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From page 1... ... Addressing needs of low- and middle-income countries has been particularly challenging. These health emergencies have exposed gaps in pandemic preparedness and revealed opportunities to enhance global vaccine infrastructure, manufacturing, distribution, and administration, highlighting how vaccines and their subsequent distribution are critical to help save lives. Read the entire page →
From page 2... ... and a global perspective, though not on a country-by-country basis. KEY FINDINGS • Since global vaccine manufacturing requires timely access to hun dreds of items, critical components must be defined, identified, and managed for seasonal and pandemic influenza to ensure unin terrupted, timely, equitable vaccine supply dependent on varying requirements of different vaccine platforms. Read the entire page →
From page 3... ... • A globally distributed network for influenza vaccine manufactur ing, including mechanisms for sustained financing, is needed to ensure equitable access to vaccines for all. • Managing the complexities of an end-to-end global influenza vac cine manufacturing supply network requires a global entity to coordinate actions of multiple stakeholders and ensure production and distribution of numerous inputs, equipment, resources, and infrastructure. Read the entire page →
From page 4... ... A standing reserve corps -- composed of highly trained and experienced experts in technology transfer chemistry, manufacturing, and controls, as well as quality control and assurance specialists -- that can be deployed immediately will help vaccine manufacturers meet demand during a pandemic influenza response. The committee concludes that global supply and equitable access to pandemic influenza vaccines will remain uncertain and at highest risk without globally and regionally distributed vaccine manufacturing networks. Read the entire page →
From page 5... ... to develop a comprehensive pandemic preparedness and response capability framework that consists of three elements: • End-to-end visibility of critical inputs: in collaboration with the World Trade Organization, the Coalition for Epidemic Preparedness Innovations, the Developing Countries Vaccine Manufacturers Network, and the International Federation of Pharmaceutical Manufacturers & Associations, evaluate a means to define, identify, and track (e.g., through barcodes and block chain technologies) the global real-time availability of potentially supply-constrained critical inputs necessary to manufacture vac cines for pandemic influenza, known as the essential global com mons list for pandemic influenza vaccine manufacturing. Read the entire page →
From page 6... ... government entities to provide tech nical and resourcing support to the committee's recommended task force to develop technical capabilities to ensure sourcing, production, distribution, risk management, and coordination of critical components necessary for manufacturing seasonal and pandemic influenza vaccines, including capabilities to ensure globally effective preparedness and response. Read the entire page →
From page 7... ... interagency stakeholders and working closely with global agencies, such as the World Health Organization, should provide technical and resourcing support to the committee's recom mended task force to evaluate the feasibility, structure, and sustain ability of a globally distributed network of regional and local vaccine manufacturing capacity. DISTRIBUTION AND DELIVERY Getting vaccines into people's arms requires carefully orchestrated global and in-country logistics. Read the entire page →
From page 8... ... , in partnership with its counterparts in other countries and relevant global stakeholders and funders, should ensure a systems approach to the design and development of vaccines for fea sible distribution and delivery in various global contexts and support relevant innovations. Read the entire page →
From page 9... ... RECOMMENDATION 4-5: The Office of Global Affairs, in partner ship with the World Health Organization, Gavi, the United Nations Children's Fund, and relevant global funders, should facilitate the de velopment of global tools to help countries with better supply planning for vaccines and ancillary supplies planning, allocation, and rollout decisions, and with obtaining necessary funding for operations. FRAMEWORKS, TOOLS, AND INNOVATIONS FOR DISTRIBUTION READINESS Vaccine distribution requires preparedness on global, national, and local levels. Read the entire page →
From page 10... ... RECOMMENDATION 5-3: The World Health Organization, working with relevant partners, such as the Coalition for Epidemic Preparedness Innovations, the United Nations Children's Fund, and Gavi, should support the development of a global influenza vaccine supply and demand planning tool. The tool should be linked or aligned to allow real-time consolidation of relevant global data to inform manufacturing and accuracy of supply and demand status to better inform allocation and avoid wastage. Read the entire page →
From page 11... ... • Global institutions, including G20, the World Bank, the International Monetary Fund, and the International Finance Corporation, and regional multilateral development banks should integrate country preparedness assessments into their country economic assistance programs, such as development assistance, loans, and grants, and they should advocate for financial support. They should also identify gaps in country preparedness and develop and evaluate pandemic preparedness and response plans. Read the entire page →
From page 12... ... The review should cover such critical areas as regulatory approval, manufacturing, global and in-country distribu tion, delivery, and lessons learned, and it should identify innovation gaps for future pandemic preparedness and response. BARRIERS, INCENTIVES, AND INNOVATIONS FOR SUSTAINABLE MANUFACTURING The global effort to produce COVID-19 vaccines highlighted pertinent issues to sustainable manufacturing for seasonal and pandemic influenza vaccines. Read the entire page →
From page 13... ... Mechanisms such as harmonization and reliance can streamline guidelines and are critical for seasonal influenza vaccine development, demonstration of its safety and efficacy, and scale-up of manufacturing for population-based use. Similarly, global agreement requirements to release pandemic influenza vaccine is needed before an outbreak begins. Read the entire page →
From page 14... ... Agency for International Develop ment should provide concessional capital and technical assistance to manufacturers in developing countries to begin producing improved seasonal and pandemic influenza vaccines. RECOMMENDATION 6-4: The World Bank should develop a global indemnification mechanism that can be applied to all vaccines with World Health Organization emergency use listing or prequalification, regardless of the mechanism (pooled or bilateral) Read the entire page →
From page 15... ... SUMMARY 15 for pandemic influenza vaccine manufacturing countries whereby they agree to undergo plant inspections by independent inspectors and only export vaccines that are approved through WHO's emergency use list ing procedures or prequalification program. Read the entire page →

From page 1...

... Addressing needs of low- and middle-income countries has been particularly challenging. These health emergencies have exposed gaps in pandemic preparedness and revealed opportunities to enhance global vaccine infrastructure, manufacturing, distribution, and administration, highlighting how vaccines and their subsequent distribution are critical to help save lives.

Summary Pages 1-16

Summary
Pages 1-16