Pneumococcal conjugate vaccination

  • 文章类型: Journal Article
    目的:自2012年以来,阿根廷国家免疫计划(NIP)中的婴儿推荐使用13价肺炎球菌结合疫苗(PCV13)。预计将很快获得15价疫苗(PCV15)的许可,20价疫苗(PCV20)最近获得了监管部门的批准。这项成本效益分析研究了阿根廷儿科NIP从PCV13过渡到PCV15或PCV20的公共卫生和经济影响。
    方法:使用了一个决策分析马尔可夫模型,其时间范围为10年,成本和收益的年折现率为3.0%。疫苗有效性估计来自阿根廷的监测数据,PCV13临床有效性和影响研究,和PCV7疗效研究。人口,流行病学,经济投入是从文献和阿根廷特有的数据中获得的。该研究采用了医疗保健系统的观点;进行了敏感性和情景分析,以评估输入参数和结构不确定性。
    结果:与PCV13相比,估计PCV20避免了另外7,378、42,884和172,389例侵袭性肺炎球菌疾病(IPD),全因肺炎,和全因中耳炎(OM),分别,以及3308人死亡,从而节省了50,973,962美元的直接医疗费用。与PCV15相比,PCV20估计也有更大的益处,避免了另外6,140,35,258和142,366例IPD,肺炎,OM,分别,以及2,624人死亡,节省了37,697,868美元的直接医疗费用。PCV20与更高的质量调整寿命年增益和更低的成本相关(即,优势)与PCV13和PCV15。在敏感性分析和情景评估中,结果仍然稳健。
    结论:在10年内,预计PCV20疫苗将占主导地位,阿根廷儿童的成本节约策略与PCV13和PCV15的比较。与低价方案相比,政策制定者应考虑PCV20疫苗接种策略,以实现最大的临床和经济效益。
    OBJECTIVE: The 13-valent pneumococcal conjugate vaccine (PCV13) has been recommended for infants in Argentina\'s national immunization program (NIP) in a 2 + 1 schedule since 2012. Licensure of the 15-valent vaccine (PCV15) is anticipated soon, and the 20-valent vaccine (PCV20) recently received regulatory approval. This cost-effectiveness analysis examined the public health and economic implications of transitioning from PCV13 to either PCV15 or PCV20 in Argentina\'s pediatric NIP.
    METHODS: A decision-analytic Markov model was used with a 10-year time horizon and a 3.0% annual discount rate for costs and benefits. Vaccine effectiveness estimates were derived from Argentinian surveillance data, PCV13 clinical effectiveness and impact studies, and PCV7 efficacy studies. Population, epidemiologic, and economic inputs were obtained from literature and Argentinian-specific data. The study adopted a healthcare system perspective; sensitivity and scenario analyses were conducted to assess input parameters and structural uncertainty.
    RESULTS: Compared with PCV13, PCV20 was estimated to avert an additional 7,378, 42,884, and 172,389 cases of invasive pneumococcal disease (IPD), all-cause pneumonia, and all-cause otitis media (OM), respectively, as well as 3,308 deaths, resulting in savings of United States Dollars (USD) 50,973,962 in direct medical costs. Compared with PCV15, PCV20 was also estimated to have greater benefit, averting an additional 6,140, 35,258, and 142,366 cases of IPD, pneumonia, and OM, respectively, as well as 2,624 deaths, resulting in savings of USD 37,697,868 in direct medical costs. PCV20 was associated with a higher quality-adjusted life year gain and a lower cost (i.e., dominance) versus both PCV13 and PCV15. Results remained robust in sensitivity analyses and scenario assessments.
    CONCLUSIONS: Over a 10-year horizon, vaccination with PCV20 was expected to be the dominant, cost-saving strategy versus PCV13 and PCV15 in children in Argentina. Policymakers should consider the PCV20 vaccination strategy to achieve the greatest clinical and economic benefit compared with lower-valent options.
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  • 文章类型: Journal Article
    UNASSIGNED:尽管13价肺炎球菌结合疫苗(PCV13)在中国的私人市场上有售,尚未将其纳入国家免疫计划(NIP),因此无法向大部分人口提供。本研究旨在评估在国家和省级层面将PCV13纳入中国NIP的成本效益。
    UNASSIGNED:我们采用了决策树马尔可夫模型,从社会角度评估了在NIP中添加3剂量PCV13与私人市场现状相比的成本效益。该模型假设了疫苗引入后五年的出生队列。根据中国疾病预防控制中心(CDC)和国家保险数据库计算治疗费用和疫苗计划费用。疾病负担数据,发病率比率,其他参数来自已发表的文献和灰色文献。避免了病例和死亡,获得的质量调整生命年(QALYs),和增量成本效益比(ICER)在省级进行了估计,区域,和国家层面。单向,进行了情景和概率敏感性分析,以探索模型的不确定性。
    联合国:在国家一级,在2019年出生队列的前5年,在NIP中引入PCV13预计可预防约4807例肺炎球菌死亡(减少66%)和1,057,650例肺炎球菌病例(减少17%).在NIP中每剂25美元的假定基本情况下,NIP中的PCV13在全国范围内具有成本效益,每QALY获得5.222美元的ICER,与现状相比,在31个省中的17个省中具有成本效益,在4个省中具有成本节约。单向和情景敏感性分析表明,当改变所有模型参数时,结果是稳健的,概率敏感性分析显示,全国范围内成本效益的概率为98%。
    UNASSIGNED:我们的研究结果突出了在中国的NIP中引入PCV13的成本效益。省级结果支持国家以下各级引入PCV13,应优先考虑社会经济欠发达的省份。由于疫苗接种成本是最有影响力的模型参数,在集中采购后提高PCV可负担性的努力将以具有成本效益的方式使公共卫生受益。
    未经批准:比尔及梅琳达·盖茨基金会。
    UNASSIGNED: Although 13-valent pneumococcal conjugate vaccine (PCV13) is available in China\'s private market, it has yet to be introduced into the National Immunization Programme (NIP) and is therefore not available to large parts of the population. This study aimed to estimate the cost-effectiveness of including PCV13 in China\'s NIP at national and provincial levels.
    UNASSIGNED: We adopted a decision-tree Markov model to estimate the cost-effectiveness of adding 3-dose PCV13 in the NIP compared to the status quo in the private market from a societal perspective. The model hypothesized a birth cohort for five years after vaccine introduction. Treatment costs and vaccine program costs were calculated from Chinese Center for Disease Control and Prevention (CDC) and national insurance databases. Disease burden data, incidence rate ratios, and other parameters were derived from published and grey literature. Cases and deaths averted, quality-adjusted life years (QALYs) gained, and incremental cost-effectiveness ratios (ICERs) were estimated at the provincial, regional, and national levels. One-way, scenario and probabilistic sensitivity analyses were conducted to explore model uncertainty.
    UNASSIGNED: At the national level, introducing PCV13 in the NIP was predicted to prevent approximately 4807 pneumococcal deaths (66% reduction) and 1,057,650 pneumococcal cases (17% reduction) in the first five years of the 2019 birth cohort. Under the assumed base case price of US$ 25 per dose in the NIP, PCV13 in the NIP was cost-effective nationally with ICER of US$ 5.222 per QALY gained, and was cost-effective in 17 and cost-saving in 4 of the 31 provinces compared to the status quo. One-way and scenario sensitivity analyses indicated robust results when varying all model parameters, and probabilistic sensitivity analysis showed a 98% probability of cost-effectiveness nationally.
    UNASSIGNED: Our findings highlight the cost-effectiveness of introducing PCV13 in China\'s NIP. Provincial results supported subnational introduction of PCV13, and priority should be given to less socioeconomically developed provinces. Since vaccination cost is the most influential model parameter, efforts to improve PCV affordability after pooled procurement will benefit public health in a cost-effective manner.
    UNASSIGNED: The Bill & Melinda Gates Foundation.
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  • 文章类型: Journal Article
    据记载,由于COVID-19大流行,儿科疫苗接种量显著下降。关于COVID-19大流行期间儿童疫苗接种的父母意愿和相关因素知之甚少。在PubMed的数据库中进行广泛的文献检索,Scopus,WebofScience,和EBSCOhost进行了。通过专题分析,共纳入了2020-2022年发表的20项合格研究,以进行系统总结。其中12项研究纳入了用R-4.2.1进行的荟萃分析.父母对儿童/常规疫苗接种和季节性流感疫苗接种意愿的患病率为58.6%(95CI2.8-98.6%)和47.3%(95CI25.3-70.5%)。此外,没有足够的证据表明父母对儿童/常规疫苗接种的意愿发生了重大变化,人乳头瘤病毒疫苗接种,或在大流行期间接种肺炎球菌结合疫苗。然而,发现父母为孩子接种季节性流感疫苗的意愿显着增加。除了在文献中得到充分研究的父母疫苗接种意愿/犹豫的因素,儿童/父母的COVID-19病史和儿童对COVID-19的易感性与父母意愿相关。在大流行期间,有必要制定协同策略来促进COVID-19疫苗接种和其他儿科疫苗接种。这可能有助于在COVID-19大流行期间和/或之后改善和/或赶上儿童的疫苗摄入量。
    A significant decline in pediatric vaccination uptake due to the COVID-19 pandemic has been documented. Little is known about the parental willingness and associated factors of pediatric vaccination during the COVID-19 pandemic. An extensive literature search in the databases of PubMed, Scopus, Web of Science, and EBSCOhost were conducted. A total of 20 eligible studies published from 2020-2022 were included for systematic summary by a thematic analysis, among which 12 studies were included in a meta-analysis conducted with R-4.2.1. The prevalence of parental willingness to childhood/routine vaccination and seasonal influenza vaccination was 58.6% (95%CI 2.8-98.6%) and 47.3% (95%CI 25.3-70.5%). Moreover, there is no sufficient evidence of significant change in parental willingness to childhood/routine vaccination, human papillomavirus vaccination, or pneumococcal conjugate vaccination during the pandemic. However, a significant increase in parental willingness to vaccinate their children against seasonal influenza was found. In addition to the factors of parental vaccination willingness/hesitancy that are well-studied in literature, children/parents\' history of COVID-19 and children\'s perceived vulnerability to COVID-19 were associated with parental willingness. Developing synergetic strategies to promote COVID-19 vaccination together with other pediatric vaccination is warranted during the pandemic. This may help to improve and/or catch up the vaccine uptake of children during and/or after the COVID-19 pandemic.
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  • 文章类型: Journal Article
    肺炎球菌结合疫苗(PCV)对侵袭性肺炎球菌疾病(IPD)负担的影响已在5岁以下的儿童中得到广泛研究;然而,尚未对PCV对青霉素非敏感型肺炎球菌(PNSP)的影响进行汇总评估.我们旨在确定PCV-10和PCV-13的引入是否导致5岁以下儿童的总体PNSP率下降。我们对已发表的监测研究进行了系统评价,这些研究报告了在引入PCV10/13的国家中,<5的儿童的PNSP发生率。从引入PCV-10和PCV-13开始的总体观察趋势是,在位于PCV-13国家的监测点中,5岁以下儿童的PNSP下降。我们发现PCV-10设置中PNSP率(血清型19A)增加。IPD中出现的NVT耐药菌株主要是5岁以下儿童的血清型24F,15A,图11A和33F以及PCV-10设置中的血清型19A。在5岁以下儿童的IPD中,有必要进行连续监测,以监测PCV-10和PCV-13对青霉素耐药趋势的长期影响。
    The impact of pneumococcal conjugate vaccines (PCVs) on invasive pneumococcal disease (IPD) burden has been extensively studied in children aged<5 years; however, a pooled estimation of the effect of PCVs on penicillin non-susceptible pneumococci (PNSP) has not yet been performed. We aimed to identify whether the introduction of PCV-10 and PCV-13 had led to the decrease of the overall PNSP rate in children < 5 years. We conducted a systematic review of published surveillance studies reporting the rate of PNSP rates in children < 5 in countries where PCV10/13 were introduced. The overall observed trend onwards the introduction of PCV-10 and PCV-13 is a decrease in PNSP among children < 5 years in surveillance sites located in PCV-13 countries. We identified an increase of PNSP rates (serotype 19A) in PCV-10 settings. Resistant NVT strains are emerging in IPD in children < 5 years mainly serotypes 24F, 15A, 11A and 33F along with serotype 19A in PCV-10 settings. Continuous surveillance is necessary in IPD in children under five to monitor the long-term effect of PCV-10 and PCV-13 on penicillin resistance trends.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
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  • 文章类型: Comparative Study
    Objective: Pneumococcal diseases including invasive pneumococcal disease (IPD), pneumonia, and acute otitis media (AOM) impose a substantial public health burden. This study performed a budget impact analysis of the use of pneumococcal conjugate vaccines (PCVs) in the National Immunization Program (NIP) in Colombia.Methods: We compared the direct medical cost of the scenario without and with PCV vaccination using either pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) or 13-valent pneumococcal conjugate vaccine (PCV-13) over 5 years (2020-2024) from the health-care system perspective. Vaccine efficacy estimates were obtained from published sources and vaccine prices were taken from the Pan-American Health Organization Revolving Fund. Vaccine coverage was assumed to be 90% based on Colombia data.Results: Using PHiD-CV in the NIP in Colombia would reduce the estimated cost for treating pneumococcal disease by US$46.1 m over the 2020-2024 period (US$40.2 m using PCV-13), with a budget impact of US$100.1 m for PHiD-CV (US$121.4 m for PCV-13), and would cost US$3.1 m less per year on vaccine doses than using PCV-13.Conclusion: These findings are potentially valuable for the selection of vaccines for their national immunization programs under conditions of budgetary constraint.
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  • 文章类型: Clinical Trial, Phase II
    Streptococcus pneumoniae is a significant global pathogen that colonises the nasopharynx of healthy children. Pneumococcal conjugate vaccines, which reduce nasopharyngeal colonisation of vaccine-type S. pneumoniae, may have broader effects on the nasopharyngeal microbiota; however, data are limited. In Fiji, nasopharyngeal carriage prevalence of S. pneumoniae and other colonising species differ between the two main ethnic groups. Here, we examined the association between the 7-valent pneumococcal conjugate vaccine (PCV7) and the nasopharyngeal microbiota of children in Fiji, including for each of the two main ethnic groups-indigenous Fijians (iTaukei) and Fijians of Indian descent (FID).
    The nasopharyngeal microbiota of 132 Fijian children was examined using nasopharyngeal swabs collected from 12-month-old iTaukei and FID children who were vaccinated (3 doses PCV7) or unvaccinated in infancy as part of a phase II randomised controlled trial. Microbiota composition was determined by sequencing the V4 region of the 16S rRNA gene. Species-specific carriage of S. pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Staphylococcus aureus was determined using real-time quantitative PCR. Associations between microbiota composition and other host and environmental factors were considered in the analysis.
    PCV7 had no overall impact on microbial diversity or composition. However, ethnic differences were observed in both diversity and composition with iTaukei children having higher relative abundance of Moraxella (p = 0.004) and Haemophilus (p = 0.004) and lower relative abundance of Staphylococcus (p = 0.026), Dolosigranulum (p = 0.004) and Corynebacterium (p = 0.003) compared with FID children. Further, when we stratified by ethnicity, associations with PCV7 could be detected: vaccinated iTaukei children had a lower relative abundance of Streptococcus and Haemophilus compared with unvaccinated iTaukei children (p = 0.022 and p = 0.043, respectively); and vaccinated FID children had a higher relative abundance of Dolosigranulum compared with unvaccinated FID children (p = 0.037). Children with symptoms of an upper respiratory tract infection (URTI) had a significantly different microbiota composition to children without symptoms. The microbiota composition of iTaukei children without URTI symptoms was most similar to the microbiota composition of FID children with URTI symptoms.
    Associations between PCV7 and nasopharyngeal microbiota differed within each ethnic group. This study highlights the influence that ethnicity and URTIs have on nasopharyngeal microbiota.
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  • 文章类型: Historical Article
    To identify a potential nadir of the impact of pneumococcal conjugate vaccination (PCV) in infancy on invasive pneumococcal diseases (IPD) in children under 16 in Germany.
    Active surveillance on IPD based on two independent data sources with capture-recapture correction for underreporting. Annual incidence rates by age group, serotypes, site of infection, and relative incidence reduction compared to pre-vaccination period (1997-2001) at nadir and for the most recent season are reported. We calculated vaccine coverage at the age of 24 months using health insurance claims data.
    96-97% of children had received at least two doses of PCV since 2009. The maximum impact on overall IPD incidence was achieved in 2012/13 (-48% [95% CI: -55%; -39%]) with a rebound to -26% [95% CI: -36%; -16%] in 2015/16. Non-PCV13 serotypes accounted for 84.1% of the IPD cases in 2015/16. The most frequent non-PCV serotypes in IPD in 2014/15 and 2015/16 were 10A, 24F, 15C, 12F, 38, 22F, 23B, and 15B. The impact at nadir was highest in children 0-1 years of age both in meningitis and non-meningitis cases, whereas the impact for other age groups was higher for meningitis cases. The rebound mainly pertained to non-meningitis cases.
    The maximum impact of pneumococcal conjugate vaccination has been attained and signs of a rebound are apparent. Sustained surveillance for IPD in children is warranted to assess whether these trends will continue. There may be a need for vaccines using antigens common to all serotypes.
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  • 文章类型: Clinical Trial, Phase III
    We previously reported 10-valent pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) efficacy in a double-blind randomized trial (ClinicalTrials.gov: NCT00466947) against various diseases, including acute otitis media (AOM). Here, we provide further analyses. In the Panamanian subset, 7,359 children were randomized (1:1) to receive PHiD-CV or control vaccine at age 2/4/6 and 15-18 months. Of these, 2,000 had nasopharyngeal swabs collected. AOM cases were captured when parents sought medical attention for children with AOM symptoms; surveillance was enhanced approximately 2 y into the study through regular telephone calls or home visits by study personnel, who advised parents to visit the clinic if their child had AOM symptoms. Mean follow-up was 31.4 months. Clinical AOM (C-AOM) cases were assessed by physicians and confirmed by otorhinolaryngologists. Middle ear fluid samples, taken from children with C-AOM after specific informed consent, and nasopharyngeal samples were cultured for pathogen identification. For 7,359 children, 2,574 suspected AOM cases were assessed by a primary healthcare physician; 649 cases were C-AOM cases as per protocol definition. From the 503 MEF samples collected, 158 resulted in a positive culture. In the intent-to-treat cohort (7,214 children), PHiD-CV showed VE against first C-AOM (24.0% [95% CI: 8.7, 36.7]) and bacterial (B-AOM) episodes (48.0% [20.3, 66.1]) in children <24 months, which declined thereafter with age. Pre-booster VE against C-AOM was 30.7% [12.9, 44.9]; post-booster, -6.7% [-36.4, 16.6]. PHiD-CV VE was 17.7% [-6.1, 36.2] against moderate and 32.7% [-20.5, 62.4] against severe C-AOM. VE against vaccine-serotype pneumococcal NPC was 31.2% [5.3, 50.3] 3 months post-booster, and 25.6% [12.7, 36.7] across all visits. NTHi colonization rates were low and no significant reduction was observed. PHiD-CV showed efficacy against C-AOM and B-AOM in children younger than 24 months, and reduced vaccine-serotype NPC.
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