Pandora Report 12.15.2023

This week covers the FDA’s ongoing investigation into contaminated applesauce, the passing of Gao Yaojie-an activist responsible for bringing to light the extent of China’s AIDS epidemic-, and more.

Biodefense MS Graduates Riley Flynn and Sophie Hirshfield at GMU’s 2023 Winter Commencement Ceremony

FDA Leadership Says Tainted Applesauce Pouches May Have Been Intentionally Contaminated

Cinnamon applesauce pouches available Weis, WanaBanana, and Schnucks have been pulled from shelves after they were found to be contaminated with lead. Dozens of children in the United States have been sickened by the tainted products. Now, the FDA’s Deputy Commissioner for Human Foods, Jim Jones, says they may have been intentionally contaminated.

In an interview with Politico, Jones said “We’re still in the midst of our investigation. But so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out.” All of the pouches in question were linked to a manufacturing facility in Ecuador that the FDA is currently inspecting.

‘“My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.”’

Politico further explained that “The FDA continues to investigate a number of theories for how the pouches became contaminated, and has not drawn any conclusions about the way the lead was added, why or by whom. The FDA says it currently believes the adulteration is “economically motivated.” That generally refers to ingredients being altered in order to make products appear higher in value, often so companies can produce a cheaper item and sell it at an elevated price.”

“The agency and the Centers for Disease Control and Prevention have collaborated with state and local health authorities as well as Ecuadorian authorities to trace the origin of the cinnamon in the applesauce pouches, which is believed to be the source of the lead contamination. More than 60 U.S. children under the age of 6 have tested positive for lead poisoning after consuming the pouches — some at levels more than 500 times the acceptable threshold for lead, according to The Washington Post.”

Gao Yaojie, Chinese Physician and Self-Exiled AIDS Activist, Dead at 95

Gao Yaojie, a gynecologist and well-known AIDS activist, died on December 10 in New York City. Gao, formerly based in China’s Henan province, was famous for her work to expose the outbreak of HIV/AIDS in the country in the 1990s and 2000s. The outbreak was large in scale and primarily driven by the country’s Plasma Economy, which arose because of restrictions on foreign imports of blood products in the 1990s. This resulted in blood plasma donation becoming a way for rural populations to make money in government-supported plasma donation centers. However, unsafe practices like repeated use of unsterilized needles and pooling multiple donors’ blood during the plasmapheresis allowed HIV to spread widely.

Because of the Chinese government’s efforts to suppress reporting on this epidemic, poor rural populations were left largely unaware of the dangers of plasma donation and the public in general was unaware of the severity of the crisis. Gao was one of the first to speak publicly about the outbreak, helping draw the attention of media outlets. She later told documentary filmmakers about her motivations for doing this, saying, “My driving thought is: how can I save more people from dying of this disease? We each only live one life.”

It is estimated that at least one million Chinese were infected with HIV during this epidemic, highlighting the importance of Gao’s and others’ bravery. For this, she garnered praise from the United Nations, several Western organizations, and even Hillary Clinton. This rising fame led to her being placed under house arrest in 2007, with about 50 police preventing her from traveling to the United States to accept an award recognizing her work. In response to this, she told NPR “I think they feel I got in the way of their political achievements and their official careers…Otherwise, why would they put me under house arrest? What law did I break to warrant mobilizing all these police?”

NPR further explained her activities later in life in their article on her passing, writing: “Despite pressure from Henan provincial authorities to stop publicizing the AIDS crisis, she continued her work, using all the proceeds from her books and pamphlets to support AIDS families, especially children orphaned by the disease or the many suicides that it caused.”

“Restrictions on her movement began hindering in work in China, however, and in 2009, she abruptly fled to the US, after fearing she would be put under house arrest again. Many admirers continued to visit her apartment in West Harlem, including a group of young Chinese students who kept her company in the loneliness of exile.”

‘”Many Chinese regarded her as a hero, and when they came to New York, if they didn’t know how to contact her , [sic] they would ask me. I would ask them for an email written in Chinese and would forward it to her. So far as I know, she always wrote back to those people and welcomed them to come visit,” remembers Andrew Nathan, a political science professor at Columbia University who handled much of Gao’s affairs in New York.”

“The Biological and Toxin Weapons Convention in 2023: Glimmers of Progress Set Against a Troubled Geopolitical Landscape”

Experts at CSR’s Nolan Center, including Biodefense PhD Program alumna and current faculty member Saskia Popescu, recently authored this blog post focused on the BWC’s potential for success in verification, universalization and effective implementation in Africa, and the creation of an International Agency for Biological Safety. They explain in their introduction: “For nearly two decades, efforts to strengthen the Biological and Toxin Weapons Convention (BWC) were in stasis, with opportunities missed and States Parties unable to agree to definite action. States Parties arrived at the Review Conference last year facing a growing biological weapons threat—augmented by rapidly converging complimentary technologies—coupled with a status quo in the BWC that was insufficient for the task. Yet nations drove a breakthrough: the consensus achieved at last year’s Review Conference proved that action is still possible despite the challenging international security environment.”

“In a world in which biological threats and vulnerabilities are exceedingly complex, there is a critical need to reinforce relationships among global experts, national governments, and civil society. Over the past two weeks, these stakeholders have met to identify, examine, and develop specific and effective measures to strengthen the Convention. An unwavering theme throughout the Meeting of States Parties underscored that preparedness and resilience are investments, rather than costs, reinforcing the deterrence by denial efforts CSR continues to promote. Although the challenging international security environment continues to hinder progress there are glimmers of genuine progress across several fronts…”

“Biosecurity in the Americas: Regional Threat Assessment”

A new from UMD’s START, co-authored by Biodefense MS Program alumna Alexandra Williams: “This publication, currently available in Spanish, provides a breadth and depth of focuses as a high-level assessment of the Central and South America regions and introduction to key topics as:

  1. The needed expansion of understanding of the differences and areas of collaboration between the concepts of biosafety and biosecurity,
  2. Existing international obligations to biosecurity through the BWC and UNSC Resolution 1540,
  3. How biosecurity applies to and may differ in application across a variety of facility types that engage in biological research or production, whether private or public laboratories, agricultural or university-based facilities,
  4. Biosecurity risks that include proliferation, bioterrorism, agroterrorism, and biocrime,
  5. The five pillars and mechanisms of biosecurity,
  6. Lastly, the application of biosecurity in the Central and South American regions.”

“NTI|Bio Convenes Workshop on Disincentivizing State Bioweapons Development and Use”

From NTI: “A week ahead of the Biological Weapons Convention (BWC) Working Group meetings in Geneva, Switzerland, NTI | bio convened a workshop on “Disincentivizing State Bioweapons Development and Use.” This two-day workshop on November 29 and 30 brought together academics, diplomats, biosecurity experts, and government policy makers to begin developing a cross-disciplinary thought and practice community to explore and develop potential disincentivizing solutions. Current thinking and policy on disincentivizing bioweapons acquisition and use is underdeveloped—especially by comparison with the nuclear security field.”

‘“We launched this effort because we see the need for more rigorous thinking on effective approaches to making bioweapons unattractive to nation-states,” said NTI | bio Vice President Jaime Yassif. “NTI’s goal is to bridge theory and practical policy-relevant approaches to develop new ideas that can invigorate international efforts to reduce biological threats.”’

Biodefense Graduate Program Director Gregory Koblentz and Associate Professor Sonia Ben Ouagrham-Gormley both participated in this workshop. Read more about it here.

“Great Powers and the Norms of the BW Prohibition Regime”

A new working paper from CBWNet: “The United States of America and the Soviet Union were instrumental in creating the biological weapons prohibition regime more than 50 years ago. This has left the regime with a big gap in its normative structure related to the verification of treaty compliance. The working paper by Alexander Kelle and Eva Siegmann analyses great power involvement in several areas of regime implementation and concludes that none of the great powers, including China, has supported the addition of declaration and inspection norms. While recent US and Chinese initiatives could still lead to a strengthening of the regime in different areas, Russian policies, most notably false accusations against the US and others, threaten to undermine the regime.”

“AI and Biorisk: An Explainer”

A new explainer from Georgetown’s CSET: “Recent government directives, international conferences, and media headlines reflect growing concern that artificial intelligence could exacerbate biological threats. When it comes to biorisk, AI tools are cited as enablers that lower information barriers, enhance novel biothreat design, or otherwise increase a malicious actor’s capabilities. In this explainer, CSET Biorisk Research Fellow Steph Batalis summarizes the state of the biorisk landscape with and without AI.”

“Bio X AI: Policy Recommendations For A New Frontier”

Jeffrey et al. discuss the work of the Federation of American Scientists’ Bio x AI Policy Development Sprint in this piece, explaining in their introduction: “Artificial intelligence (AI) is likely to yield tremendous advances in our basic understanding of biological systems, as well as significant benefits for health, agriculture, and the broader bioeconomy. However, AI tools, if misused or developed irresponsibly, can also pose risks to biosecurity. The landscape of biosecurity risks related to AI is complex and rapidly changing, and understanding the range of issues requires diverse perspectives and expertise. To better understand and address these challenges, FAS initiated the Bio x AI Policy Development Sprint to solicit creative recommendations from subject matter experts in the life sciences, biosecurity, and governance of emerging technologies. Through a competitive selection process, FAS identified six promising ideas and, over the course of seven weeks, worked closely with the authors to develop them into the recommendations included here. These recommendations cover a diverse range of topics to match the diversity of challenges that AI poses in the life sciences. We believe that these will help inform policy development on these topics, including the work of the National Security Commission on Emerging Biotechnologies.”

“Push to Improve Biosecurity in the Age of Genetic Engineering”

Wilmot James recently authored this opinion piece for Business Day, explaining in part “The possibility of using AI to develop bioweapons raises additional concerns, and remains uncharted territory. While the intersection of AI and biotechnology holds immense potential for positive applications in healthcare, research and diagnostics, it also poses risks if misused. AI algorithms could be employed to analyse vast genetic data sets and identify specific sequences for manipulation. This could accelerate the process of genetic engineering, allowing for the creation of more efficient and potentially harmful pathogens…To safeguard against such threats, multilateral and public-private sector agreements and regulations to govern the ethical use of AI in science, emphasising the prohibition of bioweapon development, should be established, with strong oversight committees responsible for assessing the ethical implications at the intersection of AI and biotechnology. These committees should include experts in AI, virology, bioethics and global health security.”

“Sounding the Alarm on Anti-Science”

Margaret Winchester provides background and overview of Peter Hotez’s latest book-The Deadly Rise of Anti-Science-in this piece for Health Affairs: “In his book, The Deadly Rise of Anti-Science, Hotez, professor and dean of the National School of Tropical Medicine at Baylor College of Medicine, and co-director of the Center for Vaccine Development at Texas Children’s Hospital, paints a bleak picture of public science denial during the pandemic, embedded in historic context. He tells the story of systematic anti-science efforts from his view in the trenches—and as a personal target for anti-science activists. This book, and his commentary in our December issue of Health Affairs on global lessons from COVID-19, highlight the very real effects of this movement, including lives lost, undermined public health efforts, foregone vaccinations, social schisms, and more, that will be felt for generations to come. As he writes, “anti-science now kills more Americans than global terrorism, or other deadly societal forces and social determinants.” Drawing from multiple sources, he estimates that approximately 200,000 people needlessly died in the US after COVID-19 vaccines became widely available.”

EU vs Disinfo Disinformation Review

The most recent edition of EU vs Disinfo’s Disinformation Review is now available and features multiple sections focused on Russia’s continued use of alleged US biological weapons laboratories as a bogeyman. Be sure to check it out for fantastic lines such as “If the only tool that you have is a hammer, everything looks like a biolab,” and “At a staged event, Putin mumbled out an announcement to veterans and the wider public that his regime would continue to rule over Russia after an orchestrated ritual not to be confused with an event known as an ‘election’ in the free world.”

2023 State of the Bioeconomy

From BIOISAC: “We have a lot to celebrate as we close 2023 and just over 12 months since the Executive Order calling for a safe, secure bioeconomy. Join us as we recap the activity, publications, outcomes, and – we will of course share a glimpse of the “behind the scenes” conversations from our 3 regional events and our one-day “Closing the Knowledge Gaps” event, our two-day table top training and the resulting “Going Viral: Bioeconomy Defense TTX” report, and, of course, the industry-demanded outputs from our hardware/software device security workgroup report and supplements, “Fortifying the Bioeconomy” as well as the Bioeconomy Security Questionnaire and Instrument Disposal Guide. We also have a lot left to do! We plan to share a few of our goals for 2024 and our upcoming regional events schedule.”

“Join us December 19th at 2pm Eastern-US for a live discussion.” Register here.

Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) Virtual Meeting

“The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) provides advice, information, and recommendations to the U.S. Secretary of Health and Human Services (HHS Secretary). The council supports and evaluates U.S. government activities focused on fighting antimicrobial resistance (AMR) in human health, animal health, and environmental health. Using this One Health approach, members of the PACCARB have expertise from a range of backgrounds, including academia, industry, public health, advocacy, veterinary, and agricultural production.”

“The PACCARB was established under Executive Order 13676 and included in the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). Since 2019, the President has given authority to the HHS Secretary as the primary recipient of PACCARB recommendations. Additional information on the authority and activities of the PACCARB can be found on the About Us page in the charter.”

“As a federal advisory committee, the PACCARB looks to engage with the public and all AMR stakeholders. The council holds several public meetings every year both in-person and live streamed on the HHS.gov website. These meetings are open to anyone with an interest in combating AMR. See how to get involved!”

This virtual meeting will take place on December 20 from 9-4 EST. Learn more here.

61st ISODARCO Course: Nuclear Order and International Security after Ukraine

“The war in Ukraine has had an enormous impact on global security, reviving nuclear fears, undermining the prospects for arms control, and shattering many of the norms and constraints that were the foundation of European security.  ISODARCO 2024 will examine the global nuclear order in light of the Ukraine war, focusing on the states, the policies and the technologies that will shape the future in a much more difficult environment.  How will we cope with this more dangerous world?”

This course will take place January 7-14, 2024, at the University of Trento. Learn more and register here.

International Conference, CBRNE Research & Innovation

“The last 40 years have demonstrated that both military and civilian populations could be exposed to highly hazardous CBRNE agents following conflicts, natural outbreaks and disasters, industrial incidents or terrorist attacks.”

“Worldwide, researchers, responders and industrial capacities have been commited to provide adapted response to these challenges.”

“Building on the success of the first 5 International Conferences « CBRNE Research and Innovation » which took place in Antibes (2015), Lyon (2017), Nantes (2019), on line (2021) and Lille (2022), we want to give you a new opportunity to build up or strengthen collaborative networks in Strabourg (March 19th – 21rst 2024).”

“The CBRNE R&I Conference is specifically devoted to scientific updates, responders’ feedbacks and expression of needs. It also includes workshops and demonstrations of innovative materials, technologies and procedures, according to the following themes: DETECTION – IDENTIFICATION, PROTECTION – DECONTAMINATION, MEDICAL COUNTERMEASURES, RISKS & CRISIS MANAGEMENT.”

“Looking forward to your proposals for communication and to welcoming you at Strasbourg in March 2024!”

Learn more here.

Registration for GHS 2024 Now Open

Registration is now open for the Global Health Security 2024 conference in Sydney, Australia. This iteration will take place 18-21 June, 2024. The call for abstracts is also still open. “The mission of the Global Health Security conference is to provide a forum where leaders, researchers, policy-makers, and representatives from government, international organisations, civil society, and private industry from around the world can engage with each other, review the latest research and policy innovations, and agree solutions for making the world safer and healthier. To that end, our mission is to help foster a genuinely multidisciplinary community of practice that is committed to working collaboratively to enhance global health security and eliminate disease, irrespective of its origin or source.”

WHO Announces Proposed Members of Technical Advisory Group on Response Use of the Life Sciences and Dual-Use Research

The WHO recently announced its proposed membership of its Technical Advisory Group on Responsible use of the life sciences and dual-use research (TAG-RULS DUR). According to WHO, “As per WHO processes, there will be now a two-week public consultation period for WHO to receive feedback on the proposed TAG-RULS DUR members and set in place the modalities for the TAG-RULS DUR’s first meeting, which is planned to take place following this consultation period…The final membership to the TAG-RULS DUR is subject to the above-mentioned public consultation period and relevant WHO practices and procedures.”

The proposed membership and instructions for providing commentary on the individuals included are both available here.

Vote: 2023 Arms Control Person(s) of the Year Nominees

“Since 2007, the independent, nongovernmental Arms Control Association has nominated individuals and institutions that have, in the previous 12 months, advanced effective arms control, nonproliferation, and disarmament solutions and raised awareness of the threats posed by mass casualty weapons.”

“In a field that is often focused on grave threats and negative developments, the Arms Control Person(s) of the Year contest aims to highlight several positive initiatives—some at the grassroots level, some on the international scale—designed to advance disarmament, nuclear security, and international peace, security, and justice.”

Voting will take place between Dec. 8, 2023, and Jan. 11, 2024. The results will be announced on Jan. 12, 2024. Follow the discussion on social media using the hashtag #ACPOY2023.”

Learn about the nominees and vote here.

Pandora Report: 1.6.2023

Happy New Year! This first edition of the year covers a number of updates from happenings over the course of our break, including the announcement of an exciting new book on genome editing from a Biodefense Program alumna. We also discuss the XBB.1.5 sub-variant, Dr. Fauci’s retirement from government, and more this week.

XBB.1.5 is the Most Transmissible COVID-19 Strain Yet According to WHO

XBB.1.5, yet another Omicron subvariant, rapidly went from accounting for just 4% of new US COVID-19 cases to more than 44% in a matter of weeks. Dr. Maria Van Kerkhove, the WHO’s COVID-19 Technical Lead, said this week “We are concerned about its growth advantage, in particular in some countries in Europe and the Northeast part of the United States, where XBB.1.5 has rapidly replaced other circulating sub-variants.” Thus far, the strain has been detected in at least 29 countries, though the WHO cautions it could be circulating in many more. Importantly, as Politico notes, “Van Kerkhove said the increase in hospitalizations in the Northeast cannot be attributed yet to XBB.1.5 because other respiratory illnesses, including flu, could be partially responsible.”

The WHO does not have data on the severity of the sub-variant yet, though it is currently conducting a risk assessment and monitoring any possible changes in severity via lab studies and real world data. Dr. Ashish Jha, White House COVID-19 Response Coordinator, recently Tweeted that immunity against this subvariant is “probably not great” if someone’s prior infection was before July 2022 or if they have not received a bivalent COVID-19 booster. However, he indicated Paxlovid and Molnupiravir as well as current COVID-19 tests should still work sufficiently against this sub-variant.

FY 2023 Omnibus Brings Changes in Global Health Funding, Gain of Function Research

Weeks before the current hullabaloo of the 118th Congress began, President Biden signed the late 2022 Omnibus appropriations bill on December 29, 2022, bringing about $1.7 trillion in funding for different programs that deal with health broadly. According to the Kaiser Family Foundation, the bill “…ncludes funding for U.S. global health programs at the State Department, U.S. Agency for International Development (USAID), Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH). Funding provided to the State Department and USAID through the Global Health Programs (GHP) account, which represents the bulk of global health assistance, totals $10.6 billion, an increase of $731 million above the FY 2022 enacted level and $15 million below the FY 2023 request. The bill provides higher levels of funding for almost all program areas compared to the FY 2022 enacted level, with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and global health security receiving the largest increases; funding for bilateral HIV and family planning and reproductive health (FPRH) remained flat. Funding for global health provided to the CDC totals $693 million, an increase of $46 million compared to the FY22 enacted level, but $55 million below the FY23 request. Funding for the Fogarty International Center (FIC) at the NIH totaled $95 million, $8 million above the FY22 enacted level and essentially flat compared to the FY23 request.”

The new legislation also takes aim at gain-of-function (GoF) research, after GOP lawmakers pushed the administration to halt federally-funded GoF research, citing beliefs that such research is responsible for the COVID-19 pandemic. On page 3,354 of the more than 4,100 page bill, it reads, “(1) IN GENERAL.—Beginning not later than 60 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall not fund research conducted by a foreign entity at a facility located in a country of concern, in the estimation of the Director of National Intelligence or the head of another relevant Federal department or agency, as appropriate, in consultation with the Secretary of Health and Human Services, involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).”

The Act also includes provision for tempering undue foreign influence in biomedical research, such as foreign talent recruitment programs, and addressing national security risks related to biomedical research generally. Importantly, too, it provides greater funding for countermeasure development, including $1.5 billion for the recently formed Advanced Research Projects Agency for Health, and $3.3 billion for MCM research and improving elements like the Strategic National Stockpile.

For a concise run-down, check out the KFF’s budget tracker to see details on historical annual appropriations for global health programming.

On the Topic of Risky Research…

With all the political mudslinging regarding GoF and biomedical research in general, it is important to have access to quality information about the facilities around the world conducting this kind of research. The Bulletin of the Atomic Scientists recently highlighted the work of Drs. Greg Koblentz and Filippa Lentzos on this front–Global Biolabs. The Bulletin explains, “George Mason University biosecurity expert Gregory Koblentz, who co-leads the project with Filippa Lentzos, a King’s College London researcher, said shining a light on the proliferation of the labs can help cut through misinformation about them and allow for a clear-eyed look at how these beneficial, yet also potentially risky facilities are managed. “One of the goals of our project is to increase transparency and educate the public and policy-makers about these labs’ activities and what governance measures are necessary to ensure they are operating safely, securely, and responsibly,” Koblentz said. “Accurate information is a prerequisite for an informed debate on the benefits and risks posed by these labs.”

Throughout the rest of the piece, Dr. Koblentz addresses common questions and assumptions about high risk work and the kinds of facilities it takes place in, covering everything from national-level biosafety and dual-use research policies to the time and effort it takes to actually build these facilities, and the challenges in gauging on-the-ground implementation of good policy.

Dr. Anthony Fauci Retires From Federal Service

After a marathon 38-years as the Director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony S. Fauci retired from government on December 31, 2022. During his tenure, he advised seven presidents on HIV/AIDS and other domestic and global health issues, even serving as one of the main architects of the President’s Emergency Plan for AIDS Relief (PEPFAR), a program estimated to have saved more than 20 million lives. Having served the American public for more than 50-years, Dr. Fauci has earned distinctions such as a Federal Citation for Exemplary Leadership from the National Academy of Medicine in 2020, the National Medal of Science from President George W. Bush in 2005, and, in 2008, the Presidential Medal of Freedom-the highest civilian award in the United States, bestowed by the President of the United States to recognize those who have made “an especially meritorious contribution to the security or national interests of the United States, world peace, cultural, or other significant public or private endeavors.” In a famous 1988 clip from that year’s presidential debate, then Vice President George H.W. Bush identified a then relatively unknown Dr. Fauci as his idea of an American hero, commending his work to fight HIV/AIDS.

Dr. Fauci’s career ended in a rocky last couple years as the COVID-19 pandemic gripped the world and, amid the United States’ lackluster response, public health and its leadership became increasingly politicized. The GOP has increasingly targeted Dr. Fauci, even going so far as to promise to investigate his role in the COVID-19 response upon taking control of the House of Representatives. Dr. Fauci has indicated he is fully willing to testify and cooperate with such an investigation, saying he has nothing to hide.

Despite the incessant calls to “fire” or “imprison Fauci,” the esteemed former NIAID director has indicated he does not plan to completely stop his work now that he is no longer a government employee. He told the New York Times that he “…hopes to do some public speaking, become affiliated with a university and treat patients if it has a medical center. He intends to write a memoir, he said, and he wants to encourage people to pursue careers in science, medicine and public service.”

When asked, “Are there other threats that you think about beyond infectious disease threats?,” Dr. Fauci responded: “What really, really concerns me is the politicization of public health principles. How you can have red states undervaccinated and blue states well vaccinated and having deaths much more prevalent among people in red states because they’re undervaccinated — that’s tragic for the population,” showcasing his unfailing concern and dedication to the mission to the very end.

IAVI’s Ebola Sudan Vaccine Arrives in Uganda

IAVI, the International AIDS Vaccine Initiative, announced in late December that the first shipment of its Sudan virus (SUDV) vaccine arrived in Entebbe, Uganda, on December 17. IAVI’s press release explains the goal of shipping its candidate, writing “The IAVI vaccine candidate is one of three intended to be evaluated in a “ring vaccination” clinical trial being planned to assess vaccine effectiveness in preventing Ebola Sudan disease, should the outbreak in Uganda continue or recur. In November, a WHO-convened expert independent group ranked IAVI’s investigational SUDV vaccine candidate as the number one priority investigational vaccine for inclusion in the trial. As public health measures implemented in Uganda have fortunately been successful in limiting new cases of Ebola Sudan virus disease, it may not be possible to conduct a formal ring vaccination study. Even if the ring vaccination trial cannot be conducted as currently designed, IAVI will continue to move our program forward as expeditiously as possible. Alternative clinical studies are being considered that would contribute to the evidence base needed to bring promising vaccine candidates to regulatory approval and support their use to control future outbreaks. These studies will be co-sponsored by the Ministry of Health in Uganda and WHO, with support from other partners.”

“Genome Editing and Biological Weapons: Assessing the Risk of Misuse”

In her new book, GMU Biodefense PhD alumna Dr. Katherine Paris introduces state-of-the-art genome editing technologies, and she assesses the risk that nefarious actors could intentionally misuse these technologies to develop more dangerous biological weapons. Dr. Paris uncovers how concerns over the possible misuse of genetic engineering began in the mid-1970s, and she traces how these warnings unfolded over time. These cautions came to a head in the 2016 Worldwide Threat Assessment of the United States Intelligence Community, which warned about the deliberate or unintentional misuse of genome editing to create harmful biological agents or products. In the foreword of Genome Editing and Biological Weapons: Assessing the Risk of Misuse, Dr. Gregory Koblentz, Biodefense Graduate Program Director, emphasizes the need for a “thorough, informed, and accessible analysis” of genome editing technologies, which Dr. Paris delivers in her book.

Dr. Paris systematically assesses both the risk of misuse and the potential governability of genome editing technologies. Policymakers have the ultimate challenge of protecting and safeguarding the continued development and use of genome editing for legitimate purposes, while putting in place biodefense and biosecurity strategies to prevent misuse. Dr. Paris provides a tailored set of recommendations that are sensitive to the cost-benefit trade-off of regulating genome editing technologies. The book is a must-read for policymakers as well as researchers, defense and security personnel, and intelligence analysts.

Dr. Paris is a Senior Program Analyst with over a decade’s worth of government contracting experience, and she is a certified Project Management Professional. Prior to her studies in Biodefense at GMU, she earned her MS in Biotechnology at Johns Hopkins University and BS in Biology from the University of Virginia. Dr. Paris continues her involvement at GMU as a mentor for students in the Schar School Alumni Mentoring Program.

“The Treaties That Make the World Safer Are Struggling”

Jen Kirby, a Senior Foreign and National Security Reporter at Vox, recently authored this piece discussing current issues in international disarmament and nonproliferation, focusing in large part on the Biological Weapons Convention. Kirby summarizes last year’s BWC RevCon, writing “But after three weeks of discussions that ended about a week before Christmas, the BWC RevCon ended up a modest success. The parties basically agreed to agree to keep talking, establishing a working group, which would meet for a little more than two weeks each year and deal with a long, long list of issues related to the BWC, including evaluating developments in science and technology and potential verification and compliance measures. And the unit that implements the convention would get another staff member. A team of three people tasked with helping to keep the world free of bioweapons became four.”

She then writes, “Modest,” then, is doing a lot of work. But in this geopolitical climate, you take what you can get.”

The piece continues, covering US political wrangling at past RevCons and comparable issues with the Nuclear Nonproliferation Treaty and the New Strategic Arms Reduction Treaty. She explains that this is part of a broader issue, writing “The Ukraine war and its fallout may be among the biggest current threats to global stability. But Russia is not alone. China is expanding its nuclear arsenal and has rebuffed attempts to engage bilaterally on arms control with the US even as the competition between Washington and Beijing escalates. North Korea is likely closing in on more nuclear tests. Tensions simmer between nuclear powers India and Pakistan. The United States tore up the Iran deal during the Trump administration, one of a few arms control treaties Washington exited in recent years, including the Intermediate-Range Nuclear Forces Agreement (INF) and the Open Skies Treaty, which allowed for unarmed reconassaince flights. The latter two exits chipped away at the arms control regime with Russia, even as the US had very valid claims of Russian noncompliance.”

“The 20-Year Boondoggle”

In this piece for The Verge, Amanda Chicago Lewis writes, “The Department of Homeland Security was supposed to rally nearly two dozen agencies together in a modernized, streamlined approach to protecting the country. So what the hell happened?” In it, she discusses the early and enduring challenges of forming DHS and ensuring it meets is goals, focusing in part on the BioWatch program in addition to ongoing issues with Congressional approval and agency morale in the catch-all department.

She writes, “The dysfunction might have been funny, in a Dilbert-meets-Veep way, if the stakes weren’t so high. Albright was overseeing a project called BioWatch, a system intended to detect traces of biological and chemical weapons of mass destruction. Bush described BioWatch in his 2003 State of the Union as “the nation’s first early warning network of sensors,” which would initiate processes to mobilize hospitals, alert the public, and deploy supplies from the national stockpile.”

She continues, “There was only one problem: BioWatch never functioned as intended. The devices were unreliable, causing numerous false positives. “It was really only capable of detecting large-scale attacks,” Albright explained, because of “how big a plume would have to be” for the sensors to pick it up. And the system was prohibitively slow: every 24 hours, someone had to retrieve a filter and then send it to a laboratory for testing, which might then take another 24 hours to discover a pathogen.”

“The time required after BioWatch might pick up evidence of a toxin and the time required to get it to somebody who might be able to reach a conclusion there might be a terrorist attack — my God, by that time, a lot of people would have gotten sick or died,” former Senator Joe Lieberman told me.”

“Hacked Russian Files Reveal Propaganda Agreement with China”

In this piece for The Intercept, Mara Hvistendahl and Alexey Kovalev cover Russia’s attempts to coordinate with China to spread disinformation about the United States’ Cooperative Threat Reduction program and its facilities in Ukraine. In their piece, they explain that, “A bilateral agreement signed July 2021 makes clear that cooperating on news coverage and narratives is a big goal for both governments. At a virtual summit that month, leading Russian and Chinese government and media figures discussed dozens of news products and cooperative ventures, including exchanging news content, trading digital media strategies, and co-producing television shows. The effort was led by Russia’s Ministry of Digital Development, Communication and Mass Media, and by China’s National Radio and Television Administration.”

“In the propaganda agreement, the two sides pledged to “further cooperate in the field of information exchange, promoting objective, comprehensive and accurate coverage of the most important world events.” They also laid out plans to cooperate on online and social media, a space that both countries have used to seed disinformation, pledging to strengthen “mutually beneficial cooperation in such issues as integration, the application of new technologies, and industry regulation.” 

Read this piece here.

Managing Hazardous and Biohazardous Materials/Waste in the Laboratory Setting

The Chesapeake Area Biological Safety Association recently announced this technical seminar offering from Triumvirate Environmental, which will take place at 6 pm on January 10, 2023 both virtually and in-person in Gaithersburg, MD. “Laboratories can generate biohazardous and hazardous waste. Confusion is not uncommon on what the differences are when it comes to disposal and handling.  This webinar will review the differences and discuss proper handling and disposal of each type of waste.  Potential recycling options will also be discussed.” Learn more and register here.

Closing the Knowledge Gaps

“BIO-ISAC, in partnership with the Department of Homeland Security and Johns Hopkins Applied Physics Laboratory, will host a one-day event (with remote participation available) on January 24, 2023.”

“This gathering of thought leaders across the industry and its partners will address knowledge gaps about the bioeconomy itself. The event is expected to deliver recommendations that demonstrate the scope and breadth of industry impacts, identify specific safety needs and goals, and carve the path forward for a secure future.” Learn more and register here.

Novel Applications of Science and Technology to Address Emerging Chemical and Biological Threats

For the first time since 2019, this Gordon Research Conference is back, this time in sunny Ventura, CA. “The Chemical and Biological Defense GRC is a premier, international scientific conference focused on advancing the frontiers of science through the presentation of cutting-edge and unpublished research, prioritizing time for discussion after each talk and fostering informal interactions among scientists of all career stages. The conference program includes a diverse range of speakers and discussion leaders from institutions and organizations worldwide, concentrating on the latest developments in the field. The conference is five days long and held in a remote location to increase the sense of camaraderie and create scientific communities, with lasting collaborations and friendships. In addition to premier talks, the conference has designated time for poster sessions from individuals of all career stages, and afternoon free time and communal meals allow for informal networking opportunities with leaders in the field.” The conference will be held March 19-24, 2023. Learn more and apply here by February 19.

Weekly Trivia Question

You read the Pandora Report every week and now it’s time for you to show off what you know! The first person to send the correct answer to biodefense@gmu.edu will get a shout out in the following issue (first name last initial). For this week, our question is “Before perpetrating the infamous Tokyo subway sarin attack in 1995, this Japanese cult attempted to disseminate botulinum neurotoxin and Bacillus anthracis, among other agents. What was the name of this cult prior to its split/name change in 2007?”

Shout out to Scott H. (a loyal reader and proud parent of a talented Biodefense MS student!) for winning last week’s trivia! The correct answer to “In 2016, there was an outbreak of what disease in reindeers in the Yamalo-Nenets region of Russia?” is anthrax.