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Biodefense Headlines – 25 October 2020

News highlights on health security threats and countermeasures curated by Global Biodefense

This week’s selections include rural biosurveillance for pandemic preparedness, high hopes (and hurdles) for therapeutic antibodies for COVID-19, and the John Snow Memorandum.

Contents

COVID-19 RESPONSE

‘There’s Only One Chance to Do This Right’—FDA Panel Wrestles with COVID-19 Vaccine Issues

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a 9-hour virtual meeting this week – members worried an EUA could contribute to the public’s growing hesitancy toward COVID-19 vaccines by fueling the perception that FDA was compromising its high standards. The committee also discussed the possibility that an early authorization of a vaccine could disrupt many of the COVID-19 vaccine efficacy trials now underway. Science

130,000 – 210,000 Avoidable COVID-19 Deaths – and Counting – in the U.S.

This report looks at the staggering and disproportionate nature of COVID-19 fatalities in the United States, which now ranks first in the world in the total number of fatalities, to estimate how many deaths were “avoidable.” With more than 217,000 lives lost, and a proportional mortality rate twice that of neighboring Canada and more than fifty times that of Japan — a country with a much older population than the U.S. – the United States has turned a global crisis into a devastating tragedy. National Center for Disaster Preparedness – Columbia University

White House Blocked CDC From Requiring Masks on Public Transportation

A sweeping federal public health order drafted under ‘quarantine powers’ requiring passengers and employees to wear masks on all forms of public and commercial transportation in the U.S. was reportedly blocked by the White House. Seattle Times

U.K. Preparing COVID-19 Vaccine Trials That Deliberately Expose Study Subjects

Researchers led by Imperial College London are preparing to start a controversial COVID-19 “human challenge” study in which dozens of healthy volunteers will be exposed to live coronavirus in an effort to speed up vaccine development. The plan is to recruit healthy people between the ages of 18 and 30 with no prior history of COVID-19 symptoms and no known risk factors for the disease. Researchers would inoculate them with a candidate vaccine, then test its effectiveness by deliberately exposing them to live coronavirus. NPR

Military to Play Logistics-Only Role in COVID-19 Vaccine Effort

During a Friday teleconference regarding Operation Warp Speed, the DOD and HHS effort to find a vaccine for COVID-19, DoD officials stated federal military will not be involved administering any future vaccines to the public, but will orchestrate key logistics support. Department of Defense

BIOPREPAREDNESS

Equipping Medical Responders for CBRN Scenarios

Field care in CBRN situations, whether military or civilian, differs according to threat. In chemical situations, there is much that responders can do to help the injured. In radiological situations, field care is usually limited to decontamination. But there is no point in trying to render care in a contaminated environment if the responders are themselves injured by doing so… making personal protective equipment (PPE) critical. European Security & Defence

Improving Pandemic Preparedness: Lessons From COVID-19

The hard lessons to date are boiled down in this report into four strategic areas to advance pandemic preparedness: treat pandemic prep as a serious national and global security threat (and invest accordingly), adopt strategies for better prevention, improve detection of epidemic threats, and strengthen U.S. and global pandemic response. Council on Foreign Relations

The Next Pandemic: Why Biodefense Experts Say We Need to Prepare Now

According to experts in biological defense and epidemiology speaking at an innovation festival this week, the preparedness tools we need include investment from both the government and public-private partnerships; an early-warning system to prevent epidemics before they start spreading (including biosurveillance in rural areas); incentives for industry to be involved; and creating and maintaining the infrastructure needed to tackle such a disease again. Fast Company

Preparations Incomplete for Next U.S. Disaster

The U.S. had many plans at hand to deal with a national emergency on the scale of the COVID-19 pandemic, but the country failed to implement them properly. Part of the reason was institutional, but much was from a lack of coordination. And, the U.S. still is unprepared for the next disaster, whether natural or human-made. AFCEA SIGNAL

What Can the United States Do to Prevent Another Pandemic? Commit to Modernizing Influenza Vaccines

The Covid-19 pandemic has laid bare the acute vulnerabilities in the United States’ health security policies and capacities. While the Covid-19 crisis is far from over, we cannot afford to be complacent about what has long been understood to be a principal health security threat: influenza viruses. CSIS

Planning for Surprise Permits DHS Pandemic Pivot

The Department of Homeland Security’s Probabilistic Analysis for National Threats, Hazards and Risks (PANTHR) scientists and researchers at the National Biodefense Analysis and Countermeasures Center (NBACC) lent their scientific resources to develop SARS-CoV-2 virus surface and airborne decay calculators, mask sanitization method development, and a living Master Question List (MQL) about the virus. AFCEA SIGNAL

CHEMICAL AND BIOLOGICAL WEAPONS

Nerve Agent Was Used to Poison Navalny, Chemical Weapons Body Confirms

The Organization for the Prohibition of Chemical Weapons—adding additional weight to the conclusions of laboratories in Germany, France and Sweden—confirmed this week that the substance used to poison the Russian opposition leader Aleksei A. Navalny had “similar structural characteristics” to the Novichok family of highly potent nerve agents. New York Times and OPCW

Germany and Allies Call for Russian Answers on Navalny

Germany and its allies at a meeting of the global chemical weapons watchdog Tuesday called on Russia to fully investigate and explain how opposition leader Alexei Navalny was poisoned with a military-grade nerve agent. The United Kingdom, which accused Russia of using a Novichok nerve agent in a 2018 attack on former double agent Sergei Skripal and his daughter in the English city of Salisbury, supported Germany’s demand for answers. AP

The Navalny Poisoning Case Through the Hybrid Warfare Lens

There must be a constant awareness that the Kremlin will see Wes­tern responses to the Navalny poisoning as foreign ‘hybrid war’ and will respond in kind. The more the West defends Navalny, the more the Kremlin will use that as ‘proof’ he is nothing less than an agent of subversion. The paper helps explain the stridency of Moscow’s reaction to Western criticisms, and the inevitable backlash that will follow. European Centre of Excellence for Countering Hybrid Threats

Biological Weapons: A Surprise Proposal from Kazakhstan Worth Exploring

In a recent address, Kazakh President Kassym-Jomart Tokayev proposed establishing a special multilateral body – the International Agency for Biological Safety – based on the 1972 Biological Weapons Convention and accountable to the UN Security Council. Though light on details, such a body could coordinate  many accusations that the virus is human-made, escaped from a laboratory or was part of a biological weapon (BW) program and the ease with which disinformation circulates through the social media, an initiative that relies on the BTWC makes sense. After all, the convention deals with questions of non-compliance or accusations of biological warfare. The Trench

Syria Is Still Trying to Use Chemical Weapons

Syria continues to obtain components for its chemical weapons and missile programs the Trump administration said in a report to Congress, as Bashar al-Assad’s regime seeks to restore capabilities eroded by a near-decade-long civil war and successive U.S. airstrikes. The U.S. attributes more than 50 instances of chemical weapons use to the Assad regime, mostly launched from aircraft and targeting civilians. Foreign Policy

The Threat and Control of Ricin as a Weapon

This month, a package addressed to President Trump was intercepted on its way to the White House after testing positive for the toxin ricin. Toxins are chemicals of biological origin, and thus hold a unique place in chemical and biological weapons nonproliferation: they are banned by both the 1972 Biological and Toxin Weapons Convention (BWC) and the 1993 Chemical Weapons Convention (CWC). James Martin Center for Nonproliferation Studies

RESEARCH + INNOVATION

Biosecurity Is Synthetic Biology’s Most Crucial Ally

The legal framework that governs synthetic biology and bioengineering varies by country, but most address cases where a gene from one organism is transferred to another. This approach is archaic and problematic when applied to new synthetic biology applications such as precision gene editing or cell-free synthetic biology. LaBioTech

The US Military’s Latest Wearables Can Detect Illness Two Days Before You Get Sick

In June, the Defense Innovation Unit and DTRA began giving wearable watch/ring monitoring kits to about 400 troops. Called Rapid Analysis of Threat Exposure, or RATE, the system can’t tell you exactly what you have, but by monitoring subtle biometric indicators, it can tell the likelihood, on a scale of 1 to 100, that a sick day is ahead. After proving useful as an alert to refer-for-testing for COVID-19, the project test pool is expanding to 5,000 troops. Defense One

Regeneron Failed to Disclose BARDA Funding in Their REGN-COV2 Patent

The obligation to acknowledge U.S. government funding in patents is required under an existing contract between Regeneron and the Biomedical Advanced Research and Development Authority (BARDA), as well as the Bayh-Dole Act and regulations issued by the U.S. Patent and Trademark Office (USPTO). KEI Online

Navigating Facilitated Regulatory Pathways During a Disease X Pandemic

In 2018, the Bill and Melinda Gates Foundation convened over thirty subject matter experts in clinical development, manufacturing, and regulatory assessment to determine how the development and approval of medical countermeasures could be accelerated in the event of Disease X. This paper discusses scenarios in which certain pathways may be applicable, the pros and cons of these approaches, and opportunities available to developers in, or developers who wish to access, low-income countries that may have nascent regulatory frameworks. NPJ Vaccines

The Race to Make COVID Antibody Therapies Cheaper and More Potent

At least ten COVID-19 antibodies are being tested in clinical trials; many more are under development. Considering how well these antibodies bind to SARS-CoV-2 proteins, many of these candidates are likely to offer some benefit to people with COVID-19. But antibodies are expensive and difficult to make, are administered at relatively high doses. Early indications are they will be best applied as a therapy to stop mild COVID-19 from becoming severe, making cost even more critical given the U.S. healthcare system. Nature

Related: COVID-19 Antibodies On Trial Nature Biotechnology

Self-Amplifying RNA Vaccines for Infectious Diseases

Vaccinology is shifting toward synthetic RNA platforms which allow for rapid, scalable, and cell-free manufacturing of prophylactic and therapeutic vaccines. Both conventional and self-amplifying RNAs have shown protective immunization in preclinical studies against multiple infectious diseases including influenza, RSV, Rabies, Ebola, and HIV-1. Self-amplifying RNAs have shown enhanced antigen expression at lower doses compared to conventional mRNA, suggesting this technology may improve immunization. Gene Therapy

Use of Adenovirus Type-5 Vectored Vaccines: A Cautionary Tale

Roll-out of an effective SARS-CoV-2 vaccine globally could be given to populations at risk of HIV infection, which could potentially increase their risk of HIV-1 acquisition. This important safety consideration should be thoroughly evaluated before further development of Ad5 vaccines for SARS-CoV-2, and informed consent documents of these potential risks should reflect the considerable literature on HIV-1 acquisition with Ad5 vectors. The Lancet

COMMENTARY

Dying in a Leadership Vacuum

The death rate in the U.S. is more than double that of Canada, exceeds that of Japan, a country with a vulnerable and elderly population, by a factor of almost 50, and even dwarfs the rates in lower-middle-income countries, such as Vietnam, by a factor of almost 2000. Covid-19 is an overwhelming challenge, and many factors contribute to its severity. But the one we can control is how we behave. And in the United States we have consistently behaved poorly. New England Journal of Medicine

Rick Bright: I Couldn’t Sit Idly and Watch People Die from Trump’s Chaotic, Politicized Pandemic Response

“I fear the benefits of dramatically improved testing capacity will be wasted unless it is a part of a coordinated national testing strategy…In an administration that suffers from widespread internal chaos, such coordination may be impossible — especially when the White House has seemed determined to slow down testing and not test people who might have asymptomatic infections.” Washington Post

‘Gross Negligence’: Public Health Experts Weigh in on Pence Participating in VP Debate

No one in the Trump administration seems to understand what public health experts have been preaching for months about how the coronavirus spreads. Nor do they seem care about the CDC’s guidance that anyone who spends more than 15 minutes within six feet of someone who tests positive should isolate for 14 days. Not only is Pence not doing that, he’s been actively campaigning, and travelled to Utah with his staff (all of whom are potential vectors) to debate Sen. Kamala Harris in an enclosed space. Rolling Stone

Related: At Least 5 of VP Pence’s Aides Test Positive for Coronavirus CNN

The Pandemic of Publications: Are We Sacrificing Quality for Quantity?

The coronavirus disease 2019 (COVID-19) pandemic has sparked an explosion in biological and medical research worldwide, with more than 30,000 COVID- 19 PubMed-indexed publications and 6200 medRxiv and bioRxiv preprints as of early July. A torrent of exaggerated or subpar research being published may threaten the evidence-based response to COVID-19 globally. Mayo Clinic Proceedings

White House Installed ‘Politicals’ at CDC to Control Info

In May, a series of leaked emails and scientific documents detailed how the White House had buried CDC’s detailed guidelines for communities reopening during a still-surging pandemic. The resulting news stories sparked renewed efforts to exert control over the CDC, according to current and former officials, prompting installation of political officials who have no public health background in the Atlanta headquarters in June, reportedly tasked with keeping an eye on Dr. Robert Redfield, the agency director, as well as scientists. AP

The John Snow Memorandum: Scientific Consensus to Act Now on the COVID-19 Pandemic

A letter initiated by 82 subject-matter-experts in health security and co-signed by a growing body of over 6200 scientists, researchers & healthcare professionals say the concept put forth by the so-called “Great Barrington Declaration”–relying upon immunity from natural infections for COVID-19 to end the pandemic in the U.S.–is “a dangerous fallacy.” Named for one of the founding fathers of modern epidemiology, the John Snow Memorandum stresses the risks of morbidity and mortality from uncontrolled transmission, impact to the healthcare system’s ability to provide acute and routine care, and lack of evidence for lasting protective immunity to SARS-CoV-2. John Snow Memorandum and The Lancet

SPECIAL INTEREST

DDSF Scholarship Program– Master’s in Biodefense

Up to $250,000 in scholarships are available to students entering the following GMU Schar School programs in Spring 2021: Master’s in Biodefense; Master’s in International Security; Master of Public Administration (Concentration in Emergency Management and Homeland Security); and Master of Public Policy (with an emphasis in National Security and Public Policy). The graduate application deadline to be considered for the scholarship is November 15, 2020. George Mason University

Biosecurity Diplomacy Workshop for Young Scientists

The call for applications to the 2nd Global South Biosecurity Diplomacy Workshop is now open! Young scientists in biosecurity from the Global South are encouraged to apply. Deadline is November 8, 2020. UNODA via the BWC Implementation Support Unit

Winners of NTI’s 2020 Next Generation for Biosecurity in GHSA Competition Announced

Jonas Sandbrink, a medical student at the University of Oxford; Joshua Monrad, a masters candidate in health policy, planning, and financing at the University of London (LSHTM, LSE); and Sriharshita Musunuri, a chemistry and computer science undergraduate student at Stanford University are the winners of the fourth annual Next Generation for Biosecurity Competition for their joint paper: Widening the Framework for Regulation of Dual-Use Research in the Wake of the COVID-19 Pandemic. NTI|bio

IN MEMORIAM

James Leonard Jr., Foreign Service Officer

James Leonard Jr., 100, a 28-year career Foreign Service officer who helped negotiate the release of the crew of a U.S. Navy spy ship captured by North Korea in 1968 and served in top diplomatic posts in the administration of President Jimmy Carter, died Aug. 29 at his home in Arlington, Va. Mr. Leonard was the lead U.S. negotiator for the 1972 Biological Weapons Convention in Geneva that banned the development, production and stockpiling of biological weapons. Washington Post

New Study Casts Doubt on Benefit of Tocilizumab for Worsening Cases of COVID-19

Five Things You Need to Know About Bats, Disease and Coronavirus