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U.S. Department of Health and Human Services

Threat-Based Approaches

PHEMCE recognizes the need to address high-priority threats. While PHEMCE is evolving toward a capability-based approach across threats, it proposes to maintain key threat-based approaches to address national health security.

Figure 1 depicts estimated PHEMCE spending by portfolio for FYs 2018-2022. As ranked by cumulative estimated spending, PHEMCE’s investments reflect the priorities established in the 2017-2018 PHEMCE SIP (increases and decreases are changes from the estimates contained in the FYs 2017–2021 report).

Across NIH, BARDA, SNS, and FDA, estimated spending on pandemic and seasonal influenza is $5.7 billion over the five-year period, which represents an increase of $1.4 billion (+33 percent). This increase is critical to support pandemic preparedness objectives as outlined in the 2017 Pandemic Influenza Plan Update. This update includes HHS’s establishment of one of its key actions to “support innovation in influenza vaccine production for improved efficiencies to enable the production and distribution of final presentation vaccines for pandemic response within 12 weeks from the declaration of an influenza pandemic.”4 Other requirements objectives include the need for improvements in diagnostics and treatment options. The increased spending estimate supports BARDA to begin a robust development program for more effective vaccines that can be made and delivered faster than currently available vaccines. NIH would continue to support discovery of innovative new pandemic influenza vaccine prototypes, while advancing the clinical development of current universal influenza vaccine candidates. Efforts to push diagnostics to home use to allow more rapid detection and treatment would be increased. Existing manufacturing facility capacity, critical to the nation’s response capabilities, will be maintained.

Consistent with the National Strategy for Combating Antibiotic-Resistant Bacteria (2015-2020), one of the largest spending estimates is for new products to address gaps in the broad-spectrum antimicrobial portfolio for threats caused by bacteria and other Gram-negative bacteria (broad-spectrum antimicrobials) that complicate the ability to respond to any public health emergency. This estimated spending totals $3.7 billion over five years, which represents an increase of $193 million (+6 percent). This total includes the transition of two products from BARDA ARD to PBS. Significant investment is also planned for development of diagnostics that quickly identify which antibiotics are effective to treat a patient and inform antibiotic stewardship.

The cross-cutting science portfolio includes the NIAID research activities that cannot be assigned to a specific threat. These investments support capabilities such as animal models, diagnostics, sequencing facilities, reagent manufacturing, clinical training programs, epitope mapping, biosafety lab support, computational biology, and development of vaccine platform technologies. The five-year budget plan estimate for this portfolio is $2.9 billion, which represents a decrease of $90 million (-3 percent).

The Other Threats portfolio is the next largest area of estimated spending and includes investments at NIAID that support activities against threats such as arboviruses, waterborne and foodborne pathogens, tuberculosis, adjuvant discovery/development, and activities investigating fundamental aspects of the human immune system. Total five-year spending on these investments is estimated to be $2.8 billion, which represents an increase of $186 million (+7 percent).

The next largest threat-specific investment is the anthrax portfolio, with total estimated spending of $2.3 billion over the five-year period, an increase of $302 million (+15 percent). This portfolio supports the development, preparation of an application for approval, and procurement of the next-generation anthrax vaccine, AV7909, as well as anthrax therapeutics and diagnostics. AV7909 will potentially lower future stockpiling and replenishment costs by reducing the number of doses of vaccine needed to treat patients. The increased spending estimate also supports the replenishment of anthrax therapeutics, including antibiotics, by the SNS.

Spending by BARDA and NIAID on MCMs against radiological and nuclear threats, the next largest investment for this five-year period, totals $2.0 billion, which represents an increase of $191 million (+10 percent). This investment includes spending for basic and advanced clinical research and development of products to address ARS and DEARE, as well as procurements for anti-neutropenic cytokines, biodosimetry devices, and artificial skin for the treatment of thermal burns.



Figure 1. Estimated PHEMCE Spending by Portfolio and Fiscal Year


In the filovirus portfolio, the PHEMCE estimates five-year spending to be $1.9 billion, which represents an increase of $282 million (+18 percent). This increase supports the late-stage development and procurement of MCMs against the Ebola virus. At this funding level, the PHEMCE would continue to support activities associated with the transition of MCM candidates from early development supported by the NIH and the DoD to advanced development at BARDA and toward FDA approval if safety and efficacy are demonstrated. These activities include the following: 1) manufacture of clinical investigational lots, 2) clinical trials to be conducted in the U.S. and West Africa, 3) development of the capacity to manufacture these MCMs at commercial scale, and, 4) ultimately, the procurement of MCMs. This portfolio includes the expected transition of one Sudan ebolavirus therapeutic from ARD to PBS.

Investment in MCMs to mitigate smallpox is forecasted to have a five-year total of $1.8 billion, which represents an increase of $563 million (+47 percent). This increase reflects the investment in a lyophilized formulation of IMVAMUNE, a non-replicating smallpox vaccine being developed for individuals at risk for adverse events from replicating smallpox virus, which is a mandate under the PHS Act. Future investments are expected to decrease over this period due to the availability of a next-generation vaccine against smallpox, potentially providing greater shelf-life and, therefore, lower replenishment costs.

Spending on MCMs to mitigate chemical threats is forecasted to have a five-year total of $1.6 billion, which represents an increase of $448 million (+39 percent). The chemical threats portfolio includes research at NIAID, the National Institute of Neurological Disorders and Stroke, other NIH institutes, and BARDA on the development of safe and more effective therapeutics for exposures to nerve agents, vesicating chemicals, pulmonary agents, and toxic industrial chemicals. This increase also includes additional estimated funding for countermeasures against pharmaceutical-based agents, such as fentanyl.

This report also includes estimated spending in BARDA for two new areas related to addressing advanced development of MCMs against emerging biological threats, for a five-year total of $525 million. Advanced development of MCMs against emerging infectious disease threats is estimated at a total of $400 million. Funds would be used to advance candidates developed by PHEMCE partners and others through late-stage advanced development and eventual application for approval if safety and efficacy are demonstrated. The funding estimate reflects the multitude of infectious diseases that have emerged over the last decades and that pose a serious threat to national health security, the need to have licensed MCMs available to detect, treat, and prevent these diseases, and the numerous countermeasures that have completed early development and are situated for advanced product development. Finally, spending to further develop the CIADMs to provide a rapid, flexible, capability (rather than specific threat-based) is forecast at $125 million over the five-year period.


 


Pandemic Influenza Plan: 2017 Update


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  • This page last reviewed: January 29, 2020