Ethical acceptability of human challenge trials: Consultation with the US public and with research personnel.

Human challenge trials (HCTs) may accelerate the development of treatments and vaccines, and deliver novel insights into the course and consequences of infection. However, HCTs are contentious because they involve purposely exposing volunteers to infection. Consultation with the public and other stakeholders is essential for understanding how HCTs can be most ethically and acceptably pursued.

Building less-flawed metrics: Understanding and creating better measurement and incentive systems.

Metrics are useful for measuring systems and motivating behaviors in academia as well as in public policy, medicine, business, and other systems. Unfortunately, naive application of metrics to a system can distort the system and even undermine the original goal. There are two interrelated problems to overcome in building better metrics in academia and elsewhere.

Managing the Transition to Widespread Metagenomic Monitoring: Policy Considerations for Future Biosurveillance.

The technological possibilities and future public health importance of metagenomic sequencing have received extensive attention, but there has been little discussion about the policy and regulatory issues that need to be addressed if metagenomic sequencing is adopted as a key technology for biosurveillance. In this article, we introduce metagenomic monitoring as a possible path to eventually replacing current infectious disease monitoring models. Many key enablers are technological, whereas others are not.

A Systematic Review of Human Challenge Trials, Designs, and Safety.

Background: Few studies have assessed participant safety in human challenge trials (HCTs). Key questions regarding HCTs include how risky such trials have been, how often adverse events (AEs) and serious adverse events (SAEs) occur, and whether risk mitigation measures have been effective.

Methods: A systematic search of PubMed and PubMed Central for articles reporting on results of HCTs published between 1980 and 2021 was performed and completed by 7 October 2021.

High-risk human-caused pathogen exposure events from 1975-2016.

Biological agents and infectious pathogens have the potential to cause very significant harm, as the natural occurrence of disease and pandemics makes clear. As a way to better understand the risk of Global Catastrophic Biological Risks due to human activities, rather than natural sources, this paper reports on a dataset of 71 incidents involving either accidental or purposeful exposure to, or infection by, a highly infectious pathogenic agent. There has been significant effort put into both reducing the risk of purposeful spread of biological weapons, and biosafety intended to prevent the exposure to, or release of, dangerous pathogens in the course of research.

Molecular and Serologic Diagnostic Technologies for SARS-CoV-2.

The COVID-19 pandemic has presented many challenges that have spurred biotechnological research to address specific problems. Diagnostics is one area where biotechnology has been critical. Diagnostic tests play a vital role in managing a viral threat by facilitating the detection of infected and/or recovered individuals.

Results of a 2020 Survey on Reporting Requirements and Practices for Biocontainment Laboratory Accidents.

Biosafety laboratory accidents are a normal part of laboratory science, but the frequency of such accidents is unclear due to current reporting standards and processes. To better understand accident reporting, a survey was created, with input from ABSA International, which included a series of questions about standards, requirements, and likely motivations for reporting or nonreporting. A total of 60 biosafety officers completed the survey.

Exploring Risks of Human Challenge Trials For COVID-19.

Human challenge trials (HCTs) are a potential method to accelerate development of vaccines and therapeutics. However, HCTs for COVID-19 pose ethical and practical challenges, in part due to the unclear and developing risks. In this article , we introduce an interactive model for exploring some risks of a severe acute respiratory syndrome coronavirus-2 (SARS-COV-2) dosing study, a prerequisite for any COVID-19 challenge trials.

Testing, tracing and isolation in compartmental models.

Existing compartmental mathematical modelling methods for epidemics, such as SEIR models, cannot accurately represent effects of contact tracing. This makes them inappropriate for evaluating testing and contact tracing strategies to contain an outbreak. An alternative used in practice is the application of agent- or individual-based models (ABM).

Option-based guarantees to accelerate urgent, high-risk vaccines: a new market-shaping approach.

Accelerating the availability of COVID-19 vaccines is critical to preventing further waves and mitigating the impact on society. However, preparations for large-scale manufacturing, such as building production facilities, are typically delayed until a vaccine is proven safe and effective. This makes sense from a commercial perspective, but incurs great costs in terms of lives lost and damage to the economy.

The Structure of Tweets About Vaccine Safety Between Health Organizations, Experts, and the Public: Analyzing Risk Communication Conversations.

Objective: This article considers how health education organizations in the World Health Organization's 9 Vaccine Safety Network (VSN) use Twitter to communicate about vaccines with the public, and whether they answer questions and engage in conversations. Almost no research in public health, to our knowledge, has explored conversational structure on social media among posts sent by different accounts.

Methods: Starting with 1,017,176 tweets by relevant users, we constructed 2 corpuses of multi-tweet conversations.

Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development.

Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify and discuss 3 potential use cases of HCTs in the current pandemic: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We outline the limitations of HCTs and find that HCTs are likely to be most useful for vaccine candidates currently in preclinical stages of development.

An open challenge to advance probabilistic forecasting for dengue epidemics.

A wide range of research has promised new tools for forecasting infectious disease dynamics, but little of that research is currently being applied in practice, because tools do not address key public health needs, do not produce probabilistic forecasts, have not been evaluated on external data, or do not provide sufficient forecast skill to be useful. We developed an open collaborative forecasting challenge to assess probabilistic forecasts for seasonal epidemics of dengue, a major global public health problem. Sixteen teams used a variety of methods and data to generate forecasts for 3 epidemiological targets (peak incidence, the week of the peak, and total incidence) over 8 dengue seasons in Iquitos, Peru and San Juan, Puerto Rico.

Questioning Estimates of Natural Pandemic Risk.

The central argument in this article is that the probability of very large natural pandemics is more uncertain than either previous analyses or the historical record suggest. In public health and health security analyses, global catastrophic biological risks (GCBRs) have the potential to cause "sudden, extraordinary, widespread disaster," with "tens to hundreds of millions of fatalities." Recent analyses focusing on extreme events presume that the most extreme natural events are less likely than artificial sources of GCBRs and should receive proportionately less attention.

SiDMAP: a metabolomics approach to assess the effects of drug candidates on the dynamic properties of biochemical pathways.

The postgenomic era in drug development is characterised by a need to describe and predict the functional actions of a given compound within the complex systems of the organism. Recent advances in analytical and computational techniques have given rise to a new and powerful tool for the measurement of biochemical pathways in cells, animals and humans. The stable isotope dynamic metabolic profiling (SiDMAP) assay measures the flow of molecules through complex metabolic pathways, rather than just measuring the gene or protein in isolation.