Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines (2022) / Chapter Skim
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3 Critical Components for Vaccine Manufacturing
3 Critical Components for Vaccine Manufacturing
Pages 59-94
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. In this chapter the committee discusses the challenges of ensuring ample supplies of the critical components for vaccine manufacturing and the capacity of the global supply chain for critical vaccine components.
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and global or regional actors for their implementation. TABLE 3-1 Summary of Recommendations on Critical Components for Vaccine Manufacturing Global or Regional Actor Recommendation Domestic Actor(s)
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• Critical workforce personnel: Any highly specialized or highly trained person (e.g., process engineer, lipid chemist, quality con
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, ionizable cationic lipids may likely be on the list of critical components for seasonal and pandemic influenza vaccines. MANUFACTURING PREPAREDNESS AND RESPONSE Supply constraints and shortages of critical components occur frequently, particularly during surge demand for vaccines.
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Care should be taken to use tools like the DPA to ease production bottlenecks and make supplies available without harming global supply chains (Bollyky and Bown, 2020)
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64 FIGURE 3-1 Supply chain challenges along the value chain. NOTES: Upstream and downstream refer to the stages in vaccine manufacturing and not the global supply chain.
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. While the direct effects of these actions are still unknown, it is clear that export restrictions have the potential to limit global access to critical components, potentially hindering vaccine manufacturing capacity worldwide (Casey and Cimino-Isaacs, 2021)
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. A Global Perspective Supply of most critical components for manufacturing influenza vaccines currently relies on an uncoordinated, decentralized global supply chain.
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. COVAX's Manufacturing Task Force and CEPI's list of critical components could serve as models for similar efforts to identify potential bottlenecks in influenza vaccine supply chains for both domestic and global vaccine manufacturing capacity.
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. While national mechanisms exist to define, identify, and appropriately track the availability of critical components necessary to manufacture seasonal or pandemic influenza vaccines (albeit subject to the usual political and fiscal "tides" of funding)
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The COVAX Manufacturing Task Force and the new U.S.–EU joint task force have made strides toward streamlining procurement of critical components. While both of these examples are limited in scope, the committee believes that a global entity could be established, building on this foundation, to further increase visibility and access to critical vaccine components for broader pandemic preparedness.
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Today, however, with recombinant technology used to make one approved influenza vaccine and other technologies primed to contribute to or completely change influenza vaccine production, forecasting derived demand has become challenging because production technologies require several common and several unique critical components. In fact, a key question to answer even before forecasting derived demand is how much demand there will be for each vaccine produced by a different process.
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Critical components necessary for vaccine production, including a skilled workforce and necessary trainers, need to be mobilized nearly instantly to address pandemic influenza in a compressed timeframe for vaccines to have a meaningful public health impact. As such, national and global mechanisms are needed to actively forecast critical component bottlenecks, inventories, and supply requirements for forecasted pandemic influenza vaccine demand, both nationally and globally.
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Having insight into potential supply bottlenecks and the length of time to produce and scale up production of critical components is essential for accurate supply forecasting and vaccine production planning. Scaling up manufacturing capacity to meet surge critical inputs, analytics, and equipment supply demands, such as during an influenza pandemic, may have long lead times and require significant at-risk capital investment and on-going maintenance and readiness costs (Mirasol, 2020)
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Because the specific composition of a well-matched influenza vaccine for use in a pandemic remains uncertain until the specific influenza strain causes an outbreak (Paules and Fauci, 2019) , stockpiling pre-pandemic influenza vaccines carries a high cost and a risk of stockpiling poorly matched vaccines (Yen et al., 2015)
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While the value of strategic stockpiles remains unquestioned in public health emergency responses, such as for pandemic influenza, establishing and sustaining fit-for-purpose strategic stockpiles of critical components for influenza vaccine manufacturing has many challenges. MANAGEMENT AND ALLOCATION Uncoordinated and unpredictable management and allocation of critical components, particularly during an influenza pandemic, can lead to bottlenecks and stockouts (Sparrow et al., 2021)
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, could serve as an example of a framework that could be applied to critical components of influenza vaccines (Huff-Rousselle, 2012)
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Agency for International Development) provide technical and resourcing support for the committee's recommended task force to fore cast supply and demand of critical inputs, including workforce personnel and training needs for pandemic influenza vaccine manufacturing, and perform a resiliency assessment of the cur rent end-to-end network to identify vulnerabilities in physical inputs, as well workforce gaps, that may impede pandemic influenza vaccine manufacturing.
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As part of Regulatory Preparedness for Human Pandemic Influenza Vaccines, published in 2007, WHO noted the inherent variability in assay systems and cautioned against comparing results from different studies. To that point, one study analyzed serological Zika-positive samples from different laboratories around the globe and found a more than 100-fold
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should evaluate the development of fast turnaround batch release (in cluding potency and stability-indicating) assays for seasonal and pan demic influenza vaccine manufacturing and ready global access to international reference standards and benchmark comparators (e.g., immunological reagents)
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The COVAX Manufacturing Task Force advocates for the need for free movement of critical components for vaccine manufacturing, which includes a skilled workforce (COVAX Manufacturing Task Force, 2021)
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A library of training materials and on-demand trainers are needed to enable manufacturers of vaccines and vaccine-critical components to select specific and relevant training for their workforce for scaling up and scaling out influenza vaccine manufacturing and its critical components. A standing "reserve corps" of highly trained and experienced technology transfer chemistry, manufacturing, controls, and quality control and assurance experts that can be deployed immediately are also needed to enable vaccine manufacturers to scale up and scale out influenza vaccine manufacturing during a response to pandemic influenza.
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To ensure manufacturing readiness for an influenza pandemic response, regular, recurrent preparedness drills (e.g., annual live-action exercises using off-the-shelf available resources and protocols, and tabletop exercises) would need to be conducted to refresh and assess scale-up and scale-out of influenza vaccine manufacturing.
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As envisioned, the educational experience would bring trainees through the entire manufacturing supply chain to learn while making a vaccine, similar to the International Influenza Vaccine Manufacturing Capacity Building Program set up by BARDA in conjunction with PATH and WHO's GAP (BARDA, 2019)
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Opportunity partners with the Training Association for Supply Chain Program Management East Africa A Rwanda-based program that trains Gavi, The Vaccine Alliance; Vaccine Supply workforce personnel in managing and United Parcel Service; the Chain Center of developing innovations for vaccine International Federation of Excellence supply chains (Gavi, 2021) Pharmaceutical Wholesalers; and LOGIVAC Center partner with the University of Rwanda Developing An alliance of vaccine manufacturers As of 2020, DCVMN Countries from developing countries that engage partnered with 41 developing Vaccine in vaccine research, development, country manufacturers from Manufacturers manufacturing, and supply of accessible 14 countries and territories Network and quality vaccines (DCVMN, 2021)
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DISTRIBUTED MANUFACTURING NETWORKS Ensuring equitable access to influenza vaccines for all, especially during a pandemic, requires a well-coordinated globally distributed sustainable vaccine manufacturing network. The design of such a network requires balancing speed, efficiency, flexibility, and responsiveness to regional needs to ensure equitable access.
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Global and even regional networking and sharing of resources for vaccine manufacturing present significant political and logistical challenges, especially in a pandemic. The ability to switch as quickly as possible from seasonal to pandemic influenza vaccine manufacturing is critical at the on
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As noted below, global manufacturing networks that rely on the complex global supply chain are even more challenging to manage during a public health emergency of international concern -- a less than ideal situation during an influenza pandemic. COVAX launched the Manufacturing and Supply Chain Task Force to urgently address shortages and expedite cross-border transit of critical components for manufacturing COVID-19 vaccines and to facilitate global and regional vaccine manufacturing networks (COVAX, 2021b)
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As discussed above, countries with robust seasonal influenza vaccine programs are better prepared to respond to a pandemic with their established capacity and greater familiarity with vaccines. Without global and regional vaccine manufacturing networks or robust local and regional vaccine production established and sustained to reduce the global threat of pandemic influenza, global supply and equitable access to pandemic influenza vaccines will remain uncertain and at highest risk.
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2019. International influenza vaccine manufacturing capacity building program.
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2021. How COVID-19 vaccine supply chains emerged in the midst of a pandemic.
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2021. The vaccine supply chain: A call for resilience analytics to support COVID-19 vaccine production and distribution.
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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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2019. Influenza vaccines: Good, but we can do better.
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2021. Global production capacity of seasonal and pandemic influenza vaccines in 2019.
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2016. Key elements of sustainability for influenza vaccine manufacturing in low and middle income countries.
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