Vaccination In Spain Research Articles

Political and regulatory key factors of transparency and independence in terms of vaccination in Spain: Information, participation and lobbies

Political and regulatory key factors of transparency and independence in terms of vaccination in Spain: Information, participation and lobbies

Changes in the pneumococcal disease-related hospitalisations in Spain after the replacement of 7-valent by 13-valent conjugate vaccine.

In Spain, anti-pneumococcal vaccination is recommended for all children under 2years old, high-risk groups and adults ≥65years old. However, it is not funded in most autonomous communities. This study aims to compare pneumococcal disease hospitalisation rates between Period 1 (2007-2009), when 7-valent (PCV7) vaccine was available, and Period 2 (2011-2013), after the change to 13-valent (PCV13) vaccine in Spain. Data on hospitalisations were obtained from the National Registry of Hospitalisations. We calculated hospitalisation rates (HRs) and hospitalisation rate ratios (HRRs) among periods by age group and autonomous community, for all and by clinical presentation. From 138,361 patients hospitalised, 83,528 (60.4 %) were males. The median age was 73.8years. The most common clinical presentation was pneumonia (133,204 hospitalisations; 96.3 %), followed by septicaemia (7053 hospitalisations; 5.1 %) and meningitis (3182 hospitalisations; 2.3 %). In Period 2, hospitalisations among children <5years old decreased for pneumonia [HRR: 0.37; 95 % confidence interval (95 % CI): 0.35 to 0.39] and meningitis (HRR: 0.53; 95 % CI: 0.44 to 0.65). For adults ≥65years old, pneumonia (HRR: 0.49; 95 % CI: 0.49 to 0.50) and peritonitis (HRR: 0.34; 95 % CI: 0.19 to 0.63) hospitalisations decreased and septicaemia hospitalisations (HRR: 1.27; 95 % CI: 1.18 to 1.36) increased. Significant changes in HRs for pneumococcal disease were observed even without an integrated and continuous vaccination programme after the introduction of PCV13, especially in children <5years old and for pneumonia. The impact of the PCV13 adult vaccination new recommendations on the septicaemia increase reported should be evaluated in the future.

Cost–effectiveness analysis of quadrivalent influenza vaccine in Spain

ABSTRACTInfluenza has a major impact on healthcare systems and society, but can be prevented using vaccination. The World Health Organization (WHO) currently recommends that influenza vaccines should include at least two virus A and one virus B lineage (trivalent vaccine; TIV). A new quadrivalent vaccine (QIV), which includes an additional B virus strain, received regulatory approval and is now recommended by several countries. The present study estimates the cost-effectiveness of replacing TIVs with QIV for risk groups and elderly population in Spain. A static, lifetime, multi-cohort Markov model with a one-year cycle time was adapted to assess the costs and health outcomes associated with a switch from TIV to QIV. The model followed a cohort vaccinated each year according to health authority recommendations, for the duration of their lives. National epidemiological data allowed the determination of whether the B strain included in TIVs matched the circulating one. Societal perspective was considered, costs and outcomes were discounted at 3% and one-way and probabilistic sensitivity analyses were performed. Compared to TIVs, QIV reduced more influenza cases and influenza-related complications and deaths during periods of B-mismatch strains in the TIV. The incremental cost-effectiveness ratio (ICER) was 8,748€/quality-adjusted life year (QALY). One-way sensitivity analysis showed mismatch with the B lineage included in the TIV was the main driver for ICER. Probabilistic sensitivity analysis shows ICER below 30,000€/QALY in 96% of simulations. Replacing TIVs with QIV in Spain could improve influenza prevention by avoiding B virus mismatch and provide a cost-effective healthcare intervention.

Vacunación frente a la hepatitis B. Impacto de los programas de vacunación tras 20 años de su utilización en España. ¿Es tiempo de cambios?

The highest incidence rate of hepatitisB (HB) in Spain is detected in adults between 20 and 54years old, whereas the incidence in children under 1year old is almost nil. The low prevalence of HB in children under 1year is mainly due to the success of gestational screening strategies for the detection of HBsAg(+) in pregnant women, and vaccination campaigns during childhood. Currently, in Spain, the last dose of the HB included in the national childhood immunization program is administered at 6months of age, although some studies show that delaying the age of the administration of the last dose of HB vaccine and increasing the time between doses, may improve immune memory by offering greater protection against this virus in the adulthood. In this article, the impact of HB vaccination in Spain is reviewed, and other potential vaccination strategies in our environment are discussed, such as extending the interval between doses, and administering the last dose in the second year of life, adapting the valid strategy in Spain to the current epidemiological context in order to reduce the prevalence of HB in adulthood.

Budget impact and cost-utility analysis of universal infant rotavirus vaccination in Spain

Rotavirus is not included in the Spanish mass infant vaccination schedule but has also not been economically evaluated for its inclusion. We analysed cost-utility of the universal infant rotavirus vaccination using RotaTeq® versus no vaccination in Spain. We also carried out a budget impact analysis and determined the effect on results of different variables introduced in the model. A deterministic Markov model was built considering loss of quality of life for children and their parents, and introducing direct and indirect costs updated to 2011.The introduction of the vaccination using RotaTeq® as a universal infant vaccination would increase the annual health care budget in 10.43million euro and would result in a gain of an additional Quality Adjusted Life Year at a cost of 280,338€ from the healthcare system perspective and 210,167€ from the societal perspective. The model was stable to variable modifications.To sum up, according to our model and estimates, the introduction of a universal infant rotavirus vaccination with RotaTeq® in Spain would cause a large impact on the health care budget and would not be efficient unless significant variations in vaccine price, vaccine efficacy and/or utilities took place.

Different vaccination strategies in Spain and its impact on severe varicella and zoster

Varicella vaccines available in Spain were marketed in 1998 and 2003 for non-routine use. Since 2006 some regions decided to include varicella vaccination in their regional routine vaccination programmes at 15–18 months of age. Other regions chose the strategy of vaccinating susceptible adolescents.This study shows the trends in severe varicella zoster virus infections through the analysis of the hospital discharges related to varicella and herpes zoster in the general population from 2005 to 2010 in Spain.A total of 11,125 hospital discharges related to varicella and 27,736 related to herpes zoster were reported during the study period. The overall annual rate of hospitalization was 4.14 cases per 100,000 for varicella and 10.33 cases per 100,000 for herpes zoster. In children younger than 5 years old varicella hospitalization rate significantly decreased from 46.77 in 2005 to 26.55 per 100,000 in 2010. The hospitalization rate related to herpes zoster slightly increased from 9.71 in 2005 to 10.90 per 100,000 in 2010. This increase was mainly due to the significant increase occurring in the >84 age group, from 69.55 to 97.68 per 100,000. When gathering for regions taking into account varicella vaccine strategy, varicella related hospitalizations decreased significantly more in those regions which included the vaccine at 15–18 months of age as a routine vaccine comparing with those vaccinating at 10–14 years old. No significant differences were found in herpes zoster hospitalization rates regarding the varicella vaccination strategy among regions.Severe varicella infections decreased after implementation of varicella vaccination in Spain. This decrease was significantly higher in regions including the vaccine at 15–18 months of age compared with those vaccinating susceptible adolescents.

Effectiveness of influenza vaccine against laboratory-confirmed influenza, in the late 2011-2012 season in Spain, among population targeted for vaccination.

BackgroundIn Spain, the influenza vaccine effectiveness (VE) was estimated in the last three seasons using the observational study cycEVA conducted in the frame of the existing Spanish Influenza Sentinel Surveillance System. The objective of the study was to estimate influenza vaccine effectiveness (VE) against medically attended, laboratory-confirmed influenza-like illness (ILI) among the target groups for vaccination in Spain in the 2011–2012 season. We also studied influenza VE in the early (weeks 52/2011-7/2012) and late (weeks 8-14/2012) phases of the epidemic and according to time since vaccination.MethodsMedically attended patients with ILI were systematically swabbed to collect information on exposure, laboratory outcome and confounding factors. Patients belonging to target groups for vaccination and who were swabbed <8 days after symptom onset were included. Cases tested positive for influenza and controls tested negative for any influenza virus. To examine the effect of a late season, analyses were performed according to the phase of the season and according to the time between vaccination and symptoms onset.ResultsThe overall adjusted influenza VE against A(H3N2) was 45% (95% CI, 0–69). The estimated influenza VE was 52% (95% CI, -3 to 78), 40% (95% CI, -40 to 74) and 22% (95% CI, -135 to 74) at 3.5 months, 3.5-4 months, and >4 months, respectively, since vaccination. A decrease in VE with time since vaccination was only observed in individuals aged ≥ 65 years. Regarding the phase of the season, decreasing point estimates were only observed in the early phase, whereas very low or null estimates were obtained in the late phase for the shortest time interval.ConclusionsThe 2011–2012 influenza vaccine showed a low-to-moderate protective effect against medically attended, laboratory-confirmed influenza in the target groups for vaccination, in a late season and with a limited match between the vaccine and circulating strains. The suggested decrease in influenza VE with time since vaccination was mostly observed in the elderly population. The decreasing protective effect of the vaccine in the late part of the season could be related to waning vaccine protection because no viral changes were identified throughout the season.

Anotaciones a la biografía de Ignacio María Ruiz de Luzuriaga (1763–1822), el inicio de la vacunación contra la viruela en España

Ignacio María Ruiz de Luzuriaga (1763–1822) played a notable role during the beginning of smallpox vaccination in Spain. From his position as secretary of the Royal Academy of Medicine, Luzuriaga encouraged an exchange of letters between progressive thinkers including physicians, surgeons, aristocrats and the bourgeoisie and provide them with the vaccine and advice on how to use it, and received information on the progress made in return. This may be seen as a failed attempt to form a central vaccination committee similar to those existing in other European countries. We review Luzuriaga's life and times, and include hitherto unknown details.

The burden of hospitalizations for head and neck neoplasm in Spain (1997-2008): An epidemiologic study.

Background: Cancers of the head and neck currently figure as the 6th most important cause of cancer globally. They are strongly associated with tobacco and alcohol consumption, but recent studies showed the presence of HPV in patients with these types of cancer. The incidence of cancers of the head and neck potentially attributable to HPV has increased in the last years. This study aims to provide population-based estimates of the burden of hospitalisation for head & neck neoplasm in Spain that may be useful when cost-effectiveness models are developed to evaluate the impact of HPV vaccination in Spain. Methods: Epidemiological retrospective survey to assess the burden of hospitalisation for head and neck neoplasm in the general population in Spain during the 1997-2008 period. Differences in proportions were assessed by the Chi-square test. ANOVA was used for multiple comparisons. The post hoc Bonferroni correction was used to adjust statistical significance for multiple comparisons. Poisson regression was used to assess differences in the hospitalisation rate during the study period in all the age groups. Results: A total of 199,304 hospital discharges for head and neck malignant neoplasm were recorded during the 12-years of study: 55,475 (46,560 males and 8,915 females) corresponded to oral cavity; 46,699 (45,020 males and 1,679 females) to pharynx and 97,139 (93,374 males and 3,765 females) to larynx malignant neoplasms. Hospitalization rates increased significantly with age. Overall hospitalization rates in men were more than 10-fold higher than in women. Rates decreased significantly in men during the study period but increased significantly in women in all locations. Conclusions: Although a slight decrease has been observed in hospitalization rates due to head and neck neoplasm in the last years in men, they still generate a substantial morbidity and mortality, especially in adults over 50 years of age.

Effectiveness of the 2010–11 seasonal trivalent influenza vaccine in Spain: cycEVA study

BackgroundIn Spain, the influenza vaccine effectiveness (VE) was estimated in the last three seasons using an observational study (cycEVA) conducted in the frame of the Spanish Influenza Sentinel Surveillance System. We aimed to measure the effectiveness of the seasonal trivalent vaccine in preventing influenza like illness (ILI) laboratory-confirmed influenza infection at the end of the season 2010–11. MethodsWe conducted a test-negative case–control study between weeks 50/2010 and 12/2011. Cases were ILI laboratory-confirmed influenza infection and controls were those testing negative. Sentinel physicians collected data on demographic and clinical characteristics, vaccination status, and on covariates related to confounding factors associating with influenza VE. We calculated adjusted odds ratios (OR), using logistic regression and computed influenza VE as (1−OR)×100. ResultsThe adjusted influenza VE against A(H1N1)pdm09 infection was 46% (95% confidence interval (95%CI): 0; 72). In A(H1N1)pdm09 infected patients who had received both 2010–11 trivalent influenza seasonal and 2009 monovalent pandemic vaccines, influenza VE was 74% (95%CI: 13; 93). The adjusted influenza VE against B infection was 23% (95%CI: −180; 79). ConclusionThe trivalent influenza vaccine 2010–11 showed a moderate VE for preventing ILI laboratory confirmed influenza infections. Influenza VE estimates were higher in patients who had received both 2010–11 seasonal trivalent and 2009 monovalent pandemic vaccines.

Early estimates of the effectiveness of the 2011/12 influenza vaccine in the population targeted for vaccination in Spain, 25 December 2011 to 19 February 2012

We present early estimates of influenza vaccine effectiveness (VE) in the population targeted for vaccination, during 25 December 2011 to 19 February 2012. The adjusted VE was 55% (95% CI: 3 to 79) against any type of influenza virus and 54% (95% CI: 1 to 79) against influenza A(H3N2) virus. This suggests a moderate protective effect of the vaccine in the targeted population in a late influenza epidemic with limited match between vaccine and circulating strains.

Hospitalization in Spain associated with malignant neoplasias of the vulva and vagina (1997-2008)

An important percentage of vulvar and vaginal cancers may be attributed to infections by the human papillomavirus. Although the incidence of invasive vulvar and vaginal cancers is low, it has remained stable over the past years. Hospital discharges related to malignant neoplasias and in situ carcinomas of the vulva and vagina from 1997 to 2008 were selected from the Minimum Data Set of the Ministry of Health in Spain. 17,883 hospital admissions related to vulvar and vaginal malignant neoplasias and 2,185 admissions related to in situ carcinomas of the vulva and vagina were gathered, with a hospitalization rate of 7,054 and 0.862 discharges per 100,000 women/year, respectively. The mean age of patients was 57 (SD:18) years, and the mean length of hospital stay was 8 (SD:10) days. There was a statistically significant increase in the hospitalization rate for malignant neoplasias and in situ carcinomas with increasing patient age. This increase was significant for all locations. Overall, there was a case fatality rate of 9.34% for vulvar and vaginal malignant neoplasias and 0.46% for in situ carcinomas of an external genital organ. Mortality and case fatality rates increased significantly throughout the length of the study. 92% of all deaths occurred in those older than 55 years of age. Mortality and case fatality rates also increased significantly with age. The hospitalization rate follows a north-south pattern. These data of the pre-anti-HPV vaccine era may be useful to develop cost-effectiveness models and strategies and evaluate the impact of HPV vaccination in Spain.

Análisis de coste-efectividad de la vacunación antineumocócica en España

Objective To perform a cost-effectiveness analysis of pediatric pneumococcal vaccination in Spain. Methods A deterministic population-based model in the form of a decision-tree with a 1-year time horizon was used to estimate the impact of vaccination with Synflorix ® or Prevenar13 ® in children aged less than 2 years in Spain from the perspective of the National Health System. Epidemiological data were obtained from the hospital discharge minimum data set (MDS) and the literature. Data on costs were obtained from national health costs databases. The main outcomes measured were the number of cases avoided of invasive pneumococcal disease, acute otitis media (AOM) and myringotomies, and hospital admissions for pneumonia. All costs were expressed in 2010 euros. Effectiveness was measured as the number of quality-adjusted life years (QALYs) gained. Results The efficacy of Synflorix ® in preventing episodes of AOM caused by non-typeable Haemophilus influenzae could lead to additional prevention of 41,513 episodes of AOM, 36,324 antibiotic prescriptions and 382 myringotomy procedures and 143 QALYs gained compared with Prevenar13 ®. The total vaccination cost with Synflorix ® would result in savings of 22 million euros. Conclusions Pneumococcal vaccination with Synflorix ® in comparison with Prevenar13 ® in children aged less than 2 years old in Spain could achieve a higher number of QALYs and a substantial cost offset. Vaccination with Synflorix ® would be a dominant strategy in terms of cost-effectiveness.

Sobredosificación accidental de vacuna con bacilo de Calmette Guérin

The anti tuberculosis vaccine in Spain is only included in the Basque Country’s vaccina tion schedule. Given the low frequency of vaccination for BCG (Bacille Calmette-Guerin) in our country, it is unusual to find cases of accidental overdose like the one described in this article.

Effectiveness of the 2010/11 seasonal trivalent influenza vaccine in Spain: preliminary results of a case–control study

We present preliminary results of a case-control study to estimate influenza vaccine effectiveness in Spain, from week 50 of 2010 to week 6 of 2011. The adjusted effectiveness of the vaccine in preventing laboratory-confirmed influenza due to any type of influenza virus was 50% (95% CI: -6 to 77%) for the trivalent seasonal vaccine and 72% (95% CI: 7 to 92%) for both trivalent seasonal and monovalent pandemic vaccines, suggesting a protective effect of seasonal vaccination lower than that reported for the previous season.

533 Rotavirus Vaccine Effectiveness in Spain

Background and aims: Current rotavirus vaccines have showed outstanding effectiveness in USA, but data coming from Europe are still scarce. Effectiveness of rotavirus vaccination in Spain - where both rotavirus vaccines are available since 2007- has been estimated. Methods: A prospective observational study was conducted from Oct-2008 through Jun-2009 including 682 children up to 5 years-old with AGE attended in primary care (n=18 centres), and ER and hospital settings (n=10 centres), covering Galicia and Asturias regions (North-West Spain). A rapid stool immunochromotagographic test for rotavirus antigen detection (test VIKIA, BioMerieux) was at least performed in all included patients. Rotavirus vaccine global effectiveness was estimated as 1-OR after comparing the frequency of rotavirus vaccination in patients positive and negative to rotavirus etiology. Rotavirus vaccine effectiveness (RVVE) to prevent hospital admission was also calculated. Results: Of 682 enrolled children, 207(30.4%) were rotavirus positive and 152(22%) had received at least one dose of rotavirus vaccine. In 163 patients (24%) hospital admission was required, but patients with rotavirus AGE were admitted to hospital more frequently (47.8%vs14%){p<.001}. RRVE (after at least one vaccine dose) to prevent rotavirus AGE was 90.5%(95%confidence interval: 82%-95%). RVVE to prevent hospital admission due to rotavirus AGE was 94.7%(83-98.4%). Once a child has an AGE, being vaccinated reduced the risk of admission by 44% with a number needed to vaccinate of 4 (p values were non significant). Conclusions: Rotavirus vaccines have also showed an outstanding effectiveness in Spain despite lowmedium coverage rates yet.

Burden of paediatric Rotavirus Gastroenteritis (RVGE) and potential benefits of a universal Rotavirus vaccination programme with a pentavalent vaccine in Spain.

BackgroundRotavirus is the most common cause of gastroenteritis in young children worldwide. The aim of the study was to assess the health outcomes and the economic impact of a universal rotavirus vaccination programme with RotaTeq, the pentavalent rotavirus vaccine, versus no vaccination programme in Spain.MethodsA birth cohort was followed up to the age of 5 using a cohort model. Epidemiological parameters were taken from the REVEAL study (a prospective epidemiological study conducted in Spain, 2004-2005) and from the literature. Direct and indirect costs were assessed from the national healthcare payer and societal perspectives by combining health care resource utilisation collected in REVEAL study and unit costs from official sources. RotaTeq per protocol efficacy data was taken from a large worldwide rotavirus clinical trial (70,000 children). Health outcomes included home care cases, General Practioner (GP)/Paediatrician, emergency department visits, hospitalisations and nosocomial infections.ResultsThe model estimates that the introduction of a universal rotavirus vaccination programme with RotaTeq (90% coverage rate) would reduce the rotavirus gastroenteritis (RVGE) burden by 75% in Spain; 53,692 home care cases, 35,187 GP/Paediatrician visits, 34,287 emergency department visits, 10,987 hospitalisations and 2,053 nosocomial infections would be avoided. The introduction of RotaTeq would avoid about 76% of RVGE-related costs from both perspectives: €22 million from the national health system perspective and €38 million from the societal perspective.ConclusionsA rotavirus vaccination programme with RotaTeq would reduce significantly the important medical and economic burden of RVGE in Spain.

Withdrawal of an advertising campaign to promote the quadrivalent human papilloma virus vaccine in Spain

The inclusion of the quadrivalent human papilloma virus (HPV) in the schedule of the Spanish National Health System sparked the debate over Gardasil, which was presented to the public as a vaccine against cervical cancer. In this context, Sanofi Pasteur MSD was sued for misleading advertising in the campaign cuentaselo.org. Although the complaint was not admitted, the lawsuit triggered five changes in the ownership of the web domain which, although backed by scientific societies, was not supported by law. Because of the violation of the Law of the Society of Information Services, and prompted by the suspicion that the pharmaceutical company was behind these changes (as it could not advertise the product), the platform for the moratorium on the HPV filed a complaint against the Spanish Society of Gynecology and Obstetrics (whose logo appeared on the webpage) for breaching the code of advertising self-regulation. Sanofi Pasteur MSD, the advertiser which was not mentioned, accepted the complaint and removed the webpage, thus corroborating its involvement.

Impacto de la vacuna tetravalente frente al virus del papiloma humano (VPH) tipos 6, 11, 16 y 18 en las enfermedades asociadas al VPH en España

ObjectiveTo assess the potential epidemiologic and economic impact of vaccination with the human papillomavirus (HPV) quadrivalent (types 6/11/16/18) vaccine in Spain. MethodsWe used a transmission dynamic model developed for the United Kingdom and applied to Spain by using Spanish-specific epidemiologic and economic data obtained from the literature, databases, and previous epidemiological studies. It was assumed that any vaccination strategy would be implemented in combination with current HPV screening and treatment programs. The strategy of routine vaccination of a cohort of 11-year-old girls was used, alone or in combination with catch-up vaccination in 12-24-year olds. ResultsIn the long term, vaccination of girls and young women would reduce the incidence of cervical cancer by 86%, precancerous cervical intraepithelial neoplasia (CIN) II/III lesions by 85%, CIN I by 79% and genital warts by 81% related to HPV 6, 11, 16 and 18. Overall, vaccination would reduce the total cost related to HPV 6, 11, 16 and 18 infections by 83.5%. Catch-up vaccination of 12 to 24-year-old females would save 77% of the costs avoided in the first 10 years of the program. In the first few years of vaccination, most of the cases and costs avoided would be attributable to the prevention of HPV-6- and 11-related diseases. ConclusionsImplementation of vaccination programs with the HPV quadrivalent vaccine, combined with current screening programs, would significantly reduce the number of cases of cervical cancer, precancerous lesions and genital warts in Spain. Vaccination of girls and women aged 12 to 24 years not included in routine vaccination programs would result in a greater and earlier reduction in the incidence of diseases related to HPV 6, 11, 16 and 18.

Long-term clinical impact of introducing a human papillomavirus 16/18 AS04 adjuvant cervical cancer vaccine in Spain

Human papillomavirus (HPV) epidemiology and screening practices vary considerably between countries and specific analyses are required to estimate the impact of HPV vaccination. This study aimed to predict the clinical benefits of introducing a bivalent HPV16/18 vaccine in Spain, where the cervical cancer (CC) incidence is 10.3 per 100 000. A Markov model based upon the natural history of HPV and CC was developed to simulate transitions between health states, in the presence of specific screening programmes. Published data were used to reflect the Spanish situation in terms of epidemiological characteristics, screening and treatment practices. Calibration consisted of varying disease progression rates within established ranges until model predictions matched observed epidemiological data. The clinical impact of vaccinating a cohort of 12-year-old girls against HPV was assessed over their lifetime using the calibrated model. Vaccination of all 12-year-old girls would result in a reduction of 75% (from 0.32% to 0.08%) in the prevalence of high-grade precancerous lesions due to oncogenic HPV, and a 79% reduction in both CC cases (from 1745 to 365) and CC deaths (from 417 to 86). Assuming a vaccine coverage of 80%, the number of CC cases and deaths would decrease by 63%. Vaccination could also substantially reduce the number of screening tests and treatments required for cervical dysplasia. Our model was successfully adapted to the Spanish epidemiological environment, screening and treatment practices and predicted a substantial long-term benefit of HPV vaccination despite a low HPV prevalence in Spain.