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years. 53 Even if an adequate supply of MCMs could be assured, for example, from preestablished stockpiles, dispensing and administration of vaccines, drugs, and other MCMs would be a significant challenge. Many countries currently do not have the capacity to accept large amounts of MCMs much less rapidly administer them en masse. Points of dispensing (PODs), mass vaccination campaigns, and other extraordinary public health measures would need to be taken to achieve population-level protection. What is needed, but is not currently possible, is the capability to get MCMs from discovery to mass administration within a few months. This would include very rapid identification of drug or vaccine targets, development of the drug or vaccine itself, safety and efficacy testing and regulatory approval, manufacturing at a global scale and ensuring MCM quality, sharing MCMs equitably throughout the population, and mass dispensing and administration. With this in mind, investment in next-generation approaches to MCM research, development, manufacturing, dispensing, and administration will be critical to creating an effective response capacity globally. CEPI is an important new global organization whose purpose is to develop vaccine candidates for diseases with epidemic potential. CEPI has engaged many vaccine development companies in this work to date. Even if CEPI succeeds as is hoped, a system will need to be built around it for creating rapid development pathways for dealing with novel, fast-moving threats; for rapid clinical testing; and for mass manufacturing of products once they are shown to be effective and safe.116 Platform technologies have been called for as a means of accelerating vaccine development for pandemic preparedness. We define a platform technology as one employing an “underlying, nearly identical mechanism, device, delivery vector, or cell line . . . for multiple target vaccines.”117,118 The chief potential advantages to this approach would be to save time and cost by building on systems that are already proven effective and to rely on systems in an emergency that have been shown to work. Nucleic acid vaccines, for example, are readily adapted for new targets by simply changing the nucleotide sequence; manufacture and its attendant safety testing is simplified because these vaccines could be considered “chemicals” and, like the manufacture of small-molecule chemical MCMs, may not need extensive batch testing once the manufacturing processes are established. Flexible manufacturing offers another approach for expediting the development of MCMs. Technologies for flexible manufacturing include single-use components for all stages of manufacture (production, processing, and fill-and-finish), modular factory design, portable modular manufacturing, and continuous processing. Some of these techniques are already in widespread use; others are in development. These technologies can be used in combination with platform vaccine technologies, which would allow multiple candidate vaccines using the same platform to be manufactured at the same site. 54 Another advance that could make scale-up of drugs and vaccines more feasible in events involving a high-impact respiratory pathogen is the strategy of distributed manufacturing. Traditional manufacturing processes often bring together, assemble, and process materials in centrally located sites, and the products are then distributed out to the customer. However, in the future it is possible to envision distributed manufacturing, in which the final products are assembled and distributed from sites closer to the final customers. A vision for distributed manufacturing posits that much of the supply chain can be supplied digitally. Decentralized, small-scale production facilities, biokits, minilabs, or 3D printers could enable widespread production of MCMs at local outlets (eg, local manufacturing centers, pharmacies, or hospitals). Globally distributed manufacturing could provide products for areas that currently lack the capacity to produce MCMs. These approaches could lead to more equitable coverage during a crisis and allow remote and at-risk populations to receive MCMs more quickly. If local outlets routinely used distributed manufacturing to produce drugs for normal use, these units could provide emergency capacity during an event involving a high-impact respiratory pathogen. Globally distributed manufacturing could also have the virtues of being less susceptible to single point failures, either by accident or deliberate disruption, and less vulnerable to trade disruptions than conventional manufacturing. While distributed manufacturing would still rely on international trade for raw materials, it would reduce reliance on a small number of critical manufacturing nodes. In contrast, today’s biopharmaceutical industry relies on centralized production in relatively few countries. Higher-income countries would likely be able to benefit from this strategy earlier, but donors and international organizations could assist in helping lower-income countries, individually or as regional or partner groups, also develop these capacities. While healthcare workers in a pandemic would require and be comfortable using PPE, specifically masks and respirators, providing masks for the public to limit risk of transmission would be a greater challenge. Widespread use of masks and respirators by the public would be complicated by the challenges of proper fit, the costs, and the inability of the supply chain to provide masks at that scale.119 The same mask suppliers would be besieged by countries and healthcare facilities around the world. If there were limited availability of masks and respirators in a given country (which would be highly probable), they would need to be prioritized for health facilities to provide protection for healthcare workers and increase infection prevention and control measures. Beyond this, in the public setting, there is very little available information that studies the effectiveness of masks outside of health facilities. Additional research into the development of easyto-use, effective, and reusable masks for wider use should be considered. 55 Box 7: The Economics of Medical Countermeasure Development The development of medical