Pandora Report: 12.11.2020

7 December marked the 79th anniversary of the attack on Pearl Harbor by the Imperial Japanese Navy Air Service. Biden is building a health team that will put science at the forefront and focus on equity. Three PhD students in the Biodefense Graduate Program attended the ABSA Annual Biosafety and Biosecurity Virtual Conference and are sharing what they learned!

63rd American Biological Safety Association (ABSA) Annual Biosafety and Biosecurity Virtual Conference

ABSA International (ABSA) is an organization that promotes biosafety as a scientific discipline and serves the growing needs of biosafety professionals throughout the world. Its goals are to provide a professional association that represents the interests and needs of practitioners of biological safety, and to provide a forum for the continued and timely exchange of biosafety information. The 63rd American Biological Safety Association (ABSA) Annual Biosafety and Biosecurity Virtual Conference convened the global community of biosafety and biosecurity practitioners and experts from November 4 – 6, 2020. This conference focused on a broad variety of topics dealing with biosafety, biosecurity, and bioethics with an emphasis on activities and challenges related to COVID-19. This year, three students from the Biodefense Graduate Program attended the conference: Rachel-Paige Casey, Sally Huang, and Yong-Bee Lim. Read their reports here.  

Spring Course with Dr. Robert House: Development of Vaccines and Therapeutics

As the world waits anxiously for a COVID-19 vaccine and various therapies against this virus move through the drug development pipeline, BIOD students have an opportunity to learn from a world-class expert with decades of experience developing medical countermeasures (MCMs) against range of biological threats. Dr. Robert House holds a PhD in medical parasitology and is Senior Vice President of Government Contracts at Ology Bioservices. Ology Bioservices was recently awarded $37 million from the Department of Defense to support the advanced development of a monoclonal antibody cocktail against COVID-19. The Department of Defense has also awarded Ology Bioservices with a contract valued at $11.9 million to work with Inovio on DNA technology transfer to rapidly manufacture DNA vaccines. Previously, Dr. House worked for over a decade at DynPort Vaccine Company, where he held the positions of Vice President of Science and Technology, Chief Scientific Officer, and President. During this time, he earned extensive experience in winning and managing large USG-funded programs for developing medical countermeasures. This spring, Dr. House will be teaching the Development of Vaccines and Therapeutics course (BIOD 766), which will explore how the US Government is developing MCMs against these threats. Students will learn about the various threat agents, the context of regulatory considerations, and the specifics of how MCMs are developed.

The Stunning Pace of Progress: One Year In, Covid-19 Treatments and Vaccines Are Close at Hand

SynBioBeta – an innovation network for biological engineers, investors, innovators and entrepreneurs – released a clever infographic summarizing the pace of progress in COVID-19 treatments and vaccines.

COVID-19 Vaccine Update

On Thursday, a panel of outside experts, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), recommended that the Food and Drug Administration (FDA) issue an emergency use authorization for the COVID-19 mRNA vaccine developed by Pfizer and BioNTech (BNT162b2). The recommendation was based on a 17-4 vote. According to VRBPAC, the “efficacy, safety, and immunogenicity data in this EUA application support a positive assessment of risk and benefit for the Pfizer-BioNTech COVID-19 vaccine and fulfill the data requirements outlined in the Food and Drug Administration (FDA) EUA guidance.”

The mRNA vaccine was administered as part of an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial using a total of 43,548 participants aged 16 years or older. Under randomization, 43,448 received injections: 21,720 with the vaccine and 21,728 with placebo. Among participants assigned to receive BNT162b2, eight cases of COVID-19 were found with onset of symptoms at least seven days after the second dose, and 162 cases were found among those assigned to placebo. was 95% effective in preventing COVID-19, and vaccine efficacy proved similar across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions.

The COVID-19 vaccine candidate (mRNA-1273) from Moderna will soon undergo the same approval process when its EUA application goes to the FDA committee on 17 December. Moderna’s vaccine is based on the same messenger RNA technology and its similar effectiveness findings bode well for approval. Moderna’s latest release of trial performance shows an effectiveness rate over 94%. Also similar to BNT162b2, the Moderna vaccine shows consistent efficacy across age, race, and ethnic groups.

AstraZeneca and Oxford University are working on the third COVID-19 vaccine, which uses DNA instead of RNA. The first peer-reviewed results of phase 3 trials of this vaccine demonstrate that it is safe and up to 90% effective in preventing infection. The interim analysis identified no severe COVID-19 disease or hospitalizations in the 11,636 adults vaccinated in the United Kingdom and Brazil.

Dr. Saskia Popescu in This Podcast Will Kill You

Dr. Saskia Popescu, an assistant professor in the Biodefense Graduate Program, was featured in the Anatomy of a Pandemic series of This Podcast Will Kill You. The Anatomy of a Pandemic series covers various aspects of the COVID-19 pandemic: the SARS-CoV-2 virus, the disease it causes, patterns in its transmission, and how we can best control it. Listen to Chapter 12 with Dr. Popescu here.

Special COVID Issue from Homeland Security Affairs

Homeland Security Affairs, the peer-reviewed online journal of the Naval Postgraduate School Center for Homeland Defense and Security (CHDS), debuted a Special COVID Issue that features 11 essays chronicling agency and jurisdictional responses to the COVID-19 pandemic and the lessons learned thus far. The essays focus on how agencies or jurisdictions changed their operations to more effectively handle the pandemic, as well as how the conditions of the pandemic constrained normal agency operations. Specific pieces include “Pandemic Policy and the Logistics of COVID-19 Mass Vaccination;” “COVID-19 Effects and Russian Disinformation Campaigns;” and “How Should The National Guard Be Employed for The Next National Disaster?” Read the special issue here.  

Biological Risks in India: Perspectives and Analysis

India is a nation that is especially vulnerable to infectious diseases due to its geographic location, large population, low healthcare spending, minimal spending on research that benefits public health, weak coordination between central and state health authorities, limited involvement of private actors, poor awareness of biosecurity, and the unsteady state of public health infrastructure. A new working paper by Shruti Sharma from the Carnegie Endowment for International Peace addresses the various biological risks faced by India. The paper, Biological Risks in India: Perspectives and Analysis, considers threats and risks related to naturally-occurring infections, safety concerns, and security concerns; safety and security regulations and policies; and implementation. It further provides a brief assessment of how these policies are being implemented today along with the scope of enhanced implementation in the future. Sharma encourages the establishment of an agency specifically responsible for preventing and managing biological threats. Such an office should focus on naturally occurring diseases, threats emerging from laboratory accidents, and deliberate weaponization of diseases. Read the working paper here.

COVID-19 and Healthcare Professional Stress and Resilience

The Assistant Secretary for Preparedness and Response (ASPR) published an issue of its Technical Resources, Assistance Center, and Information Exchange (TRACIE) that focuses on the stress and resilience of healthcare professionals in COVID-19. This output offers resources regarding acute and chronic stressors, strategies for recognizing and managing the negative behaviors and mental health issues associated with stress, and ways to care for staff to bolster their own resilience. Read the issue here.

Biden’s Health Team Offers Glimpse of His COVID-19 Strategy

President-elect Joe Biden is building a healthcare team that is expected to strengthen the federal role in the nation’s COVID-19 strategy, restore the standing of science, and emphasize equitable distribution of vaccines and treatments. For instance, California Attorney General Xavier Becerra will be Biden’s health secretary, who has experience managing California’s large attorney general’s office. Jeff Zients was selected as Biden’s White House coronavirus coordinator, and he is known for “rescuing government programs that went off course,” like the healthcare.gov website for Obamacare. Dr. Rochelle Walensky is an infectious disease expert who will head the Centers for Disease Control and Prevention (CDC). Dr. Walensky now has firsthand coronavirus experience as the chief of infectious diseases at Massachusetts General Hospital in Boston. Finally, Biden has selected Dr. Marcella Nunez-Smith from Yale University, a sign that the incoming administration will aim for equitable distribution of vaccines and treatments among racial and ethnic minorities, who have suffered a disproportionately high toll of COVID-19 deaths.

Biosecurity and Genetic Engineering

Genetic engineering is the process of modifying an organism’s genome to introduce new, desirable traits. The potential boons from genetic engineering, and biotechnology in general, are diminished by the potential for accidental or intentional misuse of these tools and techniques. A new paper published in Nature Communications, “The biosecurity benefits of genetic engineering attribution,” discusses the importance of attribution in biology as recent scientific developments have demonstrated a capability for detecting whether an organism involved in such an event has been genetically modified. Attribution has three main security benefits: (1) knowledge of who was responsible can inform response efforts; (2) attribution can identify the responsible parties for appropriate civil, criminal, or diplomatic penalty; and (3) successful attribution followed by meaningful actions to hold perpetrators accountable can deter those inclined to reckless or malicious practice in the first place. Information for attribution can be roughly divided into three categories: (1) non-technical indicators that provide contextual clues to intent; (2) intelligence from human sources, intercepted communications, and surveillance; and (3) technical forensics that unveil the properties and characteristics of the agent. Better attribution tools for ascertaining such information will deter reckless actors as well as malicious actors. The authors believe it is the responsibility of the scientific and policy communities to identify opportunities to create these tools, like genetic engineering attribution, which reduce the risk of misuse. Another article in Nature Communications, “A machine learning toolkit for genetic engineering attribution to facilitate biosecurity,” suggests that a practical and accurate toolkit for genetic engineering forensics is within reach. The authors used recurrent neural networks (RNN) on a model attribution scenario with data from the world’s largest plasmid repository, which achieved 70% accuracy on lab-of-origin prediction.

Koblentz Featured in “Death by DNA” Episode of Apocalypse How Podcast

On 7 December, Dr. Gregory Koblentz, Director of the Biodefense Graduate Program, was featured on the final episode of a BBC radio documentary talking about synthetic biology and smallpox. The documentary, 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. This episode focused on the question, “Has DNA technology advanced so far that a rogue scientist, or even a competent terrorist, could assemble a deadly pathogen from genetic sequences bought by mail order?” Dr. Koblentz shared his insights on the resurrection of the horsepox virus by a group led by virologist David Evans at the University of Alberta. This team was able to recreate the entire genome of horsepox virus and reactivate live infectious virus from its genome. In short, they reconstructed horsepox virus from scratch, which had been extinct for 30 years. For Koblentz, the concern with horsepox virus is that it is a close relative to variola virus (smallpox) and the demonstrated ability to resurrect an orthopoxvirus is also a demonstration of how to synthesize smallpox. Koblentz argues that this research has created a new pathway for a bad actor to synthesize smallpox and reintroduce this scourge into the world. Viruses spread much more rapidly today than ever before as a result of globalization. The existing stockpiles of smallpox vaccine are not sufficient to protect the whole world. Dr. David Evans, the archvillain according to critics for synthesizing the virus, asserts that there is enough of an understanding about the dangers of using smallpox as a weapon that no one would dare risk it. Resurrecting this virus is not an easy task; it requires sizable funding and requires specialized research infrastructure, likely precluding many bad non-state actors. Listen to the episode here.

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