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Jan 08
The skyrocketting need for speed: partnering to develop rapid diagnostic tests that protect patients from antibiotic resistant infections during disasters and every day

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 to isolate patients or take other precautions during the provision of everyday care.

The scale of antibiotic resistant infections is staggering. Every 11 seconds, in the United States alone, someone is infected by drug-resistant bacteria. Every 15 minutes, one of those people die, totaling at least 35,000 each year. Medical professionals and patients need rapid diagnostics every day to inform patient care, but the right tool or right drug sits just outside their reach.

In a public health emergency, the need for speed really skyrockets. Antimicrobial resistance threatens health security because every health threat – whether biological, chemical, radiological, or pandemic – leads to secondary bacterial infections that are increasingly antibiotic resistant, and many of the biological threats our nation faces can be genetically engineered to be antimicrobial resistant. To make matters worse without effective therapies, these infections can rapidly lead to sepsis, the body’s extreme, even life-threatening, response to an infection.

Each year, 1.7 million Americans get sepsis.  Each year, nearly 270,000 Amricans die from it.  Sepsis is a leading cause of hospital readmissions and one of the most costly conditions treated in U.S. hospitals.  Sepsis is a major systematic health threat in the U.S. and it poses an even greater threat in the event of a Chemical, Biological, Radiological, or Nuclear (CBRN) incident. Every hour delay of initiating the correct treatment to a person with sepsis reduces their chance of survival by eight percent.

To save as many lives as possible, medical professionals across the country will need diagnostics that can differentiate bacteria from viruses, indicate in minutes which bacteria is infecting their patients, and whether that bacteria has developed antimicrobial resistance. Consider the sheer number of diagnostics and the speed needed in bio-incident or severe pandemic. The diagnostics arena is ripe for innovation as well as full implementation of new technologies already developed. Progress also requires that new technologies be integrated quickly into our healthcare system, which presents an additional challenge.

This year one of the five of BARDA-supported diagnostics for AMR infections was designated as a Breakthrough Device by the U.S. Food and Drug Administration, allowing the company to work more closely with FDA toward clearance. That diagnostic, called the T2Resistance Panel from T2 Biosystems, shows promise in detecting 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample without waiting for blood culture. BARDA is providing expertise and funding for advanced development of the diagnostic, which became the first diagnostic to graduate into our advanced R&D portfolio from our CARB-X partnership.

BARDA also just announced a new partnership with Inflammatix to develop 3 point-of-care diagnostic tests that use gene expression patterns in the immune system to distinguish bacterial infections from viral infections and determine the severity within 20-30 minutes. The first Inflammatix test, called HostDx Fever, is intended to distinguish bacterial from viral infections in outpatient ambulatory settings; the second test, called HostDx Sepsis, is intended for inpatient hospital settings and also may determine whether a patient is likely to develop sepsis. The third test, HostDx FeverFlu, is intended for use in either setting during influenza season and combines rapid flu testing with host-response data.

Though these innovative products hold the potential to provide clinicians with critical information, they have not been FDA-approved and there is still much work do to strengthen the pipeline of products that can be used to diagnose antibiotic resistant infections.

We are looking for more partners to join us in the fight against antibiotic resistance. CARB-X is now the world’s largest public-private partnership dedicated to early R&D for products that combat antimicrobial resistant bacteria. Currently CARB-X provides funding and business support for four other diagnostics to identify antimicrobial resistant infections, as well as vaccines and novel antimicrobials.

BARDA’s Division of Research, Innovation and Ventures (DRIVe) feeds our diagnostic development pipeline through ENACT, Early Notification to Act, Control and Treat. The focus of this dynamic team is to drive diagnostics and actionable health information close to the patient, to the home and on the body. The goal is to inform a patient and their healthcare provider of infection before they even have symptoms.

If you are a product developer with an innovative idea to enhance for new diagnostic tests to combat antibiotic resistance and an interest in partnering with us, we would love to hear from you. To take the first step, submit your request to discuss your ideas with us at a TechWatch meeting.

Jan 03
Resolving to Be Ready to Protect Critical Infrastructure


Three Ways for Public Health and Medical Professionals to Enhance Preparedness


As we look forward into 2020, many of us are taking a moment to pause and consider what is coming in the next year. If you are a health care or public health professional, there is a very real chance you could be called on to respond to a disaster or emergency. In 2019, the Federal Emergency Management Agency issued one hundred disaster declarations across the 48 continental United States and territories. If a disaster strikes in your community, are you ready to respond?

When disaster strikes, critical infrastructure failures – from loss of power and water to failures of IT infrastructure and systems – can follow. There are actions you can take now that will help you respond more effectively in an emergency. By evaluating your facility’s risk and building strong partnerships now,you can be better prepared. ASPR’s Division of Critical Infrastructure Protection (CIP) has built tools, resources, and partnerships to help you achieve all of these goals.


Build Partnerships between Health Care and Public Health

This year, connect with other professionals to enhance your health care facility or public health department’s preparedness. Consider joining the Healthcare and Public Health (HPH) Sector Partnership, a network that works together to protect the essential goods, services, and functions of healthcare and public health.

In 2019, members of this partnership coordinated and shared information before, during, and after the earthquakes in Southern California, Hurricane Dorian, wildfires with related power outages in California, and the Urgent/11 cybersecurity attacks. Through the partnership, private sector partners were able to identify critical areas of resource needs for public prioritization and private to private coordination. CIP, which manages the HPH Sector Partnership, facilitated the timely exchange of information for the public and private partners.

To help prepare for the next disaster, the CIP team has worked with public and private partners across the HPH Sector Partnership to help them enhance and refresh their emergency response skills, provide unique training experiences, and validate information sharing practices. Using information, resources, and partners from these events, HPH Sector Partnership conducted a pandemic flu focused exercise in advance of this year’s National Level Exercise. These projects and events help build all-hazards preparedness across the HPH Sector.

If you are interested in joining the HPH Sector Partnership, email the CIP team at cip@hhs.gov to learn more and get involved.


Evaluate Risks and Plan for the Next Disaster

Many people throughout your organization probably know a lot about the different risks your hospital or health care facility faces, but it can be hard to get an accurate picture of biggest risks. In 2020, resolve to connect those dots.

If your facility hasn’t conducted a recent risk assessment, check out the Risk Identification and Site Criticality (RISC) Toolkit. The RISC Toolkit is an objective, data-driven all-hazards risk assessment tool that public and private organizations within the HPH Sector can use to inform emergency preparedness planning, risk management activities, and resource investments, and it can provide your team with a mechanism to promote connections between a facility’s emergency managers and its IT security staff. In fact, the RISC Toolkit was recognized by FEMA in the 2019 National Preparedness Report for connecting cybersecurity and all-hazards risks for a comprehensive assessment.

To enhance response and recovery operations, the HPH Sector Partnership developed the “Pilot Healthcare and Public Health Sector Partnership Response Playbook.” The playbook outlined partnership response roles and responsibilities, information sharing, and coordination mechanisms for all-hazards response situations. It represents the first time response procedures for HPH Sector members were outlined in an official document. Having formally outlined response roles and responsibilities led to smooth and well-coordinated responses in 2019.


Stay Informed Before, During, and After an Emergency

To get ready to respond, you need an understanding of both evolving threats and issues as well as lessons learned and best practices. To help you stay up-to-date, the CIP team has developed a series of resources.

  • Healthcare and Public Health Sector Highlights Listservs: To learn more about topics in critical infrastructure protection, subscribe to our mailing lists. These bulletins help educate our Sector partners on reports, resources, tools, and upcoming events dealing with a variety of health critical infrastructure protection-related topics including healthcare preparedness, resilience, and response; cybersecurity; the healthcare supply chain; infectious diseases; and partnership activities.

  • Building Resilient Health Infrastructure with ASPR Podcast: You can even stay up-to-date on issues in critical infrastructure protection while you are at the gym, in the car, or just about anywhere with our new podcast. Subscribe to our podcast to find out how your hospital or healthcare facility can plan to protect critical infrastructure so you are ready to ensure continuity of care in a disaster.

Preparing for disasters can help your hospital, health care facility, health care coalition, or public health department protect health and save lives when disaster strikes. As you are considering which activities are worth your time and effort in the coming year, take a moment to consider the potential benefits of preparedness, resolve to be ready to face a disaster or emergency, and take action to protect the people who rely on you during disasters and every day.

Dec 19
Making history: the world’s first FDA-approved Ebola vaccine

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 European Union-wide conditional marketing approval by the European Medicines Agency and the World Health Organization’s prequalification of the vaccine, provides healthcare workers and civilians in affected areas with more confidence in the vaccine.

The vaccine is already playing an important role in the fight against Ebola in the DRC.  ERVEBO® has been given voluntarily to over 255,000 people, including first responders, healthcare workers, and burial providers, under an expanded access protocol. Contacts of suspected or confirmed Ebola patients have also been vaccinated to form a “ring of protection” and reduce further spread of the disease. The number of Ebola infections and deaths in the region continues to decline, thanks in part to the investigational vaccines and antivirals, as well as diagnostic tools developed with the support of the U.S. Department of Health and Human Services (HHS).

Support for ERVEBO® began about two decades ago when the Public Health Agency of Canada began developing the vaccine using a live virus vaccine platform based on the vesicular stomatitis virus, a virus that typically infects livestock rather than people.  The Public Health Agency of Canada licensed ERVEBO® to NewLink Genetics Corporation in 2011.  BioProtection Systems, a wholly owned subsidiary of NewLink, continued development of the vaccine with additional funding from the HHS as well as the Department of Defense (DoD).

The 2014 West Africa Ebola outbreak – the largest in history - galvanized public and private partners’ resolve to accelerate the development of the vaccine and other medical countermeasures that would be needed to respond to Ebola outbreaks.  Recognizing the threat to public health and national security, the U.S. Congress allocated supplemental funding to support the development of medical countermeasures and domestic public health preparedness measures.

In late 2014, with the Ebola outbreak at its peak, Merck licensed ERVEBO® from NewLink Genetics, and partners from the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response, and DoD provided BioProtection Systems and Merck with funding and technical support for clinical trials, advanced development, and manufacturing of the vaccine.  When the West African Ebola outbreak finally ended in 2016, BARDA continued to support Merck’s late-stage development and manufacturing of ERVEBO®.

Merck and partners across the federal government remained committed to finishing the important work they started. In response to the current Ebola outbreak in the DRC, BARDA, CDC, and other partners in the U.S. government played an integral role in supporting the investigational use of ERVEBO®.  Throughout this time, the FDA provided critical scientific and technical input to U.S. government partners and Merck to facilitate the development of a safe and effective vaccine for EVD.

I am so proud that BARDA played an instrumental role in providing funding and technical support for this project. I am honored that our office had the opportunity to work with so many amazing people to produce a vaccine that is doing so much good. Our office supported activities from small scale manufacturing and phase 1 clinical development through the late-stage development of ERVEBO® that were required to support the licensure application. ERVEBO® is the 53rd BARDA-supported product to be approved or licensed by the FDA and it is the latest demonstration of the life-saving work that BARDA does each time it forms a new public-private partnership.

ERVEBO® is a critical part of a broader portfolio of medical countermeasures being developed to combat Ebola, including some that are already being used on an investigational basis with promising results.  In addition, BARDA supported the development and eventual marketing authorization of an Ebola diagnostic, and we continue to support the development of therapeutic products as well as another Ebola vaccine.

Although we continue to monitor the current outbreak, and invest in medical countermeasures that are urgently needed, we know that the virus will re-emerge.  When it does, ERVEBO® and the other medical countermeasures in this portfolio will continue to be a critical part of our efforts to save more lives and protect health security. 


Dec 17
The health security threat in my backyard: how my garden proved that the U.S. needs more, rapid, diagnostics for antimicrobial resistant infections

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 nicking my finger on a plant. Then the spot turned into a white pimple-size bump; within a day, a red flush began creeping up my hand. One of my colleagues, an infectious disease physician, spotted the infection and recommended that I get medical care quickly. That was great advice – but I didn’t take it. Instead, I went about my day. I attended a hearing before Congress, met with my staff and others, reviewed materials, and worked late.

As the sun set, that physician checked in on me. Frustrated, he made it very clear that if I did not get care immediately, I might not be able to the next day…the infection was spreading and could get much worse quickly.

I left and, hoping to avoid long wait times in hospital emergency rooms, I tried going to an urgent care clinic for help. The first two clinics were unable to help me – the first indicated that my case may require more complex treatment than her clinic can offer and the second was closing in 45 minutes and couldn’t take any more patients. At the third urgent care center, a doctor took a quick look, said I had some kind of infection, prescribed a common generic antibiotic, and offered to check the wound again in five days. After several minutes of my pleading and insistence that she lance and culture the wound, she agreed. She wrapped my hand and sent me home.

The next day, my hand looked worse and the redness was spreading. I saw my primary physician who immediately referred me to an orthopedic surgeon, who promptly sent me to the hospital, where I received pain meds and an IV antibiotic. The orthopedic’s team cut into the wound to better examine it, and then packed it and prescribed another antibiotic (now, the third). He advised me follow up with my doctor in a couple of days.

But the wound only got worse. I snapped some photos and sent them to some my infectious disease co-worker to ask if this was normal. Unfortunately, he answered no and he recommended I get back to the emergency room immediately.

Back in the hospital, I received two more antibiotics plus an antifungal for extra caution. The orthopedic experts determined that I needed to spend the night in the ER and plan for surgery that would include slicing open my hand for deep treatment or possibly removing my thumb.

None of the drugs were working, and we had no information from a diagnostic! The doctors had to shoot in the dark. My primary physician placed an angry call to the ER to demand an infectious disease consultation. After hours, an infectious disease doctor stopped by for a few minutes, changed the antibiotic (my sixth), and recommended that the planned surgery proceed.

I was moved to the hospital’s orthopedic unit, with dozens of elderly patients around me waiting for hip and knee replacement surgeries the next day. In what would become my home for the week, I was switched to yet another antibiotic, kept on three of the others and the antifungal, and fasted for surgery.

At 4 a.m., an orthopedic resident awoke me for surgery prep. Next came a quick check from the infectious disease doc and then a deep pause…she said it didn’t look worse today; in fact, it might even look a little better. We delayed the surgery a day to watch for continued improvement. Something, one of the four drugs going into my veins was working (or was it the antifungal?).

Six days after the urgent care clinic took culture, they received the results; however, they had to wait another day to get the appropriate staff to “interpret” the results, and they were not allowed to tell me or my doctor or even email or text a photo of the results. The only way they could share the results was in person or a fax machine. Technology from the late-1800s stood between me and informed treatment for a garden cut.

The test results clearly indicated MRSA. After nearly a week in the hospital, freely roaming the orthopedic surgery unit among potentially vulnerable patients, I knew the nurses finally got my results because they hung a sign on my door and started wearing gloves when they came into my room. The sad part of the story was that it still took another day to get the antibiotic sensitivity test results to the hospital. Only one of the drugs I was on was working; the other three were just burning my veins and potentially driving more resistance.

These results informed the length of my hospital stay and options for home treatment. The options were a disheartening: leave an IV line in my body for daily home drug infusions by a nurse or transition to a newer, expensive class of oral drugs my insurance may not cover. I chose the oral medication, which became my seventh antibiotic in two weeks, and suffered hearing, vision, concentration and muscle complications for the following two weeks. But, I kept my thumb!

Imagine how much faster the best treatment could have been determined and administered if the clinic, the ER or the hospital had a rapid diagnostic which could have told me and the doctor what the infection was and which medication would work best. I could have completely avoided unnecessary antibiotics (which helps reduce antibiotic resistance) and the hospital stay, saving money and time, and recovering faster – without mentally preparing to lose my thumb. And don’t forget the hundreds of vulnerable, high-risk people in the hospital I may have exposed to my MRSA infection while awaiting test results.

The gardening incident gave me personal insight into the many challenges that confront medical professionals and every patient fighting a resistant infection. I am more committed than ever to overcoming this challenge, to identifying solutions, and to partnering with private sector to get ahead of antimicrobial resistant infections and protect our nation’s health security. I hope more potential industry partners will look closely at the problem and join me by partnering through programs like CARB-X, BARDA DRIVe and other BARDA-supported initiatives.

To find out more, stay tuned for next week’s blog, which will focus on the research and development of innovative new diagnostic tests to inform patient care and fight antibiotic resistance.

Dec 10
Preparing for the Next Pandemic

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, most from H3N2 infections; the emergence of H7N9 in 2013 in China, which hit the elderly the hardest; and the 2009 H1N1 pandemic, which spread rapidly around the globe with an unexpectedly high rate of infection among pregnant women, young children, and other vulnerable populations.

Quite frankly, we need to become better prepared to face the next pandemic. Make no mistake, it’s not “if” there’s another pandemic; it’s “when” there’s another pandemic. According to a study on pandemic influenza by the White House’s Council of Economic Advisers, a future pandemic would likely incur costs ranging from $413 billion to $3.79 trillion and claim the lives of about half a million people in the United States alone.

Containing a pandemic will require layered end-to-end solutions: better diagnostics, closer to the patient; improved therapeutics, especially for hospitalized patients; and, perhaps most importantly, better vaccines that are produced in the United States using more modern, fast and flexible technologies. We cannot continue to rely on technologies that are old and too slow to save lives. We must continue to evolve mitigation strategies and technologies.

On September 19, 2019, the White House reaffirmed that we must take deliberate, decisive, and comprehensive action to combat the threat of both seasonal and pandemic influenza. On that day, President Trump issued his Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health to help safeguard the American people. At the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), we are proud to have a leadership role in the implementation of many key aspects of that plan.

ASPR oversees innovation, advanced research, development, manufacturing capacity improvements, and procurement of medical countermeasures. We also oversee the manufacturing, supply chain management, and stockpiling of countermeasures. Within the Biomedical Advanced Research and Development Authority (BARDA), ASPR has invested in the development and production of 23 new or improved influenza vaccines, antiviral drugs, diagnostics and devices.

But we aren’t just buying a bunch of different products – ASPR is working as a catalyst to spark change. We are partnering with the private sector to evolve from egg-based vaccines to cell-based and recombinant vaccines. One challenge with egg-based technologies is that you need eggs – in fact, you need both egg-specific vaccine strain selection and millions of eggs in advance. Also, the technology itself is slow to produce vaccine. In a pandemic, where early interventions save lives, that is a real vulnerability.

So, ASPR is investing in more flexible cell-based and recombinant technologies. ASPR has supported the development of six different cell-based manufacturing technologies since 2006, as well as four different recombinant manufacturing technologies starting in 2009. As a result of these investments, a cell-based influenza vaccine (Flucelvax®) was developed and can now be administered to individuals four years and older. In 2013, FDA licensed the first recombinant influenza vaccine (Flublok®), now available for people 18 years and older. This week, ASPR was pleased to announce that that we are partnering with Sanofi Pasteur to double its production of recombinant influenza vaccine.

To make these vaccines better – meaning vaccines that are more effective and require smaller amounts of antigen – we have partnered with a number of companies to develop and evaluate adjuvants. Adjuvants enhance the body’s immune response, reducing the amount of antigen needed. Some adjuvants can stretch a limited vaccine supply and ultimately allow more people to be protected during a pandemic.

ASPR supported the first adjuvanted pre-pandemic vaccine, which was approved by FDA in 2016. Through ASPR’s efforts, the domestic capacity for both seasonal and pandemic vaccine antigen production rose from approximately 60 million doses in 2006 to now over 600 million doses. Advances like this save lives while bolstering our domestic manufacturing capacity for seasonal vaccine. It is a win-win for domestic preparedness and our taxpayers.

Vaccination is the best protection against influenza, but vaccine alone will not be enough to save lives a pandemic. We must also be ready to treat people who have already become infected. ASPR is working to advance the development of antiviral drugs with novel mechanisms of action to reduce viral resistance, expand the timeframe for effective treatment, and allow for co-administration with other influenza antivirals.

ASPR has funded nine novel antiviral advanced development projects since 2007. One of the earliest projects supported development of intravenous (IV) peramivir, which received Emergency Use Authorization during the 2009 H1N1 pandemic. This product (Rapivab®) received FDA approval in 2014 as a single-dose influenza antiviral drug for treatment of uncomplicated influenza.

As part In 2015, ASPR awarded contracts to support the development of two influenza therapeutics that have novel mechanisms of action compared to existing approved antivirals. Novel antiviral drugs, especially when used in conjunction with early identification of infection through diagnostics, can strengthen preparedness and response levels in that the drugs enable health professionals to treat influenza disease effectively in patients, which in turn limits the spread of disease in communities.

We know diagnosing patients more quickly has a great ripple effect. The patient can get earlier treatment, leading to better health outcomes. The patient also is less likely to pass the infection to others. ASPR is supporting the development of in-home diagnostics to empower individuals with actionable information.

ASPR supported the development of a portable ventilator capable of providing mechanical respiratory support for critical care of newborn babies, adults and elderly patients. The Philips ventilator was cleared by FDA earlier this year for use in institutional, home, and field settings by minimally trained operators and is now stockpiled in the Strategic National Stockpile for immediate distribution when needed.

Through BARDA’s Division of Research, Innovation and Ventures (DRIVe), ASPR is supporting the development of wearable biometric sensors to inform and empower patients to seek earlier treatment. DRIVe is also investing in non-pharmaceutical approaches to reduce the severity of illness and spread of disease. So far, DRIVe has made six awards in support of these goals and the program continues to attract new partners from across the country to help drive innovation.

Several of the products that were developed with ASPR’s support, including cell and recombinant-based vaccines, new diagnostics, and therapeutics, are used every year to prevent, diagnose, or treat seasonal influenza. Those investments are helping to keep people healthy every day and can help save even more lives in a pandemic. Additional ASPR-supported vaccines have been licensed and, in some cases, stockpiled as pre-pandemic vaccines, ready to be rapidly formulated and distributed in a pandemic.

We must ensure that, on any given day, we are ready to respond to a new outbreak of pandemic influenza. Although we cannot predict when the next pandemic will emerge, we can expect it to come with little or no warning. ASPR is dedicated to enhancing our nation’s readiness by supporting next-generation medical countermeasures to address the threat of pandemic influenza and supporting domestic manufacturing of next-generation products. With sound investments, cutting-edge science, and strong partnerships, we are better able to protect Americans from the next influenza pandemic.

Nov 27
Giving Your Community Health, Warmth and Resilience

MRC Volunteers Strengthen Communities during the Holiday Season and Beyond

The holiday season is a time for giving. We spend hours (sometimes weeks, months…) searching for and picking out the perfect gifts for friends and family. Many of us donate to non-profits and charitable organizations. We even give to ourselves – often taking important time off to unwind and connect with our loved ones.

Warming shelter in New Orleans, LA MRC volunteers at warming shelter in New Orleans, LA

The holidays also offer an opportunity to give our time and skills to volunteer organizations and think of new ways to connect with our communities. This holiday season, consider donating your time to improve the health of your community by volunteering with the Medical Reserve Corps (MRC).

The MRC is a national network of more than 175,000 volunteers located throughout the United States and its territories. MRC units organize, train, and utilize local volunteers to prepare for and respond to emergencies. MRC volunteers include medical and public health professionals as well as other community members without healthcare backgrounds.

Although volunteering is important all year, winter typically brings a predictable but dangerous series of threats to community health across the country: colder temperatures, winter storms, and power outages.

In January and February 2019, MRC volunteers from across the country – from the Pacific Northwest to New England to the Gulf Coast – devoted more than 700 hours in response to these winter emergencies.

To help their communities weather the storms, MRC volunteers staffed warming centers and overnight shelters; provided call center support at emergency operations centers; assisted with charging stations during extended power outages for residents to charge electricity-dependent equipment and devices; and performed door-to-door wellness checks on residents who may be home bound and without power.

In addition to weather-related events, many MRC units are busy during the winter months keeping their communities healthy by combating the flu virus. MRC volunteers administer vaccines and provide logistical support at hundreds of flu clinics in their local communities, including those held at community events, health departments, and schools. These events provide MRC units with opportunities to test their capabilities to respond to a pandemic or other incident requiring mass dispensing.

All of these activities build communities that are healthier, better prepared, and more resilient. If you are interested in serving your community - whether this holiday season, this winter, or any other time throughout the year - I invite you to find an MRC unit near you, talk to your local coordinator, and ask what their needs are and how you may be able to serve.

MRC tent in Portsmouth, VA MRC volunteers in Portsmouth, VA


Nov 25
There’s No Such Thing as Just-in-time Healthcare and Public Health Preparedness

How to Create and Strengthen Partnerships to Enhance Critical Infrastructure Protection

What does it take to provide patient care? The image of a hospital or doctor’s office just popped into your mind, right? Well, that’s just part of the answer.

Every day, patients rely on complex just-in-time systems for the provision of healthcare. These systems include not only hospitals and other healthcare providers, but also insurance providers, laboratories, medical device suppliers, and more.

Working together, these systems can provide just-in-time supplies of everything from the drugs and therapeutic products to the blood and medical testing needed for patient care. When these systems are working, they can be used to support today’s miracles of modern medicine. Yet when supply chains are disrupted – whether by wildfires, hurricanes, cyber attacks on medical records and payment IT systems, or other issues related to healthcare infrastructure – patient health, even patient lives, are at risk.

Just-in-time re-supply has become the predominant business practice to support modern medicine; however, there is no such thing as just-in-time preparedness. In order to be ready to protect patient health during a disaster or public health emergency, you need to have a plan for managing critical infrastructure failures – and that plan becomes stronger when healthcare and public health partners work together before, during, and after an emergency.

The United States has 16 critical infrastructure sectors whose assets, systems, and networks, whether physical or virtual, are considered so vital to the United States that their incapacitation or destruction would have a debilitating effect on national security. Healthcare and public health form one of those sectors.

To strengthen critical infrastructure, the U.S. Department of Health and Human Services, through ASPR’s Division of Critical Infrastructure Protection, facilitates the coordination of the Healthcare and Public Health (HPH) Sector Partnership.  For efficiency, the HPH Sector Partnership is organized into eight operational categories: direct patient health care, health plans and payers, mass fatality management services, health information and technology, laboratories and blood, medical materials, federal response coordination, and public health.

The HPH Sector Partnership supports effective emergency preparedness and response to nationally significant hazards, such as terrorism and cyber terrorism, infectious disease outbreaks, and natural disasters. HPH partners work together to define and respond to risks, share threat information, develop and disseminate best practices, and address challenges so that each healthcare business, the entire health sector and your community become more resilient. Stakeholders and members of the HPH Sector Partnership engage regularly in confronting challenges in health supply chain coordination, response coordination, cybersecurity coordination, and emerging threat identification.

November is National Critical Infrastructure Security and Resilience Month and it is a great time to learn more and commit or reaffirm your commitment to keeping our nation’s critical infrastructure secure and resilient every day.

To stay up-to-date on issues at the intersection of public health, healthcare and critical infrastructure protection, join our mailing list and check out our new podcast, Building Resilient Health Infrastructure with ASPR. To get involved in the HPH Sector Partnership, email us at CIP@hhs.gov.


Nov 06
Take a Shot at Decreasing Hospital Acquired Infections and Enhancing National Health Security

A Case for Encouraging Seasonal Influenza Vaccination among Healthcare Workers


Last year marked the 100th anniversary of the 1918 influenza pandemic, which killed approximately 675,000 people in the United States according to the Centers for Disease Control and Prevention (CDC).  Although that number is daunting, it doesn't take a pandemic for influenza to seriously threaten patient health.  The disease burden for seasonal flu is still stunning 100 years later. While flu varies in severity, every year in the U.S., flu sickens millions, hospitalizes hundreds of thousands and kills tens of thousands.

How can hospitals and healthcare facilities help stop the spread of flu and protect their clinicians, staff, and patients? Start by encouraging clinicians and staff to get a seasonal flu vaccine each year, which provides important protection against flu and its potentially serious consequences.

CDC, the Advisory Committee on Immunization Practices (ACIP), and the Healthcare Infection Control Practices Advisory Committee (HICPAC) recommend that all U.S. healthcare workers get vaccinated annually against influenza.  Yet about one in five healthcare workers are not getting vaccinated to protect themselves – and their patients – from the morbidity and mortality associated with seasonal flu.  More concerning, nearly one in three healthcare workers in long-term care settings, such as nursing homes, do not get their seasonal flu vaccinations.

Vaccinating healthcare workers helps prevent the spread of healthcare acquired flu infections, as recently emphasized in the National Action Plan to Prevent Healthcare Associated Infections. Hospital acquired cases of flu threaten everyday health, but they would also severely complicate treatment during a public health emergency.

In the event of a severe flu season, hospitals and healthcare facilities will need to surge to care for patients. Increasing flu vaccination among healthcare workers decreases the incidence of healthcare worker absenteeism due to sickness or doctors' visits, and the likelihood that healthcare workers will infect or be infected by people who have come to their facilities seeking treatment.  It is one simple action that protects both everyday health and strengthens national health security.

The good news is that programs to encourage healthcare workers to get vaccinated make a difference. According to CDC, vaccination rates among healthcare workers are highest when their workplaces require vaccination or offer on-site vaccination at low or no cost.

If you manage a hospital or healthcare facility, there are many reasons to encourage your staff to get vaccinated – from the cost savings associated with lower rates of absenteeism among staff to the national security implications of influenza on surge capacity. It doesn't matter which reason motivates you the most, as long as you encourage your staff to get vaccinated. Ready to take the next steps?  Learn about additional steps your hospital or healthcare facility can take to promote vaccination in the work place.

Nov 01
Opportunities and Cybersecurity Risks for the Healthcare and Public Health Sector

Next-Generation Medical Technologies and Emerging Health Security Threats

Cutting-edge innovations in medical technology help medical professionals improve patient health outcomes during disasters and every day. While these new, evolving technologies bring great promise for patient care, they also introduce an element of risk into your hospitals and healthcare systems.

The Internet of Medical Things (IoMT), artificial intelligence (AI), and machine learning (ML) are all transforming the way healthcare is provided, but is your hospital or healthcare facility ready to face the new cyber security and privacy challenges associated with the use of these revolutionary technologies?  

The IoMT is comprised of interconnected medical devices and applications that collect data, which is then provided to healthcare IT systems through online computer networks. For example, smart beds, wearable medical devices, infusion pumps, and embedded devices are all new technologies in IoMT. These devices  present major benefits to providers and patients such as improved drug management, process automation, and enhanced data analytics across multiple domain’s, improved patient outcomes, and remote patient monitoring. IoMT devices connect to a variety of healthcare systems, networks, and other tools within a healthcare delivery organization.

However, the increased connectivity provided by IoMT also creates cybersecurity risks such as potential for unauthorized access to patient health information, changes to prescribed drug doses, and interference with the device’s function. Cyber security and privacy professionals must address the IoMT risks not only for the “device” but also holistically, across the entire network of systems and applications, which include physical security, mobile interfaces, authentication, and authorization.

An additional challenge for the IoMT is patching and updating the embedded operating systems and applications of the devices as some provide critical patient care and require specially handling. If your hospital or healthcare facility use IoMT devices, check out the Health Industry Cybersecurity Practices document on Managing Threats and Protecting Patients or the National Institute of Standards and Technology (NIST) project on Securing Telehealth Remote Patient Monitoring Ecosystem for references to help you better protect patient health while leveraging these new technologies. Check back periodically for progress because this project will result in a Cybersecurity Practice Guide with practical steps to address IoMT challenges.

Recent developments in AI and ML have led to smarter autonomous systems which can learn for themselves and keep up with the velocity and volume of data that networked systems produce. The introduction of AI and ML in health care have led to the development of new applications and tools that are starting to have a significant positive impact on chronic disease management, cancer diagnostics, radiology, and interventional medicine.

There are, however, very distinct and new vulnerabilities associated with AI and ML tools and applications. For example, data poisoning, logic corruption and data manipulation can introduce data that causes a ML-based system to make mistakes or introduce specific data patterns that are designed to be misclassified by learning systems. The most common defensive techniques for these attacks include “data sanitization” and “anomaly detection”, which themselves are in the process of maturing. To learn more about the evolution of recommendations on AI and ML, see Artificial Intelligence at NIST.

While attention to fundamental cyber security and privacy principles such as defense in depth, non-repudiation principles, encryptions, continue to be critical, it is equally important to become familiar with the innovative technologies in the HPH sector and the new cybersecurity threats that come with these technologies.   


Oct 11
The power of partnership: BARDA ushers in 50th FDA-approved product for 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.

 

BARDA FDA Approvals


From our first, a pandemic influenza vaccine licensed in 2007, to last week’s clearance of the first anthrax diagnostic test that could be used in non-government labs in a surge capacity, we have tackled hefty scientific and business challenges.

Many health security threats involve bacteria or chemicals for which clinical trials cannot be performed in humans. To overcome this hurdle, we worked closely with FDA on a path for approval of such products using the Animal Rule. Raxibacumab, a treatment for anthrax, became the nation’s first medical countermeasure to utilize this path, earning FDA approval in 2012. Since Raxibacumab was approved, our partnerships have resulted in five additional approvals using the Animal Rule, including three products that can be used to treat white blood cell depletion that occurs after a radiological or nuclear event. Even as we utilize this pathway, we continue to explore new technologies that could pave a more efficient path to approval.

Another hurdle has been the return on investment for the private sector and taxpayers. To overcome this challenge, we have reduced the business risk and costs not just by providing non-dilutive funding and deep technical assistance but also by focusing on products that could have multiple uses and commercial uses.

In some cases, we’ve sponsored development for new indications of approved products like Seizalam and Silverlon. Midazolam was an approved sedative and became the first approved as an anti-seizure drug to treat prolonged seizures caused by chemical exposure. Silverlon was cleared initially as a silver-impregnated wound dressing and became the first product cleared in the U.S. for use in treating chemical burns from mustard gas.

In other cases, we’ve sponsored development of products that meet needs in the commercial market and health security, such as for XERAVA (eravacycline), a novel, fully synthetic tetracycline antibiotic that was approved in 2018 to treat complicated intra-abdominal infections. The antibiotic also could be used against serious Gram-negative infections, including those caused by multi-drug resistant pathogens, and, with FDA Emergency Use Authorization, could be used to treat anthrax, plague, or tularemia.

Nineteen of our 51 approvals are vaccines, diagnostics, or treatments that increase our preparedness for influenza pandemics. The technologies that BARDA has supported to prevent, diagnose or treat pandemic influenza can also be used to combat the seasonal influenza epidemic.

We know the nation must be ready to face all health security threats – the ones known today, those emerging, and those not yet imagined. By partnering to create innovative countermeasures tailored to meet unique national security demands for rapid response, we become better prepared to act quickly to save lives.

Our preparedness to save lives requires end-to-end solutions – from rapidly recognizing the problem to treating patients quickly, safely, and effectively. Hence our focus on disruptive innovation to detect disease earlier; better, faster vaccine technologies that protect patients and healthcare providers; and host-directed therapeutics for more effective treatment.

Over the past 12 years, in our pursuit of transformative medical countermeasures that will protect the American people in public health emergencies, we have partnered with more than 300 companies, from micro and small businesses to global pharmaceutical corporations. We continue to build and strengthen these partnerships using every business tool at our disposal. We know that the right science and technology truly can transform how people understand and participate in the preservation of public health and health security, resulting in a world in which invention unlocks the power of the collective good to overcome potential threats.

We continue to welcome new partners who share our passion for disruptive innovation to enhance our nation’s health security. Learn more about what we are pursuing next through the BARDA Broad Agency Announcement and start a conversation with us by requesting a meeting.

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