BARDA RESEARCH

Explore the science of medical countermeasures innovation and ways BARDA scientists improve public health emergency preparedness and response

BARDA Research

BARDA scientists and their industry collaborators improve and develop medical countermeasures by driving innovation beyond traditional boundaries.

The Science Behind Medical Countermeasures: BARDA’s scientists push new ways to approach development of products for public health emergencies. By improving the science of medical countermeasures, BARDA research enhances the nation’s emergency preparedness. Learn more about BARDA’s scientists and their work to advance medical countermeasure development and deployment.
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Featured

Vaccines

Selection of Filovirus Isolates for Vaccine Development Programs
Selection of Filovirus Isolates for Vaccine Development Programs
Description

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.

BARDA Authors

All Authors: Wolfe, Daniel ; Sabourin, Carol; Merchlinsky, Michael; Florence, William; Wolfraim, LarryTaylor, Kimberly; Ward, Lucy

Keywords
ebola; Sudan; Marburg; filovirus; animal rule; viral isolate; challenge strain; CBRN Countermeasures; Vaccine Branch; Ebola; Sudan; Marburg; vaccine
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Vaccines 2021, 9(9), 1045; https://doi.org/10.3390/vaccines9091045 (registering DOI)

npj Vaccines

Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults.
Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults.
Description

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.

BARDA Authors

Christine M. Oshansky, James King, Di Lu, James Zhou, Corrina Pavetto, Gary Horwith, Karen Biscardi, Bai Nguyen, John J. Treanor, Li-Mei Chen, Brett Jepson, Chad Colfer, Pennie Hylton, James Little, Michael O’Hara, Silvija Tresnjak-Smith, Robert Walker, Bai Yeh, Rick A. Bright, Robert A. Johnson, Vittoria Cioce, Ruben O. Donis

Keywords
influenza, pandemic, NPIVS, adjuvant, H7N9, highly pathogenic avian influenza, vaccine
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Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults. npj Vaccines 6, 41 (2021). https://doi.org/10.1038/s41541-021-00287-7

Analytical and Bioanalytical Chemistry

Development of a clinical assay to measure chlorinated tyrosine in hair and tissue samples using a mouse chlorine inhalation exposure model
Development of a clinical assay to measure chlorinated tyrosine in hair and tissue samples using a mouse chlorine inhalation exposure model
Description

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.  

BARDA Authors

Brooke G. Pantazides, Brian S. Crow, Jennifer Quiñones-González, Jonas W. Perez, Jill A. Harvilchuck, Jeffrey J. Wallery, Tom C. Hu, Jerry D. Thomas, Rudolph C. Johnson, and Thomas A. Blake

Keywords
Chlorine gas; 3-chlorotyrosine; 3,5-dichlorotyrosine; in vivo mouse study; LC-MS/MS; hair and lung tissue, CBRN, Chemical Medical Countermeasures
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Analytical and Bioanalytical Chemistry (2021) 413:1765–177: Development of a clinical assay to measure chlorinated tyrosine in hair and tissue samples using a mouse chlorine inhalation exposure model. Analytical and Bioanalytical Chemistry. 

Critical Care Medicine

Sepsis Among Medicare Beneficiaries: 1. The Burdens of Sepsis, 2012–2018
Sepsis Among Medicare Beneficiaries: 1. The Burdens of Sepsis, 2012–2018
Description

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).

BARDA Authors

All Authors: Buchman, Timothy G. PhD, MD; Simpson, Steven Q. MD; Sciarretta, Kimberly L. PhD; Finne, Kristen P. BA; Sowers, Nicole MPP; Collier, Michael BA; Chavan, Saurabh MBBS, MPH; Oke, Ibijoke MPA; Pennini, Meghan E. PhD; Santhosh, Aathira MA; Wax, Marie MBA; Woodbury, Robyn PhD; Chu, Steve JD; Merkeley, Tyler G. MS, MBA; Disbrow, Gary L. PhD; Bright, Rick A. PhD; MaCurdy, Thomas E. PhD; Kelman, Jeffrey A. MD, MMSc

Keywords
cost; Medicare; mortality; sepsis; DRIVe; BARDA Research
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Critical Care Medicine: March 2020 - Volume 48 - Issue 3 - p 276-288

Critical Care Medicine

Sepsis Among Medicare Beneficiaries: 2. The Trajectories of Sepsis, 2012–2018
Sepsis Among Medicare Beneficiaries: 2. The Trajectories of Sepsis, 2012–2018
Description

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).

BARDA Authors

All Authors: Buchman, Timothy G. PhD, MD; Simpson, Steven Q. MD; Sciarretta, Kimberly L. PhD; Finne, Kristen P. BA; Sowers, Nicole MPP; Collier, Michael BA; Chavan, Saurabh MBBS, MPH; Oke, Ibijoke MPA; Pennini, Meghan E. PhD; Santhosh, Aathira MA; Wax, Marie MBA; Woodbury, Robyn PhD; Chu, Steve JD; Merkeley, Tyler G. MS, MBA; Disbrow, Gary L. PhD; Bright, Rick A. PhD; MaCurdy, Thomas E. PhD; Kelman, Jeffrey A. MD, MMSc

Keywords
Medicare; mortality; sepsis; trajectory; hospitalization; admission; inpatient
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Critical Care Medicine: March 2020 - Volume 48 - Issue 3 - p 289-301

Critical Care Medicine

Sepsis Among Medicare Beneficiaries: 3. The Methods, Models, and Forecasts of Sepsis, 2012–2018
Sepsis Among Medicare Beneficiaries: 3. The Methods, Models, and Forecasts of Sepsis, 2012–2018
Description

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.

BARDA Authors

All Authors: Buchman, Timothy G. PhD, MD; Simpson, Steven Q. MD; Sciarretta, Kimberly L. PhD; Finne, Kristen P. BA; Sowers, Nicole MPP; Collier, Michael BA; Chavan, Saurabh MBBS, MPH; Oke, Ibijoke MPA; Pennini, Meghan E. PhD; Santhosh, Aathira MA; Wax, Marie MBA; Woodbury, Robyn PhD; Chu, Steve JD; Merkeley, Tyler G. MS, MBA; Disbrow, Gary L. PhD; Bright, Rick A. PhD; MaCurdy, Thomas E. PhD; Kelman, Jeffrey A. MD, MMSc

Keywords
forecast; methods; models; sepsis
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Critical Care Medicine: March 2020 - Volume 48 - Issue 3 - p 302-318

Vaccine

Evaluation of BioThrax® and AV7909 Anthrax Vaccines in Adults 66 Years of Age or Older
Evaluation of BioThrax® and AV7909 Anthrax Vaccines in Adults 66 Years of Age or Older
Description

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.

BARDA Authors

All Authors: Daniel Wolfe, Eric Espeland, Yonghong Gao, Di Lu, Gretta Blatner, Kathryn Amass (Raine), Gary Horwith, Xiaomi Tong, Robert Hopkins, Gloria David, Brett Jepsen, James King

Keywords
anthrax; vaccine; elderly; clinical trial
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Vaccine Volume 38, Issue 50, 25 November 2020, Pages 7970-7976

Human Vaccines and Immunotherapeutics

Lessons learned from Zaire ebolavirus to help address urgent needs for vaccines against Sudan ebolavirus and Marburg virus
Lessons learned from Zaire ebolavirus to help address urgent needs for vaccines against Sudan ebolavirus and Marburg virus
Description

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.

BARDA Authors

All Authors: Daniel Wolfe, Marva Taylor, and Amanda Zarrabian

Keywords
Filovirus; Ebola; Sudan ebolavirus; Marburg; vaccine; medical countermeasures
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HUMAN VACCINES & IMMUNOTHERAPEUTICS 2020, VOL. 16, NO. 11, 2855-2860

Microorganisms

Current State of Anthrax Vaccines and Key R&D Gaps Moving Forward
Current State of Anthrax Vaccines and Key R&D Gaps Moving Forward
Description

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.

BARDA Authors

All Authors: Adam Clark and Daniel Wolfe

Keywords
anthrax; Bacillus; anthracis; vaccine
Read Full Article
Microorganisms 2020, 8, 651; doi:10.3390/microorganisms8050651
Selection of Filovirus Isolates for Vaccine Development Programs
Selection of Filovirus Isolates for Vaccine Development Programs
Daniel Wolfe
Daniel Wolfe
CBRN
September 19, 2021
Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults.
Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults.
Christine M. Oshansky
Christine M. Oshansky
IEID
March 9, 2021
Development of a clinical assay to measure chlorinated tyrosine in hair and tissue samples using a mouse chlorine inhalation exposure model
Development of a clinical assay to measure chlorinated tyrosine in hair and tissue samples using a mouse chlorine inhalation exposure model
Tom C. Hu
Tom C. Hu
CBRN
January 28, 2021
Sepsis Among Medicare Beneficiaries: 1. The Burdens of Sepsis, 2012–2018
Sepsis Among Medicare Beneficiaries: 1. The Burdens of Sepsis, 2012–2018
Timothy Buchman
Timothy Buchman
DRIVe
March 2020
Sepsis Among Medicare Beneficiaries: 2. The Trajectories of Sepsis, 2012–2018
Sepsis Among Medicare Beneficiaries: 2. The Trajectories of Sepsis, 2012–2018
Timothy Buchman
Timothy Buchman
DRIVe
March 2020
Sepsis Among Medicare Beneficiaries: 3. The Methods, Models, and Forecasts of Sepsis, 2012–2018
Sepsis Among Medicare Beneficiaries: 3. The Methods, Models, and Forecasts of Sepsis, 2012–2018
Timothy Buchman
Timothy Buchman
DRIVe
March 2020
Evaluation of BioThrax® and AV7909 Anthrax Vaccines in Adults 66 Years of Age or Older
Evaluation of BioThrax® and AV7909 Anthrax Vaccines in Adults 66 Years of Age or Older
Daniel Wolfe
Daniel Wolfe
CBRN
November 2020
Lessons learned from Zaire ebolavirus to help address urgent needs for vaccines against Sudan ebolavirus and Marburg virus
Lessons learned from Zaire ebolavirus to help address urgent needs for vaccines against Sudan ebolavirus and Marburg virus
Daniel Wolfe
Daniel Wolfe
CBRN
March 7, 2020
Current State of Anthrax Vaccines and Key R&D Gaps Moving Forward
Current State of Anthrax Vaccines and Key R&D Gaps Moving Forward
Daniel Wolfe
Daniel Wolfe
CBRN
April 29, 2020
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