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Category: Medical Countermeasures

FDA approval of anti-seizure drug provides a new tool for protecting Americans during a chemical attack

Author: Judith Laney, Ph.D., Chief, BARDA Chemical Medical Countermeasures programs, and LTC Matthew Clark, Ph.D., Joint Product Manager, Chemical Defense Pharmaceuticals, Medical Countermeasure Systems
Published Date: 10/31/2018 10:35:00 AM
Category: Medical Countermeasures;

With the recent U.S. Food and Drug Administration approval of the drug Seizalam® (midazolam injection) as an anti-seizure medication, the United States took a step forward in protecting Americans from a potentially deadly health effect of chemical weapons.

Over the last 25 years, there has been increased use of chemical weapons. Delivering effective medical countermeasures against nerve agents is essential to saving civilians’ lives in the United States, and is necessary to ensure that the Joint Force maintains mission effectiveness to protect the nation.

H  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…

BARDA and its partners bring new ammunition to the battle against superbugs

Author: Brian Tse, PhD, Project Officer, BARDA Antimicrobial Medical Countermeasures Branch, and Mark Albrecht, PhD, Acting Chief, BARDA Antibacterial Medical Countermeasures Branch
Published Date: 8/27/2018 5:41:00 PM
Category: Medical Countermeasures;

In 1954, Alexander Fleming, who discovered penicillin, began warning against the potential for bacteria to become resistant to the new antibiotic. Just over a decade later, in July 1968, physicians documented the first human case of a superbug known as MRSA, Methicillin-resistant Staphylococcus aureus. Fast forward 50 years, and MRSA has become just one of many drug-resistant infections healthcare providers and patients battle every day.

Back in the 1950s and 60s, drug manufacturers were developing an array of new antibiotics so resistance did not seem im  Read more…

ASPR’s Vision for Building Readiness: Sustaining Robust and Reliable Public 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 (HHS)
Published Date: 8/10/2018 12:54:00 PM
Category: Public Health Preparedness; National Health Security; Medical Countermeasures; Response & Recovery;

HHS’ Vision for Healthcare Preparedness is a multi-part blog series that describes ASPR’s four pillars to achieving national health security: providing strong leadership, building a Regional Disaster Health Response System, sustaining public health security capabilities, and advancing an innovative medical countermeasures enterprise. This blog focuses on sustaining public health security capabilities. Read the next post in the series here.

A catastrophic health emergency – whether n  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…

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…

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…

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…

Next-Generation Burn Care Products and Strategies Draw on Innovative Ideas

Author: Narayan Iyer, Ph.D., Chief, Burn MCM, CBRN, BARDA; Julio Barrera-Oro, Ph.D.; Danielle Turley, Ph.D.; David Simon, Ph.D.; Oxana Selivanova, Ph.D.; Joe Larsen, Ph.D. Director (Acting), CBRN, BARDA; and Gary Disbrow, Ph.D. Deputy Director (Acting), BARDA.
Published Date: 2/6/2017 9:46:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Thousands of people could need burn care following a nuclear detonation (which produces intense heat resulting in severe burns) or in a massive explosion. In addition to those catastrophic threats, between 2010 and 2014, emergency departments treated approximately 486,000 people for non-fatal burn injuries and in 2014 alone, fires took the lives of 3,275 people. Specialized treatment resources are limited, with only 127 burn centers nationwide; a mass casualty incident easily could overwhelm the nation’s burn care infrastructure.

Within ASPR, the Biomedical Advanced Re  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…

Ensuring a coordinated response to Zika and other public health threats

Author: George W. Korch, Jr., Senior Science Advisor, HHS Office of the Assistant Secretary for Preparedness and Response
Published Date: 12/5/2016 12:41:00 PM
Category: Public Health Preparedness; Innovations; Hospital Preparedness; Medical Countermeasures; Response & Recovery;

When the first confirmed case of Zika transmission was reported in Puerto Rico on December 31, 2015, there were no vaccine candidates for Zika. Today there are at least a dozen approaches in the US alone that are being evaluated to someday be available for general use. Diagnostic assays to help patients make informed decisions about their health are also under development.

How have so many medical countermeasures advanced so quickly to fight a threat that few people were worried about just last year?

The partners in the Public Health Emergency Medical Enterprise (PHEM  Read more…

Better preparing for future Ebola outbreaks globally

Author: David Boucher, Health Scientist, ASPR/BARDA’s Division of Chemical, Biological, Radiological, and Nuclear Medical Countermeasures and Dr. Richard Hatchett, acting director, ASPR’s Biomedical Advanced Research and Development Authority
Published Date: 10/13/2016 10:27:00 AM
Category: Public Health Preparedness; Innovations; Medical Countermeasures;

While the Ebola virus disease is not in the news as much now as it once was, we cannot afford to let down our guard. Ebola cases flared up again as recently as this March in West Africa, causing eight deaths in Guinea and one death in Liberia, and more than 30 other outbreaks of the disease have been recorded in the last 40 years.

The Ebola outbreak of 2014-2016 highlighted the urgent need for therapeutics that could increase the survival rate of infected patients and also aid response organizations in their efforts to limit the spread of this deadly virus. ZMapp, developed  Read more…

From the front lines of the anthrax investigation to pre-staging our future health response

Author: Dr. Rick Jaffe, Director, Medical Countermeasures Strategy and Requirements, ASPR’s Office of Policy and Planning
Published Date: 9/29/2016 4:28:00 PM
Category: Innovations; Medical Countermeasures; Public Health Preparedness;

Fifteen years ago this month, anthrax was used as a terrorist weapon against our nation. As a microbiologist with experience in dealing with Bacillus anthracis, the bacteria that causes anthrax illness, I was called in to be on the front lines of the investigation into the attack. Today, I help ensure our nation is best prepared for and can respond to a future one.

Soon after September 11, 2001, an attacker mailed letters laced with anthrax spores causing the deaths of five people and sickening 22 others. As part of the response, I donned a hazmat suit to investigate  Read more…

Why some emerging infectious diseases cause epidemics

Author: George W. Korch, Jr., Senior Science Advisor, HHS Office of the Assistant Secretary for Preparedness and Response
Published Date: 9/15/2016 10:32:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Forty years ago, a patient exhibiting symptoms believed to be from malaria sought treatment in a small village in the Republic of the Congo in Africa. Later, it was determined this patient didn’t suffer from malaria, but from a virus that would cause a major disease outbreak decades later and more than 1,000 miles away: Ebola.

When the Ebola epidemic struck in 2014, it claimed the lives of thousands. However, it also served as a reminder that nearly all emerging infectious diseases may not be altogether new to the medical community, but certain factors may have changed sinc  Read more…

Anticipating Threats, Investing in Solutions

Author: Brian N. Tse, Ph.D., Health Scientist, Antibacterials Branch, Division of Chemical, Biological, Radiological, & Nuclear Medical Countermeasures, Biomedical Advanced Research & Development Authority (BARDA), HHS Office of the Assistant Secretary for Preparedness & Response
Published Date: 6/7/2016 3:53:00 PM
Category: Innovations; Medical Countermeasures; Public Health Preparedness;

Deadly new strain of bacteria? BARDA’s already working on it.

For the first time, the bacterial gene mcr-1, which confers resistance to the “antibiotic of last resort,” colistin, was found in a bacterium isolated from a patient in the United States  Read more…

PHEMCE-supported drug achieves FDA approval

Author: Dr. Richard Hatchett, Acting Director of ASPR’s BARDA
Published Date: 3/21/2016 10:12:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Today, the FDA licensed the monoclonal antibody drug Anthim, developed by Elusys Therapeutics of Pine Brook, New Jersey, to treat inhalational anthrax. This drug’s approval not only diversifies our available medical countermeasures for use after an anthrax attack but also further demonstrates the effectiveness of partnering among federal agencies through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and the success of BARDA’s model of partnering with private industry.

  Read more…

Would old vaccine work if needed during a pandemic?

Author: Ruben Donis, Deputy Director, BARDA Influenza Division
Published Date: 3/17/2016 1:24:00 PM
Category: Public Health Preparedness; Medical Countermeasures;

One of ASPR’s goals is to protect our nation against future flu pandemics. Even before ASPR was created in 2006, our nation started stockpiling millions of doses of flu vaccine to protect Americans against the H5N1 avian flu that spread in Asia beginning in 2004.

But, would the vaccine that was stockpiled more than a decade ago still be safe and effective to use if this pandemic flu strain spread in the U.S. today?

We believe so, but this aged vaccine has not been tested in humans, so we’re going to find out.

Unknown Shelf Lives

Most seasonal flu v  Read more…

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