News highlights on health security threats and countermeasures curated by Global Biodefense
This week’s selections include discussions on a pandemic treaty for equitable access to medical countermeasures; a system for situational awareness of wildlife disease threats; and crisis communications for vulnerable populations during CBRN emergencies.
Contents
POLICY + GOVERNMENT
First Annual Report on Progress Towards Implementation of the American Pandemic Preparedness Plan
This document, released on the one-year anniversary of the public release of American Pandemic
Preparedness: Transforming our Capabilities, provides the first annual report outlining progress towards implementation of relevant capabilities, highlights priority actions that are ongoing and needed across departments and agencies in the U.S. Government and the private sector, and identifies S&T opportunities to fill gaps to ensure preparedness for emerging pandemic threats. WhiteHouse.gov .pdf
Public Health Needs Stronger Lobbying
The past two years have been replete with calls for more funding in the US public health system from editorial boards, national news organizations, think tanks, op-eds and business news to academic articles. Unfortunately, there has been little impact. Despite more than a million Americans dead and counting, permanent change appears unlikely in the near future. The truth is that public health has never been funded adequately. One such systemic barrier may be lobbying. Public health funding has remained less than 3.5 percent of total health expenditure since 1960 (with the exception of 2020, which is likely attributable to COVID-19). In 2021, there was $689,466,798 spent on lobbying by all health-related organizations, the most of any industry according to Open Secrets. More than half this spending, $356,597,531, was from pharmaceutical and health product organizations, and another $118,642,782 from hospitals and nursing homes. Some of the largest health professionals’ associations, such as the American Medical Association (AMA), which represents physicians of all specialties, spent a total of $88,000,000, with the AMA spending $19,490,000 alone in 2021. The major, national public health associations (APHA, ASPPH, NACCHO) spent a combined $500,000 in 2021, per Open Secrets. Health Affairs
US CDC Announces Major Changes After Criticism of its Responses to Covid-19 and Monkeypox
Walensky will ask Congress for new powers, including a requirement for state health agencies and counties to share their data with the CDC, as such sharing is currently voluntary. She will also ask for more flexibility in funding, as Congress currently designates funds for specific programs, making it difficult for the agency to have money available to cope with a sudden public health emergency. The BMJ
Pentagon Biological Defense Programs at ‘Pivot Point’
The Defense Department will invest an additional $300 million per year over the next five years to guard against known and emerging biological threats, a senior Pentagon official said July 28. “Technologies like artificial intelligence, nanotechnology and physics are being applied to the life sciences, creating what the national security community is calling ‘bio-convergence,’” said Deb Rosenblum, ASD for Nuclear, Chemical and Biological Programs. Rosenblum’s office is spearheading a biological defense posture review. It will look at new authorities, realignment of responsibilities, seams and gaps in defense against such weapons. The COVID-19 response will provide lessons learned for the review, which is expected to be completed this fall. National Defense
The NHS Is Not Living with Covid, It’s Dying From It
Most people (including many in the NHS) are so tired of COVID-19 that they are willfully pushing it to the back of their minds, but now is the time to face the fact that the nation’s attempt to “live with covid” is the straw that is breaking the NHS’s back. In 2020 and 2021 the NHS coped with pandemic peaks by stopping or slowing much of its routine work. 2022 was meant to be the year of full speed recovery. The omicron variant is less severe, and just under 40% of hospital patients are being treated “primarily” for the disease. But a Covid-19 diagnosis is a complicating factor for many conditions, worsening outcomes and lengthening recovery times. The need to keep people with Covid-19, uninfected people, and contacts apart means an increase in effort. Higher rates of covid-19 in hospitals and the community also result in more staff sickness, further hollowing out an already overstretched and exhausted workforce. Existing public health advice to wear masks in crowded places, ensure good ventilation, and test regularly need to be communicated much more powerfully. Above all, the government must stop gaslighting the public and be honest about the threat the pandemic still poses to them and the NHS. The BMJ
Don’t Get Distracted Over ARPA-H Fight; Let’s Win the Bigger Prize
Jockeying for the new ARPA-H headquarters overlooks the critical point that little research will take place at the HQ. Instead, Maryland and the region should be thinking of ways to compete to win ARPA-H grants, regardless of where the headquarters ends up. More importantly, this dispute should trigger Maryland to consider ways to take better advantage of the NIH in Bethesda: the world’s largest bio medical institution, comprising over 6,000 scientists. Maryland Daily Record
A Pandemic Treaty for Equitable Global Access to Medical Countermeasures: Recommendations for Sharing Intellectual Property, Know-How and Technology
While the WTO Trade-Related Aspects of Intellectual Property Rights Agreement has policy space to protect public health and to promote access to medicines for all, compliance with the legal texts requires a sophisticated understanding of both IP and trade law, and an ability to resist pressure from trading partners and rights holders. Further, the lack of technology transfer from vaccine producers in high-income countries to manufacturers (particularly in low- and middle-income countries (LMICs)) has been a major hurdle to rapidly growing the global COVID-19 vaccine supply. Technology transfer should become the norm in the pandemic preparedness and response phases, not the exception. To achieve this, a pandemic treaty should create obligations on governments that are triggered with the declaration of a Public Health Emergency of International Concern. BMJ Global Health
U.K. Set to Abandon Europe’s Top Science Funding Program
A few months ago, Teresa Thurston, a cellular microbiologist at Imperial College London, could not have imagined losing her €1.5 million European research grant. But the UK’s role in the European Union’s €95 billion Horizon Europe funding program is now crumbling thanks to lingering Brexit disputes, forcing many U.K. grant winners like Thurston to give up grants they thought they could count on, or move to Europe. In the meantime, a transitional program promises to make up for Horizon grants already won by U.K. researchers. Thurston plans to accept the government’s offer, but she says this backstop doesn’t carry the same prestige or networking opportunities. Science
A Global Forum on Synthetic Biology: The Need for International Engagement
Three fundamental premises underpin the rise of synthetic biology across the past 20 years— that life is information; that biology can be considered technology; and that policy responses hinge on the three-way convergence of the life sciences, the information sciences and engineering. Any new architecture for policy-practitioner engagement in synthetic biology needs to fully acknowledge this trend. A Global Forum on Synthetic Biology must be able to scale with cyber-biological acceleration, including artificial intelligence and machine learning while engaging with cutting-edge engineering and design issues in a post-Covid world. Nature Communications
MEDICAL COUNTERMEASURES
China Approves the World’s First Inhaled COVID Vaccine for Emergency Use as a Booster
The National Medical Products Administration of China granted CanSino approval for its inhaled vaccine to be used as a booster dose. It has similar ingredients to its injected vaccine, using a adenovirus as a carrier for the genetic code that teaches the body how to fight Covid. Nasal spray vaccines may give added immunity in the lining of the nose and upper airways, where Covid typically enters the body. CanSino says its inhaled vaccine is convenient as it requires only one-fifth of the dosage of the intramuscular version, and can be transported and stored between 2°C and 8°C – unlike some injectable vaccines that require ultra-low temperatures. EuroNews, BBC
Emergent Biosolutions to Acquire PaxVax in $270M Deal
The acquisition gives Emergent a solid development pipeline, which addresses both commercial and government needs. Last year, PaxVax licensed NIH’s virus-like particle vaccine technology for its chikungunya vaccine candidate currently in phase 2. PaxVax is also working with the Walter Reed Army Institute of Research to assess an alum adjuvant in the vaccine formulation. Under another multiyear funding contract with the DoD, PaxVax is developing an adenovirus 4/7 vaccine specifically for military personnel. PaxVax additionally already has two FDA-approved vaccines: typhoid fever vaccine Vivotif and cholera vaccine Vaxchora, both oral vaccines meant to protect travelers visiting endemic regions. Fierce Pharma
Novavax Seeks U.S. Authorization for COVID Vaccine Booster
The company has filed for U.S. authorization for its protein-based COVID-19 vaccine as a booster dose in people who had either received its shots or a different vaccine. Uptake has been slow for the Novavax vaccine, as it was just approved this summer in the U.S. amid a supply glut and soft demand. Reuters
Omicron Spike Function and Neutralizing Activity Elicited by a Comprehensive Panel of Vaccines
Primary COVID-19 vaccine regimens or infection-elicited plasma neutralizing activity was severely dampened by Omicron sublineages BA.1, BA.2, BA.2.12.1, and BA.4/5. However, administration of a booster dose increased neutralizing antibody titers and breadth against all Omicron sublineages to appreciable levels regardless of the vaccine evaluated. These results are consistent with previous studies demonstrating that a third vaccine dose results in the recall and expansion of pre-existing SARS-CoV-2 S-specific memory B cells, as well as de novo induction, leading to production of neutralizing antibodies with enhanced potency and breadth against variants. Science
Vaccine Development Needs for Marburg Virus and Sudan Ebolavirus: Leveraging Lessons Learned from the Zaire Ebolavirus
The recent outbreak of Marburg virus highlights the urgent need for vaccines that could be used to help slow the spread of disease when these outbreaks inevitably occur. It also casts a light on our collective level of preparedness in terms of available medical countermeasures. Vaccines
As Monkeypox Spreads, Fort Detrick Scientists Continue Research
Over the years, researchers at the U.S. Army Medical Research Institute of Infectious Diseases have helped develop vaccines and therapeutics that can be used for both monkeypox and smallpox. Stars and Stripes
FDA Wants Pfizer to Study COVID Rebound Cases with a Longer Course of Paxlovid
The United States regulator wants to know if a second five-day course of the drug would help prevent COVID from returning and has ordered Pfizer to conduct a trial by Sept. 30 of next year. The FDA sent its letter on Aug. 5 as President Biden was recovering from his comeback case. He originally tested positive on July 21, then again 10 days later. Another high-profile Paxlovid user, National Institute of Infectious Diseases director Anthony Fauci, experienced the same rebound effect of his case of COVID. Fierce Pharma
There’s Just One Drug to Treat Monkeypox. Good Luck Getting It.
The only drug available to treat monkeypox (tecovirimat, or TPOXX) is so difficult to access that just a fraction of the nearly 7,000 patients in the United States have been given it. Until the current outbreak, tecovirimat was given only rarely to monkeypox patients. As a smallpox treatment, its use against monkeypox is considered experimental. But vaccines developed for smallpox have been assumed to be effective against both diseases. Why not the treatment? Experts say the F.D.A.’s restrictions are a policy choice that can be quickly altered. NY Times
Monkeypox Antiviral Drug Put to the Test in Trial
Around 500 patients will take part in the PLATINUM trial. Some will be treated twice-daily with tecovirimat (also known as TPOXX) while they recuperate from the virus in their own home; others will receive a placebo instead. BBC
Polio Vaccines: New Developments on the Road to Eradication
The novel oral polio vaccine 2 (nOPV2) contains a modified strain of type 2 poliovirus that is less likely revert to a form that causes paralysis or gives rise to cVDPV2. Compared to the old monovalent vaccine, nOPV2 has a similar safety profile, induces a similar immune response and is unlikely to be shed at a greater rate. Importantly, nOPV2 is more genetically stable. As of May 2022, 350 million doses of nOPV2 had been distributed across 18 countries. The safety and efficacy of the vaccine will be monitored as it becomes more widely adopted—full licensing is expected in 2023. American Society for Microbiology
Takeda’s Dengue Fever Vaccine Picks Up First Global Nod in Indonesia
For years, Takeda has been working to bring the first travel vaccine for dengue fever to the market. The vaccine, called Qdenga, is now approved in the country for use in people 6 to 45 years of age regardless of prior dengue exposure. The country’s regulator granted the approval based on results from the company’s ongoing phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES), which enrolled more than 20,000 healthy children aged 4 to 16 living in dengue-endemic areas in Asia and Latin America. Fierce Pharma
BIOSECURITY + BIOPREPAREDNESS
Vaccination Against COVID-19 Among the Armed Forces of the Western Hemisphere: Readiness, Force Protection, and International Cooperation
This paper examines vaccination of the armed forces of North, Central and South America, and the Caribbean — not only as a response to the current pandemic, but also as purveyors of national security and emergency response services. Key focus areas are institutional vaccine requirements; any accommodations for variations or exemptions to vaccination; and incentives and penalties for non-compliance. National Defense Center .pdf
Challenges in Managing, Sustaining, and Assessing Closed Medical Countermeasure POD Sites
Public health officials should continue expanding and improving closed POD networks to enable MCM delivery and minimize morbidity and mortality related to mass casualty events. This study involved qualitative interviews with U.S. disaster planners to elucidate their approaches and challenges to managing, sustaining, and assessing existing closed POD sites. Very few jurisdictions reported doing formal assessments of closed POD sites. The largest challenges identified were staff turnover and keeping sites engaged, sometimes leading to sites voluntarily withdrawing or needing to be removed from being a closed POD. PLOS Pathogens
Identifying Operational Challenges and Solutions During the COVID-19 Response Among US Public Health Laboratories
Public health labs reported frustration with federal agencies providing confusing or insufficient operational guidance and noted the well-documented failure of the first COVID-19 testing assay deployed by the CDC, causing weeks-long delays in their abilities to initiate testing. In addition, the early requirement to ship presumptive positive samples to the CDC for confirmation delayed test results. However, the most prevalent, significant challenge reported that created later complications was the FDA’s EUA requirement allowing only a select few diagnostics early during the pandemic and that these diagnostics often required specific equipment, supplies, and extraction platforms from a select few suppliers. Because of the high demand for COVID-19 testing, there was competition between numerous testing facilities, further exacerbating the supply chain bottleneck. These were predominantly manual rather than automated, and therefore low throughput, requiring more staff time, equipment, and space per test. Antiquated information systems also ranked high on the list. Journal of Public Health Management and Practice
SELECT AGENTS + PRIORITY PATHOGENS
The Select Agent Regulations: Structure and Stricture
While intended to protect public health, the ineffectual and overly stringent nature of these regulatory policies continues to hinder essential scientific research and, in turn, may paradoxically lead to safety and security vulnerabilities now and in the future. Georgetown Scientific Research Journal
Factors Impacting Severe Disease from Chikungunya Infection: Prioritizing Chikungunya Vaccine When Available
Chikungunya results in more debilitating long-term effects than any other arboviral disease. It has a high morbidity rate and not insignificant rate of chronicity. The chronic phase of the disease, characterized by recurrent joint pain, affects a variable proportion (30%–40%) of those infected and can last for years. More severe complications of acute disease, albeit relatively rare, include myocarditis and other cardiological complications, hepatitis, ocular and neurologic disorders including Guillain-Barré syndrome, acute encephalitis and others. Severe complications of chikungunya occur disproportionately in patients over the age of 60 years, and in patients with underlying medical problems, specifically diabetes and cardiovascular disease. Efforts to prevent this disease have intensified as there is no adequate treatment once a person is infected. Prevention has heretofore been confined to barrier protection with insect repellants and bed nets and avoidance of mosquito vector. With vaccines on the horizon, it may be worthwhile to be able to predict not only who is most susceptible to disease, as well as severe disease, but also other host specific risk factors which might increase the risk of a chronic chikungunya disease. Travel Medicine and Infectious Disease
Laboratory Misidentifications Resulting from Taxonomic Changes to Bacillus cereus Group Species, 2018–2022
Here, researchers detailed 3 cases in which misinterpretation of B. cereus group whole-genome sequencing results directly hindered public health and food safety efforts. Two cases represented false-positive scenarios, in which group III B. cereus strains incapable of causing anthrax were incorrectly assumed to be anthrax-causing agents. As noted previously, strains that lack anthrax toxin-encoding genes but are assigned to B. anthracis using WGS-based methods are not uncommon. These strains have been isolated from diverse environments (e.g., meat, milk, spices, egg whites, baby wipes) on 6 continents and the International Space Station, and although some may cause illness, they cannot cause anthrax. One way of denoting that a B. cereus group strain may produce anthrax toxin is to append the term “biovar Anthracis” to the genus/species name. The remaining case represented a worst-case, false-negative scenario, in which a WGS-assigned species label with limited clinical interpretability or previous associations to foodborne illness (B. paranthracis) was assigned to an established pathogen (group III B. cereus) and directly hindered an outbreak investigation. It is anticipated that similar problems may arise with anthrax-causing B. cereus, because WGS-based methods assign some of these strains to B. tropicus, a species proposed in 2017. Emerging Infectious Diseases
Working Correlates of Protection Predict Schus4-Derived-Vaccine Candidates Against Francisella Tularensis
Francisella tularensis, the causative agent of tularemia, is classified as Tier 1 Select Agent with bioterrorism potential. The efficacy of the only available vaccine, LVS, is uncertain and it is not licensed in the U.S. These studies demonstrated the potential power of a panel of correlates to screen and predict the efficacy of Francisella vaccine candidates, and in vivo studies identified potentially better alternatives to the LVS vaccine. NPJ Vaccines
RIPpore: A Novel Host-Derived Method for the Identification of Ricin Intoxication
This work highlights the potential for Oxford Nanopore Technologies and direct RNA sequencing to detect and quantify depurination events caused by ribosome-inactivating proteins such as ricin. This methodology is proven with concentrations of ricin from 1000 to 1 picomole. As lethal exposures to ricin typically require upward of nanomolar to micromolar quantities in order to mediate its toxic effects, the picomole sensitivity of this technique means its use for the diagnosis of toxin exposure is worth further investigation. Toxins
CHEMICAL + RADIOLOGICAL THREATS
The Resurgent Scourge of Chemical Weapons
It is clear that in spite of international efforts to control these weapons, nations and non-state actors are still using chemical weapons. The Russian invasion of Ukraine shows us that large-scale combat operations are not a thing of the past and brings to the forefront the importance of being prepared for a chemical battlefield. US Army TRADOC
Develop Therapeutics as Countermeasures Against Chemical Threats
NIAID and its partners under the Chemical Countermeasures Research Program (CCRP) invite applications for the early-stage development of therapeutics and medical countermeasures (MCMs) to mitigate the adverse health effects resulting from toxic chemical exposure, including validation of therapeutic targets and preclinical characterization of lead compounds. NIAID
Crisis Communication in CBRNe Preparedness and Response: Considering the Needs of Vulnerable People
The EU project PROACTIVE aims to enhance CBRNe preparedness and response by increasing the effective management of large, heterogeneous groups including vulnerable civilians. The findings from two surveys show that CBRNe practitioners very rarely consider the needs of vulnerable groups in their communication strategies for major emergencies and seldom provide information in additional language formats (e.g. Braille and sign language). International Journal of Disaster Risk Reduction
SURVEILLANCE + DETECTION
WHISPers: Providing Situational Awareness of Wildlife Disease Threats to the Nation
The Wildlife Health Information Sharing Partnership-event reporting system (WHISPers) was developed by the U.S. Geological Survey National Wildlife Health Center to promote collaboration and sharing of wildlife health information and to provide situational awareness and timely information about wildlife disease threats. WHISPers is a free science gateway and data portal that provides interactive query, display, reporting, and export capabilities for wildlife health event summary information. USGS
Analysis of Generation and Sampling Methods for MS2 Virus Aerosols
This report characterized generation and sampling methods for viral aerosols. Different methods for aerosol generation were also evaluated, including the Collison nebulizer, bubble generator, noncirculating bubbler, spinning-top aerosol generator, and ultrasonic nebulizer. Although these methods are commonly used for general aerosol generation, they had previously not been systematically tested. Bioaerosol sampling methods assessed include filter collection, impingement into fluid, and impaction onto agar. Viral aerosol quantification methods that were evaluated include an ultraviolet aerodynamic particle sizer and an electrical low-pressure impactor. DEVCOM Chemical Biological Center .pdf
Simultaneous Detection of Foodborne Pathogens Using a Real-Time PCR Triplex High-Resolution Melt Assay
An assay was developed to detect and identify three pathogens that routinely cause multistate foodborne outbreaks, as documented by the U.S. Centers for Disease Control and Prevention, Campylobacter jejuni, Escherichia coli, and Salmonella enterica, in single bacterium assays and a multiplex. The primers were targeted to specific and unique gene sequences of each pathogen. Each pathogen was identified by its unique melting temperature in single assays. The multiplex successfully detected and identified all three of the pathogens with the distinctly separated melt peaks. Applied Microbiology
Covid-19: Asymptomatic Testing is “Paused” in England’s Hospitals and Care Homes
Regular asymptomatic testing for covid-19 in hospitals, care homes, and hospices in England will be “paused” from 31 August, the Department of Health and Social Care has said. Testing will also be halted in prisons and detention centres, as well as in domestic abuse refuges and homelessness settings. The government has said that the move is due to “low” prevalence of covid-19. Symptomatic testing will continue. The latest Office for National Statistics data estimate that around one in 40 people in England—nearly 1.5 million—tested positive for covid-19 in the week ending 8 August. The BMJ
COVID Sewage Surveillance Labs Join the Hunt for Monkeypox
With the onset of the pandemic, a research collaboration that involves scientists at Stanford University, the University of Michigan, and Emory University pioneered efforts to recalibrate the surveillance techniques for detection of the coronavirus, marking the first time that wastewater has been used to track a respiratory disease. That same research team, the Sewer Coronavirus Alert Network (SCAN), is now a leader in expanding wastewater monitoring to detect monkeypox. NPR
Rethinking Covid-19 Test Sensitivity — A Strategy for Containment
The FDA and the scientific community are currently almost exclusively focused on test sensitivity, a measure of how well an individual assay can detect viral protein or RNA molecules. Critically, this measure neglects the context of how the test is being used. Yet when it comes to the broad screening the U.S. so desperately needs, context is fundamental. The key question is not how well molecules can be detected in a single sample but how effectively infections can be detected in a population by the repeated use of a given test as part of an overall testing strategy — the sensitivity of the testing regimen. Measuring the sensitivity of a testing regimen or filter requires us to consider a test in context: how often it’s used, to whom it’s applied, when in the course of an infection it works, and whether its results are returned in time to prevent spread. New England Journal of Medicine
Awareness of SARS-CoV-2 Omicron Variant Infection Among Adults with Recent COVID-19 Seropositivity
In this cohort study of 210 adults with evidence of seroconversion during a regional Omicron variant surge, 56% reported being unaware of any recent Omicron variant infection. Findings suggest that low rates of Omicron variant infection awareness may be a key contributor to rapid transmission of the virus within communities. JAMA Network Open, NPR
SPECIAL INTEREST
Adrienne Mayor on Greek Fire, Poison Arrows, and Scorpion Bombs
“I am still amazed by the staggering and imaginative range of nefarious substances in nature that were weaponized in antiquity! Poisonous honey, viper venoms, fatal pathogens, deadly plants, catapulting hives full of enraged wasps, hurling clay grenades packed with live scorpions… tainting wells, spreading plague, creating clouds of caustic dust and toxic gases, propelling unquenchable liquid flames, and more—it seems the ancients thought of every possible option using whatever was at hand. Another surprise was that the ancient myths about poison weapons not only anticipated the practical problems of self-injury and friendly fire that still plague the use of biological armaments, but they also pondered the ethical dilemmas that we grapple with today.” Princeton University Press
Also Reading:
Optimizing and Unifying Infection Control Precautions for Respiratory Viral Infections. The Journal of Infectious Diseases
Immune memory to SARS-CoV-2 Omicron BA.1 breakthrough infections: To change the vaccine or not? Science Immunology
Global influenza surveillance systems to detect the spread of influenza-negative influenza-like illness during the COVID-19 pandemic: Time series outlier analyses from 2015–2020. PLOS Medicine
Epidemiologic Features and Control Measures during Monkeypox Outbreak, Spain, June 2022. Emerging Infectious Diseases
Dried urine spot and dried blood spot sample collection for rapid and sensitive monitoring of exposure to ricin and abrin by LC–MS/MS analysis of ricinine and l-abrine. Forensic Chemistry
Rickettsia Aglow: A Fluorescence Assay and Machine Learning Model to Identify Inhibitors of Intracellular Infection. ACS Infectious Diseases
JYNNEOS Monkeypox Vaccine Distribution by Jurisdiction. HHS ASPR
Monkeypox: UKHSA laboratory assessments of inactivation methods. Gov.UK
SARS-CoV-2 ORF6 disrupts innate immune signalling by inhibiting cellular mRNA export. PLOS Pathogens
Investigation of Salicylanilides as Botulinum Toxin Antagonists. ACS Infectious Diseases
Modeling the Impact of Sexual Networks in the Transmission of Monkeypox virus Among Gay, Bisexual, and Other Men Who Have Sex with Men — United States, 2022. MMWR
5 essential ingredients for the new Pandemic Prevention, Preparedness and Response Fund. Oxfam International