Countering the Pandemic Threat Through Global Coordination on Vaccines The Influenza Imperative (2022) / Chapter Skim
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6 Recommendations and the Path Forward
6 Recommendations and the Path Forward
Pages 155-190
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From page 155... ...
, and proposals for a pandemic treaty or instrument, have all been active in 2021. Preparing for influenza as one of, but not the sole, major pandemic threat recognizes that, epidemiologically, seasonal influenza imposes a major, annual societal burden across countries during non-pandemic years and that this family of viruses also causes influenza pandemics, which could disrupt society as much or more than any other known microbiological threat.
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From page 156... ...
Acknowledging and acting on the core principle of fair and equitable access to vaccines is a required foundation for broad and sustained support for the global coordination mechanisms and agreements necessary for a PPR agenda for respiratory pathogens, including vaccines for pandemic influenza. There are two complementary ways to approach equitable allocation of vaccines: creating specific frameworks that include equity considerations directly and scaling up and distributing manufacturing to reduce scarcity.
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From page 157... ...
Above all, a dedicated and well-resourced effort to develop a universal influenza vaccine that can provide durable protection against any influenza virus that is capable of causing serious human infections could take the threat of influenza -- both seasonal and pandemic -- off the table. The importance of scaling up surge manufacturing capacity for influenza vaccines cannot be overstated.
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From page 158... ...
, may allow establishing a "grand bargain." Crucially, the future business case for influenza must recognize that the seasonal influenza vaccine market alone will not be sufficient to drive pandemic production. When approaching global coordination, partnerships, and financing for influenza and other respiratory pathogens with pandemic potential, it is vital to consider the underlying grand bargain that must be reached among stakeholders.
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From page 159... ...
) and resources to make the development of next-generation and, ideally, universal influenza vaccines a priority; • Incentivizing the development of sustainable, geographically dis tributed hubs to scale up vaccine production and relevant supply chains, through a global partnership program coordinated by CEPI or another organization with a global reach; • Ensuring that financing solutions for global surveillance encom passes all pathogens with regional or global pandemic potential, includes zoonotic components, and incentivizes pathogen and ge netic sequence sharing; and • Building demand and national pandemic and adult vaccination planning capacity by ensuring that adequate funding is available to procure, deploy, and deliver next-generation influenza vaccines to any population group identified to be at increased risk.
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From page 160... ...
Programs supporting platform technology R&D and industry partnerships to scale up vaccine production and address supply chain chokeholds are often performed in a semi-isolated context. This is true for influenza and other respiratory pathogens with pandemic potential.
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From page 161... ...
should develop an integrated agenda to strengthen preparedness and response for all respiratory pathogens of pandemic potential, which includes surveillance, information sharing, and the development, manufacturing, and deployment of vaccines and other essential components of the vaccine manufacturing supply chain. This agenda should comprise a key component of the overarching agenda for pandemic preparedness and response, encompass pandemic influenza, and build on existing mechanisms for coordination in the influenza arena.
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From page 162... ...
Determining how to expand funding for these surveillance activities for viruses with pandemic potential, including influenza, is therefore critical. Summary of findings: Surveillance system gaps are related to both financing and barriers for more closely aligning or integrating these systems.
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From page 163... ...
The same agreement provided access to potential pandemic influenza viruses and the sharing of vaccines, antiviral medicines, and other benefits in a pandemic. However, the PIP Framework does not generate enough money to strengthen GISRS in all places.
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Recommendation 2: With urgency (over the next 3–5 years) , the G7 and G20 should ensure that increased investments are made in surveil lance systems for pathogens with pandemic potential, which support and encompass every country and region, by doing the following: a.
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From page 165... ...
3: Limits and Potential of the PIP Framework and Nagoya Protocol for Pathogen Sharing The timely sharing of influenza viruses is essential for developing lifesaving seasonal vaccines, identifying potential pandemic viral strains, and providing early warning for outbreaks. The PIP Framework supports critical surveillance needed for influenza and establishes a multilateral system that places equal importance on ABS and sharing viruses of pandemic potential but avoids a bilateral transactional approach to such sharing.
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From page 166... ...
However, the PIP Framework has limitations: it does not specifically cover genetic sequence data and only covers influenza viruses with pandemic potential and not seasonal influenza viruses or other viruses that might cause a pandemic. Its ability to ensure the availability of vaccines and antiviral medications under pandemic conditions and distribute them equitably remains untested and raises the question of whether the vaccine nationalism prominent early in the COVID-19 response would be repeated for an influenza pandemic.
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From page 167... ...
First, part of the money spent on the PIP Framework is contributed by industry annually. A future multilateral agreement would need to carefully consider that platform and recombinant technologies are bringing new firms into the market, perhaps leading to no well-defined group of firms that produce influenza vaccines (with a similar trend for vaccines for other pathogens with pandemic potential)
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From page 168... ...
A new agreement should address and resolve issues raised by the Nagoya Protocol for sharing influenza viruses and other pathogens with pandemic potential, including genetic sequence data. Recommendation 3: The World Health Assembly (WHA)
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From page 169... ...
4: Public–Private Partnerships to Accelerate Vaccine Development: Structuring Global Partnerships to Support R&D for Influenza Platform Technologies Vaccine development and production for pandemic influenza and emerging infectious diseases has traditionally suffered market failures, in large part because of the combined unknowns of whether (and when)
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From page 170... ...
Because of the high mutation rate and other characteristics of the influenza virus, developing platform technologies for pandemic and seasonal influenza viruses will require significant investment and a continued willingness of industry to form productive, synergistic partnerships. Summary of findings: Successfully responding to the "necessity" of platform innovation for influenza vaccines requires a combination of early R&D incentives, including support of Phase I–III clinical trials for platformand recombinant-based technologies.
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From page 171... ...
The Sabin-Aspen Vaccine Science and Policy Group (2019) proposed creating a new entity to support platform innovation for influenza vaccines, but at the time (2018)
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From page 172... ...
The goal in the next 3–5 years should be to progres sively pursue development and assessment of new platform technolo gies to improve the effectiveness of vaccines, expand the options for production of influenza vaccines, and optimize their production to enhance the speed and volume of manufacturing in parallel to pursuing the "ultimate prize," a universal influenza vaccine. It could take the threat of influenza -- seasonal and pandemic -- off the table.
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From page 173... ...
The G7 and G20 member nations (e.g., through the Global Health Threats Board) should name a global coordination body to specifically coordinate global and regional government–indus try partnerships for influenza vaccines.
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5: An Influenza Vaccine Moonshot: Financing for Transformational Universal Influenza Vaccine R&D, Licensure, and Procurement Universal influenza vaccines would be a complete game changer for pandemic preparedness and seasonal influenza vaccine markets. However, this is a science and not an engineering problem, these vaccines are a long shot, and there is no guarantee that any amount of money invested would yield a product broadly effective across all current and future influenza strains and provide long-term protection in people of all age groups.
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From page 175... ...
Influenza Vaccine Road Map called for exploring the feasibility of a "mission-driven" R&D public–private partnership for universal influenza vaccines, with robust funding. It underscores the importance of working with industry to derisk vaccine R&D and develop a market for producing improved or universal influenza vaccines.
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From page 176... ...
vaccines against coronaviruses with pandemic potential. Recommendation 5: The Global Health Threats Board or similar gov ernance structure created by the G7/G20 pandemic preparedness and response agenda, working with other relevant organizations, should initiate a dedicated "moonshot" program to incentivize development, licensure, and eventual procurement of a universal influenza vaccine candidate as a matter of priority.
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From page 177... ...
6: Supporting Geographically Distributed Hubs for Influenza Vaccine Manufacturing and Supply Chain Capacity Regional hubs offer promise in countering vaccine nationalism and promoting equitable access through self-sufficiency. However, distributing manufacturing does not offer a full solution for addressing issues of vaccine equity.
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New technologies may compress this time line, but capacity would still need to be expanded at least 3-fold to avoid shortages fueling vaccine nationalism. Regionally distributed manufacturing hubs are a way to provide this scaled-up vaccine manufacturing in LMICs.
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capacity remains important -- but current demands for seasonal production are not sufficient to support expansion to meet the demands during a pandemic. A business model for pandemic influenza vaccines requires a business plan for manufacturing facilities to keep them functioning between pandemics.
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From page 180... ...
Scaling up production of pandemic influenza vaccines requires investment in manufacturing, which may be best accomplished through technological assistance for and investments in geographically distributed hubs -- facilities that can produce platform technologies both for evolving influenza vaccines and other targets. Supply chain com modity production requires similar attributes to vaccine production.
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From page 181... ...
Identify or create an international entity to assume responsibility for catalyzing voluntary technology transfer initiatives for platform technologies, including influenza vaccines. The structure's governance should build on both the World Health Organization's and COVAX's work on the COVID-19 mRNA hub, expanding it to include a diverse portfolio of technologies capable of providing protection against diverse threats with pandemic potential, and the COVAX Vaccine Manufacturing Taskforce, expanding it to work with vaccine manufacturing bodies to identify supply chain inputs and needs across a variety of vaccine candidates.
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From page 182... ...
d. Encourage countries considering warming their manufacturing capacity for influenza vaccines and vaccines for other pathogens with pandemic potential to consider whether their focus should instead be on building new production capacity of key manufacturing inputs for vaccine manufacturing.
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A vaccine market supported by an immunization pro gram able to deliver vaccines coupled with a population demand for these vaccines are essential elements to ensure a sustainable vaccine manufacturing base. Stronger national plans for deployment of seasonal influenza vaccines (using next-generation/platform technologies)
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We hope that one of the principal tasks of the G7 and G20 will be to identify more specific actors, institutional arrangements, and financing mechanisms for pandemic threats -- including influenza -- to ensure accountability and provide necessary resources. A first task of the emergent Global Health Threats Board (or the entity designed with this mandate)
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From page 185... ...
The committee did not directly consider how to address these daunting geopolitical challenges, as doing so would have involved venturing far beyond its mandate. However, the committee recognizes that overcoming these challenges, or at least mitigating their consequences for global health, is a prerequisite for success for both the PPR agenda and the specific influenza vaccine recommendations that this committee put forward.
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From page 186... ...
, governance mechanisms (such as a Global Health Threats Board) , and financing programs (such as HLIP's proposed Global Health Threats Fund)
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Much more work is needed to align objectives across these institutions in the context of pandemic threats and back these objectives with dedicated financial resources. We mostly considered this realm from the perspective of surveillance financing for influenza and respiratory pathogens with pandemic potential, but this funding is best seen as the tip of the iceberg in terms of the One Health collaboration required for zoonotic disease PPR.
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From page 188... ...
The path forward for global influenza PPR will require engagement of and coordination among diverse actors, spanning civil society, industry, national entities, bilateral organizations, and multilateral organizations. Each actor will need to recognize the need to temper self-interest to counter the pandemic threat and address the influenza imperative.
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From page 189... ...
2021b. Global Action Plan for Influenza Vaccines: FAQ.
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From page 190... ...
abstract_id=3575660 (accessed August 12, 2021)
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