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Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative (2021)

Chapter: 2 The Existing Global Governance Landscape for Influenza Vaccines

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Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
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Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
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Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
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Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
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Page 40
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 41
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
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Page 42
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 43
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 44
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 45
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 46
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 47
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 48
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 49
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 50
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 51
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 52
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 53
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 54
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
×
Page 55
Suggested Citation:"2 The Existing Global Governance Landscape for Influenza Vaccines." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. Washington, DC: The National Academies Press. doi: 10.17226/26284.
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2 The Existing Global Governance Landscape for Influenza Vaccines WORLD HEALTH ORGANIZATION (WHO) AND THE INFLUENZA “REGIME COMPLEX” Global health governance structures and frameworks for pandemic preparedness have often been developed reactively. In recent years, major outbreaks and pandemics have resulted in new international agreements and reforms; the International Health Regulations (IHR) revisions were rolled out in 2005 in response to the SARS outbreak of 2002–2003, the 2009 H1N1 pandemic led to discussions that ultimately resulted in a new access and benefit sharing (ABS) system for influenza, and the WHO research and development (R&D) blueprint was a reaction to the 2013–2014 Ebola epi- demic in West Africa. This reactive dynamic does not mean that pandemic preparedness and response efforts (PPR) have lacked strategic grounding, such as linking “health” to the less altruistic (and potentially more lucrative) goal of “security.” However, such strategies were not sufficiently effective to attract the resources required to respond to the COVID-19 pandemic—and a window for “strategic reactivity” may now exist for pandemic prepared- ness and influenza governance. In David Fidler’s words (NASEM, 2018), the global governance infrastructure for pandemic influenza may be best thought of as a “regime complex: a set of interlinked and overlapping insti- tutions, rules, processes, and practices.” It provides a web of PPR activities at both the functional and strategic levels. Governance mechanisms enable surveillance, virus sharing, scientific research, and vaccine development. Strategically, the “ecosystem” also integrates national security, economic interests, human rights, and ethics into pandemic influenza governance. 37 PREPUBLICATION COPY—Uncorrected Proofs

38 THE INFLUENZA IMPERATIVE Much of the global infrastructure for pandemic preparedness is based on the scaffolds provided by long-standing governance structures for influ- enza. The first influenza vaccines were developed in 1942, and the newly minted WHO initiated the Global Influenza Program (GIP) in 1947. The Global Influenza Surveillance Network (GISN)—renamed the “Global In- fluenza Surveillance and Response System” (GISRS) in 2011—was launched under the auspices of GIP in 1952, with the recognition that more needed to be done globally to monitor changes in influenza viruses (Monto, 2017). As Hay and McCauley (2018) argue, the precise modus operandi of GISRS has changed over the years, but it has consistently been a mechanism for monitoring global influenza viral activity, identifying strains for annual vaccines, and forecasting potential pandemic threats. GISRS is based on a largely “informal autonomous trust-based sys- tem” of laboratories and collaborating centers coordinated by WHO. The backbone of this network consists of approximately 143 National Influenza Centers (NICs) spread across 101 GISRS-participating countries that pro- vide continuous surveillance of influenza. The NICs collect, analyze, and classify biological samples to monitor which strains are causing illness, how efficiently these strains are spreading, and how well previous vaccines have worked to combat their targeted viruses. Information is then disseminated through the FluNet database. These smaller centers pass the results from their wide-reaching investigations to one of six WHO Collaborating Cen- ters (WHO CCs) for Reference and Research on Influenza, which provide more in-depth analysis of strains. GISRS then aggregates the data from FluNet and collaborators to predict the prevalence of influenza strains and allow WHO to select 3–4 strains to use in seasonal vaccines (Hay and McCauley, 2018; Ziegler et al., 2018). About 60 percent of countries now participate in WHO-mediated global influenza surveillance, supporting the IHR requirement for member states to notify WHO of all human infections with novel influenza viruses (WHO, 2008). GISRS is widely seen as one of the more successful global disease surveillance mechanisms and is now being leveraged for a pilot program for respiratory syncytial virus (Broor et al., 2020; Carroll et al., 2021). GOVERNANCE GAPS EXPOSED IN THE 2009 H1N1 “SWINE FLU” PANDEMIC From 1997 to 2007, a series of avian influenza outbreaks brought international attention to WHO and GISN/GISRS. First, an H5N1 strain with a high case fatality rate emerged in Hong Kong in 1997. Its reappear- ance in 2003–2004 and spread to other countries raised fear of a highly pathogenic avian influenza pandemic, compounded by the 2002 SARS coronavirus epidemic and the threat of zoonotic H7N7 influenza (Hay PREPUBLICATION COPY—Uncorrected Proofs

THE EXISTING GLOBAL GOVERNANCE LANDSCAPE 39 and McCauley, 2018). Avian influenza fears led to a frantic period of vac- cine development and global preparations for pandemic influenza, during which issues of equitable access to vaccines and benefits from research on influenza viruses made some stakeholders question the legitimacy of GISN/ GISRS, which reached a peak when Indonesia refused to share its H5N1 virus samples with WHO because it believed that it would not receive equi- table access to the benefits derived from them (Fidler, 2010). The persistent H5N1 threat called for a wider appreciation of vaccine operations and benefits, as governments began to stockpile vaccines and antivirals, and led to “greater government scrutiny of the fairness of the global system” (Hay and McCauley, 2018). In March and April of 2009, a novel strain of H1N1 spread in Mexico and the United States (WHO, 2012). This ultimately led to the first in- fluenza pandemic of the twenty-first century, which is estimated to have caused 151,000–575,000 deaths (Rockman et al., 2020). Early reports of H1N1 outbreaks activated information-sharing networks among the nu- merous WHO surveillance units, and the GISRS backbone responded well, in terms of assessing epidemiological information provided by the NICs and characterizing the virus’ antigenic and genetic characteristics at the WHO CCs. The U.S. Centers for Disease Control and Prevention (CDC) officially reported the first cases of H1N1 to WHO on April 18, 2009. On April 29, 2009, WHO convened an emergency committee under the authority of the IHR to make recommendations on whether a pandemic should be declared (Kamradt-Scott et al., 2018). As the cases increased at more than 200 lo- cations around the world, preparations for vaccine production and other responses began. A suitable candidate vaccine virus (CVV) was selected relatively quickly (Ampofo et al., 2012); by late spring, the seasonal vaccine production cycle was nearly at its end and manufacturers were able to begin preparations for dealing with H1N1 (WHO, 2012). Although it obtained quick surveillance data for H1N1 influenza, WHO did not officially declare a global pandemic until June 11, 2009. Soon thereafter, it launched the WHO Pandemic Influenza A (H1N1) Vac- cine Deployment Initiative, which it later deemed to be the “first coordi- nated global response to an influenza pandemic” (WHO, 2012). Under this initiative, WHO coordinated the support of governments, foundations, and manufacturers to facilitate access to pandemic influenza vaccines in low- and middle-income countries (LMICs). Eventually, millions of vaccine doses, syringes, safety boxes, and other items were donated, and substantial financial and logistical support was pledged. Despite this novel deployment coordination structure, the H1N1 expe- rience is generally considered to offer a cautionary tale for the challenges of upscaling production of global influenza vaccines and deploying them dur- ing a pandemic. Box 2-1 summarizes major gaps in terms of international PREPUBLICATION COPY—Uncorrected Proofs

40 THE INFLUENZA IMPERATIVE BOX 2-1 Vaccine Governance Gaps in the 2009 H1N1 (Avian Influenza) Pandemic The surveillance mechanisms in place in 2009 did their part to quickly and successfully identify the H1N1 pandemic virus, but vaccine development and distribution did not go as well. In 2009, the estimated global influenza monova- lent pandemic vaccine manufacturing capacity was 2.7 billion doses. The world population at the time was approximately 6.85 billion, which meant that only ap- proximately one-third of the world population could be immunized—even under the best circumstances. WHO launched a deployment initiative after the pandemic began, the first adult pandemic vaccine procurement and distribution program of its kind, to improve equitable procurement and delivery of vaccines. By the end of the pandemic, only 162 million doses of pandemic influenza vaccine had been produced, of which 90 million were used (Fauci 2018). Most re- cipient countries did not receive donated vaccines until after the peak in November and December 2009, and some were still receiving the vaccine a full year after it was first made available. As a consequence, demand for vaccines was often lower than anticipated; in Africa, only 4 percent of the population received the vaccine, instead of the planned 6 percent. In spite of these issues, WHO leadership did lead to distribution of H1N1 pandemic influenza vaccines to 77 countries, many of which vaccinated large fractions of their highest-risk populations. In South and Southeast Asian countries, 95 percent of healthcare workers, 86 percent of pregnant women, and 73 percent of people with underlying health conditions received the vaccine. Governance and policy issues that contributed to this pandemic outcome include the following: • Pathogen sharing: No global framework existed for sharing benefits, including vaccines, resulting from viral samples shared with the GISRS network (Fidler 2010). • Manufacturing: Egg-based monovalent vaccines had poor efficacy and took months to produce. H1N1 did not grow as well as seasonal viruses in eggs, which led to lower vaccine yields per egg and delayed produc- tion (Knox 2009, Hampton 2011). • Procurement: No structure existed for procurement of pandemic vac- cines for low- and middle-income countries (LMICs), so a structure was developed reactively by WHO. coordination for producing and distributing vaccines. Production was not triggered quickly because the switch from seasonal to pandemic vaccine production was poorly coordinated and did not occur until after many seasonal vaccines were already delivered. High-income countries (HICs), including the United States, set up procurement contracts with manufactur- ers and began receiving vaccines as early as October 2009. But the majority of vaccines were mostly rolled out after the peak of the pandemic in the fall; PREPUBLICATION COPY—Uncorrected Proofs

THE EXISTING GLOBAL GOVERNANCE LANDSCAPE 41 ° Access issues—LMICs first received doses three months after they were available, largely because wealthier countries entered into early procurement contracts. For example, the Australian govern- ment made it clear to the Australian manufacturer CSL that it must fulfill the government’s domestic needs before exporting to the United States. The United States pledged on September 17, 2009 to donate 10 percent of its vaccine purchases to WHO, but on October 28, the U.S. Secretary of Health and Human Services reneged on this promise until all at-risk Americans had access in response to vaccine shortages created by production problems (Fidler 2010). ° Liability issues—Manufacturers worried about assuming liability for a new vaccine and required purchasers to provide protection from liability claims. Governments that received donated vaccine ultimately agreed to indemnify manufacturers, donor governments, and WHO (i.e., to pay compensation that arose out of claims of injuries)—but these agreements took time and delayed deployment (Fidler 2010, Broor, Campbell et al. 2020). ° Regulatory issues—Donations from companies across a variety of countries meant regulatory approval also took time. Manufacturer Novartis, for instance, prequalified three H1N1 vaccines, made in three countries. For each vaccine, the national regulatory authority of the country in which it was produced, WHO, and the national regula- tory authority of the receiving country had to approve its distribution through WHO (Fidler 2010, Broor, Campbell et al. 2020). • Distribution: Many countries lacked adult vaccination plans, which cre- ated confusion and delays in delivering vaccines. ° Countries who received WHO-donated vaccine mostly had little to no experience with influenza vaccines; this created bottlenecks in terms of developing plans to use vaccines, applying to WHO for donations, and granting customs clearance. ° Gavi and other international organizations are mostly designed for pediatric roll-out, and most countries had immunization systems en- tirely focused on young children but not those adults most at risk for severe influenza, such as pregnant women, the elderly, and health care workers (Hampton 2011). ° Financing: Pledges to the $56 million initiative fell short of projected expenses, and actual commitments fell short of these pledges (WHO 2012). by then, demand was low, many doses were wasted, and many low-income countries received less than planned. The egg-based vaccine also showed generally poor efficacy, which exacerbated issues with public confidence and markets. Fidler (2010) offered a particularly biting analysis of equity during the 2009–2010 pandemic: “in terms of vaccines for 2009-H1N1, donations from manufacturers and developed countries were not the product of real PREPUBLICATION COPY—Uncorrected Proofs

42 THE INFLUENZA IMPERATIVE negotiations, given that WHO and developing countries had little leverage to influence developed countries other than rhetoric about equity, justice, and solidarity.” In the end, wealthy countries “only agreed to make dona- tions after (1) they learned, unexpectedly, that a one-dose regimen would immunize adults, which doubled the amount of vaccine available; and (2) data from the northern and southern hemispheres revealed that the 2009 H1N1 virus was behaving as a mild virus and not a killer strain, which reduced the threat the virus posed.” These countries ensured that they had sufficient vaccine to cover their populations when pledging donations, and some—including the United States—postponed donations when they were not politically expedient. Apart from its role with vaccine production and distribution, WHO faced criticism over the timing of its declaration of a pandemic (a necessary step to initiate the “switch”) and its decision to remove pandemic influenza guidance from its website. Three independent panels found no evidence that WHO had engaged in inappropriate conduct but also recommended sig- nificant changes for its responses to health emergencies (Cohen and Carter, 2010; Flynn, 2010; Kamradt-Scott et al., 2018; WHO, 2011). EXPANDING AND ENHANCING INFLUENZA SURVEILLANCE SINCE 2009 The governance and financing challenges during the 2009 H1N1 pan- demic stimulated negotiations that led to the launch of the Pandemic Influ- enza Preparedness (PIP) Framework in 2011. This framework is a formal, but nonbinding, agreement between WHO member states to improve PPR, with a focus on equity and benefit sharing. Under its governance, when countries share influenza viruses with pandemic potential (IVPP) with GISRS, they are entitled to access specific benefits, including timely access to vaccines, derived from these viruses in a pandemic. The PIP Framework agreement only covers IVPP strains. Pharmaceutical companies who use virus data from GISRS for products (such as vaccines or antivirals) provide in-kind donations or discounted product doses to WHO for deployment during a pandemic and also partner contributions, which are used to bolster capabilities for PPR (such as surveillance) for low-income countries partici- pating in GISRS. Chapter 3 includes more details about areas of success and persisting gaps in the PIP Framework. Governance structures such as the PIP Framework and the Nagoya Protocol on Access to Genetic Resources to the Fair and Equitable Sharing of Benefits Arising from Their Utilization of the Convention on Biological Diversity (discussed further in Chapter 3) have yet to be tested in an influ- enza pandemic. The world can now produce more vaccines than in 2009 but has not yet developed governance or coordination mechanisms to solve PREPUBLICATION COPY—Uncorrected Proofs

THE EXISTING GLOBAL GOVERNANCE LANDSCAPE 43 serious issues of vaccine access and equity, including the “switch,” poor market-based incentives for producing pandemic vaccines, and deployment and delivery. Like access and benefit sharing, governance structures for the surveil- lance and monitoring of zoonotic influenza have evolved significantly since 2009. In 2004, the OIE/FAO Joint Network of Expertise on Animal Influ- enza (OFFLU) was founded during the peak of the H5N1 (avian influenza) crisis. WHO joined forces with the World Organization for Animal Health (OIE) and the United Nations Food and Agriculture Organization (FAO) in 2006, with the launch of the Global Early Warning System for Major Animal Diseases, including Zoonosis (GLEWS). This became an early One Health mechanism, linking together the three organizations for event-based disease surveillance. The 2009 H1N1 pandemic provided momentum for OFFLU, and in 2010, the three organizations published a Tripartite Con- cept Note on “Sharing responsibilities and coordinating global activities to address health risks at the animal-human-ecosystems interface” (FAO- OIE-WHO, 2010). They named avian influenza as a major priority for this alliance along with rabies and antimicrobial resistance (Dauphin, 2015; FAO-OIE-WHO, 2013). Through OFFLU, representatives of the veterinary and animal health sector have taken part in biannual WHO consultations on influenza virus surveillance data since 2011 that analyze surveillance data and provide recommendations on viral strains to use for influenza vaccines in the upcoming season. In this way, OFFLU participates in GISRS (routine influenza surveillance) and provides data collected from OIE/FAO Reference Centers and national animal health laboratories to WHO. Creat- ing pre-pandemic CVVs for human vaccines relies heavily on this zoonotic virus data (Dauphin, 2015; Mackenzie et al., 2014). In recent years, momentum has been building for extending the GISRS and GLEWS event-based surveillance or creating “GLEWS+” and “GISRS+.” GLEWS+ is designed as a cross-sectoral mechanism for con- ducting joint risk assessments for influenza and other zoonotic pathogens (FAO-OIE-WHO, 2013). The GISRS+ proposal is currently in its infancy at WHO. In WHO discussions during June 2021, it was suggested as a mechanism to build on and expand GISRS surveillance capabilities based on capacities developed and gaps identified during COVID-19 (Figure 2-1). GISRS+ would function as the integrated system for surveillance and monitoring of respiratory viruses with epidemic and pandemic potential (WHO, 2021). The GISRS+ proposal underscores the fact that GISRS structures have been leveraged during the COVID-19 response and can be expanded for other respiratory viruses. The laboratory network underpinning GISRS would expand, as would capacity building and training opportunities. Deciding which structures to extend (such as creating additional WHO PREPUBLICATION COPY—Uncorrected Proofs

44 FIGURE 2-1 GISRS+ capacity building. NOTE: NICs are National Influenza Centers, CCs are WHO Collaborating Centers, ORVs are other respiratory viruses. SOURCES: Moen, 2021; WHO, 2021. PREPUBLICATION COPY—Uncorrected Proofs

THE EXISTING GLOBAL GOVERNANCE LANDSCAPE 45 Collaborating Centers and how they will relate to GISRS) or redesign for other respiratory viruses (such as in the PIP Framework) will require a for- mal coordination mechanism. WHO is considering mechanisms required to support GISRS+ as a formal health governance structure. A SNAPSHOT OF CURRENT INFLUENZA VACCINE GOVERNANCE STRUCTURES AND FRAMEWORKS The WHO GISRS and PIP Framework form a major piece of the multi- lateral ecosystem for influenza surveillance and control. However, the wider “regime complex” or global ecosystem for influenza pandemic vaccines is much more complex and extends far beyond WHO’s normative power. Box 2-2 provides a nonexhaustive overview of some of the major organizations and programs involved in global and regional influenza policy and gover- nance (NASEM, 2018; Schroeder, 2018; WHO, 2019) based on whether they involve multilateral, bilateral, or regional coordination; international regulations; public–private partnerships (PPPs); industry partnerships; and civil society organization (CSO) partnerships. The structures highlighted demonstrate the often-blurred boundaries around seasonal and pandemic influenza vaccines and vaccination. The list of organizations and programs in Box 2-1 reflects the 2019 Conference Report (Ruscio et al., 2020) “Shaping meeting to explore the value of a coordinated work plan for epidemic and pandemic influenza vac- cine preparedness,” which called for a systematic effort to map the wide range of national, regional, and global actors that make up the influenza vaccine ecosystem. While this undertaking is beyond the scope of this short consensus study, it is an important next step. Our abridged analysis of major influenza governance structures reinforces that meeting’s finding that strengthening influenza vaccine PPR must be “guided by an alliance of international stakeholders, to include, among others, governmental and nongovernmental organization representation, civil society representatives, vaccine manufacturers, international organizations, and health security and influenza experts” (Ruscio et al., 2020). THE GLOBAL INFLUENZA STRATEGY AND THE GOVERNANCE PATH FORWARD Many efforts have been undertaken to distill lessons from the 2009 H1N1 pandemic for developing and rolling out vaccines, and there is, and will be, even more impetus to learn lessons from the COVID-19 pandemic. Given the centrality of WHO’s role in coordinating pandemic responses, one of the most significant post-H1N1 developments was the WHO Global Influenza Strategy 2019–2030, which was issued in 2019 (WHO, 2019). PREPUBLICATION COPY—Uncorrected Proofs

46 THE INFLUENZA IMPERATIVE BOX 2-2 Major Influenza Policy and Governance Structures Governance/coordination mechanism type Examples Multilateral global WHO Global Action Plan (GAP) for Influenza. Phase I structures (2006–2011) had three objectives: increasing sea- sonal vaccine use, increasing vaccine production capacity, and expanding research and development. Phase II (2011– 2016) focused on pandemic preparedness and technical ob- jectives. The GAP Advisory Group recommended issues that required global coordination for vaccines and WHO leader- ship. Chapter 4 includes a case study of the GAP-mediated influenza technology transfer program for manufacturers. Global Influenza GISRS is responsible for monitoring global influenza activity, Surveillance and forecasting pandemics, and identifying strains for the annual Response System seasonal vaccine. Global Vaccine WHO, UNICEF, NIAID, and the Bill and Melinda Gates Action Plan Foundation launched this plan to connect leaders across (2012–2020): across public and private sectors and increase equity in vac- cine access. Influenza was only a small part of this plan, which—by 2017— had commitments from 197 countries’ Min- istries of Health. Most influenza work was focused on identify- ing gaps in research and policy (MacDonald et al., 2020). OFFLU (est. 2004): This is the World Organization for Animal Health (OIE) and Food and Agriculture Organization of the United Nations (FAO) global network of expertise on animal influenza. It pro- vides technical assistance and expertise to member countries to prevent, diagnose, surveil for, and control animal influenza. One main objective is to collaborate with WHO (through a tri- partite agreement between WHO, OIE, and FAO) on issues related to the animal–human interface, including pandemic preparedness for the early preparation of human vaccines. WHO has been present as an observer on the OFFLU Steer- ing Committee, and the OFFLU laboratory network is consid- erably smaller than GISRS (Dauphin, 2015). Regional coordination programs Middle East, Eurasia This is a regional structure established to understand the and Africa Influenza current influenza burden in each member country and provide Stakeholders Network technical assistance with developing country-tailored action (ME’NA-ISN, est. 2014): plans. Through meetings on National Action Plans, the net- work aims to strengthen surveillance, generate disease bur- den data, and help plan for influenza vaccine introduction. PREPUBLICATION COPY—Uncorrected Proofs

THE EXISTING GLOBAL GOVERNANCE LANDSCAPE 47 Asia-Pacific This is an alliance of Asian-Pacific countries, with an independent Alliance for board of directors and members with regional expertise in the Control of influenza. Its objectives are to reduce the region’s burden of Influenza influenza by addressing epidemiological issues and expanding (est. 2011): local control initiatives, including vaccines. International instruments Pandemic This nonbinding framework brings together member states, indus- Influenza try, other stakeholders, and WHO to implement a global approach Preparedness to influenza PPR. Its key goals include improving and strengthen- (PIP) Framework ing the sharing of influenza viruses with human pandemic poten- (est. 2011): tial and increasing developing country access to vaccines and oth- er pandemic-related measures. It was developed by WHO member states and unanimously adopted by the Sixty-Fourth World Health Assembly. International The IHR are a legal instrument binding all WHO member states Health that support the international community in the prevention of, Regulations control, and response to acute public health threats, including (IHR, 2005): infectious diseases. The revised IHR (2005) require countries to notify WHO about disease events that could constitute a public health emergency of international concern. They mandate report- ing any case of human influenza of a new subtype B; require states to develop surveillance and response capacities; empower WHO to gather surveillance from nongovernmental authorities; authorize the WHO Director-General to declare a public health emergency of international concern and issue temporary recommendations; and seek to ensure the necessity of any public health measures that adversely affect trade, travel, and human rights. Nagoya Protocol As an adjunct to the Convention on Biological Diversity, the Na- (est. 2009): goya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization is an international agreement that aims at sharing the benefits arising from the use of genetic resources fairly and equitably. Bilateral programs/partnerships National Institute Part of the U.S. National Institutes of Health, it works to “under- of Allergy and stand, treat, and prevent infectious, immunologic, and allergic Infectious diseases.” NIAID has created the Collaborative Influenza Vaccine Diseases (NIAID): Innovation Centers network to coordinate and attract expertise to the effort to develop a universal influenza vaccine. Biomedical The National Strategy for Pandemic Influenza of 2005 designated Advanced the U.S. Department of Health and Human Services (HHS) as Research and the lead agency for public health preparedness and medical Development response to a probable or actual influenza pandemic. BARDA, Authority (BARDA): in the HHS Office of the Assistant Secretary for Preparedness and continued PREPUBLICATION COPY—Uncorrected Proofs

48 THE INFLUENZA IMPERATIVE BOX 2-2 Continued BARDA Response, was established by the Pandemic and All- (continued) Hazards Preparedness Act in 2006 to facilitate the research, development, and acquisition of medical countermeasures for chemical, biological, radiological, and nuclear threats and emerging infectious diseases, such as pandemic influenza. As explored in Chapter 4, BARDA undertook major influenza vaccine manufacturing partnerships with WHO and PATH. Global public–private partnerships (PPPs) Partnership for PIVI is a key program of the Task Force for Global Health. Influenza Vaccine PIVI works in partnership with the U.S. CDC, Ministries Introduction (PIVI, of Health, corporate partners, and others to create sustain- est. 2013): able, seasonal influenza vaccination programs in LMICs and with WHO programs to help countries prepare for pandemic influenza and support countries’ efforts to control and prevent seasonal influenza (Bresee et al., 2019). Global Initiative on This is a global PPP that provides open-access to the ge- Sharing All Influenza nomic data of influenza viruses and SARS-CoV-2, the virus Data (GISAID, responsible for COVID-19 (Shu and McCauley, 2017). GISAID est. 2008): was created as an alternative to the public domain sharing model, which traditionally does not offer protection of intellec- tual property rights to data or incentives for sharing (e.g., at- tribution of data owner). It is a platform for data sharing among WHO Collaborating Centers and NICs for the biannual influ- enza vaccine virus recommendations by GISRS. As of 2010, the Federal Republic of Germany is the official host of both GISAID and the EpiFlu databases (GISAID, 2020). Coalition for CEPI was launched at Davos as the result of a consensus Epidemic that a coordinated international and intergovernmental plan Preparedness was needed to develop and deploy new vaccines to prevent Innovations future epidemics. CEPI is a global partnership between public, (CEPI, est. 2017): private, philanthropic, and civil society organizations working to accelerate the development of vaccines against emerg- ing infectious diseases and enable equitable access to these vaccines for affected populations during outbreaks. In March 2021, it announced a U.S. $3.5 billion replenishment strat- egy and 5-year plan, aimed at cutting the vaccine production time line for new pandemics by two-thirds, to 100 days (CEPI, 2021). But CEPI has been more concerned with emerging pathogens, such as Chikungunya and COVID-19, than influ- enza. PREPUBLICATION COPY—Uncorrected Proofs

THE EXISTING GLOBAL GOVERNANCE LANDSCAPE 49 GlobalFunders This consortium is a mechanism to bring together major funders Consortium of R&D for universal influenza vaccines along with key stakeholders for Universal to accelerate progress in the field through creating a common land- Influenza scape, identifying critical gaps, and coordinating around a common Vaccine vision. The consortium has created a database of novel vaccine Development: candidates designed to provide broader and more durable im- munity against circulating and pandemic influenza viruses and of- fer stakeholders and funders a common source of information to monitor research progress and identify opportunities for informed investments and collaboration. Industry programs/partnerships International This global trade organization representing pharmaceutical indus- Federation of try members has an Influenza Vaccine Supply (IVS) task force, Pharmaceutical which is a specialized group of experts on influenza vaccine man- Manufacturers ufacturing. The largest manufacturers of influenza vaccines, Sanofi and Pasteur, Novartis, Sequiris, ID Biomedical, and Glaxo SmithKline, Associations: are members and mostly based in the North American and Euro- pean regions. The objective is to provide intergovernmental bodies and governments with expertise to guide pandemic and seasonal influenza vaccination; IVS has published studies of the global vac- cine supply. Developing This is a voluntary public health–driven alliance of vaccine manu- Countries’ facturers from developing countries. Its goal is to improve the capacity Vaccine of LMICs to produce vaccines and provide a consistent supply of Manufacturing high-quality vaccines for known and emerging infectious diseases Network that are accessible to these countries (especially public markets) (DCVMN): (Pagliusi et al., 2020). DCVMN’s vaccine contributions to Gavi mar- kets increased substantially from 2012 to 2018, and, as of 2020, 15 licensed influenza vaccines were available from DCVMN members (Hayman and Pagliusi, 2020; Pagliusi et al., 2020). Civil society programs Third World This independent nonprofit international research and advocacy Network (TWN, organization is focused on strengthening cooperation among est. 1984): development and environmental groups, particularly in the Global South. Its work on influenza is centered on recommending policy changes to promote human rights, justice, and equitability. TWN was involved in PIP Framework negotiations and has taken active stances on influenza and COVID-19 related issues, including ben- efits sharing, bio-hubs, and intellectual property waivers. PREPUBLICATION COPY—Uncorrected Proofs

50 THE INFLUENZA IMPERATIVE In Annex 1 of the document, WHO discusses the achievements since the release of its first Strategy document in 2002. Annex 2 enumerates the areas wherein WHO sees ongoing challenges. The most relevant of these chal- lenges, in terms of global vaccine PPR, are the following: (1) Understanding influenza disease and economic burden: Understand- ing the morbidity, mortality, and economic burden of influenza enables policy makers to prioritize influenza, make evidence-based decisions, and develop effective immunization and treatment pro- grams. WHO states that most estimates of disease and economic impact have come from high-income countries, and additional studies in LMICs are needed. (2) Undertaking consistent epidemiological and virological surveil- lance: During the decade following the 2009 pandemic, GISRS was strengthened and improved. The number of member states sharing influenza viruses increased to 130 in 2017; member states sharing laboratory and epidemiological data through FluNet and FluID also increased. However, 31 percent and 58 percent of member states did not routinely share data on these respective platforms during 2016–2017. In addition, some countries still cannot detect novel influenza viruses, which is a core capacity under the IHR. (3) Improving vaccine technologies and undertaking early and larger clinical trials that are more globally distributed: Vaccines remain the most effective means of preventing infection and potentially reducing clinical severity. The reliance on embryonated eggs for production is still predominant, but, as described in Chapter 1, it is time intensive. Furthermore, some influenza viruses are increasingly unfit to grow and tend to undergo antigenic changes with passage in eggs, underscoring the need to diversify current production ca- pabilities and technologies. The holy grail is a universal influenza vaccine that would offer broader protection against multiple in- fluenza strains. However, as Fauci underscored in 2018 (NASEM, 2018), it will require long-term investments in advanced manufac- turing techniques, such as cell-based production and new platform technologies. Pre-pandemic clinical trials in adults and children may also inform the vaccination regimen required to induce a suf- ficient immune response for a novel influenza subtype, particularly next-generation viruses. This would reduce the response time for vaccine distribution if a similar subtype causes a future pandemic (Rockman et al., 2020). (4) Building effective seasonal vaccination programs: Because influenza viruses are highly prone to mutating, seasonal vaccines are strain PREPUBLICATION COPY—Uncorrected Proofs

THE EXISTING GLOBAL GOVERNANCE LANDSCAPE 51 based, and vaccination must be against the predominant circulating strains each year. WHO states that the need for annual vaccination, coupled with varying and often low vaccine efficacy, continues to contribute to influenza vaccine hesitancy. Both vaccine distribu- tion and use also reflect major disparities. Recent data show that 47 percent of the global population (residents of countries in the WHO members in the Eastern Mediterranean, South-East Asia, and African regions) received only 5 percent of annually distributed vaccines. Countries and the global community must understand and address barriers that affect influenza vaccine distribution, up- take, import, and regulation to strengthen seasonal programs and improve the market for them if pandemic capacity is to be kept “warm” by seasonal vaccination. (5) Performing national pandemic planning: WHO developed pan- demic influenza risk management guidance to encourage countries to develop national pandemic preparedness plans. In early 2018, WHO also published a checklist to help countries develop or up- date their plans. As of September 2018, however, few countries had updated their plans, and 101 countries did not have plans or had none publicly available. Without plans, countries would be ham- pered in terms of deploying vaccines during a pandemic (WHO, 2017). In 2021, the Center for Infectious Disease Research and Policy (CI- DRAP) took a step toward highlighting precisely how new technologies may be developed and harnessed for influenza. As discussed further in Chapter 4, its influenza vaccines R&D roadmap describes programs, poli- cies, and financing that may accelerate progress for universal or broadly protective influenza vaccines. CIDRAP again underscores the importance of multi-sector and multi-actor collaboration for influenza governance; it is funded by the Wellcome Trust and advised by a steering group, composed of representatives of WHO, the Sabin Vaccine Institute, the Rockefeller Foundation, Wellcome Trust, Bill and Melinda Gates Foundation, and Global Funders Consortium for Universal Influenza Vaccine Development (CIDRAP, 2021a). The newest evolution of influenza governance may ultimately be through a pandemic treaty or instrument. The general concept of an inter- national treaty on pandemic preparedness was put forward by the president of the European Commission in December 2020 and has been endorsed by the European Union, the director-general of WHO, and 26 heads of state, although the United States has expressed a preference for a nonbinding agreement (Viñuales et al., 2021). In May 2021, the World Health As- PREPUBLICATION COPY—Uncorrected Proofs

52 THE INFLUENZA IMPERATIVE sembly reached a consensus to hold a special session in November, during which an international treaty or instrument on pandemic preparedness will be debated (CIDRAP, 2021b; Gostin, et al., 2021). This proposal follows the general pattern of reactivity; it is a product of COVID-19 reflections that individual organizations and governments cannot adequately prepare for pandemic threats alone. This argument was taken up by the Indepen- dent Review Panel for Pandemic Preparedness and Response (IPPPR). In its May 2021 report, it recommended stronger leadership and better coor- dination for pandemic preparedness through a more independent WHO, creation of a Global Health Threats Council, and a pandemic treaty. The pandemic treaty may best be viewed as a recognition that a future global health crisis response system needs to go beyond embracing the IHR and WHO as the global health coordination agency. Much work needs to be done on whether it would be modeled along the lines of the Paris Climate Change Treaty or the Geneva Conventions and what it would require under the auspices of a Global Health Threats Council and institu- tions such as the G20. More work will be required to determine its core functions and boundaries. For instance, some have argued that it should focus on “deep prevention” to reduce the risk of pathogen spillover from humans to animals (drawing on inspiration from the global governance of nuclear, environmental, and financing system risks) (Viñuales et al., 2021). Others have put forward concrete end points, such as establishing a global agency, similar to WHO, that can coordinate governments, launch large-scale operations, enforce international rules, assess health systems, and provide objective technical advice to countries (Moon and Kickbusch, 2021). The pandemic treaty debate goes beyond the boundaries of this study on influenza governance. What we are interested in is how to best to ensure that the successful governance structures and frameworks used for influenza inform proposals being advanced by the plethora of groups and studies and that the specific requirements of pandemic influenza are given due weight as a highly hazardous pathogen. Our argument is that the global influenza system may well be the most well established and functioning among those extant systems for pandemic preparedness (e.g., GISRS for surveillance, the PIP Framework for ABS, GAP for vaccine manufacturing capacity build- ing, and IFPMA IVS to provide a link to market generation). Some of these global arrangements and agreements can be made much more visible and prominent as examples that can either effectively withstand geopolitical tensions and sovereignty control or effectively operate sufficiently under the radar at R&D, technical, production, and trade levels. Each of the next three chapters considers three interrelated ques- tions. What is working for influenza vaccination, from a governance PREPUBLICATION COPY—Uncorrected Proofs

THE EXISTING GLOBAL GOVERNANCE LANDSCAPE 53 and financing perspective, and should stay specific to influenza? What is working for influenza and should be expanded or scaled up to improve integrated PPR for pathogens with pandemic potential? What is missing from the influenza vaccine governance landscape, and what partnerships or coordination structures could fill these gaps? Each chapter includes key findings and conclusions, which both respond to challenges laid out in the Global Influenza Strategy and form the basis for subsequent recommendations. KEY FINDINGS AND CONCLUSIONS • Global coordination for vaccines and vaccination will not be suc- cessful without including both public (national governments) and private actors—including civil society and the pharmaceutical and biotechnology industry. • One of the key challenges for developing broader surveillance sys- tems is how to cover multiple pathogens spanning the human and animal realms. Surveillance represents a prime example of how ministries and organizations, particularly those in the animal and health sectors, can develop misaligned objectives that contribute to silos based upon the competition for influence, power, and funding. • Programs supporting platform technology R&D and industry part- nerships to scale up vaccines and address supply chain chokeholds are often performed in a semi-isolated context. This is true for in- fluenza and for other respiratory pathogens with pandemic poten- tial. There is a need to move away from historically siloed systems toward a single architecture for the global coordination of PPR, in the spirit of the GISRS+ proposal. • WHO and other international organizations cannot direct national ministries to take certain steps. They can, however, offer technical and managerial guidance, suggest policy solutions and mechanisms to facilitate multilateral agreements at the country level, and pro- vide close follow-up. • WHO is well placed to provide normative guidance, technical support for integrated surveillance, and regulatory support for vaccine licensure, for the coordination of global, regional, and national programs for PPR that recognize the importance of oper- ating across multiple pandemic threats. • WHO is less well positioned to support activities that require deep engagement with the private sector and industry, including vaccine manufacturing, supply chains, and deployment across multiple pathogens with pandemic potential. PREPUBLICATION COPY—Uncorrected Proofs

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The COVID-19 pandemic has laid bare the fragility of the global system of preparedness and response to pandemics and the fragmentation of our research and development ecosystem. The pandemic has provided a disruptive moment to advance new norms and frameworks for influenza. It also has demonstrated how innovative global public-private partnerships and coordination mechanisms can lead to rapid successes in viral vaccine research, manufacturing, and risk pooling.

Countering the Pandemic Threat Through Global Coordination on Vaccines identifies ways to strengthen pandemic and seasonal influenza global coordination, partnerships, and financing. This report presents seven overarching recommendations for how the urgent influenza threat should be conceptualized and prioritized within the global pandemic preparedness and response agenda in the future.

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