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: 8.2.2019

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

Pandora Report: 7.26.2019

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

 

Pandora Report 7.19.2019

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

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

Pandora Report: 7.12.2019

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

Pandora Report: 6.28.2019

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

 

Pandora Report 11.16.2018

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

 

 

Pandora Report 9.28.2018

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

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

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

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

 

Pandora Report 8.17.2018

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

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

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

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

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

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

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

Stores You May Have Missed:

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

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

Pandora Report 6.22.2018

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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