Systematic review of the efficacy, effectiveness and safety of MF59® adjuvanted seasonal influenza vaccines for the prevention of laboratory-confirmed influenza in individuals ≥18 years of age.

The most effective means of preventing seasonal influenza is through vaccination. In this systematic review, we investigated the efficacy, effectiveness and safety of MF59® adjuvanted trivalent and quadrivalent influenza vaccines to prevent laboratory-confirmed influenza. A systematic literature search was conducted in electronic databases and grey literature sources up to 7 February 2020. Randomised controlled trials and non-randomised studies of interventions (NRSIs) were eligible for inclusion. The search returned 28,846 records, of which 48 studies on MF59® adjuvanted vaccines met our inclusion criteria. No efficacy trials were identified. In terms of vaccine effectiveness (VE), MF59® adjuvanted trivalent influenza vaccines were effective in preventing laboratory-confirmed influenza in older adults (aged ≥65 years) compared with no vaccination (VE = 45%, 95% confidence interval (CI) 23%-61%, 5 NRSIs across 3 influenza seasons). By subtype, significant effect was found for influenza A(H1N1) (VE = 61%, 95% CI 44%-73%) and B (VE = 29%, 95% CI 5%-46%), but not for A(H3N2). In terms of relative VE, there was no significant difference comparing MF59® adjuvanted trivalent vaccines with either non-adjuvanted trivalent or quadrivalent vaccines. Compared with traditional trivalent influenza vaccines, MF59® adjuvanted trivalent influenza vaccines were associated with a greater number of local adverse events (RR = 1.90, 95% CI 1.50-2.39) and systemic reactions (RR = 1.18, 95% CI 1.02-1.38). In conclusion, MF59® adjuvanted trivalent influenza vaccines were found to be more effective than 'no vaccination'. Based on limited data, there was no significant difference comparing the effectiveness of MF59® adjuvanted vaccines with their non-adjuvanted counterparts.

Systematic review of the efficacy, effectiveness and safety of recombinant haemagglutinin seasonal influenza vaccines for the prevention of laboratory-confirmed influenza in individuals ≥18 years of age.

The most effective means of preventing seasonal influenza is through vaccination. In this systematic review, we investigated the efficacy, effectiveness and safety of recombinant haemagglutinin (HA) seasonal influenza vaccines to prevent laboratory-confirmed influenza. A systematic literature search was conducted in electronic databases and grey literature sources up to 7 February 2020. Randomised controlled trials and non-randomised studies of interventions were eligible for inclusion. The search returned 28,846 records, of which 10 studies on recombinant HA influenza vaccine met our inclusion criteria. One study found that the quadrivalent recombinant HA influenza vaccine had higher relative vaccine efficacy (rVE) in preventing laboratory-confirmed influenza during the 2014-15 season compared with traditional quadrivalent vaccination in adults aged ≥50 years (rVE = 30%, 95% CI 10%-47%, moderate-certainty evidence). In a subgroup analysis, higher rVE was reported for influenza A (rVE = 36%, 95% CI 14% to 53%), but not for B (non-significant). Another study reported higher efficacy for the trivalent recombinant HA vaccine compared with placebo (VE = 45%, 95% CI 19-63, 1 RCT, low-certainty evidence) in adults aged 18-55 years. With the exception of a higher rate of chills (RR = 1.33, 95% CI 1.03-1.72), the safety profile of recombinant HA vaccines was comparable to that of traditional influenza vaccines. The evidence base for the efficacy and effectiveness of recombinant HA influenza vaccines is limited at present, although one study found that the quadrivalent recombinant HA influenza vaccine had higher rVE compared with traditional quadrivalent vaccination in adults aged ≥50 years.

Systematic review of the efficacy, effectiveness and safety of high-dose seasonal influenza vaccines for the prevention of laboratory-confirmed influenza in individuals ≥18 years of age.

This review sought to assess the efficacy, effectiveness and safety of high-dose inactivated influenza vaccines (HD-IIV) for the prevention of laboratory-confirmed influenza in individuals aged 18 years or older. A systematic literature search was conducted in electronic databases and grey literature sources up to 7 February 2020. Randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) were included. The search returned 28,846 records, of which 36 studies were included. HD-IIV was shown to have higher relative vaccine efficacy in preventing influenza compared with standard-dose influenza vaccines (SD-IIV3) in older adults (Vaccine effectiveness (VE) = 24%, 95% CI 10-37, one RCT). One NRSI demonstrated significant effect for HD-IIV3 against influenza B (VE = 89%, 95% CI 47-100), but not for influenza A(H3N2) (VE = 22%, 95% CI -82 to 66) when compared with no vaccination in older adults. HD-IIV3 showed significant relative effect compared with SD-IIV3 for influenza-related hospitalisation (VE = 11.8%, 95% CI 6.4-17.0, two NRSIs), influenza- or pneumonia-related hospitalisation (VE = 13.7%, 95% CI 9.5-17.7, three NRSIs), influenza-related hospital encounters (VE = 13.1%, 95% CI 8.4-17.7, five NRSIs), and influenza-related office visits (VE = 3.5%, 95% CI 1.5-5.5, two NRSIs). For safety, HD-IIV were associated with significantly higher rates of local and systemic adverse events compared with SD-IIV (combined local reactions, pain at injection site, swelling, induration, headache, chills and malaise). From limited data, compared with SD-IIV, HD-IIV were found to be more effective in the prevention of laboratory-confirmed influenza, for a range of proxy outcome measures, and associated with more adverse events.

Systematic review of the efficacy, effectiveness and safety of cell-based seasonal influenza vaccines for the prevention of laboratory-confirmed influenza in individuals ≥18 years of age.

The most effective means of preventing seasonal influenza is through strain-specific vaccination. In this study, we investigated the efficacy, effectiveness and safety of cell-based trivalent and quadrivalent influenza vaccines. A systematic literature search was conducted in electronic databases and grey literature sources up to 7 February 2020. Randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) were eligible for inclusion. Two reviewers independently screened, extracted data and assessed the risk of bias of included studies. Certainty of evidence for key outcomes was assessed using the GRADE methodology. The search returned 28,846 records, of which 868 full-text articles were assessed for relevance. Of these, 19 studies met the inclusion criteria. No relative efficacy data were identified for the direct comparison of cell-based vaccines compared with traditional vaccines (egg-based). Efficacy data were available comparing cell-based trivalent influenza vaccines with placebo in adults (aged 18-49 years). Overall vaccine efficacy was 70% against any influenza subtype (95% CI 61%-77%, two RCTS), 82% against influenza A(H1N1) (95% CI 71%-89%, 2 RCTs), 72% against influenza A(H3N2) (95% CI 39%-87%, 2 RCTs) and 52% against influenza B (95% CI 30%-68%, 2 RCTs). Limited and heterogeneous data were presented for effectiveness when compared with no vaccination. One NRSI compared cell-based trivalent and quadrivalent vaccination with traditional trivalent and quadrivalent vaccination, finding a small but significant difference in favour of cell-based vaccines for influenza-related hospitalisation, hospital encounters and physician office visits. The safety profile of cell-based trivalent vaccines was comparable to traditional trivalent influenza vaccines. Compared with placebo, cell-based trivalent influenza vaccines have demonstrated greater efficacy in adults aged 18-49 years. Overall cell-based vaccines are well-tolerated in adults, however, evidence regarding the effectiveness of these vaccines compared with traditional seasonal influenza vaccines is limited.

[Committee for Immunization Programme and Registry and changes in the National Immunization Programme in Spain]. / Ponencia de Programa y Registro de Vacunaciones y evolución del calendario de vacunación en España.

The Committee for Immunization Programme and Registry (Ponencia de Programa y Registro de Vacunaciones) was created in 1991 to advise the Interterritorial Council of the National Health System on the situation of vaccine preventable diseases and the establishment and evaluation of measures for their prevention and control. Among other functions, this Committee evaluates the immunization programmes taking into account the scientific evidence and the epidemiological situation. In this way the Committee advises decision makers on the Public Health Commission of the Interterritorial Council. Any change in the National Immunization Programme, since the first one published in 1996 by the Interterritorial Council to the current Immunization Programme throughout life, has been advised from the technical and scientific point of view by this Committee. Taking into account both the work developed and the methodology used for developing the technical advice, the Committee for Immunization Programme and Registry is considered the National Immunization Technical Advisory Group for Spain. This paper reviews the functions and work developed by the Committee for Immunization Programme and Registry, the changes conducted in the National Immunization Programme under its advice and the current challenges.

La Ponencia de Programa y Registro de Vacunaciones se creó en 1991 para asesorar al Consejo Interterritorial del Sistema Nacional de Salud en el conocimiento de las enfermedades inmunoprevenibles y el establecimiento y evaluación de medidas para su prevención y control. Entre otras funciones, la Ponencia evalúa los programas de vacunación teniendo en cuenta la evidencia científica y la situación epidemiológica. De esta manera, asesora en la toma de decisiones que se realiza en la Comisión de Salud Pública del Consejo Interterritorial. Desde su creación, la Ponencia ha realizado recomendaciones desde el punto de vista técnico y científico en las modificaciones que se han realizado en el calendario de vacunación, incluyendo la incorporación de vacunas y el cambio de pautas de vacunación, desde el primer calendario del Consejo Interterritorial de 1996 hasta el actual calendario común de vacunación a lo largo de toda la vida. La Ponencia es considerada el Comité Técnico Asesor de Vacunaciones de España, tanto por las funciones que desarrolla como por la metodología utilizada para la elaboración de propuestas. En este artículo se revisan las funciones que desarrolla la Ponencia de Programa y Registro de Vacunaciones, las modificaciones que se han realizado en el calendario con su asesoramiento y los retos en el momento actual.

[The cost of vaccination throughout life in Spain]. / El coste de vacunar a lo largo de toda la vida en España.

OBJECTIVE: The evaluation of vaccination programmes using cost estimation is an essential tool for immunization policy. The aim of this study was to describe the cost of vaccination through-out life in Spain, both in healthy and risk groups persons. METHODS: Description of cost of vaccination following the national immunization programme throughout life agreed for 2019, and the immunization programme for risk groups. RESULTS: The expected cost to immunize a healthy person is 726.06 euros for a healthy woman and 625.89 euros for a healthy man, ranging from 982.99 to 1,815 euros per person in risk groups. CONCLUSIONS: The relatively low cost and the important benefits for health of immunization throughout life make this public health measure useful and worthwhile. Evaluation of immunization programmes should be strengthened in order to assure suitable immunization in every stage of life.

OBJETIVO: La evaluación de los programas de vacunación mediante la estimación de costes es una herramienta fundamental para orientar la política de vacunación. El objetivo de este trabajo fue describir el coste que conlleva en España la vacunación a lo largo de toda la vida, tanto a personas sanas como pertenecientes a grupos de riesgo. METODOS: Se realizó un estudio de descripción de los costes para administrar las vacunas incluidas en el calendario común de vacunación acordado para el año 2019, y en el calendario para grupos de riesgo, a lo largo de toda la vida. RESULTADOS: El coste previsto de la vacunación a lo largo de toda la vida fue de 726,06 euros por cada mujer sana y 625,89 euros por cada hombre sano durante el 2019. En personas con las condiciones de riesgo que requieren mayor número de vacunas osciló entre 982,99 y 1.815 euros por persona. CONCLUSIONES: El relativo bajo coste de la vacunación a lo largo de toda la vida y los importantes beneficios para la salud que conlleva la vacunación hacen que esta medida sea útil y rentable, por lo que se debe reforzar la evaluación de los programas de vacunación para asegurar la vacunación adecuada en todos los momentos de la vida.

Ponencia de Programa y Registro de Vacunaciones y evolución del Calendario de Vacunación en España / Committee for Immunization Programme and Registry and changes in the National Immunization Programme in Spain

La Ponencia de Programa y Registro de Vacunaciones se creó en 1991 para asesorar al Consejo Interterritorial del Sistema Nacional de Salud en el conocimiento de las enfermedades inmunoprevenibles y el establecimiento y evaluación de medidas para su prevención y control. Entre otras funciones, la Ponencia evalúa los programas de vacunación teniendo en cuenta la evidencia científica y la situación epidemiológica. De esta manera, asesora en la toma de decisiones que se realiza en la Comisión de Salud Pública del Consejo Interterritorial. Desde su creación, la Ponencia ha realizado recomendaciones desde el punto de vista técnico y científico en las modificaciones que se han realizado en el calendario de vacunación, incluyendo la incorporación de vacunas y el cambio de pautas de vacunación, desde el primer calendario del Consejo Interterritorial de 1996 hasta el actual calendario común de vacunación a lo largo de toda la vida. La Ponencia es considerada el Comité Técnico Asesor de Vacunaciones de España, tanto por las funciones que desarrolla como por la metodología utilizada para la elaboración de propuestas. En este artículo se revisan las funciones que desarrolla la Ponencia de Programa y Registro de Vacunaciones, las modificaciones que se han realizado en el calendario con su asesoramiento y los retos en el momento actual

The Committee for Immunization Programme and Registry (Ponencia de Programa y Registro de Vacunaciones) was created in 1991 to advise the Interterritorial Council of the National Health System on the situation of vaccine preventable diseases and the establishment and evaluation of measures for their prevention and control. Among other functions, this Committee evaluates the immunization programmes taking into account the scientific evidence and the epidemiological situation. In this way the Committee advises decision makers on the Public Health Commission of the Interterritorial Council. Any change in the National Immunization Programme, since the first one published in 1996 by the Interterritorial Council to the current Immunization Programme throughout life, has been advised from the technical and scientific point of view by this Committee. Taking into account both the work developed and the methodology used for developing the technical advice, the Committee for Immunization Programme and Registry is considered the National Immunization Technical Advisory Group for Spain. This paper reviews the functions and work developed by the Committee for Immunization Programme and Registry, the changes conducted in the National Immunization Programme under its advice and the current challenges

El coste de vacunar a lo largo de toda la vida en España / The cost of vaccination throughout life in Spain

OBJETIVO: La evaluación de los programas de vacunación mediante la estimación de costes es una herramienta fundamental para orientar la política de vacunación. El objetivo de este trabajo fue describir el coste que conlleva en España la vacunación a lo largo de toda la vida, tanto a personas sanas como pertenecientes a grupos de riesgo. METODOS: Se realizó un estudio de descripción de los costes para administrar las vacunas incluidas en el calendario común de vacunación acordado para el año 2019, y en el calendario para grupos de riesgo, a lo largo de toda la vida. RESULTADOS: El coste previsto de la vacunación a lo largo de toda la vida fue de 726,06 euros por cada mujer sana y 625,89 euros por cada hombre sano durante el 2019. En personas con las condiciones de riesgo que requieren mayor número de vacunas osciló entre 982,99 y 1.815 euros por persona. CONCLUSIONES: El relativo bajo coste de la vacunación a lo largo de toda la vida y los importantes beneficios para la salud que conlleva la vacunación hacen que esta medida sea útil y rentable, por lo que se debe reforzar la evaluación de los programas de vacunación para asegurar la vacunación adecuada en todos los momentos de la vida

OBJECTIVE: The evaluation of vaccination programmes using cost estimation is an essential tool for immunization policy. The aim of this study was to describe the cost of vaccination through-out life in Spain, both in healthy and risk groups persons. METHODS: Description of cost of vaccination following the national immunization programme throughout life agreed for 2019, and the immunization programme for risk groups. RESULTS: The expected cost to immunize a healthy person is 726.06 euros for a healthy woman and 625.89 euros for a healthy man, ranging from 982.99 to 1,815 euros per person in risk groups. CONCLUSIONS: The relatively low cost and the important benefits for health of immunization throughout life make this public health measure useful and worthwhile. Evaluation of immunization programmes should be strengthened in order to assure suitable immunization in every stage of life

[Polio vaccines, eradication and posterradication]. / Vacunas antipoliomieliticas, erradicación y posterradicación.

Vaccination against polio generates herd immunity (both with the attenuated (OPV) and inactivated (IPV) vaccines) and this will allow the eradication of the disease. The OPV vaccine produces 2-4 polio cases per cohort of one million children and therefore IPV is used in countries that can afford its cost (about 15 times more expensive than OPV). In 1988 the World Health Assembly established the polio eradication goal as "interruption of wild poliovirus transmission". If the elimination of wild poliovirus were achieved, the use of OPV will produce annually between 250 and 500 cases of polio in the world. From 1999, it was clear that eradication would require ending of immunization with OPV. On the 25th of January, 2013 it is approved the plan for the eradication and containment of all polioviruses, wild or not, so that no child suffers paralytic poliomyelitis. The most important landmarks include the lack of wild polio cases after 2014, the introduction of at least one dose of IPV in all immunization programs and to cease the type 2 OPV vaccination by the end of 2016 and to stop the use of the oral bivalent vaccine in 2019. To achieve all this, a complex scientific work and economic solidarity will be required.

Campaña de vacunación frente a la gripe 2020-2021: este año más que nunca, vacunándonos marcamos la diferencia / No disponible

No disponible

Vacunas antipoliomieliticas, erradicación y posterradicación / Polio vaccines, eradication and posterradication

La vacunación antipoliomielítica genera inmunidad de grupo (con vacunas atenuadas (VPO) e inactivadas (VPI) y ello permitirá la erradicación de la enfermedad. La VPO produce de 2-4 casos de poliomielitis por cohorte de un millón de niños y por ello los países que pueden hacer frente al coste de la VPI (unas 15 veces más cara) la utilizan. En 1988 la Asamblea de la Organización Mundial de la Salud aprobó el objetivo de la erradicación como “la interrupción de la transmisión de poliovirus salvajes”. Si se conseguía su eliminación, el mantenimiento de la VPO produciría al año entre 250 y 500 casos de poliomielitis en el mundo. Desde 1999 era evidente que la erradicación requeriría la cesación de la vacunación con VPO. El 25 de enero del 2013 se aprobó el plan para la erradicación y la contención de todos los virus de la polio, salvajes o no, para que ningún niño sufra una poliomielitis paralítica. Los hitos más importantes incluyen, la no aparición de casos de polio salvaje tras el año 2014, la introducción de al menos una dosis de VPI en todos los programas de vacunación y que se suspenda la vacunación con VPO tipo 2 al final del 2016 y que en 2019 se pueda cesar de utilizar la vacuna bivalente oral. Para todo ello será preciso un trabajo científico complejo y solidaridad financiera (AU)

Vaccination against polio generates herd immunity (both with the attenuated (OPV) and inactivated (IPV) vaccines) and this will allow the eradication of the disease. The OPV vaccine produces 2-4 polio cases per cohort of one million children and therefore IPV is used in countries that can afford its cost (about 15 times more expensive than OPV). In 1988 the World Health Assembly established the polio eradication goal as “interruption of wild poliovirus transmission”. If the elimination of wild poliovirus were achieved, the use of OPV will produce annually between 250 and 500 cases of polio in the world. From 1999, it was clear that eradication would require ending of immunization with OPV. On the 25th of January, 2013 it is approved the plan for the eradication and containment of all polioviruses, wild or not, so that no child suffers paralytic poliomyelitis. The most important landmarks include the lack of wild polio cases after 2014, the introduction of at least one dose of IPV in all immunization programs and to cease the type 2 OPV vaccination by the end of 2016 and to stop the use of the oral bivalent vaccine in 2019. To achieve all this, a complex scientific work and economic solidarity will be required (AU)