Vaccine最新文献

{"title":"Vaccines and AMR: An analysis of the funding landscape for human bacterial vaccines in low-and middle-income countries","authors":"Catherine Fleck-Vidal ,&nbsp;Anna Doubell ,&nbsp;Christiane Gerke ,&nbsp;Usha Lamichhane ,&nbsp;Lesley Ogilvie ,&nbsp;Ralf Sudbrak ,&nbsp;Jerome H. Kim ,&nbsp;T. Anh Wartel ,&nbsp;Laura Plant","doi":"10.1016/j.vaccine.2025.126771","DOIUrl":"10.1016/j.vaccine.2025.126771","url":null,"abstract":"<div><h3>Background</h3><div>Vaccines are critical tools to prevent the emergence and spread of antimicrobial resistance (AMR) through prevention of infection and reduction of subsequent antibiotic use. Since AMR is a critical issue disproportionately affecting Low- and Middle- Income Countries (LMICs), we examined investments in research and development for bacterial vaccines with a focus on LMIC-driven research.</div></div><div><h3>Methods</h3><div>Publicly available funding data on projects active from January 2007 to 15 January 2024 from the G-FINDER and Global AMR R&amp;D Hub databases were analysed. The investment into human bacterial vaccine R&amp;D was analysed to identify the recipients and geographic distribution of funding provided directly from funders and through intermediary organisations.</div></div><div><h3>Findings</h3><div>Global funding of vaccine R&amp;D for bacterial pathogens in this dataset totals 4.50 billion USD, with the majority of funding directed towards <em>M. tuberculosis</em> and <em>S. pneumoniae.</em> Most funding was received by organisations in North America and Europe, with Asia, Africa, and Central/South America collectively receiving less than 20 % of the total funding. Philanthropic and intermediary organisations, particularly Product Development Partnerships (PDPs), emerge as critical players in mobilising and coordinating resources for bacterial vaccine R&amp;D in LMICs.</div></div><div><h3>Conclusion</h3><div>Comprehensive and transparent reporting is needed to accurately assess funding to LMICs. Nevertheless, the current analysis shows that PDPs and intermediary funders are pivotal in ensuring investments reach LMIC product developers. Data gaps remain for critical bacterial pathogens on WHO's AMR priority pathogen list.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126771"},"PeriodicalIF":4.5,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety comparison between Pfizer BNT162b2, Moderna mRNA-1273, and AstraZeneca AZD1222 in a Nationwide prospective cohort survey at the beginning of the severe acute respiratory syndrome coronavirus 2 vaccination in Japan","authors":"Suminobu Ito ,&nbsp;Nao Tsuchida ,&nbsp;Susumu Kusunoki ,&nbsp;Yoshihiro Kaneko ,&nbsp;Toshio Naito ,&nbsp;Satoshi Hori ,&nbsp;Morikuni Tobita","doi":"10.1016/j.vaccine.2025.126754","DOIUrl":"10.1016/j.vaccine.2025.126754","url":null,"abstract":"<div><div>This study was conducted at 112 government and Juntendo University hospitals in February 2021 for the primary series of SARS-CoV-2 vaccinations. We compared the timing of solicited adverse event (AE) onset and prevalence of unsolicited AEs for Pfizer, Moderna, and AstraZeneca vaccines in a nationwide, large-scale prospective cohort study. The Pfizer and Moderna mRNA vaccines were associated with a higher frequency of fever after the second dose than after the first dose. The AstraZeneca viral vector vaccine resulted in more frequent side effects after the first dose. The side effects of mRNA vaccines were the most common on the day after vaccination and almost subsided by the fourth day. The incidence of systemic AEs, including fever of ≥37.5 °C, was the highest for Moderna, followed by AstraZeneca and Pfizer. Local reactions were less frequent with the AstraZeneca vaccine than with the Pfizer and Moderna vaccines but tended to last longer. The frequency of AEs was higher in women than in men. The odds ratio for age per year regarding systemic reactions (adjusted for sex) was the least for AstraZeneca, followed by Pfizer and Moderna (&lt; 1), indicating a more pronounced decrease in the frequency of fever and systemic reactions with increasing age. Age effects varied among vaccines. Delayed skin reactions, appearing around the seventh day after the first dose (Day 8), were observed as itchy redness, particularly in women aged ≥30 with the Moderna vaccine and less often with the Pfizer vaccine. Over half of the delayed skin reactions involved local erythema immediately after the second dose, but these reactions mostly disappeared within approximately 10 days. Despite differences in the incidence of AEs among the three vaccines by age and sex, all vaccines were well-tolerated. These findings provide crucial safety information, supporting informed vaccination decisions and ongoing surveillance efforts.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126754"},"PeriodicalIF":4.5,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a genetically modified full-length human respiratory syncytial virus preF protein vaccine","authors":"Geqi Lao ,&nbsp;Jin Feng ,&nbsp;Liping Wu ,&nbsp;Wenhan Su ,&nbsp;Liyun Chen ,&nbsp;Lejun Yang ,&nbsp;Songchen Zhang ,&nbsp;Yuhua Xu ,&nbsp;Tao Peng","doi":"10.1016/j.vaccine.2025.126799","DOIUrl":"10.1016/j.vaccine.2025.126799","url":null,"abstract":"<div><div>Human Respiratory Syncytial Virus (hRSV) is a major cause of acute lower respiratory tract infections (ALRTI) in infants, the elderly, and immunocompromised individuals. The recent approval of recombinant protein-based hRSV vaccines represents significant progress in combating hRSV. However, these vaccines utilized optimized preF ectodomain attached with an exogenous trimeric motif, which may induce immunological complications. Our research addresses these concerns by employing modified “full-length” preF proteins, preF-TMCT, designed to mimic the natural F protein structure and avoid potential immunological complications. We characterized a group of preF constructs and identified two candidates that exhibited desirable expression levels, high antigenicity and good stability. Immunization of Balb/c mice confirmed the robust immunogenicity and effective in induction of cross-reactive neutralizing antibodies of these antigens, particularly the lead-construct BR40. This investigation aims to contribute new insights to hRSV vaccine development. The near-native structure of the “full-length” preF-TMCT antigen also makes it valuable for producing therapeutic monoclonal antibodies (mAbs) and other biopharmaceuticals against hRSV infection.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126799"},"PeriodicalIF":4.5,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143061938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of adverse events after Omicron XBB-adapted BNT162b2 COVID-19 vaccination in the United States","authors":"Jenny W. Sun ,&nbsp;Laura E. Dodge ,&nbsp;Eric J. Kim ,&nbsp;Li Zhou ,&nbsp;Susan Mather ,&nbsp;Henry Goebe ,&nbsp;Nicola Charpentier ,&nbsp;Kirsten Nespithal ,&nbsp;Kofi Asomaning ,&nbsp;Florence T. Wang","doi":"10.1016/j.vaccine.2024.126629","DOIUrl":"10.1016/j.vaccine.2024.126629","url":null,"abstract":"<div><h3>Background</h3><div>Limited data exists regarding the safety of the COVID-19 2023–2024 vaccine formulations and whether the safety profiles differ from the original formulations. We evaluated the association between the BNT162b2 XBB COVID-19 vaccine and the risk of 20 pre-specified adverse events of special interest (AESIs).</div></div><div><h3>Methods</h3><div>We identified commercially-insured individuals in the US age ≥ 6 months who received the BNT162b2 XBB COVID-19 vaccine between September 11, 2023 and January 15, 2024 within the Optum pre-adjudicated database. The self-controlled risk interval design was used to compare the incidence of 20 pre-specified AESIs during a risk period following vaccination to a control period. Relative incidence and 95 % confidence intervals (CI) were estimated using exact conditional Poisson regression.</div></div><div><h3>Results</h3><div>The analysis included 113,459 individuals who received the BNT162b2 XBB COVID-19 vaccine (median [interquartile range] age: 47.1 [33.0–59.1] years). Relative incidence was calculated when ≥1 event occurred in either the risk or control period. For these 10 AESIs, there was no significant association between receipt of the BNT162b2 XBB COVID-19 vaccine and the incidence of any of these AESIs. Point estimates were higher in the risk period compared to the control period for ischemic stroke (relative incidence: 1.52; 95 % CI: 0.44–5.94), myocarditis/pericarditis (relative incidence: 1.50; 95 % CI: 0.22–12.61), immune-mediated myositis (relative incidence: 1.44; 95 % CI: 0.83–2.52), herpes zoster (relative incidence: 1.24; 95 % CI: 0.69–2.28), and non-febrile convulsions/seizures (relative incidence: 1.22; 95 % CI: 0.86–1.73). These estimates were not statistically significant, though most were based on few events. Results were generally similar in subgroup analyses of individuals administered a concomitant seasonal influenza vaccine.</div></div><div><h3>Conclusions</h3><div>There was no increased risk of 20 pre-specified AESIs following receipt of the BNT162b2 XBB COVID-19 vaccine among US commercially insured individuals aged ≥6 months. Findings are consistent with the current evidence on the safety of BNT162b2 COVID-19 vaccines.</div><div>Public registration: EUPAS108135.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"45 ","pages":"Article 126629"},"PeriodicalIF":4.5,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142866952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mental illness and antibody responses after COVID-19 vaccination in a prospective population-based study in Catalonia","authors":"Marianna Karachaliou ,&nbsp;Ana Espinosa ,&nbsp;Xavier Farré ,&nbsp;Natalia Blay ,&nbsp;Gemma Castaño-Vinyals ,&nbsp;Susana Iraola-Guzmán ,&nbsp;Rocio Rubio ,&nbsp;Marta Vidal ,&nbsp;Alfons Jiménez ,&nbsp;Marc Bañuls ,&nbsp;Ruth Aguilar ,&nbsp;Judith Garcia-Aymerich ,&nbsp;Carlota Dobaño ,&nbsp;Manolis Kogevinas ,&nbsp;Gemma Moncunill ,&nbsp;Rafael de Cid","doi":"10.1016/j.vaccine.2024.126591","DOIUrl":"10.1016/j.vaccine.2024.126591","url":null,"abstract":"<div><div><strong>Background</strong></div><div>Mental illnesses have been overlooked as a potential factor influencing antibody responses to COVID-19 vaccine. Associations between mental disorders and antibody response might vary by specific disorders, depend on the long-term course of the illness and relate to psychotropic treatment.</div></div><div><h3>Methods</h3><div>The association between mental illness diagnoses (mood affective disorders, anxiety disorders, other) over ten years and psychotropic drug prescription based on electronic health records with antibody levels (IgG and IgA) post COVID-19 vaccination was assessed in 939 vaccinated adults from Catalonia, Spain. We employed linear regression models to assess associations between specific mental illnesses and psychotropic drugs with antibody levels, correcting for demographics, comorbidities and lifestyle factors. In a genotyped subset (<em>n</em> = 247) we assessed the effect of polygenic risk scores (PRS) for mental illnesses and performed a two-sample mendelian randomization (MR) analysis to examine causality between mental illness and antibody responses.</div></div><div><h3>Results</h3><div>Mood affective disorders were associated with lower IgG to receptor binding domain (RBD) [percentage change = −26.37 (95 % CI, −42.00, −6.54)]. Diagnosis of anxiety disorders was not associated with the outcome. The group of other diagnoses (mainly including insomnia and nicotine dependence) were associated with lower IgG RBD levels [percentage change: -21.53 (95 % CI, −35.38, −4.71)] and recent onset cases (≤5 years ago) showed greater decline in antibody levels. Participants on second-generation antipsychotics and multiple classes of psychotropic drugs in the last 6 months exhibited lower antibody levels. In the genotyped population, higher genetic liability (higher PRS) to schizophrenia was associated with lower IgG RBD levels [percentage change = −35.49 (95 % CI, −56.55, −4.23)]. MR analysis revealed a causal relationship between major depression genetic instrumental variables and lower IgG RBD and S levels.</div></div><div><h3>Conclusions</h3><div>These findings raise concerns about the efficacy of COVID-19 vaccines and potentially of other vaccines as well, in individuals with mood affective disorders, current/recent insomnia and nicotine dependence and people on multiple psychotropic drugs. Whether these associations are translated into increased risk for breakthrough infections and immune mediated long-term sequels of the SARS-CoV-2 infection warrants further investigation</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"45 ","pages":"Article 126591"},"PeriodicalIF":4.5,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142823024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact on meningococcal disease of different vaccination strategies with 4CMenB and MenACWY-CRM197 in infants and adolescents in Argentina","authors":"Jorge Alberto Gómez ,&nbsp;Maria Eugenia Pannunzio ,&nbsp;Piotr Karwala ,&nbsp;Florencia Nocita ,&nbsp;Analia Urueña ,&nbsp;Norberto Giglio ,&nbsp;Maria Gabriela Graña","doi":"10.1016/j.vaccine.2024.126589","DOIUrl":"10.1016/j.vaccine.2024.126589","url":null,"abstract":"<div><h3>Background</h3><div>Invasive meningococcal disease (IMD) is a life-threatening disease, primarily affecting infants and children. Argentina introduced routine meningococcal vaccination in infants and adolescents in 2017, with MenACWY vaccination targeting serogroups A, C, W, and Y (current National Immunization Program [cNIP]). Serogroup B, more prevalent since 2015, became predominant in children. The dynamic trends of IMD epidemiology and availability of a four-component meningococcal B vaccine (4CMenB) call for a reassessment of the best schedule to optimize IMD prevention. The objective was to model the public health impact of routine 4CMenB and/or MenACWY in infants and adolescents, using different vaccination strategies compared with the cNIP in Argentina.</div></div><div><h3>Methods</h3><div>A published dynamic transmission model adapted for Argentina evaluated six vaccination strategies versus the cNIP: infant 4CMenB alone (1), infant 4CMenB with adolescent MenACWY (2), adolescent MenACWY alone (3), infant 4CMenB &amp; MenACWY (4), infant MenACWY alone (5), and infant 4CMenB &amp; MenACWY with adolescent MenACWY (6).</div></div><div><h3>Results</h3><div>Strategies including adolescent MenACWY with infant 4CMenB (or 4CMenB plus MenACWY) vaccination had the largest impact on increasing IMD prevention i.e., up to 23 % higher than the cNIP after 25 years.</div><div>Strategies including 4CMenB (1, 2, 4, 6) had the largest reduction of serogroup B IMD (impact is seen among children 0–4 years old) i.e., a 39 % decrease within the first five years of introducing 4CMenB.</div><div>Strategies including adolescent MenACWY (cNIP, 2, 3 and 6) had the largest reduction of serogroup ACWY IMD, with near elimination after 30 years (impact seen in all ages, due to herd protection).</div></div><div><h3>Conclusions</h3><div>Adding routine infant 4CMenB (either to the complete cNIP or instead of infant MenACWY) could further reduce IMD cases, sequelae, and deaths in Argentina. In addition, maintaining the adolescent MenACWY program, with its herd immunity benefits, could achieve near elimination of serogroup ACWY IMD over 30 years.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"45 ","pages":"Article 126589"},"PeriodicalIF":4.5,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142886620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the toxoplasma Urm1 gene deletion mutant (PruΔUrm1) as a promising vaccine candidate against toxoplasmosis in mice","authors":"Shu Bian ,&nbsp;Qingxiu Cai ,&nbsp;Shujing Wang ,&nbsp;Ying Xie ,&nbsp;Nianyuan Chen ,&nbsp;Qingyang Song ,&nbsp;Hongmei Li ,&nbsp;Ningning Zhao ,&nbsp;Xiao Zhang","doi":"10.1016/j.vaccine.2024.126632","DOIUrl":"10.1016/j.vaccine.2024.126632","url":null,"abstract":"<div><div>Toxoplasmosis is a significant zoonotic disease that poses a serious threat to both human and animal health. Despite ongoing research, developing an effective vaccine for toxoplasmosis remains a challenge. In this study, we evaluated the vaccine potential of the <em>Toxoplasma Urm1</em> gene deletion mutant (PruΔUrm1) by assessing its pathogenicity and protective efficacy in mice. Using CRISPR/Cas9 technology, we successfully created a type II <em>Toxoplasma gondii</em> Pru mutant strain with a deleted <em>Urm1</em> gene. Compared to the wild-type parasite, the PruΔUrm1 strain exhibited significantly reduced invasive and proliferative abilities in vitro. In in vivo studies, mice intraperitoneally infected with the parental Pru strain showed severe symptoms including emaciation, hunching, and high mortality rates. In contrast, mice infected with PruΔUrm1 tachyzoites demonstrated a 100 % survival rate, no overt symptoms, and a markedly reduced parasite burden in the liver, spleen, and lungs, indicating reduced pathogenicity. Notably, PruΔUrm1 vaccination triggered a strong immune response, characterized by significantly elevated cytokine levels, including TNF-α, IFN-γ and IL-10. Furthermore, we assessed the immunoprotective efficacy of PruΔUrm1 vaccination in mice against type I strains. Mice immunized with PruΔUrm1 were able to resist the tachyzoites of type I RH wild-type parasites, achieving a 100 % survival rate and significantly reduced parasite loads in the liver, spleen and lungs. These data demonstrate that PruΔUrm1 immunization provides effective protection against acute <em>Toxoplasma</em> infections and holds promise as a potential vaccine candidate for toxoplasmosis.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"45 ","pages":"Article 126632"},"PeriodicalIF":4.5,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Seasonal influenza vaccination coverage and the social determinants of influenza vaccination among people over 50 with diabetes in Europe: Analyzing population-based SHARE data for the 2019–2020 and 2021–2022 influenza seasons","authors":"Jiancong Wang ,&nbsp;Thaddäus Tönnies ,&nbsp;Ralph Brinks","doi":"10.1016/j.vaccine.2024.126646","DOIUrl":"10.1016/j.vaccine.2024.126646","url":null,"abstract":"<div><h3>Background</h3><div>Seasonal influenza vaccination coverage data for adults with chronic medical conditions are very scarce. We aimed to investigate the influenza vaccination rates and explore the common social determinants associated with vaccination in Europe across two influenza seasons.</div></div><div><h3>Methods</h3><div>This cross-sectional study used data from the European SHARE survey for the 2019–2020 and 2021–2022 influenza seasons. Participants over 50 diagnosed with diabetes were included, and weighted influenza vaccination rates for both seasons were calculated. Multivariable analyses were used to examine the relationships between vaccination coverage and demographic, physical, social, and healthcare factors over the two seasons.</div></div><div><h3>Results</h3><div>The weighted seasonal influenza vaccination coverage rate was significantly higher in the 2021–2022 season (54 %) than in the 2019–2020 season (46 %) among people over 50 with diabetes. Factors simultaneously and positively associated with influenza vaccination in both seasons included being aged 65 or older; residing in Western, Northern, or Southern Europe; satisfaction with basic health insurance; having supplementary health insurance; and frequent medical consultations.</div></div><div><h3>Conclusions</h3><div>Despite the increase, the average European influenza vaccination level remains below the EU target of 75 %. This study fills an important data gap for the ECDC by providing information on influenza vaccination coverage rates among people over 50 with diabetes. The findings highlight the crucial role of a robust social and healthcare system in promoting vaccination. To improve vaccination rates, the ECDC-funded VENICE network should enhance vaccination knowledge, address socioeconomic disparities by strengthening local programs and funding, and collaborate with various stakeholders to develop regional strategies.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"45 ","pages":"Article 126646"},"PeriodicalIF":4.5,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142879202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What will it take? Perspectives from five low- and middle-income countries on opportunities and challenges of introducing new maternal vaccines","authors":"Ranju Baral ,&nbsp;Jessica A. Fleming ,&nbsp;Iracema Barros ,&nbsp;Patience Cofie ,&nbsp;Patience Dapaah ,&nbsp;Sadaf Khan ,&nbsp;Sophia J. Knudson ,&nbsp;Sandeep Kumar ,&nbsp;Kamran Mehedi ,&nbsp;Patrick K. Munywoki ,&nbsp;Lauren Newhouse ,&nbsp;Bryan O. Nyawanda ,&nbsp;Joyce U. Nyiro ,&nbsp;Joseph Odiyo ,&nbsp;Elkanah Otiang ,&nbsp;Rosemond Owusu ,&nbsp;Clint Pecenka ,&nbsp;Melanie Picolo ,&nbsp;Judite Pinto ,&nbsp;Diana Quelhas ,&nbsp;Surendra Uranw","doi":"10.1016/j.vaccine.2024.126654","DOIUrl":"10.1016/j.vaccine.2024.126654","url":null,"abstract":"<div><h3>Background</h3><div>New vaccines for pregnant women have recently been introduced in some high-income countries to protect infants in early life. Implementing maternal immunisation (MI) successfully in low- and middle-income countries will require planning and adaptations to immunisation and maternal health programs. To inform cost of MI delivery studies, we gathered perspectives from key stakeholders in five countries (Bangladesh, Ghana, Kenya, Mozambique, and Nepal) regarding health system requirements, opportunities, and challenges to introducing new maternal vaccines into routine health programs.</div></div><div><h3>Methods</h3><div>We convened national stakeholders for country workshops to deliberate potential delivery strategies, opportunities, and constraints for implementing new MI interventions. Divided into thematic areas, participants discussed health system adaptations needed to establish or strengthen an MI platform.</div></div><div><h3>Findings</h3><div>Stakeholders felt that existing programs that administer vaccines to pregnant women, primarily tetanus-containing vaccines, provide a proven path for the delivery of additional maternal vaccines. Maternal health and immunisation program integration was perceived strongest at the health care provision level and weakest at the national level. Concerted coordination at the national level was identified as critical to the success of introducing new interventions. Stakeholders perceived that most health workforce providing immunisation and antenatal care services undergo similar training and have transferrable skills, however developing operational guidelines with clear roles and responsibilities was deemed critical for ownership and accountability. Human resource constraints were cited as a challenge for some countries. The importance of raising awareness of disease burden and new MI interventions was also highlighted across countries. Sustainable financing was a recurring challenge cited, especially with transitions from Gavi support.</div></div><div><h3>Conclusions</h3><div>The workshops enabled country stakeholders to deliberate needs to support the introduction of new maternal vaccines. While circumstances and needs differed, stakeholders across countries were optimistic about the capability of their health systems to integrate new maternal vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"45 ","pages":"Article 126654"},"PeriodicalIF":4.5,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142901327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial","authors":"Kerry Conlin ,&nbsp;Daniel Jenkin ,&nbsp;Philip de Whalley ,&nbsp;Lily Yin Weckx ,&nbsp;Pedro M. Folegatti ,&nbsp;Sagida Bibi ,&nbsp;Teresa Lambe ,&nbsp;Parvinder K. Aley ,&nbsp;Andrew J. Pollard ,&nbsp;Merryn Voysey ,&nbsp;Sue Ann Costa Clemens ,&nbsp;COV003 Study Group","doi":"10.1016/j.vaccine.2024.126582","DOIUrl":"10.1016/j.vaccine.2024.126582","url":null,"abstract":"<div><h3>Objectives</h3><div>To identify demographic, clinical and immunological factors associated with adverse COVID-19 outcomes.</div></div><div><h3>Methods</h3><div>A large randomised controlled trial of ChAdOx1 nCoV-19 was undertaken in Brazil. Participants were randomised 1:1 either to receive ChAdOx1 nCov-19 or to a control group. COVID-19 infections were confirmed by nucleic acid amplification test (NAAT) and classified using the WHO clinical progression scale. Anti-spike antibody responses and serum neutralising activity were measured 28 days after second vaccination in some participants. Exploratory analyses were conducted into factors associated with COVID-19 infection severity and hospitalisation, using logistic regression models adjusted for demographic and clinical factors.</div></div><div><h3>Results</h3><div>10,416 participants were enrolled; 1790 had NAAT-positive COVID-19 infection; 63 cases required hospitalisation. More severe infection was associated with greater body-mass index (BMI) (odds ratio [OR] = 1.06 [95 %CI: 1.01–1.10], <em>p</em> = 0.01) and diabetes (OR = 3.67 [1.59–8.07], <em>p</em> = 0.003). Hospitalisation risk increased with greater age (OR = 1.06 [1.03–1.08], <em>p</em> &lt; 0.001) and BMI (OR = 1.10 [1.05–1.16], p &lt; 0.001). More severe infection and hospitalisation risks increased &gt;180 days after last vaccination. In the fully vaccinated subgroup (<em>n</em> = 841), only greater age predicted hospitalisation (OR = 1.07 [1.03–1.12], p &lt; 0.001). Serological responses to two vaccine doses diminished with age.</div></div><div><h3>Conclusions</h3><div>Unvaccinated individuals with high BMI and diabetes risked more severe COVID-19 outcomes. Vaccination mitigated this risk.</div><div>Clinical Trial Registration Number: <span><span>NCT04536051</span><svg><path></path></svg></span></div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"45 ","pages":"Article 126582"},"PeriodicalIF":4.5,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142831406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}