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U.S. Department of Health and Human Services

Category: Innovations

A close encounter of the worst kind: Sepsis

Author: Timothy G. Buchman, PhD, MD, FACS, FCCP, MCCM, Subject Matter Expert and IPA to BARDA DRIVe
Published Date: 9/18/2019 11:03:00 AM
Category: Medical Countermeasures; Innovations;

Day four of the annual professional meeting began like so many others: I had one more talk to give, and then a dash to the airport for the flight home. At lunchtime, I noticed a slight headache. By the time the session began mid-afternoon, the headache was worse. I bummed a couple of over-the-counter pain pills from a colleague (thank heavens for better prepared friends!), chugged a bot  Read more…

Crossing the Finish Line: Project BioShield is Transforming the Nation’s Health Security with Cutting-Edge Innovation, Sound Investments, and Strong Partnerships

Author: Rick A. Bright, Ph.D., BARDA Director
Published Date: 8/7/2019 10:53:00 AM
Category: Medical Countermeasures; Innovations; National Health Security;

Project BioShield is revolutionizing the way we protect Americans from 21st century health security threats. Think back almost 18 years ago to the anthrax attacks of 2001. That crisis highlighted just how few medical countermeasures our nation had to respond to a bioterrorism incident. The anthrax attacks taught us important lessons that still guide our thinking:  innovation is critical, partnerships matter, and the threats that we face are very real and very serious.


21st Century Health Security Threats: From Anthrax to the Unknown

Alth  Read more…

Project BioShield Evolution: Fifteen Years of Bridging the ‘Valley of Death’ in the Medical Countermeasures Pipeline

Author: By Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response
Published Date: 7/17/2019 12:15:00 PM
Category: Innovations; Medical Countermeasures; National Health Security;

Saving lives in a public health emergency requires cutting-edge medical countermeasures: medications, vaccines, diagnostics, and more. In some types of emergencies, like an act of bioterrorism, some of those medical products have no commercial market. People don’t use an anthrax antitoxin every day – thank goodness. Yet that lack of commercial market also means pharmaceutical or biotech companies had only one possible buyer for their products: the federal government for stockpiling.

In 2004, Congress passed the Project BioShield Act to create a market for products   Read more…

BARDA-supported Zika Virus Test Receives FDA Clearance; Ready for Clinical Laboratory Use

Author: Rodney L. Wallace, Director, Detection, Diagnostics, and Devices Infrastructure Division, HHS/ASPR Biomedical Advanced Research and Development Authority
Published Date: 6/6/2019 10:36:00 AM
Category: Innovations; Medical Countermeasures; Hospital Preparedness;

The first commercially available Zika virus diagnostic, a product BARDA supported through its advanced research and development program, received authorization for marketing from the U.S. Food and Drug Administration (FDA) on May 23. The test provides results from a blood sample in about four hours. Called the ZIKV Detect 2.0 IgM Capture ELISA, the test exemplifies the progress that is possible with public-private   Read more…

Combating and Containing the Ebola Outbreak

Author: Robert Kadlec, MD, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
Published Date: 3/14/2019 4:13:00 PM
Category: Public Health Preparedness; Medical Countermeasures; Response & Recovery; Innovations;

ASPR’s Strategic Approach to Ebola Medical Countermeasure Development and Utilization in the 2018 Ebola Outbreak

Blog Series:  Battling the Ebola Epidemic

Ebola reemerged as a health threat in 2018, in the Democratic Republic of the Congo (DRC), where two outbreaks of Ebola virus disease have occurred since May 2018. The first of these two outbreaks, in western DRC, was quickly contained. However, the second outbreak, in eastern DRC, has yet to be contained due in large part to the volatile security situa  Read more…

Pandemic Influenza Vaccine: An Investment in Preparedness that Lasts More Than a Decade

Author: By Ruben Donis, Ph.D., Pandemic Influenza Medical Countermeasures Division, Biomedical Advanced Research and Development Authority (BARDA), HHS Office of the Assistant Secretary for Preparedness and Response (ASPR)
Published Date: 12/13/2018 9:13:00 AM
Category: Medical Countermeasures; Innovations; National Health Security;

As part of our nation’s overall pandemic preparedness strategy, HHS set a preparedness goal of establishing and maintaining a stockpile of bulk vaccine antigen and adjuvants for influenza viruses with pandemic potential to vaccinate 26 million people immediately after a pandemic is declared. BARDA began pre-pandemic influenza vaccine procurement in 2005 for vaccines that would provide protection against emerging avian influenza H5N1 viruses posing a significant pandemic threat.  But a decade later we were compelled to ask how long would those stored vaccine components   Read more…

ASPR and the Defense Advanced Research Projects Agency (DARPA) forge new partnership to deliver novel and robust health security capabilities

Author: Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services and Steven H. Walker, Director, Defense Advanced Research Projects Agency
Published Date: 10/1/2018 3:06:00 PM
Category: Innovations; Medical Countermeasures;

On September 18, marking seventeen years since the first anthrax attack in the United States, the President unveiled a National Biodefense Strategy and signed a National Security Presidential Memorandum which directed federal agencies to collaborate on biodefense, including budgets, to make the nation safer.

That spirit of interagency collaboration is reflected in a new partnership forged between ASPR and the Defense Advanced Research Projects Agency – DARPA – to strengthen the capa  Read more…

New Smallpox Antiviral Increases National Health Security

Author: Rick Bright, Director, and Julie Schafer, Acting Director of Strategy, both of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR)
Published Date: 7/13/2018 4:20:00 PM
Category: Medical Countermeasures; Innovations; Public Health Preparedness; National Health Security;

​​In the 20th century alone, smallpox deaths worldwide numbered in the hundreds of millions. Roughly one-third of people infected with the disease died, while survivors were often left with permanent scars or blindness. After an aggressive global vaccination program in the mid-1970s, the World Health Organization declared smallpox eradicated.

​​But smallpox remains a health security threat in the 21st century. Fears that undeclared stocks of the smallpox virus might exist and that they could be used as weapons of bioterrorism spurred the U.S. government’s Biomedical Advance  Read more…

From 1918 to 2018: BARDA’s Role in the Evolution of Pandemic Preparedness

Author: Rick Bright, Director, and Julie Schafer, Acting Director of Strategy, both of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR)
Published Date: 5/21/2018 4:56:00 PM
Category: Innovations; Public Health Preparedness; Observances; Medical Countermeasures; National Health Security;

BARDA and its industry partners have made tremendous strides to build better, faster, and more flexible vaccine technologies to enable the right vaccine to be where we need it, when we need it. Combating this age-old problem is an epic challenge, and there is still work to be done to speed availability of life-saving vaccines in a pandemic.

In September 1918, a doctor stationed at Camp Devens, a military base located near Boston, Massachusetts, wrote a letter to a colleague:

Read more…

Decontamination Decoded: Disrobing, Dry Wiping Removes 99% of Chemical Contaminants

Author: Judith Wolfe Laney, PhD, Chief of Chemical Medical Countermeasures, Division of Chemical, Biological, Radiological and Nuclear Countermeasures within BARDA at the Office of the Assistant Secretary for Preparedness and Response
Published Date: 4/11/2018 9:31:00 AM
Category: Exercises & Trainings; Medical Countermeasures; Public Health Preparedness; Response & Recovery; Innovations;

Last month, a truck carrying 4,400 gallons of hydrochloric acid collided with a train in Centerville, PA. For several hours, a column of white vapor floated above the wreckage. Emergency responders acted quickly to evacuate residents in the area and clean up the spill.

On a daily basis, thousands of businesses use our nation’s roads and railways to transport hazardous chemicals used for industrial or household purposes. Whether a chemical is released by accident, such as the case in Centerville, or intentionally by rogue assailants, terrorist organizations, or non-state acto  Read more…

Lessons from Fukushima: New guide provides answers to save lives and improve emergency medical response

Author: John F. Koerner, MPH, CIH, Senior Special Advisor - Chemical, Biological, Radiological, Nuclear, High-Yield Explosive (CBRNE) Science and Operations, HHS ASPR Immediate Office
Published Date: 3/12/2018 2:22:00 PM
Category: Public Health Preparedness; Innovations; Exercises & Trainings; Hospital Preparedness; National Health Security; Response & Recovery;

Quick questions: A nuclear incident has occurred in your community and people are going to come to you for help. Do you know which medical issues you should focus on first? Or which steps need to be taken immediately after an incident to best protect the public? Or what resources might be available to help?

Before you answer “no” to any of those questions, download a copy of the newly released Decision Maker’s Guide: Medical Planning and Response for a Nuclear Detonation.

An e  Read more…

Aging and Disability Task Force: An Access and Functional Needs Approach to Addressing the Unmet Disaster Needs Following Hurricanes Irma and Maria

Author: Cheryl A. Levine, Ph.D., Senior Policy Analyst & Team Lead for At-Risk Individuals; Jose Velasco, MSW, Public Health Analyst for At-Risk Individuals; and Amit Zigelman, MPH, Jr. Management Analyst, Aveshka, Inc. in support of the ASPR Division for At-Risk Individuals, Behavioral Health & Community Resilience
Published Date: 2/21/2018 4:42:00 PM
Category: Response & Recovery; Public Health Preparedness; Innovations;

The recent impacts of Hurricanes Irma and Maria left Puerto Rico and the U.S. Virgin Islands (USVI) in complete devastation. Buildings and homes were destroyed. Hospitals, dialysis centers, and pharmacies that weren’t destroyed were closed due to water and wind damage or a lack of electricity. Transportation services were lacking or, in some areas, non-existent. These issues affected everyone; however, people with access and functional needs – including older adults and people with disabilities – were particularly vulnerable in the hurricanes’ aftermath.

In response, the Off  Read more…

BARDA Supports a Rapid, Deployable, Sensitive Diagnostic Platform to Diagnose Anthrax

Author: HHS/ASPR Biomedical Advanced Research and Development Authority
Published Date: 11/20/2017 1:55:00 PM
Category: Medical Countermeasures; Innovations; Public Health Preparedness;

In the wake of an anthrax attack, medical responders need to quickly determine who has been infected so that they can be effectively treated. A rapid, accurate diagnostic test is an essential tool for doctors and other health professionals to effectively triage people who may be infected with anthrax. Such a tool has been long requested by medical responders as a critical component of anthrax preparedness.

On September 27, 2017, BARDA awarded a $3,199,221 base period of a contract to Tangen BioSciences Inc. of Branford, CT to further advance and expand the ability to combat  Read more…

BARDA adds new antibiotic to treat drug-resistant bacterial infections in order to protect the American public

Author: Mark Albrecht, Project Officer, Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response
Published Date: 8/30/2017 1:21:00 PM
Category: Medical Countermeasures; Public Health Preparedness; Innovations; National Health Security;

Antibiotics underpin nearly every facet of modern medicine. You can’t have a hip replacement or a caesarean section without effective antibiotics to prevent or treat bacterial infections. The same holds true in a mass public health emergency involving a chemical, biological, radiological or nuclear (CBRN) threat. During a biodefense emergency, people may be hospitalized for prolonged periods, potentially exposing them to secondary infections including drug-resistant infections that are occurring at an alarming rate.

That’s why BARDA is focused on development and approval of  Read more…

Whatever it takes: Medical Reserve Corps volunteers leverage eastern tradition to aid behavioral health after disasters

Author: Stacy Sayre, Region 8 Medical Reserve Corps Liaison and Rachelle Lambert, Licensed Acupuncturist and Unit Coordinator, Colorado Acupuncture Medical Reserve Corps
Published Date: 8/16/2017 9:41:00 AM
Category: Response & Recovery; Public Health Preparedness; Innovations;

After the terrorist attacks of September 11, 2001, managers at St. Vincent’s Hospital in New York asked the nearby Lincoln Recovery Center to provide respite and ear acupuncture treatment for staff and first responders impacted by the tragedy. Some of those treated reported that after treatment they slept better than they had in days or weeks.

Lincoln Recovery had developed an ear acupuncture treatment called the NADA protocol to assist substance abuse detoxification and recovery support in concert with other behavioral health interventions. The successful use of this techni  Read more…

New Frontiers and Extreme Environments: BARDA and NASA Join Forces to Better Protect the American Public and Astronauts from Radiation Injury

Author: Mary J. Homer, PhD, Chief of Radiological and Nuclear Countermeasures Branch, HHS/ASPR/BARDA and Lynne Wathen, Biodosimetry Team Leader in the Diagnostics and Medical Devices Division, HHS/ASPR/BARDA
Published Date: 8/2/2017 10:22:00 AM
Category: Medical Countermeasures; Innovations; Public Health Preparedness;

Although an odd couple at first glance, NASA and the Biomedical Advanced Research and Development Authority in the office of the HHS ASPR share a common interest: protecting people from radiation injury.

  Read more…

EMS Infectious Disease Playbook: Combatting Infectious Disease Threats with Knowledge and Best Practices

Author: Jennifer Nieratko, ASPR TRACIE Team; John Hick, MD, Emergency Physician and Deputy Chief EMS Medical Director, Hennepin County Medical Center & HHS; and Richard Hunt, MD, Senior Medical Advisor, National Healthcare Preparedness Programs, HHS/ASPR Office of Emergency Management
Published Date: 6/26/2017 10:58:00 AM
Category: Public Health Preparedness; Innovations;

Emergency medical services (EMS) providers face a wide variety of risks on an almost daily basis, ranging from physically dangerous scenes and combative patients or bystanders to inattentive drivers to the negative behavioral health effects of exposure to traumatic incidents. While EMS personnel cannot predict which hazard they may face on any given day, the entire EMS community – medical directors who establish policies and procedures, dispatchers who direct personnel to patients, and responders at a scene – has a stake in staying up-to-date on innovations in the field and related  Read more…

Powering the next generation of antibacterial innovation to enhance national security

Author: Tyler Merkeley, MS, MBA, CARB-X Program Manager, BARDA
Published Date: 3/30/2017 11:50:00 AM
Category: Public Health Preparedness; Medical Countermeasures; Innovations; National Health Security;

It’s about the people. Picture a worried mother from Arizona walking into the hospital with her 11-year-old daughter. The girl had gone from tired to intense hip pain and a high fever in just a few days. A blood test revealed a potentially fatal condition called sepsis from a Staphylococcus infection. The infection had begun as an abscess in her hip muscle, spread into her blood, and eventually caused a devastating antibiotic-resistant bacterial pneumonia in her lungs.

Mom sat day-in and day-out watching her daughter’s health rapidly fade; tubes ran all over her body, and a   Read more…

Strengthening the Links in Disaster Supply Chain Management

Author: Laura K. Wolf, Ph.D., Branch Chief, Critical Infrastructure Protection Branch, Office of Emergency Management, HHS ASPR
Published Date: 2/1/2017 4:52:00 PM
Category: Innovations; Public Health Preparedness;

When you are responding to a pandemic flu outbreak, you don’t just need a safe and effective vaccines and antivirals – you also need syringes and other medical supplies so that they can be administered.  Sounds simple, but supply chain issues caused serious problems during the responses to the H1N1 influenza outbreak, Hurricane Sandy, and Ebola.

Healthcare and public health systems rely on the availability of products such as pharmaceuticals, laboratory testing supplies, personal protective equipment, and medical devices to care for the American people.  Ava  Read more…

BARDA-supported Zika vaccine candidate enters clinical trial

Author: Rick Bright, Director, Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response (ASPR)
Published Date: 1/9/2017 5:24:00 PM
Category: Innovations; Medical Countermeasures; Public Health Preparedness;

The U.S. government has marked another significant milestone in its effort to better protect Americans against the Zika virus: the first ASPR-supported Zika vaccine has begun a Phase I clinical trial, which will evaluate the general safety of the vaccine in people and provide information on the ways that different doses of the vaccine impact immune response.

The investigational vaccine developed by Moderna Therapeutics of Cambridge, Massachusetts, utilizes a novel messenger RNA (mRNA) vaccine technology. Moderna’s vaccine consists of a small piece of mRNA that when injec  Read more…

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