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Nov 19
BARDA Ventures: A New Approach to Partnership

How can we make sure our country has the vaccines, therapeutic treatments, diagnostics and other technology that are needed to save lives in a public health emergency? Part of the answer is encouraging innovators and entrepreneurs to partner with the federal government, and doing so requires rethinking the typical government approach to research, development and acquisition. Over the last decade, the success of HHS, ASPR, and BARDA has been to partner with the most innovative, fearless, and best partners in industry. These partnerships have helped push preparedness efforts farther along.

As part of the Office of the Assistant Secretary for Preparedness and Response, BARDA continually invests in advanced stages of development to bring forward critical technology and products to protect Americans’ health security. To date, BARDA’s support for product development has resulted in 56 FDA approvals, clearances, and licensures for critical countermeasures such as vaccines, point-of-care diagnostics, and lifesaving therapeutic drugs. We’ve established novel public-private partnerships with companies of all sizes and experience levels, from global pharmaceutical giants to innovative startups, to accelerate the development of medical countermeasures to save lives.

The foundation of these collaborations vary from traditional contracts to flexible agreements under Other Transaction Authority to allow us to transition immediately from long-standing health security threats to address immediate threats like COVID-19. While BARDA holds a unique role as the only part of the federal government dedicated to advanced stages of development for medical countermeasures the American people need in public health emergencies, we realized that to combat a unknown and ever-evolving threats, we needed a stronger pipeline of transformative technologies and products.

In 2016 we founded CARB-X, now the world’s largest public-private partnership to accelerate new countermeasures to combat antimicrobial resistant infections, which has now supported 45 novel technologies with seven graduating into advanced stages of development or regulatory approval. In 2018, we stood up DRIVe, the Division of Research, Innovation, and Ventures (DRIVe) dedicated to improving health security and enhancing our preparedness posture by specifically investing in potentially breakthrough technologies and capabilities to address systemic challenges across all health security threats, such as early notification of illness before symptoms occur, solutions for sepsis, and other disruptive innovations.

In this short time, DRIVe has partnered with 13 accelerators across the country to better source innovation across America. BARDA’s objective, to move strategically and quickly on acquisition and management activities, has fueled DRIVe’s success and resulted in 41 new public-private partnerships.

BARDA Ventures is our next step to bring medical countermeasure development up to the speed of innovation. To do so, BARDA Ventures will engage the private sector by seeking matching investments from non-governmental sources and thus multiply the impact of taxpayer dollars provided by the U.S. government.

DRIVe built a robust team of biotech, investment, and health security experts who thoroughly examined every aspect of venture capital industry practices. Our approach is based on hundreds of conversations with leading venture capital experts and through responses to two requests for information and culminated in an announcement for a non-profit fund manager with which we can partner to carry out venture capital style investments that support medical countermeasure development to help the United States prepare and respond better to future health security threats.

We ask all interested parties from the venture and investment community to join us and help identify, nurture, and commercialize transformative technologies with the required speed and flexibility that traditional government funding is not designed to do. Immediately, we are looking for a managing partner to help us transform the American health security landscape through equity-based investing. That partner would be an existing nonprofit entity with a demonstrated track record of successful healthcare and life science related venture capital investments that can establish and manage a private-public partnership with us. Learn more on the BARDA Ventures website.

Nov 18
BARDA’s Reflections on Antibiotic Resistance and the Path Forward

Antibiotic resistance is one of the greatest global health threats of our time. Antibiotics are vital tools for addressing bacterial infections and save untold millions of lives each year. However, the increasing prevalence of resistant strains of bacteria threatens the usefulness of antibiotics and can cause untreatable infections. CDC’s 2019 Report on Antibiotic Resistance Threats estimates indicate that each year, more than 2.8 million Americans develop a drug-resistant infection, and more than 35,000 die from them.

Globally, drug-resistant infections kill over 700,000 people every year, and in the United Nations’ report No Time to Wait, the United Nations warns that without a sustained effort to contain antimicrobial resistance, this figure could increase to 10 million lives lost per year by 2050, with 2.4 million deaths occurring in high-income countries between 2015 and 2050.

Last month, the U.S. government released the National Action Plan for Combatting Antibiotic-Resistant Bacteria (CARB), 2020-2025. This pivotal strategy lays the foundation for how agencies across the U.S. Government will collaborate over the next five years to equip the United States to continue its One Health response to the antibiotic resistance threats of today and prepare for new resistance that might emerge tomorrow.

The new plan builds on the successes realized under the 2015 National Action Plan for CARB. After five years of coordinated federal response, the nation is better positioned to combat the emergence, spread, and impact of antibiotic resistance, but more can and needs to be done during the next five years.

BARDA plays a critical role in the federal government’s response to combatting antibiotic-resistant bacteria and is responsible for targeted actions to meet multiple objectives within the National Action Plan for CARB. BARDA serves as the lead agency for investing in the innovation, advanced research and development (R&D), manufacturing, and procurement of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats and save lives.

Currently the private sector has too few innovative antibacterial products in development to address highly resistant infections. Making new antibiotics is difficult and expensive, and many manufacturers have shifted their efforts away from developing new antibiotics, which typically have a low return on investment, to more profitable products. BARDA is supporting the world’s largest antibacterial portfolio by incentivizing companies to focus on antibiotic development by providing non-dilutive funding to offset high R&D costs and technical assistance to reduce R&D risk.  These critical attributes, along with BARDA’s flexible and nimble authorities, enable BARDA to enter into public-private partnerships that bring critical new antimicrobial products to market.

Together with our counterparts at the National Institutes of Health, Centers for Disease Control and Prevention, and the Department of Defense, BARDA will continue to invest in projects to propel research and development for therapeutic, diagnostic, and preventative products. BARDA will support antimicrobial products from development all the way through marketing approval and will work to ensure that antibiotics used to treat infections from biothreat pathogens are appropriately stockpiled. Our efforts recognize the importance of preparing for all public health emergencies, and we seek to reduce the morbidity and mortality caused by antimicrobial-resistant bacterial infections that stem from mass casualty incidents and disease outbreaks.

Preparing for the threats of tomorrow means investing in transformative, next-generation antibacterial approaches. Having recently celebrated our 10-year anniversary, the BARDA Antibacterials program is proud of having invested over $1.3 billion dollars thus far, with partner cost-share in excess of $3.5 billion, and seeing 3 FDA approvals of new antibiotics.

Our strategy is a holistic one in terms of product type. In seeking to maximize the impact of our investments, we emphasize innovation, new classes of antibiotics, novel mechanisms of action, host-directed therapeutics, small molecules that address priority forms of resistance or unmet clinical needs, and vaccines. We are currently funding development of 60 antibacterial therapeutics, diagnostics, and vaccines: 45 in early stages of development through the CARB-X program and 15 in BARDA's antibacterial portfolio for advanced R&D, which includes 7 products in Phase 2 or Phase 3 clinical development.

BARDA also supports non-traditional approaches, which have the potential to open up new modes of treatment, circumvent known forms of resistance, reduce side effects, and augment existing medical practice. This year, we are pleased to welcome two new partners to BARDA’s antibacterial portfolio, both of whom are developing nontraditional candidates that represent firsts for us: Vedanta Biosciences for BARDA’s first live bio-therapeutic product and Locus Biosciences for a CRISPR-engineered bacteriophage therapy.

As we look to the future, we also recognize that preparedness does not stop with U.S. Food and Drug Administration (FDA) approval. As always, we must continue to improve on our existing preparedness posture. Last year we awarded our first Project BioShield contract in the antibacterials program to Paratek Pharmaceuticals, supporting both the acquisition of their FDA-approved antibiotic NUZYRA for the national preparedness and its continued development as a countermeasure for biothreats.  BARDA anticipates making a second Project BioShield award in FY2021, increasing our preparedness to treat biothreat pathogens.

Antibiotic resistance continues to harm hundreds of thousands of American lives every year, and combating this health security threat remains a priority for the U.S. government even amid the current COVID-19 pandemic. As we have seen with the response to COVID-19, tools for surveillance, early detection, containment, treatment, and prevention are key to addressing the spread of infections and treating disease. BARDA remains as committed as ever to fostering public-private partnerships to revitalize the antibacterial pipeline and combat antibiotic resistance.

Nov 17
NDMS Trauma and Critical Care Team Supported Medical Professionals with Intubated COVID-19 Patients

HHS Supported Response to the Novel Coronavirus in El Paso, Continues Support Nationwide

As part of the response to the COVID-19 pandemic, approximately 100 experts from across the country deployed recently as part of the National Disaster Medical System (NDMS) to provide temporary medical surge support to three hospitals in El Paso, Texas. Although this mission has ended, NDMS responders continue to provide important services in other communities across the country.

Beyond the whirring of the hospital machinery, past the area where clinicians don additional personal protective gear, Bridget Pelaez, Deputy Commander of a Trauma and Critical Care Team (TCCT), was helping lead a team of federal responders that deployed in El Paso where the TCCT was working with local hospital staff to respond to the increase in COVID-19 cases and provide care to patients in a COVID-19 unit.

Bridget Pelaez, Deputy Commander of a Trauma and Critical Care Team (TCCT)

The team had been seeing some of the most severe patients in El Paso, specifically providing care to intubated patients in a local hospital. Bridget helped lead the team coordinating their care and working with the hospital to ensure that everything ran smoothly.

Bridget is dedicated to ensuring that the NDMS medical professionals have the support they need to fulfill their mission of providing the best of care in the worst of times. She’s been working with NDMS for nearly a decade and has responded to many incidents, including hurricanes, earthquakes and COVID-19.

“It was an honor to be able to represent NDMS on that mission and to support the community of El Paso,” said Deputy Commander Pelaez. “We were focused on working with the hospital to provide the best possible care to patients that need it the most and support the local hospital system with important critical care.”

Deputy Commander Pelaez, a paramedic and nurse by clinical training, realized early in her career that that she wanted to have a bigger impact. So she joined the NDMS where she is able to have a seat at the table to make decisions and provide care to help Americans in the wake of disasters and emergencies.

“One of the best things you can do as a health care responder is represent our nation’s health response in disasters and be surrounded by brothers and sisters that care not only about the survivors and the mission but also about each other,” Deputy Commander Pelaez said.

When Bridget isn’t deployed with the NDMS she serves as the Assistant Director for the Division of Operations and Safety at Florida International University and as an adjunct professor for the Academy for International Disaster Preparedness. Now, she is one of the hundreds of experts deployed across the country to help the whole of government response to COVID-19.

Bridget and her TCCT’s mission in El Paso may have come to an end, but other medical personal with the NDMS are also supporting the whole of government response to the novel coronavirus across the nation. Bridget is just one of our everyday heroes of the NDMS that provide patient care, patient movement, and definitive care; contribute veterinary services; furnish fatality management support; and more.

Since January, ASPR has deployed over 1,400 of medical, logistical, and command and control personnel from NDMS to help states, territories, and jurisdictions respond to the COVID-19 pandemic. These deployed personnel include physicians, physician assistants, nurses, respiratory therapists, paramedics, pharmacists, and behavioral health specialists who serve as intermittent federal personnel. When they aren’t deployed, they are the medical and support professionals in whom we entrust our health on a day-to-day basis. Currently, NDMS teams – along with healthcare providers from U.S. Public Health Service Commissioned Corps – are providing surge support at several hospitals or long-term care facilities across the country.

To learn more about HHS’ response to COVID-19, please visit the ASPR COVID-19 Response page.

Nov 12
BARDA Ventures: Evolving Federal National Health Security Using Novel Venture Capital-Style Partnership

Partner with us to build a portfolio of next-generation of medical countermeasures using a cutting-edge business solution

After an extensive assessment of the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) in 2010, HHS found systemic gaps in the federal government’s ability to develop necessary medical countermeasures during an emergency. The review panel recommended the creation of an independent strategic investment entity to fund efforts aimed at mitigating such risks. The 21st Century Cures Act provided BARDA with the necessary authority to partner with an existing non-profit entity to make investments with the flexibility and speed of venture capitalists. This approach emphasizes revitalizing, rejuvenating, and accelerating medical countermeasure development.

As the COVID-19 pandemic has made clear, fully preparing for the unique complexity of new health security threats is an ongoing challenge. We need to continually evolve and innovate, not only scientifically, but also in the types of technologies brought to market and way in which it is utilized. Our latest step to ensure that critical lifesaving products and innovation is ready when needed is the launch of BARDA Ventures.

BARDA Ventures represents a new partnership, one that utilizes practices that have been used by the venture capital community for decades. Venture capital is one of the quickest and most empowering way to bring products to market. Through this partnership, BARDA is seeking a non-profit partner to operate an investment fund uniquely focused on enhancing national health security, transforming platform technologies, and bringing them to market to save lives and protect Americans.

BARDA Ventures will provide a mechanism to deploy needed capital so that inventors, innovators, and entrepreneurs can help combat complex, evolving health security threats. This approach will help attract the most innovative solutions that can bolster our nation’s response to future pandemics and other public health emergencies.

All investments within the BARDA Ventures portfolio must meet BARDA’s mission to address health security risks – from identifying an unknown pathogen circulating in a community to administering a medical countermeasure such as a vaccine after it has been developed. These critical technologies could be used to augment and enhance U.S. preparedness against known and unknown threats, natural, or man-made. Through this investment method, if a portfolio company succeeds in generating positive returns by bringing a product to market, goes public, or is outlicensed, proceeds from BARDA Ventures investments made with U.S. Government funds will be recycled back into the fund to further support the partnership in the advancement of health security.

Today, we are looking for a qualified entity to help us transform the American health security landscape through this unique partnership. That partner would be an existing nonprofit entity with a demonstrated track record of successful healthcare and life science related venture capital investments that can establish and manage a private-public partnership with us. If you are interested in learning more and working with us to change the future of health security and prevent the next pandemic, click here to learn more.

Oct 30
HHS Provides Guidance to Help Persons with Disabilities Return to the Community after a COVID-19 Diagnosis

Care-coordination activities are especially important to reconnect persons with disabilities to their communities when they are discharged after a COVID-19 related hospitalization, isolation, or quarantine. Ensuring that persons with disabilities have meaningful access to community life requires nurses, medical social workers, case managers, and other discharge professionals to overcome additional obstacles presented by the public health emergency including limited staff, support services, and the changing needs of persons with disabilities who are recovering from COVID-19.

A nurse

The HHS Office of the Assistant Secretary for Preparedness and Response in partnership with the HHS Centers for Medicare and Medicaid Services and the HHS Administration for Community Living developed the Discharge Planning and Care Coordination tool to address discharge planning during an emergency.

Throughout the discharge process, care coordinators need to remember to put the needs of the patient first. In order to translate this somewhat broad concept into an actionable plan, the Discharge Planning and Care Coordination tool takes a person-centered approach to planning and leverages the CMIST Framework (Communication, Maintaining Health, Independence, Support, and Transportation) to help providers find discharge solutions.

While a framework to guide discharge planning decisions is helpful, there is no one-size-fits-all solution. Providers need to take a person-centered approach and work with the patient to determine what he or she wants their post-discharge environment to look like. Working together, the patient and the provider should develop a plan to optimize the patient’s quality of life, taking into account his or her preferences, needs, and wants. The goal of person-centered planning is to create a plan that would accommodate the person’s self-defined quality of life, choice, control, and self-determination.

The CMIST Framework outlines the considerations required to select the most appropriate discharge setting from a multidisciplinary perspective. The resource takes a comprehensive approach to discharge planning and assists planners as they identify the most appropriate settings for persons with disabilities after a COVID-19 diagnosis and during an active public health emergency.

Journey Map for COVID-19 Positive Individuals with Disabilities Who Live in Community-Based Settings

Journey Map

Depending on their disability-related needs and COVID-19 recovery, people with disabilities may be discharged to three common settings: home, temporary care (nursing homes or swing bed hospital), or new housing.

While a return home is preferable and may be appropriate for those who have tested negative for COVID-19, some persons with disabilities require additional services found in a more supportive living environment as they recover from a COVID-19–related illness. A decline in health related to the COVID-19 diagnosis or loss of community support services due to the emergency may necessitate the reevaluation of living arrangements and support services. Others may find that they are able to transition to a more independent community setting upon release from the hospital.

The tool includes a number of planning resources for professionals, such as a journey map and resources detailing national and state programs and federal contracts that support care coordination activities.

Right now, nurses, medical social workers, case managers, and other discharge professionals are facing tough decisions every time COVID-19 patients are discharged. Ultimately, the goal is to empower persons with disabilities to return to a setting that is as independent and integrated as possible when it is safe to do so after a COVID-19 diagnosis. Using a standardized framework, to make more informed decisions can help people with disabilities receive appropriate care while still protecting clinicians, staff and others. To get started, check out the Discharge Planning and Care Coordination during the COVID-19 Pandemic.

Oct 23
More than 50 Million BARDA-Supported COVID-19 Diagnostic Tests Shipped to Communities across the U.S.

BARDA’s Public-Private Partnerships Support a Range of Tests from Future At-Home Kits to Major Lab Systems

As the coronavirus pandemic continues around the world, the need for rapid, accurate testing remains critical. Testing leads to the identification of active cases, helps spur more rapid treatment of people who are infected, and allows you and your doctor to take immediate action, such as isolating people who are ill.

COVID-19 is highly contagious, and the virus that causes COVID-19, SARS-CoV-2, can be transmitted by people who do not show any symptoms. Many who are infected do not know they are carrying the virus; others might have just very mild symptoms. As people continue with their daily routines, they can infect others inadvertently. To support the American people, schools, employers, healthcare providers, and public health officials in this whole-of-America pandemic response, BARDA is committed to the rapid development and production of test kits across the United States.

It might seem obvious, but testing exponentially increases not only our knowledge but also our ability to act on that knowledge. Knowledge empowers patients, healthcare providers and public health officials. In addition to isolating people who are infected, test results help officials trace contacts of confirmed cases if needed; identify hot spots or flare ups within communities which helps direct local, state and federal healthcare resources; conduct disease surveillance to track COVID-19 infections; and better understand how the disease behaves.

To meet this need, BARDA began supporting development of diagnostic tests as soon as the pandemic spread to the United States and we now have a diverse COVID-19 diagnostics development portfolio which currently contains more than 30 diagnostic tests for a variety of commercially available platforms. Traditional laboratory systems are important in the diagnostic landscape because they perform sophisticated tests with established quality assurance plans while processing a large number of samples.

The BARDA portfolio began with tests that run on platforms commonly available in the United States. Sixteen of these BARDA-supported tests have received emergency use authorization from the U.S. Food and Drug Administration, and BARDA’s partners have shipped more than 50 million tests. By investing in tests that work with the existing infrastructure in laboratories, hospitals, and clinical settings, we are helping increase the chances of fast and widespread use of the tests.

To enable testing in non-traditional laboratory settings, BARDA’s portfolio also contains tests that are small, portable, and easy to use too, such as the Cue Heath test and even in-home tests. Among the portfolio’s point-of-care systems, you’ll find a rapid mobile test designed for hospitals, long-term care facilities, urgent care centers, and doctor’s offices. Using an easy-to-use handheld reader, healthcare professionals can test patients at the first point-of-contact. Another BARDA-funded research project aims to bring COVID-19 testing into people’s homes and could become the first such test for use at home in the United States, if authorized by FDA.   

These point-of-care tests are less complex than laboratory systems’ but offer faster results, which empowers patients and providers to make informed decisions regarding diagnosis and treatment. They can be performed by personnel with little clinical laboratory training, and and individuals may even be able to administer the test in their own home.

As the part of the pandemic response, BARDA also supports development of serological tests that measure antibodies. Unlike tests that detect the presence of the virus itself, antibody tests measure the amount of antibodies in the blood to help determine whether the body has responded to a specific infection caused by a virus. As people across the country continue to demand COVID-19 tests, laboratories need diagnostic testing systems that can quickly process a large number of tests in a short period of time.

On May 29, the first two BARDA-supported antibody tests received emergency use authorization (EUA); one that can run over 400 tests per hour with results in 10 minutes. The symptoms of influenza and COVID-19 are similar and with influenza season starting in the northern hemisphere, healthcare providers, public health professionals, and patients need accurate diagnosis to make sound health decisions. To meet this need, BARDA is supporting four combination tests to provide simultaneous testing of Flu A/B and COVID-19. Often referred to as multiplex tests, these combo tests are important not only to conserve reagents and supplies but also to maximize test capacity. Because symptoms can be similar for both types of respiratory infections, a single test that requires just a single sample from the patient makes sense.

Looking toward the future, another innovative approach is a wearable device that creates an early warning algorithm to identify early symptoms of COVID-19. The device generates de-identified, patient-generated health data. BARDA is supporting a study of the effectiveness of this device to enhance current disease surveillance systems to detect respiratory infections prior to the onset of symptoms. Such a device could be extremely helpful for healthcare workers and others in the U.S. workforce whose jobs must be done in person.

BARDA is supporting another collaboration in a Veterans Health Administration (VHA) nursing home where a patient wears a biosensor to remotely monitor individuals during the COVID-19 outbreak for deterioration of  health indicators, including but not limited to respiratory rate, body temperature, blood oxygen levels (SpO2) and heart arrhythmias, to improve patient outcomes. Residents in the VHA facility volunteered to participate in the study.

BARDA’s support of a large and diverse development portfolio of COVID-19 diagnostic technologies heightens our nation’s ability to respond more effectively to the current pandemic. BARDA also is funding development of six diagnostic technologies through RADx, a partnership with the National Institutes of Health (NIH). The technologies represented in BARDA’s portfolio and in RADx have the potential to fulfill current clinical needs, optimize treatments, and improve outcomes.

There is no single product—in diagnostics, treatment, or vaccines—that alone can end the COVID-19 pandemic. Diagnostic tests are part of a broader strategy to fight the virus and one component of BARDA’s COVID-19 portfolio. We continue to support development of vaccines to help stop the spread of the coronavirus as well as the development of therapeutic medicines to treat patients. All of the medical countermeasures in this portfolio ultimately work together to help save lives.

You can learn more about our COVID-19 medical countermeasures development programs by visiting BARDA’s COVID-19 Portfolio.

Sep 23
Keeping First Responders Healthy as They Protect Communities from Wildfires

Five Ways to Prevent the Spread of COVID-19 during Wildfire Response Operations

An already active wildfire season in the American west was put into overdrive when wildfires spread across large parts of Oregon. This spread caused a significant change in the air quality index (AQI)—in some cases climbing above a 300 AQI value which can cause health problems within communities.

To combat the rapid spread of these dangerous fires, thousands of wildland firefighters and first responders from across the United States have leapt into action to protect communities and control the fires. Throughout 2020, wildland firefighters’ inherently hazardous job has become even more dangerous with the ongoing COVID-19 pandemic. Wildland firefighters and others who live and operate out of the Incident Command Post (ICP) or fire camps can be particularly vulnerable to COVID-19 because of the traditional setup of fire camps and the hazardous pollutants in wildfire smoke. Preventing the spread of COVID-19 among wildland firefighting personnel will be integral in keeping first responders healthy and limiting additional exposure within the communities they serve.  

A few cautionary and proactive measures can be taken to help firefighting personnel be more aware of how the ongoing pandemic can impact their response. Before wildland firefighters and other personnel arrive at fire camps, they should be educated with a basic understanding of COVID-19: how the disease is thought to spread, what symptoms are associated with infection, and what measures can be taken to prevent or minimize the transmission of COVID-19. Wildfire agencies should also be ready to provide non-punitive flexible leave policies that are consistent with public health guidance. Below is key guidance from the U.S. Centers of Disease Control and Prevention (CDC) and the National Wildfire Coordinating Group (NWCG) to prevent the spread of COVID-19 and keep our wildland firefighters and support personnel healthy.

Preventing the Spread of COVID-19

Just one COVID-19 case can cripple an entire unit, so preventing the spread of COVID-19 starts when fire personnel arrive at duty stations. If possible, personnel should isolate for 14 days in a separate space provided by management prior to deployment. This will help newly arrived firefighters avoid common spaces. If or when a suspected or confirmed COVID-19 infection appears, units should follow the guidance outlined in the Medical Unit COVID-19 Concept of Operations Plan for the fire community.

Social Distancing

Face-to-face contact should be limited and maintaining six feet of distance is still one of the best ways to reduce the spread of COVID-19. Fire camps should be structured in a way that encourages and enables social distancing and they should rely on remote units and virtual technology when possible for incident management team meetings, and other communications.

Module as One

Fire personnel often work together as a group in crews, units, or modules’. This year crews and modules should use the “Module as One” or “isolate as one” approach to help keep crews and the general public healthy. Units or modules will have the same people travel in the same vehicle for the entire season, no crew hopping. By isolating as a unit, crews and modules can limit outside exposure to COVID-19. This may also allow crews and modules to safely complete operational tasks in closer proximity to one another, and/or could ride in vehicles without cloth face masks when working within their “Module as One” crew. However, cloth face masks should always be worn when members of the module are in fire camps or are among the general public.

Cleaning and Disinfection

 Trained fire support personnel need to take steps to keep common areas disinfected and clean at all times. Common areas such as bathrooms need to cleaned twice a day and dining facilities should be cleaned before and after each meal, both with U.S. Environmental Protection Agency approved disinfectants. Wash stations should be set up throughout the grounds especially outside of or in very close proximity to bathrooms, portable toilets, and dining facilities. If the resources exist, individual bottles of hand sanitizer should be provided to all camp personnel. Firefighters should also look to disinfect firefighting personal protective equipment using guidance released by the Federal Healthcare Resilience Task Force.

Maintaining a Healthy Workforce

Maintaining a healthy workforce should be a priority throughout the fire season. Units should ensure all crew members are getting proper rest, hydration, and nutrition to help prevent cumulative fatigue. Specifically to limit the spread of COVID-19, cloth face masks should be worn around fire camps and all personnel should use the Wildland Fire COVID-19 Screening Tool daily. If possible, management should mitigate smoke exposure for firefighting personnel when tactics can be adjusted and operational objectives can be met.

The Centers for Disease Control and Prevention (CDC), the National Wildfire Coordinating Group (NWCG), and the U.S. Fire Administration (USFA) have developed resources, protocols, and guidance for fire personnel and fire managers.  

HHS/ASPR’s Division of Critical Infrastructure Protection (CIP) continues to actively track wildfires and other emerging issues at the intersection of disaster health and critical infrastructure protection. To receive information on the latest resources and tools to optimize your organization’s ability to respond, recover, and prepare for threats and incidents impacting the nation’s health critical infrastructure, subscribe to the ASPR CIP mailing list.

Sep 22
Clinical Synergies of New Medical Countermeasures in Burn Care

BARDA-supported Burn Products Could Help Enhance Patient Outcomes in Everyday Burn Care and Improve Preparedness for a Mass Casualty Incident

Earlier this summer, a burn patient received a minimally invasive skin graft using two BARDA-supported burn care products in tandem, an enzymatic debridement product and a product that promotes skin regeneration. Together these products helped a patient with second degree burns covering much of his body recover quickly – so quickly that he was back to working in his garden after just a few weeks.

Doctor examining a burn patient

Photo courtesy of the Medical University of South Carolina

he patient was admitted to the burn unit at the Medical University of South Carolina in Charleston. He had sustained second degree burns over 17 percent of his body. Most patients with burns of this magnitude would require surgical debridement of the deep burns and a skin autograft using some of the patient’s remaining skin from another part of the body to cover the wound. Steven Kahn, M.D., and a team of burn care experts at the Medical University of South Carolina took a different approach.

First, Dr. Kahn used an enzymatic treatment that is currently under BARDA-supported clinical development to remove the dead tissue. Then, he used the RECELL system, a product that received FDA-approval in 2018 after receiving support from BARDA, to promote skin regeneration using only a small sample of the patient’s skin. By using both products, he was able to avoid the use of traditional surgical excision debriding and skin graft procedures, both of which can be time consuming and painful, and require the skills of highly trained burn care specialists.

At ASPR/BARDA, we are committed to developing medical countermeasures and technologies that can save lives and promote the recovery of people who are injured or develop an infection during a disaster or emergency. Burn injuries are debilitating and a direct result of many of the potential incidents that threaten our nation’s health security.

Since 2013 BARDA’s collaboration with the American Burn Association has been instrumental in identifying opportunities for improvement across the continuum of burn care. After extensive analysis, BARDA identified two critical bottlenecks that could hamper care during a mass casualty incident (MCI): (1) limited treatment capacity, and (2) inherent inefficiencies in procedures.

Accordingly, BARDA has invested in a portfolio of cutting-edge technologies of medical countermeasures (MCMs) which specifically improve treatment across the burn care continuum ranging from wound assessment, debridement, through skin coverage and regeneration. BARDA’s investments in novel products are directed at specific steps in the progression and treatments in the burn care continuum. In doing so they introduce new ways to be efficient and expand capacity, the bottlenecks in the delivery of burn care in our national context.

Current burn care always requires a highly skilled surgeon to debride and excise the wounds, which is the process of carefully removing the dead tissue. With limitations in the number of surgeons in the country who are trained to perform these procedures that are both time consuming and traumatic for the patient, investing in alternatives is imperative.

BARDA has invested in a novel enzymatic debridement product that is both easier to administer than the current practice and it is incredibly precise. This promising enzymatic debridement product can remove dead tissue without damaging the surrounding live tissue. This level of precision is hard to achieve surgically. If the product receives FDA approval, many believe it has the potential to change the resource and surgical needs and enable clinicians to treat more patients quickly which is especially important during an MCI. BARDA is supporting its advanced development for introduction in the U.S. and is currently under Biologics License Application (BLA) review by the Food and Drug Administration (FDA).

To address the second bottleneck, BARDA is supporting innovative approaches to increase efficiency and reduce the need to harvest a patient’s own skin, a procedure known as autografting. Typically, skin grafting requires a donor site from another part of the patient’s body. The procedure is often quite painful and can result in additional scarring. BARDA’s support to Avita’s RECELL Spray on Skin technology received FDA approval in 2018. Like autografting, this technology requires the removal of a small patch of skin from the patient, which is then converted into a spray solution that can cover a much larger wound surface area than a standard skin graft could.

In the photo above, the three rectangles on the patient’s back are the donor site. Dr. Kahn estimated that the following conventional approach of care would have needed most of the skin from the front of the patient’s thighs. RECELL can be used to produce a skin cell spray that can cover 80 times the area of the donor site. In this case, those three small rectangles of skin were enough to treat the burns that covered 17 percent of his body. By using RECELL Spray on Skin, the burn surgeon was able to help the patient’s wounds heal with a minimally invasive procedure that was less painful and regenerated skin tissue quicker.

Just a couple of weeks after this burn injury, the patient reported that he was feeling great. He explained that the pigmentation of his new skin is even; his skin isn’t tight, itchy or painful. He has gone out and done some yard work - while covering up and keeping out of full sunshine. That is an outstanding patient outcome for a person who had second degree burns covering 17 percent of his body

For BARDA, there are key metrics to measure from the benefits these new MCMs targeted within the continuum of care program. One is whether the MCMs shorten the hospital stays for the patients. Dr. Kahn estimated that he normally would have kept such a patient in the hospital for 19 days. This patient was able to be discharged after only 12 days. This information is important for both BARDA and the community of care providers. For BARDA this data metric reflects a substantial return on investment, strengthening preparedness for a MCI and improving the standard patient care every day.

Dr. Kahn has indicated that the patient’s rapid recovery would not have been possible without the non-surgical enzymatic debridement approach combined with RECELL. By using these two cutting-edge products together and taking an end-to-end approach to burn care, Dr. Kahn was able to provide next-generation burn care to his patient.

While products that address each of these treatment targets can independently improve burn care, use of multiple products could have an even greater impact on patient health when they are used together in tandem. At BARDA, we envision such synergy further increasing the efficiency of burn care when all these new products would ultimately get integrated into routine burn care.

The overall quality of the national burn care system would consequently improve as well leading to speed recovery times, reduced pain and scarring, and improve patient outcomes. In an MCI, technologies that alleviate bottlenecks and enable doctors to treat patients more effectively and efficiently could, in turn, help doctors treat more patients and save more lives.

The successful patient outcome that resulted from the synergistic use of these two products that BARDA has funded demonstrates how we are fulfilling our mission to protect health and save lives through partnership with the private industry. This example helps validate the underlying strategy of integrating overlapping MCMs across the care continuum into routine clinical practice which builds synergy, value, and improves national preparedness over the long term.

Check out the MUSC Catalyst News to learn more about the treatment this patient received from the team at the Medical University of South Carolina.

Aug 25
Promoting Better Shelter Safety during Peak Fire Season

Six Ways Emergency Managers and Shelter Providers Can Protect Wildfire Evacuees, Shelter Workers, and Volunteers during the COVID-19 Pandemic

From 2009 to 2019, there have been an average of 64,100 wildfires annually, burning an average of 6.8 million acres each year, according to data from the National Interagency Fire Center. This year, wildfires present a tougher challenge to emergency managers and shelter operators, because shelters need to protect people from both wildfires and the spread of COVID-19.

Communities can – and often do – face multiple, complex disasters and emergencies at the same time. Experienced emergency responders, especially those in the western and southwestern parts of the US, have faced wildfires in the past, and many emergency managers have worked to help their communities combat COVID-19. Today’s emergency managers and shelter providers must be ready to provide a safe and healthy environment for evacuees that protects them from both threats.

Cleaner air shelters are an important resource during wildfire season. They create a safe space for individuals who do not have adequately clean air in their homes. Facilities used for cleaner air shelters often include school gymnasiums and civic auditoriums. However, putting individuals and groups together in cleaner air shelters can create an environment for the transmission of COVID-19 among evacuees, staff, and volunteers using the facilities.

Facility planners and emergency responders can take several steps to prevent the transmission of COVID-19 in cleaner air shelters. CDC’s COVID-19 Considerations for Cleaner Air Shelters and Cleaner Air Spaces to Protect the Public from Wildfire Smoke can help prepare shelter operators to do this. Here are six things you can do at your emergency shelter to help protect evacuees, staff, and volunteers:

  1. Screen for COVID-19: Require verbal screening and/or temperature checks upon arrival and regularly thereafter.

  2. Separate symptomatic and asymptomatic individuals: Ensure your shelter has separate areas for people experiencing symptoms of COVID-19 and evacuees who do not have COVID-19 symptoms. Have a plan for isolating COVID-19 patients to prevent the spread of infection.

  3. Maintain physical distance: Ensure at least six feet of space between individuals not from the same family or household. Consider using furniture and floor markings to partition spaces.

  4. Control air flow: Ensure that air does not flow from the space sheltering individuals with COVID-19 or COVID-19 symptoms to the space sheltering people who have not been infected. Correctly configured and maintained air systems will protect evacuees, workers and volunteers from the harmful effects of wildfire smoke, but air filtration systems are not sufficient to prevent the spread of COVID-19.

  5. Clean facilities regularly: Clean high-touch surfaces at least once a day using a US. Environmental Protection Agency (EPA) recommended disinfectant or properly diluted bleach solution. COVID-19 can survive for several days on hard (non-porous) surfaces.

  6. Communication: Enhance onsite communication about COVID-19. Use health messages and materials developed by credible public health sources, such as your state and local public health departments and CDC. Identify and address potential language, cultural, and disability barriers associated with communicating COVID-19 information to staff, volunteers, and evacuees using the cleaner air shelters and cleaner air spaces. Post signs tailored for local culture and languages at entrances and in strategic places providing instruction on:
    • Masks
    • Cough etiquette
    • Handwashing, especially after coughing, sneezing, and touching a mask or cloth face covering
    • Physical distancing

To learn more about operating a safe emergency shelter in the event that your community faces a wildfire this year, check out these resources from CDC and ASPR TRACIE.

CDC’s National Center for Environmental Health plans, directs, and coordinates a program to protect the American people from environmental hazards, including wildfire smoke. To learn more about wildfire smoke and its potential health effects, including the intersection of wildfire smoke and COVID-19, visit Protect Yourself from Wildfire Smoke.

ASPR Division of Critical Infrastructure Protection (CIP) is actively tracking wildfires and other emerging issues at the intersection of disaster health and critical infrastructure protection. To receive information on the latest resources and tools to optimize your organization’s ability to respond, recover, and prepare for threats and incidents impacting the nation’s health critical infrastructure, subscribe to the ASPR CIP mailing list.

Aug 14
Promoting Behavioral Health for Responders on the Front Lines of Health during the COVID-19 Pandemic

ASPR Implements Check-in Calls for NDMS Responders Returning from the Field

When disaster strikes, state, tribal, or territorial authorities can call on responders from the National Disaster Medical System (NDMS) to help handle some of the nation’s toughest emergency-related health challenges.  NDMS responders are elite medical professionals who work as doctors, nurses, pharmacists, and other civilian health professionals in communities across the country. Following a disaster or emergency event, NDMS responders deploy at the request of states to provide medical support and increase capacity. Since the beginning of the pandemic, NDMS responders have been serving across the country, assisting states and territories as well as tribes and local communities.

In the initial days of the Novel Coronavirus 2019 (COVID-19) outbreak, NDMS responders provided medical support during the first quarantine operations in more than 50 years.  Since then, NDMS responders helped save lives at alternate care sites, including the Javits Center in Manhattan, provided mortuary assistance, helped decompress ICUs, worked to help prevent the spread of COVID-19 in hard hit areas like the Northern Navajo Nation, and more. The response to COVID-19 is continuing at a relentless, unprecedented pace, and our NDMS responders are answering the call to service by providing the best of care during one of the greatest public health crises in a century.

The work that NDMS responders do is vital to public health – and it is hard.  NDMS responders are working with determination, dedication, and perseverance to protect health and save lives; and ASPR is committed to ensuring our responders remain healthy, both mentally and physically.   

Although some responders experience challenging stress reactions while they are deployed, some of them have distressing symptoms that only start to manifest after they return home.  After NDMS responders return home, they are contacted by behavioral health professionals who have experience working in disasters and are themselves on NDMS teams.  Building on similar programs that have been implemented by the U.S. Public Health Service and the Centers for Disease Control and Prevention, responders are contacted after they have been home 10 to 14 days.  The goal is to follow up at the 30-day mark with those responders who could benefit from additional contact.

Talking to a behavioral health specialist is completely voluntary, but many of our responders have told us that it helps.  For some responders, this is one of the few times that they pause to really reflect on their deployment and how it has impacted them personally. Many comment on just appreciating the gesture on the part of the U.S. Department of Health and Human Services and NDMS.

The signs and symptoms of stress can be identified by a behavioral health specialist over the phone, and they encourage returning responders to take such signs seriously so their symptoms do not evolve into disorders. For some responders, these symptoms can manifest as a memory that they keep reliving over and over again.  Others may have trouble sleeping or suffer from guilt or worry over potentially exposing others to COVID-19. Some people just find that they are irritable and less tolerant around family and friends. Many responders think about the patients they were not able to help and the ones who passed away despite their best efforts. Others suffer from compassion fatigue, the emotional exhaustion that comes from facing so much death and so many hard cases.

First, behavioral health professionals help responders recognize when they have a problem and need to take care of themselves.  From there, the behavioral health specialists talk to the responders about strategies they can use to cope with the stress of their deployment.  Just as the response to COVID-19 is very different from many previous responses, so are the strategies for coping in the aftermath of this challenging disaster response.  In the past, behavioral health professionals encouraged responders to  get together with people in  their communities, their friends, and their families when they returned from deployment. Now, responders have to balance the need for connection with the need to keep the people around them safe by practicing social distancing, so many of the practices we once encouraged are not viable or must be approached with extreme caution. Today, our behavioral health responders help the NDMS medical responders identify the source of their concerns; learn about simple, practical strategies like practicing mindfulness and gratitude or meditation; and connect to resources that can help responders cope.  The NDMS behavioral health professionals also help responders recognize when they need more than just a phone call.  Although a few calls can help a lot of our responders, some people need more assistance.  In those cases, we help connect them with the professionals who can provide longer term medical or psychological care.

Although responding to a disaster is hard, most responders we have talked to say that they are glad that they deployed.  Even though they face a complex set of stressors, many NDMS responders also find satisfaction in the service and a sense of connection with their NDMS teammates.  For many responders, being a part of the team that helped respond to COVID-19 at healthcare facilities in hotspots across the country makes them proud.

The challenges that NDMS responders face are, of course, not unique.  Medical professionals across the country are also suffering from stress disorders and other behavioral health issues, including compassion fatigue, moral injury, and more.  If you are in a leadership role and manage part of the healthcare workforce, check out these practical tips to help promote behavioral health. If you are a healthcare worker, try to take some time for self care.

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