HHS has established a scientific preparedness infrastructure that informs sound public health practices and incident response efforts. This system is meant to be nimble, taking advantage of the rare opportunities when these events arise so that scientists can quickly mobilize to identify research needs, collect and analyze critical and time- sensitive data, and share and build upon their findings. HHS learns something different from each outbreak of influenza with pandemic potential, addressing scientific questions about the characteristics of the virus, effects of existing mitigation measures on the spread and severity of the disease, and the effectiveness and safety of MCMs that will be needed. A robust scientific preparedness infrastructure also provides decision makers with the best evidence available to plan for the appropriate path forward, which is critical for response and recovery during a pandemic. This infrastructure also can support data collection and sharing before a pandemic and address immediate questions decision makers ask during the pandemic. For example, HHS-supported Centers of Excellence for Influenza Research and Surveillance provide ongoing genomic analysis of animal-origin influenza viruses and rapid in vitro and in vivo characterizations to evaluate their pandemic potential. These Centers provided key information on the 2009 H1N1 virus’s origin and transmission, and they continue to assess emerging viruses. These types of investments position public health experts to design additional analyses to understand the longer-term implications of actions taken to mitigate a pandemic, then translate research outcomes into more effective interventions. The 2009 A(H1N1) pandemic provided the impetus for HHS’s science preparedness infrastructure. These efforts provided significant insight into influenza virus pathology, epidemiology, and antigenic drift. Science has elucidated mechanisms of resistance to MCMs and has sought to improve the fit and performance of PPE. Notable progress and key actions for the next decade include the following: • Implementing authorities under Section 564 of the Federal Food, Drug, and Cosmetic Act, United States Code, Title 21 (FD&C Act), as amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, Public Law No. 113-5. • Establishing and expanding the clinical studies networks that provide a full range of services required to plan, perform, monitor, and interpret clinical studies. Specifically, science preparedness has resulted in performing clinical studies required for the approval of a product for human use, comparing the properties of multiple products, or evaluating the potency of products stored in the SNS. • Applying basic research studies to determine how influenza viruses emerge, transmit, and cause disease, and applying systems biology approaches to better understand host–virus interactions. These efforts have helped to identify the role of neuraminidase mutations in viral resistance to antiviral medications and broadly neutralizing antibodies against influenza viruses. Scientists also use them to develop antiviral drugs and antigenically advanced vaccines for further development and vaccination strategies. 5 • Expanding a population-based surveillance system (FluSurv-NET) in the United 5 See Chaves SS, et al. The US Influenza Hospitalization Surveillance Network. Emerg Infect Dis. 2015 Sep. 33
Pandemic Influenza Plan Page 32 Page 34