Cobertura da vacina papilomavírus humano (HPV) no Brasil: heterogeneidade espacial e entre coortes etárias / Human papillomavirus (HPV) vaccination coverage in Brazil: spatial and age cohort heterogeneity

RESUMO: Objetivo: Estimar a cobertura da primeira e da segunda dose da vacina papilomavírus humano (HPV) no Brasil, conforme a microrregião, comparando-se as coortes de meninas com 14, 15 e 16 anos em 2017, e investigar a associação da heterogeneidade espacial na cobertura vacinal com variáveis sociodemográficas. Métodos: A informação sobre doses aplicadas nos anos de 2013 a 2017 por idade foi obtida do Programa Nacional de Imunizações. O número de meninas residentes com sete, oito e nove anos em 2010, em cada microrregião, é oriundo do censo brasileiro de 2010. Para a análise, a cobertura vacinal acumulada por microrregião (n = 558) foi categorizada em baixa (< 80%) e adequada (≥ 80%), e um modelo logístico com intercepto aleatório foi ajustado, tendo cobertura vacinal adequada como desfecho. O efeito aleatório (unidade da federação) foi incluído para captar a correlação entre microrregiões que pertencem ao mesmo estado. Resultados: O percentual de microrregiões que alcançou a cobertura vacinal adequada foi significativamente maior para a primeira dose (entre 91,8 e 159,2%), independentemente da coorte. Observou-se menor cobertura da segunda dose (entre 7 e 79,9%), com heterogeneidade associada ao grau de urbanização e à presença de domicílios com banheiro de uso próprio no município. O efeito aleatório mostrou forte poder explicativo, sugerindo importantes diferenças entre os estados brasileiros no alcance da cobertura vacinal. Conclusão: Apesar de a vacina HPV estar disponível no Programa de Imunização, os achados do presente estudo apontam para uma dificuldade do alcance da cobertura vacinal adequada.

ABSTRACT: Objective: To estimate the coverage of the first and second dose of the human papillomavirus (HPV) vaccine in Brazil according to microregion, comparing cohorts of girls aged 14, 15, and 16 years in 2017, and investigate the association between spatial heterogeneity in vaccination coverage and sociodemographic variables. Methods: Information about the doses administered from 2013 to 2017 by age was gathered from the National Immunization Program. The number of girls aged seven, eight, and nine years living in each microregion in 2010 was obtained from the 2010 Brazilian Census. For the analysis, the cumulated vaccination coverage per microregion (n = 558) was categorized as low (< 80%) and adequate (≥ 80%), and a random intercept logistic model was adjusted, with adequate vaccination coverage as the outcome. The random effect (federative unit) was included to identify the correlation between microregions that belong to the same state. Results: The percentage of microregions with adequate vaccination coverage was significantly higher in the first dose (between 91.8 and 159.2%), regardless of the cohort. The coverage of the second dose was lower (between 7 and 79.9%), with heterogeneity associated with the degree of urbanization and households with private bathrooms in the municipality. The random effect showed a strong explanatory power, suggesting important differences among Brazilian states as to the outreach of vaccination coverage. Conclusion: Although the HPV vaccine is available through the Immunization Program, the findings of the present study point to a difficulty in achieving adequate vaccination coverage.

HPV vaccine implementation and monitoring in Latin America / Implementación y monitoreo de la vacuna contra el VPH en América Latina

Abstract: Objective: To describe HPV vaccine program implementation, monitoring and evaluation experiences in Latin America. Materials and methods: We reviewed published articles in peer-reviewed journals and reports from government websites, as well as the PAHO/WHO/UNICEF Joint Reporting form and the ICO/IARC HPV Information Centre database. Results: By December 2016, 13 countries/territories in Latin America (56%) have introduced HPV vaccines. The majority have done so in the past three years, targeting 10-12 year old girls with a two dose schedule, through school programs. Vaccine coverage ranges from 30 to 87%. Safety monitoring is well established, but monitoring vaccine impact is not, and data are not available. Conclusions: Although Latin America is the most advanced developing region with HPV vaccine introduction, systems for its monitoring are weak and there is a paucity of consistently available coverage data for this vaccine. Challenges remain to introduce HPV vaccines in several countries, to achieve high coverage, and to strengthen monitoring, evaluation and reporting.

Resumen: Objetivo: Describir las experiencias con la implementación, monitoreo y evaluación de programas de vacunación contra VPH en América Latina. Material y métodos: Revisamos datos publicados en revistas, informes gubernamentales, así como los informes de monitoreo de programas de inmunizaciones de la OPS/OMS/UNICEF y del centro de información del VPH del ICO/IARC. Resultados: Hasta diciembre de 2016, 13 países/territorios en América Latina (56%) han introducido vacunas contra VPH. La mayoría lo han hecho en los últimos tres años, apuntando a niñas de 10 a 12 años con un calendario de dos dosis, a través de programas escolares. La cobertura de vacunas varía entre 30 y 87%. La vigilancia de la seguridad está bien establecida, pero el monitoreo del impacto de la vacuna no, y los datos no están disponibles. Conclusiones: Aunque América Latina es la región en desarrollo más avanzada en la introducción de la vacuna contra VPH, los sistemas para su monitoreo son débiles y hay una escasez de datos de cobertura disponibles. Sigue habiendo desafíos para introducir vacunas contra VPH en varios países, para lograr una alta cobertura y para fortalecer el monitoreo, la evaluación y la presentación de informes.

Estado vacunal y motivos de no vacunación contra el virus del papiloma humano en adolescentes admitidas en el Hospital Pediátrico del Centro Hospitalario Pereira Rossell / Vaccination status and reasons for non-vaccination against human papillomavirus (HPV) in adolescents admitted at the Pereira Rossell Hospital Center Pediatrics Hospital / Estado vacinal e motivos de não vacinação contra o vírus papiloma humano em adolescentes admitidas no Hospital Pediátrico do Centro Hospitalario Pereira Rossell

Introducción: en Uruguay se ofrece gratuitamente una vacuna tetravalente contra el virus del papiloma humano (VPH) a todas las adolescentes de 12 años o mayores. Las coberturas logradas no han sido las esperadas. Objetivo: describir el estado vacunal contra el VPH, motivos de no vacunación y reporte de efectos adversos en las adolescentes hospitalizadas en un centro de referencia en Uruguay. Material y método: estudio descriptivo mediante encuesta anónima a adolescentes de 12 años o mayores hospitalizadas en cuidados moderados del Hospital Pediátrico del Centro Hospitalario Pereira Rossell durante el segundo semestre de 2016. Se excluyeron las adolescentes que se negaron a participar, las portadoras de retardo mental o pasibles de cuidados paliativos. Se analizó: edad, estado vacunal contra VPH, motivos de no vacunación y de rechazo a la vacuna, efectos adversos. Fue aprobado por el Comité de Ética de la institución. Resultados: se encuestaron 112 adolescentes. Edad media: 13,5 años (12-14,6). Reportaron recibir al menos una dosis de la vacuna contra VPH: 45/112 (40,1%). Motivo de no vacunación más frecuente reportado: desconocimiento de la existencia de la vacuna: 48/67 (71,6%), seguido de rechazo o negativa de la adolescente o adulto responsable: 13/67 (19,4%). El principal motivo de rechazo a recibir la vacuna fue la falta de información: 7/13. No se registraron efectos adversos graves. Conclusiones: se observó una cobertura vacunal similar a datos nacionales. El conocimiento y la información de las adolescentes y sus cuidadores sobre esta vacuna fueron los principales motivos de no vacunación detectados.

Introduction: Uruguay offers a free HPV quadrivalent vaccine to adolescents 12 years of age or older. However, the vaccination rate was not as expected. Objective: to describe the human papillomavirus (HPV) vaccination status, the reasons for non-vaccination and to report adverse effects in hospitalized adolescents in a reference center in Uruguay. Materials and methods: descriptive study by means of an anonymous survey of adolescents of 12 years of age or older hospitalized in moderate care at Pereira Rossell Hospital Center during the second half of 2016. Adolescents who refused to participate were excluded from the study, as well as those with mental retardation and / or subject to palliative care. We analyzed: age, vaccination status against HPV, reasons for non-vaccination and vaccine hesitancy, and adverse effects. The research conducted was approved by the institution's ethics committee. Results: the survey was answered by 112 adolescents who met the inclusion criteria. Mean age was 13.5 years old (12-14.6). 45/112 (40.1%). Adolescents reported having received at least one dose of the HPV vaccine. The most frequent reason for non-vaccination was: lack of knowledge of the vaccine in 48 out of 67 (71.6%), followed by rejection or rejection by the adolescent or responsible adult in 13 out of 67 (19.4%). The main reason for refusal to receive the vaccine reported was: lack of information (7/13). No serious adverse events were reported. Conclusions: vaccination coverage found was similar to national data. Knowledge and information of adolescents and their caregivers about this vaccine were the main reasons detected for non-vaccination.

Introdução: no Uruguai una vacina tetravalente contra o Vírus do Papiloma Humano (VPH) é oferecida gratuitamente a todas as adolescentes com 12 ou mais anos. A cobertura obtida não foi a esperada. Objetivo: descrever o estado vacinal contra o VPH, motivos de não vacinação e informação sobre efeitos adversos nas adolescentes hospitalizadas em um centro de referencia no Uruguai. Materiais e métodos: estudo descritivo, realizado com questionário anônimo respondido por adolescentes com 12 ou mais anos, internadas em cuidados intermediários do Hospital Pediátrico do Centro Hospitalario Pereira Rossell, durante o segundo semestre de 2016. Foram excluídas as adolescentes que não quiseram participar, as portadoras de deficiência mental e/ou passiveis de cuidados paliativos. As seguintes variáveis foram analisadas: idade, estado vacinal contra VPH, motivos de não vacinação e de rejeição à vacina e efeitos adversos. O estudo foi aprovado pelo comité de ética da instituição. Resultados: participaram 112 adolescentes com idade média 13,5 anos (12-14,6). 45 informaram ter recebido pelo menos uma dose da vacina contra VPH (45/112 - 40,1%). O motivo de não vacinação mais frequente foi o desconhecimento da existência da vacina 48/67 (71,6%), seguido de rejeição ou negativa da adolescente ou do adulto responsável 13/67 (19,4%). O motivo principal de rejeição a ser vacinada foi a falta de informação 7/13. Não foram registrados efeitos adversos graves. Conclusões: a cobertura vacinal registrada foi similar aos dados nacionais. O conhecimento e a informação das adolescentes e de seus cuidadores sobre esta vacina foram os principais motivos de não vacinação detectados.

Evaluación de seguridad de la vacuna contra el virus del papiloma humano / Safety assessment of the human papillomavirus vaccine

Introducción: el cáncer de cuello uterino es en Colombia el segundo cáncer con mayor frecuencia y mortalidad en mujeres. Las vacunas contra el virus del papiloma humano (VPH) han mostrado efectividad para prevenir la infección por el virus y las lesiones precancerosas asociadas, sin embargo, se han reportado eventos negativos en salud, posiblemente asociados con la aplicación de la vacuna. Objetivo: examinar la seguridad del uso de la vacuna profiláctica contra el VPH. Metodología: se realizó una búsqueda sistemática en MEDLINE, EMBASE, Cochrane Database, IBECS, LILACS y fuentes complementarias. La selección de estudios se realizó por dos revisores independientes de acuerdo con criterios de elegibilidad predefinidos. Se incluyeron estudios experimentales, observacionales analíticos y observacionales descriptivos que reportaran desenlaces de seguridad y efectividad de la vacuna contra el VPH. La calidad de los estudios analíticos fue valorada mediante herramientas previamente definidas, de acuerdo a cada diseño. Los estudios descriptivos fueron considerados con alta probabilidad de sesgo. La calidad de la evidencia fue evaluada para cada desenlace reportado mediante la etodología Grading of Recommendations Assessment, Development and Evaluation (GRADE). Los resultados por cada desenlace fueron reportados de forma narrativa y presentados en perfiles de evidencia GRADE (estudios analíticos) y tablas de evidencia genéricas (estudios descriptivos). Resultados: fueron seleccionados 112 estudios que reportaron 305 resultados de desenlaces de seguridad reportados \r\nposterior a la aplicación de la vacuna contra el VPH, que incluyeron desenlaces para los cuales la vacunación mostró asociación estadísticamente significativa como factor de riesgo, desenlaces para los cuales la vacunación no mostró asociación como factor de riesgo, y desenlaces para los cuales la vacunación mostró resultados inconsistentes. La calidad de la evidencia fue baja y muy baja para la mayoría de los resultados reportados. Discusión y conclusión: Las principales debilidades de la evidencia identificada fueron falta de periodos adecuados de seguimiento para eventos de aparición tardía, falta de precisión de los resultados, y limitaciones en la medición de los desenlaces, verificación del periodo de latencia de \r\nlos mismos y control de los potenciales factores de confusión. Los determinantes más relevantes de \r\nla calidad fueron la falta de precisión de los resultados, probablemente por la baja frecuencia de los \r\neventos, y el carácter observacional de los estudios que evaluaron la mayor parte de los desenlaces \r\nreportados. Los resultados de asociación reportados no permiten establecer causalidad entre los \r\neventos y la vacunación. La baja calidad de la evidencia no implica que los resultados no sustenten \r\nla existencia, o no, de las asociaciones evaluadas; ni que los resultados no sean suficientes para \r\norientar decisiones; sino que es probable que estudios con mayor rigor metodológico muestren \r\nresultados diferentes. La mejor evidencia disponible hasta la fecha sustenta un adecuado perfil de \r\nseguridad de la vacuna contra el VPH, similar al reportado por la OMS para otras vacunas, que apoya \r\nsu utilización teniendo en cuenta los beneficios reportados en la literatura; sin que sea posible descartar la ocurrencia de eventos adversos graves raros, por lo cual es recomendable la \r\nimplementación de un sistema de vigilancia posvacunación, que garantice un apropiado reporte, \r\ndiagnóstico, seguimiento, análisis y retroalimentación a los usuarios, de los posibles eventos adversos de la vacunación, con enfoque en los eventos descritos en esta evaluación. (AU)

HPV vaccines: a controversial issue?

Controversy still exists over whether the benefits of the available HPV vaccines outweigh the risks and this has suppressed uptake of the HPV vaccines in comparison to other vaccines. Concerns about HPV vaccine safety have led some physicians, healthcare officials and parents to withhold the recommended vaccination from the target population. The most common reason for not administering the prophylactic HPV vaccines are concerns over adverse effects. The aim of this review is the assessment of peer-reviewed scientific data related to measurable outcomes from the use of HPV vaccines throughout the world with focused attention on the potential adverse effects. We found that the majority of studies continue to suggest a positive risk-benefit from vaccination against HPV, with minimal documented adverse effects, which is consistent with other vaccines. However, much of the published scientific data regarding the safety of HPV vaccines appears to originate from within the financially competitive HPV vaccine market. We advocate a more independent monitoring system for vaccine immunogenicity and adverse effects to address potential conflicts of interest with regular systematic literature reviews by qualified individuals to vigilantly assess and communicate adverse effects associated with HPV vaccination. Finally, our evaluation suggests that an expanded use of HPV vaccine into more diverse populations, particularly those living in low-resource settings, would provide numerous health and social benefits.

Safety of human papillomavirus 6, 11, 16 and 18 (recombinant): systematic review and meta-analysis / Segurança da vacina papillomavirus humano 6, 11, 16 e 18 (recombinante): revisão sistemática e metanálise

Objective: To identify and quantify the adverse effects associated with the recombinant human papillomavirus (types 6, 11, 16 and 18) vaccine in adolescents. Data source: Systematic review of randomized clinical trials from PubMed, SciELO and Lilacs databases. Articles investigating the safety of the vaccine in subjects under 18 years and comparing the recombinant human papillomavirus types 6, 11, 16 and 18 vaccine with a control group were included. Meta-analyses were performed for the outcomes of pain, erythema, swelling and fever, using clinical trials with maximum Jadad score. Data synthesis: Fourteen studies were included. The most common adverse effects related to the human papillomavirus vaccine were effects with no severity (pain, erythema, edema, and fever). Five studies were used for the meta-analyses: pain-risk difference (RD)=11% (p<0.001); edema-RD=8% (p<0.001); erythema-RD=5% (p<0.001); fever-RD=2% (p<0.003). Conclusions: The recombinant human papillomavirus types 6, 11, 16 and 18 vaccine was safe and well tolerated. The main adverse effects related to vaccination were pain, erythema, edema and fever. The low frequency of severe adverse effects encourages the administration of the vaccine in the population at risk.

Objetivo: Identificar e quantificar os efeitos adversos associados à vacina papillomavirus humano 6, 11, 16 e 18 (recombinante) em adolescentes. Fontes de dados: Revisão sistemática de ensaios clínicos randomizados nas bases de dados do PubMed, SciELO e Lilacs. Foram incluídos artigos que abordavam a segurança da vacina em menores de 18 anos e que comparavam a vacina papillomavirus humano 6, 11, 16 e 18 (recombinante) com grupo controle. Foram feitas metanálises para os desfechos de dor, eritema, edema e febre com o uso de ensaios clínicos com escore de Jadad máximo. Síntese dos dados: Foram incluídos 14 estudos. Os efeitos adversos mais comuns relacionados à vacina foram intercorrências sem gravidade (dor, eritema, edema e febre). Cinco estudos foram usados para as metanálises, incluindo os desfechos: Dor - Diferença de Risco (DR)=11% (p<0,001); Edema-DR=8% (p<0,001); Eritema-DR=5% (p<0,001); Febre-DR=2% (p<0,003). Conclusões: A vacina papillomavirus humano 6, 11, 16 e 18 (recombinante) mostrou-se segura e bem tolerada. Os principais efeitos adversos relacionados à vacinação foram dor, eritema, edema e febre. A baixa frequência de efeitos adversos graves encoraja a aplicação da vacina na população de risco.

Controversias en torno a la utilización de la vacuna contra el virus del papiloma humano / Controversy regarding the use of the vaccine against human papillomavirus / Controvérsias sobre o uso da vacina contra o vírus do papiloma humano

La vacuna contra el virus del papiloma humano (HPV) se presenta como una medida de prevención primaria del cáncer de cuello de útero (CCU), segunda causa de muerte de las mujeres a nivel mundial. Esta vacuna genera una dicotomía a nivel social que obliga a pensar si verdaderamente es necesario administrarla. En este artículo se desarrollan las posibles causas de esta contrariedad con la finalidad de colaborar en la toma de decisión informada sobre la administración de la misma. Se revisan las vacunas disponibles, las recomendaciones para su uso y las controversias en cuanto a eficacia, seguridad, número de dosis requeridas, eficiencia en la prevención y participación ciudadana. Las vacunas contra el HPV ofrecen un enfoque prometedor para la prevención del CCU y las afecciones asociadas a estos virus, pero no reemplazan a otras estrategias de prevención debido a que no protegen contra todos los tipos de virus de HPV.

The Human Papillomavirus (HPV) vaccine is presented as a primary preventive measure of cervical cancer (CC), the second cause of women deaths in the world. This vaccine generates such social dichotomy that makes us consider whether its administration is really necessary. The possible causes of this controversy are developed in this article, with the aim of helping to make an informed decision about its administration. Available vaccines are reviewed, as well as use recommendations and controversy regarding effectiveness, security, required doses, prevention efficiency and people’s participation. HPV vaccines offer a promising approach to prevent cervical cancer and conditions associated with these viruses, but they do not replace other prevention strategies since they do not protect against all HPV types.

A vacina contra o vírus do papiloma humano (HPV) é apresentada como uma medida de prevenção primária do câncer do colo do útero (CCU), a segunda principal causa de morte entre as mulheres em todo o mundo. Esta vacina gera tal dicotomia ao nível social que obriga a pensar se é realmente necessário administrá-la. Neste artigo discutem-se as possíveis causas desta controvérsia, a fim de ajudar na tomada de decisões informadas sobre a sua administração. Consideram-se as vacinas disponíveis, as recomendações para seu uso e a polêmica sobre a sua eficácia, segurança, número de doses necessárias, a eficiência na prevenção e a participação cidadã. As vacinas contra o HPV oferecem uma abordagem promissória para a prevenção do CCU e das doenças associadas a estes vírus, mas não substituem outras estratégias de prevenção, por não protegerem contra todos os tipos de vírus do HPV.

Safety, tolerability and side effects of human papillomavirus vaccines: a systematic quantitative review

Recently, many studies have evaluated HPV vaccine safety and adverse effects. Two vaccine shave been recently evaluated in randomized controlled trials: the bivalent vaccine for HPV 16 and 18 (Cervarix, GlaxoSmithKline Biologicals, Rixensart, Belgium) and the quadrivalent vaccine for HPV 6, 11, 16, and 18 (Gardasil, Merck and Co., Inc., Whitehouse Station, NJ). We have performed a systematic review of all randomized controlled trials in which HPV vaccines were compared with placebo regarding safety, tolerability and adverse effects. Studies were searched up to March 2013 in the databases: Pubmed, Embase, Scielo and Cancerlit. Odds Ratios (OR) of most incident adverse effects were obtained. Twelve reports, involving 29,540 subjects, were included. In the HPV 16/18 group, the most frequently reported events related to the vaccine were pain (OR 3.29; 95% CI: 3.00–3.60), swelling (OR 3.14; 95% CI: 2.79–3.53) and redness (OR 2.41; 95% CI: 2.17–2.68). For the HPV 6/11/16/18 group the events were pain (OR 2.88; 95% CI: 2.42–3.43) and swelling (OR 2.65; 95% CI: 2.0–3.44). Concerning the HPV 16/18 vaccine, pain was the most common outcome detected. These effects can be due to a possible VLP-related inflammation process. Fatigue was the most relevant general effect observed followed by fever, gastrointestinal symptoms, and headache. In the HPV 6/11/16/18 group, only general symptoms, pain and swelling were observed. Pain and swelling were the most frequent. Comparing HPV 16/18 to HPV 6/11/16/18 vaccines, the former presented more adverse effects, perhaps because there are many more trials evaluating the bivalent vaccine. Other studies are needed to clarify this issue.

HPV Vaccine, Is It Really Harmful?

No abstract available.

Efficacy and safety of human papilloma virus vaccine in cervical cancer prevention: systematic review and meta-analysis / Eficacia y seguridad de la vacuna contra el virus de papiloma humano para la prevención del cáncer de cuello uterino: revisión sistemática y metaanálisis

Introduction. Cervical cancer is the third most common cancer worldwide. The human papilloma virus (HPV) has been identifed as the etiologic agent of cervical and other anogenital cancers. The aim was to perform a systematic review and meta-analysis to evaluate the efficacy and safety of HPV vaccines in preventing cervical intraepithelial neoplasias (CIN) grades 2 and 3, adenocarcinoma in situ (CIN2+) and cervical cancer. Materials and Methods. Major bibliographic databases were searched in July 2011 without any temporal nor language restrictions. Randomizedcontrolled trials that evaluated the efficacy of HPV vaccines against CIN2+ and cervical cancer were included. Results. Four of the 168 publications found were included in a meta-analysis. Among vaccinated women, the relative risk (RR) of developing CIN2+ lesions was 0.45 (95% CI 0.38 to 0.54) for HPV 16, 0.14 (0.08 to 0.25) for HPV 18, and 0.79 (0.68 to 0.93) for oncogenic serotypes not included in the vaccines 31/33/45/52/58. All studies had acceptable safety profiles. Conclusions. Vaccines currently available are effective, safe and capable of preventing CIN2+ lesions, although long term efficacy has not yet been fully tested.

Introducción. El cáncer de cuello uterino es el tercer tipo de cáncer en frecuencia en el mundo. El virus de papiloma humano (HPV, por su sigla en inglés) se ha identificado como causa de éste y otros cánceres anogenitales. El objetivo del presente trabajo es evaluar, mediante una revisión sistemática y metaanálisis, la eficacia y seguridad de las vacunas contra HPV para la prevención de neoplasias intraepiteliales (CIN) de grados 2, 3 y adenocarcinoma in situ (CIN2+) y el cáncer de cuello uterino. Materiales y métodos. Se realizó una búsqueda sistemática en las principales bases de datos durante julio de 2011 sin restricciones temporales o idiomáticas. Se incluyeron ensayos clínicos controlados aleatorizados que evaluaran la eficacia de la vacuna contra el desarrollo de CIN2 + y cáncer de cuello uterino. Resultados. Se confeccionó un metaanálisis con 4 de las 168 publicaciones halladas. Mediante el análisis por intención de tratar se observó, para mujeres vacunadas, un riesgo relativo (RR) de contraer lesiones CIN2+ asociadas a HPV 16 de 0,45 (IC 95% 0,38-0,54); a HPV 18 de 0,14 (0,08-0,25) y por serotipos oncogénicos 31/33/45/52/58 no incluidos en la vacuna de 0,79 (0,68-0,93). Todos los estudios mostraron perfiles de seguridad aceptables. Conclusiones. Las vacunas disponibles actualmente mostraron ser eficaces y seguras para la prevención de lesiones CIN2+; sin embargo, resta probar su eficacia a largo plazo.

Cervical cancer prevention & the role of human papillomavirus vaccines in India.

Human papillomavirus (HPV) is a necessary cause of cervical cancer, the leading cause of cancer deaths among Indian women. Current screening and prevention programs based on cytology have not been effective in reducing the disease burden. Two vaccines are now available for primary prevention. They generate neutralizing antibodies to HPV capsid protein. The vaccines have been shown to confer nearly 100 per cent protection against cervical pre-cancers and genital warts caused by HPV types 16/18 in HPV naïve population with few or no side effects. Though there is some cross-protection, around 30 per cent of cervical cancers will not be prevented by the vaccine. Vaccination and screening, which are complementary and synergistic, now constitute the new paradigm for prevention of this disease.

HPV vaccination: the promise & problems.

Four-fifths of the cervical cancer burden in the world is experienced in developing countries. HPV genotypes 16 and 18 account for 70 per cent of cervical cancers and currently available vaccines targeting these two types confer a high degree of protection against HPV 16/18 infection and related cervical precancerous lesions. However, widespread implementation of HPV vaccination programs are challenged by the unaffordable high costs of the vaccines and the lack of effective vaccine delivery platforms for sexually naïve girls. Other unresolved issues include long-term protection, cross-protection against HPV types not included in the vaccine and whether booster doses will be needed. Sensitivities associated with a vaccine preventing a sexually transmitted infection in girls, lack of awareness, public demand and political will, lack of coordination between cancer control, sexual and reproductive health and vaccine delivery services are additional challenges. Reduced costs, simple vaccine regimes and strengthening vaccine delivery platforms for adolescents should eventually facilitate HPV vaccine introduction in developing countries.

Can cervical cancer be eradicated by prophylactic HPV vaccination: Challenges to vaccine implementation.

Cervical cancer is the first cancer to be shown to be 100 per cent attributable to a virus; oncogenic human papillomaviruses (HPV), particularly types 16 and 18, collectively worldwide contribute to 70 per cent squamous cell carcinomas, 85 per cent of adenocarcinomas. Cervical cancer is the second commonest cancer of women, yet largely preventable with high-quality, well-organized screening of the appropriate population. Screening programmes are either nonexistent, or function opportunistically in many poorer countries, resulting in high incidence and mortality. Recently developed, prophylactic HPV vaccines against HPV 16, 18, as cervical cancer preventative vaccines, in phase 3 clinical trials have been shown, to be highly efficacious, safe and immunogenic. With the potential for cross protection against related HPV types, estimates for prevention are in the order of 75 to 80 per cent. Thus a further option exists in the battle to reduce these cancers in women. Challenges however include implementing a vaccination programme with wide coverage to the target populations to be a successful public health tool, integration and maintenance of current screening programmes where they are in existence, the need for reduced costs of the current vaccines, long-term immunogenicity (will there be a need for further doses?), appropriate education messages to the general community, governments, as well as the medical profession.

Declaración del Comité Consultivo de Inmunizaciones de la Sociedad Chilena de Infectología respecto a la vacuna anti-virus papiloma humano: septiembre 2008 / Human papillomavirus vaccine: statement of the Consultive Committee of Immunizations on behalf of The Chilean Infectious Diseases Society: September 2008

The article briefly reviews the epidemiology of human papillomavirus (HPV) infection and associated diseases in the world and in Chile and the scientific information of the licensed HPV vaccines: Gardasil® and Cervarix®. Considering the available information, the Consultive Committee of Immunizations of the Chilean Society of Infectious Diseases, summarizes its conclusions and makes recommendations for vaccination against HPV in Chile.

El artículo revisa brevemente la epidemiología de las infecciones por virus papiloma humano (VPH) y las enfermedades asociadas, tanto en el mundo como en Chile y la información científica de las vacunas contra VPH licenciadas: Gardasil® y Cervarix®. Considerando la información disponible, el Comité Consultivo de Inmunizaciones de la Sociedad Chilena de Infectología, resume sus conclusiones y hace sus recomendaciones para la vacunación contra VPH en Chile.

Declaración del Comité Consultivo de Inmunizaciones de la Sociedad Chilena de Infectología respecto a la vacuna antivirus papiloma humano: Septiembre 2008 / Human papillomavirus vaccine: Statement of the Advisory Committee of Immunizations on Behalf of the Chilean Infectious Diseases Society: September 2008

This article briefly reviews the epidemiology of human papillomavirus (HPV) infection and associated diseases globally and in Chile, and the scientific ínformatíon of the licensed HPV vaccines: Gardasil® and Cervarix®. Considering the available information, the Advisory Committee on Immunizations of the Chilean Society of Infectious Diseases recommends vaccination of teenage girls, ideally before initiating sexual actívíty, Le. approximately at the age of 12 to 13 years and vaccination of women of any age if they have not started sexual activity. If women are vaccinated after initiating sexual activity, they should be informed of the lower efficacy of immunization if HPV infection has occurred. Education on responsible sexuality and sexually transmitted diseases should be maintained as a priority. Vaccination should be highly considered for inclusion in the National Immunization Program.

Quadrivalent human papillomavirus recombinant vaccine: the first vaccine for cervical cancers.

Gardasil is the first quadrivalent human papillomavirus (HPV)-types 6, 11, 16, 18 recombinant vaccine approved by the FDA on June 8, 2006. It induces genotype-specific virus-neutralizing antibodies and prevents infection with HPV. Various clinical trials demonstrated a reduction in the incidence of vaccine-type-specific persistent infections and of associated moderate- and high-grade cervical dysplasias and carcinomas in situ after its use. Gardasil is currently approved by FDA for prevention of genital warts, cancers and precancerous conditions of cervix and vulva in 9-26 year old females. Three doses of 0.5 ml of gardasil each at 0, 2 and 6 months are given intramuscularly. It is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine, patients with bleeding abnormalities or patients on anticoagulant therapy and during pregnancy. However, the vaccine, at an estimated $300-500 per course, is too expensive for many women in developing countries. Moreover, question regarding the longevity of the protection by vaccine is still unsolved. Hence, longer studies are required to establish its real status in cancer prevention.