Explore the science of medical countermeasures innovation and ways BARDA scientists improve public health emergency preparedness and response
BARDA scientists and their industry collaborators improve and develop medical countermeasures by driving innovation beyond traditional boundaries.
Now that licensed vaccines are available for disease caused by Ebola virus (Zaire species), the US Government is pivoting to vaccine programs to target Sudan ebolavirus and Marburg virus. Absent a large outbreak, licensure of such vaccines may occur via the FDA Animal Rule. Nonclinical development will be critical to the overall success of the programs, including the selection of viral isolates to be used in testing vaccines. This manuscript provides suggested isolates for use in vaccine development.
Avian flu A(H7N9) virus has been known to cause severe, often fatal, lower respiratory disease in humans. We report the findings of a clinical study evaluating the safety and immunogenicity of a new recombinant hemagglutinin H7 subtype influenza vaccine in healthy adults. The recombinant H7 vaccine was safe and well-tolerated, with a safety and immunogenicity profile comparable to that of the egg-/cell-based vaccines produced in response to the A(H7N9) viruses from the 2013 epidemic wave. The results from this study provide critical information to develop a pandemic response strategy and support regulatory requirements for vaccination under Emergency Use Authorization.
Analytical and Bioanalytical Chemistry
Chlorine is a toxic industrial chemical with a history of use as a chemical weapon. Evaluation of acute chlorine exposure is complicated by the virtual lack of reliable biomarkers. Using our new chlorine exposure assay for hair and lung tissue samples and our improved chlorinated tyrosine quantitative assay, we report that chlorine exposure biomarker levels are more abundant and detectable for a greater duration in hair than in lung and blood.
Critical Care Medicine
BARDA partnered with CMS to study and report on sepsis among Medicare beneficiaries. In the first of a 3-paper series, we identified more than 9.5M sepsis inpatient hospital admissions during 2012–2018. Over this interval, annual admission counts increased more than 65% to nearly 1.7M in 2018; the total 2018 cost of sepsis hospitalizations and skilled nursing facility care for beneficiaries exceeded $41.5B, excluding pre/post-stay care or any professional fees. While sepsis mortality continues to decline, it remains quite high (Fig. 3).
Critical Care Medicine
In paper 2 of 3, we analyzed the trajectories of individual Medicare patients during and after inpatient hospital admissions. While inpatient admission from a nursing facility (vs. from home) was more likely to be due to sepsis, patient characteristics did not otherwise predict whether admission would be due to sepsis or another reason. Sepsis patients consume an increasing fraction of inpatient days and hospital beds. Unfortunately, sepsis has significant adverse effects 6 months after inpatient admission (Fig. 6).
Critical Care Medicine
Paper 3 in our 3-paper series forecasted long-term costs for Medicare beneficiaries. These informed a lower-bound, rough-order-of-magnitude national cost of $62B/+ for 2019; this estimate included all Americans but excluded pre/post hospital care, professional fees, and costs of care for veterans or active duty military. We forecasted $100B/+ before 2025, noting: “ …financial forecasts are influenced strongly by catastrophic events; appearance of a global pandemic such as the 1918 “Spanish Flu” would incur costs far in excess of financial forecasts generated by the models discussed.” COVID did not yet exist.
We assessed the safety and immunogenicity of Anthrax vaccines in older adults. The results suggest that a CpG adjuvant may help to elicit a protective immune response to anthrax vaccines in those over the age of 65.
Human Vaccines and Immunotherapeutics
We detailed some of the lessons learned from the vaccine development perspective, from the response to Ebola (Zaire). In this manuscript, we emphasized the key gaps in product development at the outset of the West Africa epidemic of 2014-2016, and which of those gaps must be imminently filled for vaccines against Ebola (Sudan) and Marburg virus.
We provided a summary of the current status of anthrax vaccines to include those products licensed for use, as well as those currently in clinical development. The manuscript also focuses on some of the near-term research needs.