an average LMIC (UNICEF, 2021). Pandemic effects extend beyond the health sector to include livelihoods and economy. Investments by global financing agencies, as well as the private sector, in these countries are at risk in the event of a pandemic. This risk suggests an opportunity to leverage global financing agencies and the private sector for assisting countries in preparedness. Multiple actors, such as the World Bank and the Asian Development Bank, have joined efforts to address country needs during COVID-19 (Park et al., 2021; World Bank Group, 2019). Each may have a slightly different country assessment approach. To the extent possible, there is need to harmonize these evaluation efforts to lessen the burden on countries and improve their access to the resources made available by these agencies. Private-sector entities with expertise in supply chains and product movement can also contribute knowledge and capacity to enhance supply chains. For example, WHO supports governments in outsourcing such services as procurement, importation, and transport to

private entities with capabilities in these areas (WHO, 2012). Funders of traditional immunization programs and routine health programs could also have a role to play in pandemic preparedness, as a lack of preparedness affects the delivery of routine health services costing lives during a pandemic. COVID-19 has had significant impact on delivery of vaccines and treatment for HIV, tuberculosis, malaria, and other threats (CDC, 2021). Pandemic preparedness should be considered a component of health systems strengthening and could be integrated into management of current diseases. This approach may, however, require additional support.

COVAX, as a time-limited global collaboration initiative built on the existing EPI resources, developed a new COVID-19 vaccine introduction toolkit that includes several tools to support the rollout and delivery of the COVID-19 vaccines to beneficiaries at a country level. They include tools for developing national deployment and vaccination plans for COVID-19 vaccines, and the COVID-19 vaccine introduction and deployment costing tool (described above). The committee notes that there is potential for a second iteration of COVAX to maintain a role in the vaccine procurement and pandemic readiness ecosystem. A form of “COVAX 2.0” could serve as a stable, permanent structure for future procurement and financing for pandemic vaccines. If no such structure is established, then the current system of operating will likely continue, in which entities are established after an emergency arises. Maintaining an established system will promote a global response structure that is proactive rather than reactive, saving valuable time in a pandemic scenario.

Pandemic Preparedness Exercises as Technical Assistance

Determining gaps in needed technical assistance requires an ongoing assessment of country capacities. This assessment can occur through simulations in the form of drills, tabletop exercises, functional exercises, and full-scale exercises (UNSIC, 2008). These methods test in-country response systems and supply chains during a nonemergency and can reveal strengths and weaknesses of a pandemic response network (Ghiga et al., 2021). Simulations are used to determine effectiveness of existing plans, give experience to those who are involved in emergency response, and make stakeholders aware of the plan while building assurance (UNSIC, 2008). WHO has used tabletop exercises, which generally involve scenario-based group discussions and problem solving, as a component of the Pandemic Influenza Preparedness Framework (Ghiga et al., 2021). WHO guidance on developing and improving country plans for pandemic influenza preparedness describes simulation exercises as a critical component of testing and maintenance (WHO, 2018b).

Tabletop exercises are beneficial because they are low stress, require little preparation and resources, and facilitate development of new response plans. Various simulation exercises have been implemented in Southeast Asia to assess preparedness for a potential H5N1 threat. A full-scale exercise was conducted in Australia to assess the health sector’s pandemic preparedness network. This exercise included a drill to exercise processes to activate a national medical stockpile (UNSIC, 2008). In the United States, the government conducted a pandemic drill called “Crimson Contagion” in 2019, concluding just months before the beginning of the COVID-19 pandemic. Findings from this simulation revealed that there were insufficient federal funding sources to respond to an influenza pandemic. Various planning structures, such as crisis of care standards, were highly variable across state and local jurisdictions. Operational coordination was also found to be a significant gap: exercise participants were not clear on the roles of federal agencies and partners in pandemic response. All of these gaps emerged during the COVID-19 pandemic, demonstrating the insight that simulations can provide (ASPR, 2020).

Overall, the committee finds that the tools currently available for large-scale global vaccination are primarily designed for childhood vaccinations, especially in LMICs. These platforms, while successful, do not account for the magnified scale required for pandemic vaccination. Though there has been significant collaboration to provide aid, many of these efforts have come too late, especially for the magnitude of the COVID-19 pandemic. Inadequate coordination has led to delays in vaccine access and growing case numbers (Dutta and Kucchal, 2021). Promising tools, such as ACT-A have been developed as a result of COVID-19, but they have had difficulty securing funding and promoting equitable global access.

Another tool, discussed above, is an independent joint external evaluation, a voluntary component of WHO’s international health regulations monitoring and evaluation framework; it evaluates a country’s health security preparedness and response capacity in 19 technical areas (Talisuna et al., 2019; World Bank, 2021b). This multisectoral evaluation has yielded valuable country preparedness information based on the collaborative effort between a country’s own experts and an external evaluation team. However, the COVID-19 pandemic brought to light the tool’s strengths and weaknesses resulting in calls for reviewing and revising the tool (IOAC, 2020; Stowell and Garfield, 2021). With regard to readiness, gaps remain in each of the country assessment tools, as they are not designed to manage and implement mass vaccination at scale with novel vaccines that may have different requirements from existing immunization programs. These tools also have gaps related to funding, human resource needs, supply, policies, risk communication, addressing vaccine hesitancy, access to at-risk popula-

tions, planning, stockpiling, and providing associated vaccination supplies. There is a need for more comprehensive country readiness frameworks, both for preparedness and response.

Private-Sector Engagement

The committee considered various means of filling the numerous gaps in the global pandemic preparedness and response sphere. In terms of supply chains, the committee agreed that there is currently greater potential for engaging the private sector. In the United States, the American Logistics Aid Network (ALAN) could serve as a promising model for private partnerships for vaccine supply chains. ALAN, formed in the wake of Hurricane Katrina in 2001, is a network of private-sector industry partners with expertise in logistics and coordination that provides support to supply chains in emergency situations. Industry partners join with nonprofit and relief organizations to respond quickly to disaster scenarios (ALAN, 2021). Though ALAN does not focus on vaccines or pandemic supplies, a similar model could be developed among industry partners with expertise in these areas. Healthcare Ready is another U.S.-based nongovernmental organization that models private-sector engagement in supply chains. This organization specializes in provision of health care and medical products, and works to strengthen “collaboration with government, nonprofit, and medical supply chains to build and enhance the community resiliency before, during, and after disasters” (Louissaint, 2016). Private-sector engagement in pandemic response is not a novel concept. Global institutions, such as the Coalition for Epidemic Preparedness Innovations, recognize the importance of private-sector engagement and diversity in funding and have sought support from private entities (CEPI, 2021). During the COVID pandemic, large companies, including Starbucks, Microsoft, and Costco, have joined in the vaccine rollout effort. Workers from these companies with expertise in operations, deployment, and analytics are helping design efficient vaccination sites and develop technology to distribute vaccines and track appointments (Cerullo, 2021).

The private sector has a critical role to play in global health security. Industries have expertise, resources, and abilities to scale up efforts to a degree that is necessary in pandemic scenarios. The private sector is also present and active in regions that are vulnerable to these threats (Rabin Martin, 2017). The committee notes potential incentives for private-sector involvement in pandemic response, such as the fact that in an emergency, they suffer from a halt of activities, as observed during COVID-19. Having an outlet to continue operations in the context of emergency response is a highly beneficial means of keeping a business running. This economic draw could be a sufficient incentive, particularly in the light of COVID-19, to encourage industry to form networks similar to ALAN or Healthcare Ready to respond to public health emergencies.

INNOVATIONS

Multisectoral innovations emerged throughout the COVID-19 pandemic as global leaders have worked to support public health and supply chain sustainability. Responding to COVID-19 would not have been pos-

sible without wide-ranging innovations in multiple areas, including research, development, regulatory approval, manufacturing, and distribution. From vaccine research and development to procurement and distribution, these innovations mark significant strides forward in the vaccine supply chain ecosystem. While the committee was unable to perform an exhaustive analysis of numerous innovations, especially at a country or regional level, Table 5-2 briefly describes some of the most significant mechanisms and tools that have contributed to addressing the COVID-19 pandemic. The committee believes that a more rigorous review of innovations across the end-to-end manufacturing and supply chain is needed. Innovations that increase vaccine thermostability, reduce the volume of packaging, and allow for easier administration are also needed for future vaccination efforts (Guignard et al., 2019).

TABLE 5-2 Innovations for Vaccine Development During COVID-19

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