The ball is rolling for COVID-19 vaccines with two very promising candidates in the pipeline. The pandemic continues to surge, bringing with it continued opportunities for exploitation by malign actors – extremists and hackers. A recently released research paper explores the ethical and legal implications related to the use of performance-enhancing drugs by the military. This fall, four students from the Biodefense Graduate Program attended a virtual version of the Medical Management of Chemical and Biological Casualties Course held by US Army Medical Research Institute of Infectious Diseases and the US Army Medical Research Institute of Chemical Defense. Read about their experiences and takeaways!
Medical Management of Chemical and Biological Casualties Course
The Medical Management of Chemical and Biological Casualties (MMCBC) Course is the premier chemical and biological defense training offered by the US Army. It is a six-day, two-part course offered jointly by the US Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick and the US Army Medical Research Institute of Chemical Defense (USAMRICD) at Aberdeen Proving Ground, both in Maryland. MMCBC covers topics such as the history and current threat of chemical and biological weapons, the characteristics of chemical and biological threat agents, the pathophysiology and treatment of agent exposure, and the principles of field management of chemical and biological casualties. On October 18-23, 2020, four students from the Biodefense Graduate Program at the Schar School of Policy and Government at George Mason University attended a virtual version of the course: Deborah Cohen, Madeline Roty, Marisa Tuszl, and Ishaan Sandhu. You can read about their experiences and takeaways from the MMCBC course here.
COVID-19 Vaccine Update
This week, the United Kingdom granted emergency approval to a COVID-19 mRNA vaccine developed by Pfizer and BioNTech, a German biotechnology company. In the US, the Food and Drug Administration (FDA) will consider granting the same vaccine candidate regulatory approval next week. Pfizer and BioNTech applied for emergency authorization of their coronavirus vaccine in mid-November, following the release of data showing it to be “remarkably effective.” Shortly after, Moderna announced that its candidate was showing “similarly spectacular results.”
HyungJung Kim, a PhD candidate in Biodefense, recently published a new article with the Bulletin of the Atomic Scientists about emergency use authorizations (EUA) for new vaccines. The Food and Drug Administration (FDA) is responsible for issuing such authorizations for medical countermeasures, including vaccines, therapeutic drugs, diagnostic tests, and other medical devices. Initially, the emergency use policy was exclusively aimed at the threat posed by weapons of mass destruction (chemical, biological, radiological, and nuclear weapons), but the scope was expanded to include all hazards to public health. Since the start of the COVID-19 pandemic, the FDA has issued more than 250 emergency use authorizations for antiviral drugs, diagnostic kits, ventilators, and other medical equipment. Though the EUA could provide a vaccine relatively quickly, there are also significant disadvantages to using the emergency use authorization as the legal basis for approving a COVID-19 vaccine for widespread use. Read Kim’s analysis of the pros and cons of an EUA for COVID-19 vaccines here.
World Antimicrobial Awareness Week was 18-24 November, and it was celebrated with the slogan, “Antimicrobials: handle with care.” Antimicrobial resistance (AMR) is the characteristic in which microorganisms – viruses, bacteria, and fungi – change over time and exposure in ways that that render antimicrobial medicines futile against them. Globally, about 700,000 people die from these infections annually. The combination of growing resistance across microbes to multiple therapeutics with the lagging creation of new drugs has made AMR a global issue. In the US, there are over 2.8 million antibiotic-resistant infections and 35,000 deaths each year. PEW interviewed Erin Duffy, a chemist with more than 20 years of experience in drug discovery and current Chief of R&D at CARB-X, about the urgent need for innovations to combat superbugs. Duffy pointed out that there is a critical need for economic incentives to “slow the exodus of companies from antibiotic development and stimulate development of urgently needed drugs.” She warns that we are taking antimicrobials for granted and that we may end up in a situation without safe and effective drugs.
The American Society for Microbiology (ASM) shared some good news in regard to AMR. Researchers in Montréal, Canada found that 28% of 324 unique methicillin-susceptible S. aureus (MSSA) isolates from bloodstream infections were also susceptible to penicillin, a marked occurrence given that penicillin resistant strains have persisted for several decades. There have been improvements in antibiotic subscribing: a group of epidemiologists, physicians, and public health experts from the Centers for Disease Control and Prevention (CDC) reported that fluoroquinolone (ciprofloxacin and levofloxacin) prescription rates decreased by 30% between 2011 and 2018.
Cyberattacks Targeting Health Care Must Stop
Tom Burt, Corporate Vice President of Microsoft’s Customer Security and Trust (CST) team, asserts that COVID-19 and the growing use of the internet by malign actors to disrupt society are the two issues that will shape the history of our era. This year, three nation-state actors have carried out cyberattacks targeting seven companies directly involved in vaccine and treatment research for COVID-19. The targets included premier pharmaceutical companies and vaccine researchers in Canada, France, India, South Korea, and the United States, and the attackers originated from Russia and North Korea. Sadly, these are not the first occurrences of cyberattacks targeting the health care sector. In COVID-19, there have been ransomware attacks on hospitals and healthcare organizations across the United States. The Paris Call for Trust and Security in Cyberspace is an invitation to all cyberspace actors to work together and encourage States to cooperate with the private sector, the research world, and civil society. The Paris Call includes organizations like Merck working on vaccines, top hospitals like Hospital Metropolitano in Ecuador, and government health institutes like Poland’s National Institute of Public Health. The Oxford Process, a 136-strong group of the world’s top international law experts, issued a statement emphasizing that international law protects medical facilities at all times. Microsoft announced in April that it would make AccountGuard, a threat notification service, available to health care and human rights organizations working on COVID-19. Burt implores world leaders to “unite around the security of our healthcare institutions and enforce the law against cyberattacks targeting those who endeavor to help us all.”
Stopping the Spread: Pandemics, Warning, and the IC
The National Security Institute at George Mason University’s Antonin Scalia Law School released a new law and policy paper, Stopping the Spread: Pandemics, Warning, and the IC. The paper summarizes the Intelligence Community’s (IC) focus on the national security threat posed by infectious diseases; argues that the IC, with its unique collection and analytic capabilities, can help the public health community with threat monitoring and containment efforts; and proposes actionable recommendations to enhance the US ability to detect global pathogenic outbreaks in order to implement effective mitigation measures. The recommendations include enhancing IC intelligence collection to improve early detection and forewarning of pathogenic outbreaks, increasing information sharing between the IC and Centers for Disease Control and Prevention (CDC), and improving warning mechanisms to assist pandemic preparedness and response. Read the paper here.
‘It will change everything’: DeepMind’s AI Makes Gigantic Leap in Solving Protein Structures
An artificial intelligence (AI) network developed by Google AI offshoot DeepMind is able to accurately determine the 3D shape of some proteins based on their amino-acid sequences, a giant step toward solving one of biology’s biggest challenges. The specific program, AlphaFold, outperformed 100 other teams in the Critical Assessment of Structure Prediction (CASP), a biennial protein-structure prediction challenge. Proteins are the building blocks of life, and their functions are largely determined by the 3D shape. For proteins, “structure is function.” Unraveling a protein’s structure enables a better understanding of how it works, thereby allowing better understanding of how to affect it, control it, or modify it. AlphaFold may enable the use of lower quality and easier-to-collect experimental data to determine a structure. Janet Thornton, a structural biologist at the European Molecular Biology Laboratory-European Bioinformatics Institute, hopes that the approach could “help to illuminate the function of the thousands of unsolved proteins in the human genome, and make sense of disease-causing gene variations that differ between people.”
COVID Outbreaks in the World’s Largest Office Building
The Pentagon moved to a higher health protection level last week (now at Bravo Plus), cutting its maximum occupancy to 40% and bumping up the number of temperature checks on personnel. The building has been below 50% occupancy for the last several months and meetings are regularly conducted by phone or virtually. Brig. Gen. Anthony Tata, the temporary Pentagon policy chief, tested positive for the coronavirus last week as well, though the decision to heighten the protection level was made beforehand. The Pentagon is struggling to contain the virus as new daily cases reach a record 1,300 and another outbreak occurs aboard a Navy ship. The expected surge associated with Thanksgiving celebrations contributed to the decision to up the protection level. A DOD dashboard shows that more than 73,000 coronavirus cases have been confirmed among members of the military with tens of thousands more recorded among DOD family members, contractors, and civilian personnel.
Exploiting the Pandemic
The United Nations Interregional Crime and Justice Research Institute (UNICRI) found that criminals and violent extremists are exploiting the pandemic to expand their networks, undermine trust in government, and weaponize the virus. UNICRI detected an exponential increase in the malicious use of social media to reinforce extremist narratives, ramp up recruitment, and expand territorial control. Social media incitement is a common method of exploitation to “inspire terrorism.” The European External Action Service (EEAS) report provides a snapshot overview of the current trends and insights into disinformation activities related to the coronavirus pandemic. According to the latest analysis, online misinformation and disinformation related to COVID-19 decreased and shifted focus towards vaccines; however, their spread and reach remain troublingly high. EEAS expects the pandemic to continue providing plenty of opportunities for the spread of misinformation and disinformation, especially for actors like China and Russia, who are maximizing on the effect of “vaccine diplomacy” in their campaigns. Sarah Jacobs Gamberini, a Policy Fellow in the Center for the Study of Weapons of Mass Destruction at the National Defense University, expounds on Russia’s weaponization of social media through disinformation campaigns. According to Gamberini, Russia is “drilling deeper into the preexisting fault lines of American society,” especially in regard to the pandemic and recent election. Specifically, Russia is turning the best features of the US – diversity, pluralism, and democracy – into weaknesses ripe for exploitation. Russia is using social media as its weapon by identifying a contentious issue and employing bots and trolls on various platforms to spread divisive rhetoric and amplify debates falsities. Then, it takes advantage of the divisions created by disinformation to augment discord in the US and undermine its institutions.
Pharmacological Performance Enhancement and the Military
Chatham House, a world-leading policy institute based in London, published a research paper, Pharmacological Performance Enhancement and the Military: Exploring an Ethical and Legal Framework for Supersoldiers, which explores the ethical and legal implications related to the use of performance-enhancing drugs (PEDs) by the military. This topic is often overshadowed by concerns regarding side effects and safety. In the armed forces, PEDs could be employed to improve soldier strength, mental capacity, recovery, and resistance to fatigue and trauma; however, the effects of these drugs on the human nature of soldiers remains largely undetermined. This paper avows that administering such drugs in a conflict scenario requires a different cost-to-benefit calibration and it identifies three scenarios in which pharmacological interventions would be ethically permissible: (1) in life or death situations; (2) in situations with strategically exceptional mission requirements; and (3) within restorative limits. Beyond these scenarios, the output does not support the routine use of performance-enhancing drugs in the armed forces. Further, given that the military does not exist in isolation from civil society, attitudes regarding such use of drugs will ultimately be determined by societal opinion. Read the research paper here.
Apocalypse How with Dr. Koblentz
On 7 December, Dr. Gregory Koblentz, Director of the Biodefense Graduate Program, will be featured on the final episode of a BBC radio documentary talking about synthetic biology and smallpox. The documentary series, Apocalypse How, explores the threats beyond COVID-19 that the world may soon face. Such existential threats to humanity include an electromagnetic pulse bomb, a worldwide decline in pollinating insects, and an engineered deadly pathogen. Tune in here.
The Wuhan Files
Leaked documents from the Hubei Provincial Center for Disease Control and Prevention show that China mishandled the early days of the COVID-19 pandemic. Among the 117 leaked pages, an internal and confidential document states a total of 5,918 newly detected cases on 10 February, which is more than double the official public number of confirmed cases. These files belie the Chinese government’s resolute rejection of accusations it deliberately concealed information related to the novel coronavirus. The documents span the period October 2019 to April 2020 and reveal the inflexibility of the Chinese healthcare system and the critical gaps in their preparedness. An October audit states that a “huge gap in staff and operating funds at the [Hubei] provincial CDC has seriously affected the normal performance of public health functions.” Another page says, “the rapid identification and detection of unexplained pathogens is obviously insufficient…the information infrastructure is poor, [Provincial] CDC and medical institution data are still not open to each other, infectious disease surveillance and early warning capacity is not sensitive and accurate.” In December 2019, there were reports of surges in influenzas cases. A spike in influenza and the emergence of SARS-CoV-2 are not linked to the documents, but the data about flu-like outbreaks in several cities in Hubei province will likely be of interest to those researching the origins of the disease. Speaking of the origins of the virus, there are two efforts to determine how it hopped into humans. The World Health Organization (WHO) published the rules of engagement for a multinational team of researchers to investigate the origins of SARS-CoV-2. Recently, a commission created by The Lancet and headed by Jeffrey Sachs, announced the formation of a task force of 12 experts from nine countries who will also look into the how the novel coronavirus leaped species. The goal is not to uncover patient zero, but to “elucidate the ecosystem—physical, but also viral—in which the spillover happened and ask what could make it likely to happen again.” Both teams are faced with solving a very complex problem, compounded by the possibility that the trail to the pandemic’s origin may have gone cold.
Who Votes with Russia at the OPCW?
Russian has attempted to prevent the Organization for the Prohibition of Chemical Weapons (OPCW) from holding it and other states accountable for their use of chemical weapons prohibited under the 1993 Chemical Weapons Convention (CWC). Specifically, Russia seeks to prevent the OPCW from investigating its use of a military-grade chemical nerve agent, Novichok, to poison enemies of the state, along with the al-Assad regime’s use of chemical weapons against civilians in Syria. The OPCW’s voting process, which uses open ballots and requires a two-thirds majority, has allowed the organization to function more effectively than a number of other international bodies. To counter Russia’s obstruction, the US will have to preserve and widen the coalition of OPCW member states committed to holding violators accountable. Andrea Stricker, a research fellow at the Foundation for Defense of Democracies, recommends that the United States leverage its positive relations with many countries that frequently abstain to broaden the coalition of member states committed to upholding the integrity of the CWC and the OPCW.
COVID-19 Interferes with CWC and BTWC Meeting Schedules
Dr. Jean Pascal Zanders, an independent researcher/consultant on disarmament and security based in France, highlighted the interference of COVID-19 on the meeting schedules for the Chemical Weapons Convention (CWC) and Biological and Toxin Weapons Convention (BTWC). The Organisation for the Prohibition of Chemical Weapons (OPCW) just held the 25th session of the Conference of the States Parties (CSP) on 30 November and 1 December and will reconvene for the remainder of its work by the end of April 2021. The 2021 programme and budget is the most significant agenda item for the first part of the CSP, and the programme and budget proposal are expected to be voted against by Russia and Syria, among others. These nations object to the financing of the Investigation and Identification Team, which was established in 2018 to determine the culprits of the chemical weapon attacks in Syria. For the BTWC, the Meetings of Experts (MXs) have been rescheduled for April 2021, the latest postponement among many. This may result in further delay of the Review Conference.