Embedded Files
Page 56
has changed rapidly in the past decade, toward a more decentralized and distributive process of transferring information and ideas. International public health response has struggled to evolve to fit an environment of rapid exchange of information, misinformation, and disinformation. In order to be truly effective in global public health response, WHO will need to keep up with shifting communication approaches and technologies, to embrace new ways and trends around communication. WHO will likely need to commit significant resources and political capital to invest in these leading-edge communication technologies and approaches. 7. R&D aimed at rapid vaccine development for novel threats and distributed surge manufacturing should be a top global pandemic planning priority. MCM Research and Development There are a range of promising approaches to accelerate rapid vaccine development that should be concomitantly pursued and funded, given the uncertainty in knowing which might bring the most important leaps forward. Traditional vaccine development through big pharma and biotech companies will continue for now to be the backbone of the field. Organizations like CEPI will help to accelerate the development process for vaccines that have already been identified as priorities by WHO. Nucleic acid (RNA and DNA)–based vaccines are widely seen as highly promising and potentially rapid vaccine development pathways, though they have not yet broken through with licensed products. In addition, advancements in non-nucleic acid–based platform technologies offer some hope of improving the speed with which vaccines for novel pandemic threats are developed and should be expanded. Contemporary advances in sequencing and structure function analysis—aided by AI and big data analytic approaches—are yielding improvements in both speed and precision of immunological design and should be supported. Similar gains are evident in the antimicrobial arena; as machine learning enters the drug discovery field, approaches to identifying appropriate targets for microbial control are shortening the times to leads and subsequent sensitivity and specificity studies. Academic institutions, national governments, the biopharmaceutical industry, international organizations, and 71 other stakeholders should be fully engaged in this effort, and accelerating vaccine development for rapid creation of a vaccine in the setting of a novel high-impact respiratory pathogen should be seen as an explicit, organized, highly funded top global goal. Distribution and Dispensing Mass vaccination strategies should be developed and put in place to increase immediate access. Once a safe and effective vaccine has been developed and is ready to be manufactured at scale, approaches to delivering and administering MCMs will also need to scale, and scale rapidly. A standing collaboration among international organizations, national governments, and the private sector will be needed in order to enable and coordinate global distribution to ensure maximal effectiveness and equitable access. In addition, the uptake of novel, needle-free administration technologies, specifically those that enable either simplified or, potentially, self-administration, should be a priority to improve our collective ability to administer these countermeasures in clinically relevant timeframes. For example, several different routes of administration, including the oral, nasal, patch, and intradermal routes, offer the potential for both more robust immune responses and the ability to more rapidly achieve population-level coverage. Industry, national regulatory bodies, public health authorities, and other stakeholders should invest in and promote the use of technologies that enable a rapid, streamlined approach to the administration of MCMs. Furthermore, WHO should encourage and support the creation of a public-private partnership dedicated to planning for and executing the prioritization and distribution of MCMs in a severe outbreak. Surge Manufacturing in Crisis National and international regulatory requirements need to be prepared and coordinated to enable rapid production of MCMs. Many countries maintain their own paradigm for pharmaceutical regulation, and significant regulatory challenges are associated with deconflicting the regulatory processes across countries. In addition, many countries lack tools to limit manufacturer liability during a crisis. These complexities will slow international MCM deployment and thereby impede efforts to control an outbreak as it begins to spread around the world. WHO helps coordinate activities across the essential regulatory bodies, including the FDA, the National Institute for Biological Standards and Control in the UK, and the Therapeutic Goods Administration in Australia. This coordination covers, for example, standardization of vaccine reagents that can be used across jurisdictions. While this cooperation is critical, regulatory differences across borders still delay MCM deployment during major outbreaks now and would in a pandemic given current conditions. A number of adaptations could be put in place to reduce the time to approval. For example, agencies 72 should consider regulating some platform technologies by platform, rather than by product. The relevant regulatory bodies, global authorization agencies, and public and private manufacturers should develop and exercise response plans. In addition, national regulatory agencies should establish mechanisms dedicated to decreasing timelines associated with regulatory requirements for MCMs in emergencies, while continuing to ensure safety and efficacy. WHO, industry, national regulatory bodies, and other stakeholders should work together to enable and radically increase MCM surge production and access globally through localized distributed manufacturing. Given the current geographic disparities in where such production and manufacturing efforts are conducted, access and benefit-sharing agreements will be needed. Other Research and Development During an event involving a high-impact respiratory pathogen, there will be a critical need to conduct research to inform the response.
Report abuse