Vaccine[JOURNAL]
Sun
200 papers
Residual burden of severe RSV disease in infants during the first season of maternal RSVpreF immunization in Argentina: A hospital-based, multicentre, retrospective cohort study.
Dvorkin J, Pico M, Guiñazú G … +23 more , Crespi MS, Lee S, Merlino R, Palau J, Samaruga C, Esposto S, Pichinenda M, Regalado A, Torre V, Fenelli GS, Ossorio MF, Sbruzzi A, Souto SM, Ferrero F, Losada JV, Graziano A, Ojeda MN, Lugo S, Geli G, Schpilberg M, Eymann A, Busaniche J, Caballero MT
Vaccine · 2026 Jul · PMID 42214177 · Publisher ↗
BACKGROUND: Argentina pioneered the implementation of maternal immunization (MI) with RSVpreF to prevent RSV hospitalizations in infants. This study aims to assess the residual burden of RSV-related hospitalizations in i...
BACKGROUND: Argentina pioneered the implementation of maternal immunization (MI) with RSVpreF to prevent RSV hospitalizations in infants. This study aims to assess the residual burden of RSV-related hospitalizations in infants under 12 months during Argentina's first season of MI. METHODS: This multicentre, retrospective cohort study utilized the RIMA network across five tertiary hospitals in the Metropolitan Area of Buenos Aires. We analysed RSV-related hospitalizations in infants <12 months old during the first post-MI season (2024) and compared them with historical data (2018-2023). The primary objective was to characterize the "protection gap" among hospitalized infants. FINDINGS: Overall, 10,860 infants aged <12 months were hospitalized with ALRTI during the study; 3967 (36.29%) were RSV-positive. During the first vaccination season, 91.73% (477/520) of RSV-hospitalized infants were born to unvaccinated mothers. The primary protection gap was temporal: 43.18% (133/308) of infants under 6 months hospitalized during 2024 were born before the vaccination campaign started. Severe RSV disease remained prevalent, with 131/148 infants (88.52%) requiring PICU admission. INTERPRETATIONS: While maternal immunization is a landmark intervention, a substantial residual burden of severe RSV remains in Argentina. This burden is driven by infants born outside the vaccination window and high-risk preterm cohorts. To achieve comprehensive protection, coordinated strategies, including the integration of long-acting monoclonal antibodies alongside maternal vaccines, are necessary to close existing equity and protection gaps. FUNDING: This work was supported by SANOFI and AstraZeneca (RSV00105).
Interventions to improve pre-school vaccination timeliness: a systematic review.
Sanderson K, Butt S, Campbell CNJ … +2 more , Beck CR, French CE
Vaccine · 2026 Jul · PMID 42214176 · Publisher ↗
BACKGROUND: Improving the timeliness of pre-school vaccinations (children aged 0 to 5 years) is an important public health goal to prevent outbreaks and maximise protection during early childhood. Multiple studies have h...
BACKGROUND: Improving the timeliness of pre-school vaccinations (children aged 0 to 5 years) is an important public health goal to prevent outbreaks and maximise protection during early childhood. Multiple studies have highlighted the need for effective public health interventions to improve timely vaccination, and consequently the overall effectiveness of vaccination programmes. We aim to synthesise evidence on vaccination timeliness interventions and subsequently provide recommendations to improve pre-school vaccination timeliness in England. METHODS: We conducted a systematic review of randomised controlled trials (RCTs) and non-randomised studies. Studies were eligible if they were conducted in high-income countries and evaluated an intervention to improve timeliness of any pre-school vaccination on the United Kingdom (UK) national childhood vaccination schedule. Five databases and grey literature were searched to February 2025. Risk of bias was assessed using Cochrane risk of bias tools. Data were analysed using random-effects meta-analyses and synthesis without meta-analysis (using effect direction plots). RESULTS: Of the 10,385 records from database searches and 1490 records from citation searches, 33 studies were eligible (15 RCTs, 18 non-randomised studies). Most studies were conducted in the USA (n = 24) and reported on the timeliness of multiple pre-school vaccines (n = 23). Twelve studies (36%) were judged as serious or critical risk of bias, eleven at moderate and ten at low risk. Various intervention groups were identified: call-recall (n = 10), quality improvement (n = 9), education (n = 5), multicomponent (n = 5), combination vaccines (n = 2), communication (n = 1) and vaccination schedule change (n = 1). We found limited evidence from a small number of studies of a potential beneficial effect of combination vaccines, communication, quality improvement, education and schedule change interventions. CONCLUSION: We identified several possible interventions to improve pre-school vaccination timeliness. However, we found limited quantity and quality of evidence on this topic. We recommend further high-quality studies evaluating interventions to improve vaccination timeliness in England, and application of consistent vaccination timeliness definitions.
Optimized flagellin enhances systemic and mucosal immune responses induced by SARS-CoV-2 virus-like particle vaccines.
Song L, He G, Cui Y … +7 more , Tan R, Wang Y, Zhang H, Qian W, Geng S, Pan Z, Jiao X
Vaccine · 2026 Jul · PMID 42208338 · Publisher ↗
BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mutates continuously, and current injectable vaccines induce limited mucosal immunity, while clinical subunit mucosal vaccines and safe adjuvants a...
BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mutates continuously, and current injectable vaccines induce limited mucosal immunity, while clinical subunit mucosal vaccines and safe adjuvants are lacking. Virus-like particles (VLPs) are promising vaccine candidates, and flagellin is a potential TLR5 agonist adjuvant, yet its high intrinsic antigenicity remains a challenge. METHODS: SARS-CoV-2 S, E, M proteins were expressed in Sf9 cells via the baculovirus expression system to prepare self-assembled VLPs. Full-length Salmonella flagellin (FliC) and its truncated variant NCFliC (ΔD2/D3) were expressed and purified. TLR5 ligand activity of FliC/NCFliC was verified in HEK293-mTLR5 cells. BALB/c mice were intranasally immunised with VLP alone or combined with FliC/NCFliC. The humoral, mucosal and cellular immune responses were evaluated by ELISA, splenocyte proliferation assay and cytokine detection assays. RESULTS: The prepared VLPs (≈80 nm) exhibited native structure and specific ACE2-binding activity. FliC and NCFliC both retained robust TLR5 ligand activity, activating NF-κB and promoting IL-8 secretion. Intranasal immunization showed NCFliC and FliC both significantly enhanced VLP-specific humoral immunity (IgG), Th1-type responses (IgG2a/IFN-γ), mucosal IgA (nasal/bronchoalveolar lavage fluid) and splenocyte proliferation, with no significant difference in adjuvant efficacy between them. Notably, compared with FliC, NCFliC induced significantly lower levels of FliC-specific serum IgG, IgG subclasses (IgG1, IgG2a), and IgA in nasal and bronchoalveolar lavage fluid. CONCLUSIONS: NCFliC retains potent adjuvant activity while having reduced intrinsic immunogenicity, and intranasal immunization with VLP + NCFliC elicits robust systemic and mucosal immunity in mice. NCFliC is a promising mucosal adjuvant for SARS-CoV-2 VLP vaccines, providing a potential strategy for developing next-generation anti-coronavirus mucosal vaccines.
Global cessation of bivalent oral polio vaccine (bOPV): A comprehensive review of modeling studies from 2000 to 2025.
Sun Y, Keskinocak P, Peak CM … +1 more , Steimle LN
Vaccine · 2026 Jun · PMID 42208276 · Publisher ↗
BACKGROUND: Oral polio vaccine (OPV) has been central to the Global Polio Eradication Initiative (GPEI)'s efforts due to its ability to interrupt transmission. Yet, because OPV contains live-attenuated virus, its continu...
BACKGROUND: Oral polio vaccine (OPV) has been central to the Global Polio Eradication Initiative (GPEI)'s efforts due to its ability to interrupt transmission. Yet, because OPV contains live-attenuated virus, its continued use carries risks, especially the emergence of circulating vaccine-derived poliovirus (cVDPV) in under-vaccinated communities. To reduce these risks, phased OPV cessation by serotype began in 2016 with the global "switch" from trivalent OPV (containing types 1, 2, and 3) to bivalent OPV (bOPV, containing types 1 and 3) after the eradication of wild poliovirus type 2. However, continued post-switch cVDPV type 2 outbreaks demonstrated the complexities of safe OPV cessation. Along with persistent wild poliovirus type 1 transmission and cVDPV outbreaks of other serotypes, these experiences underscored the need for evidence-based strategies to guide bOPV cessation. AREAS COVERED: We conducted a comprehensive review of modeling studies published from 2000 to 2025 that inform OPV cessation planning. 116 articles met our inclusion criteria. These studies examined OPV cessation's prerequisites, follow-up actions, and response strategies. We compared model types and assumptions. We synthesized modeling insights across decision-relevant themes: pre-cessation planning of routine immunization (RI) and supplementary immunization activities (SIAs), post-cessation risk management, surveillance, and vaccine stockpiling. CONCLUSIONS: The included articles emphasized: (i) implement multiple, high-quality bOPV SIAs over several years until cessation, with coverage levels and target age groups tailored to countries; (ii) strengthen RI before cessation by increasing coverage and introducing a immunologically effective IPV schedule of at least two doses; (iii) maintain high RI IPV coverage, rapid and high-quality outbreak response using available homotypic OPV, and strict containment protocols after cessation; (iv) ensure sensitive surveillance and adequate vaccine stockpiles before, during, and after cessation. These findings informed the Strategic Advisory Group of Experts on Immunization in its endorsement of GPEI's bOPV cessation policy framework. Nonetheless, important gaps remain, including how to measure population immunity and define target thresholds for cessation readiness considering subnational heterogeneity, whether globally synchronized cessation is necessary or geographically phased approaches could achieve comparable risk reduction, and how the availability of novel OPV formulations may influence cessation strategies. Future studies should incorporate subnational data, reflect new vaccine characteristics, and integrate diverse modeling approaches to guide more context-specific decisions.
Vaccine-preventable disease outbreaks in schools, part 2: pertussis, meningococcal disease, diphtheria, poliomyelitis, hepatitis A, and rotavirus infection.
Cassimos DC, Effraimidou E, Irakleidou I … +2 more , Medic S, Maltezou HC
Vaccine · 2026 Jun · PMID 42208275 · Publisher ↗
Schools are essential elements during childhood and adolescence, not only for providing education, but also for promoting the personal development and socialization of students. School attendance almost always takes plac...
Schools are essential elements during childhood and adolescence, not only for providing education, but also for promoting the personal development and socialization of students. School attendance almost always takes place in classrooms and in close proximity for several hours daily. Students also interact with students from other classrooms and schools through participation in sports and extracurricular activities. These characteristics render the schools ideal environments for the transmission of vaccine-preventable diseases. We reviewed 57 articles published from 2000 to June 2, 2025, presenting original data on pertussis, meningococcal disease, hepatitis A, rotavirus, diphtheria, and poliomyelitis outbreaks in schools. The published outbreaks occurred almost exclusively in high-income and upper-middle income countries. Among all outbreaks, pertussis has caused most outbreaks, and by far the largest in terms of duration, number of cases, and attack rates. Rotavirus also caused significant outbreaks, mainly in primary schools. Hepatitis A outbreaks were often waterborne or foodborne and part of community outbreaks. Diphtheria and poliomyelitis outbreaks were extremely rare. Fatalities were reported exclusively in meningococcal and diphtheria outbreaks, with high case fatality rates among students. On several occasions, school activities were disrupted. In conclusion, it is likely that school outbreaks are underreported, particularly in low-income countries. Considering the decline in vaccination coverage in recent years in many countries worldwide, the risk of school outbreaks is rising. Strengthening vaccination services, surveillance, and diagnostic capacity are needed to prevent and contain them.
TLR7 ligand-cyclodextrin conjugate is a promising adjuvant for intranasal influenza vaccine.
Jufuku R, Shinchi H, Murata K … +6 more , Chan M, Hayashi T, Cottam HB, Carson DA, Suda Y, Wakao M
Vaccine · 2026 Jun · PMID 42202427 · Publisher ↗
The development of novel vaccine adjuvants with high efficacy remains an important issue in vaccine design. In this study, we examined a 1 V209-cyclodextrin (CD) conjugate that we have previously developed and evaluated...
The development of novel vaccine adjuvants with high efficacy remains an important issue in vaccine design. In this study, we examined a 1 V209-cyclodextrin (CD) conjugate that we have previously developed and evaluated its potential as an adjuvant for intranasal vaccines. Intranasal administration of the vaccines adjuvanted with 1 V209-CD conjugate enhanced both mucosal and systemic IgA and IgG responses against a model antigen, ovalbumin, recombinant hemagglutinin (rHA) from influenza virus strain A/Puerto Rico/8/1934 (H1N1), and a commercially available split influenza vaccine. In an influenza A virus challenge experiment, mice immunized with vaccines adjuvanted with the 1 V209-CD conjugate showed significantly improved survival and reduced lung tissue damage compared with non-adjuvanted controls, indicating that the 1 V209-CD conjugate promoted protective effects. These findings demonstrate that the 1 V209-CD conjugate effectively enhanced immunogenicity of the rHA or existing influenza split vaccine and may serve as a useful adjuvant for intranasal vaccines.
Using non-primary care clinical settings to increase HPV vaccination uptake: a scoping review.
Surapaneni S, Baxter Z, Abdurrob A … +6 more , Leonard K, Bernacchi V, Chang S, Yaremchuk K, Tam S, Adjei Boakye E
Vaccine · 2026 Jun · PMID 42202426 · Publisher ↗
BACKGROUND: Despite evidence that over 90% of HPV-associated cancers can be prevented by the HPV vaccine, vaccination rates remain suboptimal. Specialty clinics that do not traditionally offer HPV vaccination, present an...
BACKGROUND: Despite evidence that over 90% of HPV-associated cancers can be prevented by the HPV vaccine, vaccination rates remain suboptimal. Specialty clinics that do not traditionally offer HPV vaccination, present an opportunity to improve vaccine uptake among adults. This scoping review evaluates the potential impact of HPV vaccination interventions on HPV-vaccination rates and acceptance in non-primary care settings. METHODS: Using the Arksey and O'Malley's scoping review framework, and the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews (PRISMA-ScR), Ovid MEDLINE, Embase, and Web of Science were queried to include articles published in US from 2006 to 2024 using search terms related to "human papillomavirus vaccination" and "specialty clinics". RESULTS: Out of the 1752 studies identified, 10 studies met the inclusion criteria. Sample size ranged from 50 to 3709 participants and age range was 18-45 years. Settings included otolaryngology, obstetrics and gynecology, family planning, and substance health outpatient clinics. Baseline vaccination rate ranged from 5.2% to 47%. Five studies were interventional, evaluating the effects of patient counseling, pharmacist-physician education, free vaccination or mailed reminders on HPV vaccination rates. The interventions resulted in increases in vaccination rate with a range of 5.6% to 16%. CONCLUSIONS: For adults eligible for HPV vaccination, specialty outpatient clinics may present a unique opportunity to discuss and deliver HPV vaccination, given that providers in these settings also treat HPV-associated diseases and are well equipped to engage in shared decision making with patients. Future research should focus on the acceptability, feasibility, and effectiveness of implementation of an HPV vaccination program in these settings.
Antifungal vaccine development: where we are, where we are headed.
Janeczko M, Kubiński K, Wawiórka L
Vaccine · 2026 Jun · PMID 42202425 · Publisher ↗
Invasive fungal infections (IFIs) represent a devastating global health crisis, causing millions deaths annually worldwide. This staggering burden disproportionately affects immunocompromised individuals, including those...
Invasive fungal infections (IFIs) represent a devastating global health crisis, causing millions deaths annually worldwide. This staggering burden disproportionately affects immunocompromised individuals, including those with HIV/AIDS, cancer, patients undergoing chemotherapy and organ transplant recipients. Current therapeutic options remain limited to only five major drug classes, which face increasing pressure from emerging resistance and frequent treatment failures. Consequently, the absence of a commercially available antifungal vaccine represents a critical gap in preventive medicine. This comprehensive review maps the progression from mechanistic immune responses to the latest vaccine platforms, while critically addressing biological and technical constraints inherent in the field. Rather than a simple enumeration of data, this review constructs a conceptual bridge between laboratory discovery and clinical reality. This integrated model is specifically tailored to address the complexities of treating high-risk, immunosuppressed populations. It highlights how emerging strategies, such as trained immunity-based and donor-derived T-cell therapies, may circumvent the inherent challenges of vaccinating the immunocompromised host. By synthesizing recent advances and identifying critical knowledge gaps, this review charts a strategic path forward for this essential field of vaccine research.
Increasing prebunking effectiveness to aid disinformation-susceptible publics in overcoming vaccine-related disinformation.
Chou S, Boman CD
Vaccine · 2026 Jun · PMID 42202424 · Publisher ↗
In the dynamic intersection of health communication and disinformation, this study investigates tailored intervention strategies for disinformation-susceptible public segments classified by the motivation-knowledge-attit...
In the dynamic intersection of health communication and disinformation, this study investigates tailored intervention strategies for disinformation-susceptible public segments classified by the motivation-knowledge-attitude framework. Using a two-phase survey and experimental design with American adults, participants were segmented into four public types (disinformation-immune, vulnerable, receptive, and amplifying) and exposed to one of three inoculation message conditions: autonomy supportive, autonomy controlling, or control. Data were analyzed using ANCOVA with Bonferroni-adjusted post-hoc comparisons to examine main and interactive effects of public segment and message type on motivational threat, autonomy support, and perceived message effectiveness (PME). Both inoculation message types elicited significantly higher motivational threat than the control (p < .001), with disinformation-vulnerable and amplifying publics reporting the highest levels overall (p < .001). Both inoculation conditions were perceived as significantly more effective than the control (p = .007 and p = .001, respectively). A significant interaction between public segment and message type was identified (p = .005), driven primarily by disinformation-immune publics, who rated both inoculation messages significantly higher in PME than the control (p < .001), while no significant message type differences emerged among other segments. These findings underscore the importance of audience segmentation in inoculation campaign design and offer practical guidance for health communication professionals crafting strategies to combat vaccine disinformation.
Drivers of and implementation strategies for influenza vaccination for cardiovascular populations in China: a scoping review.
Liu R, Fan Y, Xiong S … +5 more , Lin J, Patel A, Du X, Di Tanna GL, Liu H
Vaccine · 2026 Jun · PMID 42202423 · Publisher ↗
INTRODUCTION: Understanding the drivers of influenza vaccine hesitancy, acceptance, demand, and uptake especially in low- and middle-income countries is a priority in preventing seasonal influenza as outlined in the Worl...
INTRODUCTION: Understanding the drivers of influenza vaccine hesitancy, acceptance, demand, and uptake especially in low- and middle-income countries is a priority in preventing seasonal influenza as outlined in the World Health Organization (WHO) global influenza strategy. Individuals with cardiovascular disease (CVD) are a key target group recommended by WHO, yet influenza vaccine coverage in China is reported to be extremely low. We aim to explore drivers of this and implementation strategies used to increase the influenza vaccine coverage among CVD populations in China. METHODS: We conducted a scoping review using academic databases, the Chinese Clinical Trial Registry, and Chinese grey literature repositories from database inception till August 2025, based on predetermined inclusion criteria. Data on potential determinants of vaccine uptake and intervention details were extracted and analyzed using a narrative synthesis. Implementation strategies were mapped to the Availability, Accessibility, Acceptability, and Quality (AAAQ) health service delivery framework. FINDINGS: Thirteen publications published between 2009 and 2024 were included, with an increase in outputs since the COVID-19 pandemic. Lower vaccine uptake appeared to be associated with lower socioeconomic status and poorer health literacy. Physician recommendations, accessible vaccine clinics, and adequate vaccine supply appeared to be health system related facilitators to vaccination. Four studies reported implementation strategies comprising provider education and recommendations, public funding, and follow-up on vaccination status. Incorporating strategies that addressed a greater number of AAAQ domains appeared to result in higher influenza vaccine uptake. CONCLUSION: Drivers and implementation strategies of influenza vaccination have not been widely studied among CVD populations in China. Available information suggests that higher patient sociodemographic status, greater health literacy, presence of physician recommendations, accessible vaccine clinics, and affordable vaccines may positively drive influenza vaccination. Addressing gaps in the AAAQ domains through targeted implementation strategies could improve influenza vaccination. Future strategies should undergo rigorous evaluation. REGISTRATION DETAILS: Our protocol is registered at Open Science Foundation (OSF) with registration DOI https://doi.org/10.17605/OSF.IO/XDMBT.
Timor-Leste's immunization journey: progress, challenges, and the road to IA2030 a viewpoint on leaving no child behind.
da Silva Marques M, de Neri Machado F, Soares NG … +7 more , Dos Santos NB, de Oliveira JB, Sarmento N, da Costa Amaral BV, Babo LNMG, Amaral AXB, Mali MA
Vaccine · 2026 Jun · PMID 42202422 · Publisher ↗
BACKGROUND: Timor-Leste, a post-conflict nation with a population of 1.34 million, has steadily developed its immunization program since 2000. This viewpoint analyzes progress toward the Immunization Agenda 2030 (IA2030)...
BACKGROUND: Timor-Leste, a post-conflict nation with a population of 1.34 million, has steadily developed its immunization program since 2000. This viewpoint analyzes progress toward the Immunization Agenda 2030 (IA2030) goals, identifies persistent surveillance gaps, and extracts lessons for other low-and middle-income countries. METHODS: We synthesized data from Timor-Leste's 2023 and 2024 EPI fact sheets, the July 2024 HPV vaccine launch report, WHO surveillance guidance, and IA2030 monitoring frameworks. Coverage trends (2014-2023) and surveillance indicators were evaluated against global standards. RESULTS: Zero-dose children reduced by 22% in one year (from 4,184 to 3,254). Districts with high dropout rates (DTP1 to DTP3) fell from 36% to 0%. Government financing for vaccines increased from 64% to 80% (2022-2023). However, MCV1 coverage stagnated at 72% (far below the 95% measles elimination threshold). The non-polio AFP rate (0.42/100,000) remains well below the global target of ≥2.0. Only 38% of IgM results returned within 4 days. HPV vaccine launched in July 2024, targeting 11-14-year-old girls. CONCLUSIONS: Timor-Leste demonstrates that political commitment and targeted equity strategies can reduce zero-dose children even in resource-constrained settings. However, surveillance system gaps, particularly for AFP and laboratory turnaround times, pose serious risks for polio eradication and outbreak detection. Key lessons for IA2030 implementation include the following: (1) political stability enables cumulative health system gains; (2) one-year indicator improvements require multi-year validation; (3) surveillance quality determines outbreak response speed; and (4) school-based platforms effectively reach adolescents.
A novel ferritin-based nanoparticle vaccine targeting lgE confers protection against chronic allergic asthma in a murine model.
Li W, Liu S, Cui W … +7 more , Tang S, Huang Y, Li Y, Jin X, Ding Z, Tan W, Wei Z
Vaccine · 2026 Jun · PMID 42202421 · Publisher ↗
BACKGROUND: Allergic asthma is a major global health concern owing to its high prevalence and substantial socioeconomic burden. It is characterized by elevated levels of immunoglobulin E (IgE), which plays a pivotal role...
BACKGROUND: Allergic asthma is a major global health concern owing to its high prevalence and substantial socioeconomic burden. It is characterized by elevated levels of immunoglobulin E (IgE), which plays a pivotal role in the pathophysiology of allergic disorders. Therapeutic anti-IgE antibodies, including omalizumab, have emerged as a validated strategy for the management of IgE-mediated disorders. However, their clinical use requires repeated administration and remains costly. Here, we developed a nanoparticle-based anti-IgE vaccine by genetically fusing an IgE-derived epitope peptide to the N-terminus of a hybrid ferritin. RESULTS: The antigen was expressed in E.coli and purified to homogeneity. Preventive vaccination was conducted in a mouse model of chronic allergic asthma. High levels of anti-IgE antibodies were elicited and ameliorated key features of allergic asthma including the reduction in IgE levels, peribronchiolar inflammation, mucus production, and altered expression of inflammation-related genes. CONCLUSION: The anti-IgE vaccine developed in this study has protective effects in allergic asthma mice, offering a promising translatable strategy for the prevention and treatment of chronic allergic asthma.
Advancing national preparedness for the introduction of novel tuberculosis vaccines in South Africa: policy, evidence, and system readiness insights from a national workshop.
Ndjeka N, Subrayen P, Hanekom WA … +8 more , Jassat W, Luabeya AKK, Mkhondo N, Muloiwa R, Tisile P, Ntshiqa T, Boffa J, Giersing B
Vaccine · 2026 Jun · PMID 42190622 · Publisher ↗
Tuberculosis (TB) remains a leading cause of morbidity and mortality in South Africa despite substantial progress in diagnosis and treatment. Several candidate vaccines targeting adolescents and adults are now in advance...
Tuberculosis (TB) remains a leading cause of morbidity and mortality in South Africa despite substantial progress in diagnosis and treatment. Several candidate vaccines targeting adolescents and adults are now in advanced clinical development, raising the prospect that a new TB vaccine could become available as early as 2029. However, translating clinical trial success into population-level impact will require early policy planning, health system preparedness, and coordinated national action. To support these efforts, the South African National Department of Health and the World Health Organization convened a national TB Vaccine Preparedness Workshop in Johannesburg in July 2025, bringing together policymakers, researchers, regulators, manufacturers, and civil society and community representatives. The workshop aimed to align stakeholders on priority populations and delivery strategies for future TB vaccines, identify evidence needs to inform national policy decision-making, and outline actions required to ensure timely and equitable introduction. Discussions highlighted that successful introduction of a TB vaccine for adolescents and adults will depend on coordinated readiness across delivery systems, regulatory and manufacturing processes, financing mechanisms, and public trust. Participants emphasised pursuing a broad population-level vaccination strategy for adolescents and adults, building on existing immunisation and primary healthcare platforms while adapting delivery strategies to reach these populations. Priorities included generating South Africa-specific evidence to inform policy and financing decisions, engaging early with regulatory authorities and manufacturing partners, strengthening data systems for safety monitoring and evaluation of vaccine impact, developing sustainable financing approaches, and fostering community engagement to build vaccine confidence. These insights provide a foundation for coordinated national planning to ensure timely and equitable introduction of future TB vaccines in South Africa.
Second regulatory workshop on utilising in silico models to expedite vaccine development, testing, and lifecycle management - an expert meeting report.
Meln I, Van Molle W, Vélez MP … +24 more , Baay M, Bracewell DG, Brusselmans K, Cardillo AG, Clénet D, Forestieri C, Girardon L, Gudjonsson A, Guzzi A, Hesselink R, Jørgensen JB, Lanzrath H, Lebrun P, Li X, von Lieres E, Mansois N, Natalis L, Pollinger JC, García LR, Şenel S, Spruth M, Welin M, Olesen OF, Calvosa E
Vaccine · 2026 Jun · PMID 42177843 · Publisher ↗
The Inno4Vac consortium, funded under the Innovative Medicines Initiative 2 Joint Undertaking, was launched in September 2021. Among its four key objectives is the development of an open-source, in silico simulation plat...
The Inno4Vac consortium, funded under the Innovative Medicines Initiative 2 Joint Undertaking, was launched in September 2021. Among its four key objectives is the development of an open-source, in silico simulation platform designed to support the design, scale-up, operation, and technology transfer of vaccine manufacturing processes, including stability testing. A workshop was held on May 27, 2025, in Brussels, Belgium, which provided an opportunity for modellers to show the progress made, and have an open dialogue with regulatory health authorities' representatives. Regulators are increasingly open to advanced kinetic modelling and other modelling approaches for predicting vaccine stability and shelf-life, provided they are transparent, scientifically justified, and validated with real-time data. Initial claims can rely on accelerated studies and modelling simulating worst-case scenarios, with extensions supported by additional data. In urgent contexts, extrapolation from similar products or processes may be accepted if scientifically sound. Platform-based extrapolation requires strong similarity, but product-specific data remain critical, as small formulation changes can alter stability. Simulation studies that demonstrate robustness and predictive accuracy enhance confidence. Projects like Inno4Vac highlight Bayesian methods for formulation design, though formal guidance is limited. Regulatory scrutiny depends on model risk, with low-risk models probably still requiring justification. Transparent data practices, including justified handling of outliers, are essential. Collaboration between regulators, industry, and academia remains key to advancing science-based innovation while ensuring product quality.
Improving Tdap vaccine uptake during pregnancy: a five-year analysis at a regional center.
Perry Bryce NV, Marrero Arocho ML, Seybold D … +1 more , Calhoun B
Vaccine · 2026 May · PMID 42177158 · Publisher ↗
OBJECTIVE: To evaluate tetanus, diphtheria, and acellular pertussis (Tdap) vaccination rates among pregnant patients before, during, and after the COVID-19 pandemic and identify demographic and care-related factors assoc...
OBJECTIVE: To evaluate tetanus, diphtheria, and acellular pertussis (Tdap) vaccination rates among pregnant patients before, during, and after the COVID-19 pandemic and identify demographic and care-related factors associated with vaccine uptake at our tertiary-care medical center in Southern West Virginia. METHODS: We conducted a retrospective cohort study of pregnant patients age 18 years or older with viable pregnancies through 36 weeks of gestation from January 11, 2019, to June 30, 2024 at a single tertiary-care medical center. Patients were categorized into pre-COVID-19, during-COVID-19, and post-COVID-19 cohorts. Vaccination uptake was analyzed using ANOVA, and additional bivariate analyses were conducted to identify demographic and clinical factors associated with Tdap receipt during pregnancy. RESULTS: Among 2513 patients, 1705 (67.8%) received Tdap vaccination, which was higher than the national average of 56.6% in 2022-2023. Vaccination rates did not differ across 3 different phases relative to the COVID-19 pandemic (p = .97). Tdap vaccination was more common among patients who were married as compared with unmarried patients (70.4% vs 65.8%, p = .016), white versus non-white patients (68.9% vs 62.5%, p = .011), and patients receiving care in private-practice-based clinics versus hospital-based clinics (76.6% vs 65.6%, p < .001). No statistically significant difference was noted when stratified by insurance type (p = .24) or advanced maternal age (≥35 years) (p = .35). CONCLUSION: Tdap vaccination rates at our institution exceeded national averages and remained stable throughout the COVID-19 pandemic. Persistent disparities by race, marital status, and care setting highlight vaccination inequities and support the need for targeted interventions for patient and provider sub-groups.
Nationwide survey for household preparedness and vaccination acceptance during a novel influenza pandemic scenario in Japan, 2025.
Okubo Y, Honjyo R, Uda K … +1 more , Miyairi I
Vaccine · 2026 Jun · PMID 42176440 · Publisher ↗
Pandemics and associated mitigation measures can disrupt children's daily lives and shift substantial burden to households. However, families' actionable preparedness for future pandemics remains insufficiently understoo...
Pandemics and associated mitigation measures can disrupt children's daily lives and shift substantial burden to households. However, families' actionable preparedness for future pandemics remains insufficiently understood, including caregiving capacity and vaccination acceptance. We conducted an anonymous nationwide online cross-sectional survey in November 2025 among Japanese parents residing with at least one child aged 0-18 years (N = 4961). Respondents were presented with standardized hypothetical influenza pandemic scenarios and asked to report anticipated impacts of school/childcare closures and willingness to receive a novel influenza pandemic vaccine with profiles varying in effectiveness, out-of-pocket cost, and type. We used latent profile analyses to classify households' preparedness and examined factors associated with vaccination acceptance using generalized estimation equations. In the school/childcare closure scenario, 43.6% reported being able to maintain children's learning activities, 40.5% physical activity, 41.9% emotional support, and 52.9% restrict non-essential outings. Latent profile analysis identified three preparedness profiles (high 36.1%, moderate 47.2%, low 16.7%), with a monotonic gradient across the four items. Low preparedness was more common among households with younger children, lower income, and among dual full-time working parents. Out-of-pocket cost (4000 JPY) was inversely associated with willingness to vaccinate (RR 0.77, 95% CI 0.75-0.79), whereas recent influenza vaccination history was positively associated with willingness (RR 1.58, 95% CI 1.51-1.66). Household pandemic preparedness appears to be constrained by time and financial constraints, leading to systematic gaps. Policymakers should prioritize reducing financial barriers and reinforcing importance of seasonal influenza vaccination to reduce annual morbidity and mortality and prepare for future pandemics.
Consultation report - gonococcal immunoassays and standards for vaccine development.
MacLennan CA, Davis P, Gottlieb SL … +22 more , Seib KL, Harrison OB, Duncan JA, Gorringe A, Criss AK, Jerse A, Russell MW, Isbrucker R, Kaminski RW, Connolly K, Vipond C, Belcher T, Campbell H, Delany-Moretlwe S, Finco O, Wilson S, Vichos I, Rhyne P, Pizza M, Deal C, Bash MC, Stickings P
Vaccine · 2026 Jun · PMID 42176439 · Publisher ↗
Gonorrhoea is a sexually transmitted infection with adverse outcomes for sexual, reproductive and neonatal health. Additionally, the bacterium, Neisseria gonorrhoeae, has demonstrated increasing resistance against multip...
Gonorrhoea is a sexually transmitted infection with adverse outcomes for sexual, reproductive and neonatal health. Additionally, the bacterium, Neisseria gonorrhoeae, has demonstrated increasing resistance against multiple classes of antimicrobials, making combatting gonorrhoea a priority for the World Health Organization. An effective vaccine would have substantial global public health benefit and a major impact on the silent pandemic of antimicrobial resistance. Several candidate gonococcal vaccines, representing a number of vaccine platforms, are in pre-clinical development. In addition, a number of clinical studies are underway to assess the efficacy of the meningococcal group B vaccine, 4CMenB, against gonorrhoea. A major challenge in comparing gonococcal vaccine candidates and vaccine-induced immune responses is the lack of standardised and harmonised immunoassays. At present, immunogenicity of the different vaccine formulations is measured through assays which have been developed independently in different laboratories. As the development of candidate gonococcal vaccines moves into clinical trials, improved harmonisation in the measurement of immunogenicity is key for comparing vaccine responses across trials. This requires international standards, including an international serum standard for gonococcal immunoassays, and a panel of standard target strains, which are currently lacking. A further complication is the lack of knowledge about immune correlates of protection against gonorrhoea, and, therefore, the most appropriate assays to use to assess the immune response to a candidate vaccine. As further data are gathered from clinical studies exploring protection against gonorrhoea provided by 4CMenB, it may be possible to discern correlates of protection, but this also requires standardised assays. A workshop was held at Keble College, Oxford, United Kingdom in April 2024, with participation from vaccine developers, regulators and assay standardisation specialists. Its goal was to advance discussions on gonococcal immunoassay standardisation priorities, including generation of a gonococcal international reference serum. The meeting discussion, outcomes and recommendations are outlined in this report.
Preparing for exotic foot-and-mouth disease virus outbreaks in the European neighbourhood: cross-neutralisation of internationally available vaccines against South American serotype O and serotype A field isolates.
Parekh K, Paton DJ, Browning C … +12 more , Wilsden G, Mioulet V, Wood BA, McCarron A, Bull H, Baguisi J, Chantler V, Pituco EM, Sanchez-Vazquez MJ, J Knowles N, King DP, Ludi A
Vaccine · 2026 Jun · PMID 42176438 · Publisher ↗
Foot-and-mouth disease (FMD) is a highly contagious transboundary viral disease that affects domestic and wild cloven-hoofed animals. The disease is economically devastating due to severe production losses and restrictio...
Foot-and-mouth disease (FMD) is a highly contagious transboundary viral disease that affects domestic and wild cloven-hoofed animals. The disease is economically devastating due to severe production losses and restrictions on international trade. The emergence of novel FMD viruses in new locations can require different or new vaccines to control outbreaks. This report focuses on incursions of exotic viruses of serotypes A (A/EURO-SA topotype) and O (O/EURO-SA topotype) into Egypt in 2022. These viruses originate from South America and their introduction into North Africa poses an onward risk for circulation into Africa, the Middle east, and Europe. These cases have raised questions as to whether the vaccines held in antigen banks and those deployed during ongoing control programmes in Asia and Africa could be used to control the spread of these South American viruses. In the absence of representative serotype O and A viruses from Egypt, this study used virus neutralisation tests (VNT) to evaluate the antigenic relationship between the vaccines and representative viruses from South America, to predict the ability of current FMD vaccines to provide protection against these exotic lineages.
Modelling the impact of long-acting monoclonal antibody, maternal vaccine and hybrid programs of RSV immunisation in temperate Western Australia.
Giannini F, Hogan AB, Blyth CC … +3 more , Glass K, Moore HC, STAMP RSV investigator team
Vaccine · 2026 Jun · PMID 42176437 · Publisher ↗
BACKGROUND: Two RSV immunisations products: a maternal vaccine, Abrysvo, and a long-acting monoclonal antibody, nirsevimab, both designed to prevent RSV illness in infants, have recently become available. Modelling evide...
BACKGROUND: Two RSV immunisations products: a maternal vaccine, Abrysvo, and a long-acting monoclonal antibody, nirsevimab, both designed to prevent RSV illness in infants, have recently become available. Modelling evidence is required to inform how to optimally use these products in immunisation programs to reduce the burden of RSV in young children. METHODS: We extend a dynamic transmission model calibrated to RSV-hospitalisation data of children aged <5 years in temperate Western Australia (WA) to simulate a range of potential RSV immunisation programs. Using our model, we estimate the impact of both single-product and hybrid RSV immunisation programs. The analysis considers timing of administration, coverage levels and targeting of high-risk groups. Impact on RSV burden is analysed in the context of the WA setting and the possible significant cost differences between the two products. RESULTS: All programs analysed were effective in reducing RSV burden. Programs using nirsevimab for newborn infants at similar coverage levels to the Abrysvo programs, averted more RSV-hospitalisations annually. Seasonal programs that focused on protection during high RSV activity and programs targeting high-risk infants had the lowest number needed to immunise to avert one RSV-hospitalisation. When dose cost is considered alongside program impact on RSV burden, we find evidence to support further economic analysis of hybrid programs as they could mitigate the cost differential between the two products while remaining highly effective in reducing RSV burden. CONCLUSIONS: Our study is the first to comprehensively analyse hybrid RSV immunisation programs that use Abrysvo and nirsevimab. RSV immunisation programs can substantially reduce the burden of RSV in young children. Our modelling analysis provides evidence on immunisation type, timing, coverage, high-risk groups and dosage cost that will support decision makers and can be used in economic evaluations.
Evaluation of EcoCRM, virus-like particles, and mRNA as vaccine platforms against Borrelia burgdorferi.
Rocuskie-Marker CM, Huckaby AB, Conaway OM … +25 more , Pyles GM, Dublin SR, Witt WT, Blackwood CB, de la Paz Gutierrez M, Hall JM, Ulicny SR, Padden E, Shephard S, Chapman J, Zapotocky T, Cannon-Blachere J, Peasak K, Rader NA, Miller M, Hankinson BR, Wong I, Long DA, Nunley M, Willis D, Lee KS, Cunningham C, Weaver KL, Damron FH, Barbier M
Vaccine · 2026 Jun · PMID 42176436 · Publisher ↗
Lyme disease (LD) is the most prevalent vector-borne disease in the United States, impacting ∼476,000 individuals annually with increasing incidence. Prevention relies on personal protective measures such as insecticides...
Lyme disease (LD) is the most prevalent vector-borne disease in the United States, impacting ∼476,000 individuals annually with increasing incidence. Prevention relies on personal protective measures such as insecticides and tick checks, underscoring the need for new preventatives such as vaccines. In this work, the importance of vaccine platform in LD vaccine development efforts was evaluated using non-lipidated OspA as model antigen. Recombinant OspA conjugated to CRM197 (EcoCRM OspA), a virus-like particle vaccine utilizing SpyTag and SpyCatcher (OspA-SpyVLP), and an mRNA-based vaccine construct (OspA mRNA) were evaluated and compared in C3H mice using the needle injection challenge model. To determine immunogenicity, anti-OspA and anti-B. burgdorferi antibodies were quantified via ELISA and further assessed by measuring IgG subclass, antibody avidity, and presence of antibody secreting cells. All vaccine formulations were immunogenic and led to the release of similar levels of antigen-specific IgG in serum during the duration of the experiment. However, there were significant differences around two week post-boost in the presence of antibody secreting cells, ratio of IgG1/IgG2 subclasses, and antibody avidity between platforms. Protection was measured using PCR and darkfield microscopy to determine organ positivity post-challenge. Vaccination with recombinant non-lipidated OspA and OspA-SpyVLP significantly reduced the number of positive organs compared to the PBS challenged control group. Lastly, in vitro borreliacidal activity was quantified via darkfield microscopy and the highest borreliacidal activity was observed using OspA-SpyVLP sera, with titers 16-fold higher than recombinant OspA. Altogether, these data indicated that selection of vaccine platform/formulation influenced the immunogenicity and efficacy of OspA-based LD vaccines and should be considered during development.
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