Background/Objectives: This study evaluated changes in routine adult vaccination across the COVID-19 pandemic period in Istanbul primary care using interrupted time series (ITS) analysis, disentangling immediate from gradual effects and comparing patterns across socioeconomically distinct centers, through a multicenter retrospective analysis of routine (non-COVID-19 vaccination records). Methods: The full descriptive dataset comprised 33,016 adult vaccination records. After excluding 25,805 COVID-19 vaccination records, 7211 routine (non-COVID-19) vaccination records from nine family medicine units in three Istanbul training family health centers—Şişli-Gülbahar, Kağıthane, and Gaziosmanpaşa—were included in the routine vaccine and ITS analyses and were analyzed over 97 monthly observations (June 2017–August 2025), divided into three 672-working-day periods: pre-pandemic, pandemic, and post-pandemic. Segmented negative binomial ITS regression with a log (working days) offset was the primary analysis; Newey-West HAC-robust Poisson regression served as sensitivity analysis. Catchment districts were characterized using the 2022 Socioeconomic Development Ranking (SEGE-2022). Results: No significant immediate level change occurred in total routine vaccination at pandemic onset. Pneumococcal vaccination showed the most pronounced signal: an upward pretrend (annual slope IRR = 2.583; p = 0.001), a level increase at onset (IRR = 3.589; p = 0.013), then a rapid within-pandemic slope decline (annual slope IRR = 0.227; p < 0.001). Tetanus-diphtheria (Td) vaccination fell sharply at onset (IRR = 0.686; p = 0.002) and continued declining post-pandemic (annual slope IRR = 0.805; p = 0.008). Versus Gaziosmanpaşa (rank 85/973), Kağıthane (rank 38) showed the highest total routine vaccination rate (excluding COVID-19 vaccination) (IRR = 1.539; p < 0.001), exceeding Şişli (rank 1; IRR = 1.269; p < 0.001). Conclusions: Changes in routine adult vaccination across the pandemic period were vaccine-specific: pneumococcal vaccination surged then declined; Td vaccination showed continued post-pandemic decline. Center-level vaccination patterns were not consistently aligned with district-level socioeconomic ranking.
Background/Objectives: Catch-up vaccination is essential for reaching zero-dose and under-vaccinated children. However, community participation depends on several factors whose interactions remain insufficiently understood. This study aimed to analyze the dimensions structuring community participation in catch-up vaccination and to develop a conceptual framework describing their relationships. Methods: An analytical qualitative study was conducted between July and November 2025 in the health districts of Abobo and Yopougon, Abidjan, Côte d’Ivoire. Data were gathered from 106 participants through 26 semi-structured individual interviews and eight focus group discussions involving 80 parents or caregivers of children aged 0–59 months. Interviews and focus group discussions were transcribed in French, and thematic analysis was conducted using NVivo 14 (Lumivero, Denver, CO, USA). A standardized thematic codebook with operational definitions was used by three coders to ensure consistent coding across transcripts. Results: Thematic analysis across participant groups identified seven components shaping community participation: exposure to information, understanding of the message, trust in actors and services, social acceptance, parents’ availability and capacity, participation in the activity, and effective vaccination of the child. Five cross-cutting factors influenced progression along this pathway. Participation could break down when information was insufficient or unclear, trust was undermined by perceived costs or rumors, social acceptance was constrained, or parents faced competing work and time demands. These interactions informed the Community Participation Pathway for Catch-up Vaccination (CPP-CV), which identifies potential disruption points between information exposure and effective vaccination and highlights that non-participation may result from the interaction of informational, social, individual, structural, and organizational factors rather than vaccine hesitancy alone. Conclusions: The findings suggest that participation in catch-up vaccination goes beyond information alone and results from the interaction between community and organizational factors. Non-participation should not be treated as a single problem or assumed to reflect vaccine hesitancy. The CPP-CV provides a programmatically oriented framework for identifying where the pathway from information to vaccination breaks down and for tailoring catch-up strategies accordingly.
Psoriasis is a chronic, relapsing skin disease driven by failed immune tolerance toward self-antigens and sustained IL-23/IL-17 signaling. Systemic drugs and biologics control disease in many patients, yet they do not restore lasting tolerance, and most patients relapse after treatment withdrawal. Tolerogenic vaccines aim to re-educate the cutaneous immune system: when administered under non-inflammatory conditions, they push antigen-presenting cells toward tolerogenic dendritic cells (tDCs) and regulatory T cells (Tregs) instead of pathogenic effectors. Because the hyperkeratotic stratum corneum of psoriatic plaques blocks macromolecular vaccines, microneedle (MN) arrays can deposit nanocarriers directly into the dermal-epidermal junction. The narrative review asks whether MN-delivered tolerogenic nanovaccines can advance psoriasis therapy beyond broad immunosuppression. We first define tolerogenic vaccination and explicitly distinguish antigen-specific tolerogenic vaccines, antigen-independent immune-reprogramming nanocarriers, and conventional local drug delivery, then survey MN engineering and nanocarrier architectures, the immunomodulatory pathways involved, and translational barriers spanning manufacturing, safety, and regulation. Because most evidence is preclinical, the level of evidence is reported for each platform, and the unresolved autoantigen problem, the limitations of imiquimod-based models, and the need for human-relevant validation are emphasized.
Influenza pandemics occur when a novel influenza virus strain emerges that spreads rapidly between people with little or no immunity [...]
Background/Objectives: The bivalent RSVpreF vaccine is effective at preventing respiratory syncytial virus (RSV)-associated lower respiratory tract illness in adults. However, data regarding safety and immunogenicity of RSVpreF in Korean populations are limited. Methods: This was a phase 3, multicenter, placebo-controlled, randomized (2:1), double-blind study in Korean adults 60 years of age and older. Participants received a single 120-μg dose of RSVpreF or matching placebo. Safety endpoints included local reactions and systemic events through 7 days and adverse events (AEs) through 1 month after vaccination, and serious AEs (SAEs) throughout the study. RSV-A and RSV-B serum 50% neutralizing geometric mean titers (GMTs) and geometric mean fold rises (GMFRs) were obtained 1 month after vaccination. Results: Overall, 377 participants received study intervention (RSVpreF, n = 251; placebo, n = 126). Most local reactions and all systemic events were of mild or moderate severity. Injection-site pain was the most frequently reported local reaction (RSVpreF, 12.4%; placebo, 3.2%). The most frequently reported systemic events were fatigue (RSVpreF, 23.1%; placebo, 26.2%) and muscle pain (RSVpreF, 15.5%; placebo, 9.5%). AEs through 1 month after vaccination were infrequent (RSVpreF, 3.6%; placebo, 0.8%); none were considered vaccine related by the investigator. RSV-A and RSV-B neutralizing GMTs increased 1 month after RSVpreF, with GMFRs (95% CIs) from before to 1 month after vaccination of 9.5 (8.51–10.67) for RSV-A and 8.3 (7.37–9.39) for RSV-B. Conclusions: In older Korean adults, RSVpreF had an acceptable safety and tolerability profile and elicited robust RSV neutralizing responses 1 month after vaccination consistent with pivotal phase 3 efficacy trial results. ClincalTrials.gov Identifier: NCT06593587 (date of registration: 9 September 2024).
Objectives: This cross-sectional study characterized HBV serological profiles and associated factors among pregnant women in Nanning to inform targeted MTCT prevention strategies. Methods: A total of 1935 pregnant women were enrolled via stratified cluster random sampling from October 2024 to May 2025. Five HBV serological markers were quantified by chemiluminescence immunoassay. Multivariable analysis identified factors associated with HBsAg, HBsAb, and HBcAb positivity. HBsAb geometric mean concentration (GMC) and ratio (GMR) were calculated. Results: The overall seropositivity rates (with 95% CI) of HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb were 6.98% (5.92–8.20%), 59.48% (57.28–61.65%), 1.50% (1.05–2.14%), 15.50% (13.96–17.18%), and 33.02% (30.96–35.15%), respectively. HBsAg, HBeAb, and HBcAb positivity increased with age. The HBsAb GMC among uninfected pregnant women was 4.63 mIU/mL (95% CI: 3.72–5.75). Rural pregnant women had lower HBsAb seropositivity than urban counterparts. Unvaccinated women or those with unknown vaccination status showed higher HBsAg, HBeAg, HBeAb, and HBcAb positivity, and lower HBsAb seropositivity, compared with vaccinated women. Advanced age, chronic comorbidities, and HBV exposure were risk factors for HBsAg positivity, whereas HBV vaccination was protective. For HBsAb, higher education and vaccination were protective; advanced age, rural residence, chronic comorbidities, and non-medical occupations were risk factors. For HBcAb, advanced age, chronic comorbidities, and HBV exposure were risk factors, while higher education and vaccination were protective. Conclusions: Pregnant women in Nanning have a high HBV prevalence and insufficient immune protection. Targeted prevention strategies for reproductive-age women are urgently needed to reduce vertical transmission risk.
Despite longstanding vaccine availability, human papillomavirus (HPV) remains the most common sexually transmitted infection in the United States and a leading cause of preventable cancers. Additionally, HPV vaccination rates remain below other routinely recommended adolescent immunizations, particularly in rural populations. This study aimed to identify barriers related to healthcare access, socioeconomic conditions, cultural beliefs, and provider–patient communication in rural communities. A bibliographical review of articles published in English from 2020 to 2025 and an analysis of national datasets were conducted to establish trends in HPV vaccination rates. State-level HPV vaccination data for adolescents aged 13–17 years were obtained from America’s Health Rankings and the Centers for Disease Control and Prevention National Immunization Survey-Teen. States were classified as predominantly rural or urban using Rural–Urban Continuum Codes, and mean vaccination completion rates were compared. The mean HPV vaccination completion rate was lower in rural states (60.55%) compared to urban states (67.31%); however, this difference did not meet the selected threshold for statistical significance (p = 0.025). Barriers identified in the literature included reduced access to healthcare, differences in provider communication, socioeconomic constraints, and limited health literacy in rural communities. Of the identified barriers, healthcare provider recommendations emerged as one of the strongest predictors of vaccine acceptance. These findings highlight multilevel determinants contributing to differences in HPV vaccine uptake and underscore the need for targeted, evidence-based strategies to improve vaccine access and coverage in underserved adolescent populations.
Background: COVID-19 vaccines have proven effective in reducing severe disease and mortality from SARS CoV-2 infection. The underlying molecular mechanisms and alterations in the human serum metabolome influencing the effectiveness and development of immunity remain unclear. Methods: Serum samples were collected from 29 healthy individuals at three time points: prior to vaccination (A), post-first dose (B), and post-second dose (C). Untargeted high-resolution (HR) liquid chromatography coupled with mass spectrometry (LC-MS) was performed on these samples. Metabolites showing significant differential abundance at each time point were identified, and both multivariate and univariate statistical analyses were performed to determine changes associated with the pairwise comparisons, priming (A vs. B), booster (B vs. C), and the overall vaccine effect (A vs. C). Vaccination-specific features were determined after excluding metabolites associated with SARS-CoV-2 IgG seropositivity to better isolate vaccine-driven metabolic changes. Bioinformatics, pathway, and network analyses were conducted using Ingenuity Pathway Analysis (IPA) to identify relevant pathways. Results: Our study identified significant metabolic changes across the three time points. A total of 377 metabolites were identified, of which 59 metabolites, including prostaglandins, eicosanoids, and lipids, were shared across all three groups. The majority of these metabolites showed an initial decrease after the first dose, followed by broad upregulation after the second dose. We identified 1 (downregulated), 34 (26 upregulated and 8 downregulated), and 18 (2 upregulated and 16 downregulated) unique metabolites in the priming, booster, and the overall vaccine effect groups, respectively. L-3-hydroxykynurenine was observed to be significantly reduced by the priming dose effect. By contrast, the booster effect showed decreased myo-inositol 1,3,4,5-tetrakisphosphate, while levels of DL-DOPA, 3-methoxytyrosine, and prostaglandin-esterified phospholipids, including PC(P-16:0/PGF1α) and PE(PGF1α/18:0), increased. On the other hand, the overall vaccine effect revealed decreased cyclic AMP and increased 3′-O-methyladenosine levels. These changes were associated with perturbations in arachidonic acid metabolism, glycerophospholipid metabolism, arginine biosynthesis, and steroid hormone biosynthesis. IPA network analysis identified AKT, TP53, EGFR, and cAMP as key dysregulated nodes. Conclusions: Longitudinal metabolomic profiling demonstrated that COVID-19 vaccination induced distinct but interrelated biochemical changes throughout the vaccination course. The priming dose induced a limited set of early metabolic changes, whereas the booster was associated with more significantly changed metabolites that were involved in lipid, bile acid, steroid, amino acid, and nucleotide pathways. Together, these findings indicate that sequential vaccination is associated with dose-dependent systemic metabolic adaptation, with the booster dose having the largest number of dysregulated metabolites.
Background: Sustaining progress toward polio eradication requires not only effective vaccination but also a resilient laboratory network capable of timely poliovirus detection, confirmation, and genetic characterization. In the WHO African region, the African polio laboratory network provides essential virological support for eradication efforts; however, persistent circulating Vaccine-derived Polioviruses (cVDPVs) outbreaks and increasing demands of genomic surveillance continue to challenge laboratory capacity. Despite its critical role, evidence describing the operational performance, adaptive capacity, and evolution of regional polio laboratory network remains limited. This study evaluates the performance and operational experience of the African polio laboratory network in 2025, highlighting contributions to poliovirus detection, genomic surveillance, quality assurance, and outbreak response, while sharing lessons to inform regional public health systems. Methods: A retrospective secondary data analysis was conducted using laboratory surveillance and outbreak databases, supplemented by reviews of programmatic reports. Data were cleaned and harmonized prior to analysis. Descriptive analyses were performed to assess laboratory workload, timeliness indicators, genomic capacity, quality assurance performance, and operational challenges. Qualitative review of programmatic documents was conducted to identify contextual factors influencing performance. Results: In 2025, 77,230 Acute Flaccid Paralysis (AFP) specimens were analyzed across 16 laboratories. Ninety-two percent of specimens met the timeliness target for virus isolation, and 94% met the target for PCR-ITD. Genomic sequencing confirmed 20 cVDPV outbreaks in 10 countries. The establishment of new sequencing laboratories in Uganda and Nigeria reduced turnaround times, and a 2025 expansion plan aimed to build sequencing capacity in 12 additional countries. All laboratories assessed in 2024 for virus isolation, PCR-ITD, and environmental surveillance exceeded quality assurance accreditation thresholds and were rated “Pass”. The pilot implementation of Direct Detection Nanopore Sequencing (DDNS) techniques is expected to further strengthen genomic surveillance. Challenges remain, including stock out of essential supplies, uneven workloads, and infrastructure gaps. Conclusions: The African polio laboratory network has demonstrated sustained capacity, adaptability, and innovation in supporting polio eradication activities in the WHO African region. This study provides evidence on the importance of strengthening laboratory systems, expanding genomic capacity, and maintaining quality assurance mechanisms to support the final phase of polio eradication and broader public health surveillance.
Background/Objectives: Maternal antibodies can inhibit vaccine-specific humoral responses in early life, leaving infants at increased risk for severe disease for vaccine-preventable infections. In the case of SARS-CoV-2, infants under the age of 3 months represented most child hospitalizations, yet there is no approved vaccine for children under the age of 6 months. There is a clear need for effective immunization in early life to prevent infant morbidity and mortality. Here, we established a mouse model to define how maternally derived antibodies shape early-life responses to mRNA vaccination. Methods: Adult female mice were immunized with PBS or 5 mcg of the SARS-CoV-2 mRNA-1273 vaccine via intramuscular injection and paired with a male. Pups from subsequent litters were immunized with PBS or 5 mcg of mRNA-1273 vaccine via intramuscular injection. Peripheral blood and spleens were collected at time points post-immunization. We measured vaccine-elicited anti-Spike IgG in mouse pups exposed or unexposed to vaccine-specific maternal IgG. Results: Spike-specific maternal IgG is detectable at high levels immediately after pup immunization or mock immunization; however, in mock immunized pups, it wanes by three weeks post-pup immunization. Pups born to immunized dams developed Spike specific IgG comparable to pups born to naïve dams. IgG subclass analyses distinguished passively acquired antibodies from vaccine-induced responses. Despite robust binding antibody responses, neutralizing activity against D614G pseudovirus was heterogeneous and did not scale proportionally with IgG titers, showing qualitative differences in early-life humoral immunity. Splenic Spike-specific B cell frequencies and T follicular helper (Tfh) cell responses were detectable in vaccinated pups irrespective of maternal immunization status, with Tfh cell frequencies peaking at day 7 post-immunization in both groups. Conclusions: Using SARS-CoV-2 as a model pathogen, we found that early-life mRNA vaccination can elicit humoral immune responses in the presence of maternal antibodies. Furthermore, the presence of maternal antibody did not inhibit the development of antigen-specific B cells or Tfh cells in the spleen. Our findings support the potential of extending vaccination strategies into early infancy and provide a framework for optimizing mRNA-based vaccine timing and design in the context of maternal immunity.
Background/Objectives: In recent years, researchers have directed considerable attention toward the activation of the T-cell response in the development of vaccines against viral infections, including the tick-borne encephalitis virus (TBEV). A particularly promising approach to developing effective and safe T-cell vaccines involves the use of artificial multi-epitope immunogens. The selection of spacers that link epitopes within a construct can have a significant effect on the immunogenicity of multi-epitope constructs. The objective of this study was to design multi-epitope TBEV immunogens using various spacers and to evaluate their immunogenicity. Methods: The present study involved the design of three multi-epitope immunogens, which were developed based on T-cell epitopes from TBEV proteins. The AG1-ub construct contained optimized alanine spacers, the AG2-ub construct contained GPGPG spacers, and the AG4-ub construct contained no spacers. Three DNA vaccines encoding the designed immunogens were subsequently produced. To assess the immunogenicity of the constructs, BALB/c mice were immunized with the designed DNA vaccines via electroporation. Results: The ELISpot assay demonstrated that DNA vaccines encoding AG1-ub and AG4-ub induced a significant number of IFN-γ-producing cells. The DNA vaccine encoding AG2-ub, a multi-epitope with GPGPG spacers, exhibited low immunogenicity, potentially attributable to inadequate processing or misfolding of the AG2-ub protein, thereby affecting the molecule’s structure. Conclusions: The data provided in this study on the effect of spacers on the immunogenicity of multi-epitope constructs can be used to optimize the design of vaccine candidates. However, further research is needed to assess their clinical potential.
Background/Objectives: Hepatitis A virus (HAV) infection is a relevant biological risk in some occupational settings and has long been discussed as an occupational health concern among municipal waste collection workers. Data on HAV seroprevalence and vaccination history in this occupational group remain limited in Italy. This study investigated HAV seroprevalence, self-reported vaccination history, and factors associated with HAV seropositivity among waste collection workers in Sardinia. Methods: This retrospective cross-sectional study analyzed HAV seroprevalence and self-reported vaccination history among 326 workers in Sardinia, Italy, using occupational health surveillance data (2017–2024). Recorded variables included age, sex, smoking habits, years of service, work setting, vaccination status, and serological results. Chi-square and Mann–Whitney U tests assessed group differences; logistic regression identified factors independently associated with HAV seropositivity. Results: HAV seroprevalence was 44.2%; only 0.9% of participants reported previous HAV vaccination. Multivariable analysis identified older age, but not years of service, as independently associated with HAV seropositivity once age was modeled as a continuous variable—a pattern more consistent with birth-cohort differences in lifetime HAV exposure than with cumulative occupational exposure. Worksite 7 showed a higher prevalence ratio of HAV seropositivity relative to the reference site, but this finding was based on a small subsample and should be considered exploratory; observed worksite-level differences may reflect organizational rather than geographic factors. Conclusions: Older age, rather than occupational tenure, was independently associated with HAV seropositivity among Sardinian waste workers, a pattern consistent with birth-cohort differences in lifetime exposure. The high seroprevalence and very low vaccination uptake highlight the need to strengthen prevention through improved vaccination access, awareness, and better integration of occupational and public health strategies.
Background: Over the past decade, the East New Britain Provincial Health Authority in Papua New Guinea has worked with partner research organisations to implement data-driven interventions to improve immunisation coverage. This paper reports on facility assessments conducted as part of a cross-sectional study to understand improvements and identify enablers and barriers to routine childhood immunisation in the province. Methods: Between May and August 2023, nine urban and rural health facilities, providing immunisation services at the time of the study in five areas, were assessed using an adapted World Health Organisation (WHO) Service Availability and Readiness Assessment tool. The tool evaluated facility characteristics, routine childhood immunisation readiness and vaccine supply data. Data were analysed using descriptive statistics and findings were mapped to adapted WHO health system categories to identify service delivery improvement priorities. Findings: Several aspects of immunisation service availability and quality had improved since an assessment in 2016/17. Strengths included fixed-facility and outreach service models tailored to catchment populations, high availability of cold chain and vaccine administration equipment, improved immunisation guidance and job-aids. Priority areas included increasing workforce capacity, improving health record completion to inform outreach, increasing availability of guidelines and reporting tools, reducing stock-outs and enhancing stock tracking. Conclusions: Offering accessible vaccination at every opportunity and using quality data to inform programme implementation and resource allocation are priorities for the Provincial Health Authority. This facility-level assessment identified existing immunisation delivery strengths and highlighted community- and provincial-level priority investment areas to strengthen facility capacity and routine immunisation service delivery.
Background/objective: Older adults experience a disproportionate burden of severe influenza. In the P303 trial (NCT058279789), mRNA-1010 showed greater immunogenicity versus high-dose inactivated influenza vaccine (HD-IIV4) in adults ≥65 years of age. Here, we used a correlate-of-protection framework to estimate the relative VE (rVE) of mRNA-1010 compared with HD-IIV4. Methods: A sigmoidal function was used to model the relationship between geometric mean haemagglutinin assay inhibition (HAI) titers (GMTs) and vaccine efficacy (VE) using data from the P304 trial (NCT06602024), which compared mRNA-1010 and the standard-dose IIV4 in adults ≥50 years of age. The model was then applied to GMTs from the P303 trial to estimate rVE of mRNA-1010 vs. HD-IIV4 in adults ≥65 years. Temporal waning and weighting of case distributions were incorporated to provide a season-integrated estimate. Simulations were performed for three influenza seasons (A/H1N1-dominant, A/H3N2-dominant, and balanced), with a sensitivity analysis varying vaccination and epidemic peak timing. Results: At Day 29, rVE for mRNA-1010 vs. HD-IIV4 was 24.1% (95% CI: 18.2–29.5%) against A/H1N1, 14.5% (8.3–20.3%) against A/H3N2, and 21.0% (16.0–25.8%) against B/Victoria. The season-integrated rVE was 12.4% (3.4–21.3%) across all three strains, with point estimates ranging from 11.6% to 12.6%. Similar findings were seen across simulated seasons, with rVE estimates ranging from 8.8% to 14.3% when varying vaccination timing, peak timing, and strain dominance. Conclusions: Based on this CoP framework, mRNA-1010 was projected to have higher VE than HD-IIV4 in adults ≥65 years of age across a range of simulated epidemiological conditions.
Objective: To evaluate the association between 9-valent human papillomavirus (HPV9) vaccination and the risk of new-onset juvenile idiopathic arthritis (JIA), with particular attention to sex-specific differences, including the relative lack of evidence in males and the potential impact of the COVID-19 pandemic. Patients and Methods: Using the TriNetX U.S. Collaborative Network (2016–2023), children aged 9–13 years who received HPV9 vaccination were compared with unvaccinated controls in prepandemic and pandemic periods. Incident JIA was assessed using matched cohort analyses and time-to-event methods. Results: Similar sex-specific patterns were observed across both periods. HPV9 vaccination was associated with a lower risk of JIA among girls (HR = 0.45 95% CI = 0.22–0.95 in prepandemic and HR = 0.36 95% CI = 0.17–0.74 during pandemic period), while no increased risk was observed among boys (HR = 1.57 95% CI = 0.67–4.05 in prepandemic and HR = 1.14 95% CI = 0.56–2.34 during pandemic period). Among unvaccinated individuals, girls consistently exhibited a higher incidence of JIA than boys. The COVID-19 pandemic did not alter these associations. Conclusions: HPV9 vaccination was not associated with an increased risk of JIA in either sex. A consistent sex-specific pattern was observed across both study periods, with a lower risk of JIA among vaccinated girls but not boys. This finding suggests a potential sex difference in the association between HPV9 vaccination and JIA and warrants further investigation. However, residual confounding, including healthy-vaccinee bias and differences in healthcare utilization, cannot be fully excluded.
The authors would like to make the following corrections to this published paper [...]
Aquaculture has rapidly emerged as one of the fastest-growing industries, supplying nearly half of all aquatic food products intended for human consumption [...]
Background/Objectives: Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults, and in Mexico’s rapidly growing older-adult population it may place increasing pressure on hospital-based care; however, Mexico-specific evidence to inform adult RSV immunization policy remains limited. This study estimated the long-term clinical and economic burden of medically attended RSV among adults aged 60–99 years in Mexico and evaluated the health impact and cost-effectiveness of a year-round RSVpreF vaccination program. Methods: A population-based Markov cohort model compared the RSVpreF vaccination with no vaccination in a hypothetical Mexican cohort aged 60–99 years over a lifetime horizon. Outcomes included RSV-related hospitalizations, emergency department (ED) and physician office (PO) encounters, in-hospital deaths, life-years (LYs), and quality-adjusted life-years (QALYs). Analyses were conducted from Mexican healthcare system and societal perspectives in 2025 Mexican pesos (MXN$) and US dollars (US$), with costs and outcomes discounted at 5% annually. One-way and probabilistic sensitivity analyses and scenario analyses assessed the robustness of the findings. Results: With 58% uptake, RSVpreF reduced hospitalizations by 187,825, ED encounters by 178,278, PO encounters by 465,976, and RSV-related deaths by 15,384. In the first 5 years, hospitalizations, ED encounters, and deaths declined by 31% each, and PO encounters by 14%. Over the lifetime horizon, vaccination generated an additional 96,227 discounted LYs and 71,526 discounted QALYs, while avoiding MXN$ 19,484 million (US$ 1061 million) in direct medical costs and MXN$ 3324 million (US$ 181 million) in indirect costs. Conclusions: Year-round RSVpreF vaccination in Mexico among adults aged 60–99 years could substantially reduce medically attended RSV cases and RSV-related mortality and is projected to be cost-effective, thereby supporting the adoption of preventive strategies to address the growing clinical and economic burden of RSV in Mexico’s aging population.
Background: Pharmacovigilance systems have flagged possible associations between mRNA COVID-19 vaccination and systemic autoimmune inflammatory rheumatic diseases (AIRDs), generating uncertainty for rheumatologists counselling patients. As the first population-scale deployment of an mRNA vaccine platform, COVID-19 vaccination provides a unique setting to examine whether autoimmune safety signals detected in spontaneous reporting systems correspond to measurable disease risk. We synthesised pharmacovigilance and population-based evidence on incident EULAR-defined systemic AIRDs after mRNA COVID-19 vaccination and assessed whether disproportionality signals were corroborated by analytical studies. Methods: We conducted a PRISMA 2020-compliant systematic review searching MEDLINE, Web of Science, Scopus, Embase, and the Cochrane Library from 2019 to April 2026, supplemented by medRxiv and trial registries. Eligible studies included pharmacovigilance disproportionality analyses and analytical studies, including cohorts and randomised controlled trials, evaluating BNT162b2 or mRNA-1273 in adults without known pre-existing autoimmune disease. Risk of bias was assessed using READUS-PV, ROBINS-I, and RoB 2. Meta-analysis was not performed because of substantial heterogeneity. Results: Fourteen studies were included: seven pharmacovigilance studies and seven analytical studies. Disproportionality analyses suggested increased reporting of selected AIRDs, most consistently polymyalgia rheumatica and giant cell arteritis, mainly when all other adverse-event reports served as comparators. These signals were largely neutral when influenza vaccines were the reference. Across analytical studies, associations were inconsistent; modest increases in systemic lupus erythematosus appeared only in selected analyses. Long-term evidence was scarce: only four studies, from three countries (South Korea, Israel, and Norway), followed participants for up to approximately one year, and three of these reported at least one positive association—systemic lupus erythematosus, post-booster rheumatoid arthritis, and polymyalgia rheumatica in older adults—whereas studies restricted to risk windows of three months or less reported no increase. Conclusions: The available evidence does not indicate a consistent increase in incident systemic AIRDs after mRNA COVID-19 vaccination. Although pharmacovigilance studies identified comparator-dependent signals for selected diseases, particularly polymyalgia rheumatica and giant cell arteritis, these findings were generally not confirmed in comparative population-based studies and should be considered hypothesis-generating. Delayed-onset disease remains poorly characterised, and studies with at least one year of follow-up are needed.
