Skip over global navigation links
U.S. Department of Health and Human Services
PHE Home > ASPR Blog > Pages > default2

 

December 03
Three Perspectives on Volunteering, Growth and Service with the Medical Reserve Corps

As the holidays approach, many people are thinking about ways that they can give back to their communities and help others. Volunteering with the Medical Reserve Corps (MRC) is a great way to help your community become healthier – during disasters and every day. Across the country, MRC units offer both medical and non-medical volunteers opportunities to serve people in their communities and a chance to network with other volunteers, learn new skills through training, and gain experience in emergency management and response.

Approximately 190,000 people volunteer with the MRC to strengthen public health, improve emergency response capabilities, and build community resiliency. We asked three of them to tell us why they volunteer with the MRC and share some of their experiences. Here are their stories.

Joining a Great Team, Getting Hands-on Experience, and Protecting Community Health

Rebecca Allen is a medical volunteer with the George Washington University Medical Faculty Associates MRC in Washington, DC, and is an M.D. candidate, Class of 2020, at The George Washington University School of Medicine and Health Sciences.

“There are a number of reasons I volunteer with the MRC. I have the opportunity to work with an amazing team of not only doctors and health care providers but also Department of Defense employees, military officers, and law enforcement personnel. I genuinely enjoy providing patient care during national events like the 4th of July celebration in Washington, DC. It’s phenomenal hands-on experience for someone early in their medical training. I can always plan on coming away knowing that I helped the community that day and I always have a great time doing it." 

“I think, however, a large reason I continue to volunteer with the MRC is that small chance of something unplanned happening. A lot of our MRC training focuses on what we would do in an emergency. We live in a world where mass casualty incidents are never outside the realm of possibility. Growing up outside of D.C., I have vivid memories of 9/11, the anthrax attacks, and the D.C. sniper. My father was working at the Navy Yard during the mass shooting in 2013. So, in some ways, it is personal. I honestly hope none of these things ever happen again, but if they do, I know I want to be there to help do my part.”

You Don’t Need to be a Doctor to Fight the Flu in Your Community

Jim Watkins is a non-medical volunteer with the Cape Girardeau MRC unit in Cape Girardeau, MO, and a retired school teacher and principal.  He also serves as the Community Emergency Response Team (CERT) Coordinator for 14 counties in southeast Missouri. 

“Volunteering with the Cape Girardeau Medical Reserve Corps is an honor. The staff at the Cape Girardeau County Public Health Center are wonderful to work for and with."
 “The staff give instructions to volunteers on how to assist their clients, making a positive experience for everyone involved. For example, at a flu immunization clinic, while doctors and nurses carry out their medical mission, other volunteers, such as myself, with little medical knowledge, can assist clients and staff by setting up the area for a flu clinic, getting clients into the right immunization line, and helping clients fill out the paperwork."  
“Another way to assist can be directing traffic during the drive-through clinics, in which we provide care to individuals without them having to leave their cars."
 “The Cape Girardeau County MRC also supports the local community through its Public Health Center, which provides a number of health services to community members, including asthma management and immunizations.
“As an MRC volunteer, I can play a significant role in assisting the Health Center meet its mission of providing outreach to the community in which I live. I appreciate being a part of a successful program.”

Helping Members of the Deaf Community Prepare for Disasters

A.J. Moody is a deaf non-medical volunteer with the Rocky Mountain MRC in Aurora, Colorado.

“I volunteer to make sure people know how to prepare for any kind of emergency and to stay safe and informed. Most people think they are prepared, but that isn’t always the case. It is difficult to be prepared because emergencies happen so fast, to the point where people may be overwhelmed. I want to make sure you have everything ready to go when something happens!"
“I have participated in many different exercises as a survivor so that responders can experience the challenges of communicating with deaf people. I became the Deaf Community Leader in our MRC’s Community Inclusion Project. In this position, I teach emergency preparedness topics to the Deaf community in our preferred language, American Sign Language (ASL)."
 “In 2017, I trained our MRC volunteers on how to communicate with a deaf survivor during the Point of Dispensing exercise, and I also presented the Are You Ready? course at the National Black Deaf Advocates Conference in Baltimore, MD."
 “This year I have worked with University of Colorado, Assistive Technology Partners, on an Emergency Preparedness for Persons with Disabilities online training project. This training is being developed for individuals with disabilities, their family members, and their caregivers who were not able to attend trainings in person due to their locations or availability."
 “The online training will include closed captioning and a deaf trainer (me) providing ASL interpretation of the individual interviews and videos. Video descriptions, larger fonts, simple language, image-based handouts, and a Spanish version will also be made available."
“Once completed, the training will be posted on the University of Colorado, Assistive Technology Partners, website and be available for free to anyone who goes to the website.”

Join MRC to Protect Health in Your Community

Want to hear why others volunteer with the MRC? Check out additional volunteer profiles on the MRC website. As these stories demonstrate, the MRC has opportunities for volunteers to help their communities in many different ways. If you are thinking about ways to give back to your community this holiday season, MRC may have volunteer opportunities that are right for you. 

To get started, find an MRC unit near you. If you need help, you can email us at MRCcontact@hhs.gov or call 202-692-4724. There are nearly 900 MRC units across the United States and its territories. But if there are no MRC units close to you, you can also form a new one.

November 29
Four Ways to Enhance Language Access during Disaster Response and Recovery

Creating Disaster Health Communications Your Community Can Understand

You probably know that your community includes people who find it difficult to speak, read or understand English, and it’s easy to underestimate the diversity of language access needs in our communities. According to the U.S. Census Bureau, at least 350 languages are spoken across the country. In addition, about 15 percent of American adults report some trouble hearing, 8.1 million people across the U.S. are visually impaired and approximately 32 million adults in the U.S. can’t read.

Is your healthcare, public health, or emergency response organization ready to communicate effectively with all the people in your community who rely on you? Whether your organization already has a language access plan or you are just getting started, check out the Language Access and Effective Communication during Response and Recovery: A Checklist for Emergency Responders to learn more about ensuring effective language access for people in your community.

This checklist, which was developed by the HHS Office of the Assistant Secretary for Preparedness and Response in partnership with the HHS Office for Civil Rights, includes recommendations, specific action steps, and effective practices to assist emergency responders. The checklist also includes additional federal resources and tools for first responders. The checklist provides some basic principles you can use to communicate with various populations who have communication needs.

  • Identify Language Access Needs in Your Community: Researching is a great way to get started. Identify the major languages and dialects spoken in your community and identify people with disabilities and the types of disabilities. The U.S. Census Bureau and the Department of Education are both great resources for learning about the different languages that are spoken in your community. Centers for Independent Living, your state Developmental Disabilities Council, and organizations that serve or advocate for people with disabilities can help you learn more about the community you serve.

  • Reach Out to Partners: To make the most of your organization’s limited resources, find partners who already work with these populations in your community every day and plan ways to work together during a disaster. Schools, local libraries, and community-based organizations can be great resources to help you connect with people who have limited English proficiency (LEP). Refugee resettlement programs and programs that teach English as a second language also can help you connect with LEP members of your community.

  • Create Clear, Concise Messages in Multiple Formats: Messages that are short, clear, and concise can be translated into other languages and messaging formats more effectively than long technical messages. In high stress situations like disasters, it can be difficult for individuals to process complex information. Everybody in your community can benefit from messages that are clear and concise. Work with TV, print, radio, and online platforms to share information in multiple formats.

  • Provide Effective Language Assistance Services: When you are communicating with LEP populations and people with disabilities that may have communication needs, you are going to need an interpreter and a translator for written materials. Be ready to translate materials into other languages, as well as Sign Language or braille.

Emergency responders and local HHS grantees may encounter challenges or deficiencies to language access and effective communication during disaster preparedness, response, and recovery. Keep in mind that if your program is federally funded, your organization is legally required to ensure that people with LEP and people with disabilities can access emergency response and recovery services in accordance with Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, and other federal civil rights laws and guidance.

When public health, healthcare, and emergency response organizations plan in advance, they are better equipped to get vital health and safety information to LEP individuals and people with disabilities when seconds count. Check out the newly released checklist to see how you can help LEP individuals and people with disabilities in your community prepare for disasters and stay safe and healthy during response and recovery.

October 31
FDA approval of anti-seizure drug provides a new tool for protecting Americans during a chemical attack

With the recent U.S. Food and Drug Administration approval of the drug Seizalam® (midazolam injection) as an anti-seizure medication, the United States took a step forward in protecting Americans from a potentially deadly health effect of chemical weapons.

Over the last 25 years, there has been increased use of chemical weapons. Delivering effective medical countermeasures against nerve agents is essential to saving civilians’ lives in the United States, and is necessary to ensure that the Joint Force maintains mission effectiveness to protect the nation.

Having this drug, developed by Meridian Medical Technologies, available in multi-use vials makes drug administration easier in emergencies involving a large number of people exposed to chemicals that cause prolonged seizures, whether those situations are in combat, domestic accidents or an intentional attack in the United States.

Midazolam originally was approved by FDA for use as a sedative. This recent FDA approval of intramuscular midazolam (trade name, Seizalam) expands the possible uses of the drug, enabling it to be used to treat status epilepticus in civilian and military hospitals, as well as in combat casualty care. Expanding the indication of midazolam provides greater utility to civilian and military communities.

Status epilepticus involves a seizure that lasts longer than five minutes or multiple seizures within five minutes, without returning to a normal level of consciousness between seizures. Status epilepticus can lead to permanent brain damage or death. Nerve agents and organophosphorus pesticides as well as other conditions can cause these types of seizures.

Reaching this milestone is also the story of a successful public-private partnership. HHS and DoD offices worked closely with the company to earn this approval. Following early research by the U.S. Army Medical Research Institute of Chemical Defense and the National Institutes of Health,  the U.S. Army Joint Project Management Office for Medical Countermeasure Systems (JPM-MCS)and the Biomedical Advanced Research and Development Authority (BARDA) worked closely with Meridian Medical Technologies, a Pfizer company, to develop the drug as an anticonvulsant. 

The data necessary for the FDA consider approval came from a large HHS-funded clinical study, called RAMPART, which leveraged an NIH grant, BARDA’s Project BioShield funding, and autoinjectors provided by JPM-MCS. Under Project BioShield BARDA also funded follow-on work necessary for Meridian to apply for the FDA approval.

The JPM-MCS is capitalizing further on the RAMPART study to finish development and approval of its midazolam autoinjector medical countermeasure. This type of autoinjector device would make the drug easier to use on the battlefield, providing more immediate relief to U.S. and allied troops. The autoinjector would also function as part of a suite of medical products that serve as first-line-of-defense medical treatments for U.S. troops against chemical warfare agents and for emergency responders in the United States.

The JPM-MCS has worked closely with Meridian over the last 10 years to develop the drug-device combination product. The recent FDA approval may help the company, and the Army, to accelerate the process to apply for full FDA approval of the midazolam autoinjector in the coming years. By leveraging the RAMPART study, JPM-MCS expects to save approximately $30 million and reduce the time to apply for FDA approval by at least three years.

Now that FDA has approved the drug for use in treating seizures, BARDA has purchased 675,000 multi-dose vials for the Strategic National Stockpile, and DOD plans to field the vialed midazolam for military hospitals in the coming months. If development is successful and FDA clears the device for use with midazolam, BARDA will be able to purchase the midazolam autoinjectors for the Strategic National Stockpile to replace the anti-seizure drug currently in the stockpile’s CHEMPACKs.

Including this latest midazolam FDA approval, BARDA-sponsored medical countermeasures now have earned 42 FDA approvals, licenses, or clearances.​

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.

1 - 10Next
 

 PHE Social Media

 
 

 Blog Archives

 
 

 About this blog

 
About this blog
Welcome to SharePoint Blogs. Use this space to provide a brief message about this blog or blog authors. To edit this content, select "Edit Page" from the "Site Actions" menu.