Vaccine最新文献

{"title":"Comparison of assays used to detect antibody response in COVID-19 vaccine trials: Results from of a UK multi-Centre randomised controlled trial to determine the immunogenicity responses of COVID-19 vaccines administered concomitantly with seasonal influenza vaccines (ComFluCOV)","authors":"","doi":"10.1016/j.vaccine.2024.126369","DOIUrl":"10.1016/j.vaccine.2024.126369","url":null,"abstract":"<div><h3>Background</h3><div>The ComFluCOV trial tested the safety and immunogenicity of COVID-19 and influenza vaccines co-administration. Binding and functional SARS-CoV2 anti-spike responses were measured using assays developed in response to the COVID-19 pandemic. The three assays used to measure the immunogenicity outcomes are reported here and their performance compared to inform future vaccine development.</div></div><div><h3>Methods</h3><div>Adults aged over 18 were vaccinated with a COVID-19 and either an influenza vaccine or saline placebo. Serum sampled one month after vaccination was used to measure SARS-CoV2 anti-spike antibody concentrations using a commercial in-house enzyme-linked immunosorbent assay (ELISA), a commercial fast throughput electrochemiluminescence immunoassay (ECLIA) and a viral neutralisation assay (VNA). Geometric mean ratios were used to compare the response to COVID-19 with or without influenza vaccine with a threshold of 0.67 considered non-inferior. The relationship between the different assays was examined using Kendall rank correlations.</div></div><div><h3>Results</h3><div>The geometric mean ratios exceeded 0.67 using all assays for all COVID-19 and influenza vaccine combinations tested. Moderate rank correlations were found between the three assays.</div></div><div><h3>Conclusion</h3><div>All three assays confirmed that vaccine co-administration did not significantly impact on immunogenicity of any of the vaccines tested.</div><div><strong>Trial registration:</strong> ISRCTN14391248, registered on 17/03/2021.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0264410X2401051X/pdfft?md5=daf81b769761a25552b00d3b067afe66&pid=1-s2.0-S0264410X2401051X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142316058","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":"Determining factors associated with vaccination coverage in the first year of life in Brazil (2013−2022)","authors":"","doi":"10.1016/j.vaccine.2024.126382","DOIUrl":"10.1016/j.vaccine.2024.126382","url":null,"abstract":"<div><p>Access to vaccination has emerged as a growing global public health concern; however, there has been limited research on characteristics of local governments that are associated with vaccination coverage. The objective of this study was to evaluate predictors of vaccination coverage in Brazil for the first year of life between 2013 and 2022. We focused on variables pertaining to the available resources of local governments and their investments in infrastructure and human resources in the health sector. We used binomial generalized linear mixed models to estimate the association of these variables with vaccination coverage in Brazilian municipalities. Our results show that municipalities with better fiscal capacity were more effective in delivering vaccines. Municipalities that rely more on federal and state resources had lower vaccination coverage. Additionally, investment in health professionals was often negatively correlated with vaccination coverage. The study underscores the importance of better understanding the relationship between local government characteristics and vaccination coverage, particularly in regions where local governments are responsible for vaccine delivery.</p></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142271439","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":"Preclinical evaluation in hamster model of the mRNA COVID-19 vaccine candidate AfriVac 2121 (Wuhan) produced under the WHO/MPP mRNA Technology Transfer Programme","authors":"","doi":"10.1016/j.vaccine.2024.126378","DOIUrl":"10.1016/j.vaccine.2024.126378","url":null,"abstract":"<div><div>During the COVID-19 pandemic, access to vaccines in low- and middle-income countries was limited and delayed. To address these disparities, the mRNA Technology Transfer Programme, coordinated and led by the World Health Organization and the Medicines Patent Pool, was launched. A consortium has been set up in South Africa to develop a platform for manufacturing mRNA vaccines. In this study, the preclinical evaluation of the mRNA COVID-19 vaccine candidate, AfriVac 2121 (Wuhan) manufactured in December 2022 was conducted. The hamster model was employed to assess the immunogenicity and efficacy of this COVID-19 mRNA vaccine candidate in comparison to a commercial mRNA vaccine (mRNA-1273, Moderna). Results revealed that a vaccine regimen consisting of two 5 μg doses of AfriVac 2121 (Wuhan) elicited a protective immune response against an ancestral B.1 strain of SARS-CoV-2 similar to that obtained with the mRNA-1273 vaccine. AfriVac 2121 (Wuhan) induced robust humoral immune responses against SARS-CoV-2 and protected hamsters against a SARS-CoV-2 challenge with the B.1 strain. These results have since enabled the further development of this platform for manufacturing mRNA vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0264410X24010600/pdfft?md5=206fe694a203fc039b0cb1697fdc7716&pid=1-s2.0-S0264410X24010600-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142305363","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":"Validation of a deep learning model for classification of pediatric pneumonia in Hong Kong","authors":"","doi":"10.1016/j.vaccine.2024.126370","DOIUrl":"10.1016/j.vaccine.2024.126370","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142271440","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":"The impact of coronavirus pandemic shutdowns on immunization completion in Hadeetha, Anbar, Iraq: A case-study of vaccine completion in a recovering healthcare system","authors":"","doi":"10.1016/j.vaccine.2024.126383","DOIUrl":"10.1016/j.vaccine.2024.126383","url":null,"abstract":"<div><div>The SARS-COV2 pandemic caused significant disruptions in immunization delivery. Baseline deficit gaps in immunization completion exacerbated ongoing disparities in immunization coverage in low- and middle-income. Emerging reports focused on global strategies for return to routine immunization schedules. Currently, there are no studies that examined the dual challenge of returning to normal immunization in a conflict-recovery setting, such as the ISIS (Islamic State of Iraq and Syria) occupation of Iraq post-COVID-19 pandemic.</div><div>The objective of this study was to estimate the number of children in Hadeetha, Iraq from 12 to 24 months of age who continued to be lost to the routine immunization schedule due to the COVID-19 pandemic shutdowns. Random sampling occurred from a compiled district health facility registrar of all children in the target birth cohort who had a 12-month immunization scheduled during the 2020 lockdown and were lost to the immunization schedule<em>.</em> A total of 171 households from the sampling frame were included in the final sample. In this cross-sectional study, survey data was collected on the head of the household, the caregiver and the child. Additional questions assessed vaccine hesitancy, vaccine information trusted sources and COVID-19 impact on healthcare access. A risk factor analysis was applied to assess using Chi-square (<em>Χ</em>²) for predictors of lack of DTP3 (Diphtheria, Tetanus and Polio) third dose completion. Of children in the study, 67.3 % did not complete the 6-antigen series at 12-months of age and 46.2 % were missing DTP3 for vaccines to be completed during the pandemic shutdown. Specific risk factors for lack of immunization for the DTP3 vaccine included area of residence, age and caregiver knowledge of vaccines. Respondents indicated a dependence on mass vaccination campaigns but also indicated a willingness to receive phone reminders and television campaigns about vaccination schedules.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142305362","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":"Annual public health and economic burden of medically attended respiratory syncytial virus illnesses among US adults","authors":"","doi":"10.1016/j.vaccine.2024.126323","DOIUrl":"10.1016/j.vaccine.2024.126323","url":null,"abstract":"<div><p><strong>Background:</strong> Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract disease (LRTD) among adults and can lead to serious morbidity and mortality; however, evidence on the magnitude of the public health and economic burden of adult RSV-LRTD is limited. This study was undertaken to project annual clinical outcomes and economic costs of medically attended RSV-LRTD among US adults, and to identify subgroups responsible for a disproportionate share of disease burden. <strong>Methods:</strong> Clinical outcomes of RSV-LRTD were projected for subgroups of US adults defined by age and comorbidity profile (with vs. without chronic/immunocompromising medical conditions) based on corresponding population sizes, episode (disease) rates, and case-fatality rates. Economic costs comprised medical (i.e., direct) costs and non-medical (i.e., indirect) costs of RSV-LRTD, and were generated based on numbers of episodes and unit costs in relation to setting of care, age, and comorbidity profile. <strong>Results:</strong> Among 265 million US adults aged ≥18 years in 2023, 6.5 million medically attended episodes of RSV-LRTD were projected to occur including 349,260 requiring hospitalization, 357,892 requiring an emergency department visit (not leading to hospitalization), and 5.8 million requiring other ambulatory care. Direct costs ($15.2 billion) and indirect costs ($9.7 billion) were projected to total $25.0 billion. Persons aged 60–99 years accounted for 31 % of the adult population and over 50 % of the economic burden of RSV-LRTD, while adults aged &lt;60 years with chronic/immunocompromising medical conditions accounted for 10 % of the population and 27 % of the economic burden. <strong>Conclusions:</strong> Annual burden of RSV-LRTD among US adults—especially older adults and those of all ages with underlying medical conditions—is substantial. Preventive measures, such as recently approved RSV vaccines, have the potential to yield important improvements in public and patient health, and to reduce the economic burden of RSV-LRTD from the US healthcare system and societal perspectives.</p></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0264410X24010053/pdfft?md5=ef87abe932d953d2992d31361c130cb2&pid=1-s2.0-S0264410X24010053-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142271239","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":"Detailed review of mortality reported following COVID-19 vaccination in Victoria, Australia: 2021-2023","authors":"","doi":"10.1016/j.vaccine.2024.126368","DOIUrl":"10.1016/j.vaccine.2024.126368","url":null,"abstract":"<div><h3>Introduction</h3><p>The scale of the COVID-19 vaccine program, and appropriate focus on older individuals, emphasised monitoring of mortality as an important part of COVID-19 vaccine safety surveillance, noting many deaths temporally associated with vaccination may not be causally related. This cross-sectional study describes Victoria's vaccine safety service (SAEFVIC) process of reviewing mortality reports following COVID-19 vaccination, summarises report characteristics and identifies trends in mortality reporting.</p></div><div><h3>Methods</h3><p>Mortality cases reported to SAEFVIC following COVID-19 vaccination from 22 February 2021 to 22 February 2023 were included. Report characteristics, demographics, and cause of death information were described. Proportions of mortality reports per 100,000 vaccine doses administered were calculated, overall and stratified by age (&lt;60 years, ≥60 years), sex, vaccine type and dose number. Rate ratios (RR) were used to compare proportions.</p></div><div><h3>Results</h3><p>Reporting proportions were higher in the first three months of the vaccine program (3.98 per 100,000 doses), compared to the following 21 months (0.71 per 100,000 doses), RR:5.61, <em>p</em> &lt; 0.001. Of 159 mortality reports included, 135/159 (84.9 %) were in individuals ≥60 years. Most individuals (121/159, 90.3 %) had comorbidities relevant to cause(s) of death, and 143/159 (89.9 %) were categorised as having a ‘likely alternate’ cause of death based on treating clinician/forensic assessment. For 11/159 (6.9 %) reports vaccine contribution to death could not be determined. Five deaths (0.03 per 100,000 doses administered), all publicly reported, were assessed by the national regulator as likely vaccine-associated.</p></div><div><h3>Conclusions</h3><p>Mortality reporting predominantly reflected the health status of the population receiving vaccines, vaccine administration patterns and contextual factors surrounding COVID-19 vaccines (including public concerns regarding serious adverse events of special interest), as well as extremely rare but fatal adverse events that were likely vaccine-associated. Jurisdictional vaccine safety services such as SAEFVIC play an important role in follow-up of mortality reports, supporting the work of national regulators, and thereby supporting vaccine safety surveillance and vaccine confidence more broadly.</p></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142271442","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":"Relative effectiveness of adjuvanted versus non-adjuvanted influenza vaccines in older adults with risk factors for influenza complications during the 2019–2020 U.S. influenza season","authors":"","doi":"10.1016/j.vaccine.2024.126316","DOIUrl":"10.1016/j.vaccine.2024.126316","url":null,"abstract":"<div><p>This study estimated the relative vaccine effectiveness (rVE) of the MF59®-adjuvanted trivalent influenza vaccine (aTIV) versus standard-dose nonadjuvanted egg-based quadrivalent influenza vaccines (QIVe) for the prevention of influenza-related medical encounters (IRMEs), outpatient IRMEs, and influenza- and pneumonia-related hospitalizations during the 2019–2020 US influenza season among adults ≥65 years of age who had ≥1 high-risk condition. A secondary objective evaluated the rVE of aTIV versus QIVe in preventing these outcomes among older adults with specific high-risk conditions. This retrospective cohort study included US adults ≥65 years of age vaccinated with aTIV or QIVe between August 1, 2019, and January 31, 2020. Exposures, covariates, risk factors, and outcomes were captured from a linked dataset comprised of electronic health records (EHR) (Veradigm Network EHR) linked to insurance claims (Komodo Healthcare Map). A doubly robust approach was applied wherein multivariable-adjusted odds ratios were derived using inverse probability of treatment-weighted samples to calculate rVEs and 95 % confidence interval independently for individuals ≥1 high-risk condition and those with specific high-risk conditions. The study included 954,707 aTIV and 719,125 QIVe recipients. For all outcomes, aTIV was more effective than QIVe among adults ≥65 years of age who had ≥1 high-risk condition (any IMRE: 23.6 % [20.9 %–26.1 %]), outpatient IRME: 23.3 % [20.4 %–26.1 %], and influenza- or pneumonia-related hospitalizations: 19.0 % [16.3 %–21.6 %]), during the 2019–2020 influenza season. Similarly, aTIV was more effective than QIVe at preventing outcomes among individuals with specific high-risk conditions except for body mass index ≥40. This study demonstrated higher effectiveness of aTIV versus QIVe in preventing any IRMEs, outpatient IRMEs, and influenza- or pneumonia-related hospitalizations among adults ≥65 years of age who had ≥1 high-risk condition.</p></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0264410X24009988/pdfft?md5=2d165c033e767cf5f1c2827dfed52da4&pid=1-s2.0-S0264410X24009988-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142240443","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":"A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers","authors":"","doi":"10.1016/j.vaccine.2024.126380","DOIUrl":"10.1016/j.vaccine.2024.126380","url":null,"abstract":"<div><h3>Background</h3><p>Combination vaccines are effective in simplifying complex vaccination schedules involving multiple vaccines. A fully liquid hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)- hepatitis B (HepB)-inactivated poliovirus (IPV)-<em>Haemophilus influenzae</em> b (Hib) vaccine (HEXASIIL®), manufactured by Serum Institute of India Pvt. Ltd. was tested for safety and immunogenicity following booster vaccination.</p></div><div><h3>Methods</h3><p>This was a phase-II/III, open label, multicentric, controlled trial in toddlers (phase II) and infants (phase III) in India. This manuscript presents results of phase II. Healthy toddlers aged 12–24 months were randomized (1:1) to receive a 0.5 ml booster dose of HEXASIIL® or comparator Pentavac SD + Poliovac, intramuscularly and followed for 28 days for safety assessment. Blood samples were collected pre-vaccination and 28 days post-vaccination to assess immunogenicity. Descriptive summary statistics were provided for safety and immunogenecity analyses.</p></div><div><h3>Results</h3><p>A total of 223 subjects were randomized. One subject droped out prior to dosing, due to consent withdrawal. Thus, 222 subjects received study vaccine (110 HEXASIIL® and 112 comparator). Frequency of solicited adverse events was comparable between HEXASIIL® and comparator (85.5 % vs 90.2 %). Most local and systemic solicited AEs were mild to moderate in severity. All events resolved completely without any sequelae and none led to subject discontinuation. No vaccine related serious AE was reported. Post vaccination, seroprotection rates against tetanus, Hib and polio type 1 and 3 were 100 % in both the groups. Seroprotection rates for diphtheria (99.1 % vs 100 %) and polio type 2 (98.2 % vs 100 %) were observed in HEXASIIL® and comparator group, respectively. For Hepatitis B, seroprotection was &gt;99 % in both groups. Seroconversion observed for <em>Bordetella Pertussis</em> (94.5 % vs 95.4 %) and Pertussis Toxin (77.1 % vs 87.2 %) in HEXASIIL® and comparator group, respectively.</p></div><div><h3>Conclusion</h3><p>HEXASIIL® vaccine was found to be safe and immunogenic in toddlers and supported its further clinical development in infants.</p><p>Clinical Trial Registration – CTRI/2019/11/022052.</p></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0264410X24010624/pdfft?md5=6b03d1d6e7765d32a03087fea4ff72d3&pid=1-s2.0-S0264410X24010624-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142271441","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":"Risk of death and cardiovascular events following COVID-19 vaccination or positive SARS-CoV-2 test amongst adult Singaporeans during omicron transmission","authors":"","doi":"10.1016/j.vaccine.2024.126356","DOIUrl":"10.1016/j.vaccine.2024.126356","url":null,"abstract":"<div><h3>Importance</h3><p>Assessing population-wide risk-benefit ratio of COVID-19 vaccination remains relevant in the current era of Omicron endemicity and boosting. Assessments of mortality risk and cardiovascular events post-vaccination/infection were generally made prior to emergence of milder Omicron and booster rollout.</p></div><div><h3>Methods</h3><p>Retrospective cohort study from 6th January to 31st December 2022 (Omicron-predominant transmission), amongst adult Singaporeans aged ≥18 years. Cox regression models adjusted for demographics/comorbidities were used to estimate risk of all-cause mortality and cardiovascular events 0–180 days post-mRNA vaccination/SARS-CoV-2 infection, compared to &gt;180 days post-mRNA vaccination. Risk periods post-vaccination were further stratified by presence/absence of SARS-CoV-2 infection in the preceding 180 days; similarly, risk periods post-infection were further stratified by vaccination in the 180 days preceding infection.</p></div><div><h3>Results</h3><p>3,137,210 adults participated, with 2,047,008 vaccine doses administered (99 % being booster doses) and 1,189,846 infections. 23,028 deaths and 54,017 cardiac events were recorded. No elevated risk of all-cause mortality/cardiovascular events was observed across all age strata post-vaccination. Conversely, all-cause mortality post-infection remained elevated up to &gt;180 days in older adults (≥60 years), compared to person-time &gt; 180 days post-vaccination. For vaccine-breakthrough SARS-CoV-2 infection in older adults vaccinated &lt;180 days prior, risk of mortality was only elevated up to 60 days post-infection, but not beyond. Elevated risk of cardiovascular events 1–2 months after any SARS-CoV-2 infection was observed across all age strata, with elevated risk observed in older adults &gt;180 days post-infection (adjusted-hazards-ratio, aHR = 1.18, 95 %CI = 1.04–1.34). Preceding vaccination within 180 days prior to infection attenuated this risk, with no significantly elevated post-acute risk of cardiovascular events (&gt;180 days: aHR = 1.10, 95 %CI = 0.95–1.07).</p></div><div><h3>Conclusion</h3><p>No increased risk of all-cause mortality or cardiovascular events was observed up to 180 days after any mRNA vaccination dose in the Omicron era; vaccination attenuated post-acute cardiovascular risk in older adults. The risk-benefit ratio of vaccination remained positive during Omicron.</p></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142241221","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}