Rapid proliferation of pandemic research: implications for dual-use risks

The COVID-19 pandemic has demonstrated the world’s vulnerability to biological catastrophe and elicited unprecedented scientific efforts. Some of this work and its derivatives, however, present dual-use risks (i.e., potential harm from misapplication of beneficial research) that have largely gone unaddressed. For instance, gain-of-function studies and reverse genetics protocols may facilitate the engineering of concerning SARS-CoV-2 variants and other pathogens. The risk of accidental or deliberate release of dangerous pathogens may be increased by large-scale collection and characterization of zoonotic viruses undertaken in an effort to understand what enables animal-to-human transmission. These concerns are exacerbated by the rise of preprint publishing that circumvents a late-stage opportunity for dual-use oversight. To prevent the next global health emergency, we must avoid inadvertently increasing the threat of future biological events. This requires a nuanced and proactive approach to dual-use evaluation throughout the research life cycle, including the conception, funding, conduct, and dissemination of research

Improved understanding of biorisk for research involving microbial modification using annotated sequences of concern

Regulation of research on microbes that cause disease in humans has historically been focused on taxonomic lists of ‘bad bugs’. However, given our increased knowledge of these pathogens through inexpensive genome sequencing, 5 decades of research in microbial pathogenesis, and the burgeoning capacity of synthetic biologists, the limitations of this approach are apparent. With heightened scientific and public attention focused on biosafety and biosecurity, and an ongoing review by US authorities of dual-use research oversight, this article proposes the incorporation of sequences of concern (SoCs) into the biorisk management regime governing genetic engineering of pathogens. SoCs enable pathogenesis in all microbes infecting hosts that are ‘of concern’ to human civilization. Here we review the functions of SoCs (FunSoCs) and discuss how they might bring clarity to potentially problematic research outcomes involving infectious agents. We believe that annotation of SoCs with FunSoCs has the potential to improve the likelihood that dual use research of concern is recognized by both scientists and regulators before it occurs

International security implications of biological warfare

Thesis (Ph. D.)--Massachusetts Institute of Technology, Dept. of Political Science, 2004.Includes bibliographical references (p. 183-222).This dissertation assesses the international security implications of biological weapons and the strategic consequences of their proliferation. It examines the impact of biological weapons on four key areas of concern for international security: proliferation, deterrence, civil-military relations, and threat assessment. The dissertation draws upon a range of theories from the field of security studies and a wealth of newly available information regarding the biological weapons programs of Iraq, the former Soviet Union, the United States, United Kingdom, and South Africa. My analysis yields four major findings. First, it is extremely difficult to prevent the spread of biological warfare capabilities to actors that want them and these actors tend to be motivated by a desire to challenge the status quo. Contrary to conventional wisdom, biological weapons have utility across the spectrum of conflict and are well suited to supporting asymmetric strategies against stronger opponents. Second, biological weapons do not confer the deterrent benefits associated with nuclear weapons and will undermine reliance on deterrence as a security strategy. Biological weapons are not suitable as strategic deterrents due to the uncertainty regarding their effects, the availability of defenses and the reliance of these weapons on secrecy and surprise for their effectiveness. The accessibility of these weapons to a diverse range of actors, including terrorists, and the ease of clandestine attacks undermines the effectiveness of deterrence as a security strategy. Third, civilian oversight of biological warfare programs is hindered by the intense secrecy that shrouds these programs. This lack of supervision leads to abuse and corruption by(cont.) program managers, impedes adherence to international agreements, and increases the risk of such programs becoming the source of materials for terrorists. Fourth, states tend to have flawed assessments of their opponent's biological warfare capabilities and intentions. The result of such flawed assessments may be worst-case planning and overreaction to a perceived threat or complacency and continued vulnerability to attack. Biological. weapons will continue to exert a destabilizing influence on international security until defenses against these weapons are improved, governments can reliably detect biological weapons activities, the proliferation of biological weapons materials and expertise is staunched, and the norms against their possession and use are strengthened.by Gregory D. Koblentz.Ph.D

A Critical Analysis of the Scientific and Commercial Rationales for the De Novo Synthesis of Horsepox Virus

ABSTRACT This article evaluates the scientific and commercial rationales for the synthesis of horsepox virus. I find that the claimed benefits of using horsepox virus as a smallpox vaccine rest on a weak scientific foundation and an even weaker business case that this project will lead to a licensed medical countermeasure. The combination of questionable benefits and known risks of this dual use research raises serious questions about the wisdom of undertaking research that could be used to recreate variola virus. This analysis also raises important questions about the propriety of a private company sponsoring such dual use research without appropriate oversight and highlights an important gap in United States dual use research regulations

Strengthening biosecurity in Iraq: Development of a national biorisk management system

Since 2004, the Republic of Iraq has undertaken a concerted effort to comply with all of its international obligations to prevent the proliferation of chemical, biological, radiological, and nuclear (CBRN) weapons. A centerpiece of this effort is Iraq’s development of a national biorisk management system to prevent, prepare for, and respond to naturally occurring and deliberate biological threats. The Iraqi National Monitoring Authority (INMA), which is responsible for CBRN security and nonproliferation in Iraq, has played a key role in establishing this system. This article provides an overview of Iraq’s international nonproliferation commitments, describes the legal and organizational steps it has taken to implement these commitments, and examines current initiatives to strengthen Iraq’s biosecurity

Insidious Insights: Implications of viral vector engineering for pathogen enhancement

AbstractOptimizing viral vectors and their properties will be important for improving the effectiveness and safety of clinical gene therapy. However, such research may generate dual-use insights relevant to the enhancement of pandemic pathogens. In particular, reliable and generalizable methods of immune evasion could increase viral fitness sufficient to cause a new pandemic. High potential for misuse is associated with (1) the development of universal genetic elements for immune modulation, (2) specific insights on capsid engineering for antibody evasion applicable to viruses with pandemic potential, and (3) the development of computational methods to inform capsid engineering. These risks may be mitigated by prioritizing non-viral delivery systems, pharmacological immune modulation methods, non-genetic vector surface modifications, and engineering methods specific to AAV and other viruses incapable of unassisted human-to-human transmission. We recommend that computational vector engineering and the publication of associated code and data be limited to AAV until a technical solution for preventing malicious access to viral engineering tools has been established.</jats:p

The biosecurity benefits of genetic engineering attribution

© 2020, The Author(s). Biology can be misused, and the risk of this causing widespread harm increases in step with the rapid march of technological progress. A key security challenge involves attribution: determining, in the wake of a human-caused biological event, who was responsible. Recent scientific developments have demonstrated a capability for detecting whether an organism involved in such an event has been genetically modified and, if modified, to infer from its genetic sequence its likely lab of origin. We believe this technique could be developed into powerful forensic tools to aid the attribution of outbreaks caused by genetically engineered pathogens, and thus protect against the potential misuse of synthetic biology