Search Results (31)

CEPI (the Coalition for Epidemic Preparedness Innovation)’s CMC rapid response framework is developed to support accelerated vaccine development, manufacturing, and roll-out for various outbreak scenarios to achieve the 100 Days Mission. The framework outlines coordinated deliverables across five functional areas: manufacturing processes, formulation, analytics, supply chain, and facilities. It could serve as a tool to streamline CMC and the related activities for rapid vaccine development, identify areas for improvement and innovation, and assess preparedness for the outbreak response. The framework emphasizes the importance of thorough preparation during interpandemic periods as the foundation for the 100 Days Mission and for gaining the confidence of health authorities and the public in vaccines. Full article

Central Environmental Protection Inspection (CEPI) is a major step in China’s environmental vertical supervision reform. With the multi-period Difference-in-Differences method, we assess the impact of CEPI on enterprise green transformation. In addition, we further explore the impact of enterprise environmental self-discipline. The results show that CEPI significantly promotes enterprise green transformation, and this effect on governance is further strengthened by environmental self-discipline. The synergistic governance effect of compound environmental regulation is pronounced, particularly in enterprises lacking government–enterprise relationships and in areas covered by CEPI “look back” initiatives and where local governments rigorously enforce environmental laws. The mechanism analysis reveals that CEPI mainly promotes enterprise green transformation by improving executive green cognition, boosting investment in environmental protection, and enhancing green innovation efficiency. This study provides a fresh perspective on analyzing the governance impact of CEPI and provides valuable insights for improving multi-collaborative environmental governance systems. Full article

Background/Objectives: An initial COVID-19 candidate vaccine containing a purified ancestral SARS-CoV-2 spike antigen was characterized with an ELISA using recombinant monoclonal antibodies (mAbs) generated against this variant. Upon the emergence of a new Beta (B.1.351) spike variant early in the pandemic, the assessment of a bivalent vaccine containing ancestral and Beta spike antigens began. Due to accelerated project timelines, mAbs generated specifically against the Beta spike antigen were not available at the time to address assay development and vaccine testing requirements. Methods: Using only the initial mAb panel raised against the ancestral spike antigen, an epitope-blocking ELISA strategy was developed to independently measure Beta spike antigen in bivalent vaccine formulations. To facilitate this, epitope profiling of spike antigens from both ancestral and Beta variants was performed with biolayer interferometry and hydrogen–deuterium exchange mass spectrometry using the original panel of mAbs. Results: The resulting blocking ELISA was precise and specific for the Beta spike antigen and detected the expected amount of this antigen in bivalent vaccine formulations. The specific amount of ancestral spike protein in the bivalent vaccine was also confirmed using the original ELISA developed at the onset of the pandemic. Conclusions: This epitope-blocking strategy helped to overcome key reagent availability issues and could be applied to other projects involving related proteins. Full article

Rapid vaccine availability is essential for effective epidemic and pandemic response. Building on the Coalition for Epidemic Preparedness Innovations (CEPI) 100 Days Mission, which aims to have new vaccines ready for initial authorization and manufacturing at scale within 100 days of recognition of a pandemic pathogen, the CEPI has developed a Chemistry, Manufacturing and Controls (CMC) Rapid Response Framework to define technical and logistical CMC requirements to enable rapid vaccine availability. Central to this framework is the availability of adaptable vaccine platforms that can be readily tailored to emerging pathogens. To support strategic decision-making and identify gaps in platform capabilities, CEPI has created the Platform Readiness Dashboard. This tool provides a structured, multi-dimensional initial assessment of platform maturity across six key categories: Adaptability, Compatibility, Suitability, Regulatory, Manufacturing, and Facility Readiness. Each category includes specific technical and operational considerations scored using a color-coded system to reflect outbreak response readiness level. This Dashboard aims to enable vaccine developers, manufacturers, funders, and outbreak response teams to evaluate platform strengths and limitations at any given time, informing funding, preparedness and response activities. By offering a dynamic view of essential platform readiness indicators, the dashboard can communicate progress supporting faster responses to future health emergencies. Full article

Background: Chronic wounds represent a persistent clinical challenge and impose a considerable burden on healthcare systems. These lesions often require multidisciplinary management due to underlying factors such as microbial colonization, impaired immunity, and vascular insufficiencies. Regenerative therapies, particularly autologous approaches, have emerged as promising strategies to enhance wound healing. Adipose tissue-derived stem cells (ADSCs) and platelet-rich plasma (PRP) may improve outcomes through paracrine effects and growth factor release. Methods: A prospective observational study was conducted on 31 patients with chronic wounds that were unresponsive to conservative treatment for over six weeks. Clinical and photographic evaluations were employed to monitor healing. All patients underwent surgical debridement, with adjunctive interventions—negative pressure wound therapy, grafting, or flaps—applied as needed. PRP infiltration and/or autologous adipose tissue transfer were administered based on wound characteristics. Wound area reduction was the primary outcome measure. Results: The cohort included 17 males and 14 females (mean age: 59 years). Etiologies included venous insufficiency (39%), diabetes mellitus (25%), arterial insufficiency (16%), and trauma (16%). Most lesions (84%) were located on the lower limbs. All patients received PRP therapy; five underwent combined PRP and fat grafting. Over the study period, 64% of the patients exhibited >80% wound area reduction, with complete healing in 48.3% and a mean healing time of 49 days. Conclusions: PRP therapy proved to be a safe, effective, and adaptable treatment, promoting substantial healing in chronic wounds. Autologous adipose tissue transfer did not confer additional benefit. PRP may warrant inclusion in national treatment protocols. Full article

The 100-Day Mission, coordinated by the Coalition for Epidemic Preparedness Innovations (CEPI) and endorsed by significant international stakeholders, aims to shorten the timeframe for developing and implementing vaccines to 100 days after the report of a new pathogen. This ambitious goal is outlined as an essential first step in improving pandemic preparedness worldwide. This review highlights the mission’s implementation potential and challenges by examining it through the lens of low- and middle-income countries (LMICs), which often face barriers to equitable vaccine access. This article explores the scientific, economic, political, and social aspects that could influence the mission’s success, relying on lessons learned from previous pandemics, such as the Spanish flu, H1N1, and COVID-19. We also examined important cornerstones like prototype vaccine libraries, accelerated clinical trial preparedness, early biomarkers identification, scalable manufacturing capabilities, and rapid pathogen characterization. The review also explores the World Health Organization (WHO) Pandemic Agreement and the significance of Phase 4 surveillance in ensuring vaccine safety. We additionally evaluate societal issues that disproportionately impact LMICs, like vaccine reluctance, health literacy gaps, and digital access limitations. Without intentional attempts to incorporate under-resourced regions into global preparedness frameworks, we argue that the 100-Day Mission carries the risk of exacerbating already-existing disparities. Ultimately, our analysis emphasizes that success will not only rely on a scientific innovation but also on sustained international collaboration, transparent governance, and equitable funding that prioritizes inclusion from the beginning. Full article

Background: An effective vaccine against Nipah virus (NiV) is crucial due to its high fatality rate and recurrent outbreaks in South and Southeast Asia. Vaccine development is challenged by the lack of validated accessible neutralization assays, as virus culture requires BSL-4 facilities, restricting implementation in resource-limited settings. To address this, we standardized and validated a pseudotyped virus neutralization assay (PNA) for assessing NiV-neutralizing antibodies in BSL-2 laboratories. Methods: The NiV-PNA was validated following international regulatory standards, using a replication-defective recombinant Vesicular stomatitis virus (rVSV) backbone dependent pseudotyped virus. Assessments included sensitivity, specificity, dilutional linearity, relative accuracy, precision, and robustness. The assay was calibrated using the WHO International Standard for anti-NiV antibodies and characterized reference sera to ensure reliable performance. Findings: Preliminary evaluation of the developed NiV-PNA showed 100% sensitivity and specificity across 10 serum samples (5 positive, 5 negative), with a positive correlation to a calibrated reference assay (R² = 0.8461). Dilutional linearity (R² = 0.9940) and accuracy (98.18%) were confirmed across the analytical titer range of 11-1728 IU/mL. The assay also exhibited high precision, with intra-assay and intermediate precision geometric coefficients of variation of 6.66% and 15.63%, respectively. Robustness testing demonstrated minimal variation across different pseudotyped virus lots, incubation times, and cell counts. Conclusions: The validated NiV-PNA is a reproducible and scalable assay platform for quantifying NiV neutralizing antibodies, offering a safer alternative to virus culture. Its validation and integration into the CEPI Centralized Laboratory Network will enhance global capacity for vaccine evaluation and outbreak preparedness. Full article

In this work an evaluation of Macro Stickies was performed on thirteen different cellulose-based materials through image analysis. In particular, the materials that were evaluated consisted of different types/categories of papers/products produced by the industry, namely, molded cellulose products, unbleached kraft papers, barrier papers, one recycled paper, and a laminated paper package. The Macro Stickies Evaluation was carried out using an image analysis tool developed by our research group to perform this kind of work from now on. The results indicated that eight of the processed samples revealed low/residual contents of Macro Stickies, whereas the remaining five revealed higher amounts of Macro Stickies in their surfaces. Of the eight samples showing a low/residual Macro Stickies content, five of them belonged to the unbleached kraft papers category, with an area per mass of Macro Stickies ranging from 8.60 to 29.04 mm²/kg. However, the lowest case did not belong to this category, but to the molded cellulose products category with a value of 6.10 mm²/kg. Of the five samples showing higher amounts of Macro Stickies, the worst three cases were associated to one of the barrier papers, the recycled paper and the laminated paper, with an area per mass of Macro Stickies of 28,973.42, 6998.56, and 14,058.76 mm²/kg, respectively. Macro Stickies can assume different sizes, numbers and distributions depending on the characteristics and nature of each sample, and can be a great concern in the recycling of cellulose-based materials. In this sense, the proper assessment of Macro Stickies provides valuable information for the recycling sector to classify them in the products, and to anticipate which materials might give rise to potential stickies related problems in the recycling process. Full article

The circular economy, in which recycling plays a significant role, is increasingly becoming a primary requirement for packaging. Our research focused on the recycling of intelligent cardboard packaging. The focus of the study was to manufacture and recycle cardboard embedded with a printed RFID antenna and a thermochromic indicator and to evaluate their recyclability. The Confederation of European Paper Industries (CEPI) method was employed to assess the recyclability of cardboard printed using digital printing techniques with integrated intelligent elements. The coarse reject and concentration following coarse screening were determined, and laboratory hand sheets were made for the adhesiveness test and visual evaluation. The fine screening procedure was performed. The acquired samples were evaluated for basic, mechanical, and optical properties. The analysis indicated that the recyclability of all examined materials was exceptionally good, confirming their suitability for normal recycling processes. Furthermore, the recycling efficiency exceeds 99% for all samples. Despite the variances in the samples, including metallic functional and thermochromic ink, they did not significantly impact the final outcome. Moreover, little variations in recyclability were seen between intelligent elements printed directly on cardboard and those printed on self-adhesive labels applied to the cardboard. The research has confirmed that the printed RFID antenna and thermochromic indicator have a negligible impact on the recyclability process and final score. Full article

Background: Major global economic and health burdens due to norovirus gastroenteritis could be addressed by an effective vaccine. Methods: In this study, 428 adult recipients of various compositions of the norovirus vaccine candidate, HIL-214, were followed for 5 years, to assess immune responses to its virus-like particle antigens, GI.1 and GII.4c. Serum antibodies and peripheral-blood antibody-secreting cells (ASCs) were measured. This report focuses on the single-dose 15/50 (µg GI.1/GII.4c) composition, which had been selected for further clinical development. Results: For single-dose 15/50 recipients (N = 105), GI.1-specific and GII.4c-specific histoblood-group antigen-blocking (HBGA) antibodies appeared to have persisted to 5 years, waning from a peak at 4 to 8 weeks, and plateauing above baseline after 3 years. From 3 to 5 years, GI.1-specific GMTs ranged between 53 (95%CI, 40–71) and 60 (95%CI, 46–77; N = 69–97) and were approximately 2-fold above the baseline GMT (24 (95%CI, 20–28); N = 105). GII.4c-specific GMTs ranged between 103 (95%CI, 77–138) and 114 (95%CI, 86–152; N = 70–97) and were above baseline, but by less than 2-fold (70 (95%CI, 53–92); N = 105). Similar kinetics were observed for pan-Ig titers and ASCs in a subset. Similar kinetics were also observed for HBGA and pan-Ig titers in recipients of other 15/50 dosages. Conclusions: Immune responses to HIL-214 in adults appear to persist for five years. Full article

Background: The emergence of more than 40 new infectious diseases since the 1980s has emerged as a serious global health concern, many of which are zoonotic. In response, many international organizations, including the US Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and the European Center for Disease Prevention and Control (ECDC), have developed strategies to combat these health threats. The need for rapid vaccine development has been highlighted by Coronavirus disease 2019 (COVID-19), and mRNA technology has shown promise as a platform. While the acceleration of vaccine development has been successful, concerns have been raised about the technical limits, safety, supply, and distribution of vaccines. Objective: This study analyzes the status of vaccine platform development in global pandemics and explores ways to respond to future pandemic crises through an overview of the roles of international organizations and their support programs. It examines the key roles and partnerships of international organizations such as the World Health Organization (WHO), vaccine research and development expertise of the Coalition for Epidemic Preparedness Innovations (CEPI), control of the vaccine supply chain and distribution by the Global Alliance for Vaccines and Immunization (GAVI), and technology transfer capabilities of the International Vaccine Institute (IVI) in supporting the development, production, and supply of vaccine platform technologies for pandemic priority diseases announced by WHO and CEPI and analyzes their vaccine support programs and policies to identify effective ways to rapidly respond to future pandemics caused by emerging infectious diseases. Methods: This study focused on vaccine platform technology and the key roles of international organizations in the pandemic crisis. Literature data on vaccine platform development was collected, compared, and analyzed through national and international literature data search sites, referring to articles, journals, research reports, publications, books, guidelines, clinical trial data, and related reports. In addition, the websites of international vaccine support organizations, such as WHO, CEPI, GAVI, and IVI, were used to examine vaccine support projects, initiatives, and collaborations through literature reviews and case study methods. Results: The COVID-19 pandemic brought focus on the necessity for developing innovative vaccine platforms. Despite initial concerns, the swift integration of cutting-edge development technologies, mass production capabilities, and global collaboration have made messenger RNA (mRNA) vaccines a game-changing technology. As a result of the successful application of novel vaccine platforms, it is important to address the remaining challenges, including technical limits, safety concerns, and equitable global distribution. To achieve this, it is essential to review the regulatory, policy, and support initiatives that have been implemented in response to the COVID-19 pandemic, with particular emphasis on the key stages of vaccine development, production, and distribution, to prepare for future pandemics. An analysis of the status of vaccine development for priority pandemic diseases implies the need for balanced vaccine platform development. Also, international organizations such as WHO, CEPI, GAVI, and IVI play key roles in pandemic preparedness and the development and distribution of preventive vaccines. These organizations collaborated to improve accessibility to vaccines, strengthen the global response to infectious diseases, and address global health issues. The COVID-19 pandemic response demonstrates how the synergistic collaboration of WHO’s standardized guidelines, CEPI’s vaccine research and development expertise, GAVI’s control of the vaccine supply chain and distribution, and IVI’s technology transfer capabilities can be united to create a successful process for vaccine development and distribution. Conclusions: In preparation for future pandemics, a balanced vaccine platform development is essential. It should include a balanced investment in both novel technologies such as mRNA and viral vector-based vaccines and traditional platforms. The goal is to develop vaccine platform technologies that can be applied to emerging infectious diseases efficiently and increase manufacturing and distribution capabilities for future pandemics. Moreover, international vaccine support organizations should play key roles in setting the direction of global networking and preparing for international vaccine support programs to address the limitations of previous pandemic responses. As a result, by transforming future pandemic threats from unpredictable crises to surmountable challenges, it is expected to strengthen global health systems and reduce the social and economic burden of emerging infectious diseases in the long term. Full article

The Central Environmental Protection Inspector (CEPI) is an innovation in China’s environmental regulation. This paper uses game theory to analyze the influence of the CEPI on enterprises’ green investment. Firstly, by constructing the game model of “central government-local government-polluting enterprises”, the factors affecting green investment strategy are analyzed. Then, with the help of a system simulation model, the influence of parameters on system stability and convergence trends is analyzed, so as to obtain the influence of the CEPI on enterprise green investment. The results show the following: (1) The CEPI can effectively promote preventive green investment, and the promotion effect of preventive green investment is proportional to its risk; (2) The effect of the CEPI on local governments is not obvious; (3) The cost of the CEPI is too high, and polluting enterprises are quick to choose remedial green investment. Full article

Background: This study investigated whether point-of-care platelet function measurements could predict favorable outcomes in patients with acute ischemic stroke (AIS). Antiplatelet agents, such as aspirin, are known to reduce the risk of recurrent stroke by 20–30%. However, identifying nonresponders to therapy remains a clinical challenge. The study aimed to assess the prognostic value of serial Platelet Function Analyzer (PFA)-100 measurements and hematological ratios in AIS patients. Methods: A prospective cohort study was conducted on 212 AIS patients in Taiwan. Platelet function was assessed at baseline, week 2, and week 4 using PFA-100. The primary outcome was functional recovery, defined by a modified Rankin Scale (mRS) score of 0–3, at 1-month and 1-year. Subgroup analyses compared outcomes between pre- and post-aspirin administrations. Statistical analyses examined the association between changes in platelet function and clinical outcomes. Results: Difference in collagen and epinephrine (CEPI) measurements between baseline and week 2 was associated with favorable mRS scores (p < 0.001). A difference in CEPI closure time greater than 99 seconds was most predictive of a favorable outcome with an adjusted odds ratio of 11.859 (95% CI 2.318–60.669) at 1-month follow-up. Subgroup analyses revealed predictive value in pre-aspirin measurements at 1-month follow-up (p = 0.007). Conclusions: Serial PFA-100 measurements and hematological biomarkers, specifically changes in on-treatment CEPI closure times, may help predict favorable clinical outcome in AIS patients. These findings suggest that dynamic platelet function assessment could play a role in optimizing antiplatelet therapy in AIS management. Full article

The rapid development of equitably accessible vaccines is paramount in addressing emerging global health challenges. The safety and efficacy of vaccines hinge significantly on their ability to remain stable from manufacturing throughout the supply chain and up to administration. Furthermore, the release of vaccines requires sufficient understanding of the stability profile to allow for expiration dating. In the event of a public health crisis, the time to generate the necessary stability data and the need for rapid product release are in direct opposition. Developing manufacturing platforms with thermostable product formulations for rapid response is therefore key to meeting CEPI’s 100 Days Mission goal. This Review aims to highlight the need for stability preparedness through developing thermostable vaccine platforms and exploring innovative stability monitoring strategies that leverage advanced technologies, predictive modelling, and adaptive methodologies. By doing so, we seek to enhance the efficiency and effectiveness of stability assessments, supporting rapid development, regulatory approval, and widespread, equal distribution of vaccines—especially in an outbreak scenario. Finally, enhanced thermostability will allow for simplification across the supply chain, which will reduce the financial burden of vaccination programmes and enhance equitable access. Full article

In the summer of 2020, it became clear that the genetic composition of SARS-CoV-2 was changing rapidly. This was highlighted by the rapid emergence of the D614G mutation at that time. In the autumn of 2020, the project entitled “Agility” was initiated with funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to assess new variants of SARS-CoV-2. The project was designed to reach out and intercept swabs containing live variant viruses in order to generate highly characterised master and working stocks, and to assess the biological consequences of the rapid genetic changes using both in vitro and in vivo approaches. Since November 2020, a total of 21 variants have been acquired and tested against either a panel of convalescent sera from early in the pandemic, and/or a panel of plasma from triple-vaccinated participants. A pattern of continuous evolution of SARS-CoV-2 has been revealed. Sequential characterisation of the most globally significant variants available to us, generated in real-time, indicated that the most recent Omicron variants appear to have evolved in a manner that avoids immunological recognition by convalescent plasma from the era of the ancestral virus when analysed in an authentic virus neutralisation assay. Full article