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Advancing Biodefense Enterprise Preparedness: Goal 3 Biodefense Highlights

Goal 3: MCMs to Combat Influenza

​In addition to seasonal influenza, which causes 290,000-650,000 deaths worldwide annually, influenza viruses with pandemic potential are of global concern. Pandemic strains of influenza emerge unpredictably and can cause even more extensive morbidity and mortality than seasonal strains. Influenza vaccines limit morbidity and mortality; however, changes in circulating viruses require that vaccines be formulated and administered annually, and do not convey protection against emerging subtypes. On September 19, 2019, the White House issued Executive Order 13887​ on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health. HHS—through efforts across Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR; CDC; NIH; and the Food and Drug Administration (FDA)—has prioritized the development of rapidly available influenza vaccines that offer greater protection. This work is complex and requires cutting-edge science and an iterative, multi-year interagency process.

​For example, the National Institute of Allergy and Infectious Diseases (NIAID), which is a component of NIH, leads HHS’s work in developing a universal influenza vaccine that would eventually protect against all influenza viruses and launched the first clinical trial of a universal vaccine candidate. CDC’s systems provide the scientific basis for vaccine virus selection for each year’s seasonal influenza vaccine, as well as for pandemic influenza vaccine stockpiling.

In addition to vaccines, antiviral drugs are available for prophylaxis and treatment of influenza infection. The federal government supports research on anti-influenza therapies to reduce the human costs of seasonal influenza epidemics, to mitigate potential influenza pandemics before vaccines can be developed and made available, and​ to increase the public’s access to antiviral drugs.

​To safeguard people in America from seasonal and pandemic influenza, HHS agencies have made progress in influenza treatment and prevention:

      • ​NIAID’s Vaccine Research Center launched the first human clinical trial for a universal influenza vaccine candidate.
      • FDA approved the first new influenza therapeutic with a novel mechanism of action in more than 20 years.
      • BARDA supported two clinical trials of an influenza drug, which found that it reduced or prevented viral shedding and transmission among household members.
      • CDC, in partnership with private hospitals and pharmacies nationwide, launched the website MedFinder​ to help people find pharmacies that have antiviral drugs available making it easier to know where to go to get your prescription filled.
      • NIAID launched the Collaborative Influenza Vaccine Innovation Centers, a new network of multi-disciplinary research teams that will work together in a coordinated, focused effort to develop next generati​on ​influenza vaccines.

​Goal 3: Improving Emergency Public Health Capabilities — A State-Level Example

From 2016 through 2018, a large, multistate outbreak of hepatitis A swept the United States. Hepatitis A is a vaccine-preventable, contagious liver disease that is usually contracted by consuming contaminated food or water. By November 2018, Michigan alone had seen 907 cases, 728 hospitalizations, and 28 deaths. 7

To combat this outbreak, health department staff funded by CDC’s Public Health Emergency Preparedness (PHEP) program worked with state communicable disease and immunization programs to decrease the amount of time to report new cases, conduct public health follow-up investigations, and provide public information. The immunization programs of local health departments increased vaccination outreach and, as of November 2018, provided more than 250,000 doses of hepatitis A vaccine in areas affected by the outbreak. To prepare for and support these activities, Michigan uses PHEP funds for a community health emergency coordination center, which enables coordination of efforts among multiple program areas across the department. When an emergency occurs, the pre-established relationships between preparedness staff and experts who provide services to high-risk populations allow more rapid response to incidents.

All of these activities, made possible through years of building preparedness capacity and partnerships with program areas, have positive outcomes. Michigan, for example, has reported a consistent decline in the number of new cases each month since December 2017, demonstrating the utility of PHEP support across yet another response/public health event.

​Goal 3: Preparedness to Protect U.S. Citizens in the Event of a Highly Pathogenic Infectious Disease (HPID) Outbreak

Led by the NSC staff, the Department of State (DOS), HHS, DHS, DOD, and the Department of Transportation coordinated the adoption of a Federal Aero-Medical Evacuation Notification protocol, identifying roles and responsibilities to coordinate evacuation of U.S. citizens and other specified individuals, who have been exposed to or infected by a HPID, to appropriate treatment facilities within the United States from both overseas and within the United States. The protocol addresses federal coordination with SLTT public health officials. In addition, DOS coordinates with DOD on acceptance of an upgraded Generation 2 Containerized Bio-Containment System to improve biosecurity and safety during the aeromedical evacuation of such patients and to mitigate the risk to responders from HPID outbreaks.

DOD has also performed the first in-human testing of the now FDA-licensed vaccine used in the Democratic Republic of the Congo (DRC) Ebola outbreaks, in which, as of 2019 more than 90,000 people have been vaccinated. DOD also performed significant numbers of preclinical/animal studies with Ebola virus to evaluate trial samples for this vaccine across the globe. Additionally, DOD implemented its Agile Medical Paradigm strategic framework to optimize MCM delivery by including policy and technology-based solutions to address the root causes of MCM development inefficiencies, as well as indicators for assessing solution execution progress.

Overall, DOD’s investment and broad portfolio in global health and infectious disease research, including contributions to combating AMR, provided foundational information, infrastructure, and subject matter expert and partnership networks to rapidly respond to unanticipated biothreats and protect Americans from the dangers that these biothreats pose.

Goal 3: Improving Preparedness, Response, and Recovery to Lessen the Impacts of Bioincidents in the Underground Transportation System (UTR)

The EPA has a primary role in providing emergency response for natural, accidental, and intentional incidents. For certain bioincidents, EPA assists in determining the extent of contamination and risk-based cleanup levels, decontamination, and waste management, as seen following the attacks on 9/11.

One week after the 9/11 terrorist attacks, letters containing Bacillus anthracis spores, the bacterium that causes anthrax, were mailed to various locations throughout the United States. Response to the incidents and the resulting cleanup required cross-government efforts and illustrated a critical need for improved methods to lessen the impact of future bioterrorism incidents. If a bioincident occurred in a transportation hub, like a subway system, it would require fast and effective remediation to return to normal op​erations. 

    This figure is a photo of case study participants in a mock subway system, with equipment used to test for contamination.

Figure 7: Sampling of a biological contaminant in a mock subway system

To address this critical need, E​PA’s Chemical, Biological, Radiological, and Nuclear Consequence Management Advisory Division and Homeland Security Research Program collaborated with DHS on the UTR project, which involved multiple federal agencies and national laboratories. 8910

The EPA led several​ lab-based studies to address capability gaps in sampling, decontamination, and waste management capabilities. This project culminated in the Operational Technology Demonstration conducted in a mock subway station and tunnel at the U.S. Army Fort A.P. Hill’s Asymmetric Warfare Training Center, which identified specific tools and tactics that would be essential for first responders and other national agencies if a subway system were contaminated and a response was required.

    This figure is a photo of case study participants in a mock subway system, with equipment used to test for contamination.

Figure 8: Decontamination of a mock subway station​

Knowledge gained from the research and demonstrations enhance EPA’s ability to assist EPA Regional On-scene Coordinators and SLTT decision makers in the preparation for and recovery from a bioterrorism incident. Decision support tools and methodologies created from this UTR project help improve the nation’s preparedness and capability to respond to a biological incident over a wide area.

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