Pandora Report 2.2.2018

by spopescu, posted in Pandora Report

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

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

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

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

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

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

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

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

Stories You May Have Missed:

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

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

Pandora Report 1.26.2018

by spopescu, posted in Pandora Report

In this week’s Pandora Report we’re taking a trip down the horsepox synthesis rabbit hole, looking at influenza transmission, and so much more. But first..the Bulletin of the Atomic Scientists just announced that the Doomsday Clock has been moved and is now two minutes to midnight. You can also read the full testimony from Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security, during the US Senate Committee hearing on the reauthorization of the Pandemic and All-Hazards Preparedness Act. The Senate has also just confirmed Alex Azar as the new head of Health and Human Services.

The Perilous Road of Horsepox Synthesis 
Unless you were in a state of flu-induced delirium, last Friday was a rather big day in with world of dual-use research of concern (DURC) news. The controversial publication of Dr. Evans’ synthesis of horsepox has brought about a flurry of discussion and debate regarding the implications of not only such research, but also the publication of it. Kai Kupferschmidt provided an overview of the history of this paper and what its publication means, so if you’re needing a refresher, I’d start there. As many within the biodefense and biosecurity industry read the paper, it sparked a renewed concern for how such research has exhumed a gap within DURC oversight and publication review. GMU’s biodefense guru and graduate program director Gregory Koblentz expanded upon his thoughts regarding these oversight failures. Pointing to not only the utter disaster that a smallpox re-emergence would be, he also evaluates the PLOS editorial statement and review of DURC work. “Given the serious potential risks that this research could be used to recreate variola virus, the blanket assertion by the PLOS Dual-Use Research Committee that the benefits of this research outweighs the risks is woefully insufficient. The committee dramatically understates the risks and overestimates the benefits this research presents. The U.S. government has outlined a number of factors to consider and questions to ask about dual-use research when weighing the risks and benefits of conducting and publishing such research. Although this research did not fall under current U.S. regulations on dual-use research of concern, the authors and publisher were well aware of the risks that I and others had raised and they had an ethical responsibility to carefully consider those risks before publishing the article.” NTI’s Dr. Elizabeth Cameron, VP of Global Biological Policy and Programs, weighed in on the publication and how it underlines the need for dialogue at a global level to reduce biological risks. Cameron notes that these hurdles aren’t getting smaller and the incremental approach just isn’t getting us where we need to be. “Moving forward, it’s clear that the capability to create and modify biological agents is outpacing governmental oversight and public debate. Now more than ever, scientific stakeholders, private sector actors, and biotechnology leaders should develop and take specific actions to mitigate risk and accelerate biosecurity innovation.” Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security, has also put forth commentary on the horsepox synthesis, pointing to the lack of clear-cut benefits and and that ultimately, it created a new risk. Inglesby notes that “The most important locus of control should be whether specific research is approved and funded in the first place. When scientists are considering the pursuit of research that has the potential to increase highly consequential national population-level risks, national authorities and leading technical experts on those issues should be part of the approval process. When there are highly consequential international population-level implications, international public health leaders should also be involved. When researchers put forth claims about potential benefits of this work to justify extraordinary risks, those claims ought not be accepted without discussion; those claims should instead be examined by disinterested experts with the expertise to validate or refute them.” GMU biodefense PhD student and infection preventionist Saskia Popescu also discussed the importance of this publication and why medical providers and researchers should be paying attention to the DURC debate.

ASM Biothreats
The American Society for Microbiology will be hosting their annual conference on biological threats from February 12-14 in Baltimore, MD. If you’re not able to attend, we’ve got you covered with in-depth reporting and analysis by some of GMU’s finest biodefense graduate students. Following the conference, we’ll be providing this report-out as we did with the 2017 conference, so make sure to check back for the scoop on all things ASM Biothreats.

Chemical Weapons – No Impunity
The International Partnership Against the Impunity for the Use of Chemical Weapons has just been launched! “Ringing together around 30 countries and international organizations, its purpose is to supplement the international mechanisms to combat the proliferation of chemical weapons. This intergovernmental initiative deals exclusively with the issue of impunity for the perpetrators of chemical attacks worldwide, and is a forum for cooperation in which the participating States have made several commitments that include gathering, compiling, and retaining all available information on those who use chemical weapons, etc.” Efforts like this are increasingly needed as the use of chemical weapons in Syria has been met with little adverse outcome for those at fault. GMU’s Dr. Gregory Koblentz highlighted Syria’s CW killchain, noting that “Bringing these criminals to justice, however, will be a long, slow, and difficult process. Many individuals who comprise Syria’s chemical weapons kill chain were listed in a U.N. Security Council resolution that was vetoed by Russia and China on Feb. 28.” Koblentz also points out that “So far, the only concrete steps to hold these individuals accountable for their actions are financial sanctions and travel bans imposed by the U.S. and European governments. Although the sanctions themselves are largely symbolic, by identifying these individuals and specifying their role in the chemical attacks, the United States and its European allies are laying the groundwork for future prosecutions once Assad is no longer in power.”

Germ Transmission While Flying
Dr. Nereyda Sevilla, George Mason Biodefense PhD 2017 alum, presented the results of her dissertation at the Transportation Research Board (TRB) 97th Annual Meeting held January 7–11, 2018, at the Walter E. Washington Convention Center, Washington, D.C. The information-packed program attracted more than 13,000 transportation professionals from around the world. Nereyda’s poster entitled “Germs on a Plane:  The Transmission and Risks of Airplane-Borne Diseases” was part of the Young Professional’s Research in Aviation Session.  Her research explored the role of air travel in the spread of infectious diseases, specifically Severe Acute Respiratory Syndrome (SARS), H1N1, Ebola, and pneumonic plague. She concluded that modeling showed that the spread of Ebola and pneumonic plague is minimal and should not be a major air travel concern if an individual becomes infected. On the other hand, H1N1 and SARS have higher infectious rates and air travel will facilitate disease spread across the country.

Schar School Career Fair
Schar School students and employers looking for talented graduate students – on Wednesday, February 14th from 2-5pm, GMU’s Schar School will be hosting a Career Fair at the Arlington campus. “The Schar School of Policy and Government at George Mason University, in conjunction with the School for Conflict Analysis and Resolution, will host our annual career and internship fair that attracts more than one hundred employers from federal, business, and non-profit organizations who are eager to meet our outstanding students.” For our readership – this is also a great place to recruit biodefense students who are passionate about health security!

Nonproliferation Review Call For Papers
Calling all writers of the nuclear, chemical, and biological weapons persuasion – the Nonproliferation Review is accepting manuscripts for publication in 2018! “All submitted manuscripts that are accepted for publication in Volume 25 are eligible to win the Doreen and Jim McElvany prize of $5,000, a $3,000 runner’s-up prize, or a $1,000 honorable mention prize. The deadline to submit is July 6, 2018; however, due to the limited number of pages that we can publish in a single volume, eligible articles will be accepted for publication on a rolling basis. It is therefore in authors’ interest to submit early to ensure consideration for the prize. Submissions must contribute new ideas and insights to the nonproliferation field. The Review’s editors welcome submissions on any topic related to weapons proliferation, including but not limited to chemical, biological, radiological, nuclear, and conventional weapons. Example topics include: activities and developments in international nonproliferation regimes; social, political, and economic dynamics of specific countries and regions with regard to weapons development and/or proliferation; new information on policies or weapons programs of specific countries; the spread of knowledge, materials, or technologies with potential destructive applications; the proliferation of new technologies impinging on international security; measures, either existing or proposed, to control proliferation; the causes of proliferation or nonproliferation; the consequences of proliferation, including its influence on strategic stability and its economic or environmental effects; and the relevant activities of non-state actors, such as nongovernmental organizations or terrorists.”

 Influenza Aerosols
A new study has found that influenza aerosol-spread is more common than previously thought, especially in relation to coughing and sneezing. “To measure transmission, each participant sat in a chamber for 30 minutes with his or her face in a large metal cone, part of a ‘Gesundheit machine’ that captures and measures influenza virus in exhaled breath. Patients were also asked to cough, sneeze, and say the alphabet three times. Altogether, researchers collected 218 nasopharyngeal samples and 218 breathing sample sessions. When the team analyzed the samples, they found that a significant number of patients routinely shed infectious virus—not just RNA particles—into particles small enough for airborne transmission. They were surprised to find that 11 (48%) of the 23 fine aerosol samples acquired when patients weren’t coughing had detectable viral RNA, and of those 8 contained infectious virus, suggesting that coughing isn’t a prerequisite for generating fine aerosol droplets.” The latest news points to not only the importance of staying home when sick, but also the ease of transmission of influenza viruses. While many thought transmission was limited to droplets (i.e. heavier particles that were sneezed/coughed out about three feet), this latest analysis may change the dynamics of isolation.

Stories You May Have Missed:

  • Addressing AMR in Lower-Income Countries – Fighting antimicrobial resistance (AMR) is a global challenge, but we need to ensure that our strategies account for a range of countries and the unique barriers they face. “Although traditional efforts to reduce the spread of antibiotic resistance in these countries have focused on antibiotic use in individuals, LMICs must also address the increasing roles of animal and environmental exposures in this public health crisis, write Maya Nadimpalli, PhD, University of Versailles Saint-Quentin-en-Yvelines, France, and colleagues. ‘In particular, current strategies do not prioritize the impacts of increased antibiotic use for terrestrial food-animal and aquaculture production, inadequate food safety, and widespread environmental pollution,’ the authors stress.”

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

The Synthesis of Horsepox Virus and the Failure of Dual-Use Research Oversight

by Gregory Koblentz, posted in Commentary

On January 19, 2018, the open access scientific journal PLOS One published an article that describes the de novo synthesis of horsepox virus, the first ever synthesis of a member of the orthopoxvirus family of viruses that includes the variola virus that causes smallpox. As I have written about before, this research crosses a red line in the field of biosecurity. Given the high degree of homology between orthopoxviruses, the techniques described in this article are directly applicable to the recreation of variola virus. The synthesis of horsepox virus takes the world one step closer to the reemergence of smallpox as a threat to global health security. That threat has been held at bay for the past 40 years by the extreme difficulty of obtaining variola virus which has been eradicated from nature and is only known to exist in two WHO-designated repositories.

The reemergence of smallpox would be a global health disaster.  Prior to its eradication, smallpox killed an estimated 300 million people, more people than all the wars of the 20th century combined. Most of the world’s population is susceptible to this lethal and contagious disease since routine immunization against smallpox was discontinued after the success of the WHO’s global eradication campaign.

Continue reading “The Synthesis of Horsepox Virus and the Failure of Dual-Use Research Oversight” →

Pandora Report 1.19.2018

by spopescu, posted in Pandora Report

Happy Friday and welcome to your favorite source for all things biodefense! We hope you’re able to avoid the onslaught of respiratory viruses that are circulating right now, but on the off chance that you’re battling a bug, here’s some infectious disease new that won’t get you sick.

Fighting Influenza
Whether you’re fighting the flu or watching the mayhem unfold in the news, you can’t escape influenza right now. We’re getting hit hard with flu season in the United States and the CDC has reported that activity is still rising and we’re not out of the woods yet. You can find the latest flu data here, but what is worrying so many is the hit that hospitals are taking across the country. It’s not just that we’re facing an IV bag shortage due to the devastation Hurricane Maria wreaked upon Puerto Rico, but that hospitals are being overrun with an onslaught of ILI (influenza like illness) patients. Wait times are through the roof, staff are stretched thin, patients are being admitted into overflow areas, hospitals are having to divert patients because they’re so full, triage areas have been set up in parking lots and emergency areas, and hospitals are even struggling to ensure they have enough PPE and influenza tests. This year marks the centennial of the 1918/1919 influenza pandemic, and it seems like what’s going on is out of a history book instead of down the street. As an infection preventionist and infectious disease epidemiologist, it is not surprising or unexpected that we’re running into these issues. It’s easy for people to point to the current situation and use it as an example of why we’re not ready for a flu pandemic – and they’re right, but it shouldn’t take what’s going on to see that. These are not new issues. Infection control and hospital preparedness has been struggling for a long time and it doesn’t take a pandemic to prove it. Even after the surge of funding and focus on hospital preparedness post-Ebola, we still struggle with these issues, but throw in budget cuts and an administration that is set to pull funding away from public health…well, the outlook is dismal.

With so much attention on influenza, pandemic preparedness, and how we’re just not ready for the next great flu pandemic, what kind of household interventions can we apply in our own little ecosystems? Researchers looked at a HPAI H5N1 outbreak and estimated the reduction in primary attack rates for household-based interventions. “We show that, for lower transmissibility strains, the combination of household-based quarantine, isolation of cases outside the household, and targeted prophylactic use of anti-virals will be highly effective and likely feasible across a range of plausible transmission scenarios. For example, for a basic reproductive number (the average number of people infected by a typically infectious individual in an otherwise susceptible population) of 1.8, assuming only 50% compliance, this combination could reduce the infection (symptomatic) attack rate from 74% (49%) to 40% (27%), requiring peak quarantine and isolation levels of 6.2% and 0.8% of the population, respectively, and an overall anti-viral stockpile of 3.9 doses per member of the population.” While we all may not access to anti-virals, the use of quarantine and isolation are all effective strategies. From an infection control standpoint, it can be tough to maintain such efforts in a household where one or two people are sick. When in doubt, wash your hands, cover your cough, and clean those high-touch surfaces/objects!

GMU Biodefense MS Open House
Mark your calendars for the February 21st Master’s Open House at GMU’s Arlington campus! If you’ve been thinking about getting a MS in biodefense (who wouldn’t want to take classes on biosurveillance, historical bioweapons programs, and more?!), this is a great chance to talk to faculty and learn about the admissions process. GMU has biodefense MS programs in person and online, so even if you’re not in the DC-area, you can get your biodefense on.

Smallpox, Horsepox, And The Trouble With Poxviruses
It seems only a few months ago that news broke of a Canadian research team’s de novo synthesis of horsepox. Since then, there has been considerable discussion surrounding not only the biosafety and biosecurity behind research involving an orthopoxvirus, but also the implications of normalizing orthopoxvirus synthesis, and again, if the remaining smallpox stockpiles should be destroyed. The latest report from researchers at the University of Alberta points to the potential smallpox vaccine developments that synthetic viruses could bring. “Virologist David Evans and his research associate Ryan Noyce produced an infectious horsepox virus, which they synthetically reconstructed using a published genome sequence and DNA fragments manufactured entirely by chemical methods. The team went on to show that the synthetic horsepox virus could provide vaccine protection in a mouse model of poxvirus infection.” Unfortunately, the implications of synthesizing an orthopoxvirus aren’t so simple. GMU biodefense professor and program director Dr. Gregory Koblentz evaluated the implications of such synthesis for biosecurity and what would be needed to prevent a reemergence of smallpox. “The synthesis of horsepox virus takes the world one step closer to the reemergence of smallpox as a threat to global health security. That threat has been held at bay for the past 40 years by the extreme difficulty of obtaining variola virus and the availability of effective medical countermeasures. The techniques demonstrated by the synthesis of horsepox have the potential to erase both of these barriers. The primary risk posed by this research is that it will open the door to the routine and widespread synthesis of other orthopoxviruses, such as vaccinia, for use in research, public health, and medicine.” Koblentz notes that while there are potentially legitimate uses for synthesizing orthopoxviruses (safer smallpox vaccine development), it also means that such labs have the potential to produce smallpox from synthetic DNA and emphasized that action is needed now to avoid the misuse of synthetic biology by nefarious actors. “Unfortunately, the current legal and technical safeguards against the synthesis of smallpox virus are weak and fragmented. There is no clear international legal or regulatory framework to prevent the synthesis of smallpox virus. The WHO has a policy banning the synthesis of the smallpox and regulating who can produce and possess large fragments of smallpox DNA, but it hasn’t been widely adopted by states. Furthermore, there is no mechanism—at either the national or international level—for detecting or punishing violations of this policy.” GMU biodefense PhD student Saskia Popescu cited the importance of medical providers understanding the dual-use research of concern debate and that ultimately, biosecurity impacts us all. “From the healthcare perspective, it may not seem like something we should worry about, but the direction of gene editing and dual-use research of concern is something that is intrinsically linked to public health. Nefarious outcomes of such experiments, regardless of the origin or intent, will inevitably make their way into an emergency department, urgent care, or worse, the community. Although we may not be seeing the implications today, as medical providers and healthcare workers, we must keep our ears to the ground, listening for these biotech advancements, and then thinking through what they mean for us tomorrow.”

Blue Ribbon SLTT Ability to Respond to Large Scale Biological Events: Challenges and Solutions
If you missed the Wednesday meeting, here’s a recording to catch up on all things biodefense. “State, Local, Tribal, and Territorial Ability to Respond to Large-Scale Biological Events: Challenges and Solutions government officials, federal and academic representatives, and subject matter experts will discuss their perspectives, experiences, challenges, and recommended solutions with regard to SLTT response to large-scale biological events.”

Gene Therapy Hits a Wall With Microbial Resistance
Can gene editing trigger an immune reaction in humans? A new study is suggesting that it may be a risk. “The CRISPR-Cas9 system, which functions as a genetic scissors and tape for editing DNA, is generally derived from either Staphyloccoccus aureus or Streptococcus pyogenes bacteria.” Most of us though, have been exposed to these organisms throughout our lives. “This prior exposure could potentially render the gene editing ineffective, with the body quickly eliminating all the CRISPR–Cas9 proteins. Or worse, it could trigger the kind of immune storm that killed a young gene therapy patient named Jesse Gelsinger in 1999, derailing the field for more than a decade. ‘We share everyone’s excitement about doing Cas9 genome editing, but we want to make sure we have learned from what happened in the gene therapy world and not ignore the possibility that this could become a problem,’ Porteus says. ‘As we’re all thinking about developing Cas9-based therapeutics, we should think carefully about this potential problem’.”

Pediatric Rabies Death
A 6-year-old boy in Florida has died from rabies he contracted after being scratched by an infected bat. The boy’s father reports that he found the sick bat, put it in a bucket, and told him not to touch it however, he did and was scratched. In response, the father had the boy wash his hands thoroughly based off what he read online and opted not to take him to the hospital because the boy didn’t want to get shots. Unfortunately, within a week, the boy became ill and even after attempts at treatment, passed away. Rabies is almost always fatal once symptoms appear, which highlights the importance of seeking care immediately after exposure.

Stories You May Have Missed:

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 1.12.2018

by spopescu, posted in Pandora Report

 The Bright Side of Synthetic Biology and Crispr
GMU biodefense professor Sonia Ben Ouagrham-Gormley and Phd alum Shannon Fye-Marnien are looking at the realities of synthetic biology and fears of bioterrorism. Biological advances have inspired questions regarding the safety and potential for nefarious use, but are such technologies guilty until proven innocent or innocent until proven guilty? “As with previous advances in biology, Crispr is sometimes characterized as a blueprint for bioweapons development or bioterrorism, and it has elicited calls for increased control and regulation of science. But while it is important to examine the potential dangers of emerging technologies, reaching a balanced assessment of risks and benefits requires that technologies’ potential to improve human life be appreciated as well. Synthetic biology and Crispr offer a potentially enormous package of benefits, spanning from medicine to energy to agriculture and beyond. Discussions about the security and safety of synthetic biology and Crispr should not obscure these technologies’ potential to address a wide variety of complex and pressing problems.”

The United States Battles Influenza
Flu season is hitting hard in the United States as 46 states report widespread activity. 80% of cases are of the H3N2 strain, which is associated with severe symptoms and hospitalizations. “The flu is now widespread across the country and the peak of transmission probably occurred during the Christmas-New Year’s holiday week, just as many people were crowded into planes, buses and cars or in large family gatherings, said Dr. Daniel B. Jernigan, director of the influenza division of the Centers for Disease Control and Prevention. ‘H3N2 is a bad virus,’ Dr. Jernigan said. ‘We hate H3N2’.” 26 states (and New York City) are reporting high influenza-like illness (ILI) activity. The CDC has reported that “Influenza-like illness (ILI) went from 4.9% to 5.8%. ‎These indicators are similar to what was seen at the peak of the 2014-2015 season, which was the most severe season in recent years.” This tough influenza season is a helpful reminder that it could always get worse, especially in the context of the 1918/1919 influenza pandemic, which marks its centennial this year. Michael T. Osterholm and Mark Olshaker recently wrote an OpEd regarding the dismal truth – we’re not ready for a flu pandemic. Pointing to not only massive growth in population, but also challenges of supply shortages, and an outdated approach to vaccine research, they highlight the need to find a universal vaccine that can do battle against all influenza A strains with a longer immunity. “But there is no apparent effort to make these vaccines a priority in the current administration. Its national security strategy published last month cites Ebola and SARS as potential bioterrorism and pandemic threats, yet makes no mention of the risk of pandemic influenza nor any aspect of critical vaccine research and development. The next few weeks will highlight how ill prepared we are for even ‘ordinary’ flu. A worldwide influenza pandemic is literally the worst-case scenario in public health — yet far from an unthinkable occurrence. Unless we make changes, the question is not if but when it will come.”

GMU Biodefense Professor – Robert House
We’d like to welcome back professor Dr. Robert House to GMU biodefense, who will be teaching BioD766: Development of Vaccines and Therapeutics. Dr. House holds a PhD in medical parasitology and is a senior VP for government contracts at Ology Bioservices (previously Nanotherapeutics). The world faces a growing threat from microbiological agents in the form of terrorist weapons, pandemics (particularly influenza) and emerging/re-emerging diseases. Characteristics such as high pathogenicity/toxicity and lack of appropriate animal models, as well as lack of a viable commercial market, make it difficult to develop effective medical countermeasures for these agents. In his course, students will explore how the US Government is developing medical countermeasures (MCM) against these threats and will explore the various threat agents, the context of regulatory considerations, and the specifics of how MCMs are developed.

Infectious Disease Mapping Challenge Launched!
Do you love infectious diseases and maps? The goal of the challenge is to promote the use of geospatial mapping to address the objectives of the GHSA. The NextGen Network has partnered with the U.S. Department of State’s Virtual Student Foreign Service program to launch the 2018 challenge. You can find out more information from this engaging and informative webinar or at the page here. The deadline for signing up for the challenge is January 19, 2018. This is a great way to contribute to the GHSA goal of creating a world safe and secure from the threat of infectious diseases.

Biodefense Alum – Stay Connected! 
Are you a GMU Biodefense alum? If so, please make sure to keep your information updated in our Schar Stay Connected site. We have a strong alum community and would love to keep you up to date on future events and give shout outs for the amazing work our biodefense students accomplish.

Biopreparedness Needs to Start At the Frontlines of Disease Control
GMU biodefense PhD student and infection preventionist Saskia Popescu evaluates the attention to biopreparedness and how our focus on bioterrorism fails to address the major gaps within disease control in the United States. “The Blue Ribbon Panel report and the CNN article both highlight the bureaucratic challenges with coordination at a national level across many agencies and sectors. The crux of it all is that from a grass-roots level, we’re struggling to better prepare and respond for a host of reasons. Public health funding is always in a chronic state of too little too late and often, we don’t push out resources until we’re already in the throes of a major incident (Ebola, Zika, etc.). Preparing for biothreats, regardless of origin, requires that we strengthen the most basic surveillance and response systems within public health and health care. During the 2014–2015 Ebola outbreak, for example, there was a lot of attention on enhanced precautions. Although this was beneficial and brought attention to several gaps infection control and prevention measures, I found myself reminding staff that we can’t truly prepare and respond to rare events if we can’t get our daily practices down. The shear challenges of ensuring staff practice appropriate hand hygiene and isolation precautions in health care are indicators that we are struggling on the frontlines of disease preparedness.”

Lessons from A 2016 CRE Outbreak in A Kentucky Hospital
Hospital outbreaks are tough. The shear volume of people that go into a single patient’s room is considerable (healthcare workers, visitors, ancillary staff, etc.) and enough to spread germs throughout an entire hospital. Now imagine that the organism is a highly resistant one, such as carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CP-CRE). A hospital in Kentucky experienced this very thing in 2016 and a recent CDC MMWR revealed just how difficult it can be to conquer an outbreak involving one of the worst resistant organisms you can imagine. “Over the next 4 months, scientists identified an additional 21 CRE isolates from patients at the hospital via screening and clinical cultures. The investigators believe organisms were imported into the facility and then spread among patients.” Epidemiological investigation found that five of the thirteen interviewed patients had received healthcare outside the local area and that three of the patients may have brought CP-CRE into the facility. “The authors of the report say their investigation highlights the potential role of cleaning equipment, which frequently moves between patient rooms, in CP-CRE spread. In addition, they note that although there is a low prevalence of CP-CRE in rural areas, rural hospitals should be aware that patients who’ve also accessed healthcare in areas with higher CP-CRE prevalence—primarily urban areas—can introduce these organisms into their facilities.”

Stories You May Have Missed:

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 1.5.2018

by spopescu, posted in Pandora Report

Welcome to our first Pandora Report of 2018! While things may have been relatively quiet over the holidays, we still have some health security gems for you to start the new year right.

 An Infection Preventionist’s Take on the 2017 Biological Weapons Convention
GMU Biodefense Phd student and infection preventionist Saskia Popescu recently attended the BWC Meeting of States Parties and is discussing the importance of civil society and why even the most unlikely participants are important for the future of the BWC. “It seems an unlikely story that an infection prevention (IP) epidemiologist would attend a Meeting of the States Parties (MSP) at the United Nations (UN), but here’s why civil society has an important role in the work that IPs do.” Highlighting the Confidence Building Measures (CBMs) and the role of NGOs, she uses communicable disease reporting as an example of how so many of us play an unsuspecting role. “In fact, I feel that there are 2 things that should underline the importance of NGOs and civil society being involved in international treaties such as the BWC: 1.) Inherently, our work plays into the CBMs. Who does communicable disease reporting at a county level? Yours truly, and that feeds into the state health departments and then up through the Centers for Disease Control and Prevention (CDC), which goes into the CBM. 2.) With the rapid pace of advancements in the life sciences—such as gain-of-function research or genome editing like CRISPR—it is critical that treaties like the BWC be modernized to maintain relevancy. This requires experts from civil society who can work across international borders.”

Enhancing BioWatch Capabilities Through Technology and Collaboration
The latest proceedings of a workshop report from the National Academies are now available online. “The Department of Homeland Security’s (DHS’s) BioWatch program aims to provide an early indication of an aerosolized biological weapon attack. The first generation of BioWatch air samplers were deployed in 2003. The current version of this technology, referred to as Generation 2 (Gen-2), uses daily manual collection and testing of air filters from each monitor, a process that can take 12 to 36 hours to detect the presence of biological pathogens. Until April 2014, DHS pursued a next-generation autonomous detection technology that aimed to shorten the time from sample collection to detection to less than 6 hours, reduce the cost of analysis, and increase the number of detectable biological pathogens. Because of concerns about the cost and effectiveness of the proposed Generation 3 system (Gen-3), DHS cancelled its acquisition plans for the next-generation surveillance system.” Within the report, you can find an overview of BioWatch priorities, collaborative planning, recommendations from the GAO and DHS responses, and future opportunities at the state and local level. Some of the GAO’s findings included failure by DHS to develop performance requirements that would allow for conclusions about Gen-2’s ability to detect attacks, and that the modeling and simulation studies that DHS commissioned had not directly and comprehensively assessed Gen-2’s capabilities.

 GMU Biodefense MS Open House
Mark your calendars for the February 21st Master’s Open House at GMU’s Arlington campus! The session will provide an overview of our master’s degree programs, an introduction to our world-class faculty and research, and highlights of the many ways we position our students for success in the classroom and beyond. Our admissions and student services staff will be on hand to answer your questions. This is a great chance to speak with biodefense faculty, learn about some of the awesome classes our students get to take, and find out why we study health security threats from anthrax to Zika.

Winter 2018 Mid-Atlantic Microbiome Meetup Biodefense and Pathogen Detection
Don’t miss out on this January 10th event at the University of Maryland College Park. The University of Maryland Institute for Advanced Computer Studies (UMIACS) is hosting this regional conference next week, the Winter 2018 Mid-Atlantic Microbiome Meetup, with a focus on biodefense and pathogen detection. The workshop is a great way to learn about the latest in synthetic biology, biodefense, and pathogen detection. Several federal agencies are sending experts, and the conference will include a keynote talk from Tara O’Toole, executive vice president of In-Q-Tel.

Three Global Health Issues To Watch in 2018
What are the biggest stories health reporters are looking to follow this year? STAT polled their reporters and predicted that the three big stories in public health would be the final push to end polio, how the WHO will do with a new Director General amidst shaken confidence, and vulnerability to pandemics as we march into the centennial of the 1918 Pandemic. “This year marks the centenary of the Spanish Flu, the influenza pandemic of 1918, which killed somewhere between 50 million and 100 million people as the H1N1 flu virus swept the globe. Many of the people who died were in the prime of life. There are unsettling reports of people who were well at breakfast and dead by dinner. This uniquely fatal outbreak haunts influenza scientists and emergency response planners to this day. The latter know health systems don’t have the capacity to cope with the huge upsurges in illness that would accompany a major disease outbreak. A regular old bad flu season can severely tax hospitals. Those who worry about these issues will use the anniversary to focus attention on the risk of ‘the next Big One’.” What do you think the big pubic health topics will be this year? Tweet us @PandoraReport and we’ll report back on what the biodefense community is saying!

Three Children Hospitalized With Dengue Following Vaccination
Three Filipino children have been hospitalized with suspected dengue infections following their immunization with Dengvaxia, the latest Sanofi Pasteur dengue vaccine. “The hospitalizations come 1 month after Sanofi recommended Dengvaxia not be used in anyone who is dengue-naive. In recipients without previous dengue infections, the vaccine can lead to more severe illness.”

Stories You May Have Missed:

  • “Raw Water” Trend Sparks Public Health Concern – This is both hysterical and deadly – a new Silicon Valley obsession with untreated and unfiltered “raw” water. “When food-safety expert Bill Marler saw The New York Times’ trend piece on Silicon Valley’s recent obsession with raw water, he thought he was reading a headline from The Onion. According to The Times, demand for unfiltered water is skyrocketing as tech-industry insiders develop a taste for water that hasn’t been treated, to prevent the spread of bacteria or other contaminants.”

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 12.29.2017

by spopescu, posted in Pandora Report

This will be our last Pandora Report of 2017 and we’d like to take a moment and thank our wonderful readers for a great year of biodefense news! We hope you have a marvelous and safe New Years celebration. We’re starting the festivities early with some memories of infectious disease research from 2017.

Agroterrorism – A Threat To America’s Food Supply
Food vulnerability is not something people tend to think about very often and even less in the context of terrorism. There have been many experts noting that food safety is America’s soft underbelly for years, but just how vulnerable are we? “Agroterrorists have access to animal based bio-agents, which are easy to transport and simple to conceal. Just as ramming a speeding truck into a crowd is low-tech, an attack via the food chain has a low barrier to entry and little skill needed to execute. Weaponizing livestock is as simple as tending the flock or feeding the cattle. There is little expertise or special equipment required and given most animal borne pathogens are not communicable to humans, the logistics are easy. It really is farm to table pathogen delivery.” Increasing automation within food processing and rapid delivery from farm to table has the potential to be used as a weakness. Not only are these systems inherently weak against terrorist attacks, but one would severely damage the U.S. economy. A 2013 study found that outbreaks in FMD-free countries/zones could cause losses of more than $1.5 billion a year.

Biological Weapons Threat In The Spotlight – UN News
Check out this great podcast of UN news in which Dr. Tom Inglesby from the Johns Hopkins Center for Health Security discusses the BWC Meeting of States Parties and the importance of global cooperation to address biothreats. “He told Daniel Johnson that because most biological research now takes place ‘far outside the control of government’, a key objective should be to ensure that an information-sharing mechanism exists between industry and Member States.

Meeting of the Blue Ribbon Study Panel on Biodefense: SLTT Ability to Respond to Large-Scale Biological Events: Challenges and Solutions
Don’t miss this event on January 17th, 2018 in Miami, Florida! “The Nation continues to confront infectious disease events and the threat of biological terrorism. This meeting of the Study Panel, chaired by former Secretary of Health and Human Services Donna Shalala and former Representative James Greenwood, will provide the Study Panel with a better understanding of the ability of state, local, tribal, and territorial (SLTT) governments to: respond to large-scale biological events, identify and utilize SLTT assets and resources for immediate response (prior to a declaration of a SLTT biological emergency or disaster), operate before federal assistance arrives and after federal resources are exhausted, and shift to population management when a biological event overcomes pre-hospital and hospital response protocols.”

Analyzing the Detection and Response Aspects of Global Health Security
GMU biodefense PhD student Saskia Popescu is taking a trip down the detection and response rabbit hole of health security. Evaluating research on laboratory response networks, public health coordination, frontline epidemiology training, and more, she highlights the vulnerability we all share if even one country has a weak public health and healthcare infrastructure. “Response efforts often point to gaps within our plans, like the need to train staff on enhanced use of personal protective equipment during the Ebola outbreak, or cultural dynamics that challenge public health education efforts. Public health response is an evolving process and with each new challenge, lessons are learned and we hope that we can appropriately apply them in the future. The most important lesson is the global aspect of health security—an outbreak anywhere is an outbreak anywhere. Strengthening national prevention, detection, and response efforts will only serve to protect us all.”

WHO Priority List of Antibiotic-resistant Bacteria and Tuberculosis
The WHO has released a list of priority pathogens to help encourage the development of new antibiotics. “Detailing its findings in The Lancet Infectious Diseases yesterday, the WHO Pathogens Priority List Working Group used a multicriteria decision analysis method to select 20 antimicrobial-resistant bacteria. The experts then applied 10 criteria to assess priority: mortality, healthcare burden, community burden, prevalence of resistance, 10-year resistance trends, transmissibility, preventability in the community, preventability in healthcare settings, treatability, and drug pipeline.” The list of 20 bacterial species highlights three categories (critical, high, and medium priority), which includes “carbapenem-resistant Acinetobacter baumannii andPseudomonas aeruginosa, and carbapenem-resistant and third-generation cephalosporin-resistant Enterobacteriaceae. The highest ranked Gram-positive bacteria (high priority) were vancomycin-resistantEnterococcus faecium and meticillin-resistant Staphylococcus aureus. Of the bacteria typically responsible for community-acquired infections, clarithromycin-resistant Helicobacter pylori, and fluoroquinolone-resistantCampylobacter spp, Neisseria gonorrhoeae, and Salmonella typhi were included in the high-priority tier.”

 Drug Discovery, Development and Deployment
Speaking of the importance of drug R&D…the NIH has released their Drug Discovery, Development and Deployment Maps (4DM) to help engage and support this complicated process. There are two maps – one for small molecules and one for biologics, using monoclonal antibodies as the representative therapeutic. “The maps provide a common framework for discussing the therapeutic development process and serve as an education tool for those who are new to it. A common language and collective knowledge base for therapeutic development is essential to enable systemwide improvements that will benefit patients. The 4DM can help facilitate dialogue among those interested or participating in drug development to explore innovative solutions to existing bottlenecks and potential collaborative action to overcome those barriers and accelerate new medicine discovery.”

Bird Flu in South Korea
Avian influenza is wreaking havoc in South Korea. Officials have reported the culling of 201,000 birds in efforts to prevent the spread of H5N6 after it was found in four duck farms. “Last year, South Korea slaughtered more than 30 million birds to contain the worst outbreak of bird flu in the country‘s history.” Such efforts are especially important as the country prepares to host the Winter Olympics, which begin on February 9, 2018.

ASM Supports NIH Decision To Lift Funding Pause on GoF Research
Last week saw a surge of news regarding the official lift on the funding moratorium on GoF research. The news released an onslaught of over-the-top headlines and debates, but nonetheless the existence of GoF research will likely remain one that sparks concerns on both ends of the spectrum. The American Society for Microbiology (ASM) has come out in support of the lift on the funding pause though, noting that they are “in complete support of the National Institutes of Health lifting the funding pause on gain-of-function (GoF) experiments involving influenza, SARS, and MERS viruses. GoF research studies ways nature might make some viruses more virulent or transmissible. This is important in helping identify and develop strategies and effective countermeasures against rapidly evolving pathogens that pose a threat to public health, as well as to prepare for pandemics. ASM also applauds the review framework released by the Department of Health and Human Services. This process will ensure that any proposal that passes scientific peer review and fits the Potential Pandemic Pathogen (PPP) definition will undergo a multidisciplinary review process before funding is received. The review panel will provide oversight and facilitate safe and responsible conduct of this type of research.”

Stories You May Have Missed:

  • United States Flu Season Update– This flu season is already shaping up to be rough, so where are we? “Influenza A viruses have been most commonly identified, with influenza A(H3N2) viruses predominating. Several influenza activity indicators were higher than is typically seen for this time of year. The majority of influenza viruses characterized during this period were genetically or antigenically similar to the 2017–18 Northern Hemisphere cell-grown vaccine reference viruses. These data indicate that currently circulating viruses have not undergone significant antigenic drift; however, circulating A(H3N2) viruses are antigenically less similar to egg-grown A(H3N2) viruses used for producing the majority of influenza vaccines in the United States.” Outpatient visits have spiked with patients seeking care for influenza-like illness (ILI) across the U.S. The national average is 2.2% and last week saw 2.7% however, this week is now 3.5%, which points to a growing influenza season.

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 12.22.2017

by spopescu, posted in Pandora Report

Happy Holidays from your friends at the Pandora Report! We hope you have a lovely holiday weekend and enjoy this warm cup o’biodefense. If you’re still looking for the perfect gift for a microbe-loving person in your life, check out the latest holiday pack here.

International Criminal Court Adds Use of Biological Weapons to Rome Statute
Last week, during the Assembly of States Parties to the ICC, it was decided that three new crimes would be now be classified as war crimes within the Rome Statute. “The new war crimes added to the Rome Statute are, respectively, the use of biological and toxin weapons, the use of weapons causing injuries by fragments which in the human body escape detection by X-rays and the use of laser weapons causing permanent blindness. These weapons kill without discrimination or inflict very severe suffering. Their elevation to the rank of war crimes strengthens international law. The use of these weapons during armed conflicts will become even more difficult. The inscription of these new crimes in the Statute of Rome ensures also legal certainty to the victims and gives a specific recognition to their pain.” The Belgium Ministry of Foreign Affairs has come forward noting that “It was Belgium that had proposed these amendments to the Statute, the founding treaty of the ICC, as early as 2009. Belgium has tirelessly mobilized, through its diplomatic network and the voices of its foreign ministers, its ministers of justice and even its prime ministers to promote the adoption of these amendments.”

2017 National Security Strategy – Biodefense
Just in the nick of time, the National Security Strategy was released – and with a biodefense gem hidden on page 9! Pillar 1 (of 4) within the NSS includes a section on securing U.S. borders and territories, in which the “combat biothreats and pandemics” section is buried. Citing biological threats, whether it be natural outbreaks like Ebola, bioterrorism, or advancements in life sciences that have the potential to be mis-used, the NSS includes several priority actions. The three priority actions to combat biological threats are: “detect and contain biothreats at their source, support biomedical innovation, and improve emergency response. ”

Trump’s Biodefense Strategy – Naught, Nice, or MIA?
GMU biodefense MS student Janet Marroquin is taking a look at the Trump administration’s biodefense strategy and what the past year has shown us in terms of what we can expect. With the release of the NSS this past week, some direction is being given, but just how far have we come in terms of a true strategy? Marroquin delves into the nitty gritty and also gives us a holiday wish list for what we’d like to see on a biodefense strategy. She notes that “An important reform present in the proposed FY 2018 Federal budget is the call to dismantle the Academic Centers for Public Health Preparedness under the CDC and the distribution of its funds among state governments to support state-led public health preparedness.  Interestingly, this action seems to contradict expert recommendations to the federal government for the development of a centralized approach to health security.” In response to the release of the NSS, the Blue Ribbon Study Panel has released a statement and highlights, like Marroquin, the importance of a comprehensive approach.

Congrats to GMU’s Biodefense December Graduates!
We’re excited to announce the graduation of several GMU Biodefense students this winter. Congrats to our students graduating with a MS: Zamawang Almemar, Alexander Rowe, and Stephanie Smith – and congrats to those graduating with a Certificate in Biodefense: Mi Chung and Mary Oberlies. We can’t wait to see where the future takes you and the amazing biodefense adventures you’ll have!

Federal Funding Resumes for Gain-of-Function Research
On Tuesday, it was announced that DHHS has ended the funding pause on GoF research. Suspended since the 2014 moratorium, guidance was released in January of this year by the White House Office of Science and Technology Policy (OSTP) for individual agencies reviewing research. While the OSTP P3C0 recommendations provided guidance for agencies looking to conduct, support, or planning to conduct such research, its sole purpose was “to recommend consistent and appropriate Federal agency review and reporting processes for the enhanced oversight of Federally funded research that is anticipated to create, transfer, or use enhanced pathogens with pandemic potential.” In fact, once agencies adopted a review process and satisfied such requirements, they could lift their moratorium on GoF research. It is this week’s NIH announcement however, that fully lifted the moratorium and provided framework for guiding funding decisions about such research (FYI – you won’t find many differences between the framework and the OSTP P3C0).  “The framework, condensed into a 6-page document, spells out a multidisciplinary review process that involved the funding agency and a department-level review group that considers the merits and possible research benefits and the potential to create, transfer, or use an enhanced potential pandemic pathogen (PPP).” Funding for GoF research on potential pandemic pathogens, like SARS, MERS, and avian influenza, was resumed jointly with the DHHS framework that seeks to guide funding of proposed research that would involve enhancing such pathogens. “The HHS P3CO Framework is responsive to and in accordance with the ‘Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight’ issued on January 9, 2017  and supersedes the previous ‘Framework for Guiding U.S. Department of Health and Human Services Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets’.” The new framework includes 8 criteria for department-level review, which includes “An assessment of the overall potential risks and benefits associated with the research determines that the potential risks as compared to the potential benefits to society are justified” and “The research will be supported through funding mechanisms that allow for appropriate management of risks and ongoing Federal and institutional oversight of all aspects of the research throughout the course of the research”.

GMU Biodefense Student Tackles USPS Safety
Speaking of awesome things GMU biodefense graduates are doing…Stephanie Smith is using her forensic chemistry background and new biodefense degree to tackle safety in the USPS. “I’m a forensic chemist by training, that’s what I’ve done my entire career,” she said. “I came to Mason to study the ‘bio-side’ of this complex advisor position, but I realized I was also expanding my knowledge beyond science and into the policy side.” Having studied a range of different topics like agroterrorism and biosurveillance during her time at GMU, Smith’s capstone project “was based on her idea that the method of detecting bioagents in the mail could be improved.” While she was working on her studies at GMU, she was also working at the USPS within the Security and Crime Prevention Group and was tasked with writing the job description for a new permanent scientific advisor position. “Once Smith wrote the job description for the new position of ‘Scientific and Technical Advisor, Dangerous Mail Investigations’ for the Postal Inspection Service, it was determined there was only one person qualified to fill a job that required knowledge of chemistry, biodefense, security and public policy. That would be Stephanie Smith. She got the job.”

2017-2018 PHEMCE Strategy and Implementation Plan
The latest Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) SIP has been released, which highlights some of the priorities that the Department of Health and Human Services will focus on over the next five years. Within the SIP, you can find a summary of the major accomplishments, new activities, updates to the 2016 SIP activities, and specific information required annually under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). The latest SIP includes accomplishments from 2016 that include regulatory science management, Zika and Ebola response, international collaboration on MCMs, etc. Some of the new projects include Ebola response, bacterial threat projects like CARB-X, etc. You can also read the PHEMCE multi-year budget for fiscal years 2016-2020 here.

GMU Biodefense Students Visit DARPA
If you’ve ever wondered what it’s like to go inside the walls of the Defense Advanced Research Projects Agency (DARPA), this article is just for you! GMU biodefense professor Andrew Kilianski took students from one of his classes to visit DARPA and gain a better understanding of their biodefense efforts. Dr. Kilianski is currently a biological scientist at the DoD and his work focuses on combating current and future threats from weapons of mass destruction in addition to teaching classes on biosurveillance and virology in the GMU Biodefense graduate program. In this segment, biodefense MS student Janet Marroquin takes us on a tour of DARPA and some of the fascinating projects they work on. “These projects range from surveillance tools to diagnostics and therapeutics, using futuristic mechanisms such as a dialysis-like purification of pathogen-infected blood or unobtrusive nanoplatforms that continuously monitor the physiological state of the patient for the detection of infectious disease. ”

Preventing An “Outbreak Anywhere” From Becoming An “Outbreak Everywhere”
GMU Biodefense PhD student Saskia Popescu is addressing the trifecta of efforts within global health security – prevention, detection, and response. Drawing on the special edition Emerging Infectious Disease journal, she highlights the importance of prevention and the obstacles that are often met. “Prevention is the first component to health security, but in many ways, it is also the most difficult. Biological threats can come from anywhere: a naturally occurring outbreak, a laboratory accident, or even an act of biological terrorism. How do we prevent biothreats when they come from so many directions? Zoonotic diseases are one place to start as more than 60% of known diseases spread from animals and roughly 75% of new or emerging diseases in humans spread from animals.”

Is Captain America A Biological Weapon?
Attending the Biological Weapons Convention will make you ponder such things and Matt Shearer from the Johns Hopkins Center for Health Security is venturing down that rabbit hole. Article I of the BWC states that each state party will not develop, produce, stockpile, or otherwise acquire or retain “microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes;” and “weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.” Shearer poses a unique question about what constitutes a biological agent – what if there is no infection but rather a human who has been enhanced? “But normal humans, animals, and plants do not seem to count as “other biological agents” in the context of the BWC, but what about enhanced or modified versions like Captain America or, perish the thought, the accidentally enhanced Teenage Mutant Ninja Turtles? Have we been unwittingly cheering for bioweapons this whole time?”

Stories You May Have Missed: 

  • Cadavers in the Ballroom – Shockingly, this not the title of a zombie wedding movie, but rather a reality of medical conferences. This recent article found that some medical conferences, operating in grand ballrooms, utilize cadavers and body parts for teaching at their lectures. “When the deceased are cut open, there’s an increased risk of a disease being transmitted to others, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. ‘I will be the first to acknowledge there have been no big outbreaks or situations that have occurred yet from a dead body,’ Osterholm said. ‘But I am absolutely convinced it’s just a matter of time’.”
  • Building A National Capability to Monitor and Assess Medical Countermeasures Use During A Public Health Emergency – Don’t miss the latest NAS report on MCM use. “During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication.”

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

GMU Biodefense Visits DARPA

by spopescu, posted in Commentary

By Janet Marroquin

One of the many advantages of being a student in the Schar School of Policy and Government at GMU is having the unique opportunity to go on a field trip to the Biological Technologies Office (BTO) of the Defense Advanced Research Projects Agency (DARPA)!  Dr. Andrew Kilianski graciously arranged a visit to the facility, located less than a mile away from Founder’s Hall, for a portfolio briefing to provide insight to real-world application of the themes explored in his Biosurveillance class (BIOD 751 for those of you interested).

Team members supporting Col. Matthew Hepburn, one of the nine program managers at the BTO, briefed in great detail about the mission at DARPA, project selection and development, and the role that Scientific, Engineering, and Technical Assistance (SETA) team members play in the day-to-day operations of the Col. Hepburn’s BTO portfolio..

The mission at DARPA is consequential to its name: “creating breakthrough technologies and capabilities for national security.”  Within the BTO, Program Managers strive to develop cutting-edge biotechonologies that are 10-15 years into the future and can provide innovative support to the military and civilians alike. These projects range from surveillance tools to diagnostics and therapeutics, using futuristic mechanisms such as a dialysis-like purification of pathogen-infected blood or unobtrusive nanoplatforms that continuously monitor the physiological state of the patient for the detection of infectious disease. For the Program Managers, the challenge is not envisioning the innovative biotechnology but rather the pre-emptively assessment of risk for these projects, which is particularly a problem for biologics.  With increased innovation may come increased risk, hence the highly selective process in hiring each Program Manager and the assembly of their skilled teams.

Another challenge that comes to mind in thinking about cutting-edge biotechnology is addressing the dual-use dilemma. While BTO projects do not involve working with select agents or particular pathogens, the security implications of manipulating in vivo nanoplatforms or other platform technologies for nefarious purposes should be considered.  Rapidly advancing technology demands a strong security policy that is prepared to address dual-use research intentionally being developed ahead of its time.  Just as health risks are effectively evaluated by a highly skilled team of scientists, so should security risks be managed by a skilled team of biodefense experts.

As a biodefense student, it was exciting to witness the wonders at the BTO and to get a glimpse of the future in biotechnology.  For those unable to visit DARPA in the near future, all of Col. Hepburn’s projects are open-source and descriptions are available on the BTO website.  As I previously stated, the Schar School is full of unique opportunities to GMU students and to faculty alike, so as such, we should take full advantage!

Trump’s Biodefense Strategy: Naughty? Nice? M.I.A?

by spopescu, posted in Commentary

By Janet Marroquin

At the Aspen Security Forum this past July, homeland security adviser Thomas Bossert reassured the country that the White House would fill the void of a comprehensive biodefense strategy “as soon as we can.”

Under the Biodefense Strategy Act signed into law in December 2016, the Trump administration is required to produce a new strategy for biodefense as a joint endeavor by the secretaries of Defense, Health and Human Services, Homeland Security, and Agriculture.  This congressional requirement solicited an initial briefing on the strategy no later than March 1, 2017 and a formal strategy due to Congress no later than 275 days after December 23, 2016.  More than nine months past due, we may finally have been given a small sneak preview of biodefense policy within the US National Security Strategy.  Unfortunately, as the year comes to a close, there is still no mention of an anticipated release date and biodefense experts are left wondering about the future contours of biodefense strategy.

Upon examination of the proposed FY 2018 federal budget, the initial outlook for biodefense did not look very good.  The significant decrease in federal spending on public health agencies suggested a decrease in priority for public health and thus a decrease in health security.  According to the Congressional Review Service, the proposed budget for the CDC in FY 2018 represents a decline of 17% from the estimated FY 2017 budget.  Biodefense-related programs within the CDC all saw a negative trend in spending compared to the estimated budget allocated this year, regardless of previously rising or declining trends.

Program 2016 Budget

(in Million Dollars)

 2017 Estimated Budget (in million dollars) 2018 Proposed Budget (in million dollars)
Emerging & Zoonotic Diseases 582 585 514
Public Health Scientific Services 491 489 460
Global Health 427 435 350
Public Health Preparedness & Response 1413 1405 1266
CDC-wide Activities 411 274 105

Similarly, NIH saw a decline of 21.5% in federal spending for FY 2018, with the National Institute of Allergy & Infectious Diseases (NIAID) also experiencing a steep decline in funding despite a previously positive trend.

Program 2016 Budget (in million dollars) 2017 Estimated Budget (in million dollars) 2018 Proposed Budget (in million dollars)
NIAID 4750 4907 3783

An important reform present in the proposed FY 2018 Federal budget is the call to dismantle the Academic Centers for Public Health Preparedness under the CDC and the distribution of its funds among state governments to support state-led public health preparedness.  Interestingly, this action seems to contradict expert recommendations to the federal government for the development of a centralized approach to health security.

The initial budget proposal also called for closing the National Biodefense Analysis and Countermeasures Center (NBACC).  Fortunately, it is Congress that controls the purse strings and has the last say in the finalized federal budget.  Heavy lobbying by scientists and law-enforcement resulted in amendment of the proposal to reverse the September 2018 closure of NBACC, thus exhibiting the powers at play and illustrating the influence that various stakeholders have in biodefense policy.[1]

Furthermore, there is still some good news for the biodefense budget.  In spite of the proposed cuts to NIH and the CDC funding, there is no proposed change in federal spending for BARDA and there is even an increase of about 3% on pandemic influenza programs, underscoring a support for public health emergency funds and DoD measures against biological threats.[2]  It is also imperative to keep in mind that the proposed federal budget is only representative of priorities for the fiscal year 2018 and is not necessarily indicative of an overarching biodefense strategy.  As such, non-fiscal factors must also be considered.

Recent  U.S. participation in the Global Health Security Agenda confirms support for global health security, contrary to the proposed decrease in global health spending under the CDC for FY 2018.  At the United Nations General Assembly, President Trump expressed approval of the GHSA in his remarks to African leaders, “we cannot have prosperity if we’re not healthy.  We will continue our partnership on critical health initiatives.”  On that note, Secretary of State, Rex Tillerson, praised the Agenda and extended support a few weeks prior to the GHSA Summit in Kampala, “while we’ve made tremendous progress since GHSA was launched in 2014, considerable work remains.  That is why the United States advocates extending the Global Health Security Agenda until the year 2024.”

Biodefense scholars have expressed concern about the Trump Administration’s ability to develop an effective, coherent strategy in light of political division between and within parties, budget cuts to biodefense-related agencies, and the administration’s general anti-science attitude.[3]  Though it remains unclear of what the Trump Administration will include in the new biodefense policy, recommendations from various advisory councils such as the President’s Council of Advisors on Science and Technology, the National Security Council, the Blue Ribbon Study Panel on Biodefense and the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, all seem to have the following items on their holiday wish list for biodefense strategy:

  • A single, centralized approach to biodefense (i.e. a federal council dedicated to coordinating efforts against biological threats)
  • A comprehensive strategy that encompasses human and animal health (i.e. One Health)
  • An interdisciplinary approach to health security, inclusive of all stakeholders (i.e. policy makers, scientists, health experts, etc.)
  • Defense against both global and domestic biological threats
  • A proactive policy preventing the misuse/abuse of advancing biotechnology

The new National Security Strategy supports an international, One Health approach to biosurveillance, biomedical innovation, and improved emergency response in “protecting the homeland and the American people”.  Accordingly, the administration must now produce a biodefense strategy that effectively protects the American people from biological threats.  May the force be with the secretaries of Defense, Health and Human Services, Homeland Security, and Agriculture in granting us a unified and comprehensive biodefense strategy!

REFERENCES

[1] Kirby, “The Trump’s administration’s misaligned approach to national biodefense,” 386.

[2] U.S. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response, “Fiscal Year 2018 Budget-in-Brief: Public Health and Social Services Emergency Fund,” Accessed December 17, 2017, https://www.phe.gov/about/ofpa/Documents/bib-2018.pdf

[3] Kirby, Reid, “The Trump’s administration’s misaligned approach to national biodefense,” Bulletin of the Atomic Scientists 73, no. 6 (November 2017), 382-383.

Blue Ribbon Study Panel on Biodefense. A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts – Bipartisan Report of the Blue Ribbon Study Panel on Biodefense. Hudson Institute: Washington, DC, October 2015.

Hourihan, Matt and David Parkes. “Deep Cuts for NIH, Other Life Sciences in FY 2018 Budget Plan.” June 15, 2017. https://www.aaas.org/news/deep-cuts-nih-other-life-sciences-fy-2018-budget-plan

National biodefense strategy, U.S. Code 6 (2016), §104.

Watson, Crystal, Matthew Watson, Tara Kirk Sell. “Federal Funding for Health Security in FY2018.” Health Security 15, no. 4 (August 2017): 351-372. https://doi.org/0.1089/hs.2017.0047

U.S. Congress. Senate. Committee on Homeland Security and Governmental Affairs. Biodefense Strategy Act of 2016 (to Accompany S. 2967). 114th Cong., 2d sess., 2016. S. Rep. 114-306. I-12. https://www.congress.gov/114/crpt/srpt306/CRPT-114srpt306.pdf

U.S. Library of Congress. Congressional Research Service. Public Health Service Agencies: Overview and Funding (FY2016-2018), by C. Stephen Redhead, Agata Dabrowska, Erin Bagalman, Elayne J. Heisler, Judith A. Johnson, Sarah A. Lister, and Amanda K. Sarata. R44916. 2017.

U.S. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response. “Fiscal Year 2018 Budget-in-Brief: Public Health and Social Services Emergency Fund.” Accessed December 17, 2017. https://www.phe.gov/about/ofpa/Documents/bib-2018.pdf