Vaccine Research and Development to Advance Pandemic and Seasonal Influenza Preparedness and Response Lessons from COVID-19 (2022) / Chapter Skim
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4 Manufacturing Science
4 Manufacturing Science
Pages 81-106
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From page 81... ...
. Adding to the current influenza vaccine manufacturing landscape described in Chapter 1, understanding pandemic vaccine manufacturing preparedness and new vaccine technologies that have been rapidly developed and achieved first authorization during the COVID-19 pandemic offers the potential to be used for influenza pandemic preparedness (CEA, 2019)
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Still, the progress made in this regard during the COVID-19 pandemic points to the opportunity to improve global manufacturing capacity for influenza vaccines and set a course for sustainability and continued progress, including preparedness for pandemic influenza.
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. Therefore, different platforms had very different development times during COVID-19, with the novel mRNA vaccine technology being the platform with the fastest development timelines to create a vaccine prototype.
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. MANUFACTURING SCIENCE: APPLYING LESSONS FROM THE PRODUCTION OF COVID-19 VACCINES TO VACCINES FOR INFLUENZA Lessons learned from the production of COVID-19 vaccines highlight the critical importance of pandemic vaccine manufacturing preparedness, especially at the global level.
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In addition, given the vital role vaccine manufacturers play and their responsibilities and accountabilities for the products they develop, produce, and license, the committee identified specific actions that would strengthen seasonal and pandemic influenza vaccine manufacturing. The following sections detail lessons learned from the production of COVID-19 vaccines that can be applied to the manufacturing of influenza vaccines in the areas of global vaccine manufacturing preparedness, scientific and technical considerations, accelerating the timeline for vaccine production, the role of manufacturers and global manufacturing inequities, economic and market considerations, and global stakeholders and international collaborations.
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These vaccines would be deployed and used early in a pandemic response, diminishing the disease burden and allowing for pandemic-specific vaccines to be advanced in parallel. Currently, there are few pre-pandemic vaccines licensed for influenza (Soema et al., 2015)
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. The current vaccine production strategy for an influenza pandemic is to switch manufacturing capacity for seasonal vaccine into production of pandemic vaccines.
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Conclusion 4-1: A pandemic would require an increase in manufactur ing facilities that would be cost-effective only if they were used beyond pandemic vaccine production (Plotkin et al., 2017)
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BOX 4-3 Gaps and Challenges for the Use of mRNA-based Vaccines as a Tool for Influenza Preparedness • Publicly available information on production capacity remains scarce and fragmented. • Production capacity varies widely among vaccines and vaccine platforms (e.g., mRNA vaccine manufacturing capacity does not currently exist widely)
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. Accelerating the Timeline for Influenza Vaccine Production Leveraging Experience with Seasonal Influenza Vaccines to Enhance Pandemic Preparedness In an influenza pandemic, the vaccine manufacturing capacity will be based on the seasonal influenza vaccine production ecosystem and will be better prepared compared to COVID-19.
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Advancing Vaccine Candidates Through Clinical Development Other factors that can improve and accelerate the development time of pandemic vaccines include changes to the framework used for advancing vaccine candidates through clinical development. For influenza, when a novel virus is identified, bulk vaccine is produced and the United States creates a stockpile.
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Conclusion 4-6: As digital technologies, the science of vaccine formula tion, and adjuvant technologies expand, new platforms for the devel opment of seasonal influenza vaccines will be needed to complement rather than replace conventional vaccine platforms. The Role of Manufacturers and Global Manufacturing Inequities As discussed earlier, vaccine manufacturers have undergone significant transformation during the COVID-19 pandemic, and acceleration in technology transfer has been evident.
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. Consequently, it is important to overcome the obstacle of convincing certain regions of the world about the importance of investing in the seasonal influenza landscape, and even more so investing in the new vaccine platforms for influenza preparedness.
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FIGURE 4-3 Countries reporting adult immunization programs by vaccine type and income level. NOTE: Vaccines include Hepatitis B (HepB)
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. Between 2009 and 2019, PATH supported vaccine manufacturers in Brazil, China, India, and other countries to develop, manufacture, and supply seasonal and pandemic influenza vaccines.
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96 FIGURE 4-4 Countries with influenza vaccine production capacity in 2019. SOURCE: Sparrow et al., 2021.
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. The program resulted in an expansion of the global manufacturing capacity for seasonal and pandemic influenza vaccines, but it also showed that long-term investments and local, national, and international regulatory agility, alignment, and consistency are critical, with seasonal influenza vaccine uptake locally as an essential factor.
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Conclusion 4-8: To increase vaccine manufacturing globally, manufac turing processes need to be developed and facilities operationalized in LMICs. Vaccine manufacturing capacity in LMICs could be improved by enhancing technical competencies and quality management systems, providing technical support for the development of seasonal and pan demic influenza vaccines, and developing platforms for local technical training.
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From page 99... ...
For instance, there is interest among private companies, such as Pfizer and Moderna, in developing mRNA vaccines directed at influenza, which was in development pre-COVID-19, and the influenza vaccine research facilitated the COVID-19 vaccine response (Moderna, 2021; Pfizer, 2021)
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From page 100... ...
These investments will need to be sustained both for seasonal and pandemic influenza vaccine R&D activities and for the harmoniza tion and mutual recognition of data and standards, equivalence agree ments and quality control measures, and strengthening of regulatory and pharmacovigilance capacity. Global Stakeholders, International Collaborations, and Networks As recently as 2005, the influenza vaccine market consisted of only two major manufacturers and was of little interest to new actors.
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This includes • Convening, supporting, and encouraging multi-national, public, and private vaccine manufacturers to benchmark, prioritize, and harmonize influenza vaccine manufacturing; and • Enhancing and expanding support of the global influenza vac cine manufacturing network, creating manufacturing hubs for greater collaboration, and building capacity to address chal lenges in manufacturing in low- and middle-income countries. Recommendation 4-2: Vaccine manufacturers should take a risk-based approach to pandemic influenza preparedness.
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2018. Cell culture-derived influenza vaccines in the severe 2017–2018 epidemic season: A step towards improved influenza vaccine effectiveness.
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2021. Towards vaccinating the world: Landscape of current COVID-19 supply chain and manufacturing capacity, potential challenges, initial re sponses, and possible "solution space" -- a discussion document.
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2020. Lessons from COVID-19: Advancing development of universal influenza vaccines.
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2020. Pandemic influenza vaccines: What did we learn from the 2009 pandemic and are we better prepared now?
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2021. Global production capacity of seasonal and pandemic influenza vaccines in 2019.
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