The Evolution of United States Governance Policies for Research Using Pathogens with Enhanced Pandemic Potential.

Brain banking as a cornerstone of neuroscience in China

Research on highly pathogenic organisms is crucial for medicine and public health, and we strongly support it. This work creates a foundation of new knowledge that provides critical insights around the world’s most deadly infectious diseases, and it can lay groundwork for the future development of new diagnostics, medicines, and vaccines. Almost all such research can be performed in ways that pose negligible or no risk of epidemic or global spread of a novel pathogen. However, research that aims to create new potential pandemic pathogens (PPP) (1)—novel microbes that combine likely human virulence with likely efficient transmission in humans—is an exception to that rule. While this research represents a tiny portion of the experimental work done in infectious disease research, it poses extraordinary potential risks to the public. Experiments that create the possibility of initiating a pandemic should be subject to a rigorous quantitative risk assessment and a search for safer alternatives before they are approved or performed. Yet a rigorous and transparent risk assessment process for this work has not yet been established. This is why we support the recently announced moratorium on funding new “gain-offunction” (GOF) experiments that enhance mammalian transmissibility or virulence in severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and influenza viruses. This realm of work roughly corresponds with the work we have termed PPP above. Because the term “gain of function” in other contexts can be used to describe techniques of scientific research that have nothing to do with the creation of novel potential pandemic pathogens, we think the term can be too broad and can mislead. Throughout this commentary, we focus on research designed to create PPP strains of influenza virus, the type of research that initially attracted attention, leading to the moratorium and for which the most discussion has already occurred. Other types of gain-of-function research on influenza and studies intended to enhance pathogenicity or transmissibility of MERS and SARS coronaviruses may or may not fit the definition of PPP research and further clarification is needed and ongoing. As we discuss near the end of this article, it will be essential to clarify the different risks and benefits entailed by different types of experiments covered by the funding pause (2). The purpose of this research funding pause is to complete “a robust and broad deliberative process . . . that results in the adoption of a new [U.S. Government] gain-of-function research policy” (3). The moratorium would stop new funding for the following:

Is regulation preventing the development of therapeutics that may prevent future coronavirus pandemics?

A panel discussion between representatives of four major government funding agencies (Air Force Office of Scientific Research, Department of Energy, National Science Foundation, and Office of Naval Research) and the magnetism research community was held concerning the role of government research funding in the field of magnetism. The program consisted of presentations by each of the four agency representatives and a response by a representative of the university research community. The floor was then opened for comments and questions by the audience. This article summarizes both the prepared presentations and the response of the audience.

According to the WHO, dual use research of concern (DURC) is "life sciences research that is intended for benefit, but which might easily be misapplied to do harm". Recent studies, particularly those on influenza viruses, have led to renewed attention on DURC, as there is an ongoing debate over whether the benefits of gain-of-function (GOF) experiments that result in an increase in the transmission and/or pathogenicity of potential pandemic pathogens (PPPs) are outweighed by concerns over biosecurity and biosafety. In this Viewpoint article, proponents and opponents of GOF experiments discuss the benefits and risks associated with these studies, as well as the implications of the current debate for the scientific community and the general public, and suggest how the current discussion should move forward.

Humanity’s history contains many pandemic reports and now the scientific community has the possibility to identify the pathogens before the disease emergency. In this perspective, it is essential to carry out large-scale epidemiological studies in key animals that are in constant contact with humans. For this, the next generation sequencing (NGS) by the metagenomic approach—genetic material recovered directly from samples without previous amplification—is able to reveal the hidden microbial diversity. Metagenomes’ work aims to contribute to the facilitation of epidemiological studies through the adoption of simple effective strategies for the pathogens’ identification, understanding the evolutionary dynamic of them before the pandemic time. Here, we have presented some examples related to the successful metagenomic approaches and the continuous advice of the researchers to identify viruses and other possible pandemic pathogens.

Globalization propelled human migration and commercial exchanges at the global level, but woefully led to the introduction of non-indigenous organisms into several agroecological systems. These include pathogenic bacteria with devastating consequences for numerous crops of agronomical importance for food production worldwide. In the last decade, research efforts have focused on these noxious organisms, aiming to understand their evolutionary processes, degree of pathogenicity, and mitigation strategies, which have allowed stakeholders and policymakers to develop evidence-based regulatory norms to improve management practices and minimize production losses. One of these cases is the bacterium Pseudomonas syringae pv. actinidiae (Psa), the causal agent of the kiwifruit bacterial canker, which has been causing drastic production losses and added costs related to orchard management in the kiwifruit industry. Although Psa is presently considered a pandemic pathogen and far from being eradicated, the implementation of strict regulatory norms and the efforts employed by the scientific community allowed the mitigation, to some extent, of its negative impacts through an integrated pest management approach. This included implementing directive guidelines, modifying cultural practices, and searching for sources of plant resistance. However, bacterial pathogens often have high spatial and temporal variability, with new strains constantly arising through mutation, recombination, and gene flow, posing constant pressure to agroecosystems. This review aims to critically appraise the efforts developed to mitigate bacterial pathogens of agronomical impact, from orchard management to genome analysis, using Psa as a case study, which could allow a prompter response against emerging pathogens in agroecosystems worldwide.

In 2017, the Department of Health and Human Services adopted a policy, known as the P3CO Framework, to govern proposed research that could enhance the lethality or transmissibility of a potential pandemic pathogen. The prospect of a human-made virus with artificially enhanced lethality and transmissibility has raised serious biosafety and biosecurity concerns. The COVID-19 pandemic has generated new concerns about the risks posed by such research. Even if the origins of the pandemic are presumed or proven to be the result of a natural zoonotic spillover event, the pandemic has placed greater scrutiny on research that could generate pandemic-capable viruses and dramatically illustrated the consequences if such a virus were released from a laboratory. This article assesses the strengths and weaknesses of the P3CO Framework and provides recommendations for strengthening oversight of research with potential pandemic pathogens. The P3CO Framework should be replaced by a national policy that would apply to all relevant research, regardless of the source of funding and be implemented by a new national agency for biorisk management. This new policy would need to be accompanied by a comprehensive analysis of potential pandemic pathogen risks, clear guidance on how to identify research that falls within the scope of the policy, a rigorous process for reviewing the risks and benefits of such research, and criteria for determining the appropriate measures needed to conduct such research safely, securely, and responsibly.

ABSTRACTOysters play an important role in coastal ecology and are a globally popular seafood source. However, their filter-feeding lifestyle enables coastal pathogens, toxins, and pollutants to accumulate in their tissues, potentially endangering human health. While pathogen concentrations in coastal waters are often linked to environmental conditions and runoff events, these do not always correlate with pathogen concentrations in oysters. Additional factors related to the microbial ecology of pathogenic bacteria and their relationship with oyster hosts likely play a role in accumulation but are poorly understood. In this study, we investigated whether microbial communities in water and oysters were linked to accumulation of Vibrio parahaemolyticus, Vibrio vulnificus, or fecal indicator bacteria. Site-specific environmental conditions significantly influenced microbial communities and potential pathogen concentrations in water. Oyster microbial communities, however, exhibited less variability in microbial community diversity and accumulation of target bacteria overall and were less impacted by environmental differences between sites. Instead, changes in specific microbial taxa in oyster and water samples, particularly in oyster digestive glands, were linked to elevated levels of potential pathogens. For example, increased levels of V. parahaemolyticus were associated with higher relative abundances of cyanobacteria, which could represent an environmental vector for Vibrio spp. transport, and with decreased relative abundance of Mycoplasma and other key members of the oyster digestive gland microbiota. These findings suggest that host and microbial factors, in addition to environmental variables, may influence pathogen accumulation in oysters.IMPORTANCE Bacteria in the marine environment cause thousands of human illnesses annually. Bivalves are a popular seafood source and are important in coastal ecology, but their ability to concentrate pathogens from the water can cause human illness, threatening seafood safety and security. To predict and prevent disease, it is critical to understand what causes pathogenic bacteria to accumulate in bivalves. In this study, we examined how environmental factors and host and water microbial communities were linked to potential human pathogen accumulation in oysters. Oyster microbial communities were more stable than water communities, and both contained the highest concentrations of Vibrio parahaemolyticus at sites with warmer temperatures and lower salinities. High oyster V. parahaemolyticus concentrations corresponded with abundant cyanobacteria, a potential vector for transmission, and a decrease in potentially beneficial oyster microbes. Our study suggests that poorly understood factors, including host and water microbiota, likely play a role in pathogen distribution and pathogen transmission.

Research and patient communities were shocked by a federal judge’s decision that all US government funding for research using embryonic stem cells is to be blocked with immediate effect, pending...

Nipah virus (NiV) is a highly pathogenic paramyxovirus characterized by zoonotic infection, high mortality, and a lack of effective treatment, posing a serious threat to global public health security. Currently, it still lacks specific treatments or approved vaccines, and is listed as a potential pandemic threat pathogen by the World Health Organization. This paper systematically reviews the core progress and challenges of NiV investigation, with a focus on the development of animal models, vaccine development strategies, treatment strategy, and bottlenecks in translational medicine. Additionally, we discuss the strengths and limitations of existing animal models, including ferrets, hamsters, mice, and non-human primates (NHPs), and assess advances in vaccine platforms such as viral vectors, subunit vaccines, and mRNA-based vaccine candidates. The paper critically reviews the challenges facing translational research, conservation correlates, and outbreak preparedness, while also providing future research directions for pandemic preparedness and public health security strategies.

Public Access: Bringing It All Back Home Heather Joseph (bio) With the emergence of policies calling for rapid, unfettered access to the results of federally funded research, the notion of academic and research libraries providing "public access" to information has taken on an important new meaning. The traditional usage of the phrase referred to providing services to walk-in patrons. The new usage suggests the opportunity for anyone to have free, unrestricted, online access to final, peer-reviewed article manuscripts stemming from government-funded research. This is more than a simple change in definition. It reflects the larger transformation of information access in the time of the Internet. In addition, it is a tip-off that libraries are on the cusp of new opportunities and challenges in actively facilitating the research process. The alternate meaning of public access burst onto the scene in 2004 with the announcement of a National Institutes of Health (NIH) policy proposal entitled, "Enhanced Public Access to NIH Research Information."1 However, this was not just another routine government agency announcement. In a fundamental way, it spoke to the advancement of science in the age of the Internet. The NIH director, Elias Zerhouni, personally played a pivotal role in the development of the policy, which was an outgrowth of years of community discussion, going back at least to a May 1999 proposal by then-NIH Director Harold Varmus.2 With the weight of NIH and a continually growing group of advocates supporting the idea, public access has steadily progressed since 2004. The concept of public access, with its practical implications for the future of scientific inquiry, has quickly spread beyond NIH—and beyond the United States. As this is being written, • The U.S. Senate is considering legislation (the Federal Research Public Access Act, S. 2695) that would require public access to research from all major federal funding agencies. • The European Commission's primary recommendation in its study of scientific publishing is that public access to publicly funded research results should be guaranteed. [End Page 1] • The Canadian Institutes of Health Research is exploring similar ways to increase access to the discoveries made by their funded researchers and, in so doing, "stimulate the development of new health products that will benefit the health of Canadians as well as the global population."3 • In the United Kingdom, four of eight government research-funding councils have mandated open online availability of research outputs. • In the Ukraine, the national parliament has recommended implementing a policy mandating immediate open access to the results of government-funded research. • The Deutsche Forschungsgemeinschaft (German Research Foundation, DFG) announced that it expects the research results it funds "to be published and to be made available, where possible, digitally and on the Internet via open access."4 Why has the requirement for public access spread so quickly across so many geopolitical boundaries? In the age of the Internet, at a time when governments are investing vast sums in research on increasingly complex scientific challenges, progress is slowed by business-as-usual policies. Because scientific discovery is cumulative—with new knowledge building on earlier findings—wide, barrier-free, and rapid sharing of research on the Internet will make the scientific process faster and more efficient. It will spur innovation and discovery not only by simply investing more money but also by enabling better and broader use of the research in which taxpayers have already invested. Scientists routinely work across national boundaries. With public access (also referred to as "taxpayer access"), taxpayer returns are enhanced when the international, collaborative process of science becomes less restrictive and more open, when sharing is facilitated within and beyond nations' borders. This is true for research taking place anywhere in the world. The benefits of Internet sharing of research results are intuitively obvious to many beyond the scientific community. As Pennsylvania Congressman Mike Doyle recently said of public access at a congressional hearing, To be honest, I didn't know it wasn't already the law. …There's just no better way to put it—it's not right. The American taxpayer paid for [NIH] research—they'll pay nearly 30 billion dollars next year alone—and they are entitled to...

Offline: Scientific publishing—trust and tribulations

SummaryThis study is an initial description and discussion of the kidney and liver microbial communities of five common fish species sampled from four sites along the Eastern Mediterranean Sea shoreline. The goals of the present study were to establish a baseline dataset of microbial communities associated with the tissues of wild marine fish, in order to examine species‐specific microbial characteristics and to screen for candidate pathogens. This issue is especially relevant due to the development of mariculture farms and the possible transmission of pathogens from wild to farmed fish and vice versa. Although fish were apparently healthy, 16S rRNA NGS screening identified three potential fish bacterial pathogens: Photobacterium damselae, Vibrio harveyi and Streptococcus iniae. Based on the distribution patterns and relative abundance, 16 samples were classified as potential pathogenic bacteria‐infected samples (PPBIS). Hence, PPBIS prevalence was significantly higher in kidneys than in liver samples and variation was found between the fish species. Significant differences were observed between fish species, organs and sites, indicating the importance of the environmental conditions on the fish microbiome. We applied a consistent sampling and analytical method for monitoring in long‐term surveys which may be incorporated within other marine fish pathogens surveys around the world.

Vaginal colonization by pathogenic bacteria increases the risk of bacterial infections such as sepsis, which is associated with high neonatal mortality. More than half a million newborn deaths occur globally each year due to infections that lead to sepsis. However, the problem is worsening in Ethiopia the evidence of vaginal colonization and vertical transmission is scarce. A healthcare facility-based cross-sectional study was conducted in Dessie town from April 1 to June 30, 2023, among 348 pregnant women and their newborns. Socio-demographic, clinical, and related data were collected using a pre-tested semi-structured questionnaire. Vaginal swab samples from pregnant women and pooled external ear, nasal area, and umbilical swab samples from the newborns were collected and transported using Amies transport media. Samples were inoculated into blood agar, Todd Hewitt selective enrichment broth, and MacConkey agar for bacterial isolation, and Sabouraud Dextrose Agar and CHROM Agar for Candida species isolation. The antimicrobial susceptibility was performed on isolates using the Kirby-Bauer disc diffusion technique. Data was analyzed by SPSS version 25.0. Logistic regression model was used to identify the associated factors. Finally, variables with p < 0.05 and their 95% confidence interval were considered statistically significant. A total of 348 pregnant women attending vaginal delivery were included in the study. The maternal colonization and vertical transmission rates were 55.5% (193/348) and 53.9% (104/348), respectively. The most frequent potential pathogen among pregnant women was Escherichia coli (27.6%), followed by Candida spp. (14.1%), and Klebsiella spp. (6%). Similarly, the predominant isolates in the newborns were E. coli (16.4%), Candida spp. (6.3%), and Klebsiella spp. (3.6%). The overall multidrug resistance levels of potential pathogens were 37.3%. Living with domestic animals (p = 0.001), having premature rupture of membrane (p = 0.010) and history of urinary tract infection (p = 0.013) were significantly associated with maternal colonization. Potential pathogen colonization newborn was significantly associated with duration of labor (p = 0.024) and low birth weight (p < 0.001). The finding of the present study revealed that vaginal colonization and vertical transmissions of potential pathogens and their antimicrobial resistance is still a significant problem. This alarms the urgency of evidence based-intervention to improve maternal and neonatal health.