Pandora Report: 10.8.2021

Michelle Grundahl, a Biodefense MS student, presented a talk at the One Welfare World Conference! Dr. Yong-Bee Lim, Biodefense PhD ’21, published his first article as an Editorial Fellow: “Do-it-yourself vaccines in a pandemic: democratized science or home-brewed pipe dream?” The WHO announced its support of the widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine! The Schar School will be hosting virtual open houses for the Master’s and Certificate Programs on 21 October and 16 November at 6:30 PM EST.

Animal Disaster Response Using One Health Solutions – Case Studies of Responding to Animal Disasters: Hurricane Sandy, Joplin Tornado and COVID-19

At the One Welfare World Conference on 15-16 September 2021, Michelle Grundahl, student in the Biodefense MS program, presented a short talk, “Animal Disaster Response using One Health Solutions – Case studies of responding to animal disasters: Hurricane Sandy, Joplin Tornado and COVID-19.” Grundahl’s talk and the One Welfare World Conference took place during National Preparedness Month (September).

The presentation discussed the lived experiences of implementing One Health and Welfare during emergency responses involving companion animals. The three cases used were Hurricane Sandy, the Joplin Tornado, and the COVID-19 pandemic, the response of which all included a One Health approach. One Health is the recognition of the inextricable link between human health, animal health, and environmental health. Highlighted in the presentation were practical solutions that achieved optimal human and animal well-being during times of disaster. The human-animal bond can affect compliance with official emergency orders. When people cannot take their whole family (including pets) out of disaster zones, they might choose to stay in the danger zone. Read Grundahl’s article here.

Do-It-Yourself Vaccines in a Pandemic: Democratized Science or Home-Brewed Pipe Dream?

Dr. Yong-Bee Lim, Biodefense PhD ’21, was recently named to the inaugural class of Editorial Fellows at the Bulletin of the Atomic Scientists, where he will be writing a regular column on disruptive technology. He is a fellow at the Council on Strategic Risks, focusing on biosecurity, biodefense strategy, and emerging and converging technologies. Dr. Lim is one of seven fellows who will “publish articles regularly on nuclear risk, climate change, and disruptive technologies—key areas in the Bulletin’s mission to inform the public, policymakers, and scientists about man-made threats to human existence.”

This week, Lim published his first article as an Editorial Fellow: “Do-it-yourself vaccines in a pandemic: democratized science or home-brewed pipe dream?” Experts predict that more pandemics are coming. Climate change will drive migrations and other ecological disruptions that put species into greater contact with one another. Continued human encroachment on nature will increase the risks that a pathogen will jump from animals to people. For the next pandemic, instead of waiting a year for scientists, governments, and companies to produce and distribute life-saving vaccines, wouldn’t it be nice to whip something up … in your own kitchen? Read Lim’s article here.  

WHO Approves the First Malaria Vaccine

The World Health Organization (WHO) announced its support of the widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot program in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019. “This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.” Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260,000 African children under the age of five die from malaria annually. Key findings of the pilot studies include that the vaccine is feasible to deliver, it has a strong safety profile, and it was highly cost effective.

Applying Arms Control Frameworks to Autonomous Weapons

Zachary Kallenborn, a research affiliate with the Unconventional Weapons and Technology Division of the National Consortium for the Study of Terrorism and Responses to Terrorism and a policy fellow at the Schar School, shares his insights on the application of arms control frameworks to autonomous weapons. Mankind’s earliest weapons date back 400,000 years—simple wooden spears discovered in Schöningen, Germany. By 48,000 years ago, humans were making bows and arrows, then graduating to swords of bronze and iron. The age of gunpowder brought flintlock muskets, cannons, and Gatling guns. In modern times, humans built Panzer tanks, the F-16 Fighting Falcon, and nuclear weapons capable of vaporizing cities. Today, humanity is entering a new era of weaponry, one of autonomous weapons and robotics.

The development of such technology is rapidly advancing and poses hard questions about how their use and proliferation should be governed. In early 2020, a drone may have been used to attack humans autonomously for the first time, a milestone underscoring that robots capable of killing may be widely fielded sooner rather than later. Existing arms-control regimes may offer a model for how to govern autonomous weapons, and it is essential that the international community promptly addresses a critical question: Should we be more afraid of killer robots run amok or the insecurity of giving them up? Read the article here.

20 Years After the Anthrax Attacks, We’re Still Unprepared

October marks 20 years since the anthrax letter attacks, which “launched the most complex and concentrated public health response in US history to that point, rivaled only today by the effort to respond to COVID.” Those who played a role in the response to the anthrax attacks say that the attacks “presented hard lessons that could have helped the COVID response if they had been remembered.” The response quickly engulfed public health as tens of thousands of potentially exposed persons had to be evaluated. Across the nation, panic ensued with spills of anything powdery. The Laboratory Response Network, supported by the CDC, analyzed over 125,000 samples, and the National Pharmaceutical Stockpile delivered 3.75 million doses of antibiotics across Florida, New York, New Jersey, Connecticut, and DC. Despite this tragedy and several other health crises, the US was woefully unprepared for the COVID-19 pandemic. Dr. Thomas Frieden, former Director of the CDC, highlighted that “public health funding has always followed the pattern of, ‘Out of sight, out of mind. You get big infusions of money, but you really can’t build capacity effectively with one-time dollars.” It is the effort between crises that builds capacity. Throughout the pandemic, but especially in the early days of it, public health professionals struggled to access critically important data, making it evident to investigators “how much remains to be done to create rapid, sensitive systems for gathering information.” The echoing lesson from the anthrax attacks to now is that “looking back—something that is built into public health systems, which tend to analyze outbreaks and trends after they occur—is insufficient for future protection.”

Insidious Scourge – Critical Infrastructure at Biological Risk

The Bipartisan Commission on Biodefense released a report, Insidious Scourge – Critical Infrastructure at Biological Risk, developed to help each of the critical infrastructure sectors defend against biological threats. Critical infrastructure and national critical functions are threatened by, vulnerable to, and experience the consequences of biological attacks, accidents, and naturally occurring diseases—in other words, they are at biological risk. Biological events could destroy, incapacitate, and disrupt critical infrastructure and prevent our society from both functioning properly and protecting itself. Illness and death, physical compromise of sectors, data theft and compromise, just-in-time inventories, mass gatherings, unprotected transit and other distribution systems, and poor awareness of where and how diseases spread are all of concern. When biological events overwhelm critical infrastructure, effects on society cascade, further weakening our country. The report emphasizes that every critical infrastructure sector must maintain awareness of biological threats; prepare for biological events; and respond to biological events efficiently and effectively. The report makes several new recommendations, including:  Congress should mandate federal defense of critical infrastructure against biological threats; the Administration should establish a critical infrastructure biodefense program at the Department of Homeland Security; and sectors and sector specific federal agencies should identify and eliminate vulnerabilities in critical infrastructure to biological threats. Read the report here.

Francis Collins to Step Down as NIH Director by Year’s End

Dr. Francis Collins, Director of the National Institutes of Health (NIH), announced his resignation earlier this week after nearly 30 years of service. Collins plans to step down at the end of this calendar year, stating that he thinks it is time for a “new scientist to lead the NIH into the future.” Throughout COVID-19, Collins has “been on the front lines urging Americans to wear masks and get vaccinated.” During his 12 year stent as Director, the Institute’s budget increased by 38%, and Collins proposed a number of initiatives for Alzheimer’s disease, cancer, opioid use disorder, rare diseases and, the coronavirus pandemic.

Havana Syndrome

Havana Syndrome is series of unexplained medical symptoms – migraines, fatigue, vertigo, anxiety, dizziness, cognitive difficulties, memory loss – first experienced by State Department personnel stationed in Cuba in 2016. A leading theory behind the cause of Havana Syndrome is that a mysterious weapon is being deployed by a malign actor. In Cube, noises were linked to the syndrome, but these sounds were most likely caused by crickets and not microwave weapons. A declassified scientific review commissioned by the US State Department concluded that the “sounds accompanying at least eight of the original 21 Havana syndrome incidents were most likely caused by insects.” This report also concluded that it is “highly unlikely” that the symptoms are caused by microwaves or ultrasound beams. Specifically, the report stated, “no plausible single source of energy (neither radio/microwaves nor sonic) can produce both the recorded audio/video signals and the reported medical effects.”

Synthetic Virology: The Experts Speak

Synthetic virology—the re-creation and manipulation of viruses to study their properties—provides a powerful way of investigating how viruses cause infections and how to combat pathogenic subtypes. This is particularly true for hard-to-culture viruses. However, this approach also raises the prospect that bad actors could create more deadly viruses. Over a decade ago, the World Health Organization (WHO) issued a warning that “advances in genome sequencing and gene synthesis would render substantial portions of [variola] accessible to anyone with an internet connection and access to a DNA synthesizer,” leading to concerns about future attempts to engineer viruses from the smallpox family. In a new article, Nature Biotechnology convenes a group of experts and a biohacker to discuss the current state of synthetic virology. How far has the technology has advanced, what is currently possible, and what might the future hold in terms of best practices for advancing scientific knowledge and promoting biosecurity? Read the article here.

SYNTHETIC BIOLOGY

Built With Biology: Q2 2021 Report

SynBioBeta released its latest assessment of the synthetic biology industry. The report’s key takeaway is that the industry is on track to raise more money in 2021 than in the previous 11 years combined. One of the most impactful applications of synthetic biology is saving lives, ending disease, and reducing pain – driving continuous and high levels of investment in the space. The median funding for Health and medicine startups so far this year is $73 million, a change of 62% over last year, and 211% of the median of all deals (“Grand Total” in the chart above) since 2009. Food and beverage production has a huge impact on the health of humans and the environment – and synthetic biology startups are addressing all of those needs. Through 2Q 2021, the median investment in synbio Food and Nutrition startups is $27.9 million, down to 39% of last year’s sudden boom, but still 278% of the median since 2009. The median investment in synbio Agriculture startups so far in 2021 is $11.35 million, up 252% versus last year. Read the report here.

California Governor Vetoed AB 70

On 5 October, California Governor Gavin Newsom returned Assembly Bill 70 without his signature. This bill, also called Gene Synthesis Security bill, which would have created the first biosecurity regulations for the field of synthetic biology. Governor Newsom cited a lack of funding and lack of a national approach to the issue as the grounds for his veto. According to the announcement, the bill would require the California Department of Public Health (CDPH) to “establish a new state regulatory program to provide oversight over gene synthesis providers and manufacturers of gene synthesis operating equipment,” and it would also “require gene synthesis businesses to demonstrate membership in a voluntary industry consortium or be verified by CDPH to use customer and sequence screening protocols that meet or exceed the protocols established by that consortium.” Funding the program would “authorize CDPH to begin charging fees from the entities to be regulated before the program is established and before businesses are required to be in compliance.” The Governor asserts that “this structure is not implementable.” While the scope and sophistication of the synthetic biology industry continues to grow, biosecurity policy falls further behind.

ALL THINGS COVID-19

Masks and Respirators for the 21st Century: Policy Changes Needed to Save Lives and Prevent Societal Disruption

Masks and respirators have played an essential role in the response to the COVID-19 pandemic for both healthcare workers and the public. However, the masks and respirators that both healthcare workers and the public have needed to rely upon leave much to be desired. Despite drawbacks in terms of comfort and fit, the ubiquitous disposable masks and disposable N95 respirators used by the vast majority of healthcare workers have not appreciably improved since the mid-1990s. During the COVID-19 pandemic, the public has been advised to wear masks as well. Masks have long been known to be effective means of “source control” (i.e., reducing transmission of respiratory droplets from the wearer to others). More recently evidence has accumulated that properly constructed and worn masks as well as respirators afford a limited but not inconsequential degree of protection to the wearer as well. Existing masks and respirators run the gamut in terms of effectiveness and wearability. In a future large-scale outbreak or pandemic, it is possible to increase the protection of healthcare workers and the public from infection through more efficient, well-fitting, and comfortable masks. The design and manufacture of better masks and respirators are possible by harnessing emerging technologies, the innovative research and development spirit evidenced since the early days of the COVID-19 pandemic, and the availability of resources to support technological innovation.

A new report from the Center for Health Security provides an overview of the history and types of masks and respirators that exist and consider the development, manufacture, approval, and stockpiling of better respiratory protection for healthcare workers, the nonhealthcare workforce, and the public in the United States. The report addresses issues related to acceptance and willingness to wear face coverings, masks, or respirators. It also discusses ways to foster ingenuity in designs of new devices, promote advanced development, obtain regulatory approval, and stockpile a reasonable number of devices.

The authors found that better medical masks and respirators (collectively referred to as devices) than the ones we have been using for decades are possible, but progress in their development and manufacture is blocked by a confluence of factors including industrial inertia, lack of competition, complacent consumers (health systems prior to COVID-19), regulatory barriers, an uncertain market, and lack of US government policy. Widespread public use of effective, commercially available masks and respirators could help save many thousands of lives during the next severe pandemic of a respiratory pathogen and reduce the resulting economic damage. It is important to have a ready supply and surge manufacturing capacity of high-quality devices when severe or catastrophic respiratory epidemics emerge. Widespread public use of effective, commercially available masks during periods of other respiratory disease would reduce transmission of common respiratory pathogens such as influenza that kills on average more than 15,000 Americans per year.

Read the report here.

WSU to Lead $125 Million USAID Project to Detect Emerging Viruses

Washington State University (WSU) will lead a new five-year, $125 million global project with the US Agency for International Development (USAID) that is aimed at better identifying and preventing future pandemics. The USAID Discovery & Exploration of Emerging Pathogens – Viral Zoonoses (DEEP VZN) project will “build scientific capacity in partner countries to safely detect and characterize unknown viruses which have the potential to spill over from wildlife and domestic animals to human populations.” DEEP VZN plans to partner with 12 countries in Africa, Asia, and Latin America to conduct large-scale animal surveillance using those nation’s laboratory facilities. The project will focus on uncovering previously unknown pathogens from three viral families: coronaviruses, which includes SARS-CoV-2; filoviruses, which includes the Ebola virus; and paramyxoviruses, which includes Nipah virus. These three families have a large potential for viral spillover from animals to humans. One of the first tasks is to select the partner countries for DEEP-VZN based on their “high risk for emerging infectious disease, capacity to safely conduct viral discovery work and commitment to share data with global partners.”

This project aligns with the work of Dr. Filippa Lentzos of King’s College London & Dr. Greg Koblentz of George Mason University, who launched GlobalBioLabs.org, an interactive web-based map of global Biosafety Level-4 facilities and biorisk management policies. Their work calls for stronger international biorisk management policies for laboratories that engage in high-risk research, including gain of function research.

FDA Center Directors on Lessons from the EUA Pathway: Flexibility Serves Us Well

In a workshop at the National Academies of Sciences, Engineering and Medicine, Food and Drug Administration (FDA) center directors emphasized that the “flexibility of emergency use authorizations (EUAs), and allowing the FDA to accept more uncertainty during the pandemic so far, has ultimately aided its response to COVID-19.” Dr. Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, points out that the agility of the EUAs, which gave FDA the ability to quickly revoke, was critically important. Dr. Jeffrey Shuren, Director of Center for Devices and Radiological Health, wishes that this level of flexibility was offered during times outside of crises.

Before The Pandemic, The United States Had Begun Building a Special Pathogen System. What Can We Learn from Its COVID-19 Response?

A new Health Affairs Blog post is part of a set of posts about a National Special Pathogen System of Care that will be published over the next few months. Health Affairs received support for the series from the National Emerging Special Pathogens Training and Education Center. This blog series will describe how the National Emerging Special Pathogens Training and Education Center (NETEC)—a consortium comprising faculty and staff from Emory University, the University of Nebraska Medical Center/Nebraska Medicine, and the New York Health and Hospitals Corporation, Bellevue Hospital Center—assessed aspects of the US health care system’s COVID-19 response to date. This assessment resulted in the development of a coordinated national strategy for a systematic response to special pathogens: the National Special Pathogen System (NSPS) of Care. The NETEC developed the strategy with support from the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). Successful implementation of the strategy will engage health care leaders, public health, and government at all levels. The series will describe current capacity of our system to identify and safely manage such pathogens and then address: (1) how to leverage the existing care delivery system to prepare for and respond to various outbreak scenarios; (2) the critical need for a public-private partnership to coordinate the response; (3) how a national special pathogens system of care would function in a pandemic; and (4) the steps that must be taken to make the strategy a reality. Read the blog here.

We’re Already Barreling Toward the Next Pandemic

If the US had learned from its mishandling of the original SARS-CoV-2 virus, it would have been better prepared for the variant that was already ravaging India.” In the spring and early summer of this year, President Biden had “all but declared victory against SARS-CoV-2,” and the CDC announced that vaccinated people could be unmasked indoors. Then, the Delta variant hit the US, again overburdening hospitals and healthcare workers. “Delta was an audition for the next pandemic, and one that America flubbed.” Despite the impressive and rapid authorization of COVID-19 vaccines, the rate of uptake has plateaued, and the death toll continues to climb despite these vaccines being widely available. Though Biden has called for a new council of national leaders and a new fund focused on infectious disease threats, many worry that COVID-19 might leave the US weaker against the next disease, as the temporary surge in investments are funneled improperly. This is not a new trend. The US has repeatedly “failed to sustain progress in any coherent manner in its capacity to handle infectious diseases.” This pattern shows a “Sisyphean cycle of panic and neglect that is now spinning in its third century. Progress is always undone; promise, always unfulfilled.”

EVENTS & ANNOUNCEMENTS

Schar School Open Houses

The Schar School will be hosting virtual open houses for the Master’s and Certificate Programs! These sessions will take place on 21 October and 16 November at 6:30 PM EST. This online session will provide an overview of our master’s degree programs – such as the Biodefense Program – and our Graduate Admissions team will be available to answer questions about admissions requirements, application deadlines, and materials to prepare. By working closely with faculty who draw on world-class research and practical experience, the Schar School prepares students for a high-powered career in the public, private, and non-profit sectors. Register here.

The Schar School Is Hiring!

The Schar School is hiring! Positions available include the Don E. Kash Postdoctoral Fellowship in Science and Technology Policy; a Full, Associate, or Advanced Assistant Professor; and a Full or Associate Professor.

The George Mason University Schar School of Policy and Government invites applications for the Don E. Kash Postdoctoral Fellowship in Science and Technology Policy. The Schar School is seeking talented recent graduates with the potential to contribute to the School’s research and teaching capacity at the intersection of technology and policy. For this cycle, the School is looking for postdoctoral applicants focusing on emerging technology, society, and public policy. Areas of interest in relation to public policy include, but are not limited to, big data surveillance and privacy; algorithmic bias and discrimination; legal and human rights issues relating to AI and big data; digital innovation and the digital divides; and regulation and oversight of emerging technology. Apply here.

The Schar School also invites applications for three tenure-line hires. Rank and field are open. The School encourages applications from talented scholars with diverse backgrounds who are committed to being part of and contributing to a nationally and internationally recognized school of policy and government. Apply here.

The Terrorism, Transnational Crime and Corruption Center (TraCCC) at the Schar School invites applications for a faculty position at the level of Professor or Associate Professor. TraCC seeks an imaginative and entrepreneurial colleague with an international reputation among both scholars and practitioners to assume a senior role, and as a faculty member within the school, teaching in TraCCC-related areas. TraCCC is the first center in the United States devoted to researching and shaping the policy discussion around transnational, corruption and terrorism.  The center addresses such diverse concerns as new and emerging security challenges, environmental crime and corruption, human trafficking, illicit trade, counterfeits, and antiquities smuggling. It uses advanced data analytics in much of its research. TraCCC’s research is global, diverse and multidisciplinary, focusing on problems of crime and corruption stemming from post-Soviet countries, the Middle East, and China, as well as Central and South America. Apply here.

Policy Exchange: The Future of Global Health Security

The COVID-19 pandemic revealed unexpected weaknesses in our preparedness for pandemic threats, and it continues to pose serious challenges around the world. How are health authorities in the United States and around the world trying to reduce these vulnerabilities so we are better equipped for the next pandemic?

Join faculty members from the Schar School’s Biodefense master’s program as we discuss the future of global health security considering lessons learned from the COVID-19 pandemic. The panel will feature Adjunct Professors Ashley Grant and Andrew Kilianski, and Term Assistant Professor Saskia Popescu. The discussion will be moderated by Associate Professor Gregory Koblentz, director of the Master’s in Biodefense Program. Register here.

Saving Sisyphus: Course Corrections for National Biodetection

In its 2015 report, A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts, the Bipartisan Commission on Biodefense addressed inadequacies of BioWatch, the Department of Homeland Security environmental biodetection program. Established in 2003, the federal government intended for BioWatch to provide early warning of biological attacks on major metropolitan areas. However, after nearly two decades of operation, the system is ineffective. There is little evidence that the system effectively detects pathogens of interest, and even if it did, pathogen detection turnaround time is too slow for the government to effectively respond to any actual biological attack. If the federal government continues to spend more taxpayer money on next generation biodetection systems, a reassessment of current efforts is necessary.

Join in on 2 November at 10 AM EST for an in-person meeting of the Commission, Saving Sisyphus: Course Corrections for National Biodetection, to provide a better understanding of challenges facing federal biodetection programs, public and private advancements in environmental biodetection technology, and mission requirements for 21st Century biodetection capabilities. More details will be available here.

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