Global challenges of implementing human papillomavirus vaccines

Human Papillomavirus vaccines are widely hailed as a sweeping pharmaceutical innovation for the universal benefit of all women. The implementation of the vaccines, however, is far from universal or equitable. Socio-economically marginalized women in emerging and developing, and many advanced economies alike, suffer a disproportionately large burden of cervical cancer. Despite the marketing of Human Papillomavirus vaccines as the solution to cervical cancer, the market authorization (licensing) of the vaccines has not translated into universal equitable access. Vaccine implementation for vulnerable girls and women faces multiple barriers that include high vaccine costs, inadequate delivery infrastructure, and lack of community engagement to generate awareness about cervical cancer and early screening tools. For Human Papillomavirus vaccines to work as a public health solution, the quality-assured delivery of cheaper vaccines must be integrated with strengthened capacity for community-based health education and screening

Tissue-specific regulation of sirtuin and nicotinamide adenine dinucleotide biosynthetic pathways identified in C57Bl/6 mice in response to high-fat feeding

Funding: The Scottish Government's Rural and Environment Science and Analytical Services Division.Peer reviewedPostprin

Global vaccine safety blueprint: the landscape analysis (survey of regulators)

The perspectives of regulatory licensing authorities were assessed in countries that produce, procure, and both produce and procure vaccines. A web-based survey was developed to explore regulators’ knowledge, attitudes and practices concerning their national vaccine safety system. Additionally, their opinions about what would be needed to ensure future capacity and capabilities for a global vaccine safety system were probed, along with models of collaboration for regulatory authorities and the private sector that address public safety issues

From Sandbox to Pandemic: Agile Reform of Canadian Drug Regulation

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new agile licensing framework known as the Advanced Therapeutic Pathway (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada’s COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID- 19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amend- ments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement

Risks of nutrigenomics and nutrigenetics? What the scientists say

Nutrigenomics and nutrigenetics (hereafter NGx) have stimulated expectations for beneficial applications in public health and individuals. Yet, the potential achievability of such promise is not without socioethical considerations that challenge NGx implementation. This paper focuses on the opinions of NGx researchers about potential risks raised by NGx. The results of an online survey show that these researchers (n = 126) are fairly confident about the potential benefits of NGx, and that most downplay its potential risks. Researchers in this field do not believe that NGx will reconfigure foods as medication or transform the conception of eating into a health hazard. The majority think that NGx will produce no added burden on individuals to get tested or to remain compliant with NGx recommendations, nor that NGx will threaten individual autonomy in daily food choice. The majority of researchers do not think that NGx will lead to discrimination against and/or stigmatization of people who do not comply with NGx dietary recommendations. Despite this optimism among NGx researchers, we suggest that key risk factors raised by the socioethical context in which NGx applications will be implemented need to be considered

Inter-individual variation in postprandial glycaemic responses in women co-ingesting green leafy vegetables with a carbohydrate meal : interactions with the sirtuin system

The authors acknowledge the support of the Scottish Government Rural and Environment Science and Analytical Services (RESAS) Strategic Research Programme. Clinical biochemistry lab at the Foresterhill hospital for analysing sex hormone samples, Human Nutrition Unit staff and analytical staff and the Rowett Institute, University of Aberdeen and Alex Stewart for providing the compositional information for the meal interventions used. Finally, we would like to thank the volunteers participating in VegGI study. Open access via Wiley agreementPeer reviewedPublisher PD

BOOSTing Patient Mobility and Function on a General Medical Unit by Enhancing Interprofessional Care

Low mobility during hospitalization remains prevalent despite associated negative consequences. The goal of this quality improvement (QI) project was to increase patient mobility and function by adding a physical therapist (PT) to an existing interprofessional care team. A mobility technician assisted treatment group patients with mobility during hospitalization based on physical therapist recommendations. Change in functional status and highest level of mobility achieved by treatment group patients was measured from admission to discharge. Observed hospital length of stay (LOS), LOS index, and 30-day all cause hospital readmission comparisons between treatment group and a comparison group on the same unit, and between cross-sectional comparison groups one year prior were used for Difference in Difference analysis. Bivariate comparisons between the treatment and a cross-sectional comparison group from one year prior showed a statistically significant change in LOS Index. No other bivariate comparisons were statistically significant. Difference in Difference methods showed no statistically significant change in observed LOS, LOS Index, or 30-day readmission. Patients in the treatment group had statistically significant improvements in functional status and highest level of mobility achieved. Physical function and mobility improved for patients who participated in mobility sessions. Mobility technicians may contribute to improved care quality and patient safety in the hospital

Royal society of Canada COVID-19 report: Enhancing COVID-19 vaccine acceptance in Canada

COVID-19 vaccine acceptance exists on a continuum from a minority who strongly oppose vaccination, to the moveable middle heterogeneous group with varying uncertainty levels about acceptance or hesitancy, to the majority who state willingness to be vaccinated. Intention for vaccine acceptance varies over time. COVID-19 vaccination decisions are influenced by many factors including knowledge, attitudes, and beliefs; social networks; communication environment; COVID-19 community rate; cultural and religious influences; ease of access; and the organization of health and community services and policies. Reflecting vaccine acceptance complexity, the Royal Society of Canada Working Group on COVID-19 Vaccine Acceptance developed a framework with four major factor domains that influence vaccine acceptance (people, communities, health care workers; immunization knowledge; health care and public health systems including federal/provincial/territorial/indigenous factors) - each influencing the others and all influenced by education, infection control, extent of collaborations, and communications about COVID-19 immunization. The Working Group then developed 37 interrelated recommendations to support COVID vaccine acceptance nested under four categories of responsibility: 1. People and Communities, 2. Health Care Workers, 3. Health Care System and Local Public Health Units, and 4. Federal/Provincial/Territorial/Indigenous. To optimize outcomes, all must be engaged to ensure co-development and broad ownership

A Brief Measure of Fidelity for Mindfulness Programs: Development and Evaluation of the Concise Fidelity for Mindfulness-Based Interventions Tool

BackgroundMindfulness research and clinical programs are widespread, and it is important that mindfulness-based interventions are delivered with fidelity, or as intended, across settings. The MBI:TAC is a comprehensive system for assessing teacher competence, yet it can be complex to implement. A standardized, simple fidelity/engagement tool to address treatment delivery is needed.ObjectiveWe describe the development, evaluation, and outcomes of a brief, practical tool for assessing fidelity and engagement in online mindfulness-based programs. The tool contains questions about session elements such as meditation guidance and group discussion, and questions about participant engagement and technology-based barriers to engagement.MethodsThe fidelity rating tool was developed and tested in OPTIMUM, Optimizing Pain Treatment in Medical settings Using Mindfulness. The OPTIMUM study is a 3-site pragmatic randomized trial of group medical visits and adapted mindfulness-based stress reduction for primary care patients with chronic low back pain, delivered online. Two trained study personnel independently rated 26 recorded OPTIMUM sessions to determine inter-rater reliability of the Concise Fidelity for Mindfulness-Based Interventions (CoFi-MBI) tool. Trained raters also completed the CoFi-MBI for 105 sessions. Raters provided qualitative data via optional open text fields within the tool.ResultsInter-rater agreement was 77-100% for presence of key session components, and 69-88% for Likert ratings of participant engagement and challenges related to technology, with discrepancies only occurring within 2 categories: ‘very much’ and ‘quite a bit’. Key session components occurred as intended in 94-100% of the 105 sessions, and participant engagement was rated as ‘very much’ or ‘quite a bit’ in 95% of the sessions. Qualitative analysis of rater comments revealed themes related to engagement challenges and technology failures.ConclusionThe CoFi-MBI provides a practical way to assess basic adherence to online delivery of mindfulness session elements, participant engagement, and extent of technology obstacles. Optional text can guide strategies to improve engagement and reduce technology barriers

Coordinated Regulation of SIV Replication and Immune Responses in the CNS

Central nervous system (CNS) invasion during acute-stage HIV-infection has been demonstrated in a small number of individuals, but there is no evidence of neurological impairment at this stage and virus infection in brain appears to be controlled until late-stage disease. Using our reproducible SIV macaque model to examine the earliest stages of infection in the CNS, we identified immune responses that differentially regulate inflammation and virus replication in the brain compared to the peripheral blood and lymphoid tissues. SIV replication in brain macrophages and in brain of SIV-infected macaques was detected at 4 days post-inoculation (p.i.). This was accompanied by upregulation of innate immune responses, including IFNβ, IFNβ-induced gene MxA mRNA, and TNFα. Additionally, IL-10, the chemokine CCL2, and activation markers in macrophages, endothelial cells, and astrocytes were all increased in the brain at four days p.i. We observed synchronous control of virus replication, cytokine mRNA levels and inflammatory markers (MHC Class II, CD68 and GFAP) by 14 days p.i.; however, control failure was followed by development of CNS lesions in the brain. SIV infection was accompanied by induction of the dominant-negative isoform of C/EBPβ, which regulates SIV, CCL2, and IL6 transcription, as well as inflammatory responses in macrophages and astrocytes. This synchronous response in the CNS is in part due to the effect of the C/EBPβ on virus replication and cytokine expression in macrophage-lineage cells in contrast to CD4+ lymphocytes in peripheral blood and lymphoid tissues. Thus, we have identified a crucial period in the brain when virus replication and inflammation are controlled. As in HIV-infected individuals, though, this control is not sustained in the brain. Our results suggest that intervention with antiretroviral drugs or anti-inflammatory therapeutics with CNS penetration would sustain early control. These studies further suggest that interventions should target HIV-infected individuals with increased CCL2 levels or HIV RNA in the CNS