Pandora Report: 11.15.2019

We’re back and we’ve got quite a packed newsletter for you, so grab a beverage and get ready for the warm fuzzies of biodefense news.

Failing to PREDICT the Next Pandemic
A few weeks back, it was announced that funding for the PREDICT program would cease after $207 million was sunk into the initiative. GMU biodefense MS student Michael Krug has provided a deep-dive into what PREDICT worked towards, the debated success, and what its cancellation means. “However, even with the billions of dollars spent on ensuring a robust global biosurveillance network, it remains unknown if this network can predict what the next disease will be or where the next outbreak will occur.” Read more here.

An Antibiotic Eclipse – Scenario or Future?
GMU Biodefense doctoral alum and infection preventionist Saskia Popescu discusses the looming threat of antibiotic resistance and what a future with little to no treatment options would look like. From dwindling options for secondary infections related to influenza to declining surgeries, a future without antibiotics is dim. Popescu highlights what this looks like and how we’re quickly approaching it through both the drying antibiotic pipeline, but also limited surveillance, and challenges in changing both stewardship and infection control measures. The existential threat of antimicrobial resistance is very real and Popescu provides a scenario portraying the economic and human costs that antimicrobial resistance could impose on society 30 years from now, if it is not addressed soon. You can read the full article here. This is an especially relevant topic as the CDC just released new data, finding that annually, 2.8 million resistant infections and 35,000 related deaths occur in the United States. The CDC report notes that “However, deaths decreased by 18 percent since the 2013 report. This suggests that prevention efforts in hospitals are working. Yet the number of people facing antibiotic resistance in the United States is still too high.”

Event Recap – People, Pigs, Plants, and Planetary Pandemic Possibilities 
If you happened to miss this November 5th event, no worries – GMU biodefense doctoral student Stevie Kiesel has provided an in-depth summary of the panel and discussions. Kiesel notes that the panel had insightful discussions on the need to understand local context and empower people and local public health communities. Local context is important for combating misinformation and getting a more accurate understanding of conditions on the ground. For example, the public health community must understand why a country may be disincentivized to report a disease outbreak in its early stages, when it is more easily controlled. Authoritarian governments who maintain tight messaging control may not want to admit to an active outbreak, or the economic drawbacks of announcing an outbreak may be so severe that leaders try to hide what’s going on. You can read more here.

Pandemic Policy: Time To Take A Page Out Of The Arms Control Book
Rebecca Katz is holding back no punches in her latest article on the broken policy approaches we have to international outbreak accountability, and frankly, it’s long overdue. Full disclosure, the first line is one of my favorites – “Last month, the World Health Organization (WHO) was reduced to the equivalent of playground pleading: ‘But you promised!’” Katz highlights that in the face of countries failing to meet their obligations within the International Health Regulations (IHR), the WHO has little recourse to act and frankly, the path to accountability isn’t particularly clear. Ultimately, this problem could be solved though, if instead of rewriting the IHR, we modeled such treaties in the image of the Biological Weapons Convention (BWC) to help convene regular review conferences, discuss developments, and establish a regulatory response that could help drive accountability. “As the former US representative to the BWC, Charles Flowerree, wrote, treaties ‘cannot be left simply to fend for themselves’.”

The 5th Annual Pandemic Policy Summit at Texas A&M University
GMU Biodefense doctoral student Rachel-Paige Casey has provided an in-depth review of this important summit earlier this week. The objective of each Summit is to convene researchers, medical professionals, practitioners, private sector experts, NGO representatives, and political leaders to examine issues in pandemic preparedness and response, health security, and biodefense. The foci of this year’s Summit were the promises and perils of technology; BARDA leadership through its history and today; the effect of the anti-vaccine movement on pandemic preparedness and response; and ongoing outbreaks. Key discussions included the inadequacy of biopreparedness, worries regarding emerging biotechnologies, the modern vaccine hesitancy movement in the US, and the leadership and future of BARDA. You can read more about the summit here.

Catalyst- A Collaborate Biosecurity Summit 
Don’t miss this February 22, 2020 event in San Francisco. “Catalyst will be a day of collaborative problem-solving for a broad range of people invested in the future of biotechnology, including synthetic biologists, policymakers, academics, and biohackers. We aim to catalyze a community of forward-looking individuals who will work together to engineer a future enhanced by biology and not endangered by it.The summit is free to attend for everyone accepted, and the application only takes a few minutes. We expect participants to come from diverse backgrounds, and welcome applicants who do not work professionally in biosecurity or biotechnology, who are early in their careers, and who are skeptical of how biosecurity discussions are typically framed. You can apply to attend here.

Firehosing – the Antivaxxer Strategy for the Transmission of Misinformation
Researchers Christopher Paul and Miriam Matthews of Rand introduced this idea in 2016 and it’s proving to be pretty accurate for how anti-vaccine advocates are pushing out their opinions. Lucky Tran of The Guardian recently made the link between antivaxxers and the strategy of firehosing, which entails a massive flow of disinformation to overwhelm the audience. Just like it sounds, firehosing involves pushing out as many lies as frequently as possible to overwhelm people with information and making it nearly impossible for a logical response to combat that much disinformation. Tran stumbled across this application by seeing it on a television show with anti-vaccine influencers like Jay Gordon and he employed this strategy. “Anti-vax influencers such as Jay Gordon and Andrew Wakefield can keep repeating disproved claims – and in the case of Wakefield, doing so despite having had his medical license revoked – because their lying effectively debases reality and gains them followers and fame in the process.” The Rand study can be found here, which originally discussed firehosing in the context of Russian propaganda – as it has two “distinctive features: high numbers of channels and messages and a shameless willingness to disseminate partial truths or outright fictions. In the words of one observer, ‘[N]ew Russian propaganda entertains, confuses and overwhelms the audience’.” In the face of this relatively new tactic, there is a desperate need to remove false anti-vaccine content from social media and websites, and to put more pressure on media and news platforms to not provide support for such guests/conversations.

Crowd-Control Weapons – Are They Really Non-Lethal?
The term “non-lethal” or “less-than-lethal” gets thrown around a lot when it comes to crowd/riot-control weapons but just how non-lethal are these methods if they’re overused? Physicians for Human Rights (PHR) dug into this very issue because frankly, the use of these weapons is quite common and if they’re not used properly, or with the proper training, they can be devastating. Routine use or misuse of agents like tear gas can be deadly. The PHR conducted several investigations into their use by governments in Bahrain, Georgia, Kashmir, Turkey, and other countries and ultimately, what they found was some pretty startling misuse that can result in long-term health outcomes or even death. They put together a report and factsheets on specific “non-lethals” like acoustic weapons, rubber bullets, stun grenades, tear gas, and even water cannons. Within each factsheet, you can read about the history, how they work, device types, health effects, legality of use, and considerations and policy recommendations. Within the report, they reviewed usage of the weapons including things like people who suffered injuries or even death. As protests occur in China, the use of sonic weapons for crowd control are a very real reminder of the fine line we walk when using “non-lethals”.

Ebola Outbreak Updates and Vaccine Approval 
This week, the European Medicines Agency (EMA) approved the V920 vaccine for Ebola Virus Disease (EVD) and it is already being administered in the Democratic Republic of the Congo. The ongoing EVD outbreak in the Democratic Republic of the Congo (DRC) started in August 2018 and has now exceeded 3,000 cases and 2,000 deaths. Since the 2014-15 outbreak in West Africa, advances in medical research produced new vaccination and therapeutic options. The V920 vaccine, developed and produced by Merck, was tested during the outbreak and showed a 97% efficacy rate and protects against the Zaire species, which is the strain responsible for the current outbreak. Johnson-and-Johnson is also beginning trials for its investigational EVD vaccine. Johnson-and-Johnson’s vaccine requires two doses, a barrier for patient compliance, and does not contain any antigens from the Ebola Bundibugyo species of the virus. Dr. Dan Lucey, professor of medicine at Georgetown University, wrote an editorial in the British Medical Journal about the new treatments for EVD. Dr. Lucey’s article reviews the findings and shortcomings of the four-arm randomized controlled trial (RCT) evaluating the efficacy of four potential EVD treatments: ZMapp, remdesivir, mAb114, and REGN-EB3. The RCT was discontinued when a strict statistical threshold for decreased mortality was reached REGN-EB3, a monoclonal antibody drug. The punchline for the efficacy of REGN-EB3 is that it is efficacious if administered during the early stage of the disease but not as the diseases progresses. Lucey recommends continuing research on EVD treatments that are successful at later stages of the diseases. Last but not least, the article applauds the rigor and difficulty of this randomized-controlled trial given it was conducted during the outbreak, making it a precedent-setting achievement.

GMU Biodefense Alum Changing the Face of Aerospace Physiology 
We’re excited to share some of the achievements of one of GMU’s biodefense alum – Nereyda Sevilla, a May 2017 doctoral graduate in Biodefense, who is a civilian aerospace physiologist for the Defense Health Agency working as Acting Director of the Military Health System Clinical Investigations Program. She was also recently awarded the Air Force Medical Service Biomedical Specialist Civilian of the Year Award and the Air Force Meritorious Service Medal. If you’d like to see more of Nereyda’s hard work in action, check out the article she and the Spatiotemporal Epidemiologic Modeler (STEM) Team published in the Sept 2019 edition of Health Security,  “STEM: An Open Source Tool for Disease Modeling.” (Volume 17, Number 4, 2019).

Phase 3 Trial of Modified Vaccinia Ankara Against Smallpox
In the last Pandora Report, we discussed the FDA approval of the new smallpox vaccine JYNNEOS, that was tested by USAMRIID. The vaccine, developed by biotechnology company Bavarian Nordic, will enter the market under the name JYNNEOS. You can read about the Phase 3 efficacy trial of JYNNEOS (a modified vaccinia Ankara, MVA) as a possible vaccine against smallpox in the latest New England Journal of Medicine. GMU Biodefense professor and director of the graduate program, Dr. Gregory Koblentz noted that one of the key findings of this Phase 3 efficacy trial is that even though the FDA has approved a two-dose regimen for MVA (since it is a non-replicating vaccine that uses an ), a single dose of MVA provided the same level of protection as a single dose of the replicating vaccinia vaccine ACAM 2000. “At day 14, the geometric mean titer of neutralizing antibodies induced by a single MVA vaccination (16.2) was equal to that induced by ACAM2000 (16.2), and the percentages of participants with seroconversion were similar (90.8% and 91.8%, respectively).” An additional advantage of MVA over ACAM 2000 is that the former can be administered by a subcutaneous injection while the latter requires scarification through the use of a bifurcated needle. The article concludes that “No safety concerns associated with the MVA vaccine were identified. Immune responses and attenuation of the major cutaneous reaction suggest that this MVA vaccine protected against variola infection.”

Key Global Health Positions – A Who’s Who in the U.S. Government
Have you ever wondered who helps support global health within the U.S. government?  The Kaiser Family Foundation (KFF) has created a substantial list on not only the positions, but also who (if anyone) is occupying them. From the Department of Health and Human Services to the Department of the Treasury, you’ll want to utilize this list to not only realize the scope of global health efforts within the USG, but also who you might need to get in touch with.

Stories You May Have Missed:

  • African Swine Fever Continues to Spread in Asia – Unfortunately, this outbreak isn’t showing signs of letting up… “The update shows new outbreaks in Vietnam, Cambodia, Laos, the Philippines, South Korea and on the Russian side of the Chinese border reported during the first week of November. Meanwhile, formal confirmation is awaited of ASF outbreaks in Indonesia. The FAO reports that more than 4,500 pigs are said to have died in 11 regencies/cities in North Sumatra. Dead pigs were also found in a river. FAO is liaising with the Indonesian authorities to ‘confirm the cause and explore needs’.”

Pandora Report: 10.11.2019

 

GMU Biodefense Graduate Program Open House
Have you considered expanding your education and experiences through a graduate degree in biodefense? Learn more about our MS (online and in-person) and PhD programs in our upcoming Open Houses! The Master’s Open House will be held on Thursday, October 17th at 6:30pm at our Arlington campus, and the PhD Open House will be on Thursday, November 7th, at 7pm at the Fairfax campus. We invite you to learn more about our programs by attending an open house. You will have the opportunity to discuss our graduate programs with program directors, faculty, admissions staff, current students, and alumni. The current schedule is reflected below, but be sure to sign up for emails from the Schar School’s Graduate Admissions Office to be notified of future admissions events!

What Can We Glean from a Bean: Ricin’s Appeal to Domestic Terrorists
GMU biodefense doctoral student Stevie Kiesel breaks down the use of ricin and its application as an agent of domestic terror. “Just as policymakers have been slow to acknowledge and act upon the threat of domestic CBRN terrorism, timely extant research on the issue is scarce as well. In this article, I focus on ricin as an agent of domestic terror. As government agencies acknowledge the threat domestic terrorism poses, policymakers and law enforcement should take ricin seriously as a potential weapon. To understand the plausibility of ricin’s use as a weapon, I reviewed a number of journal articles, news articles, and court records from 1978 through 2019 and compiled data on 46 incidents of ricin acquisition and/or use. Of these 46 incidents, 19 could be credibly tied to terrorism, 19 were not related to terrorism, and 8 were unclear. The most common motivation after terrorism was murder (10 instances). Of the 19 terrorist incidents, 58% were committed by extreme right-wing terrorists, a term that here encompasses the following ideologies: neo-Nazi/neo-fascist, white nationalist/supremacist/separatist, religious nationalist, anti-abortion, anti-taxation, anti-government, and sovereign citizen.”

GMU One Health Day Panel Discussion                                          Save the date for this November 5th event sponsored by the GMU Next Gen Global Health Security Network and the GMU Biodefense Discussion Group. “One Health Day is November 3 – Connecting Human, Animal, and Environmental Health. One Health is the idea that the health of people is connected to the health of animals and our shared environment. Learn why One Health is important and how, by working together, we can achieve the best health for everyone. [CDC} Did you know that animals and humans often can be affected by many of the same diseases and environmental issues? Some diseases, called zoonotic diseases, can be spread between animals and people. More than half of all infections people can get can be spread by animals – a few examples include rabies, Salmonella, and West Nile virus.” On November 5th, you can listen to the panel from 5-7:10pm in Van Metre Hall at the GMU Arlington Campus. Panel members include Michael E. von Fricken,  PhD, MPH   GMU Global Health and Community Health Security, Dr Jason Hanson,   DVM, PhD, DACVPM,  Associate Editor at Program for Monitoring Emerging Diseases, Willy A. Valdivia-Granda, CEO, ORION INTEGRATED BIOSCIENCES, INC., and Dr Taylor Winkleman,  DVM, CEO, Winkleman Consulting, LLC. “This panel will discuss emerging ONE HEALTH approaches through the various lens of their real world experiences in the world of Global and Community Health, national security arenas, and the international biodefense security domain. Discussions and interactions with the audience will address insightful views of innovation and emerging technology developments for biodefense leveraging data mining, genomics of infectious diseases, implementation of algorithms for the development of medical countermeasures against known and unknown biothreats, one health biosurveillance challenges in detecting infectious diseases, and strategies for integrating the efforts of health security professionals and biotech experts working together to improve the health of people, animals — including pets, livestock, and wildlife —as well as the environment. Common types of professionals involved in One Health work include disease detectives, human healthcare providers, veterinarians, physicians, nurses, scientists, ecologists, as well as policy makers.”

Ebola Outbreak Updates
After two weeks of halted response efforts due to security concerns, things are resuming in the DRC. “The WHO said though the decline in cases is encouraging and gains have been made in the response, several challenges remain and that the current trends should be interpreted with caution.” On Wednesday, case counts reached 3,207 with 2,144 deaths and 441 suspected cases being investigated. There was concern over a Swedish patient admitted for Ebola testing, but results have come back negative.

Biosafety Levels in Laboratories – Whats the Difference?
We throw around the term “BSL-4” around a lot, but how well do you actually know the different biosafety levels? “The United States is home to several types of laboratories that conduct medical research on a variety of infectious biological agents to promote the development of new diagnostic tests, medical countermeasures, and treatments. To promote safe medical research practices in laboratories studying infectious agents, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health have established four BSLs. The levels consist of requirements that have identified as protective measures needed in the laboratory setting to ensure the proper management of infectious agents to avoid accidental exposure or release into the environment. The BSL designations, ranked from lowest to the highest level of containment, are BSL-1, BSL-2, BSL-3, and BSL-4. The BSL designations outline specific safety and facility requirements to achieve the appropriate biosafety and biocontainment. The BSL is assigned based on the type of infectious agent on which the research is being conducted. The CDC has designed an infographicto help visualize the differences between each level. Each level builds on the previous level, adding additional requirements.”

African Swine Fever: An Unexpected Threat to Global Supply of Heparin
In a conversation I never thought I’d have in healthcare…the outbreak of African swine fever (ASF) is hitting heparin supplies at a global level – what a prime example of One Health! “Since August 2018, China has culled more than one million pigs in efforts to contain the spread of ASF within the country. Widespread culling of pigs consequently affects the supply of raw materials needed to produce heparin, which is derived from mucosal tissues in pig intestines. Heparin is a critical anticoagulant drug used to treat and prevent the formation of blood clots in blood vessels in healthcare. As pig herds continue to become infected and culled, should the United States form contingency plans in the event of a heparin shortage?”

Getting Ahead of Candida auris 
“As IDWeek 2019 continued into the weekend, there was no shortage of information for those seeking to prevent and control infectious diseases. For many of us, the threat of antimicrobial resistance has been a major challenge and one for which guidance is desperately needed. Challenging organisms, like Candida auris, make infection prevention efforts in health care that much more difficult and patient care intrinsically more dangerous. In a presentation at the meeting, the presenting author and medical epidemiologist, Snigdha Vallabhaneni, represented the US Centers for Disease Control and Prevention (CDC), while co-authors included experts from health care and public health from California, Connecticut, and CDC.  Researchers emphasized that over 1600 patients have been identified in the United States to have C auris infections or colonization. Of those confirmed cases, risk factors were identified, which include high-acuity post-acute care admissions – like long-term acute care hospitalizations, colonization with carbapenemase-producing organisms (CPOs), or hospitalization abroad.”
 
2019 White House Summit on America’s Bioeconomy
“On October 7, 2019, The White House hosted the Summit on America’s Bioeconomy. The Summit marked the first gathering at The White House of our Nation’s foremost bioeconomy experts, Federal officials, and industry leaders to discuss U.S. bioeconomy leadership, challenges, and opportunities. The bioeconomy represents the infrastructure, innovation, products, technology, and data derived from biologically-related processes and science that drive economic growth, improve public health, agricultural, and security benefits. Bioeconomy outputs are incredibly diverse, and future applications limitless in terms of both application and value, including new ways to treat cancer; enable novel manufacturing methodologies for medicines, plastics, materials, and consumer products; create pest and disease resistant crops; and support DNA-based information systems that can store exponentially more data than ever before. Advances realized over the past two decades have resulted from the unique U.S. innovation ecosystem and the convergence between biology and other disciplines and sectors, such as nanotechnology and computer science. The U.S. bioeconomy – spanning health care, information systems, agriculture, manufacturing, national defense, and beyond – is growing rapidly with increasing impact on our Nation’s vitality and our citizens’ lives. Biotechnology represents 2% of the U.S. GDP, or $388 billion. To remain a world leader in the bioeconomy, the U.S. must foster an ecosystem that puts innovative research first in addition to promoting a strong infrastructure, workforce, and data access framework.”

Social Media and Vaccine Hesitancy                                                    As of this year, vaccine hesitancy is listed one of the WHO’s 10 big threats to global health. Vaccine hesitancy is the foot-dragging or refusal to vaccinate yourself or your children, when vaccines are available. Social media are platforms for the dissemination of both accurate and inaccurate information regarding vaccine safety and benefits. Unfortunately, vaccine content shared on social media is overwhelmingly anti-vaccine material and often lacking scientific or medical evidence. According to Ana Santos Rutschman at Saint Louis University, malicious bots are being used to more efficiently disseminate vaccine misinformation on these platforms. Fortunately, major platforms are instituting policies to curb the spread of vaccine misinformation and support the spread of accurate information from credible sources. Though misinformation remains abundant online, these new policies are promising steps toward eliminating erroneous data. Santos Rutschman “believe[s] social media can and should be redesigned to facilitate the promotion of accurate vaccine information.”

Stories You Might Have Missed:

  • UK Report Cites Lack of AMR Progress-“A paper issued yesterday by policy institute Chatham House concludes that not enough progress has been made on recommendations from a series of reports that alerted the world to the rising threat of antimicrobial resistance (AMR). The AMR Review, commissioned in 2014 by former UK Prime Minister David Cameron and chaired by British economist Lord Jim O’Neill, outlined the threat of AMR to global public health and highlighted the potential costs of inaction in eight separate reports issued over 2 years. Among the highlights from the first AMR Review paper were two startling figures—that drug-resistant infections could cause the deaths of 10 million people by 2050 and could cost the global economy up to $100 trillion if the problem was not addressed in the coming years.”

 

 

Pandora Report: 10.4.2019

What’s New with Novichoks?
Gregory Koblentz, Director of the Biodefense Program, and Stefano Costanzi, a chemistry professor at American University, have published an article in The Nonproliferation Review about recent efforts to add Novichok nerve agents to the Chemical Weapons Convention’s list of Schedule 1 chemicals which are subject to the highest level of verification. Novichok become a household word after Russian agents used this new type of chemical weapon in the attempted assassination of Sergei and Julia Skripal in Salisbury, United Kingdom in March 2018, but there is still a good deal of public confusion about this family of nerve agents. In “Controlling Novichoks After Salisbury: Revising the Chemical Weapons Convention Schedules,” Koblentz and Costanzi clarify the identity of the nerve agent  used in the Salisbury incident and evaluate two proposals regarding Novichoks that will be considered by the Organization for the Prohibition of Chemical Weapons (OPCW) in November. This will be the first time the CWC’s Schedules have been revised since the  treaty was opened for signature in 1993.

Bipartisan Commission on Biodefense Cyberbio Convergence Recap & The Germy Paradox
GMU Biodefense graduate student Georgia Ray has provided us with a detailed summary of this Commission event. We’d also like to show off her blog, Eukaryote Writes, which just so happens to delve into bioweapons and how close we’ve gotten to actual use. Georgia notes “I’ve heard a lot about ‘nuclear close calls.’  Stanislav Petrov was, at one point, one human and one uncomfortable decision away from initiating an all-out nuclear exchange between the US and the USSR. Then that happened several dozen more times. As described in Part 1, there were quite a few large state biological weapons programs after WWII. Was a similar situation unfolding there, behind the scenes like the nuclear near-misses?” In Georgia’s in-depth review of the Cyberbio Convergence event, she notes that “Tom Dashchle described biosecurity as a cause area with ‘broad support but few champions’ and agreed with the importance of creating career paths and pipelines into the field. (Great news for optimistic current Biodefense program students like myself.) The panel also agreed on the importance of education starting earlier, through STEM education and basic numeracy skills.”

1918/1919 Pandemic Museum Exhibit
Check out the Mutter Museum for a permanent exhibit on the influenza pandemic that hit Philadelphia, PA. “On Sept. 28, 1918, in the waning days of World War I, over 200,000 people gathered along Broad Street in Philadelphia for a parade meant to raise funds for the war effort. Among the patriotic throngs cheering for troops and floats was an invisible threat, which would be more dangerous to soldiers and civilians than any foreign enemy: the influenza virus. Officials went ahead with the parade despite the discouragement of the city health department about the ever-spreading virus. Within 72 hours of the parade, all the hospital beds in Philadelphia were full of flu patients. Within six weeks, more than 12,000 people died — a death every five minutes — and 20,000 had died within six months.” Named “Spit Spreads Death”, the exhibit opens on October 17th and will include interactive maps, artifacts, and images. Personal stories and accounts from historians brings this exhibit to life and drives home the message.

The Story of Technology
GMU biodefense doctoral alum Dr. Daniel Gerstein has the latest book for you to add to the reading list – The Story of Technology.  “Technology–always a key driver of historical change–is transforming society as never before and at a far more rapid pace. This book takes the reader on a journey into what the author identifies as the central organizing construct for the future of civilization, the continued proliferation of technology. And he challenges us to consider how to think about technology to ensure that we humans, and not the products of our invention, remain in control of our destinies? In this informative and insightful examination, Dr. Daniel M. Gerstein–who brings vast operational, research, and academic experience to the subject–proposes a method for gaining a better understanding of how technology is likely to evolve in the future. He identifies the attributes that a future successful technology will seek to emulate and the pitfalls that a technology developer should try to avoid. The aim is to bring greater clarity to the impact of technology on individuals and society.” As General David Petraeus (former commander of the troop surge in Iraq, US Central Command, and Coalition Forces in Afghanistan, and former director of the CIA), noted “Gerstein brings a unique perspective to The Story of Technology, as both a national security expert and a technologist. He examines, in a compelling fashion, the inextricable link between humans and technological advancement—and specifically how the latter has granted America security, economic, and societal advantages. But he also cautions, rightly, that many of the foundations on which these advantages have been built are eroding, threatening our interests and perhaps even redefining what it means to be human. This book is a must-read for our national leaders, technology specialists, and general readers alike.”

Starting with the focus on food safety that we saw within the FDA Food Safety Modernization Act (FSMA), the FDA is launching a new tool to help ensure food safety and security occurs in the U.S. “The new Food Safety Dashboard launched today is part of FDA-TRACK, which is one tool the FDA uses to monitor certain FDA programs through key performance measures and projects, and regularly updates to ensure transparency to the public. While we expect that it will take several years to establish trends in the data, the initial data show that since 2016, the majority of companies inspected are in compliance with the new requirements of the preventive control rules. Additional FDA data also show that overall, industry has improved the time it takes to move from identifying a recall event to initiating a voluntary recall, from an average of four days in 2016 to approximately two days in 2019. In fact, comparing the FSMA data with our recall data shows the bigger picture, demonstrating the effectiveness of preventive measures as food recalls once again have reached a five-year low.”
Ebola Outbreak Update
As cases continue to be identified, albeit slowly (total is now 3,198),  much focus has been on community resistance as new research is being released. Researchers “explored community resistance using focus group discussions and assessed the prevalence of resistant views using standardized questionnaires. Despite being generally cooperative and appreciative of the EVD response (led by the government of DRC with support from the international community), focus group participants provided eyewitness accounts of aggressive resistance to control efforts, consistent with recent media reports. Mistrust of EVD response teams was fueled by perceived inadequacies of the response effort (“herd medicine”), suspicion of mercenary motives, and violation of cultural burial mores (“makeshift plastic morgue”). Survey questionnaires found that the majority of respondents had compliant attitudes with respect to EVD control. Nonetheless, 78/630 (12%) respondents believed that EVD was fabricated and did not exist in the area, 482/630 (72%) were dissatisfied with or mistrustful of the EVD response, and 60/630 (9%) sympathized with perpetrators of overt hostility. Furthermore, 102/630 (15%) expressed non-compliant intentions in the case of EVD illness or death in a family member, including hiding from the health authorities, touching the body, or refusing to welcome an official burial team.” GMU Biodefense doctoral alum Saskia Popescu notes that “This research shed light on many of the suspected social dynamics that challenge response efforts but also delved into detail of what is needed to refine education and community outreach to truly be effective.” The U.K. has issued Tanzania travel warnings over a probable Ebola death. “The U.K. advised travelers to Tanzania to be aware of a ‘probable’ Ebola-related death in the East African nation, its Foreign and Commonwealth Office said Tuesday in a statement on its website. About 75,000 British nationals visit Tanzania every year, it said.”
James F. McDonnell, a presidential appointee who over the last two years downsized the Department of Homeland Security’s efforts to prevent terrorism involving weapons of mass destruction, has agreed to resign. McDonnell’s resignation, department sources said, comes at the request of acting Homeland Security Secretary Kevin McAleenan and would become effective at noon on Thursday, according to an email McDonnell sent his staff at 12:57 p.m. EDT on Wednesday. McDonnell’s seven-sentence memo did not provide a reason for his resignation, saying only it was ‘time for a new leadership team to take things to the next level’.”
“Perhaps one of the increasingly more apparent challenges of battling antimicrobial resistance is that of surveillance. This presentation by Michael Y. Lin, MD, MPH, of Rush University Medical Center, discussed the Illinois XDRO Registry. Created in 2013, this data source for XDROs focuses on carbapenem-resistant Enterobacteriaceae (CRE), carbapenemase-producing Pseudomonas aeruginosa, and Candida auris. The registry essentially allows health care facilities to access data to identify if patients being admitted have a history of colonization or infection with the aforementioned organisms.  Data is submitted through hospitals and allows for alerts to be created, automatically, which are sent via email, page, or even a text to the hospital’s infection preventionist when the patient is admitted. Perhaps one of the increasingly more apparent challenges of battling antimicrobial resistance is that of surveillance. This presentation by Michael Y. Lin, MD, MPH, of Rush University Medical Center, discussed the Illinois XDRO Registry. Of those patients who were unknown to the facilities, 33% were not in contact precautions when the alert occurred, indicating that it is highly beneficial for reducing disease transmission.”

Stories You May Have Missed:

  • EEE Cases Continue in Michigan – “The threat from Eastern Equine Encephalitis is continuing to grow, especially in Michigan where state health officials now say 12 counties have confirmed having human or animal cases of EEE. The mosquito-borne virus usually infects only about seven people annually, but there have been 28 human cases reported so far this year across the country. Nine people have died.”

 

Pandora Report: 9.19.2019

This week your dose of biodefense news is arriving a bit early – what a way to kick off the weekend! Flipper fans will be sad to hear that dolphins are a new source for antibiotic resistance.

Russian Virology Research Center Hit By Blast/Fire
In perhaps not the best of places to have a gas-cylinder explosion, the Russian Virology Center, Vektor, is causing a bit of concern around the world. Cue the conversations regarding the destruction of smallpox stockpiles…”Russia’s consumer-safety watchdog Rospotrebnadzor said on September 16 that one worker was sent to hospital for third-degree burns suffered in the incident at the State Research Center of Virology and Biotechnology (Vector) near the Russian city of Novosibirsk. It added that no biohazardous substances were present in the sanitary inspection room at the time of the fire. The city’s mayor, Nikolai Krasnikov, said the laboratory, on the fifth floor of a six-story building in the city of Koltsovo, was undergoing renovation and repair work at the time of the incident. All glass in the building was said to have been broken in the blast. A fire covering about 30 square meters was extinguished after the explosion. In the 1970-1980s, the research center developed biological and bacteriological weapons, as well as means of protection against them.”

Preparedness for a High-Impact Respiratory Pathogen Pandemic
The Johns Hopkins Center for Health Security has just released their report, which “examines the current state of preparedness for pandemics caused by ‘high-impact respiratory pathogens’—that is, pathogens with the potential for wide- spread transmission and high observed mortality. Were a high-impact respiratory pathogen to emerge, either naturally or as the result of accidental or deliberate release, it would likely have significant public health, economic, social, and political consequences. Novel high-impact respiratory pathogens have a combination of qualities that contribute to their potential to initiate a pandemic. The combined possibilities of short incubation periods and asymptomatic spread can result in very small windows for interrupting transmission, making such an outbreak difficult to contain. The potential for high-impact respiratory pathogens to affect many countries at once will likely require international approaches different from those that have typically occurred in geographically limited events, such as the ongoing Ebola crisis in Democratic Republic of the Congo (DRC).”

UK Vaccine Network – Mapping Pathogens of Pandemic Potential
Do you know what the United Kingdom is doing to develop vaccines against pandemic pathogens? “During the 2013–2016 Ebola outbreak in West Africa an expert panel was established on the instructions of the UK Prime Minister to identify priority pathogens for outbreak diseases that had the potential to cause future epidemics. A total of 13 priority pathogens were identified, which led to the prioritisation of spending in emerging diseases vaccine research and development from the UK. This meeting report summarises the process used to develop the UK pathogen priority list, compares it to lists generated by other organisations (World Health Organisation, National Institutes of Allergy and Infectious Diseases) and summarises clinical progress towards the development of vaccines against priority diseases. There is clear technical progress towards the development of vaccines. However, the availability of these vaccines will be dependent on sustained funding for clinical trials and the preparation of clinically acceptable manufactured material during inter-epidemic periods.”

Global Preparedness Monitoring Board
In their very first report, the GPMB “reviewed recommendations from previous high-level panels and commissions following the 2009 H1N1 influenza pandemic and the 2014-2016 Ebola outbreak, along with its own commissioned reports and other data. The result is a snapshot of where the world stands in its ability to prevent and contain a global health threat.” The report includes actions for leaders to take, like commitment and investment from heads of government, building strong systems, and preparing for the worst. For example, they note that “Donors, international financing institutions, global funds and philanthropies must increase funding for the poorest and most vulnerable countries through development assistance for health and greater/earlier access to the United Nations Central Emergency Response Fund to close financing gaps for their national actions plans for health security as a joint responsibility and a global public good. Member states need to agree to an increase in WHO contributions for the financing of preparedness and response activities and must sustainably fund the WHO Contingency Fund for Emergencies, including the establishment of a replenishment scheme using funding from the revised World Bank Pandemic Emergency Financing Facility.”

Blue Ribbon Study Panel Becomes Bipartisan Commission on Biodefense
At their latest event, the Blue Ribbon Study Panel announced it would be “taking on a new name to more accurately reflect its work and the urgency of its mission. Effective immediately, the organization now will be known as the Bipartisan Commission on Biodefense. ‘We do not simply study the problem,’ said Executive Director Dr. Asha M. George. ‘We conduct our activities with a self-imposed mandate and the same sort of urgency that congressional commissions demonstrate. Moving forward, we will be the Bipartisan Commission on Biodefense. Our leadership team and unyielding focus remain unchanged.’ The organization was established in 2014 to comprehensively assess the state of U.S. biodefense, and to issue recommendations to foster change. The Commission will continue to be co-chaired by former Senator Joe Lieberman and former Governor Tom Ridge, the first Secretary of Homeland Security.”

NAS Workshop – Public-Private Partnerships for Global Health at the National, Municipal, and Community Levels
Don’t miss this National Academies event on October 23rd and 24th in Washington, D.C. “The National Academies’ Forum on Public-Private Partnerships for Global Health and Safety is convening a 1.5 day workshop to examine the enabling environments for public-private partnerships (PPP’s) at the national, municipal, and community levels. Panelists will provide case studies that focus on the mechanics of building a partnership in a region, the conditions the private sector needs to establish itself in a region, and how a country becomes PPP-ready to accept private partners. The panelists will include: the private sector actors who established a business in a region; the government representative who worked with the private sector actors to create the conditions for private sector involvement; and the intermediary who helped to facilitate the partnership. Additionally, local business owners who distribute the products from larger businesses, or that develop their own businesses within a region, will be brought in to discuss the conditions they need at the local level to form sustainable business models. Intermediaries that work to facilitate global partnerships will also give a broader view of how partnerships are enabled.”

Efforts to Reduce Nosocomial Ebola Transmission
Today there were 15 new cases of Ebola virus reported in the DRC, bringing the case counts to 3,145. Ongoing violence has been a concern, but the growing number of nosocomial infections is also worrisome. “In the wake of this outbreak, the threat of health care-associated infections has grown and thus far 18% of the outbreak cases are nosocomial. The ability for hospitals and treatment centers to act as amplifiers in the middle of an outbreak is not a novel concept. Unfortunately, this number is deeply concerning and represents critical breakdowns in infection control measures. In addition to the avoidable cases, the high number of nosocomial cases is also a driving factor for many to avoid care within the treatment centers. Consider an already skeptical community, and now include the fact that nearly 1 out of 5 cases occur as a result of exposure within a medical setting. Not only can this fuel fear and apprehension to seek care within the community, but it also can put health care workers in danger. In response to this trend, the WHO is partnering up with agencies like the United Nations Children’s Fund, and the US Centers for Disease Control and Prevention (CDC) to help boost health care response and infection prevention in the 3000 nurses, physicians, and health care workers responding to the outbreak.”

Big Pharma Drops New Drugs Despite Drying Antibiotic Pipeline
Despite the continued warnings of the drying antibiotic pipeline and the growing threat of antimicrobial resistance, the pharmaceutical world has shown little interest in investing in the production of new antimicrobials. These costly efforts are a considerable hurdle for companies as a new class of antibiotics is desperately in need. “According to an in-depth report from German public broadcaster NDR this week, the reason for this lack of preparation for the impending crisis is simple: Antibiotics simply aren’t profitable. Antibiotics are only used for a few days once in a while, and are being prescribed less as doctors become more aware of the dangers of overprescription. Instead, drug companies are focusing on lucrative medications for chronic conditions such as high cholesterol, arthritis, epilepsy and cancer. Johnson & Johnson, Sanofi, Pfizer, AstraZeneca, Novartis, Otsuka and many others have all gutted their antibiotic development teams and moved those budgets elsewhere. This is despite a 2016 pledge signed by over 100 companies, including Johnson & Johnson and Novartis, saying they would help prevent the next epidemic by investing in ways to combat the rise of antibiotic-resistant superbugs.”

Stories You May Have Missed:

  • Rising Cases of EEE in Massachusetts – “Eastern equine encephalitis (EEE) virus—a rare but often fatal mosquito-borne virus—has been found in Massachusetts for the first time since 2013. Since the beginning of August, seven people in the state have tested positive for the virus, and one woman from Bristol County has died from the illness. State officials have additionally found the virus in 400 mosquito samples.”
  • The Future of Duodenoscopes – “Over the years, these scopes have shown a propensity for making the transmission of multidrug-resistant organisms easier than we anticipated. There continues to be a strong infection control and regulatory focus on reprocessing to ensure patient safety. The flexible medical devices are used to help visualize and assess not only the small intestine, but also the pancreas and bile ducts. Since they products are reusable, the complex, error-prone process of reprocessing becomes critical to avoid disease transmission between patients. Unsurprisingly, there has been increased pressure to move to avenues that reduce the risk for patient exposure and promote safety during these procedures. On August 29, 2019, the US Food and Drug Administration (FDA) put forth a recommendation that both duodenoscope manufacturers and health care facilities alike, should move towards those scopes with disposable components, specifically the endcaps.”

 

Pandora Report: 9.13.2019

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

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

Pandora Report: 9.6.2019

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

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

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

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

Pandora Report: 8.30.2019

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

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

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

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

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

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

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

Stories You May Have Missed:

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

Pandora Report: 8.23.2019

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

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

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

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

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

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

Stories You May Have Missed:

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

 

Pandora Report: 8.16.2019

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

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

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

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

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

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

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

Stories You May Have Missed:

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

Pandora Report: 8.9.2019

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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