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1.
Hum Vaccin Immunother ; 20(1): 2343199, 2024 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-38647026

RESUMO

The "reemergence of pertussis" has elicited international concerns, occurring paradoxically amidst the expansion of immunization programs. This study was aimed to evaluate quantitatively the economic burden and identify the determinants that influence the cost associated with treating pertussis in Chinese children. We evaluated the economic burden by Chinese children diagnosed with pertussis at the Children's Hospital, Zhejiang University School of Medicine in 2022. Direct medical expenses and the utilization of medical resources attributed to pertussis were calculated. A generalized linear regression model was applied to analyze the determinants that were associated with the direct medical expenses among patients. Among the 1110 pertussis patients included in the study, 1060 were outpatients and 50 were inpatients. The average direct medical cost was ¥1878.70(i.e. $279.33). Living in urban areas (OR:1.27, p = .04), complications (OR:1.40, p < .001), hospitalization (OR:10.04, p < .001), and ≥ 3 medical visits (OR:3.71, p < .001) were associated with increased direct medical expenses. Having received four doses of the pertussis vaccine was associated with reduced direct medical expenses (OR:0.81, p = .04). This study underscores a substantial economic burden of pertussis in Hangzhou, with pronounced implications for patients residing in urban areas, experiencing complications, requiring hospitalization, having multiple medical consultations, or lacking comprehensive pertussis vaccination.


Assuntos
Efeitos Psicossociais da Doença , Custos de Cuidados de Saúde , Hospitalização , Vacina contra Coqueluche , Coqueluche , Humanos , Coqueluche/economia , Coqueluche/epidemiologia , Coqueluche/prevenção & controle , China/epidemiologia , Masculino , Feminino , Pré-Escolar , Lactente , Criança , Vacina contra Coqueluche/economia , Vacina contra Coqueluche/administração & dosagem , Custos de Cuidados de Saúde/estatística & dados numéricos , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Adolescente , Vacinação/economia
2.
Hum Vaccin Immunother ; 19(1): 2208514, 2023 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-37171153

RESUMO

We developed a machine learning algorithm to identify undiagnosed pertussis episodes in adolescent and adult patients with reported acute respiratory disease (ARD) using clinician notes in an electronic healthcare record (EHR) database. Here, we utilized the algorithm to better estimate the overall pertussis incidence within the Optum Humedica clinical repository from 1 January 2007 through 31 December 2019. The incidence of diagnosed pertussis episodes was 1-5 per 100,000 annually, consistent with data registered by the US Centers for Disease Control and Prevention (CDC) over the same time period. Among 18,573,496 ARD episodes assessed, 1,053,946 were identified (i.e. algorithm-identified) as likely undiagnosed pertussis episodes. Accounting for these undiagnosed pertussis episodes increased the estimated pertussis incidence by 110-fold on average (34-474 per 100,000 annually). Risk factors for pertussis episodes (diagnosed and algorithm-identified) included asthma (Odds ratio [OR] 2.14; 2.12-2.16), immunodeficiency (OR 1.85; 1.78-1.91), chronic obstructive pulmonary disease (OR 1.63; 1.61-1.65), obesity (OR 1.44; 1.43-1.45), Crohn's disease (OR 1.39; 1.33-1.45), diabetes type 1 (OR 1.21; 1.17-1.24) and type 2 (OR 1.12; 1.1-1.13). Of note, all these risk factors, except Crohn's disease, increased the likelihood of severe pertussis. In conclusion, the incidence of pertussis in the adolescent and adult population in the USA is likely substantial, but considerably under-recognized, highlighting the need for improved clinical awareness of the disease and for improved control strategies in this population. These results will help better inform public health vaccination and booster programs, particularly in those with underlying comorbidities.


Assuntos
Asma , Doença de Crohn , Coqueluche , Humanos , Adulto , Adolescente , Estados Unidos/epidemiologia , Coqueluche/epidemiologia , Coqueluche/prevenção & controle , Incidência , Custos de Cuidados de Saúde , Vacinação , Vacina contra Coqueluche
3.
Vaccine ; 40(38): 5601-5607, 2022 09 09.
Artigo em Inglês | MEDLINE | ID: mdl-35999078

RESUMO

Safety and potency assessment for batch release testing of established vaccines still relies partly on animal tests. An important avenue to move to batch release without animal testing is the consistency approach. This approach is based on thorough characterization of the vaccine to identify critical quality attributes that inform the use of a comprehensive set of non-animal tests to release the vaccine, together with the principle that the quality of subsequent batches follows from their consistent production. Many vaccine antigens are by themselves not able to induce a protective immune response. The antigens are therefore administered together with adjuvant, most often by adsorption to aluminium salts. Adjuvant function is an important component of vaccine potency, and an important quality attribute of the final product. Aluminium adjuvants are capable of inducing NLRP3 inflammasome activation. The aim of this study was to develop and evaluate an in vitro assay for NLRP3 inflammasome activation by aluminium-adjuvanted vaccines. We evaluated the effects of Diphtheria-Tetanus-acellular Pertussis combination vaccines from two manufacturers and their respective adjuvants, aluminium phosphate (AP) and aluminium hydroxide (AH), in an in vitro assay for NLRP3 inflammasome activation. All vaccines and adjuvants tested showed a dose-dependent increase in IL-1ß production and a concomitant decrease in cell viability, suggesting NLRP3 inflammasome activation. The results were analysed by benchmark dose modelling, showing a similar 50% effective dose (ED50) for the two vaccine batches and corresponding adjuvant of manufacturer A (AP), and a similar ED50 for the two vaccine batches and corresponding adjuvant of manufacturer B (AH). This suggests that NLRP3 inflammasome activation is determined by the adjuvant only. Repeated freeze-thaw cycles reduced the adjuvant biological activity of AH, but not AP. Inflammasome activation may be used to measure adjuvant biological activity as an important quality attribute for control or characterization of the adjuvant.


Assuntos
Vacinas contra Difteria, Tétano e Coqueluche Acelular , Difteria , Tétano , Coqueluche , Adjuvantes Imunológicos/farmacologia , Alumínio , Hidróxido de Alumínio/farmacologia , Anticorpos Antibacterianos , Linhagem Celular , Difteria/prevenção & controle , Vacina contra Difteria, Tétano e Coqueluche , Humanos , Inflamassomos , Proteína 3 que Contém Domínio de Pirina da Família NLR , Vacina contra Coqueluche , Tétano/prevenção & controle , Coqueluche/prevenção & controle
4.
Vaccine ; 40(32): 4513-4521, 2022 07 30.
Artigo em Inglês | MEDLINE | ID: mdl-35717266

RESUMO

Testing for inactivation of pertussis toxin and reversion to toxicity in aP vaccines has historically relied on the murine histamine sensitization test, that lacks mechanistic understanding, suffers from standardization problems and is associated with severe animal suffering. Though the regulatory requirements for in vivo testing of acellular pertussis (aP) vaccine products have been waived in Europe, it is still common practice globally. Easy and quantitative in vitro methods are therefore urgently needed. One of the alternatives under development is our reporter cell line - CHO-CRE cells - that carries a cAMP-reporter construct. After exposure to pertussis toxin, cells are stimulated with a low concentration of forskolin to allow detection of pertussis toxin dependent changes in intracellular cAMP levels. Here, the results of two prevalidation studies with purified pertussis toxin and pertussis toxin spiked aP vaccines are described that were performed according to the principles of the ICH Q2(R1) guidelines for a content assay. We confirmed the assay's specificity, accuracy, precision, linearity and range. The cAMP-PTx reporter assay allows for objective, reliable and quantitative assessment of pertussis toxin levels in aP vaccines and can thereby boost broad and global replacement of the histamine sensitization test.


Assuntos
Coqueluche , Animais , Células CHO , Cricetinae , Cricetulus , Histamina , Camundongos , Toxina Pertussis , Vacina contra Coqueluche , Vacinas Acelulares , Coqueluche/prevenção & controle
5.
Int J Epidemiol ; 51(2): 440-447, 2022 05 09.
Artigo em Inglês | MEDLINE | ID: mdl-35045177

RESUMO

BACKGROUND: Changes to pertussis vaccination programmes can have impacts on disease burden that should be estimated independently from factors such as age- and period-related trends. We used age-period-cohort (APC) models to explore pertussis incidence in Manitoba over a 25-year period (1992-2017). METHODS: We identified all laboratory-confirmed cases of pertussis from Manitoba's Communicable Diseases Database and calculated age-standardized incidence rates. We used APC models to investigate trends in pertussis incidence. RESULTS: During the study period, 2479 cases were reported. Age-standardized rates were highest during a large outbreak in 1994 (55 cases/100 000 person-years), with much lower peaks in 1998, 2012 and 2016. We saw strong age and cohort effects in the APC models, with a steady decrease in incidence with increasing age and increased risk in the cohort born between 1980 and 1995. CONCLUSIONS: The highest risk for pertussis was consistently in young children, regardless of birth cohort or time period. The 1981 programme change to an adsorbed whole-cell pertussis vaccine with low effectiveness resulted in reduced protection in the 1981-95 birth cohort and contributed to the largest outbreak of disease during the 25-year study period.


Assuntos
Vacina contra Coqueluche , Coqueluche , Criança , Pré-Escolar , Estudos de Coortes , Efeitos Psicossociais da Doença , Humanos , Incidência , Lactente , Manitoba/epidemiologia , Vacina contra Coqueluche/uso terapêutico , Vacinação , Coqueluche/epidemiologia , Coqueluche/prevenção & controle
6.
Washington, D.C.; OPS; 2022-01-27. (OPS/FPL/IM/21-0040).
em Espanhol | PAHO-IRIS | ID: phr-55693

RESUMO

Los países de las Américas, con apoyo de la Organización Panamericana de la Salud (OPS), han logrado avances notables al proporcionar a los niños y las niñas una protección general contra las enfermedades prevenibles mediante vacunación. Los niveles sostenidos de elevadas coberturas nacionales de vacunación, la erradicación de la poliomielitis, la interrupción de la transmisión endémica del virus del sarampión y las iniciativas más recientes en favor de la eliminación de la rubéola y el síndrome de rubéola congénita son hitos continentales de este progreso. En la actualidad, los países administran vacunas a grupos etarios distintos de los incluidos en los programas tradicionales de inmunización infantil. La introducción de la vacuna estacional contra la gripe en los adultos en riesgo; la vacunación de adolescentes y adultos, hombres y mujeres, para la eliminación de la rubéola, y la definición de la carga de enfermedad del cáncer cervicouterino son las actividades que apoyan la necesidad fundamental de efectuar una transición de los programas nacionales de inmunización infantil a programas de inmunización de la familia. Una de las funciones de la OPS en su apoyo a los países es difundir información que destaque el progreso de la Región y los desafíos que enfrenta. Con ese fin, publica varios documentos técnicos relacionados con la inmunización, tales como los boletines de inmunización, los módulos de capacitación en inmunización y la serie de guías prácticas sobre rubéola, sarampión, tétanos neonatal, poliomielitis, vacuna pentavalente y fiebre amarilla.


Assuntos
Imunização , Vacinação , COVID-19 , Vacinas contra COVID-19 , Sarampo , Vacina contra Sarampo-Caxumba-Rubéola , Vírus da Rubéola , Vacina contra Rubéola , Difteria , Vacina contra Difteria, Tétano e Coqueluche , Febre Amarela , Rotavirus , Vacinas contra Rotavirus , Poliovirus , Coqueluche , Caxumba , Meningite , Vacina contra Coqueluche , Vacina contra Caxumba , Parotidite , Vacina contra Febre Amarela , Vacinas , Programas de Imunização , América , Doenças Preveníveis por Vacina , Indicadores Básicos de Saúde , Região do Caribe
7.
BMC Pregnancy Childbirth ; 21(1): 771, 2021 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-34781905

RESUMO

BACKGROUND: Maternal immunisation is an essential public health intervention aimed at improving the health outcomes for pregnant women and providing protection to the newborn. Despite international recommendations, safety and efficacy data for the intervention, and often a fully funded program, uptake of vaccines in pregnancy remain suboptimal. One possible explanation for this includes limited access to vaccination services at the point of antenatal care. The aim of this study is to evaluate the change in vaccine coverage among pregnant women following implementation of a modified model of delivery aimed at improving access at the point of antenatal care, including an economic evaluation. METHODS: This prospective multi-centre study, using action research design, across six maternity services in Victoria, Australia, evaluated the implementation of a co-designed vaccine delivery model (either a pharmacy led model, midwife led model or primary care led model) supported by provider education. The main outcome measure was influenza and pertussis vaccine uptake during pregnancy and the incremental cost of the new model (compared to existing models) and the cost-effectiveness of the new model at each participating health service. RESULTS: Influenza vaccine coverage in 2019 increased between 50 and 196% from baseline. All services reduced their average cost per immunisation under the new platforms due to efficiencies achieved in the delivery of maternal immunisations. This cost saving ranged from $9 to $71. CONCLUSION: Our study demonstrated that there is no 'one size fits all' model of vaccine delivery. Future successful strategies to improve maternal vaccine coverage at other maternity services should be site specific, multifaceted, targeted at the existing barriers to maternal vaccine uptake, and heavily involve local stakeholders in the design and implementation of these strategies. The cost-effectiveness analysis indicates that an increase in maternal influenza immunisation uptake can be achieved at a relatively modest cost through amendment of maternal immunisation platforms.


Assuntos
Análise Custo-Benefício , Atenção à Saúde/métodos , Vacinas contra Influenza , Serviços de Saúde Materna , Vacina contra Coqueluche , Cobertura Vacinal/métodos , Austrália , Atenção à Saúde/economia , Feminino , Humanos , Gravidez , Estudos Prospectivos , Cobertura Vacinal/economia , Cobertura Vacinal/tendências , Vitória
8.
Vaccine ; 39(1): 121-124, 2021 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-33303179

RESUMO

This issue of Vaccine is devoted to papers from a research project that developed two types of simulation models, static and dynamic transmission, to evaluate the cost-effectiveness of maternal immunization to prevent pertussis in infants in low- and middle-income countries (LMICs). The research was conducted by a multinational team of investigators and funded by the Bill & Melinda Gates Foundation to gain an understanding of when and where maternal immunization might be a good public health investment for LMICs. Here we review the project's central lessons for vaccine policy and research. Models require a lot of data. As most LMICs lack good data, the models were built using pertussis disease burden data from Brazil, a middle-income country with three long-established, independent information systems (disease surveillance, hospitalization, and mortality), on the hypothesis that the disease process is similar across countries. Values for key parameters, particularly infant mortality, infant vaccine coverage, and costs of vaccination and treatment, were then varied to represent other LMICs. The results show that coverage levels of infant whole cell pertussis (wP) vaccine are key to the cost-effectiveness of maternal pertussis immunization. In settings where infant wP coverage is below the threshold thought necessary to eliminate pertussis in the population, 90-95%, maternal immunization is cost-effective, even cost-saving. By contrast, it is very expensive in countries capable of maintaining infant vaccination in or above the threshold range. The research also suggests that, while static models may serve to explore an intervention's cost-effectiveness initially, dynamic transmission models are essential for more accurate estimates. These findings can help guide policies toward maternal pertussis immunization, but also show that developing better data on neonatal pertussis mortality burden and infant vaccine coverage in LMICs, and on the duration of immunity of currently available pertussis vaccines, are key priorities to support better vaccine policy.


Assuntos
Coqueluche , Brasil , Análise Custo-Benefício , Países em Desenvolvimento , Humanos , Imunização , Programas de Imunização , Lactente , Vacina contra Coqueluche , Vacinação , Coqueluche/prevenção & controle
9.
Vaccine ; 39(1): 158-166, 2021 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-33303183

RESUMO

BACKGROUND: This paper compares cost-effectiveness results from two models of maternal immunization to prevent pertussis in infants in Brazil, one static, one dynamic, to explore when static models are adequate for public health decisions and when the extra effort required by dynamic models is worthwhile. METHODS: We defined two scenarios to explore key differences between static and dynamic models, herd immunity and time horizon. Scenario 1 evaluates the incremental cost/DALY of maternal acellular pertussis (aP) immunization as routine infant vaccination coverage ranges from low/moderate up to, and above, the threshold at which herd immunity begins to eliminate pertussis. Scenario 2 compares cost-effectiveness estimates over the models' different time horizons. Maternal vaccine prices of $9.55/dose (base case) and $1/dose were evaluated. RESULTS: The dynamic model shows that maternal immunization could be cost-saving as well as life-saving at low levels of infant vaccination coverage. When infant coverage reaches the threshold range (90-95%), it is expensive: the dynamic model estimates that maternal immunization costs $2 million/DALY at infant coverage > 95% and maternal vaccine price of $9.55/dose; at $1/dose, cost/DALY is $200,000. By contrast, the static model estimates costs/DALY only modestly higher at high than at low infant coverage. When the models' estimates over their different time horizons are compared at infant coverage < 90-95%, their projections fall in the same range. CONCLUSIONS: Static models may serve to explore an intervention's cost-effectiveness against infectious disease: the direction and principal drivers of change were the same in both models. When, however, an intervention too small to have significant herd immunity effects itself, such as maternal aP immunization, takes place against a background of vaccination in the rest of the population, a dynamic model is crucial to accurate estimates of cost-effectiveness. This finding is particularly important in the context of widely varying routine infant vaccination rates globally. CLINICAL TRIAL REGISTRY: Clinical Trial registry name and registration number: Not applicable.


Assuntos
Coqueluche , Brasil , Análise Custo-Benefício , Humanos , Imunização , Programas de Imunização , Lactente , Vacina contra Coqueluche , Vacinação , Coqueluche/prevenção & controle
11.
Int J Infect Dis ; 96: 482-488, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32413606

RESUMO

The Global Pertussis Initiative is an expert scientific forum that publishes consensus recommendations concerning pertussis for many regions of the world. Here, we give recommendations for the primary vaccination of infants in those countries where whole-cell pertussis (wP)- and acellular pertussis (aP)-containing combination vaccines are used in parallel. A selective literature review was performed concerning the influence on safety, immunogenicity, and effectiveness of mixing wP- and aP-containing vaccines for primary immunization of infants. In addition, local data were collected from various countries and the results discussed in a face-to-face meeting. Very few data addressing issues of mixing combination vaccines were identified, and no data were available concerning the effectiveness or duration of protection. It was also found that pharmacovigilance data are scarce or lacking in those countries where they would be needed the most. We then identified frequent problems occurring in low- and middle-income countries (LMICs) where both vaccine types are used. Relying on local knowledge, we give practical recommendations for a variety of situations in different settings. Specific needs for additional data addressing these issues were also identified. International bodies, such as the World Health Organization (WHO), as well as vaccine producers should try to find ways to highlight the problems of mixing wP- and aP-containing combination vaccines with robust data. Countries are urged to improve on their pharmacovigilance for vaccines. For practicing physicians, our recommendations offer guidance when wP- and aP-containing vaccines are used in parallel during primary immunization.


Assuntos
Vacina contra Coqueluche/administração & dosagem , Coqueluche/prevenção & controle , Humanos , Pobreza , Vacinação , Coqueluche/economia , Coqueluche/epidemiologia , Organização Mundial da Saúde
12.
Vaccine ; 38 Suppl 2: B8-B21, 2020 12 22.
Artigo em Inglês | MEDLINE | ID: mdl-32061385

RESUMO

INTRODUCTION: The public-private ADVANCE consortium (Accelerated development of vaccine benefit-risk collaboration in Europe) aimed to assess if electronic healthcare databases can provide fit-for purpose data for collaborative, distributed studies and monitoring of vaccine coverage, benefits and risks of vaccines. OBJECTIVE: To evaluate if European healthcare databases can be used to estimate vaccine coverage, benefit and/or risk using pertussis-containing vaccines as an example. METHODS: Characterisation was conducted using open-source Java-based (Jerboa) software and R scripts. We obtained: (i) The general characteristics of the database and data source (meta-data) and (ii) a detailed description of the database population (size, representatively of age/sex of national population, rounding of birth dates, delay between birth and database entry), vaccinations (number of vaccine doses, recording of doses, pattern of doses by age and coverage) and events of interest (diagnosis codes, incidence rates). A total of nine databases (primary care, regional/national record linkage) provided data on events (pertussis, pneumonia, death, fever, convulsions, injection site reactions, hypotonic hypo-responsive episode, persistent crying) and vaccines (acellular pertussis and whole cell pertussis) related to the pertussis proof of concept studies. RESULTS: The databases contained data for a total population of 44 million individuals. Seven databases had recorded doses of vaccines. The pertussis coverage estimates were similar to those reported by the World Health Organisation (WHO). Incidence rates of events were comparable in magnitude and age-distribution between databases with the same characteristics. Several conditions (persistent crying and somnolence) were not captured by the databases for which outcomes were restricted to hospital discharge diagnoses. CONCLUSION: The database characterisation programs and workflows allowed for an efficient, transparent and standardised description and verification of electronic healthcare databases which may participate in pertussis vaccine coverage, benefit and risk studies. This approach is ready to be used for other vaccines/events to create readiness for participation in other vaccine related studies.


Assuntos
Vacina contra Coqueluche , Coqueluche , Europa (Continente) , Humanos , Lactente , Vacina contra Coqueluche/uso terapêutico , Medição de Risco , Convulsões , Vacinação , Cobertura Vacinal , Coqueluche/epidemiologia , Coqueluche/prevenção & controle
13.
Clin Infect Dis ; 71(8): 1984-1987, 2020 11 05.
Artigo em Inglês | MEDLINE | ID: mdl-32095810

RESUMO

In October 2012, a maternal pertussis vaccination program was implemented in England following an increased incidence and mortality in infants. We evaluated the cost-effectiveness of the program by comparing pertussis-related infant hospitalizations and deaths in 2012-2017 with nonvaccination scenarios. Despite considerable uncertainties, findings support the cost-effectiveness of the program.


Assuntos
Coqueluche , Análise Custo-Benefício , Inglaterra/epidemiologia , Hospitalização , Humanos , Lactente , Vacina contra Coqueluche , Vacinação , Coqueluche/epidemiologia , Coqueluche/prevenção & controle
14.
Pediatrics ; 145(2)2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31932361

RESUMO

BACKGROUND: Mandatory vaccination has been effective in maintaining high vaccination coverage in countries such as the United States. However, there are no peer-reviewed analyses of the association between mandates and both coverage and subsequent incidence of vaccine-preventable disease in Europe. METHODS: Using data from the European Centre for Disease Prevention and Control and the World Health Organization, we evaluated the relationship between country-level mandatory vaccination policies and (1) measles and pertussis vaccine coverage and (2) the annual incidence of these diseases in 29 European countries. Multivariate negative binomial and linear regression models were used to quantify these associations. RESULTS: Mandatory vaccination was associated with a 3.71 (95% confidence interval [CI]: 1.68 to 5.74) percentage point higher prevalence of measles vaccination and a 2.14 (95% CI: 0.13 to 4.15) percentage point higher prevalence of pertussis vaccination when compared with countries that did not have mandatory vaccination. Mandatory vaccination was only associated with decreased measles incidence for countries without nonmedical exemptions (adjusted incidence rate ratio = 0.14; 95% CI: 0.05 to 0.36). We did not find a significant association between mandatory vaccination and pertussis incidence. CONCLUSIONS: Mandatory vaccination and the magnitude of fines were associated with higher vaccination coverage. Moreover, mandatory vaccination was associated with lower measles incidence for countries with mandatory vaccination without nonmedical exemptions. These findings can inform legislative policies aimed at increasing vaccination coverage.


Assuntos
Programas Obrigatórios/estatística & dados numéricos , Vacina contra Sarampo/administração & dosagem , Sarampo/epidemiologia , Vacina contra Coqueluche/administração & dosagem , Cobertura Vacinal/estatística & dados numéricos , Coqueluche/epidemiologia , Intervalos de Confiança , Europa (Continente)/epidemiologia , Humanos , Incidência , Programas Obrigatórios/economia , Sarampo/prevenção & controle , Cobertura Vacinal/economia , Coqueluche/prevenção & controle
15.
Vaccine ; 38 Suppl 2: B65-B75, 2020 12 22.
Artigo em Inglês | MEDLINE | ID: mdl-31677947

RESUMO

BACKGROUND: The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private collaboration aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines using electronic health record (eHR) databases in Europe. Proof-of-concept studies were designed to assess the proposed processes and system for generating the required evidence to perform B/R assessment and near-real time monitoring of vaccines. We aimed to test B/R methodologies for vaccines, using the comparison of the B/R profiles of whole-cell (wP) and acellular pertussis (aP) vaccine formulations in children as an example. METHODS: We used multi-criteria decision analysis (MCDA) to structure the B/R assessment combined with individual-level state transition modelling to build the B/R effects table. In the state transition model, we simulated the number of events in two hypothetical cohorts of 1 million children followed from first pertussis dose till pre-school-entry booster (or six years of age, whichever occurred first), with one cohort receiving wP, and the other aP. The benefits were reductions in pertussis incidence and complications. The risks were increased incidences of febrile convulsions, fever, hypotonic-hyporesponsive episodes, injection-site reactions and persistent crying. Most model parameters were informed by estimates (coverage, background incidences, relative risks) from eHR databases from Denmark (SSI), Spain (BIFAP and SIDIAP), Italy (Pedianet) and the UK (RCGP-RSC and THIN). Preferences were elicited from clinical and epidemiological experts. RESULTS: Using state transition modelling to build the B/R effects table facilitated the comparison of different vaccine effects (e.g. immediate vaccine risks vs long-term vaccine benefits). Estimates from eHR databases could be used to inform the simulation model. The model results could be easily combined with preference weights to obtain B/R scores. CONCLUSION: Existing B/R methodology, modelling and estimates from eHR databases can be successfully used for B/R assessment of vaccines.


Assuntos
Técnicas de Apoio para a Decisão , Vacina contra Coqueluche , Coqueluche , Criança , Europa (Continente) , Humanos , Imunização Secundária , Itália , Vacina contra Coqueluche/efeitos adversos , Medição de Risco , Espanha
16.
J Pediatric Infect Dis Soc ; 9(2): 118-127, 2020 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-30535079

RESUMO

BACKGROUND: Recent increases in pertussis morbidity and mortality rates among young infants have led to a recommendation in some countries for vaccination against pertussis during pregnancy. Having data on the burden of pediatric pertussis in a large population over time is important for establishing the true burden of disease in the acellular pertussis (aP) vaccine era. Here, we describe age-specific epidemiology and morbidity and mortality rates in children hospitalized with pertussis over 17 years across Canada in the aP vaccine era. METHODS: Patients aged ≤16 years who were admitted to 1 of 12 pediatric tertiary-care hospitals across Canada between 1999 and 2015 with confirmed (laboratory-confirmed or epidemiologically linked) or probable (clinically diagnosed) pertussis were included. RESULTS: Overall, 1402 patients with pertussis were included. Infants aged <2 months had the highest mean annual incidences of pertussis hospitalization and intensive care unit (ICU) admission (116.40 [95% confidence interval (CI), 85.32-147.49] and 33.48 [95% CI, 26.35-40.62] per 100 000 population, respectively). The overall proportion of children who required ICU admission was 25.46%, and the proportion was highest in infants aged <2 months (37.90%). Over the span of this study, 21 deaths occurred. Age of <16 weeks, prematurity, encephalopathy, and a confirmed pertussis diagnosis were independent risk factors for ICU admission. Age of <4 weeks, prematurity, and female sex were independent risk factors for death. CONCLUSIONS: In the aP vaccine era, endemic pertussis still contributes considerably to childhood morbidity and death, particularly in infants aged <2 months. Vaccination against pertussis during pregnancy has the potential to reduce this disease burden.


Assuntos
Hospitalização/estatística & dados numéricos , Coqueluche/epidemiologia , Adolescente , Fatores Etários , Canadá/epidemiologia , Criança , Pré-Escolar , Comorbidade , Efeitos Psicossociais da Doença , Vacinas contra Difteria, Tétano e Coqueluche Acelular , Feminino , Hospitais Pediátricos , Humanos , Incidência , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Pediátrica , Tempo de Internação , Modelos Logísticos , Masculino , Vacina contra Coqueluche , Fatores de Risco , Fatores Sexuais , Coqueluche/complicações , Coqueluche/mortalidade
17.
Vaccine ; 38(6): 1402-1407, 2020 02 05.
Artigo em Inglês | MEDLINE | ID: mdl-31839466

RESUMO

Infants aged under one year are at the highest risk of severe complications or death from pertussis infection. Prompt vaccination with a three dose course at two, three and four months of age decreases the amount of time they are vulnerable following waning of maternal antibodies. In Wales, uptake of all three doses of the primary course of pertussis containing vaccine is high. However, timeliness and equity at a population level have not been previously reported. This analysis included 163,733 children born from 1st January 2013 to 31st December 2017. In this cohort 87.9% received the first dose of a pertussis containing vaccine by 12 weeks of age, 87.1% had received all three doses by 24 weeks of age, and 96.3% received three doses by 52 weeks of age. Differences in uptake between those living in the most deprived and least deprived quintiles of Lower Super Output Area (LSOA) were smaller than differences in timeliness, but statistically significant. In 2017 the difference in timely uptake between those living in the most and least deprived quintiles was 4%, 5% and 7% for doses one, two and three respectively. There was a difference of 10% in the proportion of infants receiving all three primary vaccinations on time between the most and least deprived quintile of LSOAs. Consideration is needed on interventions that will help improve timeliness such as enhanced follow up of defaulters, electronic communication between primary care data systems, enhanced health visitor intervention and opportunistic vaccination in those who fail to attend scheduled vaccination appointments. There is also the need for routine monitoring of timeliness and further research into what influences delayed vaccination.


Assuntos
Esquemas de Imunização , Vacina contra Coqueluche/administração & dosagem , Coqueluche , Estudos de Coortes , Equidade em Saúde , Humanos , Lactente , Vacinação , País de Gales , Coqueluche/prevenção & controle
18.
Clin Microbiol Infect ; 26(5): 645.e1-645.e8, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31610300

RESUMO

OBJECTIVES: Quantifying IgG antibodies to pertussis toxin (PT) is the most specific and sensitive method for the serodiagnosis of a Bordetella pertussis infection. Since PT is a component of acellular pertussis vaccines, anti-PT IgG is also induced by vaccination, precluding pertussis serodiagnosis based exclusively on anti-PT IgG in recently vaccinated subjects. Here, we aim to identify additional B. pertussis-specific serological markers that can discriminate between infection and recent vaccination. METHODS: The clinical usefulness of measuring IgA directed to the vaccine antigen PT and IgG directed to non-vaccine antigens (Fim2/3, LPS, ACT, CatACT) was evaluated in nine well characterized subject groups, aged 10-89 years (n = 390). Serum anti-PT IgG levels (>125 IU/mL) served as an indicator for a recent B. pertussis infection. Comparing symptomatic pertussis-infected subjects (n = 140) with recently vaccinated, non-infected subjects (n = 100) revealed the optimal cut-off, accuracy, sensitivity and specificity for each single parameter. RESULTS: For pertussis diagnosis in recently vaccinated subjects, the measurement of anti-PT IgA (cut-off 15 IU/mL) and anti-ACT IgG (cut-off 15 U/mL) resulted in accuracies of 95% (91.5-97.1) and 87.5% (82.7-91.1), sensitivities of 92.9% (87.4-96.0) and 83.6% (76.5-88.8) and specificities of 98% (93.0-99.4) and 93% (86.3-96.6), respectively. Comparing anti-PT IgA levels between the youngest (10-19 years, n = 38) and oldest (70-89 years, n = 17) age groups revealed an age-dependent increase in antibody levels in pertussis-infected subjects (p < 0.0001). CONCLUSIONS: Reflex testing of anti-PT IgA and anti-ACT IgG improves pertussis serodiagnosis in recently vaccinated symptomatic subjects with elevated anti-PT IgG levels. Furthermore, both markers can discriminate between vaccination and recent infection in pertussis serosurveillance studies.


Assuntos
Antígenos de Bactérias/imunologia , Bordetella pertussis/imunologia , Toxina Pertussis/imunologia , Vacina contra Coqueluche/administração & dosagem , Testes Sorológicos/métodos , Coqueluche/diagnóstico , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticorpos Antibacterianos/sangue , Criança , Feminino , Humanos , Imunoglobulina A/sangue , Imunoglobulina G/sangue , Masculino , Pessoa de Meia-Idade , Vacina contra Coqueluche/imunologia , Sensibilidade e Especificidade , Vacinação , Coqueluche/sangue , Coqueluche/patologia , Coqueluche/prevenção & controle , Adulto Jovem
19.
Arch Argent Pediatr ; 117(2): S37-S119, 2019 04.
Artigo em Espanhol | MEDLINE | ID: mdl-31833342

RESUMO

Beginning in 1974, the date on which the Expanded Program on Immunization was established in the Americas, the number of deaths and disabilities due to certain infectious diseases decreased considerably thanks to universally applied vaccines. A program that initially included four vaccines that protected against six diseases (tuberculosis, diphtheria, pertussis, tetanus, polio and measles) was consolidated, over the years, by incorporating new vaccines and significantly raising coverage rates. The Sociedad Argentina de Pediatría (Argentine Society of Pediatrics), as a leader of opinion, played a leading role in the incorporation of new vaccines, currently reaching one of the most complete vaccination calendars in the world, which improves the levels of inequality and inequity in public health. Taking into account the significant role of the pediatrician in decision-making, the National Committee of Infectious Diseases, together with the Subsidiary Committees, prepared a document on updates and recommendations for 2018 on Polio, Rotavirus, Pneumococcus, Meningococcus, Human Papillomavirus, Chickenpox, Flu, Dengue vaccines and Whooping Cough.


A partir del año 1974, cuando se estableció el Programa Ampliado de Inmunizaciones en las Américas, la cantidad de muertes y discapacidades por enfermedades infecciosas disminuyó de manera considerable gracias a las vacunas aplicadas. Inicialmente, se incluyeron cuatro vacunas que protegían contra seis enfermedades (tuberculosis, difteria, coqueluche, tétanos, polio y sarampión), y, a través de los años, al incorporar nuevas vacunas, aumentaron considerablemente las tasas de cobertura. La Sociedad Argentina de Pediatría tuvo un rol destacado en la incorporación de nuevas vacunas y, en la actualidad, hay uno de los calendarios de vacunación más completos del mundo, lo que permite mejorar los niveles de desigualdad e inequidad en salud pública. Teniendo en cuenta el rol que tiene el pediatra en la toma de decisiones, el Comité Nacional de Infectología, junto con comités de filiales, elaboró un documento sobre actualizaciones y recomendaciones de 2018 acerca de polio, rotavirus, neumococo, meningococo, virus del papiloma humano, varicela, gripe, dengue y coqueluche.


Assuntos
Programas de Imunização/normas , Esquemas de Imunização , Vacina contra Coqueluche/administração & dosagem , Vacinas Estreptocócicas/administração & dosagem , Vacinas Virais/administração & dosagem , Adolescente , Argentina/epidemiologia , Varicela/epidemiologia , Varicela/prevenção & controle , Criança , Pré-Escolar , Tomada de Decisão Clínica , Contraindicações , Dengue/epidemiologia , Dengue/prevenção & controle , Diagnóstico Diferencial , Armazenamento de Medicamentos/métodos , Feminino , Saúde Global , Humanos , Lactente , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , América Latina/epidemiologia , Masculino , Infecções Meningocócicas/epidemiologia , Infecções Meningocócicas/prevenção & controle , Infecções Meningocócicas/transmissão , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Pediatria , Vacina contra Coqueluche/efeitos adversos , Vacina contra Coqueluche/imunologia , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Poliomielite/diagnóstico , Poliomielite/epidemiologia , Poliomielite/prevenção & controle , Poliomielite/transmissão , Vacinas contra Poliovirus/administração & dosagem , Vacinas contra Poliovirus/efeitos adversos , Vacinas contra Poliovirus/imunologia , Infecções por Rotavirus/epidemiologia , Infecções por Rotavirus/prevenção & controle , Sociedades Médicas , Vacinas Estreptocócicas/efeitos adversos , Vacinas Estreptocócicas/imunologia , Vacinas Conjugadas/administração & dosagem , Vacinas Conjugadas/efeitos adversos , Vacinas Conjugadas/imunologia , Vacinas Virais/efeitos adversos , Vacinas Virais/imunologia , Coqueluche/epidemiologia , Coqueluche/prevenção & controle
20.
J Prev Med Hyg ; 60(3): E171-E177, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31650050

RESUMO

BACKGROUND: The inadequate knowledge about vaccinations of healthcare workers, including medical doctors, has certainly contributed to the spread of the vaccine hesitancy. Therefore, it is essential to improve the level of knowledge of future doctors. The aim of the study is to evaluate the impact of a course about vaccinations on the knowledge of medical students. METHODS: Medical students were asked to complete an anonymous questionnaire before and after a seminar on vaccination that they willingly attended. The two questionnaires contained the same 10 questions about vaccines. Only the students who had attended the lecture were allowed to fulfil the post-lecture questionnaires through the learning management system (LMS) called "Moodle". A descriptive statistical analysis of the data collected through the comparative evaluation of the answers before and after the seminar was performed. Mann-Whitney test for two independent samples was used to compare medians score before and after the interventions. RESULTS: A total of 100 medical students filled the pre-lecture questionnaire and 81 of them completed the post-lecture questionnaire. Knowledge of the students on the indication of the MMR (Measles-Mumps-Rubella) vaccine strongly improved after the seminar. Moreover, the number of students who would recommend vaccination for pertussis and influenza during pregnancy increased significantly by 37% and 19% respectively after the seminar and those aware of the need for Herpes Zoster vaccination over the age of 65 increased by 22%. DISCUSSION: For future doctors, a thorough knowledge about vaccinations is increasingly required in order to deal with vaccine hesitancy. Extracurricular seminars about vaccines, provided in the second half of the course of study, can have a highly positive impact.


Assuntos
Competência Clínica , Currículo , Educação de Graduação em Medicina , Vacinação , Vacina contra Herpes Zoster , Humanos , Esquemas de Imunização , Vacinas contra Influenza , Vacina contra Sarampo-Caxumba-Rubéola , Vacina contra Coqueluche
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