News highlights on health security threats and countermeasures curated by Global Biodefense
This week’s selections include declaration of an mpox emergency by Africa CDC, threat agnostic sequencing for biosurveillance, and a fire at Ukraine’s Zaporizhzhia nuclear plant.
FEATURED
Mpox Declared Public Health Emergency in Africa
Mpox has been declared a public health emergency in Africa by the continent’s top health body. Scientists from the Africa Centres for Disease Control and Prevention (Africa CDC) say they are alarmed by the speed at which a new strand of mpox has been spreading. Cases are up 160% compared to this time last year (more than 13,700 cases and 450 deaths recorded in the DRC), and have spread to six new countries in 10 days. The WHO today released an updated mpox risk communication and community engagement toolkit. BBC, The BMJ
Are We There Yet? Agent Agnostic Metagenome Sequencing for Biothreat Detection
There is no comparison data for metagenome assay to gold standard PCR or any other test. Until such information is available, it is a futile exercise to deploy untargeted metagenome sequencing for routine biosurveillance or claim it is ready for generalized, operational use. Global Biodefense
POLICY + GOVERNMENT
Public Health Emergency Determinations to Support an Emergency Use Authorization for Avian Flu
The U.S. Department of Health and Human Services on 18 July issued a declaration of emergency announcing that some flu viruses — including H5N1 bird flu — could cause a pandemic and threaten national security. The announcement by HHS Secretary Xavier Becerra amended a 2013 section of the Federal Food, Drug, and Cosmetic (FD&C) Act, which allows the agency to extend the availability of emergency use medical countermeasures to Pandemic influenza A viruses and influenza A viruses with pandemic potential. Prior to the amendment, the declaration only focused on the H7N9 strain of bird flu. Federal Register
Pathogens Prioritization: A Scientific Framework for Epidemic and Pandemic Research Preparedness
This WHO R&D Blueprint for Epidemics has a primary goal to accelerate the development of medical countermeasures and functions as a global platform for research and development collaboration. WHO
Schumer Vows To Block Measure That Would Slash CDC Funding 22%
The Senate’s top Democrat said Sunday he will work to block a plan that would significantly cut the proposed budget of the Centers for Disease Control and Prevention, warning that such a spending reduction could endanger the public. Democrats said the proposal in a House bill includes a reduction of the CDC’s proposed budget by $1.8 billion, or about 22%, that would harm public health. The Republican-led effort also would mean a major cut in programs designed to address firearm injuries and opioid overdose prevention. AP
The United States Announces Additional Assistance for the Democratic Republic of the Congo
On 7 Aug, the United States, through USAID, announced nearly $424 million in humanitarian and health assistance to address the ongoing catastrophe in the Democratic Republic of the Congo. This includes $414 million in humanitarian assistance to support people experiencing persistent humanitarian needs resulting from conflict and displacement, and an additional $10 million in health assistance to respond to the current mpox outbreak in the DRC and in other affected countries in the region. USAID is also donating 50,000 mpox vaccines to the DRC, which is the country most impacted by this outbreak. U.S. State Department
The Coronavirus Lab Leak Hypothesis is Damaging Science
Many politicians, pundits, and the general public now favor the lab leak idea. Most scientists, particularly virologists, do not. Those who eagerly peddle suggestions of laboratory involvement have consistently failed to present credible arguments to support their positions. Having faced targeted harassment, there are now long-term risks that fewer actual experts will help combat future pandemics; and that scientists will be less willing to communicate the findings of sophisticated, fast-moving research on global health topics. Pandemic preparation research has already been deferred, diverted or abandoned. STAT, The Lancet Microbe
BIOSECURE Act Could Signal a Seismic Shift for Biopharma in US and China
More than three-quarters of American biotech companies contract out preclinical and clinical services to Chinese companies, and 30% of the participants are also dependent on China-linked companies for manufacturing of approved medicines. Many life sciences firms are already aiming to shift their supply sourcing away from China as a result of the BIOSECURE Act, legislation introduced in January 2024 to distance the U.S. from foreign companies of concern. BioSpace
MEDICAL COUNTERMEASURES
Defining Access to Countermeasures: Landscape Report
The structures, investment, and political will generated during the COVID-19 pandemic are now receiving less support. We must work to enhance our ability to conduct surveillance and discover emerging pathogens and changes among known ones, support and conduct basic research and translational research, develop and evaluate candidate MCMs for priority and for prototype pathogens. The management of Pandemic Influenza, including the Pandemic Influenza Preparedness (PIP) framework, provides a strong basis for pandemic preparedness, but its operationalization requires further strengthening. WHO
Novel Approaches for Radiation Biodosimetry and Medical Countermeasure Development
This funding opportunity supports exploratory and conceptual research projects in radiation research focused on medical countermeasures, biodosimetry, and animal model development to diagnose/mitigate/treat injuries arising from radiation exposure sustained during a radiation mass casualty incident. NIH Grants
Bavarian Nordic Scores $157M Contract to Replenish US Supplies of Smallpox/Mpox Vaccine Jynneos
Following the commercial launch of Bavarian Nordic’s smallpox/mpox vaccine Jynneos earlier this year, the Danish company has locked up yet another supply agreement with the U.S. government. The company is set to receive $139.7 million for the vaccine bulk product itself, which will be manufactured and invoiced in 2024. The remaining $17 million covered by the contract will help fuel additional services from 2025 through 2027, including storage of vaccine doses in the U.S. Fierce Pharma
Recombinant Vesicular Stomatitis Virus-Vectored Marburg Vaccine in NHPs
The purpose of these experiments was to expand upon the foundational data obtained from rVSV-MARV-vaccinated guinea pigs in the well-characterized cynomolgus macaque model. A single dose of rVSV-MARV (PHV01) protected NHPs against a lethal MARV infection. Viruses
Evaluation of a Novel Intramuscular Prime/Intranasal Boost Vaccination Strategy Against Influenza in the Pig Model
Nasally administered live-attenuated influenza vaccines induce a mucosal immune response that can effectively prevent primary infection and virus shedding. However, the development of alternative live vaccine strategies must consider the balance between eliciting a robust immune response and reducing the virulence of the vaccine candidate. To address this problem, here researchers test a novel prime/boost vaccination strategy consisting of an initial intramuscular immunization with a propagation-defective RNA virus vector and subsequent nasal immunization with a modified attenuated influenza virus that has lost its ability to counteract the host innate immune response. PLOS Pathogens
BIOSECURITY + BIOPREPAREDNESS
The Clear and Present Threat of Chem-Bio and Data and Cyberscientific and Technological (CB-DCST) Tools
An overview of current and emerging developments in chem-bio and data and cybersciences and technologies (CB-DCST), describing trajectories for their deterrent applications in non-kinetic and/or kinetic engagements and proposing a paradigm to inform surveillance, forecasting, and regulatory control. HDIAC
Leveraging the Biocontainment Unit Leadership Workgroup for Special Pathogen Outbreak Response
Established in 2017, the Biocontainment Unit Leadership Workgroup is a consortium of the 13 Regional Emerging Special Pathogen Treatment Centers in the USA. This case study describe the framework and experience of this partnership, along with the structure of rapid deployment for group convening. Health Security
Artificial Intelligence and Automated Laboratories for Biotechnology: Leveraging Opportunities and Mitigating Risks
Summary of a National Academies’ workshop series looking at opportunities to leverage AI and automated laboratories for biotechnology, such as the landscape of DNA sequence and protein function and to create new proteins via a learning cycle without requiring human involvement (directed evolution). NASEM
SELECT AGENTS + PRIORITY PATHOGENS
Non-Ebola Filoviruses: Potential Threats to Global Health Security
Filovirus research is mostly focused on EBOV, paying less attention to other equally deadly orthoebolaviruses (Sudan, Bundibugyo, and Taï Forest viruses) and orthomarburgviruses (Marburg and Ravn viruses). Some of these filoviruses have emerged in nonendemic areas, as exemplified by four Marburg disease outbreaks recorded in Guinea, Ghana, Tanzania, and Equatorial Guinea between 2021 and 2023. Similarly, the Sudan virus has reemerged in Uganda 10 years after the last recorded outbreak. Moreover, several novel bat-derived filoviruses have been discovered in the last 15 years (Lloviu virus, Bombali virus, Měnglà virus, and Dehong virus), most of which are poorly characterized but may display a wide host range. Viruses
New Clinical Trial Will Assess if Mpox Vaccination Works After Virus Exposure
The SMART clinical trial, due to launch in the Democratic Republic of Congo (DRC) and other countries in Africa, has received US $4.9 million from CEPI and the Canadian Institutes of Health Research to find out if post-exposure vaccination of Bavarian Nordic’s MVA-BN mpox vaccine could reduce the risk of secondary mpox cases, or, if a person contracts mpox, could reduce their severity of illness. CEPI
Attempted Transmission of Marburg Virus by Bat-Associated Fleas
These study findings seem to demonstrate that bat fleas lack vectorial capacity to transmit MARV biologically, but the authors note that their role in mechanical transmission should not be discounted. Regular blood-feeds, intra- and interhost mobility, direct feeding on blood vessels resulting in venous damage, and roosting behaviour of bats provide a potential physical bridge for MARV dissemination in densely populated cave-dwelling bats by fleas. Viruses
AVIAN INFLUENZA
Upstart Manufacturers in Low- and Middle-Income Countries to Start Early Vaccine Work
A network of nascent vaccine manufacturers in low- and middle-income countries will soon start preliminary work to develop messenger RNA vaccines targeting the H5N1 bird flu virus, an effort that could speed production during a pandemic, should this virus trigger one. STAT
Could Cow Vaccines Help Halt the Spread of Bird Flu in U.S. Herds? Experts are Divided
A number of scientists question whether investing too heavily in H5N1 vaccinations for cows is a wise approach at this point, given that there remain many outstanding questions about whether vaccinating cows would be an effective way of stopping spread of the virus in cattle in the first place. Some wonder whether farmers will be willing to absorb the costs of vaccines to prevent an infection they don’t currently view as a serious threat to their operations, or whether they would agree to the stringent post-vaccination surveillance that must go hand-in-glove with any attempt to use vaccines to solve this vexing problem. STAT
CHEMICAL + RADIOLOGICAL THREATS
Fire Reported at Zaporizhzhia Nuclear Plant
Russia and Ukraine accused each other of starting a fire at the Russian-occupied Zaporizhzhia nuclear power plant in Ukraine on Sunday, but both sides reported no sign of elevated radiation. The IAEA nuclear watchdog said its staff had seen thick, dark smoke coming from the northern part of the vast six-reactor plant in southern Ukraine, currently in “cold shutdown”, after multiple blasts. “These reckless attacks endanger nuclear safety at the plant and increase the risk of a nuclear accident. They must stop now,” IAEA chief Rafael Grossi warned. Reuters, CNN, IAEA
California Prison Employee Dies After Exposure to Mail ‘Saturated’ in Substance
A veteran mailroom supervisor at Atwater Prison has died after coming into contact with mail “saturated in an unknown substance”, the US Federal Bureau of Prisons said. The victim began to feel “unwell” after he was exposed to the substance and died after he was rushed to a hospital. A second worker was also exposed and hospitalized, but has been released. Investigators are examining whether the substance was fentanyl, according to the Associated Press. Los Angeles Times, BBC
The Current Global Threat of Weapons of Mass Destruction to Humanity and Public Health
Weapons of mass destruction have profoundly shaped global conflict and security landscapes throughout history. From the nuclear bombings of Hiroshima and Nagasaki to the chemical attack in Halabja, these catastrophic events underscored the devastating potential of WMDs on health, humanity, ecosystems, and international stability. This study explored the immediate and long-term impacts of WMDs, analyzing historical precedents and current global conflicts to highlight ongoing risks. Discover Public Health
Biomarker Dosimetry of Acute Low Level of Thermal Neutrons and Radiation Adaptive Response Effect
Study focuses on the effects of acute neutron radiation exposure at low levels of 5 and 10 mSv on some biophysical properties of rat blood. Is acute low-dose neutron exposure harmful? Which parameters measured can be applied as biological dosimeters for acute doses of thermal neutrons? Scientific Reports
SURVEILLANCE + DETECTION
FDA’s Draft Guidances for Emergency Use LDTs Spark Mixed Reactions
When the FDA announced their final rule to regulate LDTs on April 30, 2024, they also issued two draft guidance documents related to enforcement policies: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 and Consideration of Enforcement Policy for Tests During a Section 564 Declared Emergency. While several groups reiterated their opposition to the LDT final rule, to describing a laboratory performing LDTs as a “manufacturer,” and to classifying LDTs as medical devices, the comments support, in principle, establishing enforcement discretion in emergent situations. Commenters also asked for clarification of certain terms and elements.Today’s Clinical Lab
Laboratory Developed Tests Guidance from FDA
Laboratories in the United States are facing a major regulatory landscape shift. To ensure transparency, the FDA intends to respond to generally applicable questions, as appropriate, in a public manner, such as in webinars, guidances, FAQ page, and other resources over the course of the phaseout period. The House Appropriations Committee has requested the FDA suspend efforts to implement its final rule on LDTs, noting “the risk of greatly altering the United States’ laboratory testing infrastructure and reducing patient access to information that informs their healthcare decision making.” The FDA proposed and finalized its LDT rule after Congress repeatedly failed to pass legislation to clarify the regulatory framework for the tests. FDA
Labs Should Consider Action Now to Meet New FDA Test Regulations
The FDA in May announced its rule regulating laboratory developed tests, or LDTs, which generally didn’t have to meet the compliance standards of other medical devices under the FDA’s prior approach (characterized by the agency as “enforcement discretion”). A final rule changed that approach by redefining in vitro diagnostic products (diagnostic tests) to explicitly include LDTs that were manufactured and offered by a laboratory as medical devices. Affected laboratories, hospitals, practitioners, and medical device makers should start preparing for compliance with and enforcement of new regulations for LDTs and not wait for the outcome of litigation against the FDA. Bloomberg Law
Development of an Amperometric Biosensor for the Detection of Bacillus Anthracis Spores
A screen-printed electrode and magnetic bead-based amperometric electrochemical immunosensor for rapid and specific detection of B. anthracis spores. Diagnostic Microbiology and Infectious Diseases
Overview of Molecular and Genotyping Techniques in Diagnosis of Coxiella burnetii
A future task of public health and veterinary public health officers will be to analyze the vector competence of local tick species, to make a reasonable risk assessment for the role of these ticks in the transmission of C. burnetii. This information is essential to prevent Q fever, as treatment remains difficult and the morbidity high. The current state of diagnostics and funding prioritization for development faces some challenges. Infection, Genetics and Evolution
INFECTIOUS DISEASES
Dengue Fever’s Worrisome Surge
While 2023 saw 4.6 million reported cases of dengue in the Americas, this year’s count (as of June 24) had already doubled, reaching 9.7 million. And that’s before much of the region would have entered its highest-transmission months. MedPage Today
PAHO Upgrades Oropouche Virus Risk, Probes More Fetal Deaths
The Pan American Health Organization (PAHO) recently issued an epidemiological alert for rising Oropouche virus infections, urging countries to step up surveillance amid spread to new areas, reports of the first deaths, and suspected maternal transmission. CIDRAP
An Undetected Expansion, Spread, and Burden of Chikungunya and Dengue Cocirculating Antibodies in Nigeria
This study highlighted the unexpectedly high seroprevalence and hidden endemicity of CHIKV and DENV arboviral seropositivity in three regions of Nigeria. Several intrinsic and extrinsic factors are responsible for the high seroprevalence. It was also evident in the present study that these arboviral infections could go unnoticed, especially when causing fever, and will end up being treated as other common infections because of their clinical presentation. Zoonotic Diseases
COVID-19 PANDEMIC
Déjà Vu All Over Again — Refusing to Learn the Lessons of Covid-19
Although the threat of pandemic H5N1 doesn’t appear to be imminent — this variant has yet to show the potential to be transmitted from human to human — the federal government’s initial response suggests that, rather than heeding the lessons from Covid-19, elected officials and other key decision makers may be relying on a dangerous type of revisionism that could lead to more deaths, should H5N1 cause a pandemic. NEJM
Single Monoclonal Antibodies Should Not Be Used for COVID-19 Therapy
In this paper, the authors argue that while mAb use for PreEP is justified, single mAbs should not be used for COVID-19 therapy. In contrast to PreEP where the viral inoculum is small, immunosuppressed people with COVID-19 have large viral burden that can harbor mAb-escape variants that single-agent mAb treatments can rapidly select for resistance. Clinical Infectious Diseases
HISTORICAL REFLECTIONS
Ebola: Ten Years Later – Lessons Learned and Future Pandemic Preparedness
On August 8, 2014, the WHO Director-General declared the Ebola outbreak in West Africa a Public Health Emergency of International Concern (PHEIC). Despite global efforts to control the outbreak, it lasted for over two years, resulting in over 28,000 cases and more than 11,000 deaths by the time it was declared over on June 9, 2016. A decade later, it is essential to reflect on the lessons learned from the West Africa Ebola crisis and their impact on current and future pandemic preparedness efforts. PLOS Speaking of Medicine and Health, USAID
Opening a 60-Year Time Capsule: Sequences of Historical Poliovirus Cold Variants Shed a New Light on a Contemporary Strain.
Many polioviruses have been isolated and phenotypically characterized in the 1940s-50s for the purpose of identifying attenuated strains that could be used as vaccine strains. Among these historical PVs, only few are genetically characterized. Here researchers report the sequencing of four PV strains stored for more than 60 years in a sealed box. Virus Evolution
IN MEMORIAM
J. Robin Warren, Who Proved That Bacteria Cause Ulcers, Dies at 87
In 1984, Dr. Warren and his collaborator, the gastroenterologist Barry Marshall, published a paper in The Lancet describing their finding that the spiral-shaped bacterium now commonly called Helicobacter pylori festered in the stomachs of patients with ulcers and gastritis. Dr. Warren had first noticed the bacterium on a gastric biopsy sample in 1979. The paper’s conclusion upended centuries of conventional wisdom about the cause of ulcers. At the time, the idea that bacteria could even grow in the stomach was considered blasphemy. New York Times
ALSO READING
The influence of synthetic biology on national bioeconomy strategies. SynBioBeta
Tim Walz beat COVID skeptic doc in 2022 race for Governor. MedPage Today
A prM mutation that attenuates dengue virus replication in human cells enhances midgut infection in mosquitoes. Science Translational Medicine
Enhancing mass vaccination programs with queueing theory and spatial optimization. PubMed pre-print
Prevalence of respiratory pathogens in nasopharyngeal swabs of febrile patients with or without respiratory symptoms in the Niakhar area of rural Senegal. Pathogens
Next-generation sequencing for characterizing respiratory tract virome and improving detection of viral pathogens in children with pneumonia. Influenza and Other Respiratory Viruses
Multiplex dual-target reverse transcription PCR for subtyping avian influenza A(H5) virus. Emerging Infectious Diseases