Search Results (10)

Introduction: Inequities in access to medicines persist for asylum seekers, refugees, and undocumented migrants in Europe. For vaccines, access gaps not only exist for these groups in childhood routine immunization, but also for life-course and catch-up vaccinations. As part of a broader project examining access to medicines and vaccines for migrants across all stages of the migration cycle, this scoping review synthesizes evidence on the determinants of access to vaccines. Methods: We conducted a scoping review across PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Database of Systematic Reviews, Scopus, and grey literature sources, covering the period 2000–2024. Sources were eligible if they addressed access to vaccines among migrants. We examined access to vaccines along the life course, and across phases of the migratory cycle, including departure, transit, reception and settlement, and return or deportation. Results: A total of 47 research studies and grey literature reports were included. Most studies focused on migrants in reception and settlement (destination) settings, with only twelve sources addressing other phases of the migratory cycle. Across European countries, migrants were frequently reported to have lower uptake of routine vaccines (e.g., measles–mumps–rubella (MMR), polio, diphtheria–tetanus–pertussis (DTP), and human papillomavirus (HPV)) and COVID-19 vaccines than host populations. The most frequently reported barriers were related to migrants’ legal status, administrative requirements, and lack of documentation, alongside poor affordability of vaccination, limited awareness of their rights, and mistrust in the health system. Conclusions: Health systems need to adopt innovative approaches to expand vaccine access for migrant populations. Further, protecting confidentiality is essential for building trust and reducing ethical and legal risks. Flexible and coordinated vaccination strategies are required to address migrants’ mobility across the different migration stages and settings. Our findings appeal for sustained improvements in access to vaccines among migrants in Europe, contingent on strong policy commitments to equity, data protection, and the adoption of life-course and catch-up vaccination strategies. Full article

Introduction: Human metapneumovirus (HMPV), though commonly perceived as a pediatric pathogen, significantly impacts adults, yet its role in acute respiratory tract infections (ARTIs) remains underappreciated. The COVID-19 pandemic has reshaped respiratory virus epidemiology and amplified the need for comprehensive differential diagnosis. This study aimed to comprehensively investigate the prevalence, clinical characteristics, and post-COVID-19 trends of HMPV infection in adults and to elucidate its critical role in the differential diagnosis of ARTIs by distinguishing it from other common viral pathogens. Methods: This was a retrospective, multicenter study conducted across six hospitals within the Acibadem Hospitals Group in Istanbul, Turkey. Data were collected from two periods: January 2016 to January 2020 (pre-COVID-19) and January 2021 to September 2023 (post-COVID-19), excluding the peak pandemic phase (March 2020 to May 2021). Respiratory samples (sputum, BAL, nasopharyngeal/nasal/throat swabs) were analyzed using multiplex PCR (Seegene RV12-ACE), with an expanded panel including SARS-CoV-2 in the post-COVID-19 era. Demographic data, comorbidities, symptoms, hospitalization, and ICU admission rates were collected. Results: In the post-COVID-19 period, 2197 positive viral panels were recorded, an increase from 1357 in the pre-COVID period, reflecting enhanced testing. HMPV prevalence reached 9.7% post-COVID-19, making it the fourth most common respiratory virus in adults (8.7% of 644 positive adult tests), following SARS-CoV-2 (26.4%), influenza A (21.3%), and rhinovirus (17.5%). The average age of HMPV-infected adults was 52.14 years (18–90 years); 64% were female. While 52% had no comorbidities, common underlying conditions included hypertension (24%), cancer (12%), and diabetes (10%). Weakness (34%), lower respiratory symptoms (16%), and fever (12%) were frequent. A significant proportion of HMPV patients required hospitalization (34%) and ICU admission (18%), with 40% receiving antibiotics. Despite potential severity, the mortality rate was low (2.8%). No significant difference in severity was observed between HMPV monoinfection and co-infected groups (e.g., with influenza A, rhinovirus, SARS-CoV-2, parainfluenza virus 2). Conclusion: Our findings establish HMPV as a significant and increasingly prevalent respiratory pathogen among adults in Istanbul in the post-COVID-19 era. Its non-specific clinical presentation underscores the critical importance of multiplex PCR for accurate differential diagnosis, enabling appropriate patient management and antimicrobial stewardship. While HMPV can lead to severe outcomes requiring hospitalization and ICU admission, particularly in patients with comorbidities, the overall mortality rate remains low. Given the lack of specific antiviral treatments and vaccines, sustained surveillance and continued research into targeted interventions are crucial. Full article

Background: Globally, pneumonia claims the lives of about 700,000 children under the age of 5 every year. Pneumococcal conjugate vaccine (PCV) was introduced in India phase-wise, beginning in high-burden states, and the rollout was completed nationwide by 2021—representing a major initiative by the Ministry of Health and Family Welfare (MoHFW). Despite the challenges posed by the COVID-19 pandemic, the campaign succeeded in maintaining progress and achieving nationwide coverage. This narrative review highlights the significant decisions, processes, and coordinated efforts of the various stakeholders involved that led to this successful PCV rollout. Methodology: A comprehensive desk review of both published and unpublished literature relevant to pneumonia burden and the efficacy and effectiveness of PCVs, along with documentation of PCV introduction and the scale-up was carried out. Results: The documentation of the PCV journey has been broken down into four sections: pre-introduction, PCV Phase-I introduction, pan-India rapid expansion, and the period post-introduction. Since the nationwide rollout in 2021, PCV coverage in India has steadily increased, reflecting successful immunization efforts. WUENIC, which is an annual WHO, and UNICEF estimates of national immunization coverage also show a positive trend in vaccination coverage (PCV booster coverage = 25% (2021), rising to 83% (2023), aligning with the goals of the WHO and UNICEF’s Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea (GAPPD). Conclusions: The phased rollout was an ambitious effort by the MoHFW, which was particularly challenging given the overlap with the COVID-19 pandemic. Despite these hurdles, the MoHFW, along with strong collaboration from development partners and stakeholders, successfully navigated the complex rollout. Future studies on the role of PCVs in reducing antibiotic resistance and the economic benefits of PCV introduction could help policymakers sustain funding and prioritize vaccine procurement decisions. Full article

Background: China’s pharmaceutical regulatory framework is undergoing a pivotal shift from a traditional “command-control” model to a “lifecycle regulation” approach, aiming to balance drug safety, innovation, and accessibility. This study systematically examines the evolution, achievements, and challenges of China’s regulatory reforms, offering insights for global pharmaceutical governance. Methods: Using a mixed-methods approach integrating historical analysis, policy text mining, and case studies, we reviewed the pharmaceutical laws and regulations enacted since 1949, supplemented by case studies (e.g., COVID-19 vaccine emergency approvals) and a comparative analysis with international models (e.g., U.S. FDA and EU EMA frameworks). The data were sourced from authoritative platforms such as the PKULAW database, criminal law amendments, and international regulatory texts. Results: China’s regulatory evolution is categorized into four phases: Emergence (1949–1984), Foundational (1985–2000), Deepening Reform (2001–2018), and Lifecycle Regulation (2019–present). The revised Drug Administration Law (2019) institutionalized risk management, dynamic GMP inspections, and post-market surveillance, marking a transition to holistic lifecycle oversight. Key milestones include the introduction of the Vaccine Management Law (2019) and stricter penalties under the Criminal Law Amendment (XI) (2020). Conclusions: China’s lifecycle regulation model demonstrates potential to harmonize safety and innovation, evidenced by improved API export compliance (e.g., 15% increase in international certifications by 2023) and accelerated approvals for breakthrough therapies (e.g., domestically developed PD-1 inhibitors). However, challenges persist, including uneven enforcement capacities, tensions between conditional approvals and risk mitigation, and reliance on global supply chains. These findings provide critical lessons for developing countries navigating similar regulatory dilemmas. Full article

Introduction: As the COVID-19 pandemic becomes an endemic state, still many questions remain regarding the risks and impact of SARS-CoV-2 infection and vaccination in patients with immune-mediated inflammatory diseases (IMIDs) who were excluded from the phase 3 COVID-19 vaccination trials. Methods: The BELCOMID study collected patient data and serological samples from a large, multicentric IMID patient cohort that was prospectively followed during sequential stages of the pandemic. Patients were stratified according to vaccination status into five groups across three sampling periods. Interactions between SARS-CoV-2 infection, COVID-19 vaccination status, IMID-treatment modalities and IMID course were explored. Results: In total, 2165 patients with IBD, a dermatological or rheumatological IMID participated. SARS-CoV-2 infection rates increased over the course of the pandemic and were highest in IMID patients that had refused every vaccine. After baseline COVID-19 vaccination, serologic spike (S)-antibody responses were attenuated by particular types of immune-modulating treatment: anti-TNF, rituximab, JAKi, systemic steroids, combined biologic/immunomodulator treatment. Nonetheless, S-antibody concentration increased progressively in patients who received a booster vaccination, reaching 100% seroconversion rate in patients who had received two booster vaccines. Previous SARS-CoV-2 infection was found as a predictor of higher S-antibody response. Patients who had refused every vaccine showed the lowest rates of S-seroconversion (53.8%). Multiple logistic regression did not identify previous SARS-CoV-2 infection as a risk factor for IMID flare-up. Furthermore, no increased risk of IMID flare-up was found with booster vaccination. Conclusions: Altogether, the BELCOMID study provides evidence for the efficacy and safety of COVID-19 vaccination and confirms the importance of repeated booster vaccination in IMID patients. Full article

Background: The aim of the rapid introduction of vaccines during the COVID-19 pandemic was a reduction in SARS-CoV-2 transmission and a less frequent occurrence of severe COVID-19 courses. Thus, we evaluated COVID-19 severity in vaccinated individuals to examine variant-specific symptom characteristics and their clinical impact on the serological immune response. Methods: A total of 185 individuals previously vaccinated against and infected with the SARS-CoV-2 Delta (B.1.617.2) or Omicron (BA.4 and BA.5) variant, were enrolled for anti-SARS-CoV-2 anti-N- and anti-RBD/S1-Ig level detection. A structured survey regarding medical history was conducted. Results: In 99.5 percent of cases, outpatient treatment was satisfactory. Specific symptoms associated with variants included ageusia and anosmia in patients with Delta infections and throat pain in Omicron infections. Among Delta-infected individuals with specific symptoms, significantly higher levels of anti-N antibodies were observed. Conclusion: Our study identified variant-specific differences in the amount of SARS-CoV-2 antibody production and COVID-19 symptoms. Despite this, vaccinated individuals with Omicron or Delta infections generally experienced mild disease courses. Additionally, asymptomatic individuals exhibit lower anti-SARS-CoV-2 antibody levels, indicating a clinical correlation between disease-specific antibodies and distinct symptoms, particularly in the case of the Delta variant. In follow-up studies, exploring post-COVID syndrome and focusing on cognitive symptoms in the acute phase of Omicron infections is crucial as it has the potential to longitudinally impact the lives of those affected. Full article

Introduction: The therapeutic impact of molnupiravir in the Omicron variant phase is unknown. The goal of the current meta-analysis was to compare the real-world clinical outcomes of molnupiravir for the treatment of mild to moderate COVID-19 during the dominance of the Omicron variant in adult patients to that of a placebo. Methods: To be included, studies had to directly compare the clinical effectiveness of molnupiravir in treating adult COVID-19 patients to that of a placebo. Studies were included based on the following outcomes: all-cause mortality, composite outcome of disease progression, hospitalization rate, and viral load. Results: The current meta-analysis included six studies that indicated that the risk of mortality was reduced by 34%, and the risk of composite outcome of disease progression was reduced by 37% among patients who received molnupiravir. Molnupiravir was associated with faster reduction in viral loads than the placebo. There was no clinical benefit of reducing all-cause mortality in mild to moderate COVID-19 patients with high COVID-19 vaccination coverage. Conclusion: The clinical effectiveness of molnupiravir was associated with COVID-19 vaccination coverage in COVID-19 patients. There is a lack of detailed data on its effectiveness in vaccinated patients, especially those with low COVID-19 vaccination coverage. Full article

Understanding vaccine hesitancy, considering the target region and phase, is an urgent issue to quell the coronavirus disease (COVID-19) pandemic. This study aimed to monitor COVID-19 vaccine hesitancy in the Japanese population during the three phases of vaccine approval and introduction, and evaluate the association of vaccine hesitancy with vaccine confidence and literacy. We conducted web-based cross-sectional surveys during the three phases of COVID-19 vaccine introduction: January 2021, before approval; June, start of vaccination of the elderly; and September, when about 70% of the target population was vaccinated with at least one dose. There were 7210 participants, aged 20–80 years. We evaluated the association of vaccine hesitancy with vaccine confidence and literacy in the three phases using multivariate logistic regression analysis. The proportion of hesitancy in January, June, and September was 17.5%, 65.3%, and 19.4%, respectively. In any phase, lower vaccine confidence and literacy showed a higher adjusted odds ratio (AOR) of vaccine hesitancy in most items (AOR > 1, p < 0.001). Vaccine hesitancy in June had a different trend in perception of COVID-19 compared to that in the January and September surveys. The findings suggested that hesitancy increases transiently during vaccination introduction phases, and changes as the vaccination program progressed or waves of epidemic. Careful risk communication to increase vaccine confidence and literacy is essential to reduce vaccine hesitancy, especially in the introduction phase. Full article

Human papilloma virus (HPV) is a viral agent whose transmission occurs mainly by sexual means. It causes different pathological conditions in both males and females, ranging from benign pathologies up to cancers. The introduction of vaccination has certainly had a major impact in terms of reducing the incidence of both HPV infections and diseases but in the European Union and the European Economic Area (EU/EEA) there are still about more than 13,000 deaths due to cervical cancer each year. To date in Europe and in Italy there are three vaccines available (bi-, tetra-, and nonvalent vaccines). The vaccination campaign started irregularly in Europe and Italy in 2007, with pre-adolescent girls as the primary target. Later, other cohorts were introduced such as 12-year-old boys, additional cohorts of >25-year-old women, women who already underwent cervical surgery and other subjects entitled to free vaccination. The COVID-19 pandemic has strongly impacted on public health services, particularly on vaccinations that, especially during the first pandemic phase, have been often delayed and/or canceled. The most affected vaccinations by the pandemic have been the non-mandatory ones, particularly those addressing the adolescent and adult population, such as immunization against papillomavirus. To date the achievement of the coverage target set by the Italian National Immunization Plan (NIP) has not yet been achieved. The aim of this work is to summarize the current situation in Italy and to discuss the strategies that have been implemented to increase overall vaccination coverage rates. Full article

Background: Varicella is a common pediatric infection. Even if it generally has a benign course, it may complicate and require hospitalization. The aim of our study was to estimate the acute hospitalization cost (AHC) for varicella in the acute phase in a pediatric population. Methods: We calculated the AHC of pediatric patients admitted for varicella at Bambino Gesù Children Hospital, Rome, Italy, from 1 November 2005 to 1 November 2020. Results: In the study period, 825 pediatric patients affected by varicella were hospitalized. The mean hospitalization cost was EUR 4015.35 (range from EUR 558.44 to EUR 42,608.00). Among patients, 55% were unvaccinable due to either their age or their immunosuppression status. They would benefit from herd immunity, reducing the overall AHC by EUR 182,196,506. Since the introduction of the compulsory vaccination against varicella in Italy, we observed a significant reduction in AHC cost of 60.6% in 2019 and of 93.5% in 2020. Finally, from the beginning of the COVID-19 pandemic, we documented a decline of 81.2% and 76.9% in varicella hospitalization, compared to 2018 and 2019, respectively. Conclusions: Varicella AHC is an important economic and health assessment point and can be useful for improving preventive strategies. Full article