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Mar 19
Virtual Wedding Bells

Disaster Medical Assistance Team Helps Unite Father under Quarantine with his Daughter on her Wedding Day

At quarantine sites across the country, some passengers from the Grand Princess are missing important milestones as they wait out their quarantine, but responders from the National Disaster Medical System (NDMS) are committed to making things a little bit easier for them. Earlier this month, NDMS responders helped a dad who was not able to be physically present virtually walk his daughter down the aisle while he was in quarantine. 

Joel Young attends wedding virtually

Joel Young, a resident of the Phoenix, AZ area and a guest in quarantine at the Marine Corps Air Station Miramar was able to participate in the wedding ceremony of his daughter even though he was over 1000 miles away.   Joel coordinated with a company to provide a robot controlled by a tablet device to enable him to attend the wedding remotely.  

“They called it Daddy-Bot," Joel said as he described his proxy during the ceremony.  As the video broadcast went live, wedding guests walked in front of the camera to wave, say hi and to let Joel know he was missed.  

NDMS responder Sarah Caven first met Joel as she and more than a hundred medical and non-medical personnel from NDMS and the U.S. Public Health Service welcomed over 480 guests from the cruise ship that docked in Northern California to the quarantine site at Marine Corps Air Station Miramar.  As part of the required quarantine to protect the American public from the further spread of the COVID-19, guests were moved to housing on the base and provided services to meet their needs.  

Sarah heard that Joel was trying to join his daughter’s wedding, but was a few pieces of equipment short of a solution and she really wanted to help this dad virtually walk his daughter down the aisle.  So she let him borrow her personal iPad and got him an HDMI cable for his TV so he could control and watch the robot acting as his stand-in. 

Joel had a hard time being so far away from his family and coping with the isolation of quarantine, but he was really touched by the support he received from NDMS responders, including Sarah. “Having you guys with me during the ceremony was so nice. I was a contractor on the cruise ship and traveling alone. I was then restricted to my interior stateroom and then placed in a room alone here.  It has been so lonely,” said Joel.

Three responders in PPE with sparkling cider

A few DMAT staff were able to attend the wedding as Joel’s plus one.  Joel had the yellow-gowned staff in personal protective equipment (PPE) poke their heads into the camera frame to wave.  The wedding guests were pleased to see Joel as he wept in joy seeing the beautiful bride in her dress joined in matrimony. “He is a very nice guy and perfect fit for my daughter,” said Joel.  “I am so proud of the couple they will become.”  

Coping with quarantine is hard for many passengers, but the dedicated professionals from NDMS are working to make it easier for the people they are helping at quarantine locations across the country. 

In communities across the country, community spaces are closing and many people are practicing social distancing to prevent the spread of the novel coronavirus, which can be very stressful.  If you are finding it difficult to practice social distancing, check out these tips on coping from SAMHSA’s fact sheet, Taking Care of Behavioral Health: Tips for Social Distancing, Quarantine, and Isolation during an Infectious Disease Outbreak.

Feb 22
BARDA Leverages Strong Public-Private Partnerships to Spur a Rapid Response to the Novel Coronavirus Outbreak

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 month, BARDA has expanded agreements with three companies to develop medical countermeasures that enhance national health security, and we continue to seek insight from our partners in the private and public sectors to identify promising technologies.

Strengthening health security in the face of the novel coronavirus outbreak will take more than one single product. To protect the American people from this new coronavirus, healthcare professionals need medical countermeasures that enable them to diagnose patients quickly and accurately, vaccinate people to prevent the spread of the virus, and treat infected people with effective therapeutics or antivirals. 

To help protect the American people from COVID-19, we have invested in two novel coronavirus vaccines. On February 11, we announced that we were expanding our collaboration with Janssen Research & Development, part of Johnson & Johnson, to expedite the development of vaccines that protect against this new coronavirus.  BARDA and Janssen will share the research and development costs to help move Janssen’s investigational novel coronavirus vaccine into clinical evaluation. The candidate coronavirus vaccine will be developed using Janssen’s flexible, rapid vaccine platform. BARDA and Janssen have collaborated in the recent past to combat another threat to health security: Ebola. The Ebola vaccine developed by Janssen is being used to fight the disease in the Democratic Republic of the Congo today.

On February 18, BARDA expanded our partnership with Sanofi to develop a novel coronavirus vaccine candidate using the company’s recombinant DNA platform. This technology will be leveraged to produce a vaccine in the U.S. with an exact genetic match to proteins of the virus. Sanofi has worked with us in the past to strengthen health security in another area: pandemic influenza preparedness. We have worked with Sanofi since 2004, to meet a number of pandemic preparedness milestones, most recently on licensure of recombinant technology for influenza vaccines and on increasing domestic manufacturing capacity for these vaccines.

BARDA is also investing in therapeutics to treat patients who are infected with the virus. On February 4, we announced that we are expanding our existing agreement with Regeneron to develop multiple monoclonal antibodies that, individually or in combination, could be used to treat COVID-19. Two weeks later, on February 18, BARDA and Janssen agreed to expand our existing collaboration to screen libraries of compounds with the potential to treat coronavirus infections and minimize the severity of the illness. Under this expanded agreement, Jansssen will evaluate approved medicines and investigational compounds that have antiviral activity against the novel coronavirus – an important first step in developing treatments

Vaccines and treatments are vital, but so is accurate, timely diagnosis. Bringing diagnostics closer to the patient helps ensure that patients get prompt, appropriate care. To spur innovation, BARDA has issued its business-friendly, streamlined Easy Broad Agency Announcement (EZ-BAA) for COVID-19 molecular diagnostics. The diagnostics must leverage FDA-cleared platforms and have a viable plan to meet requirements for the FDA to consider Emergency Use Authorization (EUA) within 12 weeks of an award. 

This week we broadened that EZ-BAA even further to include abstracts for nonclinical assays and models to support the development of multiple medical countermeasures to protect the American people. If your company has an innovative coronavirus diagnostic or nonclinical assays underway, submit your abstract through the EZ-BAA.

In addition, the federal government established a single point of entry for product developers to submit their research on 2019 novel coronavirus medical countermeasures. If your organization has research available, submit an abstract through our market research initiative

BARDA and its partners throughout the federal government continue to look for new ways to collaborate on promising technologies. This is the third coronavirus in less than 20 years, and it is time for us to get new medical countermeasures over the finish line. 

We have been able to move quickly in the current coronavirus response because of the flexibility built into the agreements with these private sector collaborators. With these and other private sector partners, we have built portfolios of products that address complex health security challenges, including emerging infectious diseases like the 2019 novel coronavirus. Our partnerships with industry and with counterparts from across the federal government have brought products over the regulatory finish line to protect the American people, strengthen health security and, ultimately, save lives.

Feb 15
Sepsis is Skyrocketing in the Medicare Population

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 whole.

Sepsis is the body’s extreme response to an infection and a life-threatening medical emergency. Anybody can have an infection, and any infection can lead to sepsis. However, older adults and people with chronic illnesses like kidney diseases or cancer are most likely to suffer from sepsis – which is why sepsis rates for Medicare beneficiaries were studied.

The study, described in a series of journal articles in Critical Care Medicine, revealed that one of every five patients who had a sepsis admission either died during the hospitalization or during the following week. However, the risk of death in the following years can be as high as 75 percent.

Sepsis consequences for patients with sepsis mortality rates infographic

In addition, even if patients survive sepsis, they are more likely to suffer adverse long-term health consequences. Sepsis survivors are less likely to return home after a hospital stay, more likely to need custodial care or skilled nursing care, and more likely to be admitted for hospice care in the first six months after they leave the hospital.

Just as staggering is the economic cost. In 2012, the estimated overall inpatient and skilled nursing facility care costs of sepsis to Medicare was $27.7 billion dollars. By 2018, that estimate cost climbed to more than $41.5 billion. Based on these Medicare costs, national cost for sepsis is estimated conservatively to reach roughly $62 billion for 2019 – and that figure does not include the costs of treating sepsis in facilities run by the Veteran’s Administration, the Defense Health Agency, physician fees, or outpatient care.

All infections – whether they originate from a natural disaster, a chemical, biological, radiological, or nuclear event, or an emerging infectious disease like the novel coronavirus – can lead to sepsis. Sepsis threatens our nation’s health security which makes solving sepsis a priority so that we can be better prepared to save lives during any public health emergency.

In 2018, the Biomedical Advanced Research and Development Authority (BARDA) launched DRIVe, the Division of Research, Innovation and Ventures. Through the DRIVe Solving Sepsis program, BARDA has taken a different, more holistic approach to sepsis, bringing together industry, academia, and non-government partners with a vested interest in developing diagnostics that can detect sepsis earlier and with greater accuracy; improving sepsis education and training for healthcare providers; encouraging the adoption of clinical management strategies, developing novel therapeutics, and leveraging other innovative technologies.

To solve sepsis, the U.S. government, industry, academia, nonprofits and many others must collaborate. We look forward to expanding our network of public and private partners to find and implement lifesaving solutions.

The study was published as three articles in the journal:

Feb 03
New Pandemic Influenza Vaccine Uses Next Generation Technology to Strengthen Health Security

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 of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, will be produced at a facility in Holly Springs, North Carolina to help ensure the vaccine will be available to the American people when they need it most.

Modernizing influenza vaccines and domestic manufacturing capacity is a priority for the Trump administration and critical for national health security.   On September 19, 2019, the President issued an executive order that set a clear direction for the next generation of pandemic influenza vaccines: the nation needs more modern, domestically manufactured vaccines that can be produced without relying solely on egg-based processes. AUDENZTM uses two leading-edge technologies - an antigen-sparing adjuvant and cell-based vaccine technology – that represent a game-changing advance in the state of pandemic influenza preparedness.

Most influenza vaccines are manufactured using embryonated chicken eggs, which makes the production of pandemic influenza vaccines vulnerable to disruptions in the egg supply and variations in the ways different strains of the virus grow in an egg. Like many agricultural products, egg production is seasonal and the supply of eggs wanes just as the demand for a pandemic influenza vaccine could increase. Although BARDA worked with egg producers to overcome this challenge, responding to a pandemic requires large-scale continuous manufacturing, and egg-based processes have limitations. We would need to use an array of vaccine technologies to produce enough vaccine domestically as quickly as possible.

AUDENZTM uses cell-based vaccine technology and an adjuvant, which boosts the body’s immune response and makes the vaccine more effective overall. In the early days of a pandemic, the amount of vaccine that can be manufactured is limited by the amount of antigen – the part of a vaccine that arms the immune system – that can be produced. However, the adjuvant used in AUDENZTM reduces the amount of antigen needed for the vaccine. By using this antigen-sparing technology, more doses of AUDENZTM can be made from the same amount of antigen while maintaining the safety and effectiveness of the vaccine. Ultimately, that means more vaccine is available in a given time period.

AUDENZ will use the same adjuvant production facility as FLUAD®, a seasonal influenza vaccine produced by Seqirus in North Carolina. In a pandemic, that facility would ramp up and begin supporting AUDENZTM. By leveraging the existing domestic manufacturing infrastructure in a facility that is used to make a seasonal product, we are able to enhance the sustainability of our pandemic preparedness.

Vaccines are only one part of BARDA’s pandemic preparedness portfolio. Since the development of the National Pandemic Influenza Strategy in 2005, BARDA has taken a multi-faceted approach to preparing for the next influenza pandemic by collaborating with partners in government and industry to develop innovative therapeutics, vaccines, diagnostics, and devices; establish vaccine stockpiles; and begin to revitalize domestic vaccine manufacturing capacity.

Through these partnerships, BARDA has supported the regulatory approval of a diverse portfolio of medical countermeasures to prevent, detect and treat influenza. Today, we added AUDENZTM to that portfolio.

As the recent outbreak of a novel coronavirus reminds us, people travel around the world every day and the viruses they may carry do not respect borders. Just over a decade ago, the H1N1 pandemic spread throughout the globe in just a few weeks. During the 2009 pandemic, pregnant women, young children, and other vulnerable populations suffered particularly high rates of infection. A decade before that, the threat of an H5N1 influenza pandemic emerged, with periodic transmission of H5N1 from birds to people, and the threat remains real. Now, we have a licensed cell-based and adjuvanted vaccine that can be manufactured in the U.S. to protect children over 6 months of age, older adults, and other medically vulnerable people. We are better prepared to protect people during an H5N1 pandemic.

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 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

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