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.
The Pandora Report 