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.”

Pandora Report: 6.28.2019

Summer Workshop – Early Registration Discount Ends Soon
Just a few more days to get your early registration discount and we’ve only got a few spots left – make sure to grab yours! We’re excited to have top professionals and researchers in the health security field speak to the biological threats we’re facing- from securing the bioeconomy to vaccine development and pandemic preparedness, you’ll want to be there for the 3.5 days of all things pandemics, bioterrorism, and global health security.

Re-thinking Biological Arms Control for the 21st Century
Dr. Filippa Lentzos discusses the challenges of biological arms control in the face of synthetic biology and technological advances. “Innovations in biotechnology are expanding the toolbox to modify genes and organisms at a stagger- ing pace, making it easier to produce increasingly dangerous pathogens. Disease-causing organisms can now be modified to increase their virulence, expand their host range, increase their transmissibility, or enhance their resistance to therapeutic interventions. Scientific advances are also making it theoretically possible to create entirely novel biological weapons, by synthetically creating known or extinct pathogens or entirely new pathogens. Scientists could potentially enlarge the target of bioweapons from the immune system to the nervous system, genome, or microbiome, or they could weaponize ‘gene drives’ that would rapidly and cheaply spread harmful genes through animal and plant populations.” Lentos notes that “The political backdrop to these technical advances in biotechnologies and other emerging technologies is also important. There is increased worldwide militarization, with global military spending at an all-time high since the fall of the Berlin Wall. Unrestrained military procurement and modernization is creating distrust and ex- acerbating tensions. In the biological field, the proliferation of increasingly sophisticated biodefense capacities, within and among states, can lead to nations doubting one another’s intentions.”

GAO – Biodefense: The Nation Faces Long-Standing Challenges Related to Defending Against Biological Threats
The GAO testified before a House committee on their efforts to identify and strengthen U.S. biodefense and here are their overall findings in a report. Despite President Trump signing off on the Pandemic and All-Hazards Preparedness and Advancing Innovations Act (PAHPA) on Monday, there is still a lot of work to be done. “Catastrophic biological events have the potential to cause loss of life, and sustained damage to the economy, societal stability, and global security. The biodefense enterprise is the whole combination of systems at every level of government and the private sector that contribute to protecting the nation and its citizens from potentially catastrophic effects of a biological event. Since 2009, GAO has identified cross-cutting issues in federal leadership, coordination, and collaboration that arise from working across the complex interagency, intergovernmental, and intersectoral biodefense enterprise. In 2011, GAO reported that there was no broad, integrated national strategy that encompassed all stakeholders with biodefense responsibilities and called for the development of a national biodefense strategy. In September 2018, the White House released a National Biodefense Strategy. This statement discusses GAO reports issued from December 2009 through March 2019 on various biological threats and biodefense efforts, and selected updates to BioWatch recommendations made in 2015. To conduct prior work, GAO reviewed biodefense reports, relevant presidential directives, laws, regulations, policies, strategic plans; surveyed states; and interviewed federal, state, and industry officials, among others.” GAO identified several challenges in the ability for the U.S. to defend against biological threats: “Assessing enterprise-wide threats. In October 2017, GAO found there was no existing mechanism across the federal government that could leverage threat awareness information to direct resources and set budgetary priorities across all agencies for biodefense. GAO said at the time that the pending biodefense strategy may address this. Situational awareness and data integration. GAO reported in 2009 and 2015 that the Department of Homeland Security’s (DHS) National Biosurveillance Integration Center (NBIC)—created to integrate data across the federal government to enhance detection and situational awareness of biological events—has suffered from longstanding challenges related to its clarity of purpose and collaboration with other agencies. DHS implemented GAO’s 2009 recommendation to develop a strategy, but in 2015 GAO found NBIC continued to face challenges, such as limited partner participation in the center’s activities. Biodetection technologies. DHS has faced challenges in clearly justifying the need for and establishing the capabilities of the BioWatch program—a system designed to detect an aerosolized biological terrorist attack. In October 2015, GAO recommended that DHS not pursue upgrades until it takes steps to establish BioWatch’s technical capabilites. While DHS agreed and described a series of tests to establish capabilities, it continued to pursue upgrades. Biological laboratory safety and security. Since 2008, GAO has identified challenges and areas for improvement related to the safety, security, and oversight of high-containment laboratories, which, among other things, conduct research on hazardous pathogens—such as the Ebola virus. GAO recommended that agencies take actions to avoid safety and security lapses at laboratories, such as better assessing risks, coordinating inspections, and reporting inspection results. Many recommendations have been addressed, but others remain open, such as finalizing guidance on documenting the shipment of dangerous biological material.”

ABSA 1st International Biosecurity Symposium Call for Papers
“You are now able to submit papers for ABSA’s 1st International Biosecurity Symposium. The symposium will take place May 12-15, 2020 in Minneapolis, Minnesota. We anticipate having attendees from all over the world and approximately 20 commercial exhibits. The professional development courses will take place Tuesday, May 12, 2020. The symposium presentations (platform/poster) will take place Wednesday, May 13 to Friday, May 15, 2020. The Call for Platform/Posters Abstract submission deadline is July 31, 2019 at 5pm Central.”

Blue Ribbon Panel – U.S. Is Not Prepared for Biological Incidents – Testimony
June 26th- “Dr. Asha George, Executive Director of the Blue Ribbon Study Panel on Biodefense, served as an expert witness this afternoon before the House Oversight and Reform Subcommittee on National Security. Chaired by Rep. Stephen Lynch (MA), the Subcommittee is evaluating the readiness of the U.S. government and healthcare system, including hospital and emergency professionals, to respond to naturally occurring pandemics and biological attacks that could be perpetrated by state and non-state actors. The Subcommittee also is investigating the growing threat of antimicrobial-resistance, as well as the implications of this challenge for U.S. national security. ‘Our Panel has assessed and continues to assess the state of our country’s biodefense. We scrutinize the status of prevention, deterrence, preparedness, detection, response, attribution, recovery, and mitigation – the spectrum of activities necessary for biodefense,’ said Dr. George. ‘As expected, we found both strengths and weaknesses, including serious gaps that four years after the release of our Panel’s Blueprint for Biodefense in 2015 continue to make the nation vulnerable. In short, the nation is not prepared for biological outbreaks, bioterrorist attacks, biological warfare, or accidental releases with catastrophic consequences’.” This is especially relevant as many are wondering what Congress is doing to respond to health security threats.

Ebola Outbreak – Updates
As of Wednesday, the outbreak has reached 2,277 cases and security threats are increasingly making response efforts challenging. “In its weekly situation report on the outbreak, the WHO said Ebola activity continues with steady and sustained intensity, with security incidents returning to Beni—one of the outbreak’s former major hot spots—and armed group movements in Musienene and Manguredjipa impeding access to a health area next to Mabalako’s hardest-hit area. Another concern it aired is a tense security situation in neighboring Ituri province cities Bunia and Komanda in the wake of attacks in early June. Over the past few weeks, indicators show hints of easing transmission intensity in the two biggest recent epicenters, Katwa and Butembo. However, the optimism is offset by new cases in previously affected areas, including Komanda, Lubero, and Rwampara. For example, over the past week, Komanda reported its first case after going 11 days without one.”

A Dose of Inner Strength to Survive and Recover from Potentially Lethal Health Threats
“Breakthroughs in the science of programmable gene expression inspired DARPA to establish the PReemptive Expression of Protective Alleles and Response Elements (PREPARE) program with the goal of delivering powerful new defenses against public health and national security threats. DARPA has now selected five teams to develop a range of new medical interventions that temporarily and reversibly modulate the expression of protective genes to guard against acute threats from influenza and ionizing radiation, which could be encountered naturally, occupationally, or through a national security event. The program builds from the understanding that the human body has innate defenses against many types of health threats, but that the body does not always activate these defenses quickly or robustly enough to block the worst damage. To augment existing physiological responses, PREPARE technologies would provide a programmable capability to up- or down-regulate gene expression on demand, providing timely, scalable defenses that are proportional to anticipated threats. Service members and first responders could administer these interventions prior to threat exposure or therapeutically after exposure to mitigate the risk of harm or death.”

Global Community Bio Summit 3.0
From October 11-13, you can attend this community biotechnology initiative at MIT Media Lab. “The Community Biotechnology Initiative at the MIT Media Lab is organizing the third annual Global Summit on Community Biotechnology this October 11 to 13, 2019! Our goal is to provide a space for the global community of DIY biologists / community biologists / biohackers / biomakers and members of independent and community laboratories to convene, plan, build fellowship, and continue the evolution of our movement. You can learn more about last year’s Summit, including our program, here. While all are welcome, space is limited, so we are prioritizing active practitioners in the community with an emphasis on diversity across geographic, cultural, ethnic, gender, and creative backgrounds. We will add accepted participants to the directory on a rolling basis with the goal of accepting everyone interested in joining.”

Stories You May Have Missed:

  • Tackling Dirty Sinks – Did you ever think your hospital sink could be a disease reservoir? “Earlier this year, there were studies that identified sink proximity to toilets as a risk factor for contamination. Bugs like Klebsiella pneumoniae carbapenemase-producing organisms tend to be prolific in moist environments and are often pervasive in intensive care unit sinks and drains. Researchers found that sinks near toilets were 4-times more likely to host the organisms than those further from toilets. More and more, infection prevention is having to look at hospital faucets and sinks for their role in hosting microbial growth. This was also a topic of interest at last week’s annual conference of the Association for Professionals in Infection Control and Epidemiology (APIC 2019). Investigators with the University of Michigan Health System discussed how they worked to identify vulnerabilities and potential sink designs that might contribute to bioburden and biofilm in hospital faucets. Assessing 8 different designs across 4 intensive care units, the research team ultimately found that those sinks with a more shallow depth tended to allow higher rates of contamination (ie, splash of dirty water) onto equipment, surfaces, and patient care areas. In some instances, the splash of contaminated water could be found up to 4 feet from the sink.”

 

Pandora Report 11.16.2018

We’re back from the 5th Ministerial Meeting of the Global Health Security Agenda (GHSA)! We’ll be reporting out on this event in the coming weeks, so keep an eye out for all things GHSA. Influenza season is ramping up and you’ll want to check out the latest article on looking beyond the decade of vaccines.

Preventing Pandemics and Bioterrorism: Past, Present, and Future
We’re just weeks away from this exciting event – are you registered? Preventing Pandemics and Bioterrorism: Past, Present, and Future is a special event in celebration of the 15th anniversary of the George Mason University Biodefense Program at the Schar School of Policy and Government. We invite you to attend this exciting opportunity to hear from Dr. Kadlec of ASPR about lessons learned for pandemic preparedness since the 1918-1919 influenza pandemic, plans for implementing the new National Biodefense Strategy, and the importance of education for the future of biodefense. Following his speech and Q&A session, you are invited to an informal reception for academic and professional members of the biodefense community to socialize and network. Make sure to RSVP soon as seats are limited for this December 4th event.

Russian Disinformation & the Georgian “Lab of Death”
A recent BBC investigation has found some disturbing information regarding Russian media making false claims about a U.S.-funded lab in Georgia. “The Russian Foreign Ministry, Defence Ministry and pro-Kremlin media claimed recently that untested drugs were given to Georgian citizens at the lab, resulting in a large number of deaths. The US has accused Russia of disinformation in order to distract attention away from incidents such as the Salisbury poisonings.” This episode is part of a series the BBC is providing on disinformation and fake news.

Ebola Outbreak Updates
The Ebola virus disease outbreak in the DRC continues to grow. 15 cases were reported on Monday as well as another violent attack in Beni. “WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said on Twitter that he had been briefed on a violent attack that occurred in Beni on the night of Nov 10. ‘All WHO staff safe, but my heart goes out to families who have lost loved ones in this appalling and unacceptable attack, which we condemn in the strongest terms,’ he wrote. According to a local media report translated and posted by H5N1 Blog, which focuses on infectious disease news, at least five civilians were killed and several children kidnapped in an attack by rebels with the Allied Democratic Forces (ADF) in Beni’s Mayimoya district. The report said two other people were killed in two other attacks the same day in Beni’s Runwenzori neighborhood, one linked to ADF rebels and the other by suspected Mai Mai militia members.” The latest situation report lists 333 cases and 209 deaths, with 31 new confirmed cases reported during the reporting period (Nov 5-11). Early this morning, the DRC announced three more cases and 1 death. Health officials are also reportedly planning to launch a clinical trial of three antibody treatments and an antiviral drug, within the area. These drugs are currently in utilization in the Ebola treatment centers within the area but only under compassionate use. The UK is contributing funds to help Uganda step up prevention and preparedness efforts as well. “On a recent visit to The Medical Research Council/Uganda Virus Research Institute (URVI) and the London School of Hygiene and Tropical Medicine Research Unit in Entebbe, UK Minister for Africa Harriett Baldwin announced that the UK will support Uganda’s National Task Force with up to £5.1 million ($6.6 million USD) to support Ebola preparedness and prevention efforts in Uganda. This funding will support surveillance in high-risk districts at the border with the Democratic Republic of Congo (DRC); risk reduction communication in communities; infection prevention and control measures as well as provide for improved case management.” Peter Salama, WHO Emergency Response Chief, has noted that the outbreak could last another six months – “It’s very hard to predict timeframes in an outbreak as complicated as this with so many variables that are outside our control, but certainly we’re planning on at least another six months before we can declare this outbreak over,”.

ELBI Fellowship Application Opens
The Emerging Leader for Biosecurity Initiative (ELBI) run by the Center for Health Security is now accepting applications. This is a great opportunity that several Biodefense students have been able to take advantage of for the last several years. GMU Biodefense has had several fellows – Yong-Bee Lim  is currently an ELBI fellow and Saskia Popescu, Siddha Hover, and Francisco Cruz have represented our biodefense program in previous years. If you’re a current GMU biodefense student or alumni and are interested in applying and plan to request a letter of recommendation from the Biodefense program director, please do so ASAP. Dr. Koblentz asks that applicants send a copy of their application materials (personal statement, essay, and current resume or cv) and an unofficial GMU transcript by December 5, 2018.

 One Health in the 21st Century Workshop
The One Health in the 21st Century workshop will serve as a snapshot of government, intergovernmental organization and non-governmental organization innovation as it pertains to the expanding paradigm of One Health. One Health being the umbrella term for addressing animal, human, and environmental health issues as inextricably linked, each informing the other, rather than as distinct disciplines. This snapshot, facilitated by a partnership between the Wilson Center, World Bank, and EcoHealth Alliance, aims to bridge professional silos represented at the workshop to address the current gaps and future solutions in the operationalization and institutionalization of One Health across sectors. The workshop will be held on November 26th at the Wilson Center. You can RSVP here.

USDA ARS 5th International Biosafety & Biocontainment Symposium: Biorisk and Facility Challenges in Agriculture
Registration is open for this February 11, 2019 event! The symposium will provide 2.5 days of scientific presentations and exhibits regarding agricultural biosafety and biocontainment.

WHO Report on Surveillance of Antibiotic Consumption
The WHO has just released their report on global antibiotic consumption and the surveillance methods surrounding efforts to reduce antimicrobial resistance. “Since 2016, WHO has supported capacity building in monitoring antimicrobial consumption in 57 low- and middle-income countries through workshops, trainings and technical support. At this stage, 16 of these countries were able to share their national data with WHO. Other countries are currently in the process of data collection and validation.In total, 64 countries and Kosovo1 contributed data on antibiotic consumption for this report, with the bulk of data coming from the European region and countries with pre- existing, mature surveillance systems. The consumption data showed wide intra- and interregional variation in the total amount of antibiotics and the choice of antibiotics consumed. The overall consumption of antibiotics ranged from 4.4 to 64.4 DefinedDaily Doses (DDD) per 1000 inhabitants per day.”

Stories You May Have Missed:

  • Influenza Vaccine Efficacy Among Patients with High-Risk Medical Conditions in the U.S. – Researchers utilized data from the US Influenza Vaccine Effectiveness Network from 2012-2016 to analyze vaccine effectiveness (VE) “of standard-dose inactivated vaccines against medically-attended influenza among patients aged ≥6 months with and without high-risk medical conditions. Overall, 9643 (38%) of 25,369 patients enrolled during four influenza seasons had high-risk conditions; 2213 (23%) tested positive for influenza infection.Influenza vaccination provided protection against medically-attended influenza among patients with high-risk conditions, at levels approaching those observed among patients without high-risk conditions. Results from our analysis support recommendations of annual vaccination for patients with high-risk conditions.”

 

 

Pandora Report 9.28.2018

Happy Friday biodefense gurus! October is right around the corner, which means the flu vaccine will be available soon. Make sure to get vaccinated this season, as the CDC just announced that 80,000 people died of the flu during the 2017/2018 season, which is the highest death toll in 40 years.

GMU Global Health Security Ambassador
We’re excited to announce that two graduate students from the Schar biodefense program will be attending the 5th GHSA Ministerial Meeting in Bali, Indonesia. The two students, Annette Prieto and Saskia Popescu, will observe the Global Health Security Agenda in action and the the GHSA 2024 planning. Following their attendance in early November, we’ll be providing a report out on the events. Meet our two GMU Global Health Security Ambassadors – Annette Prieto has a background in Microbiology and Immunology and is currently a Biodefense student in the Master’s Program here at George Mason University. Before coming to George Mason, Annette focused on medical Microbiology at the University of Miami before moving into the laboratory and becoming a Teacher’s Assistant. From there, Annette became an Adjunct Instructor at Daytona State College and taught for a year before entering the Biodefense Program. Annette is also a part of the Next Generation Global Health Security Network. Saskia Popescu is a biodefense doctoral candidate at GMU and infection preventionist. She worked as an infection preventionist during the Dallas Ebola cluster, a 2015 measles outbreak, and is an external expert for the ECDC. She is a 2017 ELBI fellow and trained infectious disease epidemiologist. Saskia’s research focuses on the utilization of infection control in the U.S. healthcare system and it’s impact on biodefense. Make sure to check back in the weeks following their trip to learn about their experiences at the ministerial meeting.

Why Poor Pandemic Preparedness is Deadly
Ebola response efforts in the DRC are struggling and were suspended earlier this week, after violence between rebels and armed forces. While outbreak response in Beni have resumed, events like these are a prime example of why outbreaks can quickly spread beyond control and ultimately emphasize the need for pandemic preparedness. Drs. Tom Inglesby and Eric Toner from the Johns Hopkins Center for Health Security recently discussed the importance of investing in biopreparedness and how their Clade-X tabletop revealed many of the existing weaknesses. “Could a natural or man-made pandemic happen today? Yes. New lethal viruses are emerging from nature, and dizzying developments in biotechnology mean that biological weapons no longer are the sole province of a few state-sponsored programs — a manufactured pandemic could be unleashed by a rogue regime or by terrorists utilizing one of the thousands of laboratories around the world capable of making a dangerous pathogen. If the worst-case scenario unfolds, strong pandemic preparedness planning would save millions of lives. But progress is possible only with effective leadership.”

Rebuilding Health Security in the Wake of Ebola
GMU Biodefense graduate student Stephen Taylor discusses the latest talk from Georgetown University on global health security following the 2013-2016 Ebola outbreak. “In the midst of this disaster, the U.S. Centers for Disease Control turned to health security experts at the Georgetown Center for Global Health Science and Security to support the expansion and augmentation of the Guinean public health infrastructure.  Dr. Alpha Barry, Dr. Erin Sorrell, Dr. Claire Standley, and Ms. Aurelia Attal-Juncqua supported on-the-ground efforts to develop and implement improved health security policy that would make Guinea more resilient against future infectious disease outbreaks.  The Guinean government’s priorities for capacity and capability building were to prevent further outbreaks of zoonotic diseases, improve the capacity of surveillance laboratories and capabilities of the healthcare workforce to identify outbreaks, and to better respond to outbreaks by streamlining and coordinating emergency response operations.  On September 14th, 2018, as part of its Global Health Security Seminar Series, Georgetown University hosted a panel discussion of Dr Sorrell, Dr. Standley, and Ms. Attal-Juncqua on their efforts in Guinea.”

 The AMR Challenge
The United Nations (UN) General Assembly was held this week and one particular topic captured our attention – antimicrobial stewardship and a new initiative to combat resistance. “The AMR Challenge is a way for governments, private industries, and non-governmental organizations worldwide to make formal commitments that further the progress against antimicrobial resistance. The challenge encourages a One Health approach, recognizing that the health of people is connected to the health and animals and the environment. The AMR Challenge launches at the United Nations (UN) General Assembly in September 2018. Organizations can make commitments beginning September 25, 2018 until September 2019. CDC will feature commitments throughout the year. At the 2019 UN General Assembly, antimicrobial resistance will continue to be a priority topic for world leaders.” Within the Challenge, there are commitments to tracking and sharing data, reducing the spread of resistant germs through infection prevention and control, improving antibiotic use, decreasing antibiotics and resistance in the environment, and investing in vaccines, therapeutics, and diagnostics.

NASEM – Review & Assessment of Planetary Protection Policy Development Processes
How do we protect the Earth from contamination following space exploration? How can we avoid bringing microorganisms from Earth to other planets and solar system bodies? The latest NASEM report discusses how scientists tackle these issues and implement such policies. As you read the text, you’ll also see one of the Center for Health Security’s ELBI fellows in there – Betsy Pugel of NASA. “For decades, the scientific, political, and economic conditions of space exploration converged in ways that contributed to effective development and implementation of planetary protection policies at national and international levels. However, the future of space exploration faces serious challenges to the development and implementation of planetary protection policy. The most disruptive changes are associated with (1) sample return from, and human missions to, Mars; and (2) missions to those bodies in the outer solar system possessing water oceans beneath their icy surfaces.” This gives new insight into a field we may not be considering in health security – what about interstellar health security?

The Spanish Flu, Epidemics, and the Turn to Biomedical Responses
We already discussed the impact of poor pandemic preparedness, but what about biomedical efforts? A recent article from AJPH discusses the role of the 1918/1919 pandemic in bringing biomedical approaches to the forefront of outbreak response. “A century ago, nonpharmaceutical interventions such as school closings, restrictions on large gatherings, and isolation and quarantine were the centerpiece of the response to the Spanish Flu. Yet, even though its cause was unknown and the science of vaccine development was in its infancy, considerable enthusiasm also existed for using vaccines to prevent its spread. This desire far exceeded the scientific knowledge and technological capabilities of the time. Beginning in the early 1930s, however, advances in virology and influenza vaccine development reshaped the relative priority given to biomedical approaches in epidemic response over traditional public health activities. Today, the large-scale implementation of nonpharmaceutical interventions akin to the response to the Spanish Flu would face enormous legal, ethical, and political challenges, but the enthusiasm for vaccines and other biomedical interventions that was emerging in 1918 has flourished.”

HHS Sponsors TPOXX
Speaking of biomedical measures…the Department of Health and Human Services (HHS) just announced its sponsorship of a new formulation of the world’s first approved smallpox treatment – TPOXX. This purchase will be used for the Strategic National Stockpile and will work with Siga Technologies to develop an IV formulation of the drug. “Purchase of TPOXX in pill form and development of an IV formulation will be completed under a contract between Siga Technologies and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. BARDA will use funding from the Project BioShield Special Reserve Fund. The contract can be extended for up to 10 years and $629 million if necessary to complete development of the IV formulation.”

NASEM – Engaging the Private-Sector Health Care System in Building Capacity to Respond to Threats to the Public’s Health and National Security
Don’t miss the latest NASEM report on the intersection of preparedness and healthcare. From Ebola patients to natural disasters, and even terrorism, the private-sector healthcare system plays a critical role in response. “As a result, disasters often require responses from multiple levels of government and multiple organizations in the public and private sectors. This means that public and private organizations that normally operate independently must work together to mount an effective disaster response. To identify and understand approaches to aligning health care system incentives with the American public’s need for a health care system that is prepared to manage acutely ill and injured patients during a disaster, public health emergency, or other mass casualty event, the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop on March 20 and 21, 2018. This publication summarizes the presentations and discussions from the workshop.”

USDA ARS 5th International Biosafety & Biocontainment Symposium
ABSA has just announced this event being held on February 11-14, 2019 in Baltimore, Maryland. “The focus of the symposium will be Biorisk and Facility Challenges in Agriculture. Seven professional development courses will address topics including life science security, facility maintenance and operational issues, agricultural risk assessment, emergency response and preparedness for livestock disease outbreaks, waste management, and strategic leadership. Courses will be held on Monday, February 11. There will be 2 1/2 days of scientific presentations covering various topics including; governance updates, design methodologies, deferred maintenance, rabies, occ health laboratory to the field, gene editing, risk management and communication, and many others. The poster and networking reception will be held on Wednesday, February 13, attendees will have the opportunity to meet with presenters and discuss their presentations. Exhibits showcasing the latest biosafety, biosecurity, and biocontainment products and services will be open February 12-13.”

Next Generation Biosecurity Webinar 
Don’t miss this webinar today, Friday 9.28, at 11am (CDT, Mexico City). Hosted by Next Generation GHSA, this webinar will be with Luis Alberto Ochoa Carrera, Coordinator of Biosafety and Biochemistry of the GHSN and Coordinator of the Biosafety Laboratory Level 3 of the National Reference Laboratory (InDRE) of Mexico.

Stories You May Have Missed:

  • Airplanes and Airports – Hubs for Germs: GMU biodefense doctoral candidate Saskia Popescu discusses the latest on germ transmission during air travel. “Most people have a general sense that air travel tends to involve exposure to germs. Whether it’s through the thousands of people we will come into contact with, the sick person next to us on the plane, or the dirty surfaces, many of us get a sense of unease knowing there is a real chance we may arrive at our destination with a microscopic companion.”

 

Pandora Report 8.17.2018

Happy Friday fellow biodefense nerds! Welcome to your weekly roundup of all things global health security. If you’re finding yourself a food source for mosquitoes and ticks this summer, just a friendly heads up – the associated diseases are on the rise (hint: climate change may be a big reason).

The Lingering Scare of Smallpox
The recent FDA approval of TPOXX to treat smallpox, a disease eradicated since 1980, has many wondering, especially those of us born in a time where the vaccine was not necessary, why so much attention is being raised. It’s an easy thing to forget – the peril of a disease long since eradicated, but the threat of smallpox is very much still a concern in biodefense. Between the concerns of a laboratory biosecurity/biosafety incident at the two remaining stockpile locations or the chance that a frozen corpse (aka corpsicle) who died of smallpox could defrost as the Arctic permafrost melts. Did I mention the risk of a de novo synthesis like the horsepox one in Canada? These are the reasons we haven’t been able to shake the nightmare that is smallpox. “The greatest threat is advances in synthetic biology, which could permit a rogue lab to re-engineer a smallpox virus. In 2016, researchers in Canada announced that they had created horsepox using pieces of DNA ordered from companies. A synthetic smallpox virus could be even more dangerous than the original, because it could be designed to spread more easily or with ways to survive new therapies.” While we eradicated smallpox and proved that such a feat was possible, there is the painful reality that such efforts left an unvaccinated and inherently vulnerable population.

Biological Events, Critical Infrastructure, and the Economy: An Unholy Trinity
Biodefense graduate student Stephen Taylor is reporting on the latest Blue Ribbon Study Panel. “At its recent meeting about resilience, the Blue Ribbon Study Panel on Biodefense explored the potential impacts of a biological event on critical infrastructure in the United States, as well as the best way to approach risk mitigation.  Ann Beauchesne, former Senior Vice President of the National Security and Emergency Preparedness Department at the U.S. Chamber of Commerce, summed up critical infrastructure as ‘the critical services for our society and the backbone our economy.’  Projected increases in global travel, trade, and development all rely on critical infrastructure, magnifying the potential impact of insults to infrastructure systems.  Concurrently, biological threats are also on the rise. As the world warms and urbanizes, natural infectious disease outbreaks manifest in unexpected places.”

Ebola, Healthcare Workers, and the Pandemic Potential in Vulnerable Countries 
Every day brings news of the Ebola virus disease outbreak along the eastern border of the DRC. On Thursday, cases jumped by seven – one of whom is a healthcare worker. The outbreak is up to 73 cases, 46 of which are confirmed and 27 are probable. 43 deaths have been reported. Nearly a thousand people are under surveillance as contacts of cases and healthcare workers are again, experiencing increased risk of transmission. On Tuesday, it was reported- “that health worker Ebola infections could amplify the current outbreak in the Democratic Republic of Congo (DRC), the country’s health ministry today reported five more confirmed cases, including four involving health workers at a health center in Mangina. The other is a patient recently treated at that facility.” The hope is that the new vaccine can help put an end to the outbreak and curb the risk for healthcare workers. The recent outbreak draws attention yet again, to the inherent danger that infectious disease outbreaks pose in vulnerable countries. We’ve seen how fast and unexpectedly such outbreaks can spread beyond international borders (SARS, MERS, Ebola, etc.), which means that these are global health security issues. The 2013-2016 Ebola outbreak taught us a “great deal about how to respond in a fragile state setting. Traditional leaders and faith leaders played an important role in communicating necessary information and behavior change requirements to isolated groups who did not necessarily trust the government or health care workers.” Preventative measures like stronger public health and healthcare infrastructure can make a world of difference. “Preventative investments can mean the difference between life and death for people in those countries and the difference between an outbreak being contained or becoming an epidemic. As we face repeated outbreaks of infectious diseases, including new pathogens, it is essential that U.S. policy-makers continue funding the operations that make containment possible.”

BWC Meeting of Experts
Don’t miss out on the daily reports from Richard Guthrie on the latest MX. You’ll definitely want to check out days six and seven, where national implementation and preparedness were discussed. How would countries respond to a potential act of bioterrorism? Guthrie notes that “Concerns were raised about whether bodies such as the World Health Organization should be engaged with any assessment of the cause of an outbreak if there were indications it was deliberate in case this brought the health body into the security realm with potential negative consequences for other health work. A number of contributions to the discussion noted that health officials would have different roles to officials looking to attribute the cause of an attack and there was a need to ensure that effective ways of operating together were established. An example of the challenges was given in WP.10 from the USA in the section on ‘preservation of evidence’.” The response and preparedness measures for each country can be complex and challenging when considering the global context of the BWC. For example, Saudi Arabia discussed its own preparedness measures for natural events during times when influxes of people were expected (pilgrimages).

 The Economic Burden of Antimicrobial Resistance and the Drive For Intervention
A recent study enumerated the economic cost of antimicrobial resistance per antibiotic consumed to inform the evaluation of interventions affecting their use. Their model utilized three components – correlation coefficient between human antibiotic consumption and resulting resistance, economic burden of AMR for five key pathogens, and the consumption data for antibiotic classes driving resistance in these organisms. “The total economic cost of AMR due to resistance in these five pathogens was $0.5 billion and $2.9 billion in Thailand and the US, respectively. The cost of AMR associated with the consumption of one standard unit (SU) of antibiotics ranged from $0.1 for macrolides to $0.7 for quinolones, cephalosporins and broad-spectrum penicillins in the Thai context. In the US context, the cost of AMR per SU of antibiotic consumed ranged from $0.1 for carbapenems to $0.6 for quinolones, cephalosporins and broad spectrum penicillins.” Ultimately, they found that the cost of AMR per antibiotic frequently exceeded the purchase cost, which should encourage policy and consumption changes.

NASEM Report: Cooperative Threat Reduction Programs for the Next Ten Years and Beyond
The latest report from the National Academies is now available regarding the Cooperative Threat Reduction (CTR) Program. “The Cooperative Threat Reduction (CTR) Program was created by the United States after the dissolution of the Soviet Union to provide financial assistance and technical expertise to secure or eliminate nuclear weapons delivery systems; warheads, chemical weapons materials, biological weapons facilities, and nuclear, biological, and chemical weapons technology and expertise from the vast Soviet military complex. In a 2009 report, Global Security Engagement: A New Model for Cooperative Threat Reduction, the National Academy of Sciences (NAS) recommended adoption of a modified approach to thinking about CTR, including the expansion of CTR to other countries and specific modifications to CTR programs to better address the changing international security environment.” The report has insight from some of the time minds in the field of biological threats – Elizabeth Cameron, David Franz, James Le Duc, etc.

Stores You May Have Missed:

  • Key Global Health Positions and Officials in the USG – Have you ever wondered who is in charge for global health programs throughout the government? Look no further than this comprehensive list by the Kaiser Family Foundation.
  • CEPI Collaborative for Lassa Fever Vaccine“In a deal worth up to $36 million to advance the development of a vaccine against Lassa fever, the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a new partnership with Profectus BioSciences and Emergent BioSolutions.”

Thank you for reading the Pandora Report. If you would like to share any biodefense news, events, or stories, please contact our Editor Saskia Popescu (biodefense@gmu.edu) or via Twitter: @PandoraReport

Pandora Report 6.22.2018

 US Military Asks – What Would A SynBio Weapon Look Like?
A new study ordered by the DoD seeks to evaluate the potential for synthetic biology to be a biodefense threat. The report, Biodefense in the Age of Synthetic Biology, was issued by the National Academies of Sciences, and provides an actual ranking of national security threats that genetic engineering technology, like CRISPR, pose. “’Synthetic biology does expand the risk. That is not a good-news story,’ says Gigi Gronvall, a public health researcher at Johns Hopkins and one of the report’s 13 authors. ‘This report provides a framework to systematically evaluate the threat of misuse’.” The report includes a framework for assessing synbio capabilities as well as concerns related to the production of chemicals or biochemicals, bioweapons that alter the human host, pathogens, etc. The report also includes a section on related developments that impact the ability to effect an attack using a synthetic biology-enabled weapon, where the authors note several mitigation challenges posed by synbio. Some of the challenges to deterrence and prevention include accessibility of biotechnology, pointing to DIY biohackers, the iGEM competition, and traditional pathways like academic laboratories. Regarding the challenges in recognizing and attributing an attack, they note that “synthetic biology could also confound the ability to identify the causative agent in a biological attack. Despite the breadth and depth of available repository resources, there would not always be a reference specimen to use as comparator, particularly if the agent is markedly different from natural pathogens or toxins.” “According to the report, the US must now also track ‘enabling developments’ including methods, widely pursued by industry, to synthesize DNA strands and develop so-called chassis’ organisms designed to accept genetic payloads.” Consider the recent de novo synthesis of the horsepox virus by researchers in Canada that has opened up Pandora’s box regarding synbio and biosecurity. GMU Biodefense professor and graduate program director Gregory Koblentz noted that “Synthetic biology has provided the tools necessary to recreate the smallpox virus,” and “Safeguards against the misuse of those tools are weak and fragmented.”  “The US government should pay close attention to this rapidly progressing field, just as it did to advances in chemistry and physics during the Cold War era,” says Michael Imperiale, a microbiologist at the University of Michigan. The recent tabletop hosted by the Center for Health Security (Clade-X) even presented some real-world scenarios and gaps for dealing with a bioterrorism event that involved an engineered organism.

Gene Drives and Frank Discussions With CRISPR Scientists
Speaking of gene editing…GMU Biodefense professor Sonia Ben Ouagrham-Gormley recently sat down with Vox to discuss the good and bad side of gene drives in the context of genetically modified mosquitos and their place in the fight against malaria. Malaria kills hundreds of thousands a year and despite eradication efforts, it’s still a monumental task for public health. “We have eliminated malaria from the rich world; it used to be endemic to France just as it is to Mali today. And now, with CRISPR gene drives, we have the potential to wipe it out globally and save millions of lives. Gene drives allow humans to change the genetic makeup of a species by changing the DNA of a few individuals that then spread the modification throughout an entire population. In the case of malaria, the idea is to change the three species of mosquito most responsible for its transmission — Anopheles gambiae, Anopheles coluzzii, and Anopheles arabiensis — so that all their offspring would be male, effectively leading to the species’ extinction.” The debate though is that if gene drive was used poorly, it could cause irreversible changes in the ecosystem. Many worry about the potential for weaponization of gene drives or nefarious actors using it, but several biosecurity experts have pointed to the limitations of gene drive when it comes to making diseases more potent. “The biosecurity experts I talked to are deeply skeptical of those nightmare scenarios. Sonia Ben Ouagrham-Gormley, a professor in the biodefense program at George Mason University, says she doubts gene drives will be militarily effective in targeting rival countries’ harvests. ‘Animals and plants that are raised for food are generally monitored, and a gene drive can be easily detected in the genome of the animal,’ she explained. ‘Because of that regular monitoring, I don’t think gene drives would be a good tool for affecting a country via agriculture.’ Biosecurity experts like Ben Ouagrham-Gormley and Filippa Lentzos have concerns that are more social. “What happens if one of the few thousand fruit fly biologists around the world decides to act unilaterally and throws international talks on the matter into chaos? What if a grad student creates a gene drive that can’t reliably hurt people but can reliably terrify them?” If she wasn’t busy enough, Sonia Ben Ouagrham-Gormley recently returned from a research trip to China where she met with several CRISPR scientists and toured their laboratories. She discussed CRISPR developments in China and gave a talk at the University of the Chinese Academy of Sciences in Beijing (UCAS) on the technological, regulatory and technical challenges of CRISPR.

Summer Workshop on Pandemics, Bioterrorism, and Global Health Security
We’re less than a month away from the workshop on all things health security, are you registered? Since we’re on the topic of biotechnology and biosecurity, our workshop is a great chance to hear from Supervisory Special Agent Edward You of the FBI’s WMD Directorate, Biological Countermeasures Unit. “Mr. You is responsible for creating programs and activities to coordinate and improve FBI and interagency efforts to identify, assess, and respond to biological threats or incidents. These efforts include expanding FBI outreach to the Life Sciences community to address biosecurity. Before being promoted to the Weapons of Mass Destruction Directorate, Mr. You was a member of the FBI Los Angeles Field Office Joint Terrorism Task Force and served on the FBI Hazardous Evidence Response Team.” Don’t miss Mr. You’s talk on the bioeconomy and biosecurity threats during this three-day workshop on all things biodefense!

WHO Releases New International Classification of Disease (ICD11)
The World Health Organization (WHO) released the latest ICD-11, which includes 55,000 codes for specific injuries, diseases, and causes of death. “The ICD is also used by health insurers whose reimbursements depend on ICD coding; national health programme managers; data collection specialists; and others who track progress in global health and determine the allocation of health resources. The new ICD-11 also reflects progress in medicine and advances in scientific understanding. For example, the codes relating to antimicrobial resistance are more closely in line with the Global Antimicrobial Resistance Surveillance System (GLASS). ICD-11 is also able to better capture data regarding safety in healthcare, which means that unnecessary events that may harm health – such as unsafe workflows in hospitals – can be identified and reduced.”

Ebola Virus Disease Outbreak Updates
The DRC has reported 5 more suspected cases in the Iboko health zone, which brings the total to 60 cases, included 28 deaths (38 confirmed, 14 probable, and 8 suspected) as of June 19th. The case fatality rate for this outbreak is at 47% and “‘The number of contacts requiring follow-up is progressively decreasing, with a total 1,417 completing the mandatory 21-day follow-up period,’ the WHO said. As of Jun 17, a total of 289 contacts were still being monitored.” WHO Director General Tedros Adhanom Ghebreyesus recently tweeted “Just over a month into the response in , further spread has largely been contained. In spite of progress, there should be no room for laxity and complacency until it’s finally over. This is a collaborative effort led by

 MERS Trends in Saudi Arabia – Hospitals and Households
Since January of this year, the WHO has reported 75 laboratory confirmed MERS-CoV cases and 23 deaths in Saudi Arabia. 21 of these cases were involved in four clusters (2 household and 2 healthcare) – “Cluster 1: From 2 through 4 February, a private hospital in Hafer Albatin Region reported a cluster of three (3) health care workers in addition to the suspected index case (four [4] cases in total). Cluster 2: From 25 February through 7 March, a hospital in Riyadh reported six (6) cases, including the suspected index. No health care workers were infected. Cluster 3: From 8 through 24 March, a household cluster of 3 cases (index case and 2 secondary cases) was reported in Jeddah. No health care workers were infected. Cluster 4: From 23 through 31 May, a household cluster was reported from Najran region with eight cases including the suspected index case. This cluster is still under investigation at the time of writing. As of 31 May, no health care workers have been infected and the source of infection is believed to be camels at the initial patient’s home.” The total number of MERS cases since 2012 is now 2,220. These clusters underscore the role of hospitals as amplifiers for MERS transmission during outbreaks and the importance of infection prevention efforts.

Infection Prevention Gaps Found Across Critical Access Hospitals
GMU Biodefense doctoral student Saskia Popescu addresses infection prevention failures and gaps within the United States and specifically in critical access hospitals. “These findings are not novel as staffing issues are problematic across the country in all types of hospital systems. The importance of having IPs within health care and ensuring they have access to training and the ability to focus on infection control activities—not just reporting tied to CMS reimbursement—is critical. IPs need time for activities such as education, rounding, antibiotic stewardship, and more. This study supports the notion that not only should hospitals be ensuring proper staffing and support for infection prevention programs, but that significant gaps exist across CAHs. In the areas where CAHs are the only health care patients may access, it is vital that infection prevention processes be supported and followed”

How Ready Is the United States For The Next Anthrax Attack?
This week the CDC reviewed their recommendations for mass vaccination in the event of an anthrax attack. “The way that people think about [nuclear weapons] is on a much, much grander scale than biological weapons, and I think that’s a misperception,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. “If you use a contagious infectious disease, you really could create havoc on a different scale.” The Amerithrax attack was in 2001 and since then we’ve seen SARS, MERS, and Ebola as potential infectious disease threats that reveal a rather large spectrum of avenues for microbial events. “But there’s still a long way to go in terms of preparedness, Redlener said, adding that no city is fully prepared. Questions remain about what dosage of the vaccine to use for children, the safety of the vaccine for the general public, delivery and distribution of the vaccine and medications. ‘I think a vaccination program would be a nightmare. Who would administer it? Who would pay for it? Who would manufacture it? The cost of complications that may occur. I don’t think it would be practical,’ Redlener said.”

Stories You May Have Missed:

  • Gene-edited Farm Animals – “The team edited the animals’ DNA to make them resist the deadly respiratory disease known as PRRS – a move that could prevent billions of pounds in losses each year. However, consumers have traditionally been reluctant to eat genetically altered animals and crops. This poses a significant barrier to farmers owning gene-edited pigs. And because genome, or gene, editing (GE) is relatively new, the absence of regulation currently prevents their sale anyway.”
  • FDA Releases New Food Defense Guidance – “Today the US Food and Drug Administration (FDA) released the first of three installments of draft guidance on the intentional adulteration (IA) rule, part of the Food Safety and Modernization Act (FSMA). The rule is meant to guide the food industry on reducing the risk of exposing food facilities to IA, such as acts of terrorism. Unlike other FSMA rules that address specific foods or hazards, IA will require preventive measures for reducing vulnerabilities at all domestic and foreign companies that are required to register with the FDA as food facilities.”

Pandora Report 6.15.2018

Welcome back to your favorite weekly dose of all things biodefense! We’ve got a lot of health security news to cover this week as microbes just don’t seem to take a break.

Outbreak Updates
The latest data from the DRC has reported four more suspected Ebola cases, which would bring the overall outbreak total to 59 cases (38 confirmed, 14 probable, and 7 suspected), and 28 deaths. You can find the timeline of Ebola response for the DRC outbreak here, that was released by the WHO. In the latest WHO statement on the outbreak, Director-General Dr. Tedros Adhanom Ghebreyesus noted that “’It’s far too early to declare victory, but the signals are positive and we are cautiously optimistic,’. ‘We have new weapons and together with the government and our partners, we have acted with urgency to save lives. We will remain vigilant until this outbreak is over’.” You can also read the latest WHO situation report here. As the DRC works to contain the Ebola outbreak, the Nipah virus outbreak in India is ongoing, as 17 cases have been identified. Kenya is also currently facing a Rift Valley fever outbreak as 10 people were found to be sick and 5 have died. “The disease primarily strikes livestock by the mosquito-borne route. Though humans can be infected by mosquitoes, the virus is more commonly passed by contact with blood or organs of infected animals or drinking milk from sick ones. The disease is usually mild, but some patients experience a severe form.”

 Workshop on Pandemics, Bioterrorism, and Global Health Security
Are you registered for the summer workshop on all things health security? From Anthrax to Zika, we’re talking vaccine development, bioterrorism, the Ebola outbreak, and more. Don’t miss the chance to attend this July 18-20 workshop in Arlington, where you’ll learn from the top minds in the field and chat with others passionate about global health security. Make sure to register before July 1st for an early registration discount. If you’re a GMU student or alum, returning workshop attendee, or large group, you can even get an additional discount!

Clade-X Policy Recommendations
Following the Clade-X pandemic tabletop last month, the Johns Hopkins Center for Health Security has released their policy recommendations. If you missed the chance to observe the tabletop, make sure to check it out on YouTube or read through the resources here. The policy recommendations focus on a strong and sustainable global health security system, a robust, highly capable national public health system that can manage the challenges of pandemic response, etc. The Washington Post noted of the tabletop, “Even though many players in the scenario had decades of experience in health security and national and global policy and law, ‘there were still so many unanswered questions and capability gaps,’ said Beth Cameron, formerly senior director for global health security and biodefense at the National Security Council under President Barack Obama. Cameron, who was in the audience, is vice president for global biological policy at the Nuclear Threat Initiative.”

FEMA Wants Local Governments to Step Up
GMU Biodefense PhD alum Daniel M. Gerstein is pulling back the curtain on FEMA’s new strategic plan and the reality that its capacity doesn’t grow when there are high volumes of natural disasters. Gerstein notes of the FEMA Administrator Brock Long- “Long’s language signals that FEMA’s disaster policy, upon which so many communities may depend, is changing. FEMA’s recently released strategic plan reveals several important shifts in federal disaster relief policy. FEMA is streamlining its mission to focus on coordination with state and local stakeholders before disasters even strike in order to shorten disaster recovery times. Why the changes? 2017 was particularly full of disasters – there were 16 events that exceeded $1 billion in total damage. An estimated $306 billion in losses made 2017 the most expensive year ever for natural disasters. Three hurricanes in succession in August and September combined with the Western wildfires greatly stressed FEMA’s capacity to support these response and recovery operations.” Moreover, Gerstein underscores that this approach is central to getting the message across that FEMA is not a first-responder agency, but rather offers coordination and resourcing for catastrophic disasters.

Characteristics of a Pandemic- The Devil Is In The Details
GMU Biodefense doctoral student Saskia Popescu reviewed the Center for Health Security publication regarding the characteristics of microorganisms that are more likely to cause a global catastrophic biological risk. “The CHS findings pose critical questions as to how we handle global health security and pandemic preparedness, as well as what inherently makes a microorganism likely to cause a pandemic. Moreover, the report speaks to medical providers and those working on the frontline, which is a breath of fresh air for so many of us who are all too often given non-specific guidance that fails to meet the true demands of preparing for pandemics. ”

Book Reviews
Still in need for that book to read during a summer vacation? Here are reviews of two books for anyone interested in antibiotic resistance. First, a review of Superbugs: An Arms Race Against Bacteria, in which Jerome Groopman discusses the importance of understanding this growing threat and the origin of AMR. Groopman notes that “Fleming’s advice to use the antibiotic properly was widely disregarded, not by “the ignorant man” but by “negligent” medical professionals. Prescriptions of penicillin in suboptimal dosages led to the emergence of bacteria resistant to it.” Next, GMU biodefense doctoral student Saskia Popescu reviews Maryn McKenna’s book, Big Chicken, which reveals the truth about antibiotic usage in poultry. Popescu notes that “Showcasing the complexity of this microbial threat and the role of poultry, McKenna chronicles the efforts across the United States and Europe to understand novel outbreaks of common bacterial infections that began springing up in the 1950s and left medical providers struggling to find treatments, but also the scientific work done to provide proof of the problem.”

NTI Presentation – Biosecurity By Design: Getting Ahead of Risk in the World of Designer Operations
GMU Biodefense doctoral student Carlos Alvarado is reporting on the NTI event this week regarding the rapid advances in biotechnology and what that means for biosecurity. Alvarado notes that Dr. Reshma Shetty, co-founder of Ginkgo Bioworks, began with posing a unique scenario for the audience – she “explained how technology and biology are very similar in the fact they’re both made form unique core codes. One of the slides within her presentation contained a photo of a desk with a plant, cell phone, tablet, computer, and other technological devices. She then asked the audience what is the most technological item in this picture,  to which she stated the answer was the plant because the plant was self-replicating, self-cleaning, and self-sensing. She explained that with bio synthesis and bioengineering, Ginkgo Bioworks is working on developing these codes for specific bio synthesized organisms.” Overall, while the presentation mostly focused on the work of Ginkgo Bioworks, it did provide insight into the industry perspective for biosecurity and what such advances might mean for the future.

 Medical Benefits Now Available for Vets Subjected to Chem-Bio Tests
Operation Whitecoat is an infamous example of American soldiers – conscientious objectors, who became the human guinea pigs for biological weapons, and now those soldiers are able to receive medical care. “About 6,000 of the soldiers that the U.S. Army tested potential chemical and biological substances on are still living and may be eligible for medical care. A recent class action lawsuit filed by the Vietnam Veterans of America required the U.S. Army to provide medical care to veterans who volunteered to contribute to the advancement of the U.S. biological and chemical programs.”

ISDS Presentation: Outbreak Observatory
Don’t miss out on the chance to learn about Outbreak Observatory at this presentation held by the International Society for Disease Surveillance (ISDS) on Wednesday, June 27th from 11am-noon EST. “During this presentation, researchers will discuss how Outbreak Observatory, a pilot project initiated by the Johns Hopkins Center for Health Security, will facilitate the conduct of real-time operational research during outbreak responses, helping to improve outbreak preparedness and response capabilities.”

Preventing Pandemics – Spend on Surveillance
Where do we put the funds for pandemic prevention? Despite the inherent importance of these efforts, financial support for prevention is often problematic. Researchers are emphasizing that funding should be put towards surveillance, not prediction, as such efforts can easily be a double-edged sword in terms of public trust. Credibility issues arise for the public when predictions are wrong (H1N1 or Ebola). “In short, there aren’t enough data on virus outbreaks for researchers to be able to accurately predict the next outbreak strain. Nor is there a good enough understanding of what drives viruses to jump hosts, making it difficult to construct predictive models.” Fundamentally, the researchers argue, it is in the surveillance of human populations that is the most effective and realistic approach to fighting outbreaks. Efforts should focus on the vulnerable countries and locations, strengthen detailed screening of those symptomatic, etc. “This will best be achieved through an established global network of highly trained local researchers, such as the WHO Global Outbreak Alert and Response Network (GOARN). Real-time tools for reconstructing and tracking outbreaks at the genomic level, such as portable sequencing devices, are improving fast. Information gathered during recent outbreaks has quickly had tangible impacts on public-health decisions, largely owing to data generation and analysis by many research teams within days of people being infected.” More and more, researchers are also underscoring the importance of including veterinarians in pandemic prevention, in fact, many say to follow the bats when looking for the next Ebola outbreak.

Stories You May Have Missed:

  • Salmonella Outbreak Tied to Pre-Cut Melons – The CDC has announced that the culprit of this multi-state outbreak is pre-cut melon. “As of June 8, 2018, 60 cases of Salmonella Adelaide have been reported spanning 5 states; a little more than half (31) of these individuals have required hospitalization for their infections. To date, no deaths have been reported. The infected individuals range from 1 to 97 years in age, with a median age of 67, according to the CDC. Available data indicate that 65% of those who have fallen ill are female. The reported dates of illness range from April 30 to May 28; however, according to the CDC, Salmonella can take up to 2 to 4 weeks to diagnose and report. As such, any illnesses that have occurred after May 28 may not have been reported yet.”

Thank you for reading the Pandora Report. If you would like to share any biodefense news, events, or stories, please contact our Editor Saskia Popescu (biodefense@gmu.edu) or via Twitter: @PandoraReport

Pandora Report 3.2.2018

Happy Friday! We’ve got a full plate of biodefense news this week, so we hope you’re hungry for everything from ASM Biothreats 2018 coverage to Gain of Function research, and a side of pandemic budgeting.

ASM Biothreats 2018 – GMU Biodefense Coverage
We’re excited to present our annual coverage of the ASM Biothreats conference from some of GMU’s very own biodefense graduate students. Our overview is a great way to catch up on some of the hot topics and captivating breakout sessions from the conference. You can find a landing page for all the reviews here, which will have links and a brief synopsis for each section the students wrote. GMU biodefense graduate students covered a variety of sessions – from artificial intelligence in biosecurity to the GHSA, future DoD programs in biodefense policy, and BARDA/DARPA projects- we’re reporting it all!

New Pathogen Research Rules: Gain of Function, Loss of Clarity
GMU Biodefense professor and graduate program director Gregory Koblentz is teaming up with Lynn Klotz (co-managing director of Bridging BioScience and BioBusiness LLC), to evaluate the December 2017 release of the latest Gain of Function (GoF) research rules. The DHHS release finally lifted the funding moratorium on GoF research following the controversial projects involving H5N1 in 2011. While the DHHS policy (or “Framework for guiding funding decisions about proposed research involving enhanced potential pandemic pathogens”) is similar to the Office of Science and Technology Policy guidance that was released in January 2017 (the “P3C0 Framework”), it came with the bonus of restoring funding for such research. Unfortunately, there are still considerable concerns with how GoF research is evaluated and if these frameworks have really addressed the gaps. “We, the authors, harbor concerns about adequate oversight of potentially dangerous research, and the framework incorporates several elements that address those concerns. The framework is thorough. It does a good job of laying out the principles and processes through which the Health and Human Services Department will make funding decisions regarding research that involves enhanced potential pandemic pathogens. The framework’s approach to dual-use research of concern is not based on lists of experiments or on specific pathogens, but instead takes a risk-based approach that focuses on the attributes of modified organisms. While the identity of starting organisms is central to existing oversight policy for dual-use research of concern, the framework emphasizes the importance of organisms’ properties once the experiment is over. This more comprehensive approach to dual-use research is a welcome change. Some elements of the new framework, however, remain worrisome.” Koblentz and Klotz point to several limitations of the new framework – it’s too narrow and not broad enough in that it only applies to research funded by DHHS, the terminology and definitions are lacking (especially in the definition of a potential pandemic pathogen), and the review process that was created is a limited. The framework also has new criteria for risks and benefits, which is “inherently problematic” and agreement is often never achieved. “The criteria used to judge which experiments involving enhanced potential pandemic pathogens warrant review by the Health and Human Services Department—and how the risks, benefits, and ethical aspects of such experiments are measured and weighed—are ambiguous enough to provide departmental reviewers wide latitude in their funding decisions. The process and outcomes must be transparent in order to demonstrate that the process is conducted in good faith and that policy is implemented appropriately. The framework, though it recognizes the importance of transparency for maintaining public trust in science, does not go far enough in actually providing the requisite level of transparency.” Lastly, Koblentz and Klotz point to the international considerations as a considerable weakness within the new framework. Sadly, it only applies to research done within the United States and the truth is that this is an international issue and needs global consideration and collaboration.

 2018 NASPAA Student Simulation – Global Health Security
How did you spend your Saturday? Battling a virtual pandemic? We were fortunate to participate as judges at an international collaboration and simulation to test students on their response during a pandemic. The NASPAA-Batten simulation (Network of Schools of Public Policy, Affairs, and Administration) involved a total of 563 students in 117 teams, from 159 universities across 27 countries. Teams represented approximately 336 million fictitious people in 4 fictitious countries per 1 fictitious world and were battling 1 seriously tough outbreak. GMU’s Schar School and the biodefense program were represented in both participants and judges. Professor and graduate program director Gregory Koblentz and PhD student Saskia Popescu were judges while six Schar students participated (four of which were biodefense students!) at the Carnegie Mellon University site in DC – Alexandra Williams (Biodefense MS), Annette Prietto (Biodefense MS), Stephen Taylor (Biodefense MS), Justin Hurt (Biodefense PhD), Fleciah Mburu (MPA), and Ryan Kennedy (MPP). The two finalist teams from the CMU site included biodefense MS students Alexandra and Justin, which means they’ll now move on to the global round where they are competing for the $10,000 prize. GMU biodefense students know how to battle a pandemic – whether it’s simulated or real! From a judge’s perspective, this was a great experience to not only observe how people respond to the complexities of a global outbreak, but also pose questions that help them see all the moving pieces in response.

Blue Panel Study Panel on Biodefense Calls For Strategic Budgeting Tied to New National Biodefense Strategy
The Blue Ribbon Study Panel has released a statement on the desperate need for decision-makers to commit to biodefense funding and recognize it as an imperative component to national security.  “We would do well to remind ourselves that we are really just as vulnerable now as we were then. In addition to the enormous potential toll on human health that intentional or natural outbreaks can inflict, the cost of the relentless rise of outbreaks is also entirely unsustainable based on current funding approaches. Emergency appropriations reach into the billions in direct outlays to the U.S. government. Economic impacts of a catastrophic outbreak could reach into the trillions.” You can also read the OpEd by Sen. Joe Lieberman and Former Gov. Tom Ridge, stating that American lives are worth budgeting for biodefense. “We call upon the president to release the National Biodefense Strategy soon and ensure that his next budget request to Congress conforms to the priorities in this strategy, showing how money requested for biodefense programs support the National Strategy’s goals and objectives.”

CDC Plans for New High Containment Lab
The CDC is asking congress for $350 million to start building the high containment continuity laboratory on their main campus to replace the existing one that has been used since 2005, but requires replacement by 2023. “The existing facility contains a number of BSL4 labs and labs that are one step down the biosafety and biosecurity ladder, BSL 3 enhanced. That’s where research on dangerous avian influenza viruses like H5N1 and H7N9 is conducted. Buildings that house these types of labs simply require a lot of maintenance, explained Dr. Dan Jernigan, head of the CDC’s influenza branch. ‘We’re just faced with the realities of what it takes to maintain something as complex as the high containment lab,’ he said.” The complex design of high containment labs makes them both expensive to build and maintain.

Battelle Takes On Biological Threats With New Software
Between naturally occurring outbreaks, bio-error, and bio-terror, there are a lot of ways infectious diseases can pose a threat to human life and safety. Battelle is seeking to change this through a new software for the U.S. government that “would screen small bits of DNA and assess whether they belong to potentially dangerous genetic sequences.The local research institution is one of six groups awarded an $8.7 million, two-and-a-half-year grant by the Intelligence Advanced Research Projects Activity (IARPA), an organization within the Office of the Director of National Intelligence.” The growing application of CRISPR and other genome editing technologies has underlined the gaps in DNA sequence screening for biosecurity concerns, especially when one considers the recent horsepox synthesis. “In the absence of national or international policy that would monitor bioengineering activity — and the technological gap for keeping an eye on never-before-encountered organisms — Battelle and the other groups awarded the federal contract are trying to figure out how to stay a step ahead. ‘At first I thought it would be too big of a lift for us,’ Dickens said. At the end of January, Battelle researchers completed a first version of the software, which they are now testing and optimizing. It can, for example, analyze a small fraction of an influenza virus’ genetic code and identify or predict whether it has the potential to make people, animals or the environment sick. The tool then assigns the genetic scrap a threat level: dangerous, potentially hazardous or safe. The tool is artificially intelligent enough to detect whether the sample is related to any known specimens, such as botulism or anthrax, and predict the function of never-seen-before DNA sequences.”

Workshop on Women’s Health In Global Perspective
GMU Schar School is hosting this free workshop on March 7-8th in Arlington,VA – don’t miss out! “The Workshop on Women’s Health in Global Perspective seeks to contribute to understanding and improve policy on women’s health and wellbeing around the world. The program includes panels on Communicable and Non-Communicable Disease; Health and Wellbeing; Maternal Health; and Reproductive Technology and Family Planning. It will cover topics such as HPV Vaccine Awareness, Maternal Mortality, and Cross-border Reproductive Care.”

GMU Biodefense Alum Leads NEIC Laboratory 
We love getting to brag about the amazing things that GMU Biodefense students and alum do with their passion for health security. Biodefense MS alum Francisco Cruz was recently named the Chief of the EPA’s National Enforcement Investigations Center (NEIC) Laboratory Branch! “The branch’s primary responsibility is conducting forensics analysis on environmental samples related to criminal and civil cases. The lab is a fully accredited forensics laboratory staffed by 21 chemists who can not only conduct the lab analysis, but also testify in court regarding the science behind the analysis. Additionally, the lab is capable of developing novel analytical methods for rare and difficult matrices that most labs cannot analyze. The lab supports EPA and other federal law enforcement partners with either lab analysis or technical consultation on how to process a sample.” Biodefense alums – don’t forget to stay connected so we can recognize you for all the amazing biodefense work you do!

DARPA Names Pandemic Prevention Platform Researchers
Launched in 2017, the P3 program from DARPA hopes to stop the spread of an outbreak before it becomes a pandemic. “In contrast with state-of-the-art medical countermeasures, which typically take many months or even years to develop, produce, distribute, and administer, the envisioned P3 platform would cut response time to weeks and stay within the window of relevance for containing an outbreak.” DARPA recently announced the institutions that are contracted for the program and will hopefully make progress in the fight against pandemics – MedImmune, Abcellera Biologics Inc., Duke University, and Vanderbilt University.

 The WHO – What Went Wrong from Swine Flu to Ebola?
The WHO has struggled to find its strong foot since 2009’s H1N1 influenza pandemic and then the 2014/2015 Ebola outbreak. With new leadership, many are hoping the WHO’s abilities can be strengthened and some faith restored in their capacity to prevent and respond to international health events. One particular evaluation of this can be found in a chapter of Political Mistakes and Policy Failures in International Relations. “This chapter examines a series of mistakes and the structural, cultural, political and epidemiological factors that contributed to the WHO’s mishandling of the first pandemic of the twenty-first century and the world’s largest ever outbreak of Ebola. The chapter then concludes by examining the reforms currently being implemented to strengthen the WHO’s global health security capabilities and what these signify for the future.”

Stories You May Have Missed:

  • CDC Epidemiologist Missing – “Police investigators are bewildered as they work through the “extremely unusual” circumstances surrounding the missing-person case of Timothy Cunningham, a researcher who vanished Feb. 12, shortly after hearing why he had been passed over for a promotion at the Centers for Disease Control and Prevention (CDC). Cunningham, 35, told colleagues he was not feeling well and left work at CDC headquarters in Atlanta, not long after speaking with his supervisor about why he had not been promoted, Atlanta Police Maj. Michael O’Connor told reporters. Cunningham works in the chronic disease unit at the CDC, not in the part of the CDC that deals with infectious disease, according to authorities.”
  • Iraqi, Dutch, Vietnamese Officials Report Avian Flu Outbreaks – Several countries reported new avian flu outbreaks, including two more H5N8 events at commercial poultry farms in Iraq, an H5 outbreak at a poultry farm in the Netherlands, and the first known H5N6 detection of the year in Vietnam. In Iraq, which has reported ongoing H5N8 activity since early January, authorities reported new outbreaks in Diyala and Baghdad province that began on Feb 13 and Feb 14, respectively, according to a report yesterday from the World Organization for Animal Health (OIE). The investigation said the source of the virus was contact with wild species.”
  • 11 Fall Ill After Suspicious Letter Arrives At Military Base– “Eleven people fell ill after a suspicious letter was opened in an administrative building at Joint Base Fort Myer-Henderson Hall in Arlington, Virginia, on Tuesday, according to the Arlington County Fire Department. A law enforcement official said field tests for the letter all came back negative for any harmful substance, but the FBI is transporting it tonight to its lab in Quantico for further analysis. The law enforcement official said the text of the letter contained derogatory, at time unintelligible and ranting language, and was addressed to a commanding officer at the base. Investigators are still determining what relationship, if any, the sender had with the base. A corporal, gunnery sergeant and a colonel all exhibited symptoms of a burning sensation on their hands and face, according to Specialist Nicholas Hodges who spoke to CNN from the base.”

Thank you for reading the Pandora Report. If you would like to share any biodefense news, events, or stories, please contact our Editor Saskia Popescu (biodefense@gmu.edu) or via Twitter: @PandoraReport

Pandora Report 2.2.2018

The world of health security has been busy this week as news of CDC leadership changes and ongoing flu troubles have caused ripples. A new mouse study is also hinting that West Nile virus may cause Zika-like birth defects. Check out Maryn McKenna’s latest article on changing the market for flu shots and the desperate need for innovation.

 CDC’s Plans to Scale Back Global Health Security Activity 
A recent article brought attention to CDC plans that would reduce efforts to prevent and respond to outbreaks on a global scale through the global health security agenda (GHSA). “In an email to U.S. and overseas leaders in its global health center, the CDC said it anticipates that if its funding situation remains the same, it will have to narrow activities to 10 ‘priority countries’ starting in October 2019. The email was reviewed by The Wall Street Journal.” The 10 countries include Vietnam, India, Nigeria, etc. “Reductions now would halt critical work midstream and result in a loss of newly trained local experts, said Tom Frieden, the former CDC director who led the effort until a year ago and is now president and chief executive of Resolve to Save Lives, an initiative working on strengthening epidemic preparedness.” In response to this alarming plan, the Global Health Security Agenda Consortium, Global Health Council, Next Generation Global Health Security Network, and Global Health Technologies Coalition, have drafted a letter to newly appointed HHS Secretary Alex Azar, regarding the serious implications of such actions. Sent to HHS, CDC, OMB, State and NSC leadership, they underline the funding ramifications of scaling back on CDC’s efforts regarding the GHSA. “US investments in global health security and deployed CDC personnel are making America safer today. For example, US investments in surveillance capacity in Cameroon have decreased the disease outbreak response time from 8 weeks to just 24 hours.” The letter highlights the recent Ebola and Marburg outbreaks as prime examples of work within the GHSA, but also what occurs when global efforts are not available or lacking. “As the United States and the world begin to reap the benefits of our investments in better disease preparedness, now is not the time to step back. The ongoing danger that biological threats pose to American health, economic, and national security interests demands dedicated and steady funding for global health security. Congress and the Administration must invest in our deployed global biodefense capability.” Nothing short of serendipitous, the National Academies have also released their report from a workshop on Exploring Partnership Governance in Global Health. “In global health, collaboration frequently occurs through public–private partnerships (PPPs), with public and private parties sharing risks, responsibilities, and decision-making processes with the objective of collectively and more effectively addressing a common goal. PPPs include government and industry as well as partners from a range of other sectors. The workshop examined what role governance assumes in global health PPPs through presentations and discussion on transparency and accountability, operational challenges, legal considerations, barriers and strategies for engagement, examples of governance structures and lessons learned, and measurement. This publication briefly summarizes the presentations and discussions from the workshop”

Antimicrobial Resistance Surveillance Efforts and Needs
While the outcome is not surprising, this first release of the WHO’s surveillance data on AMR isn’t pretty. Surveillance data is revealing high levels of antibiotic resistance are in fact, found worldwide. “WHO’s new Global Antimicrobial Surveillance System (GLASS) reveals widespread occurrence of antibiotic resistance among 500 000 people with suspected bacterial infections across 22 countries. The most commonly reported resistant bacteria were Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, and Streptococcus pneumoniae, followed by Salmonella spp. The system does not include data on resistance of Mycobacterium tuberculosis, which causes tuberculosis (TB), as WHO has been tracking it since 1994 and providing annual updates in the Global tuberculosis report.” The GLASS program includes 52 countries (25 high-income, 20 middle-income, and 7 low-income countries) and was launched in 2015 as a way to better track and understand the complexities of AMR. Wellcome Trust has also just announced a new strategy to combat AMR on an international scale. SEDRIC (Surveillance and Epidemiology of Drug-Resistant Infections Consortium) will work to strengthen country capacity for AMR surveillance and detection. “We need to better understand where patients acquire bacteria that cause infections – are they acquiring bacteria from other patients, from healthcare settings, water or food or the general environment? Drug-resistant infections are, like us, international travellers. We need to track which borders they cross, and how quickly. Without detailed and up-to-date information we cannot effectively intervene.” SEDRIC will work to fix surveillance gaps across countries by focusing on improving global coordination, identifying critical gaps and barriers, and helping countries to adopt sustainable best practice and strategies. These surveillance efforts and strategies are desperately needed to understand the AMR problem at a global level, especially as it was reported that India’s farmed chickens are dosed with colistin (the antibiotic of last resort). 

CDC Director Steps Down
Dr. Brenda Fitzgerald has stepped down from her role as director of the CDC due to conflicts of interest. “Politico reported on Tuesday that Fitzgerald, a physician and former commissioner of the Georgia Department of Public Health, bought shares in a tobacco company a month into her leadership of CDC, an agency charged with safeguarding public health, including reducing rates of smoking. She took over leadership at CDC in July. After advising the HHS secretary of the status of her financial interests and the way in which it limited her ability to do her job, Azar accepted her resignation, HHS said in a statement.” Dr. Fitzgerald began her role in July and is the second of top health positions appointed by the Trump Administration to resign. Dr. Anne Schuchat is now the Acting Director for the CDC. 

GMU Master’s Open House – February 21st
We’re just a few weeks out from the GMU Schar School MS Open House on February 21st and you won’t want to miss this opportunity to talk to faculty about our biodefense graduate degrees. Whether you’re looking to attend in person or online, this is a great opportunity to discuss the application process, curriculum, and how students are supported in their academic and career goals.

 Hawaii’s False Missile Alert and The Woeful State of US Preparedness
For 38 minutes, residents of Hawaii were alerted that a ballistic missile was approaching the island. A deep-dive of this mishap has found that the “emergency worker who sent a false public safety alert on Jan. 13 warning of an imminent  ballistic missile attack on Hawaii believed that a ballistic missile was truly bound for the state after mishearing a recorded message as part of an unscheduled drill,”. A mix-up in communication between shift supervisors regarding when the drill would run led to a trickle-down of confusion as the day-shift workers were notified of a missile threat (as part of the drill). “Following standard procedures, the night-shift supervisor posing as Pacific Command played a recorded message to the emergency workers warning them of the fake threat. The message included the phrase ‘Exercise, exercise, exercise.’ But the message inaccurately included the phrase ‘This is not a drill.’ The worker who then sent the emergency alert failed to hear the ‘exercise’ portion of the message and acted upon the ‘This is not a drill’ part of the message that should not have been included, according to the report.” Furthermore, the computer systems in place that should’ve been a stop-gap did not detect the difference between test alerts and actual alerts. This event is a prime example of the traditional failure in emergency preparedness exercises (and real events) – communication. Such an event, while frustrating, should be utilized as a teaching tool to truly fix the communication gaps. Sometimes it’s the “did that seriously just happen?” events that teach us the most about the fissures in our preparedness.

Flu Wreaking Havoc on Hospitals, Infection Control Practices Struggling
GMU Biodefense PhD student and infection preventionist Saskia Popescu is looking at the current flu situation from the perspective of infection control and healthcare response. “Hospitals are being hit hard by a rapid influx of individuals who are requiring isolation, treatment, and manpower during a time where health care institutions are already suffering from an intravenous (IV) bag shortage. I’ve seen some hospitals go on diversion because they are so inundated with patients that they are unable to accept any more. Hospitals are experiencing shortages of influenza testing kits, conference rooms and outside tents are being set up as triage/waiting areas, personal protective equipment (PPE) stores are being strained. Furthermore, infection prevention and control practices are being stressed against the influx of patients and staff calling in sick. All the while, clinicians are trying to maintain proper isolation precautions. To add insult to injury, a recent study on the transmissibility of aerosols and the role they play in spreading influenza has uncovered some disheartening results.”

Tests Link Syrian Government Stockpile to Largest Sarin Attack
Laboratories performing analysis for the Organisation for the Prohibition of Chemical Weapons (OCPW) have confirmed linkage between the Syrian government’s chemical weapons stockpile and the largest sarin attack of the civil war. “The tests found ‘markers’ in samples taken at Ghouta and at the sites of two other nerve agent attacks, in the towns of Khan Sheikhoun in Idlib governorate on April 4, 2017 and Khan al-Assal, Aleppo, in March 2013, two people involved in the process said. ‘We compared Khan Sheikhoun, Khan al-Assal, Ghouta,’ said one source who asked not to be named because of the sensitivity of the findings. ‘There were signatures in all three of them that matched’.” The test results further reinforce the widespread belief that the Assad regime has not destroyed their chemical weapons supply (and continues to use them), which would violate not only the Chemical Weapons Convention, but also several UNSC resolutions. Russia continues to maintain that the Syrian government has not carried out such attacks and that the OCPW inquiries aren’t reliable, but inspectors continue to find evidence of chemical weapons in Syria. “Independent experts, however, said the findings are the strongest scientific evidence to date that the Syrian government was behind Ghouta, the deadliest chemical weapons attack since the Halabja massacres of 1988 during the Iran-Iraq war.” “A match of samples from the 2013 Ghouta attacks to tests of chemicals in the Syrian stockpile is the equivalent of DNA evidence: definitive proof,” said Amy Smithson, a U.S. nonproliferation expert. “The hexamine finding ‘is a particularly significant match,’ Smithson said, because it is a chemical identified as a unique hallmark of the Syrian military’s process to make sarin. ‘This match adds to the mountain of physical evidence that points conclusively, without a shadow of doubt, to the Syrian government,’ she said.” Furthermore, experts are dispelling the notion that the attacks could have been carried out by rebels, noting that it would be impossible for them to achieve such a coordinated, large-scale attack.

Stories You May Have Missed:

  • South Korea Works to Eradicate Avian Flu Before Olympics – “With the PyeongChang Winter Olympics set to begin on Feb. 9, the South Korean Ministry of Agriculture, Food and Rural Affairs announced Monday that it had confirmed the presence of a highly pathogenic strain of the H5N6 avian influenza virus at two chicken farms south of Seoul, Korea JoongAng Daily reportsThe two farms both are approximately 80 miles to the west of PyeongChang. The government has culled 190,000 chickens at the farm in Hwaseong and another 144,000 at the farm in Pyeongtaek. It also has ordered that 430,000 chickens on farms in a 500-meter radius of the Pyeongtaek farm be slaughtered and has destroyed nearly 500,000 eggs at the Hwaseong farm as a precautionary measure. The government also will inspect and disinfect other farms in the area.”
  • Yellow Fever in Brazil – Cases of yellow fever have jumped in Brazil, based upon data from the Ministry of Health data. “In 1 week, the number of recorded deaths from yellow fever rose from 20 to 53, reported cases rose from 470 to 601, while confirmed cases jumped from 35 to 130, O Globo reported yesterday. All deaths have occurred in Minas Gerais, Sao Paulo, and Rio de Janeiro states. Ministry of Health data lag behind data from state officials, Brazilian media reported. The state health data for Minas Gerais notes 24 deaths (1 more than the federal government count), and Rio de Janeiro recorded 8 deaths (also 1 more than the federal total for that state.)  All reports indicate that Sao Paulo has 21 deaths.”

Thank you for reading the Pandora Report. If you would like to share any biodefense news, events, or stories, please contact our Editor Saskia Popescu (biodefense@gmu.edu) or via Twitter: @PandoraReport