Pandora Report: 9.13.2019

CSPS Annual Symposium on International Security
Don’t miss this event on navigating the nuclear future – “Join CSPS for their 2nd Annual Symposium on International Security on September 27, 2019. This year’s topic is Navigating the Nuclear Future and will discuss the issues of nuclear energy, nuclear weapons, and the nonproliferation regime. Speakers will include General Frank Klotz, Suzanne DiMaggio, Brian Mazanec, Laura Holgate, Ketian Zhang, and others. Lunch will be provided.”

DoD Inspector General to Reevaluate Select Agent Facilities
“The Department of Defense Office of the Inspector General (DoD OIG) is conducting a Follow-Up Evaluation of DoD Biological Select Agents and Toxins (BSAT) Biorisk Program Office implementation of recommendations from the April 2016 ‘Evaluation of DoD Biological Safety and Security Implementation’. The OIG assessment was announced in a 12 Aug 2019 memorandum distributed to the Secretary of the Army; Surgeon General of the Army; Office of the Secretary of the Army; U.S. Army Medical Research and Material Command; Director, DoD Biological Select Agents and Toxins Biorisk Program Office; Under Secretary of Defense for Acquisition and Sustainment; Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense Programs; Deputy Assistant Secretary of Defense for Chemical and Biological Defense; and the Director, Defense Health Agency. The memo noted the OIG objective is to validate implementation of recommendations from the April 2016 report (available below), and assess the development of the oversight capabilities of the Biological Select Agents and Toxins (BSAT) Biorisk Program Office.”

GMU Master’s & PhD Open Houses
Curious about what it takes to get a biodefense graduate degree? Check out our Open Houses to learn about the MS program (online and in-person) or our PhD program. The PhD Open House is next Thursday, September 19th at 7pm at our Arlington campus. The  next Master’s Open House will be on Thursday, October 17th, at 6:30pm at the Arlington campus as well.

Cyberbiosecurity in Advanced Manufacturing Models
A new article published in Frontiers in Bioengineering and Biotechnology identifies weaknesses in biomanufacturing standards relating to cybersecurity attacks and failures. The healthcare industry, especially hospitals, is often the victim of cyberattacks. In fact, the Department of Health and Human Services found that the occurrence of healthcare cyberattack reports increased by 10% since 2010. The authors purport that the biomanufacturing sector is an attractive and vulnerable target to cyberattacks due to its reliance on intellectual property, cyber-physical systems, and government-mandated production regulations. The article details considerations for emerging biologic products, specifically regarding the flow of information in various biomanufacturing operations. Recommendations to increase the resiliency of the biomanufacturing sector include heightened investment in training employees, boosting attention to cybersecurity, and improved collaboration between industry and regulators to design and implement safeguard policies.

Antibiotic Alerts: Building Better Processes to Encourage Stewardship
In the battle against resistant infections, response efforts have been focused on developing and deploying new tools to help reduce antimicrobial use. It is estimated that roughly 50% of antibiotic prescriptions in hospital and outpatient settings in the United States are unnecessary or inappropriate. Therefore, any tool that can enhance antimicrobial stewardship is a welcome addition to the toolkit. Given these startling numbers, it’s not surprising that many hospitals are looking to more automatic hard-stops to prevent the misuse of antibiotics. Mercy Hospital in St. Louis, Missouri, sought to make this a reality by developing and implementing an automatic antibiotic time-out alert that would de-escalate broad-spectrum antibiotics. A new study published in Infection Control & Hospital Epidemiology details the program. The 1252-bed community hospital worked to develop this automatic approach because, like so many of us working in infection prevention, they saw that despite education, efforts to de-escalate broad-spectrum antibiotics were rolled out inconsistently. The research team defined the outcome as the proportion of patients who had their broad-spectrum antibiotics de-escalated at 72 hours in the year prior to the initiation of the antibiotic time-out alert that was developed in 2016. Furthermore, they assessed the total antibiotic days, cost per day, hospital length of stay, antibiotic-related adverse events, and in-hospital mortality of patients whose antibiotics were de-escalated versus those who continued treatment with broad-spectrum antibiotics.

DRC Ebola Outbreak Updates and Behind the Frontlines of the Ebola Wars
On Tuesday it was announced that HHS Secretary Alex Azar will be visiting the DRC with other US health officials to help gauge the situation and address concerns. “Azar will lead a delegation that includes Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and Robert Redfield, MD, director of the Centers for Disease Control and Prevention (CDC). Redfield has traveled previously to the outbreak region, but this will be the first trip for Azar. Joining the US delegation will be director-general of the World Health Organization, Tedros Adhanom Ghebreyesus, PhD, who has made nearly monthly trips to the DRC since August 2018, when the outbreak began in North Kivu and Ituri provinces. ‘President Trump and Secretary Azar are committed to ending the outbreak as quickly as possible,’ HHS said in a news release. ‘That is why responding to the outbreak, coordinating with and assisting the governments responding, and providing the necessary assistance has been the top global health priority for the Trump administration since August of 2018’.” The Ebola virus disease outbreak in the northeastern region of the Democratic Republic of the Congo has claimed over 2,000 lives despite the round-the-clock efforts by health and aid workers to prevent its spread. A recent exclusive featured in Nature provides insight regarding the struggles of the outbreak response from WHO Director-General Tedros Adhanom Ghebreyesus. Such struggles spur from militia violence in the region and the general suspicion of outsiders, namely the health and aid workers. Most unfortunately, the conflict and distrust further fuel the outbreak by inhibiting the dispersal of the new Ebola vaccine and other drugs to treat the ill. The militias terrorize the noncombatant inhabitants of the region and the disease responders – killings, arson, rapes, abductions, explosions. Ebola treatment centers are targets for attacks, jeopardizing both patients and healthcare providers. As Ghebreyesus summarizes, “the outbreak of Ebola is a symptom, the root cause is political instability.” Beyond the domestic issues, the response faces other hardships: limited funds, media scrutiny, and additional severe public health concerns. Altogether, these obstacles create an environment for Ebola to return after this outbreak is squelched.

Rising Risk of Global WMD
Is the risk of weapons of mass destruction (WMD) growing? Many are saying it’s time we get proactive and do something. “WMD-related arms control and disarmament measures are important components of the rules-based international order. They make an underappreciated contribution to stability and strategic predictability. They underpin efforts toward a more peaceful, nuclear weapon free world in the longer run. Allowing the WMD treaty regimes to crumble could usher in a destabilizing scramble towards the development of weapons that most hoped to be rid of. It would erode longstanding norms, weaken transparency and undermine efforts to prevent terrorists from gaining access to WMD-related technology. It could ultimately lead to WMD use becoming commonplace. This erosion is not in the long-term interests of any state. Unilateral actions to tackle WMD-related concerns are occasionally an option. But they are risky, politically challenging, expensive and arduous even for the most powerful states. And when they have occurred, such actions have sometimes broken down, tragically in some cases. The lesson here is two-fold: WMD treaties matter on normative and practical levels, and states need to deal with WMD-related compliance issues cooperatively.”

Is the US Ready if Ebola Returns?
From the viewpoint of this infection preventionzist…nope. Here are the thoughts from Blue Ribbon Study Panel’s Joe Lieberman and Tom Ridge. “Today, the threat from Ebola is more serious. The World Health Organization has declared it to be a global public health emergency because Ebola has again defied controls and spread to the city of Goma in the Democratic Republic of Congo, where it could in turn spread throughout more densely populated urban areas and gain access to the global transportation system. We support this declaration and the additional resources and attention it should bring to the situation, but the WHO should have made it earlier. Ebola was an emergency long before it spread to Goma. There are encouraging signs that some experimental Ebola drugs are working, and the CDC and U.S. Department of Health and Human Services seem to be more effectively tracking the disease. On the other hand, changes made previously to help local hospitals in the U.S. better prepare to treat those infected are not being implemented as designed. And that will have real human consequences the next time Ebola or another highly infectious disease — including a new highly pathogenic strain of influenza — reaches America.”

Mapping the Cyberbiosecurity Enterprise– Upcoming
A newly-accepted editorial piece written by Randall S. Murch and Diane DiEuliis and published in Frontiers in Bioengineering and Biotechnology provides an overview and insights on cyberbiosecurity. Cyberbiolosecurity is defined as the “understanding the vulnerabilities to unwanted surveillance, intrusions, and malicious and harmful activities which can occur within or at the interfaces of comingled life and medical sciences, cyber, cyber-physical, supply chain and infrastructure systems, and developing and instituting measures to prevent, protect against, mitigate, investigate and attribute such threats as it pertains to security, competitiveness and resilience.”

Stories You May Have Missed:

  • C-diff Sniffing Dogs – “Linked to rising use of broad-spectrum antibiotics, which can wipe out a patient’s normal gut bacteria and allow the bacterium to multiply and produce toxins that inflame the colon, C difficile infections are the leading cause of hospital-acquired diarrhea in the world. The Centers for Disease Control and Prevention estimates that each year C difficile causes more than 450,000 infections in US hospitals, is associated with more than 29,000 deaths, and costs the US healthcare system nearly $5 billion. One of the main reasons C difficile has become such a burden for hospitals is that it spreads easily—typically through contact between sick patients and healthcare workers—and it’s very hard to get rid of.”

Pandora Report: 9.6.2019

Happy Friday! We hope you had a lovely week as the summer winds down. If you’re considering reading the latest Richard Preston book, you might want to check out this review.

Journal of Biosecurity, Biosafety and Biodefense Law 
Volume 10 is now available, which “offers both a legal and scientific perspective on current issues concerning bioterrorism, public health and safety, and national security. Edited by an international board of leading scholars from all the continents, our journal is aware that bioterrorism related issues are global problems. Our goal is to develop a unique international community of legal scholars, scientists and policy experts who will address current issues in these fields.” Within this latest volume, you can find articles on vaccine exemptions, the looming threat of agroterrorism, the history of tuberculosis quarantine, and much more.

The Oversecuritization of Global Health: Changing the Terms of Debate
“Linking health and security has become a mainstream approach to health policy issues over the past two decades. So much so that the discourse of global health security has become close to synonymous with global health, their meanings being considered almost interchangeable. While the debates surrounding the health–security nexus vary in levels of analysis from the global to the national to the individual, this article argues that the consideration of health as a security issue, and the ensuing path dependencies, have shifted in three ways. First, the concept has been broadened to the extent that a multitude of health issues (and others) are constructed as threats to health security. Second, securitizing health has moved beyond a rhetorical device to include the direct involvement of the security sector. Third, the performance of health security has become a security threat in itself. These considerations, the article argues, alter the remit of the global health security narrative; the global health community needs to recognize this shift and adapt its use of security-focused policies accordingly.”

The Soldiers Who Took On Yellow Fever
Battling Aedes aegypti to help combat Yellow Fever isn’t for the faint of heart and here’s insight into how it went down. “The Yellow Fever Board, led by then-Major Walter Reed and Jesse Lazear, had convened at the Army’s Columbia Barracks in Cuba, at the height of a deadly yellow fever epidemic ravaging Cuba in 1900. Today, we know that yellow fever spreads when Aedes aegypti mosquitoes bite infected people, then carry the virus to the next person they bite. But in 1900, American doctors weren’t sure if the virus spread through infected blood, or through traces of infected material on bedding. Volunteer soldiers subjected themselves to living in yellow fever survivor filth, and later to mosquito bite tests, to advance understanding of disease transmission.”

Lyme Disease – It’s Not A Bioweapon… 
In case you missed the several other times we mentioned how Lyme disease isn’t an escaped bioweapon….here’s another breakdown. “One of the most important characteristics of a biowarfare agent is its ability to quickly disable target soldiers. The bacteria that cause Lyme disease are not in this category. Many of the agents that biowarfare research has focused on are transmitted by ticks, mosquitoes, or other arthropods: plague, tularemia, Q fever, Crimean Congo hemorrhagic fever, Eastern equine encephalitis or Russian spring summer encephalitis. In all of them, the early disease is very debilitating, and the fatality rate can be great; 30 percent of Eastern equine encephalitis cases die. Epidemic typhus killed 3 million people during World War I. Lyme disease does make some people very sick but many have just a flu-like illness that their immune system fends off. Untreated cases may subsequently develop arthritis or neurological issues. The disease is rarely lethal. Lyme has a weeklong incubation period – too slow for an effective bioweapon. And, even though European physicians had described cases of Lyme disease in the first half of the 20th century, the cause had not been identified. There was no way the military could have manipulated it because they did not know what ‘it’ was.”

Why We Need More Open-Source Epidemiological Tools 
“A newer tool, though, is changing the game in outbreak response and modeling. The Spatiotemporal Epidemiologic Modeler (STEM) is an open-source software that is available to the global health community. This is not just a rigid instrument against disease, in that it is not pre-set to a specific disease or environment and has the flexibility for hundreds of variations. ‘STEM has been used to study variations in transmission of seasonal influenza in Israel by strains; evaluate social distancing measures taken to curb the H1N1 epidemic in Mexico City; study measles outbreaks in part of London and inform local policy on immunization; and gain insights into H7N9 avian influenza transmission in China. A multi-strain dengue fever model explored the roles of the mosquito vector, cross-strain immunity, and antibody response in the frequency of dengue outbreaks,’ the authors of a briefing in Health Security wrote.
The latest version was just released this year and allows users to really refine it based on their needs. From Ebola in West Africa to Salmonella in Germany, it has been used by agencies and universities alike. In fact, one of the authors, Nereyda Sevilla, PhD, used it for her doctoral dissertation work to model SARS, H1N1, and pneumonic plague in air travel in order to assess its role as a vector in the transmission of infectious diseases. What makes STEM so helpful to users is not only that it’s open access, but also its wide application and historical usage in tracking multi-strain vector-borne diseases, human behavioral responses, earth science data, pathogens from farm to fork, and so much more.”

Ebola Outbreak Updates
This week, cases of Ebola virus disease continued to rise in the DRC, as 6 were reported over 4 days, bringing to the outbreak to 3,043 cases and 2,035 deaths. The epidemiological investigation into the 9-year-old girl who died from Ebola in Uganda last week is also pointing to a potential nosocomial source for her infection. “The cases were confirmed during a weekend of unrest throughout the outbreak region, including Kalunguta, where a motorcycle was burned and several people clashed with local Ebola response agents who were attempting to perform a safe and dignified burial for a patient. According to translated media reports, the conflict began when family members protested the declaration of the deceased as an Ebola patient. In the latest update from the World Health Organization’s (WHO’s) African regional office, the WHO says the new ‘hot spot’ status of Kalunguta is of highly worrisome. ‘A review of key performance indicators at week 34 (19-25 August 2019) shows, in comparison with the previous week, an increase in the number of new confirmed cases, a decrease in the proportion of deaths on notification, persistence of the low proportion of new confirmed cases listed as contacts and an extension of affected health areas,’ the WHO said. ‘All these, along with the addition of Kalunguta as a hot spot area, are of grave concern’.”

Restricting the Use of Riot-Control Chemicals 
Mounting discussions to restrict the use of riot-control chemicals have come in the face of use in Hong Kong and the US-Mexico border. “Police forces use these riot-control chemicals to clear crowds or to stop fighting. In theory, exposure should be minimal — a group should disperse within minutes to avoid the gas. The line between civilian and military applications of these chemical agents is a fine one. Rules governing their use are confused. Reference books and training materials continue to cite toxicology studies from the 1950s. And those were done on animals and soldiers, not the public. The chemicals involved are mainly CS (2-chlorobenzalmalononitrile, the primary component of tear gas) and OC (oleoresin capsicum, a chilli-pepper extract used in pepper spray). Tear gases were developed to harass the enemy or to clear bunkers and tunnels in conflicts such as the Vietnam War, as alternatives to deadly force. Pepper sprays came into use in the 1980s for police and self-defence use after being developed as an animal repellent in the 1960s.”

Identifying and Responding to Newly Resistant Infections
Infection preventionist and GMU biodefense doctoral alum Saskia Popescu discusses the frontlines of antimicrobial resistance surveillance and response. “In the world of growing antimicrobial resistance, the identification of patients with highly resistant (or newly resistant) infections is critical. Because this is an emerging challenge, national and international surveillance efforts are still being strengthened to tackle all the avenues that contribute to antimicrobial resistance. The frontline identification of these newly resistant infections is critical though and surveillance is not only the first step in identifying and understanding the problem, but it also allows us to properly isolate the patient to avoid further transmission. Bacteria like Klebsiella pneumoniae are increasingly developing resistance to antimicrobials and can easily be spread through health care facilities. Klebsiella bacteria are also showing a relatively new resistance to the carbapenem class of antibiotics. Typically, these bacteria cause infections like pneumonia, bloodstream infections, wound or surgical site infections, and even urinary tract. A recent publication in the US Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report (MMWR) described experiences surrounding the identification of a Klebsiella pneumoniae isolate that had 3 carbapenem-resistant genes (CR-Kp) and was related to urinary procedures.”

Surgical Masks vs. N95s
In the battle against influenza, there can only be one..”In outpatient settings, surgical masks and more expensive respirator masks appear to be equally effective for protecting health workers against flu and other respiratory viruses, according to a new study based on data over four flu seasons. Earlier studies comparing the two forms of respiratory protection have shown mixed results. Uncertainty over which is better has been a sticking point in forming recommendations on how best to protect healthcare workers, especially during the 2009 H1N1 pandemic. And the new findings come in the wake of 2018 research that showed that flu likely also spreads by small aerosol particles, not just by respiratory droplets. Tighter-fitting N95 masks are designed to filter at least 95% of airborne particles, but some healthcare workers find them less comfortable than surgical masks, leading to problems with adherence. During the 2009 H1N1 flu pandemic, some hospitals and clinics had problems restocking their N95 supplies.”

GMU Research Team Sequence Komodo Dragon Genome
“George Mason University researchers Monique van Hoek and Barney Bishop and their collaborators have released their findings on sequencing the Komodo dragon genome, revealing multiple clusters of antimicrobial peptide genes that could prove instrumental in the fight against multi-drug resistant bacteria. Their work, which was published in the latest issue of BMC Genomics, identified key clusters of Komodo dragon antimicrobial peptide genes, which are protein-like molecules that contribute to the front line defense of its immune system. Komodo dragons are resilient reptiles with robust immune systems that regularly dine on dead and decaying flesh and whose saliva is known to be rich in bacteria.”

Stories You May Have Missed:

  • Brooklyn Measles Outbreak Over – “Today the Centers for Disease Control and Prevention (CDC) confirmed 19 new measles infections, raising the 2019 total to 1,234 cases in 31 states. One additional state has been affected since the CDC’s last update, but the number of active outbreaks has been reduced to four, down from six noted last week. As of Aug 29, 125 of measles case-patients had been hospitalized, and 65 reported having complications, including pneumonia and encephalitis, the CDC said. More than 75% of measles cases recorded in 2019 have come from two outbreaks among New York State’s Orthodox Jewish communities—one in Williamsburg, Brooklyn, and one in Rockland County.”

Pandora Report: 8.30.2019

Alumna Spotlight: Biodefense Grad Tam Dang, Dallas County Epidemiologist
“Tam Dang started in the biology world, earning her Bachelor’s of Science degree from George Mason University in 2008. But it was her course of study in the Master’s in Biodefense program at the Schar School that put her on her present career path. The degree, she said, ‘introduced me to the public health field, and offered a unique perspective from a biosecurity and bioterrorism standpoint.’ Today, Dang is an epidemiologist for the Dallas County Department of Health and Human Services in Dallas, Texas. She works in the Acute Communicable Disease Epidemiology Division, helping to lead epidemiological investigations for infectious disease outbreaks or potential bioterrorism events. She monitors local, regional, and state data sources related to infectious diseases, and helps develop outbreak and bioterrorism plans to help support public health preparedness. Her work is at the intersection of public health and health security, an important field in the modern era.”

BioWatch Data Stored on Vulnerable Contractor Website for Years
Well that’s a big oops… “For more than a decade, the Department of Homeland Security failed to properly secure sensitive information on the primary BioWatch information portal, which contained bioterrorism surveillance testing information and response plans that would be put in place in the event of an attack. In August 2016, Harry Jackson, who worked for a branch of Homeland Security that deals with information security, was assigned to the BioWatch program. Three months later, he learned about biowatchportal.org and demanded the agency stop using it, arguing that it housed classified information and that the portal’s security measures were inadequate. A security audit completed in January 2017 found ‘critical’ and ‘high risk’ vulnerabilities, including weak encryption that made the website ‘extremely prone’ to online attacks. Internal Homeland Security emails and other documents reviewed by the Los Angeles Times show the security issue set off a bitter clash within the department over whether keeping the information on the dot-org website run by Logistics Management Institute posed a threat to national security.”

Oversight of Lab-Created Potential Pandemic Pathogens and the BWC
Lynn C. Klotz discusses accidental releases and research with pathogens of pandemic potential in relation to the Biological Weapons Convention. “Seeding a pandemic is not a problem for future consideration; the possibility is upon us now. There is an urgent need for international oversight and regulation of this research. The countries that are party to the Biological Weapons Convention  (BWC) may not believe it to be within the BWC mandate to oversee academic research whose goal is public health. But if the parties decide this kind of oversight is within the BWC mandate (under Article XII), guidelines and regulations could be enacted fairly quickly. At the very least, the parties could act as a catalyst, launching discussions toward a new international treaty on oversight and regulation of this dangerous research. In the meantime, since enacting new treaties is an uncertain and long process, the BWC parties should work to pass legislation in their nations.” Klotz breaks down if such a release could result in a pandemic and if those pathogens could be classified as a biological weapon. “For lab-created potentially pandemic pathogens, any quantity, however small, could seed an outbreak or pandemic. In this circumstance, development also implies production and stockpiling, since a single vial of infectious agent and one to a few infected individuals are all that is necessary to launch an attack. From a military tactical point of view, however, lab-created pandemic pathogens would not be good biological weapons; they would boomerang back on the attackers since they are highly transmissible. Nonetheless, a suicidal terrorist group or a desperate country might employ them as a last resort, or threaten to employ them as a means of extortion.” Klotz ultimately notes that there is a need for action from the parties of the BWC – “Hopefully, the states that are party to the BWC will set in motion a process for overseeing relevant new research and technologies. If they decide that lab-created potentially pandemic pathogens are within the BWC mandate under Article XII, they could speed up the enactment of guidelines and regulations.”

Data Collection Gaps Are Damning the Ebola Outbreak
The outbreak in the DRC is continuing to spread as 14 new cases were reported on Wednesday and the South Kivu cluster has grown by 5, bringing the outbreak closer to 3,000. GMU Biodefense PhD alum Saskia Popescu discusses the implications of the data gaps within the current Ebola outbreak in the DRC. “Late last week 2 Ebola virus disease (EVD) cases were confirmed in the South Kivu region of the Democratic Republic of the Congo (DRC), some 400 miles away from where the outbreak first began. The cases were reported in a woman, who had been vaccinated, and her child who had traveled from Beni. The government is currently working to vaccinate and monitor 120 contacts of these 2 individuals. In the face of this expanding outbreak that has surpassed 2700 confirmed cases, there has been much attention on the drug and vaccine trials that are ongoing. Unfortunately, in the fervor of excitement surrounding the promise of treatment, few have paid attention to the quality of data that is made available. Pierre Rollin, MD, a veteran Ebola fighter, recently drew attention to some deeply concerning issues in the outbreak response in an article in The Lancet Infectious Diseases. Rollin underscored that although there was initial confidence in the response to the outbreak, mostly due to therapeutics and experienced personnel, leadership and coordination failures amid a conflict zone and community mistrust all helped the outbreak spiral. One component of Rollin’s review is deeply concerning—the ‘ineffectiveness of the collection, analysis, and diffusion of epidemiological data, the centerpiece of any response, is predictive of the situation worsening.’ Similar to what was felt by many on the ground during the 2014-2016 West African Ebola outbreak, the various databases between agencies, groups, etc., all made situational awareness and response that much more challenging.”

How Does USAMRIID’s Shutdown Impact US Biodefense and Bioterrorism Laboratory Response Network?
“The Laboratory Response Network (LRN) is a collaborative federal effort run by the U.S. Centers for Disease Control and Prevention in cooperation with other federal agency and public health partners. Most state public health laboratories participate as reference laboratories of the LRN. These facilities support hundreds of sentinel laboratories in local communities throughout the U.S. and its territories, providing confirmatory diagnosis and typing of biological threats used in a bioterrorist attack or causing a public health emergency. The U.S. Army Research Institute of Infectious Diseases (USAMRIID) Special Pathogens Laboratory at Fort Detrick is one of only three National Laboratories at the top of the protective umbrella of the LRN structure, along with those operated by the CDC and the Naval Medical Research Center (NMRC), responsible for specialized characterization of organisms, bioforensics, select agent activity, and handling highly infectious biological agents. It begs the question then, what happens when an important component of the nation’s biopreparedness infrastructure fails to meet CDC biosafety requirements and has its Federal Select Agent certification pulledGlobal Biodefense submitted requests to USAMRIID and the CDC on Aug. 6 for information on the status of the Institute in the LRN structure and whether another Biosafety Level-4 laboratory will be designated as an interim substitute National Laboratory.”

Identifying and Responding to Newly Resistant Infections
“In the world of growing antimicrobial resistance, the identification of patients with highly resistant (or newly resistant) infections is critical. Because this is an emerging challenge, national and international surveillance efforts are still being strengthened to tackle all the avenues that contribute to antimicrobial resistance. The frontline identification of these newly resistant infections is critical though and surveillance is not only the first step in identifying and understanding the problem, but it also allows us to properly isolate the patient to avoid further transmission. Bacteria like Klebsiella pneumoniae are increasingly developing resistance to antimicrobials and can easily be spread through health care facilities. Klebsiella bacteria are also showing a relatively new resistance to the carbapenem class of antibiotics. Typically, these bacteria cause infections like pneumonia, bloodstream infections, wound or surgical site infections, and even urinary tract. A recent publication in the US Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report (MMWR) described experiences surrounding the identification of a Klebsiella pneumoniae isolate that had 3 carbapenem-resistant genes (CR-Kp) and was related to urinary procedures.”

NTI’s Educational Resources
Whether you’re a student or an educator, you’ll love these resources from NTI’s Education Center. “You’ll find teaching tools, such as the new Building Security Through Cooperation report about working with North Korea on denuclearization and Middle East Missile Mania, our new comprehensive interactive map and analysis detailing the history of missile programs in 12 countries across the Middle East. Do you want to know more about what’s making headlines but only have a few minutes to catch up? We have a new U.S.-Russian arms control infographic and a one-page fact sheet on the INF Treaty. You may also want to watch our 3-minute video about the importance of the New START treaty. Those wanting a deeper dive for their advanced classes might want to check out our updated Global Incidents and Trafficking database, which tracks global incidents involving nuclear or other radioactive material, or the North Korea Missile Test Database.”

Stories You May Have Missed:

  • Outbreak of Resistant Salmonella Newport Tied to Soft Cheese-“The Centers for Disease Control and Prevention (CDC) today detailed an unusual 255-case outbreak of Salmonella Newport infections in 32 states tied to both beef and soft cheese and showing resistance to multiple antibiotics. ‘Infections were linked to beef obtained in the United States and soft cheese obtained in Mexico, suggesting that this strain could be present in cattle in both countries,’ the CDC said in an overview emailed to physicians as part of its Clinician Outreach and Communication Activity (COCA) efforts.

Pandora Report: 8.23.2019

Welcome to your favorite source for biodefense nerdom! We hope your week was wonderful and you’re ready for a dose of health security news…

STEM: An Open Source Tool for Disease Modeling
Have you been looking for a good epidemiological modeling software? Lucky for you, there’s STEM (Spatiotemporal Epidemiologic Modeler) and one of GMU’s very own biodefense doctoral alums, Nereyda Sevilla, was part of a team who published on how great this software is. “The Spatiotemporal Epidemiologic Modeler (STEM) is an open source software project supported by the Eclipse Foundation and used by a global community of researchers and public health officials working to track and, when possible, control outbreaks of infectious disease in human and animal populations. STEM is not a model or a tool designed for a specific disease; it is a flexible, modular framework supporting exchange and integration of community models, reusable plug-in components, and denominator data, available to researchers worldwide at www.eclipse.org/stem. A review of multiple projects illustrates its capabilities. STEM has been used to study variations in transmission of seasonal influenza in Israel by strains; evaluate social distancing measures taken to curb the H1N1 epidemic in Mexico City; study measles outbreaks in part of London and inform local policy on immunization; and gain insights into H7N9 avian influenza transmission in China. A multistrain dengue fever model explored the roles of the mosquito vector, cross-strain immunity, and antibody response in the frequency of dengue outbreaks. STEM has also been used to study the impact of variations in climate on malaria incidence. During the Ebola epidemic, a weekly conference call supported the global modeling community; subsequent work modeled the impact of behavioral change and tested disease reintroduction via animal reservoirs. Work in Germany tracked salmonella in pork from farm to fork; and a recent doctoral dissertation used the air travel feature to compare the potential threats posed by weaponizing infectious diseases. Current projects include work in Great Britain to evaluate control strategies for parasitic disease in sheep, and in Germany and Hungary, to validate the model and inform policy decisions for African swine fever. STEM Version 4.0.0, released in early 2019, includes tools used in these projects and updates technical aspects of the framework to ease its use and re-use.”

GMU Biodefense Fall Courses – Are You Registered?
The start of the Fall semester is just around the corner and if you’re a GMU biodefense graduate student, you’ve got a great menu of courses this term. There are still open spots in three courses – Global Health Security Policy taught by Ashley Grant (lead biotechnologist at the MITRE Corporation and previously the Senior Biological Scientist at the Government Accountability Office where she led government-wide technical performance audits focused on biosafety and biosecurity issues), Nonproliferation and Arms Control with Richard Cupitt (Senior Associate and Director of the Partnerships in Proliferation Prevention program at Stimson and prior to joining Stimson, he served as the Special Coordinator for U.N. Security Council resolution 1540 in the Office of Counterproliferation Initiatives at the U.S. State Department from 2012 through 2016.), and Biosurveillance with Andrew Kilianski (GMU professor and CINO for the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense JPEO-CBRND). These are just a handful of the classes but since there are a few spots left in each, now is your change to grab a seat!

GMU Biodefense MS and PhD Open Houses
Have you been considering investing in your education and career through a graduate degree in biodefense? Check out one of our Schar School Open Houses to get a feel for what the MS and PhD programs are like – you can chat with faculty, students, and learn more about the coursework and application process. The Master’s Open House will be at 6:30pm on Thursday, September 12th, and the PhD Open House will be at 7pm on Thursday, September 19th – both will be held at our Arlington campus in Van Metre Hall.

Ebola Outbreak – New Cases in Remote Areas 
Late last week two remote regions in the DRC reported cases of Ebola virus disease – North and South Kivu, of which there hadn’t been cases for several incubation periods. Moreover, there were 27 cases reported over 3 days, bringing the outbreak closer to 2,900. “According to Reuters, DRC officials today confirmed a new case of Ebola in the remote, militia-controlled territory of Walikale, which is 95 miles northwest of Goma. Goma recorded four cases of Ebola in the last 6 weeks, and it is unclear if the case in Walikale had any contact with other Ebola patients. Reuters also reported the DRC confirmed a third case in South Kivu region, which reported its first case late last week. South Kivu is more than 430 miles from the outbreak’s epicenter. The first cases in South Kivu were a mother and child who were likely exposed in Beni. For almost a year, the DRC’s Ebola outbreak—the second largest in history—was contained to North Kivu and Ituri provinces along the country’s eastern border.” Unfortunately, there has also been transmission within healthcare facilities where patients are being treated, as infection control is increasingly a challenge. “The World Health Organization (WHO) said today the third case of Ebola identified in South Kivu province was in a patient who contracted the virus at a health center where other Ebola patients had been treated. The details on the nosocomial transmission emerged in the WHO’s latest situation report on the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC). In the past week, two more DRC regions far from outbreak hot spots have reported cases: South Kivu province and Pinga health zone, which is in North Kivu province. The WHO is still investigating how the case-patient in Pinga contracted the virus, but investigations have shown a mother and child in Mwenga, South Kivu, became infected after contact with a patient from Beni, the city most hard hit by the outbreak this summer. The two towns are about 473 miles apart, and South Kivu province shares a border with Rwanda and Burundi.” The Department of Health and Human Services (HHS) is helping via $23 million funding towards Merck’s Ebola vaccine production. The WHO also just released their list of eight lessons being applied to the DRC outbreak in a “Ebola then and now” segment. This list includes things like putting research at the heart of response and supporting survivors.

Syria: Anniversary of the Ghouta Chemical Weapons Attack
The U.S. State Department recently released a statement on the attack that occurred six years ago. “On August 21, 2013, the Assad regime launched a horrific chemical attack with the nerve agent sarin on the Ghouta district in Damascus – killing more than 1,400 Syrians, many of them children. On this solemn anniversary we remember the numerous lives lost to the Assad regime’s use of chemical weapons.  We reiterate our resolve to prevent further use of these deadly weapons and to hold the Assad regime accountable for these heinous crimes. The regime’s barbaric history of using chemical weapons against its own people cannot and will not be forgotten or tolerated. Assad and others in his regime who believe they can continue using chemical weapons with impunity are mistaken.  The United States remains determined to hold the Assad regime accountable for these heinous acts and will continue to pursue all efforts alongside partner countries to ensure that those involved in chemical attacks face serious consequences.  We will continue to leverage all of the tools available to us to prevent any future use. We condemn in the strongest possible terms the use of chemical weapons anywhere, by anyone, under any circumstances.”

Stories You May Have Missed:

  • Packed Dorms Help MERS Transmission – Crowded living spaces and a high stress environment encouraged the transmission of a respiratory virus? Shocker… “New findings from an investigation into a large MERS-CoV cluster in a women’s dormitory revealed that crowded living conditions can lead to higher attack rates and hints that even healthcare workers who don’t directly care for patients can play a role in disease spread. In other developments, Saudi Arabia reported one new MERS-CoV (Middle East respiratory syndrome coronavirus) case.”
  • NIH Study to Offer Genetic Counseling – “A US government study that aims to sequence the genomes of one million volunteers will partner with a genetic-counselling company to help participants understand their results. It will be the largest US government study to provide such a service. The National Institutes of Health (NIH) is leading the project, called All of Us. And on 21 August, the agency announced the award of a US$4.6-million, 5-year grant to Color. The firm, in Burlingame, California, will counsel every study participant with a genetic variant that could have serious health implications — such as BRCA mutations associated with breast cancer — when they receive their results. Color will also develop educational materials for all study participants, and will offer telephone consultations to anyone who wishes to discuss their results with a counsellor.”

 

Pandora Report: 8.16.2019

 Pandemic Bonds – Designed to Fail Ebola 
Is the World Bank’s funding approach to outbreak response hurting the DRC during their fight against Ebola? Olga Jones discusses how the Pandemic Emergency Financing Facility (PEF) works and how it is ultimately helping investors but not health security. “The World Bank has said that the PEF is working as intended by offering the potential of ‘surge’ financing. Tragically, current triggers guarantee that payouts will be too little because they kick in only after outbreaks grow large. What’s more, fanfare around the PEF might have encouraged complacency that actually increased pandemic risk. Following false assurance that the World Bank had a solution, resources and attention could shift elsewhere. Rather than a lack of funds, vigilance and public-health capacity have been the main deficiencies. When governments and the World Bank are prepared to respond to infectious-disease threats, money flows within days. In the 2009 H1N1 influenza outbreak in Mexico, clinics could diagnose and report cases of disease to a central authority that both recognized the threat and reacted rapidly. The Mexican government requested $25.6 million from an existing World Bank-financed project for influenza response and received the funds the next day.” Jones notes that “the best investment of funds and attention is in ensuring adequate and stable financing for core public-health capacities. The PEF has failed. It should end early — and IDA funds should go to poor countries, not investors.”

Maximizing Opportunities for US Bioeconomy Growth and National Security with Biology
“Recently, the Johns Hopkins Center for Health Security and Gingko Bioworks convened key science, technical, academic, and industry experts for a meeting to solicit stakeholder input on specific ways that national policy can strengthen the US bioeconomy. Their recommendations are synthesized in a summary report, released today. Participants considered the benefits to the US if its bioeconomy were to be expanded; examined the current health of the US bioeconomy; discussed existing US government programs, policies, and initiatives related to the bioeconomy; and identified priorities for strengthening the US bioeconomy.”

DRC Ebola Outbreak Updates
Beni and Madnima continue to be hotspots for the disease as they have accounted for 60% of recent cases, not to mention ongoing violence and unrest. “The security situation increased in volatility as a result of a surge in attacks from suspected ADF elements in Beni Health Zone and successive demonstrations,” the WHO said. “A recent attack in Mbau on the Beni/Oicha axis led to the deaths of six civilians, including a prominent civil society leader. EVD operations in the area were temporarily suspended with resumption pending improvement in the security situation.” On a more positive note, two outbreak treatment trials are showing promise. “An independent monitoring board meets periodically to review safety and efficacy data, and at their Aug 9 review recommended that the study be stopped and all future patients be randomized to receive either Regeneron, an antibody cocktail, or mAB 114, an antibody treatment developed from a human survivor of the virus. The other two drugs involved in the original trial were zMapp, which in an earlier trial didn’t show  statistically significant efficacy but performed better than standard care alone, and Remdesivir, an antiviral drug. Earlier in the outbreak, an ethics committee in the DRC approved the four experimental treatments for compassionate use, and patients at all of the country’s Ebola treatment centers have had access to them, along with safety monitoring. However, the formal clinical trial has been under way since November at four treatment centers with the help of the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Doctors Without Borders (MSF). At a media telebriefing today, Anthony Fauci, MD, director of the National institute of Allergy and Infectious Diseases (NIAID), said Regeneron was the drug that crossed the efficacy threshold, triggering a pause in the study. And he said the group recommended proceeding with mAb 114, because there were only small differences in the data between the two drugs.”

Combatting Legionella and Carbon Footprints
Can we reduce the burden of Legionnaire’s disease while reducing our carbon footprint? GMU Biodefense PhD student and infection preventionist Saskia Popescu discusses a new strategy to preventing this water-based bug. “Typical health care control methods range from routine sampling to temperature control measures, like keeping cold water below 20°C and hot water at a minimum of 60°C. This has been the tried and true approach to Legionella control since there will always be some small level of the bacteria in water and the ultimate goal is to avoid growth that can cause human disease. Investigators in the United Kingdom recently published a study assessing a large health care facility’s approach to reducing Legionella risk through use of copper and silver ionization at hot water temperatures that were deliberately reduced to 43°C within a new water system. The research team collected 1589 water samples between September 2011 and June 2017, looking for not only Legionella bacteria, but also copper and silver ion levels, and total viable counts. To also assess the internal costs and function of this system, investigators collected data on energy consumption and water usage.”

2015 HPAI Outbreaks in the US – Insight Into Airborne Transmission 
“The unprecedented 2015 outbreaks of highly pathogenic avian influenza (HPAI) H5N2 in the U.S. devastated its poultry industry and resulted in over $3 billion economic impacts. Today HPAI continues eroding poultry operations and disrupting animal protein supply chains around the world. Anecdotal evidence in 2015 suggested that in some cases the AI virus was aerially introduced into poultry houses, as abnormal bird mortality started near air inlets of the infected houses. This study modeled air movement trajectories and virus concentrations that were used to assess the probability or risk of airborne transmission for the 77 HPAI cases in Iowa. The results show that majority of the positive cases in Iowa might have received airborne virus, carried by fine particulate matter, from infected farms within the state (i.e., intrastate) and infected farms from the neighboring states (i.e., interstate). The modeled airborne virus concentrations at the Iowa recipient sites never exceeded the minimal infective doses for poultry; however, the continuous exposure might have increased airborne infection risks. In the worst-case scenario (i.e., maximum virus shedding rate, highest emission rate, and longest half-life), 33 Iowa cases had > 10% (three cases > 50%) infection probability, indicating a medium to high risk of airborne transmission for these cases. Probability of airborne HPAI infection could be affected by farm type, flock size, and distance to previously infected farms; and more importantly, it can be markedly reduced by swift depopulation and inlet air filtration.”

Serbia Suspects African Swine Fever – Implications for Imports 
One Health in a nutshell – the economic implications of zoonotic diseases like African swine fever (ASF). “Serbia has reported four suspected outbreaks of African swine fever among backyard pigs, the Paris-based World Organisation for Animal Health (OIE) said on Monday, prompting neighbouring countries to ban imports of the animals. Three of the cases were detected in the Belgrade area and one in the district of Podunavski, the OIE said, citing a report from Serbia’s Agriculture Ministry. The suspected cases of the disease killed seven pigs while another 114 were slaughtered, the report showed. Bosnia, Montenegro and North Macedonia banned imports of pigs, wild boar and related products from Serbia to prevent the spread of the outbreak, the countries’ veterinary authorities said.”

A New Drug to Tackle Extensively Drug-Resistant TB
XDR-TB is a disease that causes significant health issues on a global scale and the effort to try and treat can be costly. A “new drug, pretomanid, has been approved by the US Food and Drug Administration (FDA) for use in a treatment for XDR-TB. Amazingly, it’s the first time that a treatment for XDR-TB infections has been recognized for actually working—no other treatment has demonstrated any consistent effectiveness. Up until now, people with XDR-TB had to suffer through up to two years or more of toxic treatment that worked only one third of the time. Today’s news means that treatment time is drastically reduced—to six months—while the effectiveness of treatment is significantly improved. We welcome this approval as it shows the real-world impact of US government investment in finding new cures and vaccines for the world’s deadliest diseases. The developer of pretomanid, the nonprofit organization TB Alliance, could not have succeeded in advancing this breakthrough without support from the American people, through the US Agency for International Development (USAID) and National Institutes of Health (NIH).”

Stories You May Have Missed:

  • Mega Malaria Vaccine Test Postponed in Kenya – “Kenya has postponed a large-scale pilot test for a malaria vaccine that could reduce the burden of the disease. The World Health Organisation (WHO) chose Malawi, Ghana and Kenya to vaccinate 360,000 children per year; and while the two nations began the rollout in April, Kenya is yet to start. The introduction in Kenya, planned for this Thursday, was postponed by the Ministry of Health. ‘I regret to inform you that the stakeholders breakfast meeting planned for this Tuesday, August 13, and the launch planned for Thursday, August 15, have been postponed to a later date to be communicated to you shortly. This is due to the upcoming Health Summit scheduled on August 14 and 15,’ head of the National Vaccines and Immunisation Programme, Dr Collins Tabu, said.”

Pandora Report: 8.9.2019

From Legionella to the BWC, we’re the spot for all things biodefense. Did you know that China recently approved an ethics advisory group after the CRISPR-babies scandal? Welcome to your weekly dose of global health security news!

Launch of the 2019 Next Generation Biosecurity Competition
Are you a global health security and biosecurity student or professional? “NTI | bio is partnering with the Next Generation Global Health Security (GHS) Network to advance the biosecurity and biosafety-related targets of the Global Health Security Agenda (GHSA). Together, we are launching the third annual joint competition to foster a biosecurity professional track within the Next Generation GHS Network. The 2019 competition will spur next generation experts in health security to discuss catalytic actions that can be taken to reduce biological risks associated with advances in technology and promote biosecurity norms. For the 2019 Next Generation for Biosecurity Competition, we will publish creative and innovative papers that promote regional, multi-sectoral, and global collaboration.  Each team can include up to three people and should: 1) explore concrete collaborative actions that can be taken to build national, regional, and global norms for preventing deliberate and/or accidental biological events; and 2) promote cross-sectoral and cross-regional partnerships to advance biosecurity and biosafety. Papers should directly address the biosecurity targets included within the World Health Organization Joint External Evaluation and the GHSA Action Package on Biosecurity and Biosafety (APP3).” If you’re a GMU biodefense student or alum – you’re in luck as we’ve got a Next Generation Global Health Security Network chapter (membership is a requirement for the competition).

CSIS- Federal Funding for Biosafety Research is Critically Needed
The Center for Strategic & International Studies (CSIS) has just released their report on why we desperately need to provide funding for biosafety research in the face of new biotech and emerging infectious disease threats. “Currently, we lack the evidence basis to take new, needed measures to prevent accidents in biological laboratories, which, as mankind continues to expand its capabilities to manipulate life (including the viruses and bacteria that cause disease), leaves us more vulnerable to the accidental initiation of disease outbreaks with potentially dangerous consequences locally, regionally, and beyond. New biotechnologies are enabling scientists to design or modify life in ways not previously possible. These biotechnologies enable professional and amateur researchers to use simple life forms (e.g., bacteria and yeast) to create simple sensors and produce industrial chemicals, materials, and pharmaceuticals cheaply and from commonplace reagents. The manipulation of pathogens (the microbes that cause disease) fosters a better understanding of how these agents evolve and interact with the body, enabling the development of next generation cures. Despite the significant U.S. and global investment in biotechnology, concern has been voiced by scientists, policy experts, and members of the community  that scientists may be ill-equipped to handle novel, manipulated microbes safely, potentially resulting in accidental infection of themselves or their local communities, accidental release into the environment, or even the initiation of a global pandemic.”

Biological Weapons Convention Meeting of Experts – Updates and Deciding on Emergency Assistance in Cases of Bioweapons Use
If you’ve been missing the MXs, Richard Guthrie has you covered with his daily accounts of these meetings and events. Thursday was the closing day of MX4 and focused on the financial situation. “The Chair of the 2019 Meeting of States Parties (MSP), Ambassador Yann Hwang (France), held informal consultations with delegates from states parties to discuss the financial situation for the BWC which remains difficult. Non- payments of agreed assessments by a number of states parties continue to cause problems. While some of these eventually appear as late payments, the ongoing deficit is sufficiently large to put the MSP at risk. As the financial accounting period is the calendar year, the MSP at the end of the year is always going to be the most vulnerable activity if there is a financial shortfall. In 2018, some economies were made on the MSP by having one informal day of activities without interpretation, putting a number of delegates at a disadvantage. The government of France has a clearly stated position on multilingualism within multilateralism and so the MSP Chair would be extremely reluctant to implement a similar route to financial savings. The Working Capital Fund established by the 2018 MSP is specifically designed not to subsidise non-payment, but to smooth out cash flow during the year. Depleting the fund — which is not even close to its target value – in its first year to cover the costs of the MSP would render it useless for purposes of supporting core activities such as the ISU. There are also financial implications of decisions that will need to be taken in relation to the Ninth Review Conference to be held in 2021.” Dr. Jean Pascal Zanders was also in attendance and has reported out on discussions surrounding Article VII – “Being one of the more obscure provisions in the BTWC, Article VII only attracted state party attention over the past ten years or so. In follow-up to the decision of the 7th Review Conference (2011), parties to the convention looked for the first time more closely at the provision during the August 2014 Meeting of Experts (MX). As it happened, the gathering coincided with the expanding Ebola crisis in West Africa. The epidemic gave urgency to the concrete implementation of Article VII. The daily images of victims and fully protected medical staff broadcast around the world left lasting impressions of how a biological attack from another state or terrorist entity might affect societies anywhere. Operationalising Article VII has proven more complex than anticipated. The provision comprises several clauses that fit ill together upon closer inspection and hence obscure its originally intended goals. In addition, it contains no instructions about how a state party should trigger it or the global community respond after its invocation.”

CSIS Commission on Strengthening America’s Health Security Meeting
“On June 26, 2019, the CSIS Commission on Strengthening America’s Health Security convened for the third time since its launch in April 2018. The Commission’s core aim is to chart a dynamic and concrete vision for the future of U.S. leadership in global health security—at home and abroad.” “On June 26, Commission members—a diverse group of high-level opinion leaders who bridge security and health and the public and private sectors, including six members of Congress—met to discuss a proposed U.S. doctrine for global health security. Commission members deliberated and reached a broad consensus endorsing a doctrine of continuous prevention, protection, and resilience, which would protect the American people from the most pressing global health security threats we face today. The measures outlined in the paper are affordable, proven, and draw support from across the political spectrum. The time to act is now.” Participants called for Congress and the administration to take action across seven areas, including ensuring full and sustained, multi-year funding for the GHSA, ensuring ample and quick-disbursing finances, establishing a global health crises response corps, etc.

Combatting AMR Through Payment Shifts
In the battle against the resistant bug, sometimes you have to change tactics and bring in the big guns – like the Centers for Medicare and Medicaid Services (CMS). Developing antimicrobials has been a particular challenge, despite efforts to push and pull research and development. BARDA Director Rick A. Bright recently discussed this problem, but now a new CMS rule could help guide change. “Without payment reform, the antimicrobials marketplace will not survive. CMS Administrator Seema Verma understands this reality and the necessity for a strong marketplace for both public health and national security purposes. On Friday, August 2, CMS issued its fiscal year (FY) 2020 Hospital Inpatient Prospective Payment System (IPPS) Final Rule. Among other changes to the way CMS pays for Medicare services, CMS recognized the need for greater payment of newer, potentially safer and more effective antimicrobial drugs. The new rule will (1) change the severity level designation for multiple ICD-10 codes for antimicrobial drug resistance from ‘non-CC’ to ‘CC’ (which stands for complications or comorbidities) to increase payments to hospitals due to the added clinical complexity of treating patients with drug-resistant infections, (2) create an alternative pathway for the new technology add-on payment (NTAP) for qualified infectious disease products (QIDPs), under which these drugs would not have to meet the substantial clinical improvement criterion, and (3) increase the NTAP for QIDPs from 50 percent to 75 percent. This final rule lessens economic incentives to utilize older antimicrobial drugs such as colistin, and shift medical practice to employ more appropriate, newer generation antimicrobials. Payment more closely aligned with the value of these lifesaving medicines will shift the current market realities of these drugs for companies, investors, and patients. No single action will solve the antimicrobial resistance problem; however CMS’ efforts undoubtedly can improve the marketplace and re-catalyze innovation in basic science discovery, and research and development efforts. We appreciate and congratulate Administrator Verma for taking such bold leadership in this fight. ”

Ebola in the DRC
The latest WHO dashboard is showing that the outbreak has reached 2,787 cases. Seven cases were reported from the DRC ministry of health earlier this week and there is growing concern about the impact the outbreak is having on children in the area. “Last December UNICEF sounded the alarm about the high number of children infected in the outbreak, noting that one of every third people confirmed infected in the DRC’s outbreak was a child, unusual for Ebola epidemics. The agency noted that 1 in 10 children were under age 5 and that kids were more likely to die from the disease than adults. Save the Children said in its statement yesterday that around 737 children have been infected with Ebola in the DRC’s outbreak. And based on the latest numbers, the impact on kids has increased. In the first 6 months of the outbreak, which was declared on Aug 1, 2018, just under 100 deaths in children had been reported. However, in the 6 months that followed, over four times as many have died. Heather Kerr, Save the Children’s country director in the DRC, said, ‘This is another grim milestone in a crisis that is devastating children in its path, especially the youngest. Some 40% of children who have contracted the disease are under the age of five, and many of them have died.’ She also said the outbreak has had a wider impact on children because of the high overall fatality rate from the virus, with thousands losing at least one of their parents or separated from their families.”

SWP Comment- Why the Containment of Infectious Diseases Alone Is Not Enough
You can now access this commentary by Daniel Gulati and Maike Voss here, which discusses the current DRC Ebola outbreak and that in “crisis situations like these, the interdependencies between health and security are highly complex. Which population groups and which diseases are perceived as suspected health risks, and why, is a normative question for donor countries. It has political consequences above all for affected developing countries. Where health and security are common goals, it is not enough to contain infectious diseases in developing countries. Instead, resilient, well-functioning, and accessible health systems must be established. This fosters the implementation of the human right to health, creates trust in state structures, and takes into account the security interests of other states. In the United Nations (UN) Security Council, the German government could advocate for policies based on the narrative ‘stability through health’.” 

Stories You May Have Missed:

  • MERS and Healthcare Transmission– “Since its last update in June 2018, 219 cases were reported in four countries: Saudi Arabia (204), Oman (13), South Korea (1), and the United Kingdom (1). However, of the 97 secondary cases reported to the WHO, 52 were linked to transmission in hospitals, including 23 infections in healthcare workers. Since the virus was first detected in humans in 2012, 2,449 cases have been reported through Jun 30, 84% of them in Saudi Arabia. The virus is known to spread more easily in healthcare settings, and research is under way to better understand the factors that drive transmission. The WHO said awareness of the disease is still low, and the nonspecific early symptoms can make it difficult to identify cases. Gaps in infection prevention and control measures also contribute to disease spread. ‘Much more emphasis on improving standard IPC [infection prevention and control] practices in all health care facilities is required,’ the WHO said.”
  • Managing Measles: A Guide to Preventing Transmission in Health Care Setting– “Perhaps one of the most challenging aspects of this outbreak from a health care perspective is preparation. Although some may not consider this to be a concern, between 2001-2014, 6% of US measles cases (that were not imported) were transmitted within a health care setting. Sadly, I experienced this firsthand during a 2015 exposure at the health care facility I worked at, in which a health care worker was exposed to the virus while treating a patient and subsequently became infected. As a result of the health care worker’s infection, 380 individuals were exposed and the response efforts were extensive and significantly disruptive to the daily infection prevention duties. Due to the fact that hospitals can easily act as amplifiers for airborne diseases like measles, the CDC has provided interim infection prevention and control recommendations for measles in health care settings. At its core, this guidance focuses on health aspects of both the employee and the patient. For health workers, it is critical to ensure presumptive evidence of immunity to measles and manage exposed/ill health care workers properly. On the patient side, rapid identification and isolation of known or suspected cases and proper isolation maintenance is critical. “

Pandora Report: 8.2.2019

Greetings fellow biodefense friends! We hope your summer is winding down nicely and you’re ready for your weekly dose of all things health security. You might want to avoid pig ear dog treats as there’s currently an outbreak of multi-drug resistant Salmonella infections.

 Bioweapons Convention – Meeting of Experts
The BWC Meeting of Experts (MX) is currently under way and you can get detailed, daily reports via Richard Guthrie’s BioWeapons Prevention Project, which has been covering the BWC since 2006. Guthrie notes “The first Meeting of Experts (MX1) in the 2019 series opened on Monday morning with Ambassador Victor Dolidze (Georgia) in the Chair. Owing to refurbishment work in the Palais des Nations, MX1 opened in Room XX [renowned for its elaborately decorated ceiling] instead of the usual location for BWC meetings two floors below. One advantage of using Room XX is that the proceedings can be webcast via <<http://webtv.un.org/>&gt; After brief opening formalities, six sub-topics were covered during Monday, the full titles of which can be found in the agenda for MX1. There was a full day of activities which means that this report can only be a selective snapshot of proceedings. The background information document produced by the Implementation Support Unit (ISU) for the MX1 held in 2018 contains much information relevant to the discussions this year.” You can also find the Joint NGO Statements that were given here. “In her reflections on last year’s MX1, the Chair, Ambassador Almojuela of the Philippines, suggested several concrete proposals for further consideration at today’s meeting. These included: An action plan for Article X implementation; Guidelines on Article X reports; The creation of a BWC Cooperation and Assistance Officer position within the ISU; and An open-ended working group to monitor, coordinate and review activities of cooperation and assistance. These are all proposals that the NGO community strongly endorses, and which were also set out in our Position Paper last year. Ambassador Almojuela also proposed to further collaboration with INTERPOL, OIE and WHO; we would also wish to draw attention to the importance of further collaboration with non-governmental entities. We would also urge States Parties to facilitate regional S&T dialogues that are focused on regional BWC-related interests and problems, and that draw in regional and international expertise to share information and stimulate collaboration and cooperation.”

DRC Ebola Outbreak 
The outbreak has now hit the one year mark and it continues to worsen – with 41 new cases reported since the end of last week. “According to the World Health Organization’s (WHO’s) online Ebola dashboard, the outbreak total now stands at 2,671 cases. The dashboard also recorded a total of 1,782 deaths, an increase in 20 fatalities over the weekend. So far the DRC president’s office, which last week shifted outbreak response activities to its technical group, has not issued any detailed daily updates following the resignation of the country’s health minister.” A day later, the second case of Ebola was identified in the city of Goma. “Reports from DRC journalists and international media outlets said the case was announced at a media briefing where the head of a presidential expert committee, Jean Jacques Muyembe Tamfum, PhD, shared details about the development. The country’s president put the committee in charge of outbreak management on Jul 20, prompting the DRC’s health minister to resign. The infected man, a father of 10 children, is from Mongbwalu, about 43 miles from Bunia, the capital of Ituri province, according to a Tweet from DRC journalist Cedric Ebondo Mulumb. Goma and Bunia are about 347 miles apart, with road travel taking about 13 hours.” The WHO has recently noted how “relentless” this outbreak has been since it began one year ago.

 GMU Biodefense MS and PhD Open Houses
Have you been considering adding to your education and career through a graduate degree in biodefense? Check out one of our Schar School Open Houses to get a feel for what the MS and PhD programs are like – you can chat with faculty, students, and learn more about the coursework and application process. The Master’s Open House will be at 6:30pm on Thursday, September 12th, and the PhD Open House will be at 7pm on Thursday, September 19th – both will be held at our Arlington campus in Van Metre Hall.

MERS-CoV: Novel Zoonotic Disease Outbreak a Hard Lesson for Healthcare
“Middle East respiratory syndrome coronavirus (MERS-CoV) was first identified in 2012 and since then, sporadic but continued outbreaks have been occurring within the Arabian Peninsula. There have been 2,428 cases of the coronavirus since 2012, and 838 associated deaths. Reported across 27 countries, this has been a disease that seems to have found a stronghold and established itself as endemic. MERS-CoV challenges response in that while we have diagnostic testing now, there truly is not treatment outside of supportive measures. Spread through the respiratory secretions of infected individuals, there has also been transmission via close contact (i.e. caring or living with an infected person), and ongoing investigation into the role of camels in zoonotic transmission. The disease does circulate in dromedary camels in Africa, the Middle East, and southern Asia, but cases have tended to be related to healthcare exposures and household contacts, with some camel-to-human transmission occurring. Hospitals are encouraged to ensure adherence to Standard, Contact, and Airborne isolation precautions, meaning that the patient should be placed in a negative pressure isolation room and healthcare workers should wear a gown, gloves, eye protection, and N95 respirator. Given the need for these isolation precautions, it’s not surprising that exposures often come from delays in isolation and crowded emergency rooms.”

WHO Statement on Governance and Oversight of Human Genome Editing
The World Health Organization has released the statement from this expert advisory committee held in March of this year. “At this meeting the Committee in an interim recommendation to the WHO Director-general stated that ‘it would be irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing.’ WHO supports this interim recommendation and advises regulatory or ethics authorities to refrain from issuing approvals concerning requests for clinical applications for work that involves human germline genome editing. ‘Human germline genome editing poses unique and unprecedented ethical and technical challenges,’ said WHO Director-General Dr Tedros Adhanom Ghebreyesus. ‘I have accepted the interim recommendations of WHO’s Expert Advisory Committee that regulatory authorities in all countries should not allow any further work in this area until its implications have been properly considered.’ WHO’s Expert Advisory Committee continues its consideration of this matter, and will, at its forthcoming meeting in Geneva on 26-28 August 2019. evaluate, inter alia, effective governance instruments to deter and prevent irresponsible and unacceptable uses of genome edited embryos to initiate human pregnancies.”

Breaking Down Resistant Rumors and C diff Disinfectants
GMU biodefense doctoral student and infection preventionist Saskia Popescu discusses how poor communication regarding resistant organisms can cause confusion and misleading headlines. A recent study noted resistance of Clostridioides difficile to disinfectants however, “The investigators sought to treat the gowns with disinfectant to test its efficacy and whether it would help with the bioburden. The research team found that after being treated with the 1000 ppm chlorine-based disinfectant for 10 minutes, the gowns still were able to pick up and hold the C diff spores. This concern over resistance sent shockwaves and many news outlets picked up on this as an indicator of what’s on the horizon. But an issue with the study was the disinfectant that was used. First and foremost, as an infection preventionist and the first to stand on my soapbox to shout about the perils of antimicrobial resistance, I know that the efficacy of our disinfectants will eventually fail. The issue with this study is that much of the media coverage speaks broadly of a chlorine-based disinfectant and goes into little detail about what exactly what used. For my infection prevention peers, you know that not all disinfectants are alike and, well, some just weren’t designed for combatting hardier bugs like C diff. This is the playbook we live by in health care.”

 Rinderpest, Smallpox, and the Imperative of Destruction
To destroy or not to destroy…that is indeed the question. “In June, The Pirbright Institute (UK) announced that it had destroyed its final archived stocks of rinderpest, the devastating viral disease of cattle that was declared eradicated in 2011. Rinderpest is only the second infection to be eradicated from the wild. The decision raises the question once again of what to do with the remaining stocks of the first eradicated virus—smallpox. The Pirbright Institute did not hold the final stocks of rinderpest in existence; samples are also known to be stored in a handful of facilities in China, Ethiopia, France, Japan, and the USA. Still, The Pirbright Institute is the World Reference Laboratory for rinderpest, previously storing more than 3000 viral samples. That it has taken the decision to destroy them represents a bold commitment to permanently ridding the world of the disease and should encourage others to do the same. France plans to destroy its remaining stocks, and discussions continue at other facilities.” The debate surrounding the survival and destruction of smallpox stocks has been ongoing for decades – some argue the risk of accidental or intentional release is too great, while others argue that destruction would remove the potential for research…however the Pirbright Institute’s practice countered this with their “sequence and destroy” policy, which is encouraging others to push for this policy regarding smallpox. “Smallpox stocks have been earmarked for destruction since eradication of the disease in 1980. Yet, successive meetings of the World Health Assembly have postponed making a final recommendation while the threat of re-emergence from elsewhere remains. At its last meeting in September, 2018, the Advisory Committee on Variola Virus Research told WHO that live virus is still needed for the development of new antivirals, with split opinion on whether it is needed for diagnostics. Huge strides have been made in these areas in recent years. New more advanced and safer vaccines have been developed; new diagnostic tests are in development; and the first specific antiviral for smallpox—tecovirimat—was approvedby the US Food and Drug Administration in June last year, after some innovative regulatory manoeuvres. The deliberations over smallpox stocks happen regularly, but the decisions are ad-hoc. For rinderpest, destruction seems only a matter of time. Smallpox stocks will also likely be destroyed once diagnostics are finalised and a second antiviral, with a different mode of action in case of resistance, is approved (many are in development).”

Stories You May Have Missed:

  • Surge in Drug-Resistant HIV Across Africa, Asia, and the Americas – “Surveys by the World Health Organization (WHO) reveal that, in the past 4 years, 12 countries in Africa, Asia and the Americas have surpassed acceptable levels of drug resistance against two drugs that constitute the backbone of HIV treatment: efavirenz and nevirapine. People living with HIV are routinely treated with a cocktail of drugs, known as antiretroviral therapy, but the virus can mutate into a resistant form. The WHO conducted surveys from 2014 to 2018 in randomly selected clinics in 18 countries, and examined the levels of resistance in people who had started HIV treatment during that period. More than 10% of adults with the virus have developed resistance to these drugs in 12 nations (see ‘Resistance rises’). Above this threshold, it’s not considered safe to prescribe the same HIV medicines to the rest of the population, because resistance could increase. Researchers published the findings this month in WHO report.”

Pandora Report: 7.26.2019

 Summer Workshop on Bioterrorism, Pandemics, and Global Health Security – A Recap
“The spectrum of biological threats is often much wider than many realize. From the current Ebola virus disease outbreak in the Democratic Republic of the Congo to CRISPR-designed babies, there are a lot of biological issues that trickle over into health care and public health. This week, I attended the Summer Workshop on Pandemics, Bioterrorism, and Global Health Security: From Anthrax to Zika, where conversations ranged from protecting the bioeconomy to vaccine development. Here are the key takeaways: First, it’s a startling truth, but biological threats aren’t just black and white, but a vast spectrum of gray. We no longer live in a world where it’s just pandemics and bioterrorism, but also conversations surrounding dual-use research of concern (DURC), gene drive worries with CRISPR-modified mosquitoes, pandemic response, vaccine development, and so much more. FBI Supervisory Special Agent Edward You discussed concerns of garage biohacking and how the US government has policies on oversight for life sciences DURC. Furthermore, You discussed synthetic biology and how the price for DNA synthesis kits (ie, biohacking kits) have dramatically dropped over the years.”

Bashar al-Assad is Waging Biological War – By Neglect
Going against the traditional definition of biological warfare, Annie Sparrow discusses how the deliberate efforts by the Assad regime to destroy public health and healthcare are actually a form of biological warfare. “Beyond being unpredictable and difficult to control, anthrax or sarin attacks are too visible and risk a global reaction. And in war, they kill in far smaller numbers and much less reliably than common diseases and wound infections. In contrast, the behavior of Assad’s preferred pathogens is predictable. Here lies the key to a far more insidious strategy: By deliberately degrading an already precarious public health situation, the new biological warfare is able to fly under the radar. Assad’s most visible mass atrocities include indiscriminate attacks on and the resulting forced displacement of civilians, devastating sieges, and assaults on hospitals. But an unappreciated dimension of his total-war strategy has been his attacks on public health infrastructure and programs in order to fast-track the epidemic diseases that thrive in the crowded living conditions created by mass displacement, while simultaneously withholding essential public health tools and medicines. The aim is to weaken the entire population in these areas and overburden the rudimentary medical facilities that were able to survive in an effort to punish populations opposed to Assad. While there is a brutal battlefield logic to these attacks on health care infrastructure, they are prohibited by the Geneva Conventions, which are designed to spare civilians—and the institutions on which they depend—from the hazards of war. Assad is deliberately engaging in war crimes.”

In Memory of Prof. Andrew Price-Smith
The biodefense world got a bit dimmer with the passing of one its greats – Dr. Andrew Price-Smith. The author of one of my personal favorites – Contagions and Chaos, “Professor Andrew Price-Smith, David Packard Professor of International Relations and Director of the Global Health Initiative, passed away last week after a lengthy illness. He is survived by his wife, Janell Price-Smith, and their two children. Our thoughts and prayers are with Drew’s family, colleagues, and friends. Professor Price-Smith joined the CC faculty in 2005 and served as chair of the political science department from 2013-2016 and as the founding director of our Global Health Initiative. Drew’s research focused on the effects of disease, environmental change, and energy scarcity on the security of nations and taught courses on the environment, health and security, and international relations.”

 UK Parliament Inquiry into Government’s Biosecurity Efforts
It’s been a year since the UK Government published their first ever Biosecurity Strategy, and the Joint Committee on the National Security Strategy is set to inquire how they’re approaching biosecurity and human health. “The strategy is intended to coordinate a cross-government approach to biosecurity threats, whether they materialise naturally, accidentally or deliberately in the form of a malicious attack. It cites globalisation and technology as key factors in today’s biosecurity risks. The Government has long prioritised public health as a national security issue, with pandemics and emerging infectious diseases categorised as a top-tier risk in the 2010 and 2015 National Security Risk Assessments. Attacks using biological weapons are categorised as a second-tier risk, along with attacks using chemical, radiological and nuclear weapons. In 2018, the Government’s National Security Capability Review elevated ‘diseases and natural hazards affecting the UK’ to one of six principal challenges likely to drive national security priorities over the coming decade.” You can read the UK Biological Security Strategy here,  which “recognises the importance of intervening early to prevent biological threats from emerging, or from spreading once they emerge. To this end, it sets out how we will make best use of our international activity to help reduce the risks to the UK and our interests, at home and overseas. This includes our engagement with international partners (at local, regional and national levels) and forums. Our investment in overseas biological security education and our international work on global health security, led by DHSC and DFID, is building resilience to health threats in developing countries.”

Ebola Outbreak Updates
The outbreak of Ebola virus disease in the DRC has been changing daily, but here’s an update to help catch you up. On Wednesday, it was reported that more violence has occurred in the outbreak region, “the Allied Democratic Forces (ADF), a rebel group, attacked two villages near Beni, killing 12 people who live in the heart of the Democratic Republic of the Congo’s (DRC’s) ongoing Ebola outbreak. The terrorists killed nine in Eringeti and three in Oicha, according to Reuters. ADF has not publically pledged allegiance to the Islamic state (ISIL), but that hasn’t stopped ISIL from claiming responsibility for the attacks.” This comes has the World Bank Group announced it would be mobilizing $300 million to help respond to the outbreak. “The US$300 million in grants and credits will be largely financed through the World Bank’s International Development Association (IDA) and its Crisis Response Window, which is designed to help countries respond to severe crises and return to their long-term development paths. The financing package will cover the Ebola-affected health zones in DRC and enable the government, WHO, UNICEF, WFP, IOM and other responders to step up the frontline health response, deliver cash-for-work programs to support the local economy, strengthen resilience in the affected communities, and contain the spread of this deadly virus. This amount is approximately half of the anticipated financing needs of the Fourth Strategic Response Plan (SRP4), which is expected to be finalized in the coming week by the Government and the international consortium of partners working on the response. The World Bank has been supporting programs to combat DRC’s ongoing battle with Ebola since May 2018, with resources going to the frontline response, health system strengthening, and preparedness to reduce the risk of spread.” This outbreak in particular has forced response efforts to change the way we approach not only outbreak control, but also vaccine deployment. “Every aspect of the outbreak is affected by the area’s long history of conflict and trauma. Residents have endured more than two decades of terror from armed groups, along with resource exploitation, political instability and neglect from the world at large. That has bred distrust of authorities — including foreign health workers — and conspiracy theories about why Ebola is thriving. One popular rumour alleges that Ebola responders inject people with deadly substances at treatment centres and vaccination sites. These false ideas have fostered nearly 200 attacks on Ebola responders and treatment centres so far this year, according to the WHO. Seven people have been killed and 58 injured.” You can check the latest case-counts here, which shows now 2,620 cases.

Defense Officials See Increased Threat from Chinese, Russian Chem-Bio Weapons
At a recent CBRN Conference, a hot topic of concern was the threat of Chinese and Russian CBW. In fact – Dr. Kilianski (GMU biodefense professor) spoke on this – “Much attention has been focused on Russia and China’s modernization of their nuclear and conventional forces. But there is growing concern at the Pentagon about those nations’ chemical and biological weapons, U.S. officials said July 23. There is now an increased focus on threats posed by near-peer adversaries, noted Andrew Kilianski, chief intelligence officer at the joint program executive office for chemical, biological, radiological and nuclear defense. ‘They’re in that emerging space … in terms of things we haven’t seen before or things that we don’t have a lot of information on,’ he said during remarks at the National Defense Industrial Association’s annual CBRN Conference and Exhibition in Wilmington, Delaware. The question now is, ‘how do we build capability against a threat space which … we don’t know much about?’ he added”.

DARPA Awards ASU Contract to Build Epigenetic-based WMD Exposure Measurement Tool
For $38.8 million, Arizona State University will get the chance to help build a measurement tool against WMDs. “Arizona State University announced today that it has been awarded $38.8 million by the US Defense Advanced Research Projects Agency (DARPA) to build a field-deployable, point-of-care device that can determine if a person has been exposed to weapons of mass destruction or their precursors, in 30 minutes or less. The grant, which will be funded over four years in phases and options, was awarded under DARPA’s Epigenetic Characterization and Observation (ECHO) program, which aims to identify epigenetic signatures created by exposure to threat agents and to develop technology that performs highly specific forensic and diagnostic analyses to reveal the exact type and time of exposure. ASU said the device it plans to develop will be capable of detecting the health effects of a number of substances associated with weapons of mass destruction — including biological agents, radiation, chemicals, and explosives — from a single drop of blood. The technology could also eventually be used for simple, low-cost monitoring of epigenetic changes to detect a broad range of human diseases.”

 Troublesome Ticks: Dispelling Bioweapon Rumors
“A government-owned island used for biodefense testing, a devastating vector-borne disease, and an amendment quietly slipped into major legislation—Although these might sound like scenes from the latest sci-fi movie, they are actually part of a current hot topic that stemmed from some rather poor information. Let’s start from the beginning as we tackle the misinformation circulating in today’s anti-vaccine movement. Plum Island, as idyllic as it sounds, is an island off the coast of Orient Point, New York. Purchased by the US government in the 1950s, it became the home for animal disease research, first for the US Army and then for the US Department of Agriculture. The island is now the site of the Plum Island Animal Disease Center (PIADC), which falls under the Department of Homeland Security (DHS) Science and Technology Office of National Laboratories (ONL). The island allows PIADC to maintain a safe, isolated area to develop biodefense efforts to defend against intentional, accidental, or natural animal diseases like foot-and-mouth (FMD), which can be devastating to cattle. Hundreds of investigators and employees come to the island to work on research, which can include efforts of treatment, diagnostics, vaccines, and bioforensics. Not surprisingly, rumors about the island and its work have swirled for decades. Like all the other biodefense laboratories, it maintains a heavy biosecurity and biosafety culture.”

Stories You May Have Missed:

  • Highly Resistant Malaria Spreading Rapidly in Southeast Asia – “An aggressive strain of drug-resistant malaria that originated in Cambodia has rapidly spread into neighboring countries, causing high rates of treatment failure to first-line treatment and complicating efforts to eliminate the disease, according to two studies published yesterday in The Lancet Infectious Diseases. One of the studies found that the KEL1/PLA1 strain of Plasmodium falciparum, the parasite that causes malaria, now accounts for more than 80% of the malaria parasites in northeastern Thailand and Vietnam, and has acquired new genetic mutations that have enhanced its fitness and ability to resist treatment. The strain is resistant to dihydroartemisinin-piperaquine, a form of artemisinin-based combination therapy (ACT) that has been the first-line treatment for malaria in Cambodia for more than a decade, and was more recently adopted as the preferred treatment in Thailand and Vietnam.”
  • Outbreak of Chapare-like Virus in Bolivia– “On June 28, 2019, the Bolivian Ministry of Health received notice of three cases of hemorrhagic fever syndrome. Two additional cases have since been reported. Current evidence suggests that the etiologic agent is Chapare virus or a similar virus, according to the US CDC”.

 

Pandora Report 7.19.2019

Ebola Outbreak Updates- From PHEIC Declaration to Vaccines 
On Wednesday, the WHO declared the outbreak a PHEIC (Public Health Emergency of International Concern). “‘It is time for the world to take notice and redouble our efforts. We need to work together in solidarity with the DRC to end this outbreak and build a better health system,’ said Dr. Tedros. ‘Extraordinary work has been done for almost a year under the most difficult circumstances. We all owe it to these responders — coming from not just WHO but also government, partners and communities — to shoulder more of the burden.’ The declaration followed a meeting of the International Health Regulations Emergency Committee for EVD in the DRC. The Committee cited recent developments in the outbreak in making its recommendation, including the first confirmed case in Goma, a city of almost two million people on the border with Rwanda, and the gateway to the rest of DRC and the world.” A new case of Ebola has been identified in the city of Goma, which represents what the WHO is calling “a game-changer” since the city is a major transportation hub. On July 11th, it was announced that “the Democratic Republic of the Congo (DRC) ministry of health and government officials have agreed that Merck’s rVSV-ZEBOV is the only vaccine that will be used during the current, ever-growing Ebola outbreak in North Kivu and Ituri provinces. ‘Due to the lack of sufficient scientific evidence on the efficacy and safety of other vaccines as well as the risk of confusion among the population, it was decided that no clinical vaccine trials will be allowed throughout the country,’ the ministry said in its daily update yesterday. As of yesterday, a total of 158,830 people have been vaccinated with rVSV-ZEBOV, which clinical data suggest has as high as a 97.5% effectiveness rate against the virus.”

Trump Administration Gutting WMD Detection Programs
Despite 2017 pledges to secure, eliminate, and prevent the spread of WMD and related materials, a new investigation has found that such efforts through the Department of Homeland Security, have been drastically impacted. “Among the programs gutted since 2017, however, was an elite Homeland Security ‘red team,’ whose specialists conducted dozens of drills and assessments around the country each year to help federal, state and local officials detect such potential threats as an improvised nuclear device concealed in a suitcase, or a cargo ship carrying a radiation-spewing ‘dirty bomb.’ Another Homeland Security unit, the Operations Support Directorate, had helped lead up to 20 WMD-related training exercises each year with state and local authorities. The directorate participated in less than 10 such exercises last year and even fewer so far this year, according to internal Homeland Security documents.” The Homeland Security’s National Technical Nuclear Forensics Center has also seen a hit as their leadership is out and staffing has dropped from 14 to 3. “A separate Homeland Security component, the International Cooperation Division, which worked closely with foreign counterparts and the United Nations nuclear watchdog agency to track and stop the smuggling of dangerous nuclear materials overseas, has been disbanded.” “Homeland Security also has halted work to update a formal ‘strategic, integrated’ assessment of chemical, biological and nuclear-related risks.” The investigation also notes that more than 100 scientists and policy experts who specialize in radiological and nuclear threats, have either been reassigned or pushed into jobs that are wholly unrelated to their works. ‘The changes have undermined the U.S. government’s multi-agency commitment since 2006 to build and maintain a ‘global nuclear detection architecture,’ according to the present and former officials.”

 Weaponized Ticks, Lyme Disease, and the Smith Amendment
Remember that time a conspiracy-theory book triggered an investigation into whether the DoD ever weaponized ticks? Well here we are…. Earlier this week the US House of Representatives voted on the Smith Amendment on Bioweaponization of Ticks – and it passed. A lot of this stems from stories of Plum Island and the whispers that Lyme disease actually originated from the testing site and ticks were either intentionally or accidentally released into the surrounding areas…triggering the disease a few decades ago. Since the release of a book on the “secret history of Lyme disease and biological weapons”, there’s been a renewed interest in the bedtime story of the disease’s sinister origin story. Unfortunately, the proposed investigation really doesn’t hit the nail on the head. For one, it’s been widely known for years that ticks, among other vectors, were a part of the bioweapons and biodefense research. Two, the “smoking gun” within the book that’s been used to reinvigorate interest, claims an interview with Dr. Willy Durgdorfer (the researcher who identified Lyme disease) gave confirmation of the true origin of the disease….alas, this was reported post-mortem, when he was not able to confirm or deny such statements. Third, Lyme disease actually has some pretty old origins. Last, but not least, this new amendment doesn’t even touch on Lyme disease…but rather focuses on if the DoD did experiments with insects and vectors as disease delivery systems…which we already know to be true. Ultimately, this does a disservice to not only the people with Lyme disease, but also encourages conspiracy theories.

Using “Outbreak Science” to Strengthen Usage of Models in Epidemics
If you’ve been on the frontlines of an outbreak, you’ve likely heard of disease modeling…but sometimes it can be hard to actually apply this technology to drive change. A new article has created “outbreak science” as an inter-disciplinary field to apply epidemic modeling in a way that can really help. “Nevertheless, the integration of those analyses into the decision-making cycle for the Ebola 2014–2016 epidemic was not seamless, a pattern repeated across many recent outbreaks, including Zika. Reasons for this vary. Modeling and outbreak data analysis efforts typically occur in silos with limited communication of methods and data between model developers and end users. Modeling “cross talk” across stakeholders within and between countries is also typically limited, often occurring within a landscape of legal and ethical uncertainty. Specifically, the ethics of performing research using surveillance and health data, limited knowledge of what types of questions models can help inform, data sharing restrictions, and the incentive in academia to quickly publish modeling results in peer-reviewed journals contribute to a complex collaborative environment with different and sometimes conflicting stakeholder goals and priorities. To remedy these challenges, we propose the establishment of ‘outbreak science’ as an inter-disciplinary field to improve the implementation of models and critical data analyses in epidemic response. This new track of outbreak science describes the functional use of models, clinical knowledge, laboratory results, data science, statistics, and other advanced analytical methods to specifically support public health decision making between and during outbreak threats. Outbreak scientists work with decision makers to turn outbreak data into actionable information for decisions about how to anticipate the course of an outbreak, allocate scarce resources, and prioritize and implement public health interventions. Here, we make three specific recommendations to get the most out of modeling efforts during outbreaks and epidemics.” From establishing functional model capacity and fostering relationships before things happen to investing in functional model capabilities, this guide could be a game-changer for outbreak response.

Building a Case of (non?)compliance Concern
Looking for a new book? Check out this review of Biosecurity in Putin’s Russia – “In the early 1990s, the world was rocked when defectors from the Soviet Union revealed the existence of a massive civilian and military biological-weapons program that had employed more than 65,000 people from 1928 to 1992, directly contravening the 1972 Biological and Toxin Weapons Convention (BWC). In 2012, Raymond Zilinskas, a leading biological- weapons expert, coauthored with Milton Leitenberg a comprehensive account of the program, The Soviet Biological Weapons Program: A History, a reference source so thorough that it ran to nearly a thousand pages. Last year, Zilinskas, in collaboration with Philippe Mauger, produced Biosecurity in Putin’s Russia, a sequel of sorts in which the cautionary note that Zilinskas and Leitenberg sounded earlier—that Russia’s relationship with biological weapons remained complicated, and that the current status of its old programs could not be verified—proved to have been foreshadowing.”

Modeling the Complexities of the Gut for Biodefense Application
“The Nutritional Immunology and Molecular Medicine Laboratory (NIMML), with research funding assistance from the Defense Threat Reduction Agency (DTRA), has developed a high-resolution model of the gut immune system to help solve emerging and re-emerging infectious diseases and biodefense challenges. The advanced model predicts new emerging behaviors and responses to biological threats. The gut ecosystem includes trillions of interactions between host epithelial and immune cells, molecules (cytokines, chemokines and metabolites) and microbes is a massively and dynamically interacting network, like a multidimensional jigsaw puzzle with pieces that are constantly changing shape. These interactions with cooperativity and feedback lead to nonlinear dynamics and unforeseen emergent behaviors across spatiotemporal scales. The NIMML agent-based modeling (ABM) of the gut uses an array of HPC-driven advanced computational technologies such as the ENteric Immunity SImulator (ENISI) – multiscale modeling (MSM). These models and tools simulate cell phenotype changes, signaling pathways, immune responses, lesion formation, cytokine, chemokine and metabolite diffusions, and cell movements at the gut mucosa.”

Radiation Injury Treatment Network Meeting 
Are you attending this event later this month? If so, check out GMU Biodefense doctoral student Mary Sproull discussing Radiation Biodosimetry – A Mass Screening Tool for Radiological/Nuclear Events.

MERS-CoV Clusters
New WHO insight into 14 cases has identified 2 clusters that involved 4 of the infected people. “Of the 14 patients, 3 had been exposed to camels, a known risk factor for contracting the virus. Ten were men and four were women, and patient ages ranged from 22 to 80. Eleven had underlying health conditions, which is a risk factor for MERS. Ten were from Riyadh region, with other cases reported from Jeddah, Medina, Najran, and Al Qassim. One of the clusters involved two people living in the same household in Al Kharj in Riyadh region, a 22-year-old woman who had diabetes and epilepsy and a 44-year-old woman who had no underlying health conditions. The other cluster consisted of a 65-year-old male patient and a 23-year-old female healthcare worker in Riyadh. Five of the people died from their infections.”

CDC Announces E Coli Outbreak Linked to Ground Bison
Put down your bison burger and take a slow step back….”The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) have announced that they are collaborating with the Canadian Food Inspection Agency to investigate a multistate outbreak of E coli O103 and E coli O121 infections. Early epidemiologic and traceback information point to ground bison products as the likely source of the outbreak. As of July 12, 2019, there have been 21 individuals infected with E coli in this outbreak. In total, 6 individuals have been infected with the O103 strain, 13 cases of the O121 strain have been confirmed, and 2 individuals have been found to be infected with both strains.”

Stories You May Have Missed:

  • Polio in Pakistan – “The Global Polio Eradication Initiative (GPEI) today reported nine new cases of wild poliovirus type 1 (WPV1), and, for the first time in more than a year, China has confirmed a case of vaccine-derived poliovirus. In addition, Angola has a new circulating vaccine-derived poliovirus type 2 (cVDPV2) case. The Pakistan patients reported symptom onset on dates ranging from May 28 to Jun 20. The total number of WPV1 cases recorded in Pakistan this year is now 41; last year, the country recorded 12 cases over the entire year. Five of the nine cases originated in Bannu province, where health workers have been targeted by anti-vaccine extremists.”
  • Food Defense and Intentional Adulteration Rule Training – “The Food Protection and Defense Institute is hosting a Food Defense and Intentional Adulteration Rule training on August 20-21 in Minneapolis, MN. This two-day course provides the convenience and interaction of a single, in person class to more comprehensively learn the breadth and interconnections of IA Rule requirements including how to: Prepare a Food Defense Plan Conduct vulnerability assessments including the full FSPCA Intentional Adulteration, Conducting Vulnerability Assessment Course (IAVA) Identify and explain mitigation strategies, Conduct reanalysis”

Pandora Report: 7.12.2019

 Summer Workshop Welcomes New Instructor
We’re excited to announce that Nancy Connell will be joining us for the Summer Workshop on Pandemics, Bioterrorism, and Global Health Security next week. Dr. Connell “is a Senior Scholar at the Johns Hopkins Center for Health Security and a visiting Professor in the Department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health. She is a microbial geneticist by training. Dr. Connell’s work at the Center is focused on advances in life sciences and technology and their application to a number of developments in the areas of biosecurity, biosafety and biodefense.  Her research projects analyze novel biotechnologies that might impact the development of Global Catastrophic Biological Risks (GCBR) in ecosystems, and the development of surge capacity for medical countermeasure manufacturing and other response mechanisms in the event of a global pandemic or other global catastrophic event.  Dr. Connell is a member of the Board on Life Sciences and is a National Associate of the National Academies of Sciences, and she completed a six-month sabbatical as Visiting Scholar at the Board on Life Sciences.  Dr. Connell is a member of the US-CDC’s Biological Agent Containment Working Group in the Office of Public Health Preparedness and Response and was recently appointed the serve on the National Science Advisory Board for Biosecurity. Before joining the Center, Dr. Connell was Professor and Director of Research in the Division of Infectious Disease in the Department of Medicine at Rutgers New Jersey Medical School and the Rutgers Biomedical Health Sciences.  Dr. Connell’s major research focus was antibacterial drug discovery in respiratory pathogens such as M. tuberculosis and B. anthracis. Dr. Connell chaired the Institutional Biosafety Committee of Rutgers University and directed NJMS’s biosafety level three containment laboratory beginning in 1997. Her recent work focused on the use of predatory bacteria as novel therapeutics for treatment of Gram negative bacterial infections, including MDR strains and select agents. Dr. Connell was continuously funded by the NIH, the Department of Defense and DARPA, industry, and/or other sources from 1992 to 2018.  She received a PhD in microbial genetics from Harvard University.” If you’re not able to make the workshop next week, keep an eye on the @PandoraReport twitter for updates.

Is the U.S. Ready for A Tech War?
GMU Biodefense doctoral alum Daniel Gerstein discusses technological priorities and how the US invests in technological advances related to national security. “Today, important technology development changes are underway that could dramatically affect world order. The continued shift in global research and development spending highlights how far U.S. dominance has eroded. In 1960, when considering federal, industry and academia, the United States accounted for 69 percent of the global R&D. By 2016, the United States accounted for only 28 percent of the global R&D. With such a shift, it is no wonder that U.S. technology leadership and superiority can no longer be assured.” Gerstein notes that “the Trump administration should develop technology priorities, and technologies considered vital to U.S. economic and national security should receive investments to stimulate advances and promote U.S. leadership. The administration’s recent call to have greater industry investment in basic research, in lieu of government funding, seems shortsighted and should be reconsidered given the emerging tech war. A reevaluation of programs such as export controls, programs for approving foreign investment transactions, and intellectual property protections would also be useful to both protect and promote U.S. technology.”

Ebola Outbreak – Cases Surge with Violence – and How the CDC Made a Synthetic Ebola Virus to Test Treatments
Recently, the WHO Director General, Dr. Tedros, warned that instability in the DRC is fueling the Ebola outbreak. “In an interview with The Guardian, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus, PhD, said the political climate in the Democratic Republic of the Congo (DRC) is preventing an end to the current Ebola outbreak. ‘The root cause of the problem is lack of peace, the lack of a political solution. The incidence of Ebola, malaria and cholera is the symptom,’ Tedros told the British newspaper. ‘I know we can finish this Ebola outbreak…But at the same time it can come back because all the [political and security] conditions remain the same.’ The DRC outbreak expanded by 10 cases today, to 2,428 cases, according to the WHO’s online Ebola dashboard. Tedros’s comments come 1 day after the UK’s International Development Secretary, Rory Stewart, returned from a trip to the DRC and called on G7 world leaders to increase funding for outbreak response. ‘There is a real danger, that if we lose control of this outbreak, it could spread beyond DRC’s borders to the wider region and the wider world. Diseases like Ebola have no respect for borders and are a threat to us all,’ Stewart said in a Department for International Development (DID) news release.” Ebola has been challenging response efforts since 2013 and the CDC has been working to combat testing and treatment roadblocks through a unique strategy – a synthetic Ebola virus. Helen Branswell recently discussed how the CDC created a synthetic version of the Ebola virus to help guide diagnostic tests and experimental treatments…and it ended up working. “The research, conducted in the agency’s most secure laboratories — BSL4 — showed that even though the tests and two of the treatments being used in the field were developed based on earlier variation of Ebola viruses, they continue to be effective against the virus causing the current outbreak, the second largest on record. The results, reported Tuesday in the journal Lancet Infectious Diseases, are encouraging, but also raise questions about why outside research groups have not received direct access to viral specimens from the DRC and instead had to create a synthetic version. The paper noted that there have been no Ebola samples available to the scientific community from the past four outbreaks in the DRC. Those outbreaks occurred in 2014, 2017, and 2018.”

Mason Hosts Department of Homeland Security Centers of Excellence 2019 Summit 
“George Mason University will host Homeland Security Challenges: Evolving Threats and Dynamic Solutions, a Department of Homeland Security Centers of Excellence Summit, July 31-Aug. 1 at its Arlington Campus. The summit is an opportunity to gather some of the nation’s best academic, public, and private sector leaders to discuss strategies for advancing the DHS mission. Sponsored through the DHS Science and Technology Directorate Office of University Programs, the Department of Homeland Security Centers of Excellence network is a consortium of universities conducting groundbreaking research to address homeland security challenges by developing multidisciplinary, customer-driven, homeland security science and technology solutions and helping train the next generation of homeland security experts. The summit provides a platform for creating connections, fostering collaborations and inspiring new ideas to address homeland security challenges. It also provides an opportunity to highlight student research and innovative problem solving.”

ASPR Updates- the SNS and Biodefense Strategy Summit 
The Office of the Assistant Secretary for Preparedness and Response (ASPR) just released several good resources for the biodefense community. First, they’re celebrating the 20th anniversary of the Strategic National Stockpile (SNS) and you can find some great information on it here. “When state, local, tribal, and territorial responders request federal assistance to support their response efforts, the stockpile ensures that the right medicines and supplies get to those who need them most during an emergency. Organized for scalable response to a variety of public health threats, this repository contains enough supplies to respond to multiple large-scale emergencies simultaneously.” Next, ASPR provided the transcripts from the Biodefense Summit that occurred in April. “The Biodefense Summit, was held on April 17, 2019 in Washington, D.C.  The Summit aimed to engage the biodefense stakeholder community to inform national biodefense enterprise efforts to counter biological threats, reduce risk, prevent, prepare for, respond to, and recover from biological incidents. The Summit informed stakeholders of the implementation of the National Biodefense Strategy. “

Arizona Battles Hepatitis A
Arizona is working to contain an outbreak of hepatitis A and GMU biodefense doctoral student Saskia Popescu discusses how they’re incorporating healthcare providers into these efforts. “Despite making great strides in reducing the burden of HAV, Arizona is experiencing a growing outbreak that began in late 2018. Currently, there have been 424 cases and 3 deaths documented since November 2018, with a 79% hospitalization rate. The outbreak has spread to 7 counties within Arizona, including the largest—Maricopa. A total of 48% of Arizona’s HAV cases have occurred in those individuals who are homeless and report drug use, 25% of cases have been in those reporting using drugs (ie, no reported homelessness), and 22% of cases are in individuals with no identified risk factors. Public health investigators found that 28% of the cases have been in patients who are currently or were recently incarcerated. Five percent of the HAV cases in this ongoing Arizona outbreak have been reported in patients who report homelessness, but no drug use.  More recently, an employee at a restaurant in Maricopa County tested positive for HAV and may have exposed people visiting the restaurant over a 9-day period from late May to June. Public health officials are encouraging those patrons to get vaccinated against HAV to reduce the risk of transmission.”

Worldwide Reduction in MERS-CoV Cases Since 2016
In the latest CDC Morbidity and Mortality Weekly Report, they note the overall decline in MERS-CoV cases and mortality since 2016. “From 2012 through May 31, 2019, Middle East respiratory syndrome coronavirus (MERS-CoV) has infected 2,442 persons and killed 842 worldwide. MERS-CoV is currently circulating in dromedary camels in Africa, the Middle East, and southern Asia; however, most cases of human infection have been reported in the Arabian Peninsula. Large hospital outbreaks in 2014 and 2015 motivated affected countries to substantially invest in prevention and control activities. To estimate the potential number of MERS cases and deaths that might have been averted since 2016 had the risk levels of 2014–2015 continued, we analyzed case-based data on laboratory-confirmed human cases of MERS-CoV infections reported to the World Health Organization. We categorized cases as either secondary (human-to-human transmission) or community-acquired (presumed camel-to-human transmission). In addition, we used case-based data on date of onset (for symptomatic infections) or report (for asymptomatic infections), outcome (died/recovered), and dates and sizes of reported clusters of human-to-human–transmission cases”.

Self-destructing Mosquitoes and Sterilized Rodents: the Promise of Gene Drives
What might the consequences of this novel biotech be? In the face of potential eradication of disease and alteration of an entire animal population’s genome, researchers have very real concerns. “As soon as researchers began to make gene drives regularly in labs, animals developed resistance against them — accumulating mutations that prevented the drives from spreading. In tests of two drives inserted into fruit flies, for example, genetic variants conferring resistance formed frequently. Most commonly, mutations alter a sequence that CRISPR is set to recognize, preventing the gene from being edited. In experiments with caged mosquitoes, Crisanti and Target Malaria researcher Tony Nolan watched a gene drive gradually decrease in frequency over multiple generations owing to resistant mutations at the target gene. The results rocked the field. Would resistance render gene drives impotent? Not necessarily — if researchers select the right target. Some genes are highly conserved, meaning that any change is likely to kill their owners. Picking these genes as a drive target means fewer mutations and less resistance. In September 2018, Crisanti and his team crashed a population of caged Anopheles gambiae mosquitoes with 100% efficiency by making a drive that disrupts a fertility gene called doublesex. With the drive in place, female mosquitoes cannot bite and do not lay eggs; within 8–12 generations, the caged populations produced no eggs at all. And because it is crucial for procreation, doublesex is resistant to mutations, including those that would confer resistance to a drive construct.” “Before Kevin Esvelt ever built a single CRISPR-based gene drive, he’d wake up in cold sweats thinking about the ramifications. ‘I realized, oh hey, this isn’t just going to be about malaria, this is potentially going to be something any individual who can make a transgenic fruit fly could build to edit all the fruit flies.’”

Stories You May Have Missed:

  • UK Works to Test New Payment Model for Antibiotics – “In an effort to stimulate the development of new antibiotics, Britain’s National Health Service (NHS) yesterday announced the launch of a trial for a new pilot program that will pay drug companies for antibiotics using a subscription-style model. Under the program, NHS will pay pharmaceutical companies up front for access to effective antibiotics, rather than reimbursing them based on the quantity of antibiotics sold. The idea behind the program is to delink profit from the volume sold, pay for antibiotics based on their public health value, and encourage the development of new antibiotics.”