Harmonize rules for digital sequence information benefit-sharing across UN frameworks.

As multiple UN fora develop parallel rules for sharing benefits from digital sequence information, we urge better coordination. International policymakers should focus on harmonizing new benefit-sharing rules to ensure open access to data, database interoperability, and better benefit sharing outcomes.

Six dilemmas for stakeholders inherently affecting data sharing during a zoonotic (re-)emerging infectious disease outbreak response.

Background: Timely access to outbreak related data, particularly in the early events of a spillover, is important to support evidence based control measures in response to outbreaks of zoonotic Emerging Infectious Diseases (EID). Yet, this is impeded by several barriers that need to be understood to promote timely sharing of data. Using the MERS epidemic as a model for a zoonotic EID outbreak, this study sought to provide an in-depth understanding of data sharing practices.

Regional differences in historical diphtheria and scarlet fever notification rates in The Netherlands, 1905-1925: a spatial-temporal analysis.

Background: We describe how rates of two frequently occurring notifiable diseases-diphtheria and scarlet fever-varied between regions of The Netherlands in the early twentieth century, and identify potential factors underlying this variation.

Methods: Digitized weekly mandatory notification data for 1905-1925, municipality level, were aggregated into 27 'spatial units' defined by unique combinations of province and population density category (high: more than 4500; mid : 1250-4500; low: less than 1250 inhabitants km). Generalized additive regression models were fitted to estimate the associations between notification rates and population density, infant mortality rate and household income, while adjusting for temporal trends per spatial unit.

A framework for measuring timeliness in the outbreak response path: lessons learned from the Middle East respiratory syndrome (MERS) epidemic, September 2012 to January 2019.

BackgroundEpidemics are a constant threat in the 21st century, particularly disease outbreaks following spillover of an animal virus to humans. Timeliness, a key metric in epidemic response, can be examined to identify critical steps and delays in public health action.AimTo examine timeliness, we analysed the response to the Middle East respiratory syndrome (MERS) epidemic, with a focus on the international and One Health response efforts.

The dynamics of scarlet fever in The Netherlands, 1906-1920: a historical analysis.

Scarlet fever, an infectious disease caused by , largely disappeared in developed countries during the twentieth century. In recent years, scarlet fever is on the rise again, and there is a need for a better understanding of possible factors driving transmission. Using historical case notification data from the three largest cities in The Netherlands (Amsterdam, Rotterdam and The Hague) from 1906 to 1920, we inferred the transmission rate for scarlet fever using time-series susceptible-infected-recovered (TSIR) methods.

International expert group collaboration for developing an adverse outcome pathway for radiation induced leukemia.

Purpose: The concept of the adverse outcome pathway (AOP) has recently gained significant attention as to its potential for incorporation of mechanistic biological information into the assessment of adverse health outcomes following ionizing radiation (IR) exposure. This work is an account of the activities of an international expert group formed specifically to develop an AOP for IR-induced leukemia. Group discussions were held during dedicated sessions at the international AOP workshop jointly organized by the MELODI (Multidisciplinary European Low Dose Initiative) and the ALLIANCE (European Radioecology Alliance) associations to consolidate knowledge into a number of biological key events causally linked by key event relationships and connecting a molecular initiating event with the adverse outcome.

Safe-and-Sustainable-by-Design Framework Based on a Prospective Life Cycle Assessment: Lessons Learned from a Nano-Titanium Dioxide Case Study.

Safe-and-sustainable-by-design (SSbD) is a concept that takes a systems approach by integrating safety, sustainability, and functionality throughout a product's the life cycle. This paper proposes a framework based on a prospective life cycle assessment for early safety and sustainability assessment. The framework's purpose is to identify environmental sustainability and toxicity hotspots early in the innovation process for future SSbD applicability.

Risk factors associated with the incidence of self-reported COVID-19-like illness: data from a web-based syndromic surveillance system in the Netherlands.

During the first wave of the severe acute respiratory syndrome-coronavirus-2 epidemic in the Netherlands, notifications consisted mostly of patients with relatively severe disease. To enable real-time monitoring of the incidence of mild coronavirus disease 2019 (COVID-19) - for which medical consultation might not be required - the Infectieradar web-based syndromic surveillance system was launched in mid-March 2020. Our aim was to quantify associations between Infectieradar participant characteristics and the incidence of self-reported COVID-19-like illness.

Modeling low-dose radiation-induced acute myeloid leukemia in male CBA/H mice.

The effect of low-dose ionizing radiation exposure on leukemia incidence remains poorly understood. Possible dose-response curves for various forms of leukemia are largely based on cohorts of atomic bomb survivors. Animal studies can contribute to an improved understanding of radiation-induced acute myeloid leukemia (rAML) in humans.

Improving the Environmental Risk Assessment of Substances of Unknown or Variable Composition, Complex Reaction Products, or Biological Materials.

Substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs) pose unique risk assessment challenges to regulators and to product registrants. These substances can contain many constituents, sometimes partially unknown and/or variable, depending on fluctuations in their source material and/or manufacturing process. International regulatory agencies have highlighted the difficulties in characterizing UVCBs and assessing their toxicity and environmental fate.

Building biosecurity for synthetic biology.

The fast-paced field of synthetic biology is fundamentally changing the global biosecurity framework. Current biosecurity regulations and strategies are based on previous governance paradigms for pathogen-oriented security, recombinant DNA research, and broader concerns related to genetically modified organisms (GMOs). Many scholarly discussions and biosecurity practitioners are therefore concerned that synthetic biology outpaces established biosafety and biosecurity measures to prevent deliberate and malicious or inadvertent and accidental misuse of synthetic biology's processes or products.

Tuberculin skin test reaction depends on type of purified protein derivative: implications for cut-off values.

Due to purified protein derivative (PPD) RT23 stock-outs in 2014, PPD-Tubersol and PPD-Bulbio have been used for latent tuberculosis infection (LTBI) testing in the Netherlands. To determine whether PPD-RT23, PPD-Tubersol and PPD-Bulbio were associated with differential indurations and confirmation using interferon-gamma release assays (IGRAs). LTBI surveillance data from 2013 to 2016 were extracted.

Dutch fog: On the observed spatio-temporal variability of fog in the Netherlands.

The Netherlands is characterized by highly variable land use within a small area, and a strong influence of the North Sea on national climate. Devoid of significant topography, it is an excellent location for assessing the relative influence of various factors on fog occurrence in the absence of terrain effects. Using observations from a dense network of weather stations throughout the country, the climatology of fog in the Netherlands is assessed over a period of 45 years.

Hepatitis B and C testing strategies in healthcare and community settings in the EU/EEA: A systematic review.

An estimated 9 million individuals are chronically infected with hepatitis B virus (HBV) and hepatitis C virus (HCV) across the European Union/European Economic Area (EU/EEA), many of which are yet to be diagnosed. We performed a systematic review to identify interventions effective at improving testing offer and uptake in the EU/EEA. Original research articles published between 1 January 2008 and 1 September 2017 were retrieved from PubMed and EMBASE.

HIV care cost in England: a cross-sectional analysis of antiretroviral treatment and the impact of generic introduction.

Objectives: Reliable and timely HIV care cost estimates are important for policy option appraisals of HIV treatment and prevention strategies. As HIV clinical management and outcomes have changed, we aimed to update profiles of antiretroviral (ARV) usage pattern, patent/market exclusivity details and management costs in adults (≥ 18 years old) accessing HIV specialist care in England.

Methods: The data reported quarterly to the HIV and AIDS Reporting System in England was used to identify ARV usage pattern, and were combined with British National Formulary (BNF) prices, non-ARV care costs and patent/market exclusivity information to generate average survival-adjusted lifetime care costs.

Overcoming challenges for designing and implementing the One Health approach: A systematic review of the literature.

Collaborative approaches in health, such as One Health (OH), are promising; nevertheless, several authors point at persistent challenges for designing and implementing OH initiatives. Among other challenges, OH practitioners struggle in their efforts to collaborate across disciplines and domains. This paper aims to provide insights into the existing challenges for designing and implementing OH initiatives, their causes and solutions, and points out strategic solutions with the potential to solve practical challenges.

Hepatitis B and C among healthcare workers and patient groups at increased risk of iatrogenic transmission in the European Union/European Economic Area.

In the European Union/European Economic Area (EU/EEA) approximately 9 million people are chronically infected with hepatitis B virus (HBV) or hepatitis C virus (HCV), and many are undiagnosed. Targeted active case finding initiatives are needed. Iatrogenic transmission of HBV/HCV is relevant in Europe but people at risk of infection are often overlooked.

Impact of Repeated Influenza Immunization on Respiratory Illness in Children With Preexisting Medical Conditions.

Purpose: Annual influenza immunization in medical risk groups is recommended in many countries. Recent evidence suggests that repeated inactivated influenza vaccine (IIV) immunization throughout childhood may impair long-term immunity against influenza. We assessed whether prior immunization altered the effect of IIV in children with preexisting medical conditions on primary care-diagnosed respiratory illness (RI) episodes during the influenza season.

Towards improved process efficiency in vaccine innovation: The Vaccine Innovation Cycle as a validated, conceptual stage-gate model.

Continuing investments in vaccine innovation are insufficiently translated into market entries of novel vaccines. This innovation paradox is in part caused by stakeholders lacking complete understanding of the complex array of steps necessary for vaccine development and collaboration difficulties between the wide variety of stakeholders involved. Models providing cross-domain understanding can improve collaboration but currently lack both comprehensibility and granularity to enable a prioritized view of activities and criteria.

Effect of Antibiotic-Mediated Microbiome Modulation on Rotavirus Vaccine Immunogenicity: A Human, Randomized-Control Proof-of-Concept Trial.

Rotavirus vaccines (RVV) protect against childhood gastroenteritis caused by rotavirus (RV) but have decreased effectiveness in low- and middle-income settings. This proof-of-concept, randomized-controlled, open-label trial tested if microbiome modulation can improve RVV immunogenicity. Healthy adults were randomized and administered broad-spectrum (oral vancomycin, ciprofloxacin, metronidazole), narrow-spectrum (vancomycin), or no antibiotics and then vaccinated with RVV, 21 per group per protocol.

Heterogeneity of Colorectal Cancer Risk Factors by Anatomical Subsite in 10 European Countries: A Multinational Cohort Study.

Background & Aims: Colorectal cancer located at different anatomical subsites may have distinct etiologies and risk factors. Previous studies that have examined this hypothesis have yielded inconsistent results, possibly because most studies have been of insufficient size to identify heterogeneous associations with precision.

Methods: In the European Prospective Investigation into Cancer and Nutrition study, we used multivariable joint Cox proportional hazards models, which accounted for tumors at different anatomical sites (proximal colon, distal colon, and rectum) as competing risks, to examine the relationships between 14 established/suspected lifestyle, anthropometric, and reproductive/menstrual risk factors with colorectal cancer risk.

How ownership rights over microorganisms affect infectious disease control and innovation: A root-cause analysis of barriers to data sharing as experienced by key stakeholders.

Background: Genetic information of pathogens is an essential input for infectious disease control, public health and for research. Efficiency in preventing and responding to global outbreaks relies on timely access to such information. Still, ownership barriers stand in the way of timely sharing of genetic data from pathogens, frustrating efficient public health responses and ultimately the potential use of such resources in innovations.