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October 01
ASPR and the Defense Advanced Research Projects Agency (DARPA) forge new partnership to deliver novel and robust health security capabilities

On September 18, marking seventeen years since the first anthrax attack in the United States, the President unveiled a National Biodefense Strategy and signed a National Security Presidential Memorandum which directed federal agencies to collaborate on biodefense, including budgets, to make the nation safer.

That spirit of interagency collaboration is reflected in a new partnership forged between ASPR and the Defense Advanced Research Projects Agency – DARPA – to strengthen the capabilities needed to protect the nation from 21st century health security threats.

The partnership agreement, signed just days before the National Biodefense Strategy was released, will focus on research, development, and deployment of medical countermeasures and advanced technologies that advance U.S. readiness to respond to health security threats. Through the new partnership, ASPR and DARPA will share data and collaborate to maximize both agencies’ impacts and investments.

In the past 12 years, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) has worked across HHS and the federal government and with over 200 private industry partners to develop medical countermeasures for public health emergencies. So far, BARDA-sponsored medical products and technologies have earned 42 FDA approvals, licenses, or clearances that help meet ASPR’s mission to save lives and protect Americans from 21st century health security threats.

DARPA has a 60-year history of making pivotal early investments in breakthrough technologies for national security. Its Biological Technologies Office supports universities, government labs, and commercial industry to develop breakthrough capabilities to protect U.S. forces and the homeland from natural and engineered threats, including novel forms of bioterrorism.

ASPR and DARPA will focus on two initial areas of collaboration. The first targets bacterial pathogens to combat microbial threats. BARDA and DARPA will conduct preclinical and clinical studies of a new type of therapeutic for antibiotic resistant bacteria based upon mRNA encoded antibodies.  The goal: a commercial product that mitigates the effects of multidrug-resistant infections.

The second area of collaboration focuses on discovering molecular biomarkers - molecules found in blood, other body fluids, or tissues that are signs of a condition or disease – to define a person’s exposure to a virus before the person shows symptoms of infection. 

As part of uncovering biomarkers that predict infection before a patient becomes symptomatic, DARPA and BARDA, through its new Division of Research, Innovation, and Ventures (DRIVe), will validate anticipated biomarkers and develop tests that can pinpoint infected patients quickly enough to minimize the spread of disease and help contain an outbreak. This research is fundamental to developing at-home tests for infections and to developing non-invasive or minimally invasive approaches for early disease detection.

And this is just the start. ASPR and DARPA will build off early successes to identify other promising transformational technologies that can be leveraged to enhance health security for civilian and military populations alike.  For more information on supporting breakthrough initiatives with BARDA and DRIVe, please navigate to medicalcountermeasures.gov and drive.hhs.gov. For opportunities with DARPA, please visit DARPA: Opportunities.  

September 20
Building hope while rebuilding health and social services: a year after the historic 2017 hurricanes

Disaster anniversaries can be difficult emotionally for survivors and responders alike. As the months and years go by, the television cameras and the imagery of destruction often leave the airwaves far earlier than when the effects of the disaster are resolved. As national attention fades, the communities must sustain their momentum with a focused recovery effort, which can be complicated and frustrating.

Disaster anniversaries are also opportunities for noting progress and ultimately…for hope because residents and leaders saw disaster recovery as an opportunity to learn from this disaster and rebuild. Since recovery operations began in November 2017, HHS has deployed over 250 staff to deliver over 86,000 hours of support as subject matter experts. ASPR has worked with its partners in Puerto Rico to establish the first healthcare system baseline readiness assessment of capabilities in hospitals, clinics, long term care, and dialysis facilities, so we are better able to understand current vulnerabilities.

Understanding that major disasters need resources and coordination at the local, regional and federal levels, we worked with our partners to develop seven regional health district planning frameworks to establish regional preparedness networks. With great effort and coordination the healthcare system in Puerto Rico has been restored and has been enhanced with a new emphasis for preparedness, redundancy, and capacities to confront future disasters at the local and regional levels.

In USVI, temporary dialysis units are in place while the centers rebuild. Impacted states and territories worked with local and federal personnel on joint teams to assess long-term recovery needs, conducted train-the-trainer and peer-to-peer workshops to learn from each other, recover faster and prepare for the future.

Over the past year, ASPR worked with health and social service leaders - hospitals, long-term care, dialysis, school leaders, social service providers, plus emergency management and local government - in all the impacted states and territories to help them work through how they will respond together this season and in seasons to come. Our goal was to shorten the distance between resource need and resource provider to support each state and territory in having a more efficient and effective recovery.

The “resource” can come in many forms; sometimes that resource is information about grants that can help fund recovery issues; sometimes that resources is knowledge where we partnered with professionals from across the country to share their experience with those in the thick of their own recovery; lastly, those resources can come in the form of people and money – where experts provide technical assistance and financial assistance is identified to help meet immediate recovery needs. This was a new approach for many of them.

I was once asked, “how long do we have to prepare?” The answer is simple: “until the next one.” Whenever the “next one” arrives, ASPR will be ready to work with its partners to save lives, protect Americans, and help support the health and social services recovery needs of communities impacted by disasters. National Preparedness Month is a great time to learn more about better preparing your organization and community so you recover faster.

September 04
Modernizing the National Disaster Medical System to Meet the Health Security Threats of the 21st Century

In 2017, our nation suffered three back-to-back hurricanes that caused catastrophic damage in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands. That experience highlighted the importance of the National Disaster Medical System (NDMS) – a federally coordinated system that augments the Nation's medical response capability during times of disasters or public health emergencies. ASPR, the government agency overseeing NDMS, deployed more than 4,600 personnel and 944 tons of medical supplies and equipment to treat approximately 40,200 patients affected by the hurricanes.



NDMS is called into action at the request of state or local authorities or by a federal department, such as the Federal Emergency Management Agency, to provide medical personnel, supplies, and equipment to a disaster area for the purposes of providing patient care, patient movement, and definitive care; contributing veterinary services; and furnishing fatality management support.

Last year’s multiple deployments stretched our resources almost to the breaking point. Yet, these larger and more frequently occurring storms are just one of many 21st century health security threats our nation faces; terrorist activities and naturally occurring infectious disease outbreaks (think Ebola, Zika, SARS, and pandemic flu) are also on the rise. The increasing demand to provide public health and medical infrastructure support to states and territories in need drove ASPR’s decision to modernize its NDMS capabilities. The changes described below will better position NDMS to respond to these 21st century health security threats

The Future of NDMS

Increase Workforce. ASPR is seeking to increase by 2,500 the number of NDMS responders – including physicians, nurses, first responders, and logistic personnel – who are trained, exercised, and equipped with the resources needed to respond to the growing list of health security threats. NDMS teams will be trained and exercised to meet the demands of a variety of disasters, whether naturally occurring or man-made, no matter their scope, complexity, or consequences. If you are interested in becoming one of these highly trained disaster response professionals, check out the NDMS open opportunities and apply today.

Eliminate Operational Gaps. We are working with state and local health and disaster response officials to identify and address operational gaps. For example, NDMS will be increasing engagement with the National Emergency Management Association (NEMA) to identify the response shortfalls within each state and territory and the measures needed to fill these gaps. These measures could enhance a state’s Emergency Management Assistance Compact (EMAC) Exit Icon mutual aid agreements and/or working with other states to collaborate on how they meet their shortfalls.

Increase Partnership Engagement. Understanding the capabilities of all entities involved in a disaster response – both at the federal, state, and local government levels as well as with private-sector partners – is critical to establishing and maintaining awareness and in reducing duplication of efforts and assets.

For example, states can better plan, train, and exercise for an emergency knowing NDMS’ capabilities and what federal personnel and resources can do to support or supplement local efforts.

Become More Modular and Agile. NDMS’ response must be scalable, flexible, and adaptable to ensure that our response efforts are the right size. Over the past two years, NDMS has adjusted its team and caches to be modular. Now state governors and health officials can request and receive the resources they need tailored to a specific mission versus receiving a standardized resource package that exceeds their needs. Standardized resource packages could be overwhelming for emergency managers to work with during a response whereas mission-specific resources fit the space and the need and can reduce the cost of response and recovery efforts to taxpayers.

ASPR is an organization that is mission driven and results oriented. The role of NDMS is based on that mission: assist state and local authorities to save lives and protect Americans. To achieve its greatest impact, NDMS must commit itself to continuous improvement, identifying any deficiencies or shortfalls that exist and addressing them promptly. The hurricanes of 2017 taught us a lot. The lessons learned are helping us prepare for and respond to the health security threats of the 21st century and beyond.

For more information about NDMS, the different teams that comprise the federal NDMS response, or how to call on an NDMS team, visit https://www.phe.gov.

August 27
BARDA and its partners bring new ammunition to the battle against superbugs

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

Back in the 1950s and 60s, drug manufacturers were developing an array of new antibiotics so resistance did not seem important because health care providers could turn to an alternate drug. Today, antibiotics are over-prescribed and improperly used, which can increase the number of resistant infections. In addition, few alternative drugs capable of overcoming antibiotic resistance are available because most manufacturers have abandoned antibiotic development in favor of products that provide a greater return on investment. The result is a public health crisis and a national security risk.

Antibiotic development, a national health security measure

As it was designed to do, BARDA stepped in to turn around that narrative. The nation faces health security threats from bacteria that could be weaponized, such as anthrax, and much like hospital and community acquired bacteria, these bioweapons can become resistant to antibiotics either naturally or through bioengineering. In addition, the illnesses or injuries caused by all national security threats can lead to secondary bacterial infections, and those secondary infections can be antibiotic-resistant superbugs, like MRSA, pneumonia, or complicated urinary tract infections. New antibiotics are among the nation’s most powerful weapons in the battle against these and other antibiotic resistant threats to ensure national health security.

Since 2010, BARDA has worked with 12 private companies on developing 15 new antibiotics, and already three have earned approval by the U.S. Food and Drug Administration. These approvals, among the 40 approvals of BARDA-sponsored medical countermeasures, mark critical milestones in our nation’s health security preparedness.

Driving innovative new products at a break-neck pace

The most recent FDA approval came for XERAVA (eravacycline), a novel, fully synthetic tetracycline antibiotic, developed by Tetraphase Pharmaceuticals Exit Icon in partnership with BARDA and another company called CUBRC. FDA approved the drug to treat complicated intra-abdominal infections; the antibiotic also could be used against serious Gram negative infections, including infections caused by multi-drug resistant pathogens that the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) consider to be urgent public health threats.

The company also conducted BARDA-supported studies necessary for FDA to consider Emergency Use Authorization to use XERAVA in treating anthrax or tularemia.

Another FDA approval came earlier this summer for an intravenous drug called ZEMDRI (plazomicin) to treat complicated urinary tract infections. ZEMDRI is a member of a class of antibiotics engineered to overcome the drug resistant mechanisms that cause other member of this class to fail.

Achaogen, maker of ZEMDRI, had worked with BARDA’s advanced research and development program on earlier development of the drug and, in August 2010, became the first company to collaborate with BARDA’s antibacterials medical countermeasures program to develop new antibiotics.

With BARDA’s support, the company also conducted studies that could make the drug available under an FDA Emergency Use Authorization to treat the effects of biothreats like plague, tularemia, or anthrax, as well as public health threats like CRE. BARDA and Achaogen continue to work on another drug that, if successful, could reduce the use of antibiotics for certain types of infections and, ultimately, could reduce the number of drugs to which CRE is resistant.

The first product ever approved in BARDA’s antimicrobial medical countermeasures program, VABOMERE (carbavance), earned FDA approval in 2017 to treat complicated urinary tract infections and a kidney infection called pyelonephritis in adults. The antibiotic is a combination drug composed of a commercially available, best-in-class antibiotic, called meropenem and a novel, first-in-class, beta-lactamase inhibitor called Vaborbactam. BARDA’s partner, The Medicines Company, also conducted studies that show the drug also is effective against Gram-negative bacteria such as Carbapenem-resistant Enterobacteriacea (CRE), which tops the CDC’s and WHO’s list of antibiotic resistant infections that threaten public health.

Currently, the BARDA antibacterials portfolio includes a mix of early and late-stage products with an emphasis on Phase 3 advanced clinical development in humans. Two companies recently joined BARDA on antibiotic development. One is Spero, with an oral carbapenem antibiotic to treat complicated urinary tract infections. Spero, BARDA and the Defense Threat Reduction Agency are collaborating to evaluate the product against five biothreats. The other is Summit, with a treatment for Clostridium difficile infections (CDI). Patients can develop CDI while being treated with antibiotics for prolonged periods after an anthrax exposure.

Efforts by BARDA and its industry partners now span the majority of pathogens called out in CDC’s 2013 Antibiotic Resistance Threats Report as urgent or serious threats to public health. BARDA also is working with international partners through CARB-X Exit Icon to fund initial development of antibiotics and diagnostics. Most recently, BARDA has launched a program called DRIVe to tackle systemic problems like sepsis and develop methods to detect illness before people even realize they are sick.

The majority of the antimicrobial products BARDA and its partners are working on also are designed to treat infections caused by biodefense pathogens and potentially to be used in an emergency. By earning FDA approval to treat day-to-day infections that threaten public health, these products become familiar to healthcare providers, giving healthcare providers another tool to combat resistant bacteria including biodefense pathogens. Because they are available on the commercial market, they would be easily accessible in a mass exposure to a biothreat while requiring little or no stockpiling at taxpayer expense. BARDA’s funding and expertise also decrease corporate development costs, which for a marketable product can translate into a greater return on investment for the developers.

BARDA continues to collaborate with industry to make more options available for treating infections caused directly by biological weapons, as well as for treating the life-threatening secondary infections that can follow, adding new ammunition to the battle against antibiotic resistant bacteria. Learn more about what partnership opportunities are available through the Broad Agency Announcement (BARDA-CBRN-BAA-11-100-SOL-00009 at www.fbo.gov).

August 10
ASPR’s Vision for Building Readiness: Sustaining Robust and Reliable Public Health Security Capabilities

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

A catastrophic health emergency – whether naturally occurring such as an influenza pandemic or deliberate, such as a chemical, biological, radiological, or nuclear attack – could threaten our national security, weaken our economy, strain our federal resources, cause widespread panic, and result in hundreds of thousands of casualties.

During the past decade, public health emergencies and biothreats, such as the 2009 H1N1 pandemic, the 2014 Ebola outbreak, the 2016 Zika outbreak, and the 2017-18 chemical attacks in Syria, accentuate the need for public health officials and healthcare professionals to be able to access real-time information about emerging threats to enable them to make timely, responsive decisions.

ASPR advocates for the sustainment of robust and reliable public health security capabilities, primarily through the Centers for Disease Control and Prevention (CDC), but also through other components of HHS. Working together, we must improve the detection and diagnosis of infectious diseases and other health threats. We also must be ready to get critical medical countermeasures to patients when seconds count. HHS accomplishes this by enhancing disease situational awareness, strengthening disease containment, improving risk communication, and improving medical countermeasure distribution and dispensing.


Enhancing Disease Situational Awareness

Situational awareness provides the foundation for enhancing decision-making; improving prevention, protection, mitigation, response, and recovery efforts; ensuring that resources are used wisely; and promoting health security.

Situational analysis also requires effective coordination of information dissemination across federal, state, and local governments, as well as with international organizations, other

countries, community-based organizations, academia, and health system and other private sector entities.1

Although biosurveillance is primarily a CDC function, ASPR enhances situational awareness by managing the Secretary’s Operations Center (SOC), the focal point for synthesis of critical public health and medical information. The SOC monitors and evaluates domestic and international emerging health threats 24 hours a day, seven days a week, to ensure HHS, the CDC, and others are fully prepared to activate. ASPR uses multiple tools and databases, including GeoHEALTH and the HHS emPOWER Map, to further enhance situational awareness.


Strengthening Disease Containment

To mitigate the spread of a contagious disease, HHS aims to contain an outbreak using non-pharmaceutical interventions, such as isolation, quarantine, social distancing, and decontamination. The CDC is primarily responsible for implementing these actions.

To ensure that U.S. health care providers and facilities are prepared to safely identify, isolate, transport, and treat patients with an infectious disease, ASPR’s Hospital Preparedness Program (HPP) funds a Regional Treatment Network for Ebola and Other Special Pathogens. This network consists of 10 regional special pathogen treatment centers, 69 state or jurisdiction treatment centers, and more than 170 assessment hospitals that can safely receive and isolate a person under investigation for Ebola or other infectious disease. In collaboration with the CDC, ASPR’s HPP also funds the National Ebola Training and Education Center Exit Icon.


Improving Risk Communication

The right message at the right time from the right person can save lives. CDC is the primary HHS agency responsible for providing the trainings, tools, and key messages to help health communicators, emergency responders, and organizational leaders communicate effectively before, during, and after a major disease outbreak.

ASPR works with the CDC to amplify those messages and resources. To help the CDC, health departments, and other health entities identify trending health issues, ASPR’s NowTrending web-based application identifies potential health issues emerging in a specified geographical area based on open source Twitter data.


Improving Medical Countermeasure Distribution and Dispensing

Rapidly getting vaccines, antibiotics, medications, and other medical supplies to an affected population is critical for saving lives in an emergency. ASPR anticipates that the Strategic National Stockpile (SNS) will be transferred to ASPR in fiscal year 2019. As part of this transfer, ASPR is dedicated to improving the final distribution and dispensing of products contained in the SNS by providing robust operational support to state and local authorities.

For example, ASPR in collaboration with the CDC, is working with other federal agencies to explore how to: facilitate and coordinate federally-funded residential delivery capabilities (e.g. DHL, FedEx, USPS), solicit and coordinate public-private partnerships at the national level (e.g. pharmacies, big box stores), pre-position caches for specific populations (e.g. first responders), and provide mechanism to increase federal staffing to assist states and locals in an emergency.

For more information about ASPR or CDC efforts to identify, contain, communicate, and respond to an infectious disease event, visit www.phe.gov or www.cdc.gov, respectively.



1 The National Public Health and Medical Situational Awareness Strategy Implementation Plan (2015-2018), U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, September 2015.

July 13
New Smallpox Antiviral Increases National Health Security

​​In the 20th century alone, smallpox deaths worldwide numbered in the hundreds of millions. Roughly one-third of people infected with the disease died, while survivors were often left with permanent scars or blindness. After an aggressive global vaccination program in the mid-1970s, the World Health Organization declared smallpox eradicated.

​​But smallpox remains a health security threat in the 21st century. Fears that undeclared stocks of the smallpox virus might exist and that they could be used as weapons of bioterrorism spurred the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) to fund the advanced research and development of antiviral drugs against smallpox. Today, the Food and Drug Administration (FDA) approved the use of TPOXX® (tecovirimat), produced by SIGA Technologies, as a treatment for smallpox.

TPOXX® is the first – and only – smallpox antiviral treatment approved by the FDA. It works by preventing the smallpox virus from leaving an infected cell and spreading to the rest of the body, effectively containing the infection until the body’s immune system can fight off the disease. This is important because smallpox vaccination ended in the U.S. in the early 1970s, so people born after that time are highly vulnerable to the disease. If the virus were used in a bioterrorism attack, HHS estimates that 1.7 million people or more could need treatment. Under Project BioShield, BARDA has acquired 2 million courses of TPOXX® for the Strategic National Stockpile​​.

​​The U.S. biodefense goal for protecting Americans against intentional or unintentional release of the smallpox virus or a naturally occurring outbreak is to have two antiviral drugs to compliment smallpox vaccines that are already licensed or under development. In addition to TPOXX®, BARDA is supporting the development of a smallpox vaccine for at-risk populations and has an open solicitation under Project BioShield (PBS) to develop an intravenous formulation of a smallpox antiviral for patients who are too young or too sick to take oral medications. The development of these products supports not only U.S. national health security, but also strengthens global public health security, since any confirmed case of smallpox in the world would become a cause for international concern.

​​The approval of TPOXX® serves as an exemplary model of government working collaboratively with its interagency partners and industry to meet a national biodefense need. TPOXX has received support from the National Institutes of Health, the Centers for Disease Control and Prevention, the U.S. Department of Defense United States Army Medical Research Institute of Infectious Disease and the Defense Threat Reduction Agency, and BARDA. The commercial market for medical countermeasures against bioterrorism threats is practically non-existent. The diminished return on investment for these products presents considerable barriers to most pharmaceutical companies and their investors. Without federal government support, few medical countermeasure drugs, vaccines, or treatments would ever become candidates for development.

BARDA partners with and invests in a diverse portfolio of researchers and companies, fostering innovation and bolstering America’s preparedness against bioterrorism threats. These partnerships have resulted in 38 FDA approvals, licenses or clearances for BARDA-supported products. These products protect Americans from chemical, biological, radiological, and nuclear threats; pandemic influenza; and emerging infectious diseases. For information about BARDA’s medical countermeasures, go to MedicalCountermeasures.gov.​​​

​Statement by Rick Bright, PhD, Director of ASPR’s Biomedical Advanced Research and Development Authority on the recent FDA approval of TPOXX® as a treatment for smallpox.

May 21
From 1918 to 2018: BARDA’s Role in the Evolution of Pandemic Preparedness

BARDA and its industry partners have made tremendous strides to build better, faster, and more flexible vaccine technologies to enable the right vaccine to be where we need it, when we need it. Combating this age-old problem is an epic challenge, and there is still work to be done to speed availability of life-saving vaccines in a pandemic.

In September 1918, a doctor stationed at Camp Devens, a military base located near Boston, Massachusetts, wrote a letter to a colleague:

This epidemic started about four weeks ago and has developed so rapidly that the camp is demoralized….These men start with what appears to be an attack of la grippe or influenza, and when brought to the hospital they very rapidly develop the most vicious type of pneumonia that has ever been seen…. It is only a matter of a few hours then until death comes, and it is simply a struggle for air until they suffocate. It is horrible.

That local epidemic was part of the great influenza pandemic of 1918 that is estimated to have infected nearly one third of the world’s population – roughly 500 million people. The infections caused by the virus responsible for the pandemic were particularly deadly, killing more than 2.5 percent of those it infected, compared to most influenza viruses, which typically kill less than 0.1 percent of those infected. Estimates of the death toll range from 50 million to as high as 100 million people. Although most influenza deaths typically occur in children and the elderly, the 1918 virus struck down mostly healthy young adults between the ages of 20 and 40.

Scientists also believe that secondary bacterial infections contributed to the large numbers of deaths in what is usually a healthy population. The lack of vaccine to prevent infections and the lack of available treatments for influenza, along with secondary bacterial infections, left the entire world vulnerable to this virus.

Influenza viruses are known for their rapid changes and global spread. Influenza viruses that typically circulate seasonally can undergo small changes that can render a virus less recognizable to the human immune system, which relies on a prior immune response. The viruses can also change dramatically, leaving human populations immunologically naïve to these new viruses. If adapted to humans, these viruses can spread quickly from person to person and cause severe sickness and death.

A contributing factor to the virus’s rapid spread during 1918 was World War I. It provided a level of mobility not previously seen, as infected military troops carried the virus with them around the globe. An estimated 35,000 United States soldiers and sailorsExit Icon died from influenza.

Twenty years after the 1918 pandemic, researchers Jonas Salk and Thomas Francis developed the first vaccine against influenza. That early vaccine was produced using fertilized chicken eggs – the most advanced technology of its time – and was first used to protect American troops mobilizing during World War II.

Optimized for manufacturing speed and reliability, egg-based influenza vaccine production is still used today and is an important component of domestic pandemic preparedness. During egg-based vaccine production, manufacturers inject influenza virus into fertilized eggs. These eggs are incubated for several days to allow the virus to replicate. Then, the replicated virus is harvested, purified, and tested. Egg-based vaccine production relies on a readily-available supply of hundreds of millions of chicken eggs (one egg can produce enough virus to make two or three doses of pandemic vaccine) and usually takes about six months.

BARDA has also supported the development of additional influenza vaccine production technologies, which are now licensed and used in seasonal vaccines. These technologies that do not use eggs may hold several advantages to traditional egg-based vaccines, including faster production times.

One such technology is the use of cultured mammalian cells (“cell-based”). During cell-based vaccine production, manufacturers introduce the influenza virus onto the cultured cells, and the virus is allowed to replicate over a period of a few days. The rest of the process is very similar to that used for egg-based vaccine production. The first U.S. cell-based influenza vaccine was licensed by the FDA in November 2012, and a U.S. cell-based manufacturing facility was approved by the FDA in June 2014. Cell-based production can be done in less time than traditional egg-based production and, of course, does not rely on eggs, which can be a rare and vulnerable starting material during a pandemic.

Recombinant production methods are also used to produce a licensed influenza vaccine. This method can produce vaccine much faster than egg- or cell-based production – taking only about six to eight weeks – and doesn’t rely on a living influenza virus. In recombinant technology, manufacturers take genetic sequences from the influenza virus of concern and use this to make the vaccine. No eggs are needed, nor is there a need to rely on growth variability of influenza viruses. The sequence provides the information that the cell needs to produce the vaccine protein. From there the rest of the process is similar to that used for egg- or cell-based vaccine production. Recombinant technologies are fast and may allow for greater flexibility as a vaccine production platform, so that we are able to respond quickly to other emerging disease threats.

BARDA’s support for enhancing domestic vaccine manufacturing production, and the development of other technologies to produce influenza vaccines has diversified, expanded and enhanced the influenza vaccine market. We are learning more every day about the advantages of these newer technologies.

However, there is more to be done. In addition, there are methods that can improve the effectiveness of our current vaccines, including exploring higher doses and the addition of adjuvant. Our colleagues at the National Institutes of Health continue to pursue the promise of universal influenza vaccines, and BARDA is working hard to make vaccines that are more effective and can be produced more rapidly. BARDA also continues to develop and maintain the National Pre-pandemic Influenza Vaccine Stockpile (NPIVS) of vaccine against influenza viruses with pandemic potential. In addition to providing faster vaccine options in the event of the spread of these viruses, the NPVS has also allowed for continued research on these vaccines.

Medical advances since 1918 have provided us with tools to fight influenza. However, a more mobile global population and ever-changing viruses present daunting challenges. In order to save lives and protect Americans in a pandemic, BARDA will continue to advance modern, rapid ways to identify influenza viruses and to produce effective influenza vaccines and treatment options against these newly emerging viruses, an essential component to saving lives.

May 21
EMS: A Critical Partner in Successful Community Disaster Planning and Response

During EMS Week, we want to draw attention to the vital role EMS plays in disaster healthcare and salute our Emergency Medical Services colleagues nationwide. We know that across the country, our EMS colleagues work on the frontlines of health, providing lifesaving services every day, even on the worst days in your communities. EMS is the first point of contact with medical services for millions of Americans, and with every call EMS professionals put years of training and education to use to make a difference. Your care saves lives.

All too frequently, EMS must respond not just to every-day emergencies but also to hurricanes, earthquakes, wildfires, mass casualty incidents (including cases of mass violence), chemical spills, possible Ebola cases, and other natural and manmade disasters. At ASPR, we encourage EMS to take a strong role in all phases of emergency and disaster management; we know that when it comes to saving lives, the health care community is stronger together.

ASPR has identified EMS as one of four core members of Health Care Coalitions, making it easy for your EMS agency to be engaged with other disaster preparedness and response organizations. These coalitions are funded and guided by ASPR’s Hospital Preparedness Program (although it’s really a healthcare preparedness program). The $255 million grant program provides funding to states, major cities, and U.S. territories to develop and institutionalize health care coalitions. Together as a coalition, all facets of the community’s, the state’s or the entire region’s healthcare system can plan and respond to disasters.

These coalitions provide a foundation for disaster health care and medical readiness in that they enable members of the coalition to coordinate efforts before, during, and after emergencies; continue operations; and surge as necessary. Health care coalitions incentivize diverse and often competitive health care organizations to work together to improve health outcomes after disasters. Core members of coalitions include hospitals and other healthcare facilities, EMS, emergency management, and public health.

Health care coalitions also serve as the foundation of a regional disaster health response system.

EMS: Essential Members of Health Care Coalitions

While EMS, hospitals, emergency management, and public health all are fundamental components of disaster health response, none responds alone. The community’s, even the region’s, entire health care system must work together to assure the best patient care is provided given the resources available. EMS can contribute to planning and response for medical surge; assess risks and resources, bring your unique experience to evacuation planning, communications systems integration, and emergency operations plan; and participate in coalition exercises.

The value of participating in a health care coalition reaches beyond emergency readiness and collective response. Coalitions also contribute to daily operations, providing:

  • Accessing clinical and non-clinical expertise;
  • Networking among peers;
  • Sharing leading practices;
  • Developing interdependent relationships;
  • Reducing risk – including from infectious disease transmission (check out the ASPR-TRACIE resource EMS Infectious Disease Playbook); and
  • Addressing other community needs, including meeting requirements for tax exemption through community benefit.

How does my EMS unit get involved?

  • Contact your state health department’s health care coalition lead or your regional hospital preparedness program liaison to connect your organization to a nearby health care coalition.
  • Take note of the specific roles for EMS recommended in ASPR’s 2017-2022 Health Care Preparedness and Response Capabilities.
  • Share and coordinate your preparedness and response plans with coalition members. Your expertise can be an invaluable resource for other members.
  • Identify and share your organization’s unique needs and contributions to disaster response.
  • Work with other EMS organizations state and region to ensure all EMS organizations’ strengths, resources, and interests are represented and coordinate in your coalition.
  • If invited by the coalition, volunteer to participate in the ASPR/FEMA-sponsored Health Care Coalition Response Leadership Course.
  • Complete the EMS section of the ASPR TRACIE Health Care Coalition Resource and Gap Analysis Tool to assist in identifying priority areas for planning.
  • Explore disaster-related topics of interest on the TRACIE website. TRACIE provides a wealth of vetted resources for disaster planning for EMS and other stakeholders through our topic collections and assistance center!

Bottom line – with EMS participating in a health care coalition, your community can respond better to manmade and natural disasters. EMS is an invaluable asset for our nation’s health security. Thank you for your service today and every day.

May 09
What’s in Your State’s Disaster Management Plan? 4 Ways to Incorporate Mental and Behavioral Health into Disaster Planning

Last year was one for the record books: hurricanes, floods, severe cold, drought, and wildfires – totaling over $1 billion in climate- and weather-related damages. Hurricane Preparedness Week is a perfect time for states, tribal nations, and territories to start reviewing state and local disaster preparedness plans to ensure they are up-to-date and address all aspects of planning, response, and recovery. 

A recent analysis by the U.S. Department of Health and Human Services found that 64% of the state emergency response plans that are available online do not adequately plan for behavioral health needs. Behavioral health services - the provision of mental health, substance abuse, and stress management services to disaster survivors and responders – is a critical component of disaster response. 

To help states build psychological resilience for both victims and responders of a disaster, recovery specialists from HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) reviewed each of the 16 behavioral health plans to identify programs and methods that promoted successful outcomes.

  • Crisis Counseling Assistance and Training Program (CCP) Implementation
  • Continuity of Medications Implementation Plan
  • Spontaneous Volunteer Supervision Implementation Plan
  • Training Inclusion Implementation Plan

States are encouraged to use this information as a starting point to help integrate mental and behavioral health needs into preparedness, response, and recovery activities.

The following examples illustrate some ways states have successfully incorporated and utilized these components in their state preparedness plans.

 

SAMHSA CCP 

In the event of a Presidential disaster declaration, the Federal Emergency Management Agency has the authority to activate supplemental assistance to help states address behavioral health needs utilizing the Crisis Counseling Assistance and Training Program. States interested in applying for this assistance, which is managed by the Substance Abuse and Mental Health Services Administration (SAMSHA), must adhere to strict deadlines for submission.  Preparing prior to a disaster will allow for more efficient grant submission and implementation.   

California addresses CCP in its Mental/Behavioral Health Disaster Response Plan by providing a brief program description along with recommended actions for implementation, and appendices that provide more detailed information.  Some key features of California’s plan are:

  • Familiarizing yourself and your behavioral health staff with the CCP application and other available federal resources in advance of a disaster.
  • Educating state and local stakeholder groups on federal resources available and how to incorporate them locally.  
  • Pre-identifying local providers for CCP services and having a system in place for documenting the behavioral health efforts expended.

Texas utilized the CCP program following Hurricane Harvey. FEMA provided $13.9 million in disaster crisis counseling, most of which the Texas Health and Human Services Commission put toward the Texans Recovering Together program.  This program helped people recover by providing extended crisis counseling services that allowed local providers to travel to clients’ homes and community centers to offer counseling, education, resources, and referral services to survivors of Hurricane Harvey.

Continuity of Medications

Following a disaster, continuity of care poses a major challenge as many individuals are forced to evacuate their homes and leave medications behind.  Interruption of routine medication schedules poses health risks, and can add to individual distress during disasters.  Integrating medication availability, stockpile location, transportation, and administration into state disaster response plans promotes a coordinated approach to continuity of care during and following disasters.

Mississippi’s Disaster Preparedness and Response Plan specifies that each Department of Mental Health facility have a limited supply of medications available in the event of an emergency.  Each facility director is responsible for providing wholesaler and/or vendor information to the Mississippi Mental Health Disaster Coordinator (MHDC) who can then reach out to wholesalers if additional supplies are needed.  The MHDC also coordinates medication delivery if regular procedures are unavailable or not accessible.  Lastly, Mississippi’s plan includes information on how to access and distribute resources from the Strategic National Stockpile. 

Managing Spontaneous Volunteers

Spontaneous and unaffiliated volunteers sometimes converge on the disaster site.  Although these volunteers arrive with good intentions, they are usually not associated with any existing emergency management response system, which can present challenges.  FEMA has a guide, Managing Spontaneous Volunteers in Times of Disasters: The Synergy of Structure and Good Intentions, to help communities plan for and manage spontaneous volunteers.

The Arizona Department of Health and Human Services has developed a Volunteer Management Plan and pre-identified a health volunteer coordinator to use in conjunction with the state Emergency Response Plan.  This plan ensures statewide coordination of all volunteers, including spontaneous ones who have not undergone credentialing or enrolled in the Arizona Disaster Healthcare Volunteer database.  

Training before a Disaster

Crisis responders, including disaster behavioral health professionals, may experience psychological effects after responding to a disaster.  It is important for these responders to receive training prior to a disaster to prepare for and respond to such events.  Suggested trainings include: National Association of County and City Health Officials’ Building Workforce Resilience through the Practice of Psychological First Aid Exit Icon and FEMA’s Incident Command trainings 100-800.

Colorado has developed a Crisis Education and Response Network (CoCERN) that suggests trainings for individuals at several different levels of disaster behavioral health response.  CoCERN also has a trainee position where individuals new to the field can gain experience working closely with the incident management and response teams.

During Hurricane Preparedness Week, take some time to get ready for the upcoming hurricane season. ASPR’s Division for At-Risk Individuals, Behavioral Health & Community Resilience (ABC) has identified numerous behavioral health and at-risk planning resources. Also available for download is SAMSHA’s Mental Health All-Hazards Disaster Planning Guidance

April 24
Healthcare Response to a No-notice Incident: Lessons Learned from Las Vegas Festival Shooting

On October 1, 2017, during the Route 91 Harvest Music Festival on the Las Vegas Strip, a gunman opened fired from the 32nd floor of a nearby hotel on the crowd of concertgoers. He fired more than 1,100 rounds leaving 59 dead and 527 injured.

Recently, ASPR staff spoke with responding agencies from the Las Vegas shooting to help identify lessons learned that can help other communities, specifically members of the nation’s 476 health care coalitions Exit Icon, prepare for, respond to, and recover from these traumatic, no-notice incidents. Here are some of those lessons:

Lesson One: Prepare for Non-triaged Patients. EMS transported fewer than 20% of the victims from the Las Vegas shooting; most were self-transported or transported to healthcare facilities. Healthcare facilities must be ready to provide triage services at or outside the hospital to quickly identify where patients should be treated, and they should collaborate with EMS and other healthcare facilities throughout the region, as part of a health care coalition, to transfer patients based on acuity and available resources. This is especially important for trauma centers that may receive many “walking wounded” patients and hospitals that do not provide trauma services that may initially receive critically injured patients. EMS and other community partners should consider developing a re-distribution plan to move casualties between hospitals.

Lesson Two: Identify and Conduct Drills Using Personnel Notification Tools. Immediately after hearing about the shooting, many healthcare providers arrived at their respective hospitals to help. Make sure your facility has a plan and a tool or messaging solution in place to rapidly notify staff who should come to the hospital and when, based on the needs of the injured and the need for providing round-the-clock care, potentially for days to come. Be aware that no-notice incidents often overwhelm landline and cellular networks.

Lesson Three: Anticipate Challenges in Intake and Throughput. Immediately following the shooting, one hospital received more than 215 patients. Treating that number of patients with limited staff and resources presents inherent challenges. A disaster plan should address which areas of your facility are appropriate for use as expanded emergency department space; how best to group arriving patients, such as by the type and severity of injuries; moving non-incident patients to other areas of the hospital; modifying surgery schedules; and discharging or transferring non-emergent patients.

Lesson Four: Expand Traditional Healthcare Roles to Address Patient Surge. Healthcare facilities should consider having specialty providers and other personnel assume non-traditional roles to help address patient surge. For example, consider using anesthesiologists to manage secondary triage and using pediatric providers to care for ambulatory victims. Take advantage of EMS providers who may be at your facility and willing to assist. Also, consider dedicating certain personnel—respiratory therapist, pharmacist, hospitalists, and intensivist—to only manage the patients coming in from the incident.

Lesson Five: Coordinate Communications with Area Hospitals. Be Ready to Shelter Patients in Place. Community triage systems may be challenged in the immediate aftermath of a no-notice incident. All healthcare facilities in the area should prepare to treat what you can, coordinate patient transfers with other healthcare facilities, and shelter patients in place. Trauma centers may need to prioritize transfers due to the lack of EMS or trauma center resources. Traffic restrictions and misinformation resulting from the event may delay or prevent the timely transfer of patients.

Lesson Six: Review Your Existing Mass Fatality Plan. Determine if your existing mass fatality plan is adequate for a mortuary surge. Consider other areas of your facility where you can expand your mortuary space. Since the coroner or medical examiner may need to visit multiple hospitals after a mass casualty event, prepare for delays in the identification and notification processes. Remember: A no-notice incident resulting from an active shooting situation is also a crime. Collect evidentiary materials from patients and their clothing as per local standards.

Lesson Seven. Incorporate Family Notification in Planning Efforts. Expect loved ones to show up looking for patients, even if those patients are not being cared for by your facility. Designate a location away from treatment spaces where loved ones can wait and establish a process to provide regular updates even if there is no new information to give. Provide patient status information on a case-by-case basis in a room separate from the waiting location. Ensure social workers, clergy, and case managers are available to provide mental health support.

Lesson Eight. Plan for Intense Media Interest. The media will want access to your hospital, your staff, and patients and their families. Pre-identify a media staging area, away from where patients are entering/exiting the hospital. Have public affairs staff available to help coordinate media interviews utilizing hospital spokespersons. Provide regular updates even if there is nothing new to report. Know the story you want to tell, coordinate with other hospitals and responding organizations, and be consistent in messaging.

“Mass casualty emergencies require a coordinated response involving the entire healthcare community,” said Melissa Harvey, director of ASPR’s Division of National Healthcare Preparedness Programs. Ms. Harvey oversees ASPR’s Hospital Preparedness Program (HPP), the only source of federal funding for health care system readiness.

HPP prepares the health care system to save lives through the development of health care coalitions (groups of health care and response organizations that collaborate to prepare for and respond to medical surge events).

For more information about the lessons learned from the Las Vegas shooting, watch the webinar Healthcare Response to a No-notice Incident: Las Vegas Exit Icon. In addition, ASPR TRACIE has developed resources to help communities and health care coalitions save lives during mass violence incidents.

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