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Biodefense Headlines – 11 July 2021

by Global Biodefense Staff
July 11, 2021
Biodefense Headlines – 11 July 2021

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

This week’s selections include mRNA vaccine trials for influenza, reforming the public health emergency enterprise, and creating more resilient food systems through traceability.

Contents

  • POLICY + INITIATIVES
    • Skeptics Question if Biden’s New Science Agency is a Breakthrough or More Bureaucracy
    • China Fires Back at Biden with Conspiracy Theories About Maryland Lab
    • Reforming and Strengthening ASPR
    • Recommendations to Improve Nation’s Public Health and Medical Preparedness and Response Programs
    • How the I.M.F. Plans to Build a $650 Billion Fund to Fight the Pandemic
  • MEDICAL COUNTERMEASURES
    • Pfizer Says It’s Time for a Covid Booster; FDA And CDC Say Not So Fast
    • JCVI Interim Advice on a Potential Covid-19 Booster Vaccine Programme for Winter 2021 To 2022
    • Moderna Starts Human Trials of an mRNA-Based Flu Shot
    • Small Molecular Weapons Against Multi-Drug Resistance
    • Developing Recombinant Antibodies by Phage Display Against Infectious Diseases and Toxins for Diagnostics and Therapy
    • Scalable Live-Attenuated SARS-Cov-2 Vaccine Candidate Demonstrates Preclinical Safety and Efficacy
  • BIOSECURITY + BIOPREPAREDNESS
    • The Future of Pandemic Preparedness: Agile Coordination Around Clinical Trials
    • The Origins of SARS-CoV-2: A Critical Review
    • Americans Were Confident in the Health Care System’s Ability to Handle a Pandemic—Until a Pandemic Happened
    • How to Make Sure the Labs Researching the Most Dangerous Pathogens are Safe and Secure
    • Protecting Olympic Participants from Covid-19 — The Urgent Need for a Risk-Management Approach
  • SELECT AGENTS + CBRNE THREATS
    • Time to Reconsider the Role of Ribavirin in Lassa Fever
    • Ebola Virus IgG Seroprevalence in Southern Mali
    • Terrorism-Related CBRN Attacks: A Historical Global Comparison Influencing the Emergence of Counter-Terrorism Medicine
    • Could Treatment with Botulinum Toxin Protect Against Subsequent Infection with COVID-19?
    • Federal Circuit Court Revives Claim of Army Vet Over Secret Chemical Agent Tests
    • Chronicle Down Memory Lane: India’s Sixty Years of Plague Experience
  • SURVEILLANCE + DETECTION
    • Covid Protections Kept Other Viruses at Bay. Now They’re Back
    • The UK Has a Plan for a New ‘Pandemic Radar’ System
    • Covid’s Lambda Variant: Worth Watching, but No Cause for Alarm
    • FDA Challenges Stakeholders to Help Develop Tools for Better Traceability
    • Combining Genomic and Epidemiological Data to Compare the Transmissibility of SARS-Cov-2 Lineages
    • Arkansas: State’s Covid-19 Hospitalizations Soar
  • SPECIAL INTEREST
    • Covid-19: Vaccines Journal Retracts Controversial Paper After Editorial Board Members Quit
  • IN MEMORIAM
    • Richard C. Lewontin, Eminent Geneticist With a Sharp Pen, Dies at 92

POLICY + INITIATIVES

Skeptics Question if Biden’s New Science Agency is a Breakthrough or More Bureaucracy

The proposed Advanced Research Projects Agency for Health aims to deliver breakthrough treatments for diseases. But the way Biden would make “ARPA-H” and its $6.5 billion budget part of the sprawling National Institutes of Health is raising concern within the research community and in Congress about whether it will bring a new approach to old problems or become a duplicative bureaucracy. Politico, Forbes

China Fires Back at Biden with Conspiracy Theories About Maryland Lab

Asked at a May 27 press conference about the U.S. investigation into a possible virus leak at the Wuhan Institute of Virology, Chinese Foreign Ministry spokesperson Zhao Lijian quickly changed the subject. “What secrets are hidden in the suspicion-shrouded Fort Detrick and the over 200 U.S. biolabs all over the world?” Since then, Chinese diplomats and government officials have repeatedly returned to this focus of suspicion on Fort Detrick. Foreign Policy

Reforming and Strengthening ASPR

Over the course of the COVID-19 response, HHS and the Assistant Secretary for Preparedness and Response (ASPR) preparedness and response efforts were inadequate. Some of these failures can be attributed to a lack of specific authorities in statute, ineffective inter- and intra-agency coordination mechanisms, and inconsistent and insufficient federal appropriations for preparedness and response activities. This policy brief outlines key improvements to better prepare for future public health emergencies. U.S. Senate

Recommendations to Improve Nation’s Public Health and Medical Preparedness and Response Programs

The Center has identified 13 proposals that, if empowered through bipartisan legislation, would improve the nation’s public health, and increase medical preparedness and response programs for future public health events. Johns Hopkins Center for Health Security

How the I.M.F. Plans to Build a $650 Billion Fund to Fight the Pandemic

The reserve fund will be created through an allocation of Special Drawing Rights, and it will be the largest such expansion of the asset in the organization’s nearly 80-year history. If approved by the I.M.F.’s board of governors, as is expected, the reserves could become available by the end of August. To use the S.D.R.s, countries can agree to trade this interest-bearing asset with other countries in exchange for cash. New York Times

MEDICAL COUNTERMEASURES

Pfizer Says It’s Time for a Covid Booster; FDA And CDC Say Not So Fast

Pfizer said it would soon publish data about a third dose of vaccine and submit it to the US FDA and other regulators. The company specified it would seek FDA emergency use authorization for a booster dose in August. Scientists were critical of the announcement, pointing to evidence that the current two-dose regimen is powerfully effective against the coronavirus. In an unusual move, hours after Pfizer issued its statement, the FDA and CDC issued a joint statement saying Americans do not need booster shots yet. CNN, New York Times

JCVI Interim Advice on a Potential Covid-19 Booster Vaccine Programme for Winter 2021 To 2022

This will be the first winter in the UK when SARS-CoV2 will co-circulate alongside other respiratory viruses, including seasonal influenza. JCVI advises that any potential booster program should begin in September 2021, in order to maximize protection in those who are most vulnerable to serious COVID-19 ahead of the winter months. Influenza vaccines are also delivered in autumn, and JCVI considers that, where possible, a synergistic approach to the delivery of COVID-19 and flu vaccination could support delivery and maximize uptake of both vaccines. GOV.UK

Moderna Starts Human Trials of an mRNA-Based Flu Shot

Moderna gave its mRNA-based seasonal flu vaccine to the first set of volunteers in a clinical trial, the pharmaceutical company announced this week. Moderna is the second group to start testing its mRNA flu shot in human trials — Sanofi and Translate Bio kicked off a trial this summer. The Verge

Small Molecular Weapons Against Multi-Drug Resistance

Despite these emerging clinical problems and projections that by 2050 MDR infections will outpace cancer’s mortality rate, the discovery of new antibacterial strategies has been stifled by complicated politico-economic forces on the antibiotic market. This special issue contains contributions from chemists aiming to describe the current horizons for small molecule therapeutic development and highlight some of the challenges that drug discovery in this arena faces. Accounts of Chemical Research

Developing Recombinant Antibodies by Phage Display Against Infectious Diseases and Toxins for Diagnostics and Therapy

An overview of phage display derived recombinant antibodies against bacterial, viral and eukaryotic pathogens, as well as microbial toxins, intended for diagnostic and therapeutic applications. Universal antibody gene libraries offer an alternative if immunization is not possible, ethically not feasible or patient samples are not available. As a preparedness platform, this approach should also have a budget for immediate start of GMP production and clinical phase I/II studies. Frontiers in Cellular and Infection Microbiology

Scalable Live-Attenuated SARS-Cov-2 Vaccine Candidate Demonstrates Preclinical Safety and Efficacy

Highly attenuated COVI-VAC, the only live attenuated SARS-CoV-2 vaccine currently in clinical development, showed protection at a single intranasal dose in a relevant in vivo model. Like other codon-pair–deoptimized vaccines, it presents all viral antigens with their native amino acid sequence, can be administered intranasally, is safe and effective in small animal models with a single dose, appears to be resistant to reversion, and can be grown to high titers at a permissive temperature. A Phase 1 clinical trial is currently underway to test its safety and efficacy in humans. PNAS

BIOSECURITY + BIOPREPAREDNESS

The Future of Pandemic Preparedness: Agile Coordination Around Clinical Trials

Unlocking a global response that makes it possible to develop new molecules and run agile and internationally mobile clinical trials at the speed required to contain a new pandemic will be essential. Essential to this goal is establishing an infrastructure to prioritize the most promising compounds; and global coordination of clinical trials with access to real-time epidemiological intelligence. STAT

The Origins of SARS-CoV-2: A Critical Review

Since the first reports of a novel SARS-like coronavirus in December 2019 in Wuhan, China, there has been intense interest in understanding how SARS-CoV-2 emerged in the human population. Recent debate has coalesced around two competing ideas: a “laboratory escape” scenario and zoonotic emergence. Here, researchers critically review the current scientific evidence that may help clarify the origin of SARS-CoV-2. Zenodo

Americans Were Confident in the Health Care System’s Ability to Handle a Pandemic—Until a Pandemic Happened

New polling data from Pew shows that only 55 percent of Americans believe the health care system could handle another pandemic, which is the lowest level of belief among 17 countries surveyed. This drop is likely due to the pandemic laying bare the astounding inequities present in America’s institutions. Slate

How to Make Sure the Labs Researching the Most Dangerous Pathogens are Safe and Secure

Only a quarter of the world’s 59 BSL-4 labs are in countries that score highly in a ranking of international biosafety and biosecurity metrics by the US-based Nuclear Threat Initiative. The index measures whether countries have legislation, regulation, oversight agencies, and other facets of sound biorisk management. Furthermore, only three of the countries with BSL-4 labs have established policies on dual-use research. Bulletin of the Atomic Scientists

Protecting Olympic Participants from Covid-19 — The Urgent Need for a Risk-Management Approach

In late July, approximately 11,000 athletes and 4000 athletic-support staff from more than 200 countries will gather for more than 2 weeks of competition at the Tokyo Olympics. One month later, another 5000 athletes and additional staff will attend the Paralympics. According to the International Olympic Committee (IOC) Tokyo 2020 playbooks,1 which are intended to protect both participants and the people of Japan from SARS-CoV-2 infection, Olympic athletes are instructed to supply their own face coverings, are encouraged (but not required) to be vaccinated against Covid-19, and will undergo testing at unspecified intervals after they arrive in Japan. New England Journal of Medicine

SELECT AGENTS + CBRNE THREATS

Time to Reconsider the Role of Ribavirin in Lassa Fever

Ribavirin is the only available Lassa fever treatment. The rationale for using ribavirin is based on one clinical study conducted in the early 1980s. However, reanalysis of previous unpublished data reveals that ribavirin may actually be harmful in some Lassa fever patients. An urgent reevaluation of ribavirin is therefore needed. PLOS Neglected Tropical Diseases

Ebola Virus IgG Seroprevalence in Southern Mali

Mali had 2 reported introductions of Ebola virus (EBOV) during the 2013–2016 West Africa epidemic. Previously, no evidence for EBOV circulation was reported in Mali. This serosurvey study in southern Mali found low seroprevalence in the population, indicating local exposure to EBOV or closely related ebola viruses. Emerging Infectious Diseases

Terrorism-Related CBRN Attacks: A Historical Global Comparison Influencing the Emergence of Counter-Terrorism Medicine

Counter-Terrorism Medicine is a developing Disaster Medicine sub-specialty focusing on the mitigation of health care risks from such events. This study aims to provide the epidemiology of CBRN use in terrorism, to detail specific agents used, and to develop training programs for responders. Prehospital and Disaster Medicine

Could Treatment with Botulinum Toxin Protect Against Subsequent Infection with COVID-19?

Botulinum neurotoxin type A (BoNT/A) is known to block acetylcholine (ACh) as well as many other neuroreceptors and neuromodulators. The recent mention of a potential protective effect of nicotine in COVID 19, by blocking ACh, attracted researchers to report comparative results, over three months, of the impact of SARS-CoV2 in patients injected with botulinum toxin for functional purposes, compared to the general population. J Stomatol Oral Maxillofac Surg

Federal Circuit Court Revives Claim of Army Vet Over Secret Chemical Agent Tests

A U.S. Army veteran who took part in secret tests of toxic chemical agents in 1969 is entitled to disability benefits going back before 2007, when he was finally allowed to discuss the tests, a federal appeals court has ruled in a unanimous decision. Reuters

Chronicle Down Memory Lane: India’s Sixty Years of Plague Experience

This perspective documents the historical aspects of outbreaks of plague of last six decades, establishment of plague surveillance network in India with detailed insights about its activities and recent developments requiring focus on plague surveillance. Indian Journal of Medical Microbiology

SURVEILLANCE + DETECTION

Covid Protections Kept Other Viruses at Bay. Now They’re Back

The US isn’t the only place to experience an out-of-season respiratory syncytial virus (RSV) surge, after COVID-19 measures were lifted. There are not a lot of models to indicate what might happen next. Will RSV return again this year and have a smaller, weaker season in its normal time slot? Will it slowly rotate around the calendar until it ends up back where it belongs? “Seasonality will probably come back after several seasons. What’s complicated is next season, what will happen.” Wired

The UK Has a Plan for a New ‘Pandemic Radar’ System

The world might not need another surveillance system. The existing plethora is one reason why the Rockefeller Foundation’s recently announced Pandemic Prevention Institute instead proposes to create a hub for aggregating and analyzing data that is held in existing systems, rather than creating a new one. Wired

Covid’s Lambda Variant: Worth Watching, but No Cause for Alarm

A growing drumbeat of news coverage has started to raise alarm about Lambda, a variant first detected in Peru late last year. The variant, initially known as C.37, has spread rapidly through parts of South America.  On June 14, the W.H.O. designated it as a “variant of interest”. Latin America has “limited capacity” to do genomic surveillance and follow-up laboratory investigations of new variants, he said. That has led to an information gap fueling concerns about Lambda. New York Times

FDA Challenges Stakeholders to Help Develop Tools for Better Traceability

The COVID-19 pandemic showed us that further enabling a digitally traceable food system could help create the type of transparency needed to anticipate and help prevent supply chain disruptions in a public health emergency, thereby resulting in a more resilient food system. Food Safety News

Combining Genomic and Epidemiological Data to Compare the Transmissibility of SARS-Cov-2 Lineages

Researchers develop a framework that may be used to monitor near real-time variant dynamics in a myriad of settings by integrating genomic surveillance data to estimate the relative effective reproduction number (Rt) of co-circulating lineages. medRxiv pre-print

Arkansas: State’s Covid-19 Hospitalizations Soar

The number of patients hospitalized with covid-19 in Arkansas jumped Tuesday by 55, to 416, the largest one-day increase since January. Fifteen more covid-19 patients were admitted into intensive care units, raising the total to 176, a week-to-week increase of 34 from the 142 reported the previous Tuesday. Gov. Asa Hutchinson attributed the uptick to the state’s low vaccination rates. Arkansas Democrat Gazette

SPECIAL INTEREST

Covid-19: Vaccines Journal Retracts Controversial Paper After Editorial Board Members Quit

A research paper that was promoted by anti-vaccination activists has been retracted by the journal Vaccines after several members of its editorial board resigned. The article misinterpreted data to essential conclude vaccines were causing more deaths than they were saving. “It is grossly negligent, and I can’t believe it passed peer review,” stated one of the resigning board members. None of the article’s three authors has a background in vaccinology, virology, or epidemiology. The BMJ

IN MEMORIAM

Richard C. Lewontin, Eminent Geneticist With a Sharp Pen, Dies at 92

Widely considered one of the most brilliant geneticists of the modern era and a prolific, elegant and often caustic writer who condemned the facile use of genetics and evolutionary biology to “explain” human nature, Lewontin died on Sunday at his home in Cambridge, Mass. He was 92. New York Times, The Scientist

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