It’s Friday again and this time we are kicking it off with some great news from our program. We then discuss the Biden administration’s new National Biodefense Strategy and the Boston University preprint controversy. As always, we finish the week out with new publications and upcoming events, including an entire issue supplement of Clinical Infectious Diseases dedicated to anthrax. Finally, mark your calendars, because November 3 is One Health Day (more on that in the announcements section).
First, Some Good News from the Biodefense Program!
Biodefense Faculty Member Joins Council on Strategic Risks and Wins Schar School of Policy and Government Distinguished Alumni Award…All in One Week!
This week, Dr. Saskia Popescu, an epidemiologist, prominent infection prevention consultant, an assistant professor at the Schar School, and more (No, seriously, she does all that AND more.) was named a Senior Fellow at the Janne E. Nolan Center on Strategic Weapons at the Council on Strategic Risks. In case that somehow was not enough for one week, she is also being honored today as this year’s Schar School of Policy and Government Distinguished Alumni Award winner. Read all about Dr. Popescu’s hero origin story here on the Schar School site.
Biodefense PhD Student Named Bulletin of the Atomic Scientists Editorial Fellow
Kimberly Ma, a first year Biodefense PhD student and senior analyst with the Preparedness division at the Association of State and Territorial Health Officials, was recently named an Editorial Fellow at the Bulletin of the Atomic Scientists. Over the next year, she will author a number of pieces on biosecurity for the Bulletin, so keep an eye out for her upcoming work!
The Biden Administration Releases New National Biodefense Strategy
This week, the White House announced the release of the new National Biodefense Strategy and President Biden’s intent to sign National Security Memorandum 15-“Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security”. The strategy takes a comprehensive approach, aiming to make improvements in these areas-“detect pandemic and other biological threats, “prevent outbreaks from becoming epidemics and prevent biological incidents before they can happen,” “prepare for pandemics and other biological incidents,” “rapidly respond to outbreaks when they occur,” and “recover from a pandemic or biological incident.”
Among other points about the strategy, the Nuclear Threat Initiative explains that “The new strategy’s requirement that the National Security Council and the Office of Science and Technology Policy conduct an interagency policy review regarding biosafety and biosecurity norms and oversight for life sciences research also is valuable. As the largest funder of bioscience and biotechnology research and development in the world, the U.S. Government has a responsibility to put guardrails in place to prevent laboratory accidents or deliberate misuse of the tools of modern bioscience and biotechnology. Doing so can have a profound direct impact in reducing global biological risks and serve as a valuable example for other funders around the world.”
National Security Memorandum 15, “National Security Memorandum on Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security,” directs the heads of agencies addressed to:
- “implement the Biodefense Strategy, as well as related strategies such as the U.S. Global Health Security Strategy, and include biodefense-related activities, including resourcing and achieving the goals of the Biodefense Strategy and the priorities, targets, and actions of its Implementation Plan, within their strategic planning and budgetary processes;
- in the event of the determination of a nationally or internationally significant biological incident, implement Federal response efforts in accordance with Homeland Security Presidential Directive 5 of February 28, 2003 (Management of Domestic Incidents), Presidential Policy Directive 8 of March 30, 2011 (National Preparedness), Presidential Policy Directive 44 of November 7, 2016 (Enhancing Domestic Incident Response), and Federal Government response and recovery frameworks and operational plans;
- coordinate their biodefense policies with other agencies that have responsibilities or capabilities pertaining to biodefense, as well as with appropriate non-Federal entities;
- share information and coordinate decision-making related to the biodefense enterprise; and
- monitor, evaluate, and hold their respective agencies accountable for the implementation of section 3(a) of this memorandum.”
The memorandum also states that “To facilitate effective implementation of the Biodefense Strategy, within 90 days of the date of this memorandum and at least quarterly thereafter, the NSC staff Directorate for Global Health Security and Biodefense shall convene lead agencies identified in the Biodefense Strategy’s Implementation Plan at the Assistant Secretary level. These agencies shall brief the NSC staff on progress towards key milestones and timelines, as well as on critical gaps and barriers to progress. The NSC staff Directorate for Global Health Security and Biodefense shall provide updates quarterly to the APNSA based off of these briefs, summarizing progress towards the implementation of the Biodefense Strategy by highlighting the extent to which the goals and objectives are being met, outlining major gaps and impediments to timely and effective implementation, and presenting options for overcoming these gaps. The APNSA shall provide to the President, on an annual basis, a memorandum summarizing these updates.”
Transcripts of the background call on this new strategy are available here, and check out the Council on Strategic Risks discussion of the strategy here.
Boston University Controversy
Last week, researchers from Boston University’s (BU) National Emerging Infectious Diseases Laboratories (NEIDL) posted results from their controversial work on BA.1 variant spike proteins in preprint. As Science explains, “They took the gene for Omicron’s surface protein, or spike protein, which SARS-CoV-2 uses to enter cells and added it to the genome of a “backbone” virus—a variant of SARS-CoV-2 from Washington state that was identified soon after the pandemic first emerged in Wuhan, China, in early 2020. The objective was to tease apart whether Omicron’s spike protein explains why it is less pathogenic (meaning it causes less severe disease). The answer could lead to improved COVID-19 diagnostic tests and better ways to manage the disease, the preprint authors say.”
By Monday, a UK tabloid, Daily Mail, ran with the story, indicating in their headline that the lab had created a strain of SARS-CoV-2 with an “80 percent kill rate,” and had created a much more dangerous strain of the virus. While the Daily Mail piece is very clearly from a tabloid, this did spark debate online, as this preprint describes what some argue is gain of function research. This work was not approved by the National Institutes of Health, though it was approved by the institutional biosafety committee at NEIDL. Critics argue that this study lacks scientific value and that its potential risks were not properly reviewed before it was conducted. Some, including Francois Balloux, a virologist at University College London, expressed concern over the study’s relevance to human health, noting that findings in mice frequently do not carry over to humans. Others, however, are far less alarmed, generally arguing that the hybrid virus is far less lethal than the original, pointing to the extreme sensitivity of the mice used in the study, and highlighting that similar SARS-CoV-2 variants have already emerged before later fading away.
The university responded to accusations made in the Daily Mail, stating “We want to address the false and inaccurate reporting about Boston University COVID-19 research, which appeared today in the Daily Mail,” said the BU statement. “First, this research is not gain-of-function research, meaning it did not amplify the Washington state SARS-CoV-2 virus strain or make it more dangerous. In fact, this research made the virus replicate less dangerous.” BU also explained that “The animal model that was used was a particular type of mouse that is highly susceptible, and 80 to 100 percent of the infected mice succumb to disease from the original strain, the so-called Washington strain,” says Corley. “Whereas Omicron causes a very mild disease in these animals.” On the topic of funding, BU said the lab “…did not amplify the [backbone] SARS-CoV-2 virus strain or make it more dangerous. In fact, this research made the virus replicate less dangerous,” as reason for not reporting the study to NIH. They also stated this work did not need to be cleared by NIH as it was not directly funded by the agency as the lab used NIAID grants only to pay for tools and platforms.
Science reports that “Emily Erbelding, director of the NIAID division that helped fund the work, said the hybrid virus experiments weren’t described in BU’s grant proposal or progress reports. But she said if BU had informed NIAID about its plans, the institute probably would have evaluated it to determine whether it qualified for review by a special Department of Health and Human Services (HHS) committee.”
NIH also released a statement this week: “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, did not review nor issue awards for experiments described in a pre-print article on SARS-CoV-2 research at Boston University’s National Emerging Infectious Diseases Laboratories (NEIDL). NIH is examining the matter to determine whether the research conducted was subject to the NIH Grants Policy Statement or met the criteria for review under the HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO framework)…”
While the debate is sure to keep raging, it is also likely to add fuel to the ongoing review of federal oversight policies for GoF research led by the National Science Advisory Board for Biosecurity (NSABB). According to Science, “In September, an NSABB task force issued a draft report that recommended the review policy be expanded to sweep in some kinds of research, and some pathogens, that are now exempt. And experts on all sides of the GOF debate have said the criteria for review need to be clearer. The government is expected to release new rules as early as next year. (For more, see this week’s feature in Science.)”
However, as Science has also previously written, “A U.S. clampdown will have no sway over privately funded GOF research or what happens in other countries, which typically lack policies like the P3CO framework. In Japan and most of Europe, for example, oversight is limited to rules on biosafety and, sometimes, biosecurity along with voluntary self-regulation, say biosecurity experts Gregory Koblentz of George Mason University and Filippa Lentzos of King’s College London. It’s too soon to say how a 2020 Chinese biosafety law will affect PPP research, they say.”
“National Security Snapshot: Department of Defense and Intelligence Community Preparedness for Biological Threats”
The Government Accountability Office (GAO) recently released this National Security Snapshot co-authored by Dr. Brian Mazanec, an alumnus of the Biodefense PhD program. This snapshot discusses core issues like biopreparedness and the PRC’s intent to exploit US genetic data. The authors write, “We made several key recommendations to improve how DOD and the Intelligence Community prepare for and respond to biological threats. DOD is taking a number of positive steps, such as coordinating with partners to research and develop vaccines. But, DOD doesn’t have a comprehensive strategy that, for example, shows where biodefense resources are needed.”
“Public Health Preparedness: HHS Should Address Strategic National Stockpile Requirements and Inventory Risks”
GAO also recently released this report discussing the Department of Health and Human Services’ inventory planning reports and their failure to “meet most legal requirements enacted in 2019 or communicate risks associated with not meeting recommended inventory levels. This is partly because HHS hasn’t updated its processes for completing the reports and a key advisory body was inactive.” This report makes a number of recommendations while also noting that HHS’s leadership and coordination of public health emergencies is on the office’s high risk list.
“COVID-19: A Warning – Addressing Environmental Threats and the Risk of Future Pandemics in Asia and the Pacific”
From the UN Environment Programme: “This scientific review begins with the history of humans and zoonoses and provides clarity on the issues of zoonoses and emerging infectious diseases. It then presents the seven anthropogenic drivers of zoonotic disease emergence as well as the concept of viral mixing. After providing rich context, this review continues to outline solutions that address the intricate link between nature and human health and strategies to prevent future zoonotic outbreaks.”
“”It was Compromised”: The Trump Administration’s Unprecedented Campaign to Control CDC and Politicize Public Health During the Coronavirus Crisis”
The House Select Subcommittee on the Coronavirus Crisis recently released its third installment of staff reports detailing the Trump administration’s response to the COVID-19 pandemic. In the report, the committee explains its findings from its investigation into the Trump administration’s “rampant political interference with the federal public health response to the coronavirus pandemic.” Chairman Clyburn released this statement about the report: “The Select Subcommittee’s investigation has shown that the previous administration engaged in an unprecedented campaign of political interference in the federal government’s pandemic response, which undermined public health to benefit the former president’s political goals. As today’s report shows, President Trump and his top aides repeatedly attacked CDC scientists, compromised the agency’s public health guidance, and suppressed scientific reports in an effort to downplay the seriousness of the coronavirus. This prioritization of politics, contempt for science, and refusal to follow the advice of public health experts harmed the nation’s ability to respond effectively to the coronavirus crisis and put Americans at risk. As we continue to recover from the coronavirus crisis, we must also continue to work to safeguard scientific integrity and restore the American people’s trust in our public health institutions.”
Clinical Infectious Diseases “Issue Supplement 3, Anthrax Preparedness”
This issue supplement of Clinical Infectious Diseases is all about anthrax, including articles ranging from “Responding to the Threat Posed by Anthrax: Updated Evidence to Improve Preparedness” to “Risk Factors for Severe Cutaneous Anthrax in a Retrospective Case Series and Use of a Clinical Algorithm to Identify Likely Meningitis and Evaluate Treatment Outcomes, Kyrgyz Republic, 2005-2012”. So, if it has been a while since you were deeply concerned about anthrax, this issue is for you!
“How SARS-CoV-2 Battles Our Immune System”
If you like medical illustrations and interactive timelines, this one is for you. This new story available from Science walks readers visually through SARS-CoV-2’s interaction with the human immune system, offering detailed yet easily understood, general explanations along the way. Readers can even learn about the virus’s different proteins and their specific effects on the immune system.
What We’re Listening To 🎧
This Podcast Will Kill You: Episode 107: Sepsis: It’s a Mess
“Over the years of the podcast, we have often struggled with questions of why: why pathogens act the way they do, why certain people get sick while others don’t, or why we know little about some diseases. This episode is no exception – sepsis certainly inspires many “whys”. But for perhaps the first time on the pod, we find ourselves grappling not only with “why?” but also with “what?”. What, indeed, is sepsis? Ask a dozen doctors and you may get a dozen different answers. Our first goal for this episode is to sift through the various definitions of sepsis and what we know about its pathology to get a firm handle on this deadly consequence of infection. We then turn our sights to a thrilling period of sepsis history – Joseph Lister and his carbolic acid spray – before attempting to address the status of sepsis around the world today. By the end of the episode, your picture of sepsis may not be crystal clear, but hopefully the edges are a little less blurry.” Listen here on Spotify or wherever you listen to podcasts!
Project Responder 6: Evolving Response Environment Webinar
From DHS: “You’re invited to join the Department of Homeland Security (DHS) Science & Technology Directorate (S&T) for a briefing on the Project Responder 6 report, designed to document emergency response capability needs across significant changes in the operating environment. The innovative approach this data collection effort—now in its sixth generation—takes is to bring together S&T’s First Responder Resource Group (FRRG), which includes responders from traditional (fire service, law enforcement, emergency medical services, emergency management) and non-traditional (public health, public works, medical examiner/coroner, search and rescue) response agencies, to focus on identifying and validating needs across disciplines.” Learn more and register here. Download the report here. This event will take place on October 24, at 11 am ET.
Addressing Health Inequities by Strengthening Antibiotic Stewardship
From NCEZID: “Please join The National Center for Emerging and Zoonotic Infectious Disease (NCEZID) on Tuesday, October 25, 2022, at 10 a.m. EDT for the next AMR Exchange webinar on addressing health inequities by strengthening antibiotic stewardship entitled Addressing health inequities by strengthening antibiotic stewardship. The discussion will feature experts from CDC, The Pew Charitable Trusts, the Federal Office of Rural Health Policy, and Emory University School of Medicine who work to strengthen antibiotic use and prescribing and improve the quality of health care across the United States. Please register here.”
South Korea as a Global Vaccine Hub
The Korea Economic Institute of America is hosting this event October 27, at 3 pm EST virtually: “Early in the pandemic, South Korea drew widespread praise for the speed and efficiency of its response to slowing the spread of the virus and saving lives. However, despite this initial success, South Korea faced vaccine nationalism and other access challenges in its effort to secure Covid-19 vaccines. Spurred by these challenges, South Korea established a national strategic policy to become a global vaccine hub, not only to meet the current and future public health needs of its own population but also to assist low- and middle-income countries (LMICs) facing even starker obstacles in accessing safe and effective vaccines.”
“Please join KEI for a discussion with the Thomas Byrne, Claire Callahan, Irene Kyoung, and Salomé Da Silva Duarte Lepez about how global vaccine access and equity was hindered by the shortcomings of national and bilateral vaccine diplomacy and multilateral mechanisms during the Covid-19 pandemic, and how South Korea’s demonstrated capabilities to rise as global vaccine development, manufacturing and training hub will help bolster global public health capacities in the future.” Register here.
The Case for the Use of “Red Lines” in the Governance of Life Sciences Research with David Relman
From CISAC: “The nature of evolving risks in life sciences research, a brief history of risk governance, and the case for the use of so-called “red lines” in the governance of life sciences research will be presented. The goals of this presentation are to elicit discussion about the benefits and pitfalls of red lines, or guardrails, in general, including a historical perspective, and options for public policy recommendations to address concerns about the present and future risks arising from life sciences research.” This event will take place on October 27, at 3:30 pm PT. Register here.
Infection Prevention and Control: Incorporating Lessons Learned in Managing Special Pathogens
“After nearly three years responding to the COVID-19 pandemic, hospitals and other healthcare facilities have learned many lessons about the management of special pathogens and essential infection prevention and control practices. The U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response’s Technical Resources, Assistance Center, and Information Exchange (ASPR TRACIE) and the National Emerging Special Pathogens Training and Education Center (NETEC) invite you to learn more about some of those lessons. Speakers will share their perspectives on how our approach to outbreaks has changed since the pandemic began. They will address issues such as infection prevention for healthcare workers and patients and mitigating disease spread. Speakers will also highlight newly developed tools and resources. This webinar will take place November 7 at 2:00 pm ET. Register today!”
ICYMI: IARPA, Gingko Bioworks and Draper Announce New Technologies to Detect Engineered DNA
This week, Gingko Bioworks, Draper, and IARPA held an event to announce the completion of IARPA’s Finding Engineering-Linked Indicators (FELIX), a program aimed at improving existing biodetection and surveillance capabilities. “The event featured a panel with Catherine Marsh, IARPA Director; David A. Markowitz, IARPA Program Manager; Joshua Dunn, Head of Design, Ginkgo Bioworks; Laura Seaman, Principal Scientist and Machine Intelligence Group Leader, at Draper; and Erin Rosenberger, Senior Member of Technical Staff, Biological Microsystems Group, at Draper. During the panel, the panelists discussed the program findings and also featured a demo of the research results.” A recording of the livestream is available here.
November 3 is One Health Day
Mark your calendars for this year’s One Health Day on November 3. One Health Day is an international campaign that was launched in 2016. The One Health Commission explains that “The goal of One Health Day is to bring attention around the world to the need for One Health interactions and for the world to ‘see them in action’. The One Health Day campaign is designed to engage as many individuals as possible from as many arenas as possible in One Health education and awareness events, and to generate an inspiring array of projects worldwide.” If you are hosting an event on this day, you can register your event here with the Commission. A list of registered One Health Day events for 2022 is also available here.
The Pandora Report 