![]() The Biden administration’s National Strategy for the COVID-19 Response and Pandemic Preparedness recognized this challenge specifically in its call to use the Defense Production Act (DPA) to accelerate the manufacture, delivery, and administration of the COVID-19 vaccine (White House, 2021): see Box 3-1. Though manufacturers had a 10-month lead time between developing and producing a vaccine at scale, securing sufficient quantities of ionizable cationic lipids and the associated production capabilities to make billions of doses of vaccine proved to be a heroic undertaking. Food and Drug Administration ) and machinery that are also limited in number ( Hatchett et al., 2021). Even then, the process of turning the lipids into lipid nanoparticles that encase mRNA molecules requires specialized facilities capable of Good Manufacturing Practices (promulgated by the U.S. Synthesizing these lipids entails a complex, multistep process, and only a few facilities worldwide were set up to carry out that synthesis ( McCoy, 2021). ![]() For example, mRNA vaccines that were authorized for use under emergency approval required relatively large amounts of ionizable cationic lipids to create the lipid nanoparticles in which the mRNA constructs were encased for delivery to the appropriate sites in the body ( Crommelin et al., 2021 Schoenmaker et al., 2021). and global or regional actors for their implementation.Ĭritical workforce personnel: Any highly specialized or highly trained person (e.g., process engineer, lipid chemist, quality control analyst, facility engineer, or quality assurance director) whose shortage has the potential to cause a significant delay in the manufacture or release of an unadulterated filled and finished vaccine.ĭuring the COVID-19 pandemic, many of the critical components were in short supply ( Hatchett et al., 2021). Table 3-1 summarizes the recommendations in this chapter, delineated by the U.S. The final two sections consider workforce issues and distributed manufacturing networks. The next five sections consider five aspects of them: manufacturing preparedness and response, forecasting demand, production, stockpiling, and management and allocation. The first section below delineates the critical components that are needed broadly across vaccine manufacturing platforms. ![]() 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. During a pandemic with the need to scale production rapidly, a shortage of trained workers can restrict the quantity of vaccine that is produced ( Hatchett et al., 2021 Tarbet et al., 2013). In addition, vaccine manufacturing at scale requires a highly trained workforce that understands the exact procedures needed for a product that requires quality standards and regulatory approval for use in humans. That is, a resilient and robust supply chain is essential, both to operate at one scale during “normal” years of seasonal influenza and to dramatically scale up during a pandemic. If the supply of one of these components cannot meet the demand, then the entire production of a vaccine can grind to a halt. Manufacturers must also procure adequate supplies of more than 100 different critical components, including glass vials, filters of various types, tubing, stabilizing agents, and disposable bags ( Hatchett et al., 2021). A manufacturing plant may require about “9,000 different materials sourced from some 300 suppliers across approximately 30 different countries” to produce vaccines ( WTO, 2020, p. After a new vaccine is designed and shown to be safe and effective, the main challenge that manufacturers face is scaling production. Producing large amounts of a vaccine in a short period of time entails more than developing the proper biological construct-such as a candidate vaccine virus, recombinant antigen, or mRNA-as quickly as possible.
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