The ability of NIAID to prepare for and mount a rapid and effective research response to an emerging pathogen relies on knowledgeable staff, up-to-date facilities and flexible infrastructure, cutting-edge technology, and a robust, centralized coordination hub.
A dedicated preparedness coordination team of NIAID staff and scientists working closely with the NIAID Office of the Director will serve as the coordination hub for the NIAID pandemic preparedness efforts. This team will track the prototype pathogen research portfolio, ensuring adequate pathogen coverage and resource allocation to address scientific gaps. NIAID will continuously engage with leadership in other federal agencies and international funders with preparedness and response capabilities to inform them on preparedness research progress.
The NIAID Pandemic Preparedness Plan outlines the cross-cutting epidemiology, infrastructure, technology, and coordination and communication approaches necessary to successfully prepare for future pandemics.
Epidemiology and Pathogen Discovery
Underpinning preparedness research and development is a robust global disease discovery and epidemiology program aimed at identifying emerging infectious disease threats, which are crucial for risk assessment, reagent collection, pandemic preparedness efforts and rapid response measures. Early discovery and appraisal of pathogens of concern is a major element of overall pandemic preparedness. Epidemiology and surveillance will ensure that we are able to rapidly identify, characterize, and act upon newly emerging and re-emerging pathogens in zoonotic reservoirs and in geographic regions where outbreaks are likely to occur. The NIAID PREMISE program (Pandemic Response Repository through Microbial and Immune Surveillance and Epidemiology) will contribute significantly to the pathogen discovery mission and overall pandemic preparedness. PREMISE will pair virologic and immunologic surveillance of viruses and facilitate the development of diagnostic tests and MCMs in anticipation of potential pandemic threats. To further pandemic preparedness, NIAID will utilize its global network of research centers to study how and when viruses and other pathogens emerge from wildlife and spillover into humans. The Centers for Research in Emerging Infectious Diseases (CREID) will enable early warnings of emerging diseases, facilitating a rapid response and potentially curbing potential disease threats before they develop into widespread pandemics. In addition, the NIAID Centers of Excellence for Influenza Research and Response (CEIRR) program will focus on the study of influenza in humans and at the human-animal interface and provide international research infrastructure needed to address zoonotic influenza outbreaks in humans or a pandemic.
NIAID will also liaise with other USG agencies and global partners to help support the enhancement of in-country capacity to expand worldwide surveillance, genetic sequencing, epidemiology, virus or viral variant discovery. Such coordination will help prioritize development of diagnostics, reagents, and MCMs.
NIAID will continue to support and advance platform technologies that can be leveraged to develop MCMs. By investing in research to develop specific MCMs for known threats and utilizing platform-based and prototype-pathogen approaches to allow for adaptation when unexpected outbreaks arise, NIAID and its partners–both domestic and international–can prepare to effectively combat future disease outbreaks. Broad, wide-range platforms that can be used to significantly reduce the time and cost required to bring MCMs to market. For example, mRNA and adenovirus vaccine platform technologies were successfully utilized during the COVID-19 pandemic to develop effective vaccines against SARS-CoV-2; these and other innovative technologies can be leveraged in the NIAID global preparedness efforts. Other examples of platform technologies include screening systems, in vitrosafety testing, protein expression methodologies, manufacturing technologies, and chemical synthesis designs. The potential to rapidly apply such platform methods to developing new MCMs, particularly when pursued on a global scale, will considerably shorten and streamline the process of countermeasure development.
NIAID will also continue to support and advance technology transfer agreements that attract potential industry partners and shorten the timeframe from discovery to licensure of effective public health tools, such as diagnostics, vaccines, and biologics. Appropriate technology transfer agreements serve to protect publicly funded discoveries while also accelerating the time to commercial availability.
Preclinical and Clinical Research Infrastructure
Appropriate research infrastructure capacity will enable effective pandemic preparedness and rapid response research. The enhancement and expansion of dedicated USG owned or funded pre-clinical testing facilities with Animal Biosafety Level 3 (ABSL-3) and ABSL-4 capacity can boost the testing of promising candidate drugs and vaccines and mitigate delays in the event of a pandemic.
Global clinical trial networks that provide research capacity for all patient populations against emerging threats are essential to an effective research response. Preparedness includes leveraging and expanding existing domestic and international outpatient and inpatient clinical trial sites, enhancing on-site expertise, and developing the clinical research infrastructure needed to evaluate countermeasures and rapidly respond to infectious diseases. For example, the COVID-19 Prevention Network was a successful example of leveraging several existing clinical trial networks originally established for other purposes, to test vaccines and mAbs quickly and effectively against SARS-CoV-2. Internationally, other networks also were able to adapt to undertake coordinated COVID-19 clinical studies.
Pilot cGMP Manufacturing Capacity and Process Development
Preparedness efforts will require adequate capacity for process development and pilot Current Good Manufacturing Practice (cGMP) manufacturing of MCMs against prototype and priority pathogens. By manufacturing product and conducting Phase I/II trials, NIAID aims to attract industry partners and shorten the timeframe from scientific discovery to licensure to application of effective public health tools.
Regulatory Science and Strategy Infrastructure
Pandemic preparedness efforts will require close interaction with regulatory authorities and USG partners, particularly the FDA, as well as an understanding of foreign regulatory agencies and processes. Regulatory coordination will ensure that all NIAID-wide pandemic preparedness efforts are harmonized to the extent possible.
Coordination and Communication
Effective coordination and communication are central to effective preparedness research efforts and requires close collaboration both among the NIH ICs and with external partners in the United States, other countries, international organizations, and biomedical research-oriented philanthropies. The NIAID Pandemic Preparedness Plan will ensure that all internal NIAID pandemic preparedness efforts, encompassing intramural and extramural programs, are harmonized and supported by the effective mobilization of logistical, administrative, and technical resources. NIAID will also actively collaborate and integrate its efforts with similar ones undertaken by other USG entities, including CDC, USAID, DoD, and other agencies. Through multiple mechanisms, NIAID also will coordinate its programs with foreign government entities; international organizations, including WHO, the Global Fund, CEPI, GAVI, BMGF, and others; and domestic and international academic, private sector, and NGO entities.