Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines (2022) / Chapter Skim
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Appendix A: Review of Previous Recommendations for Pandemic Vaccine Manufacturing
Appendix A: Review of Previous Recommendations for Pandemic Vaccine Manufacturing
Pages 193-222
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There was significant thematic overlap in recommendation topics across reports, which can be categorized in five areas: • innovation in vaccine development and production technologies, • optimization of pandemic vaccine production processes, • regulatory harmonization, • stakeholder coordination, and • sustainable funding.
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In 2006, the World Health Organization's Global Action Plan for Influenza Vaccines (GAP) urged the development of more potent and effective vaccine candidates (WHO, 2006)
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, highlighting the importance of funding mechanisms in expanding and sustaining development efforts. Alternative recommendations to facilitate rapid availability of pandemic influenza vaccines have included the development of mock-up "pandemic-like" vaccines designed to protect against anticipated pandemic virus characteristics (WHO, 2004)
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. Another prominent recommendation to address the manufacturing capacity constraints for pandemic influenza vaccines has been to globally increase and sustain seasonal influenza vaccine programs.
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. Other recommendations included updating global vaccine manufacturing preparedness plans for switching from seasonal to pandemic vaccine manufacturing (WHO, 2019)
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. STAKEHOLDER COORDINATION Given the interdependence of vaccine development, production, regulation, and distribution, pandemic vaccine manufacturing has consistently faced challenges in timely scale-up.
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For most influenza vaccine technologies, this process begins with sharing the candidate vaccine viruses and reference reagents needed for vaccine development and production with vaccine manufacturers. These materials are critical as both egg-based and cell-based vaccine production require the candidate vaccine viruses to replicate and process with their respective technologies (PCAST, 2010)
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. Analysis of the H1N1 and Ebola responses made clear that investments in health infrastructure, including vaccine manufacturing capacity, have been inadequate despite formal commitments of national governments to do so under the 2005 International Health Regulations (Moon et al., 2015)
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. CONCLUSION The recommendations identified in this review highlight that pandemic vaccine manufacturing capacity is impacted by each phase of the pandemic
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In addressing pandemic manufacturing capacity, recommendations emphasize investment in research and development of more efficient and flexible production technologies, including the use of cell-based technologies and vaccine platforms that can more readily be mobilized for pandemic manufacturing. Recommendations addressing production capacity have evolved given recent experiences with outbreaks, shifting emphasis away from stockpiles as a mechanism for ensuring pandemic influenza vaccine supply to the development of stronger manufacturing capacity driven by established demand for seasonal influenza vaccines.
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WHO (Simon et al., Recommend formation of Create a patent pool for SARS genomic CDC, Health Canada, 2005) a patent pool for SARS sequence to facilitate vaccine development and HKU/Veritech, Erasmus genomic sequence.
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of vaccine manufacturers vaccines, at a sufficient scale influenza vaccine manufacturing through 3.
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clearer government and manufacturer Deployment Initiative Deployment Initiative and agreements, and collaborators, including identify action points to 2. approval and licensing changes to technical agencies, donor improve upon the systems accelerate pandemic vaccine manufacturing governments, and private established to respond more process.
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. supply pandemic influenza vaccines to low- 3.
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Expedite development of a universal Unspecified lessons learned from pandemic influenza vaccine. influenza pandemics and 2.
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Build integrated planning tools and CEPI Norway and India, coordinate and finance sustain investments for end-to-end the Bill & Melinda vaccine development against capabilities through joint coordination and Gates Foundation, the emerging infectious diseases management. Wellcome Trust, and with epidemic potential.
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agencies, solution for manufacturing 2. Invest in vaccine platforms and international agencies, and pandemic influenza vaccines manufacturing processes that achieve a vaccine manufacturers in extremely compressed shorter timeline to first dose.
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platforms and increase and sustain seasonal influenza vaccine production with these technologies and platforms that can be leveraged for pandemic response. COVAX Identify and resolve issues 1.
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Invest in platform vaccine technologies The global community from key informant insights providing flexibility to accelerate on how to improve global manufacturing capabilities. vaccine manufacturing 2.
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Develop new influenza vaccines that are Vaccine manufacturers vaccine production in higher-yielding, faster to produce, broader LMICs. in protection, and longer-lasting.
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Food and Drug Administration; GAP = Global Action Plan for Influenza Vaccines; GISRS = Global Influenza Surveillance and Response System; HHS = U.S. Department of Health and Human Services; IFPMA = International Federation of Pharmaceutical Manufacturers & Associations; IOM = Institute of Medicine; IP = intellectual property; IVS = Influenza Vaccine Supply; LMIC = low- and middle-income country; LSHTM = London School of Hygiene & Tropical Medicine; NASEM = National Academies of Sciences, Engineering, and Medicine; NGOs = nongovernmental organizations; NIAID = National Institute of Allergy and Infectious Diseases; NVAC = National Vaccine Advisory Committee; PCAST = President's Council of Advisors on Science and Technology; R&D = research and development; SAGE = WHO Strategic Advisory Group of Experts on Immunization; SARS = severe acute respiratory syndrome; WHO = World Health Organization.
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. Develop influenza vaccines offering broad multi-strain protection for stockpiles (Newland et al., 2021)
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. Pandemic Vaccine Establishment of pandemic 2007 Produce and donate avian flu vaccines to the WHO Production Processes influenza vaccine stockpiles stockpile (SAGE, 2007)
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. Improve and sustain domestic production platforms and increase and sustain seasonal influenza vaccine production with these technologies and platforms that can be leveraged for pandemic response (ASPR, 2020)
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. Enhance vaccine production 2010 Improve surge production capacity mechanisms (IOM, capacity for pandemic 2004)
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2017. Guide to revision of national pandemic influenza preparedness plans: Lessons learned from the 2009 A(H1N1)
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2010. Report to the president on reengineering the influenza vaccine production enterprise to meet the chal lenges of pandemic influenza.
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2004. Vaccines for pandemic influenza: Informal meeting of WHO, influenza vaccine manufacturers, national licensing agencies, and government representatives on influenza pandemic vaccines.
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2016. The ten years of the Global Action Plan for influenza vaccines.
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