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U.S. Department of Health and Human Services

Category: Medical Countermeasures

The Evolution of Influenza Preparedness during the COVID-19 Pandemic

Author: Kristin L DeBord, PhD,Director, Strategy Division, HHS Office of the Assistant Secretary for Preparedness and Response
Published Date: 6/29/2020 1:12:00 PM
Category: Hospital Preparedness; Medical Countermeasures; National Health Security; Public Health Preparedness;

New Federal Strategy Brings Continued Focus to Modernizing the Domestic Development and Manufacturing of Life-Saving Influenza Vaccines

On September 19, 2019, President Trump issued an executive order calling on public and private partners to modernize influenza vaccines to strengthen national security and public health. Today, I am proud to announce that the National Influenza Vaccine Modernization Strategy 2020-2030 has been released.  This strategy is aimed at building domestic capacity and capability through the use of new technologies to speed up the overall  Read more…

Why sepsis solutions can help COVID-19 patients

Author: Kimberly Sciarretta, Ph.D., BARDA DRIVe Solving Sepsis Program Manager, and Meghan Pennini, Ph.D., Solving Sepsis Project Officer
Published Date: 6/22/2020 3:02:00 PM
Category: Hospital Preparedness; Medical Countermeasures; National Health Security; Public Health Preparedness; Response & Recovery;


Assessing sepsis predictive technologies to aid in the pandemic response

In the current pandemic, ICUs worldwide are caring for COVID-19 patients with life-threatening multiple organ dysfunction, in other words, sepsis. This trend provides a stark reminder that sepsis is likely to arise as a secondary confounder of any health security threat, whether in the current coronavirus pandemic or a future public health emergency.

BARDA focuses on developing safe, effective medical countermeasures, such as vaccines, trea  Read more…

A Critical Time to be in Public Service: A Perspective from a Pair of Experienced Doctors Caring for COVID-19 Patients

Author: Timothy G. Buchman, MD, and Steven Q. Simpson, MD, BARDA/DRIVe
Published Date: 5/20/2020 11:44:00 AM
Category: Medical Countermeasures; Public Health Preparedness; Hospital Preparedness;

As critical care physicians, we can think of no more important time to be in public service than now. Across the country, thousands of healthcare professionals and scientists - not only from the private sector but also in the public sector - are fighting to save lives amid the worst pandemic the world has seen in the last 100 years. We are honored to count ourselves among both groups.

As physicians we are treating COVID-19 patients in Intensive Care Units; as professors, we are teaching the next generation of critical care physicians, and while both roles are rewarding, we ar  Read more…

Raising Awareness: Many roads lead to sepsis, even for COVID-19 patients

Author: Timothy G. Buchman, MD, and Steven Q. Simpson, MD, BARDA/DRIVe
Published Date: 5/15/2020 5:30:00 PM
Category: Medical Countermeasures; Response & Recovery;

COVID-19 patients who are ill enough to require admission to an intensive care unit (ICU), often suffer from a major organ dysfunction. As a pair of critical care physicians with more than 80 years of combined service at the bedside in the ICU, we have spent our entire professional lives caring for patients with life-threatening organ dysfunction resulting from infections. We recognize this condition; it’s called sepsis.

While the most widely reported organ dysfunction for COVID-19 patients involves the lungs, many of these patients also have some combination of heart  Read more…

BARDA Leverages Strong Public-Private Partnerships to Spur a Rapid Response to the Novel Coronavirus Outbreak

Author: Rick A. Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response
Published Date: 2/22/2020 10:35:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Unprecedented Speed in the Medical Countermeasure Response to an Emerging Threat

On January 31, 2019, Health and Human Services Secretary Alex Azar declared a nationwide public health emergency in response to the novel coronavirus outbreak. Three days later, BARDA entered into the first in a series of expanded public-private partnerships to develop a new medical countermeasure. BARDA is acting with unprecedented speed to initiate research and development to spur innovative medical countermeasures to fight the 2019 novel coronavirus. 

In less than a   Read more…

Sepsis is Skyrocketing in the Medicare Population

Author: Rick A. Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response
Published Date: 2/15/2020 9:19:00 AM
Category: Medical Countermeasures; Hospital Preparedness; Public Health Preparedness;

New study reveals the shocking frequency, cost, and mortality of sepsis


A recent study sponsored by HHS has returned some sobering findings: a 40 percent increase in the rate of sepsis-related hospital admissions among Medicare beneficiaries between 2012 and 2018 and as a result, costs are soaring despite a decreasing inpatient stay cost per patient.

These findings, from the largest known sepsis study of Medicare beneficiaries ever recorded in the United States, ring a warning bell for the health of every American and for our healthcare system as a who  Read more…

New Pandemic Influenza Vaccine Uses Next Generation Technology to Strengthen Health Security

Author: Rick A. Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response
Published Date: 2/3/2020 10:32:00 AM
Category: National Health Security; Medical Countermeasures; Public Health Preparedness;

Innovative FDA-licensed vaccine and domestic manufacturing capacity investment bolster domestic pandemic preparedness

On January 31, 2020, we achieved a major milestone in pandemic influenza preparedness:  the U.S Food and Drug Administration’s licensure of AUDENZTM, the first adjuvanted, cell-based influenza vaccine designed to protect our nation from the H5N1 avian influenza virus.  AUDENZTM, which was developed by Seqirus with support from the Biomedical Advanced Research and Development Authority (BARDA) within the Office o  Read more…

The skyrocketting need for speed: partnering to develop rapid diagnostic tests that protect patients from antibiotic resistant infections during disasters and every day

Author: Rick Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response
Published Date: 1/8/2020 1:32:00 PM
Category: Medical Countermeasures; National Health Security; Public Health Preparedness; Hospital Preparedness; Innovations;

Relatively minor injuries, like a cut that I got while gardening, can quickly become more serious if they become infected with antibiotic-resistant bacteria. Today, doctors often don’t have the diagnostic tests needed to inform patient care, and the tests that do exist may take too long to provide results. Without this vital information, doctors don’t have the information they need to ensure patients are getting the right antibiotics, serve as good stewards of antibiotics to prevent resistance, or when   Read more…

Making history: the world’s first FDA-approved Ebola vaccine

Author: Robert Kadlec, MD, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
Published Date: 12/19/2019 7:31:00 PM
Category: Medical Countermeasures; National Health Security; Public Health Preparedness; Response & Recovery;

Public-private partners collaborate to prevent the spread of a global health threat

Today, we achieved a historic milestone in global health security with the approval of ERVEBO®, the first vaccine approved by the U.S. Food and Administration (FDA) for the prevention of the Ebola virus disease (EVD). A safe and effective vaccine is a vital tool in combatting the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC), which is the second largest outbreak since the virus was discovered in 1976. Today’s approval by the FDA, which follows last month’s Europ  Read more…

The health security threat in my backyard: how my garden proved that the U.S. needs more, rapid, diagnostics for antimicrobial resistant infections

Author: Rick Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response
Published Date: 12/17/2019 1:53:00 PM
Category: National Health Security; Medical Countermeasures; Hospital Preparedness;

Although a range of health security threats - from bad actors to new infectious diseases - loom and are always emerging, I fell victim to a threat in my own backyard: an antibiotic resistant infection. To complicate matters, I couldn’t get an accurate diagnosis until it was almost too late. But the delayed diagnosis didn’t just threaten my health – it also added to healthcare costs, led to the misguided use of antibiotics, and potentially threatened the health of other patients in a hospital.

Last year, I cut my thumb while gardening. At first, I didn’t think much about  Read more…

Preparing for the Next Pandemic

Author: Robert Kadlec, MD, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
Published Date: 12/10/2019 3:38:00 PM
Category: Hospital Preparedness; Observances; Medical Countermeasures; Public Health Preparedness;

End-to-end Solutions to Combat Next Influenza Pandemic

Last year, many of us paused to recognize the 100th anniversary of the 1918 influenza pandemic that infected approximately one third of the world’s population and killed at least 50 million people. Yet influenza outbreaks and pandemics are not just some footnote of history. In just the last decade, we have faced three serious influenza-related incidents: a severe flu season in 2017 claimed the lives of 79,000 people,  Read more…

The power of partnership: BARDA ushers in 50th FDA-approved product for health security

Author: Rick Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response
Published Date: 10/11/2019 2:49:00 PM
Category: Medical Countermeasures; Observances; National Health Security;

At BARDA, we are proud to have established unique partnerships with industry that create solutions for the American people. By working together, we have earned – as of last week – our 50th and 51st U.S. Food and Drug Administration (FDA) approvals, licensures and clearances in the past 12 years for products that address some of our nation’s most challenging health security threats. BARDA and our private sector partners achieved eight of these in the past year alone, substantially increasing the nation’s health security preparedness.

 

Read more…

Helping Your Community Become Prepared, Not Scared

Author: Esmeralda Pereira, Medical Reserve Corps Program Director
Published Date: 9/26/2019 11:16:00 AM
Category: Medical Countermeasures; Exercises & Trainings;

Eight Trainings Your MRC Unit Can Offer to Enhance Community Preparedness



Is your Medical Reserve Corps unit looking for a way to bolster community preparedness? You can start by providing community members with training that gives them skills they need to respond – and the confidence to use those newfound techniques.  When an emergency or natural disaster happens, many people want to help – but they just don’t know what to do.  

The good news is that many people can learn lifesaving skills in a cou  Read more…

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…

The Evolution of the Strategic National Stockpile

Author: Greg Burel, Director, Strategic National Stockpile, and Denise Williams, Technical Writer-Editor, Strategic National Stockpile
Published Date: 8/21/2019 10:02:00 AM
Category: Response & Recovery; Medical Countermeasures; Public Health Preparedness;

Twenty Years of Stockpiling Critical Medical Products and Training Professionals to Respond to 21st Century Health Threats


Twenty years ago, Congress established the Strategic National Stockpile (SNS), originally named the National Pharmaceutical Stockpile, with a $51 million appropriation and a handful of staff quietly housed in CDC’s National Center for Environmental Health. Today, the SNS is part of the HHS Assistant Secretary for Preparedness and Response and holds a $7 billion inventory as well as vast experience in preparing for and responding to a variety   Read more…

Expanding Your Partnerships to Enhance Medical Surge: Seven Ways to Engage Outpatient Care Settings

Author: ASPR TRACIE
Published Date: 8/13/2019 11:09:00 AM
Category: Medical Countermeasures; Response & Recovery; Hospital Preparedness;

Outpatient care settings  - including federally qualified health centers (FQHCs), rural health clinics (RHCs), urgent care centers, home health and hospice agencies, and primary care provider practices - have a wide range of capabilities that could be used to save lives in an emergency, but are they integrated into our nation’s emergency healthcare response system? How can healthcare coalitions better engage outpatient healthcare providers to enhance disaster response?

These are just some of the questions the experts from ASPR’s Technical Resources, Assistance Cen  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…

Novel Partnerships, Payment Shifts, and Emerging U.S. Leadership for Antimicrobial Drugs

Author: Rick A. Bright, Ph.D., BARDA Director
Published Date: 8/5/2019 9:01:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Antimicrobial resistance (AMR) is an increasingly serious threat to America’s public health and national security. The resources necessary to discover, develop and commercialize innovative, life-saving antimicrobials are similar to other disease areas; however, the relative return on investment is exceedingly low.

In May, I highlighted the need for an immediate paradigm shift in the antimicrobials marketplace. I specifically called out the importance of building new business models, developing novel partnerships,  Read more…

Building a Better Pipeline of Candidate Products for Project BioShield

Author: By Rick A. Bright, Ph.D., BARDA Director
Published Date: 7/31/2019 9:38:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Project BioShield has revolutionized the way we protect Americans from 21st century health security threats. Our ultimate goal is to save lives during a national disaster; we prepare for this eventuality by pursuing FDA approval and availability of countermeasures in preparation for such emergencies. The government alone cannot fill the need for medical products to save lives in public health emergencies and disasters; public-private partnerships are essential every step of the way.

BARDA’s approach to public-private partnerships is remarkable. We reduce business risk  Read more…

Fifteen Years, Fifteen Stockpiled Medical Countermeasures: Leveraging Project BioShield to Build an Unprecedented Array of Drugs, Vaccines, Therapeutics, and More to Enhance Health Security

Author: Gary Disbrow, Ph.D., BARDA Deputy Director
Published Date: 7/24/2019 8:36:00 AM
Category: Medical Countermeasures;

When Project BioShield was signed into law 15 years ago, the nation had few medical countermeasures to rely on in national emergencies. In the interceding years, BARDA has worked with its partners throughout government and industry to find creative solutions to address health security threats. Together, we have developed safe and effective medical countermeasures to protect the public in emergencies.

BARDA has supported 27 projects using Project BioShield authorities and funding. We’ve added 15 products to the Strategic National Stockpile. We’ve worked with industry pa  Read more…

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