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Suggested Citation:"7 A Way Forward." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Page 189
Suggested Citation:"7 A Way Forward." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Page 190
Suggested Citation:"7 A Way Forward." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Page 191
Suggested Citation:"7 A Way Forward." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Page 192

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7 A Way Forward Each year, approximately 10 to 20 percent of the world’s population is infected with influenza viruses, inflicting a vast toll in terms of lives lost and economic burden (Peasah et al., 2013). Should a pandemic strain of influenza virus emerge, that toll could soar, as the appearance of the SARS-CoV-2 coro- navirus, the virus that causes COVID-19, demonstrated. As the COVID-19 pandemic also demonstrated, vaccines will be at the forefront of all efforts to stem a pandemic, as well as to reduce the toll of seasonal influenza outbreaks. Given that the emergence of an influenza pandemic is unpredictable, the most prudent action the world can take is to be alert and prepared. Meeting the challenges of influenza preparedness will require new ap- proaches to developing vaccines that go beyond the current egg-based tech- nologies, which are not sustainable on a global scale. Developing improved vaccines, however, depends on an end-to-end design that considers feasibil- ity from the point of production to “last mile” delivery and administration when developing products. In that respect, intentional efforts to harmonize every step of vaccine manufacturing and distribution will be integral to the success of new products; harmonization, standardization, and decreasing regulatory barriers are critical to pandemic preparedness. A critical lesson the COVID-19 pandemic has taught the world is that to effectively respond to a pandemic, it truly requires a global multi-stake- holder response. Manufacturers, regulators, and global agencies all need to be coordinated for there to be a sustainable and viable system, including the supply chain that supports vaccine manufacturing and distribution, to produce and supply life-saving vaccines. All of these concerns depend on 189

190 GLOBALLY RESILIENT SUPPLY CHAINS demand and market considerations, and as new platforms are risky for manufacturers, incentives will be required to facilitate production. The committee briefly outlines below a way forward for governments, multilateral organizations, civil society, manufacturers, and others to be bet- ter-prepared to meet the demands of both seasonal and pandemic influenza. VACCINE TECHNOLOGIES AND INNOVATIONS Nucleic acid–based, primarily mRNA, technologies have been at the crux of rapid development and production scale-up for COVID-19 vac- cines. Although the COVID-19 vaccines are the first mRNA vaccines to be widely used, mRNA technology has been in development for decades. Responding to COVID-19 would not have been possible without a wide range of innovations in vaccine research and development, as well as expe- dited regulatory review, manufacturing, and distribution. The response to COVID-19 forced innovations in different aspects of the end-to-end supply chain. The committee believes that it would be worthwhile for other groups to further explore the impact of innovations that have grown out of the COVID-19 pandemic. A detailed assessment of these innovations could allow a greater understanding of how they could be further advanced and applied to future endeavors. Working to identify cutting-edge and innova- tive vaccine platform technologies is key. There has also been comparatively little research and investment on therapeutics for direct oral antivirals for coronaviruses, and the committee believes that the world is seriously suffering from this lack. These types of investment are also crucial. The world would benefit from a retrospective analysis of COVID-19 innovation gaps, which would identify the most challenging areas in which innovation could have led to greater success. These innovations did not occur out of sheer luck, but from years of re- search, development, and investment. However, there are consistent gaps that the committee has identified: they will need to be addressed in the future to avoid many of the challenges seen throughout the COVID-19 pandemic, as well as in prior public health events of international concern. AN INTEGRATED APPROACH ACROSS THE VACCINE LANDSCAPE Appendix A of this report highlights many of the recommendations that have been put forth to address vaccine manufacturing in the last 20 years. A review of these recommendations (see Table A-1) indicates a need for better accountability to ensure that the world does not encounter the same vaccine manufacturing challenges—that it learns from the past. Previous public health emergencies of international concern have taught the world

A WAY FORWARD 191 that addressing manufacturing gaps in a siloed manner is insufficient. There is an urgent need to examine how vaccine manufacturing, supply chains, and overall preparedness can be better coordinated in the future. The cur- rent siloed approach is not equipped to truly address global challenges. The COVID-19 pandemic highlighted that the status quo is ineffective when there is a need to manufacture and distribute life-saving vaccines as quickly as possible throughout the entire world. Domestically, this integration can be very complex in a pandemic. Currently, there are “pop-up” structures that are established in light of a pandemic, as well as elaborate interagency groups that keep one another informed, so agencies like the Biomedical Advanced Research and Devel- opment Authority in the U.S. Department of Health and Human Services (HHS) are not operating in total isolation. But the overall public health countermeasures enterprise is not limited to just HHS and its constituent agencies: it also includes the U.S. Departments of Defense, Homeland Secu- rity, State, and Commerce. Globally, the COVID-19 pandemic highlighted that international organizations, including COVID-19 Vaccines Global Ac- cess, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization have a degree of collaboration, but that better coor- dination is needed between the United States and these entities. There is also a need to evaluate regulatory bottlenecks within global entities such as medicine regulatory agencies in other countries, particu- larly in low- and middle-income countries. These agencies have significant influence over the vaccines that are used within their countries, and it is important that they not be overlooked. Global coordination needs to oc- cur at all levels, not just among multilateral institutions. The demonstrable lesson from the COVID-19 pandemic is that siloed domestic and global responses proved to be counterproductive and ineffective. In order to be prepared for future pandemics, a more interactive and dynamic structure for vaccine manufacturing, regulation, and the end-to-end supply chain needs to be a high priority. FINAL THOUGHTS It is the committee’s hope that the future of vaccine manufacturing and supply chains is resilient, data-driven, and equitable, and has a well- coordinated risk-management structure. The recommendations in this re- port provide strategies and approaches to enable future designs that can be adopted and adapted based on specific needs. It is important to note that that many aspects of vaccine manufacturing and end-to-end supply chains are dynamic, especially as the global structures for pandemics evolve. There have been many discussions about where financing will come from and how it will be organized. More guidance on the intricacies of how it should be

192 GLOBALLY RESILIENT SUPPLY CHAINS organized and addressed can be found in the upcoming report of one of this committee’s sister committees, on global coordination, partnerships, and financing for advancing pandemic and seasonal influenza vaccine pre- paredness and response.1 Additionally, the committee notes that many of the vaccine platform technologies used for influenza vaccines are dynamic in how they are de- veloped and manufactured. The recommendations of the committee will at times need to be viewed in recognition of these changes to define a path forward, which relies on coordination among global and domestic entities. It is also extremely important for the global community to interpret this report and its recommendations in tandem with other reports that examine the response to the COVID-19 pandemic, not only those of the sister com- mittees of the National Academies of Sciences, Engineering, and Medicine, but also those of other organizations, including COVID-19: Make It the Last Pandemic (IPPPR, 2021) and A Global Deal for Our Pandemic Age (G20, 2021). Many of the committee’s recommendations complement these reports and the recommendations they offer regarding pandemic financing, preparedness, and prevention. There is no escaping the inevitability of seasonal and pandemic influ- enza, so it is best to be prepared for when they do occur. It is the com- mittee’s hope that this report aids in the future preparation that is so desperately needed. REFERENCES G20. 2021. A global deal for our pandemic age. Report of the G20 High Level Independent Panel. https://www.g20.org/wp-content/uploads/2021/07/G20-HLIP-Report.pdf (ac- cessed October 17, 2021). IPPPR (Independent Panel for Pandemic Preparedness and Response). 2021. COVID-19: Make it the last pandemic. https://theindependentpanel.org/wp-content/uploads/2021/05/ COVID-19-Make-it-the-Last-Pandemic_final.pdf (accessed October 17, 2021). Peasah, S. K., E. Azziz-Baumgartner, J. Breese, M. I. Meltzer, and M. A. Widdowson. 2013. In- fluenza cost and cost-effectiveness studies globally—A review. Vaccine 31(46):5339–5348. 1 Information about the larger project and all four committees is available at https://www. nationalacademies.org/our-work/advancing-pandemic-and-seasonal-influenza-vaccine- preparedness-and-response-harnessing-lessons-from-the-efforts-to-mitigate-the-covid-19- pandemic (accessed October 17, 2021).

Next: Appendix A: Review of Previous Recommendations for Pandemic Vaccine Manufacturing »
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Influenza viruses, both seasonal and pandemic, have the potential to disrupt the health and well-being of populations around the world. The global response to the COVID-19 pandemic and prior public health emergencies of international concern illustrate the importance of global preparedness and coordination among governments, academia, scientists, policy makers, nongovernmental organizations, the private sector, and the public to address the threat of pandemic influenza. These health emergencies have revealed opportunities to enhance global vaccine infrastructure, manufacturing, distribution, and administration.

Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines outlines key findings and recommendations to bolster vaccine distribution, manufacturing, and supply chains for future seasonal and pandemic influenza events. This report addresses the challenges of manufacturing and distributing vaccines for both seasonal and pandemic influenza, highlighting the critical components of vaccine manufacturing and distribution and offering recommendations that would address gaps in the current global vaccine infrastructure.

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