The contribution of field efficacy studies to the evaluation of applications for veterinary vaccines evaluated through the European Union centralised authorisation procedure.

To examine the contribution that field efficacy studies made to the assessment of marketing authorisation (MA) applications, a retrospective analysis was conducted for 100 veterinary vaccines that had been evaluated by the European Medicines Agency (EMA) between 1996 and 2017. For 52 veterinary vaccines, scrutiny of the European Public Assessment Report (EPAR) and/or the summary of product characteristics (SPC) identified objective evidence that field efficacy studies made an important or substantial impact on the efficacy claims and/or benefit-risk evaluation. For 24 applications, the contribution of field efficacy studies was classified as either supportive or was not detectable from the publicly available documents on which the analysis was based. For a further 24 applications, data exemptions were applied and the MAs were granted in the absence of field studies. The difficulty in achieving challenge in the field was highlighted by the observation that natural exposure was reported in less than half of the applications where field efficacy studies were conducted (34 out of 76). This analysis may help to inform policy decisions on the role, conduct and contribution that field efficacy studies make to the assessment of efficacy for veterinary vaccines.

How to improve access to therapy in hepatitis B patients.

Despite the availability of a preventive vaccine and active antiviral treatments that stop disease progression and reduce the risk of hepatocellular carcinoma, hepatitis B is still a major public health problem. Only an estimated 10% of the 257 million people living with HBV have been diagnosed and as few as 1% are being adequately treated. Barriers to diagnosis and treatment include: (i) limited awareness and lack of knowledge about HBV infection and HBV-related diseases; (ii) under-diagnosis with insufficient screening and referral to care; (iii) limited treatment due to drug availability, costs, reimbursement policies and the need for long-term or life-long therapy. These barriers and the actions needed to improve access to treatment are strongly influenced by the prevalence of infection and affect middle-high vs low-middle income countries differently, where most HBV carriers are found. In high-prevalence regions and low-to middle-income countries, the main challenges are availability and cost while in low-prevalence regions and middle-to high-income countries low screening rates, public awareness, social stigma and discrimination play an important role. Overcoming these challenges on a global scale is a complex clinical and public health challenge and multilateral commitment from pharmaceutical companies, governments, funders and the research community is lacking. The new WHO 2016 Global Health Sector Strategy on viral hepatitis targets testing and treatment, suggesting that important but strong actions are needed from advocacy groups, scientific societies and funding agencies to foster awareness and access to cure.

Lessons from a decade of adult vaccine rollout in low- and middle-income countries: a scoping review.

INTRODUCTION: The historical focus of vaccines on child health coupled with the advent of novel vaccines targeting adult populations necessitates exploring strategies for adult vaccine implementation. AREAS COVERED: This scoping review extracts insights from the past decade's experiences introducing adult vaccines in low- and middle-income countries. Among 25 papers reviewed, 19 focused on oral cholera vaccine, 2 on Meningococcal A vaccines, 2 on tetanus toxoid vaccine, 1 on typhoid vaccine, and 1 on Ebola vaccine. Aligned with WHO's Global Framework for New TB Vaccines for Adults and Adolescents, our findings center on vaccine availability, accessibility, and acceptance. EXPERT OPINION: Availability findings underscore the importance of understanding disease burden for prioritization, multi-sectoral collaboration during planning, and strategic resource allocation and coordination. Accessibility results highlight the benefits of leveraging existing health infrastructure and adequately training healthcare workers, and contextually tailoring vaccine delivery approaches to reach challenging sub-groups like working male adults. Central to fostering acceptance, resonant sensitization, and communication campaigns engaging the communities and utilizing trusted local leaders countered rumors and increased awareness and uptake. As we approach the introduction of a new adult TB vaccine, insights from this review equips decision-makers with key evidence-based recommendations to support successful and equitable vaccinations targeting adults.

Practices, Attitudes, and Knowledge Regarding Recombinant Zoster Vaccine Among Family Medicine Residents in Riyadh, Saudi Arabia.

Background The aim of the research is to determine the existing knowledge, perceived practices, and attitudes toward the recombinant Zoster vaccine among family medicine residents (FMR) included in the medical profession. The present study aims to narrow down the identified gap in knowledge and develop vaccinations that will assist the targeted deme to eradicate zoster and the aftermaths that accompany it. Methods This research utilizes a descriptive cross-sectional survey design to assess the knowledge, practices, and attitudes of FMR toward the zoster vaccine in Riyadh, Saudi Arabia. By quantifying data at a specific point in time, this design allows for a detailed examination of the current status across various levels of residency programs. Participants from different institutions are interviewed simultaneously, enabling a thorough study of the targeted population group. The study includes 154 FMR from three different levels (R1, R2, R3) enrolled in residency programs at various institutions in Riyadh, Saudi Arabia. These participants were selected from a group of individuals invited to share their prior knowledge, habits, and beliefs regarding the recombinant Zoster vaccine. The study offers detailed statistical insights into demographics, vaccination attitudes, and knowledge among healthcare professionals. Key findings highlight diverse recommendations for different adult groups, the prevalence of vaccine availability, and the main sources of immunization information. Results The study found diverse recommendations for vaccination among different adult groups, with mean recommendations ranging from 2.50 to 2.94. Nearly all respondents (96.8%) reported having the vaccine available at their place of practice. However, knowledge gaps were evident, particularly concerning vaccination timing and specific requirements, highlighting the need for targeted education and clearer guidelines in vaccination practices among healthcare providers. Conclusion The study highlights the nuanced vaccination recommendations among healthcare professionals, particularly for different adult populations, and the availability of varicella-zoster virus (VZV) vaccines. The reliance on diverse information sources underscores the need for targeted educational efforts to ensure accurate and consistent immunization practices across healthcare settings. Addressing uncertainties and promoting informed decision-making can enhance vaccination uptake and patient care outcomes in clinical practice.

Improving the availability of vaccines in primary healthcare facilities in South Africa: is the time right for a system redesign process?

An uninterrupted supply of vaccines at different supply chain levels is a basic component of a functional immunization programme and care service. There can be no progress toward achieving universal health coverage and sustainable development without continuous availability of essential medicines and vaccines in healthcare facilities. Shortages of vaccines, particularly at health facility level is an issue of grave concern that requires urgent attention in South Africa. The causes of vaccine stock-outs are multifactorial and may be linked to a broader systems issue. These factors include challenges at higher levels such as delays in the delivery of stock from the pharmaceutical depot; health facility level factors, which include a lack of commitment from healthcare workers and managers; human resource factors, such as, staff shortages, and lack of skilled personnel. Therefore, there is a compelling need to address the factors associated with shortages of vaccines in health facilities. This paper highlights the challenges of vaccine availability in South Africa, the associated factors, the available interventions, and recommended interventions for the expanded programme on immunization in South Africa. We propose a system redesign approach as a potentially useful intervention.

The association of COVID-19 vaccine availability with mental health among adults in the United States.

Objective: To assess whether COVID-19 vaccine approval and availability was associated with reduction in the prevalence of depression and anxiety among adults in the United States. Methods: We adopted cross sectional and quasi-experimental design with mental health measurements before vaccine availability (June 2020, N = 68,009) and after vaccine availability (March 2021, N = 63,932) using data from Census Pulse Survey. Depression and anxiety were derived from PHQ-2 and GAD-2 questionnaires. We compared rates of depression and anxiety between June 2020 and March 2021. Unadjusted and adjusted analysis with replicate weights were conducted. Results: Depression prevalence was 25.0% in June 2020 and 24.6% in March 2021; anxiety prevalence was 31.7% in June 2020 and 30.0% in March 2021 in the sample. In adjusted analysis, there were no significant differences in likelihood of depression and anxiety between June 2020 and March 2021. Conclusion: Depression and anxiety were not significantly different between June 2020 and March 2021, which suggests that the pandemic effect continues to persist even with widespread availability of vaccines.

Model-Based Planning and Delivery of Mass Vaccination Campaigns against Infectious Disease: Application to the COVID-19 Pandemic in the UK.

Vaccination plays a key role in reducing morbidity and mortality caused by infectious diseases, including the recent COVID-19 pandemic. However, a comprehensive approach that allows the planning of vaccination campaigns and the estimation of the resources required to deliver and administer COVID-19 vaccines is lacking. This work implements a new framework that supports the planning and delivery of vaccination campaigns. Firstly, the framework segments and priorities target populations, then estimates vaccination timeframe and workforce requirements, and lastly predicts logistics costs and facilitates the distribution of vaccines from manufacturing plants to vaccination centres. The outcomes from this study reveal the necessary resources required and their associated costs ahead of a vaccination campaign. Analysis of results shows that by integrating demand stratification, administration, and the supply chain, the synergy amongst these activities can be exploited to allow planning and cost-effective delivery of a vaccination campaign against COVID-19 and demonstrates how to sustain high rates of vaccination in a resource-efficient fashion.

A scoping review of interventions for vaccine stock management in primary health-care facilities.

One of the challenges facing the success of immunization programs is shortages of vaccines at health facilities, which could result from inadequate vaccine stock management. Several approaches have been designed by countries to improve vaccine stock management. This review summarizes currently available information on interventions for vaccine stock management.We considered both randomized trials and non-randomized studies eligible for inclusion in this review. The following databases were searched: PubMed, Embase, Cochrane Central Register of Controlled Trials, World Health Organization Library Information System, Web of Science, and PDQ-Evidence. We searched the websites of the World Health Organization, Global Alliance for Vaccine and Immunization, PATH's Vaccine Resources Library, and United Nations Children's Fund. The reference lists of all the included studies were also searched. Two authors independently screened search outputs, reviewed full texts of potentially eligible articles, evaluated risk of bias, and extracted data; resolving disagreements through consensus.Four studies met our inclusion criteria (three before-after studies and one randomized trial). Three studies were conducted in low- and middle-income countries while one was conducted in Canada (a high-income country). All the studies had various limitations and were classified as having a high risk of bias. Study findings suggest that the use of digital information systems to improve information and stock visibility, coupled with other interventions (such as training of health-care workers on the use of innovative tools and redesign of the supply chain to tackle certain bottlenecks), has the potential to increase vaccine availability, reduce response times, and improve the quality of vaccine records.

Protocol for a systematic review of the effects of interventions for vaccine stock management.

BACKGROUND: Inadequate vaccine stock management in health facilities leads to vaccine stock-outs. The latter threatens the success of immunisation programmes. Countries have used various approaches to reduce stock-outs and improve vaccine availability, but we are not aware of a systematic review of these interventions. This protocol describes the methods we will use to assess the effects of existing approaches for improving vaccine stock management. METHODS: We include randomised and non-randomised studies identified through a compehensive search of peer-reviewed and grey literature databases. We will search PubMed, Cochrane Central Register of Controlled Trials, Embase, Web of Science, PDQ-Evidence and Scopus. We will also search websites of the World Health Organisation (WHO), Global Alliance for Vaccine and Immunisation, PATH Vaccine Resources Library and United Nations Children's Fund. In addition, we will search the WHO International Clinical Trials Registry Platform and reference lists of included studies and relevant reviews. Finally, we plan to do a citation search for included studies. We will use Cochrane recommended methods to screen search outputs, assess study eligibility and risk of bias, extract and analyse study results. We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool to assess the certainty of the evidence on the effects of the interventions. DISCUSSION: We believe that the findings of this review will serve as valuable information for policy makers on ways to improve vaccine stock management and vaccine availability. When vaccine availability is improved, those who need them, especially children, will be adequately protected from vaccine-preventable diseases. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018092215.

Influenza vaccine availability at urgent care centers in the state of Arizona.

We surveyed urgent care centers (UCCs) in the state of Arizona to determine whether they offered the influenza vaccine during the 2016-2017 influenza season. Overall vaccine availability was 80.3% at these facilities. During this season, one-third of the UCCs offered influenza vaccination to children 6 months or older; approximately two-thirds offered influenza vaccination to children and young adults 16 years or older. This is the first study of influenza vaccine availability at UCCs.