Pandora Report: 5.28.2021

The 74th World Health Assembly is underway in Geneva; you can watch the webcast here! Listen here as Dr. Saskia Popescu, an assistant professor in the Biodefense Graduate Program as well as an alumna, will be interviewed on the With Good Reason podcast today, 28 May. The lab leak theory for the origin of COVID-19 is gaining traction.

Schar School Open House

You’re invited to attend a virtual open house to learn more about the Schar School of Policy and Government and our academic programs. The online session will provide an overview of our master’s degree programs and graduate certificate programs, student services, and admissions requirements. Attendees will be provided with an application fee waiver for the Fall 2021 graduate application. Biodefense applicants are eligible for funding from the Diane Davis Spencer Foundation Scholarship. The fall application deadline is July 15th. The Open House will be held virtually on 9 June at 6 PM EST. Register here.

74th World Health Assembly

The 74th World Health Assembly (WHA) is underway until 1 June, and it is taking place virtually. The WHA is the decision-making body of World Health Organization (WHO), and it is attended by delegations from all WHO Member States. The primary functions of the WHA are to determine the policies of the WHO, appoint the Director-General, supervise financial policies, and review and approve the proposed budget. The theme of this year’s meeting is, “Ending this pandemic, preventing the next: building together a healthier, safer and fairer world.” On Monday, United Nations Secretary-General Antonio Guterres called for the “application of wartime logic in the international battle against COVID-19.” Guterres explains the pandemic as being “at war with the virus.” WHO Director-General Tedros Adhanom Ghebreyesus lamented the “scandalous inequity” of vaccine distribution that is perpetuating the pandemic. Though COVID-19 is the main topic of this year, other issues include proposals for WHO reforms and the exclusion of Taiwan. Taiwan maintains hope that it will be granted a seat at the WHA meeting. The nation’s successful handling of COVID-19 for more than a year and a half has brought renewed attention to Taiwan’s absence from the WHA.”

MCMi Program Update on FDA

The Food and Drug Administration (FDA) plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. The FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure. The FDA works closely with interagency partners through the US Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE, or Enterprise) to build and sustain the MCM programs necessary to effectively respond to public health emergencies. The FDA also works closely with the US Department of Defense (DoD) to facilitate the development and availability of MCMs to support the unique needs of American military personnel. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), requires the FDA to issue an annual report detailing its medical countermeasure activities. This report responds to that requirement for the latest fiscal year available. The FY 2020 report includes a snapshot of the Agency’s COVID-19 response efforts through September 30, 2020. Read the report here.

DHS Exploring New Methods to Replace BioWatch and Could Benefit from Additional Guidance

The Department of Homeland Security (DHS) is following the agency’s acquisition policy and guidance to acquire Biological Detection for the 21st Century (BD21). This system-of-systems concept—an assembly of technologies to gain higher functionality—is intended to combine various technologies, such as biological sensors, data analytics, anomaly detection tools, collectors, and field screening devices to enable timelier and more efficient detection of an aerosolized attack involving a biological agent than the current biodetection system. The BD21 program is early in the acquisition lifecycle and DHS has not yet selected the technologies to be used. Potential technologies are still being analyzed to demonstrate that certain components of the overall concept are feasible, such as an anomaly detection algorithm.

However, BD21 faces technical challenges due to inherent limitations in the technologies and uncertainties with combining technologies for use in biodetection. For example, biological aerosol sensors that monitor the air are to provide data on biological material in the environment, but common environmental material such as pollen, soil, and diesel exhaust can emit a signal in the same range as a biological threat agent, thereby increasing false alarm rates. Program officials report that the risk of false alarms produced by biological sensor technologies could be reduced by using an anomaly detection algorithm in addition to the sensor. However, it is too early to determine whether integration of an anomaly detection algorithm will successfully mitigate the false alarm rate. Specifically, because the algorithms have never been developed and used for the purpose of biodetection in an urban, civilian environment.

BD21 program is following the agency’s acquisition policy and guidance to mitigate technological risks in acquisition programs, and plans to conduct technology readiness assessments (TRA) along the way. In 2020, DHS issued a TRA guide, but it lacked detailed information about how the department will ensure objectivity and independence, among other important best practices GAO has identified. If DHS follows GAO’s best practices guide, decision makers and program managers will be in a better position to make informed decisions at key acquisition decision events. Read the report here.

The Eroding Norms Against Chemical Weapons Use Will Need More Than Another Syria Censure to Survive

Last month, the members of the Chemical Weapons Convention (CWC) voted to suspend Syria’s rights and privileges under the treaty. The CWC prohibits the use, production, and stockpiling of chemical weapons. The suspension is a “modest step” toward holding Syria accountable for its chemical weapons attacks and reinforcing the global norm of prohibition against chemical weapons use. In 2013, Syrian forces deployed nerve gas on neighborhoods near Damascus, killing about 1,300 people. Unfortunately, the international responses to Syria’s atrocities have been lackluster. Despite the latest vote, the “Assad regime could continue to maintain, expand, and employ its illegal chemical weapons arsenal as a terror weapon against opposition forces and civilians.” A possible next step in the event that Syria does not comply with the CWC is to refer Syria to the UN Security Council (UNSC). Another option would be to “demand a challenge inspection in Syria pursuant to Article IX of the CWC to clarify outstanding inconsistencies with its stockpile declaration.”

Will Biden Blink Over Navalny?

This week, Jen Psaki, the White House Press Secretary, announced that President Biden and Russian President Putin will meet in Geneva, Switzerland on 16 June. This highly anticipated meeting comes as relations between the US and Russia plummet to a historic low since the Cold War. The US is compelled to respond to the use of chemical weapons as a result of the first round of sanctions under the Chemical and Biological Weapons Control and Warfare Elimination Act. This first set of penalties was in response to the Novichok attack on Alexei Navalny, and included “personal sanctions on seven senior Russian officials believed to have been involved in the decision to poison and later imprison the opposition leader, who was arrested upon his return to Moscow in January, as well as penalties on several entities involved in Russia’s chemical weapons program.” Thus far, Russia has not made any effort to signal its intent to not use these weapons again, so a second round of sanctions is required by law. The administration hopes that the upcoming meeting will “restore predictability and stability to the US-Russia relationship.” The Biden administration must tread carefully, however, as severe sanctions before the summit could derail the interaction but overly mild sanctions could be perceived as “too soft.” Dr. Gregory Koblentz, Director of the Biodefense Graduate Program, explains, “There’s a tension between wanting to punish Russia for its use of chemical weapons but, at the same time, allowing for the relationship to improve between the countries on strategic issues.”

Launch of GlobalBioLabs.org

GlobalBioLabs.org has officially launched! This is an interactive web-based map of global Biosafety Level-4 facilities and biorisk management policies. An accompanying policy brief, entitled Mapping Maximum Biological Containment Labs Globally, was also released. This brief is offered by Dr. Filippa Lentzos of King’s College London & Dr. Greg Koblentz of George Mason University. The map is available here and the report is available here.

COVID-19 Lab Leak Theory

On Wednesday, President Biden implored the US intelligence community to “redouble their efforts” in determining the origin of SARS-CoV-2. This is an about-face from the previous reliance on the World Health Organization to investigate the origins of the pandemic. This is a shift from the assessment that the novel coronavirus emerged naturally, jumping from an animal species to humans. The theory that the virus may have escaped from the Wuhan Institute of Virology in China is gaining traction, but is far from conclusive. The Adminsitration’s message follows a letter from 18 prominent biologists published in the journal Science that calls for a new investigation into all conceivable origins of the novel coronavirus, and implores Chinese laboratories and agencies to “open their records” for independent analysis. They write:

“As scientists with relevant expertise, we agree with the WHO director-general, the United States and 13 other countries, and the European Union that greater clarity about the origins of this pandemic is necessary and feasible to achieve. We must take hypotheses about both natural and laboratory spillovers seriously until we have sufficient data. A proper investigation should be transparent, objective, data-driven, inclusive of broad expertise, subject to independent oversight, and responsibly managed to minimize the impact of conflicts of interest. Public health agencies and research laboratories alike need to open their records to the public. Investigators should document the veracity and provenance of data from which analyses are conducted and conclusions drawn, so that analyses are reproducible by independent experts.”

On the other hand, many researchers find the tone of growing demands for an investigation to be “unsettling.” There are worries that the “volatility of the debate could thwart efforts to study the virus’s origins.” These demands are also exacerbating existing tensions between the US and China, an unfortunate development with crucial meetings about curbing the pandemic and preparing for future health emergencies underway and upcoming. Global health policy experts assert that it is critical for the world to “work together to curb the pandemic and prepare the world for future outbreaks.” Actions needed immediately include the expansion of vaccine distribution and the reform of biosecurity rules, such as standards for reporting virus-surveillance data.

Event – Pandemics and Global Health Security Workshop

COVID-19 has exposed just how unprepared governments, corporations, and societies are for a global pandemic. While the SARS-CoV-2 virus is only the most recent threat to global health security, it will certainly not be the last. Threats to global health security continue to evolve due to the emergence of new infectious diseases, globalization, advances in science and technology, and the changing nature of conflict. Pandemics and Global Health Security is a three-day virtual, non-credit workshop designed to introduce participants to the challenges facing the world at the intersection of pandemic preparedness and response, public health, national security, and the life sciences. Over the course of three days, participants will discuss how the biology and epidemiology of SARS-CoV-2 contributed to the emergence of that virus as a global pandemic, lessons learned from Operation Warp Speed about the development of medical countermeasures, obstacles to hospital biopreparedness, challenges to science communication during a pandemic, the bioethics of resource allocation during a public health emergency, the future of global health security, and the role of science and technology in preventing and responding to pandemics. The workshop faculty are internationally recognized experts from the government, private sector, and academia who have been extensively involved in research and policy-making on public health, biodefense, and security issues. Live, interactive sessions will include Dr. Rick Bright, The Rockefeller Foundation; Dr. Nicholas G. Evans, University of Massachusetts-Lowell; Dr. Andrew Kilianski, Department of Defense; Dr. Gregory D. Koblentz, George Mason University; Dr. Jennifer Nuzzo, Johns Hopkins Center for Health Security; Dr. Saskia Popescu, George Mason University; Dr. Angela L. Rasmussen, Vaccine and Infectious Disease Organization-International Vaccine Centre; and Jessica Malaty Rivera, COVID Tracking Project. The workshop is organized by the Biodefense Graduate Program at the Schar School of Policy and Government at George Mason University and will be held virtually on July 19-21, 2021. Each day will run from 9am to 12:30pm ET. Prior to June 18, the course fee is $400. Starting June 18, the course fee is $500. Register here.

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