Calendario de inmunizaciones de la Asociación Española de Pediatría: recomendaciones 2024 / Immunisation schedule of the Spanish Association of Pediatrics: 2024 recommendations

El Calendario de Inmunizaciones de la AEP para 2024, con sus recomendaciones de inmunización para embarazadas, niños y adolescentes residentes en España, hace el número 25 desde el primero presentado en 1995, siendo anual desde 2003, como calendario de vacunaciones, y desde 2023 como calendario de inmunizaciones por la inclusión de un anticuerpo monoclonal para la prevención de la enfermedad por VRS. Como novedades de este año, se encuentran las siguientes: • Tabla de inmunizaciones sistemáticas para personas sanas y otra para pertenecientes a grupos de riesgo. • Aunque ya anteriormente se hacían recomendaciones de vacunación en embarazadas, se han añadido a la tabla y se ha creado un apartado específico. • Se recomienda la vacunación frente al neumococo con una de las nuevas vacunas conjugadas de valencia ampliada, en sustitución de VNC13. • Se recomienda la sustitución de la vacuna frente al meningococo C a los 4 meses de edad por la vacuna MenACWY, quedando la pauta recomendada como 1+1+1 (4 meses, 12 meses y 12 años, manteniendo el rescate en adolescentes hasta los 18 años). • Se recomienda la vacuna intranasal frente a gripe como la preferente en mayores de 2 años. • Siguiendo las propuestas de OMS, ECDC y CISNS, la vacunación frente al SARS-CoV-2 pasa a ser recomendada solo para personas mayores de 6 meses con factores de riesgo, con preparados que contengan el linaje XBB.1. Las recomendaciones de vacunación contra la covid en pediatría se actualizarán periódicamente en la web del CAV-AEP.Se mantienen el resto de las recomendaciones del calendario anterior.(AU)

The AEP Immunization Calendar for 2024, with its immunization recommendations for pregnant women, children and adolescents residing in Spain, marks the 25th edition since the first one was introduced in 1995, being annual since 2003, as a vaccination calendar, and since 2023 as immunization schedule due to the inclusion of a monoclonal antibody for the prevention of RSV disease. Novelties for this year include the following: • Tables of systematic immunizations for healthy people and those belonging to risk groups. • Although vaccination recommendations were previously made for pregnant women, they have been now included in the table and a specific section has been created. • Vaccination against pneumococcus is recommended with one of the new expanded valence conjugate vaccines, replacing PCV13. • It is recommended to replace the meningococcus C vaccine at 4 months of age with the MenACWY vaccine, thus leaving the recommended schedule as 1+1+1 (4 months, 12 months and 12 years, with a catch-up for adolescents up to 18 years). • The intranasal flu vaccine is recommended as the preferred vaccine for people over 2 years of age. • Following the proposals of the WHO, ECDC and CISNS, vaccination against SARS-CoV-2 is now recommended only for people over 6 months of age with risk factors, using vaccines containing the XBB.1 lineage. Vaccination recommendations against covid in pediatrics will be updated periodically on the CAV-AEP website.The rest of the recommendations from the previous calendar remain unchanged.(AU)

Immunisation schedule of the Spanish Association of Pediatrics: 2024 recommendations.

The AEP Immunization Calendar for 2024, with its immunization recommendations for pregnant women, children and adolescents residing in Spain, marks the 25th edition since the first one was introduced in 1995, being annual since 2003, as a vaccination calendar, and since 2023 as immunization schedule due to the inclusion of a monoclonal antibody for the prevention of RSV disease. Novelties for this year include the following: The rest of the recommendations from the previous calendar remain unchanged.

Evaluation of antibody-based preventive alternatives for respiratory syncytial virus: a novel multi-criteria decision analysis framework and assessment of nirsevimab in Spain.

BACKGROUND: Respiratory syncytial virus (RSV) is a highly infectious disease that poses a significant clinical and medical burden, as well as social disruption and economic costs, recognized by the World Health Organization as a public health issue. After several failed attempts to find preventive candidates (compounds, products, including vaccines), new alternatives might be available, one being nirsevimab, the first and only option approved for RSV prevention in neonates and infants during their first RSV season. The objective of this study was to develop a novel multi-criteria decision analysis (MCDA) framework for RSV antibody-based preventive alternatives and to use it to assess the value of nirsevimab vs. placebo as a systematic immunization approach to prevent RSV in neonates and infants during their first RSV season in Spain. METHODS: Based on a pre-established model called Vaccinex, an ad-hoc MCDA framework was created to reflect relevant attributes for the assessment of current and future antibody-based preventive measures for RSV. The estimated value of nirsevimab was obtained by means of an additive linear model combining weights and scores assigned by a multidisciplinary committee of 9 experts. A retest and three sensitivity analyses were conducted. RESULTS: Nirsevimab was evaluated through a novel framework with 26 criteria by the committee as a measure that adds value (positive final estimated value: 0.56 ± 0.11) to the current RSV scenario in Spain, by providing a high efficacy for prevention of neonates and infants. In addition, its implementation might generate cost savings in hospitalizations and to the healthcare system and increase the level of public health awareness among the general population, while reducing health inequities. CONCLUSIONS: Under a methodology with increasing use in the health field, nirsevimab has been evaluated as a measure which adds value for RSV prevention in neonates and infants during their first RSV season in Spain.

Efficacy and effectiveness of influenza vaccination in healthy children. A review of current evidence / Eficacia y efectividad de la vacunación frente a la gripe en niños sanos. Una revisión de la evidencia actual

Influenza is common in healthy children and adolescents and is associated with a high rate of hospitalization in this group, especially for those <5 years. Although the WHO has recommended vaccination in children under 5 years of age since 2012, it is really implemented in few countries today. The aim of this paper was to review the available evidence on the efficacy/effectiveness of influenza vaccination in healthy children <18 years of age through a non-systematic search of studies conducted between 2010 and 2020. Despite the high variability in results due to differences in design, vaccine type and season included in the 41 selected studies, statistically significant studies show efficacy values for the influenza vaccine of between 25.6% and 74.2%, and effectiveness from 26% to 78.8%. Although a systematic review would be necessary to corroborate the evidence, this review suggests that paediatric vaccination is generally an effective measure for preventing influenza in healthy children in line with international organisms’ recommendations.(AU)

La gripe tiene una elevada incidencia en niños y adolescentes sanos, y se asocia a una alta tasa de hospitalización, especialmente en los < 5 años. Desde 2012, la Organización Mundial de la Salud recomienda la vacunación en < 5 años, pero pocos países aplican hoy esta recomendación. El objetivo de este documento es revisar la evidencia disponible sobre la eficacia/efectividad de la vacunación antigripal en niños sanos < 18 años mediante una búsqueda no sistemática de estudios entre 2010-2020. A pesar de la gran variabilidad en los resultados debido a las diferencias de diseño, tipo de vacuna y temporada incluidos en los 41 estudios seleccionados, aquellos con significación estadística muestran valores de eficacia para la vacuna antigripal del 25,6% y al 74,2%, y de efectividad del 26% al 78,8%. Aunque sería necesaria una revisión sistemática para corroborar la evidencia, esta revisión sugiere que la vacunación pediátrica es globalmente una medida eficaz/efectiva para prevenir la gripe en niños sanos, en línea con las recomendaciones de organismos internacionales.(AU)

The Path Towards Effective Respiratory Syncytial Virus Immunization Policies: Recommended Actions

The respiratory syncytial virus (RSV) causes a substantial burden worldwide. After over six decades of research, there is finally a licensed immunization option that can protect the broad infant population, and other will follow soon. RSV immunization should be in place from season 2023/2024 onwards. Doing so requires thoughtful but swift steps. This paper reflects the view of four immunization experts on the efforts being made across the globe to accommodate the new immunization options and provides recommendations organized around five priorities: (I) documenting the burden of RSV in specific populations; (II) expanding RSV diagnostic capacity in clinical practice; (III) strengthening RSV surveillance; (IV) planning for the new preventive options; (V) achieving immunization targets. Overall, Spain has been a notable example of converting RSV prevention into a national desideratum and has pioneered the inclusion of RSV in some of the regional immunization calendars for infants facing their first RSV season. (AU)

The Path Towards Effective Respiratory Syncytial Virus Immunization Policies: Recommended Actions.

The respiratory syncytial virus (RSV) causes a substantial burden worldwide. After over six decades of research, there is finally a licensed immunization option that can protect the broad infant population, and other will follow soon. RSV immunization should be in place from season 2023/2024 onwards. Doing so requires thoughtful but swift steps. This paper reflects the view of four immunization experts on the efforts being made across the globe to accommodate the new immunization options and provides recommendations organized around five priorities: (I) documenting the burden of RSV in specific populations; (II) expanding RSV diagnostic capacity in clinical practice; (III) strengthening RSV surveillance; (IV) planning for the new preventive options; (V) achieving immunization targets. Overall, Spain has been a notable example of converting RSV prevention into a national desideratum and has pioneered the inclusion of RSV in some of the regional immunization calendars for infants facing their first RSV season.

Efficacy and effectiveness of influenza vaccination in healthy children. A review of current evidence.

Influenza is common in healthy children and adolescents and is associated with a high rate of hospitalization in this group, especially for those <5 years. Although the WHO has recommended vaccination in children under 5 years of age since 2012, it is really implemented in few countries today. The aim of this paper was to review the available evidence on the efficacy/effectiveness of influenza vaccination in healthy children <18 years of age through a non-systematic search of studies conducted between 2010 and 2020. Despite the high variability in results due to differences in design, vaccine type and season included in the 41 selected studies, statistically significant studies show efficacy values for the influenza vaccine of between 25.6% and 74.2%, and effectiveness from 26% to 78.8%. Although a systematic review would be necessary to corroborate the evidence, this review suggests that paediatric vaccination is generally an effective measure for preventing influenza in healthy children in line with international organisms' recommendations.

Immunisation schedule of the Spanish Association of Paediatrics: 2023 Recommendations.

As it does every year, the CAV-AEP publishes the update of its recommendations for the use of vaccines in children, adolescents and pregnant women residing in Spain. The 2 + 1 schedule is maintained in infants (at 2, 4 and 11 months), including preterm infants, with the hexavalent vaccine (DTaP-IPV-Hib-HB) and the pneumococcal 13-valent conjugate vaccine. A booster dose with DTaP-IPV is needed at 6 years for those who received the 2 + 1 series with hexavalent vaccine as infants, in addition to 1 dose of dTap in adolescence. Routine vaccination of pregnant women with a dose of dTap is recommended in each pregnancy, preferably between weeks 27 and 32 of gestation, although can be given from 20 weeks if there is risk of preterm delivery. All infants should receive the rotavirus vaccine (2-3 doses) and the 4CMenB vaccine (2 + 1 series). All children aged 6-59 months should be vaccinated against influenza each year. The MenACWY vaccine should be given routinely at 12 months of age and in adolescence between ages 12 and 18 years. The recommendations for the MMR vaccine (12 months and 3-4 years) and varicella vaccine (15 months and 3-4 years) also remain unchanged, using the MMRV vaccine for the second dose. Recommendations for the use of SARS-CoV-2 vaccines in the paediatric age group will be updated periodically on the CAV-AEP website. The HPV vaccine is indicated in all adolescents, regardless of sex, at age 12 years. Novelties include the recommendation of routine administration of nirsevimab to neonates and infants aged less than 6 months for passive immunization against RSV, and the recommendations regarding the hexavalent vaccine are consolidated in a single section.

Calendario de inmunizaciones de la Asociación Española de Pediatría: recomendaciones 2023 / Immunisation schedule of the Spanish Association of Paediatrics: 2023 Recommendations

Como cada año, el Comité Asesor de Vacunas de la Asociación Española de Pediatría (CAV-AEP) actualiza sus recomendaciones de inmunización en niños, adolescentes y embarazadas residentes en España.Se mantiene el esquema 2+1 en lactantes (dos, cuatro y 11 meses), incluyendo prematuros, para vacunas hexavalentes (DTPa-VPI-Hib-HB) y neumocócica conjugada 13-valente.A los seis años de edad, refuerzo con DTPa-VPI a los que recibieron la pauta 2+1 con hexavalentes siendo lactantes, y, en la adolescencia, Tdpa, una dosis. En gestantes, Tdpa en cada embarazo, preferentemente entre las semanas 27 y 32, aunque si hay riesgo de parto pretérmino se puede desde la semana 20 de gestación.Todos los lactantes deben recibir vacunas contra rotavirus (dos o tres dosis) y meningococo B (2+1).Todos los niños de entre seis y 59 meses deben ser vacunados anualmente contra la gripe, además de los grupos de riesgo desde los 6 meses.MenACWY debe administrarse a los 12 meses de edad y a los adolescentes entre 12 y 18 años que no la hayan recibido.Se mantienen las recomendaciones sobre SRP (12 meses y tres a cuatro años) y varicela (15 meses y tres a cuatro años), procurando en la segunda dosis el uso de la vacuna tetravírica (SRPV).Las recomendaciones para el uso de las vacunas contra la COVID-19 en la edad pediátrica se actualizarán periódicamente en la web del CAV-AEP.Vacuna contra el virus del papiloma humanon (VPH) indicada para todos los adolescentes, independientemente del género, a los 12 años.Como novedades, se incluyen la recomendación de uso de nirsevimab sistemático en recién nacidos y lactantes menores de seis meses como inmunización pasiva contra el virus respiratorio sincitial (VRS), y se aglutinan las hexavalentes en un solo apartado. (AU)

As it does every year, the CAV-AEP publishes the update of its recommendations for the use of vaccines in children, adolescents and pregnant women residing in Spain.The 2 + 1 schedule is maintained in infants (at 2, 4 and 11 months), including preterm infants, with the hexavalent vaccine (DTaP-IPV-Hib-HB) and the pneumococcal 13-valent conjugate vaccine.A booster dose with DTaP-IPV is needed at 6 years for those who received the 2 + 1 series with hexavalent vaccine as infants, in addition to 1 dose of dTap in adolescence. Routine vaccination of pregnant women with a dose of dTap is recommended in each pregnancy, preferably between weeks 27 and 32 of gestation, although can be given from 20 weeks if there is risk of preterm delivery.All infants should receive the rotavirus vaccine (2–3 doses) and the 4 CMenB vaccine (2 + 1 series).All children aged 6–59 months should be vaccinated against influenza each year, in addition to risk groups from 6 months.The MenACWY vaccine should be given routinely at 12 months of age and in adolescence between ages 12 and 18 years.The recommendations for the MMR vaccine (12 months and 3–4 years) and varicella vaccine (15 months and 3–4 years) also remain unchanged, using the MMRV vaccine for the second dose.Recommendations for the use of SARS-CoV-2 vaccines in the paediatric age group will be updated periodically on the CAV-AEP website.The HPV vaccine is indicated in all adolescents, regardless of sex, at age 12 years.Novelties include the recommendation of routine administration of nirsevimab to neonates and infants aged less than 6 months for passive immunization against RSV, and the recommendations regarding the hexavalent vaccine are consolidated in a single section. (AU)

Epidemiology, prevention and control of pertussis in Spain: New vaccination strategies for lifelong protection.

Pertussis is a highly contagious, vaccine-preventable respiratory tract infection, with high morbidity and mortality and a particularly severe effect on newborns and infants under 2 months. The first pertussis vaccines were introduced in the 1940s. Since 1980, however, the incidence of cases has risen despite the extensive vaccination programmes and antibiotic adjuvant treatments available. Transition from the use of whole-cell vaccines to acellular vaccines and the antigenic modifications of Bordetella pertussis have contributed, among other factors, to a reduction in vaccine-acquired immunity and reemergence of the disease. Today, there are still unmet needs not covered by conventional prevention measures and existing antibiotic treatments. This review aims to update the available data, and to discuss which vaccine strategies might contribute to better disease control and prevention.

Epidemiology, prevention and control of pertussis in Spain: New vaccination strategies for lifelong protection / Epidemiología, prevención y control de la tosferina en España: nuevas estrategias de vacunación para la protección a lo largo de la vida

La tosferina es una infección respiratoria inmunoprevenible altamente contagiosa, con alta morbilidad y mortalidad, y que afecta con especial gravedad a recién nacidos y lactantes menores de 2 meses. Las primeras vacunas comenzaron a emplearse en la década de los 40. Sin embargo, desde 1980 la incidencia de casos ha aumentado a pesar de los amplios programas de vacunación y tratamientos antibióticos adyuvantes disponibles. El cambio del uso de vacunas celulares a vacunas acelulares, y las modificaciones antigénicas de B. pertussis han podido contribuir entre otros factores a la disminución de la inmunidad adquirida tras la vacunación y a la reemergencia de la enfermedad. En la actualidad, todavía existen necesidades no cubiertas por las medidas convencionales de prevención y los tratamientos antibióticos existentes. Esta revisión pretende actualizar los datos disponibles y plantear qué estrategias vacunales pueden contribuir a un mejor control y prevención global de la enfermedad.

Pertussis is a highly contagious, vaccine-preventable respiratory tract infection, with high morbidity and mortality and a particularly severe effect on newborns and infants under 2 months. The first pertussis vaccines were introduced in the 1940s. Since 1980, however, the incidence of cases has risen despite the extensive vaccination programmes and antibiotic adjuvant treatments available. Transition from the use of whole-cell vaccines to acellular vaccines and the antigenic modifications of Bordetella pertussis have contributed, among other factors, to a reduction in vaccine-acquired immunity and reemergence of the disease. Today, there are still unmet needs not covered by conventional prevention measures and existing antibiotic treatments. This review aims to update the available data, and to discuss which vaccine strategies might contribute to better disease control and prevention.

Factors influencing HPV knowledge and vaccine acceptability in parents of adolescent children: results from a survey-based study (KAPPAS study).

Human Papillomavirus (HPV) is one of the most common sexually transmitted infections associated with a wide range of diseases and cancers that may affect both genders. Since 2007, the Spanish National Immunization Program includes HPV vaccination, and currently it only targets 12-year-old girls. The objective of our study is to assess differences in the knowledge of HPV and HPV vaccine acceptability according to different factors, and to identify the role of different sources of information. A cross-sectional, multicenter survey research was carried out in twenty-four pediatric offices in Spain, and included parents of children aged 9 to 14 years old. 1,405 valid survey-responses were considered for the analysis. Parental awareness of HPV and HPV vaccine, as well as vaccine acceptability, are still strongly associated with child gender (girls) and age (12-14 years old). HPV knowledge and HPV vaccine acceptability are related to parental gender, HPV vaccination status and having at least one daughter. Parents who consulted a healthcare source to obtain further information about HPV had greater HPV and HPV vaccine knowledge and acceptability. HPV and HPV vaccine awareness and acceptability are strongly associated with child gender and age, which correlates with the current immunization program.

Immunization schedule of the Pediatric Spanish Association: 2022 recommendations.

After reviewing the best available scientific information, CAV-AEP publishes their new recommendations to protect pregnant women, children and adolescents living in Spain through vaccination. The same recommendations as the previous year regarding hexavalent vaccines, pneumococcal conjugate vaccine of 13 serotypes, booster with tetanus, diphtheria, pertussis and inactivated poliomyelitis (Tdpa-IPV) at 6 years and with tetanus, diphtheria and pertussis (Tdpa) at 12-14 years and pregnant women from week 27 (from week 20 if there is a high risk of preterm delivery). Also with rotavirus, tetraantigenic meningococcal B (2+1), meningococcal quadrivalent (MenACWY), MMR, varicella and human papillomavirus (HPV) vaccines, for both genders. As novelties this year the CAV-AEP recommends: Influenza vaccination from 6 to 59 months of age whenever feasible and does not harm the vaccination program aimed at people at higher risk. According to official national recommendations, the CAV-AEP recommends the systematic use of COVID mRNA vaccines since 5 years old.

Calendario de vacunaciones de la Asociación Española de Pediatría: Recomendaciones 2022 / Immunisation schedule of the Pediatric Spanish Association: 2022 recommendations

Tras la revisión de la mejor información científica disponible, el CAV-AEP publica las nuevas recomendaciones para proteger con vacunas a las embarazadas, los niños y los adolescentes residentes en España. Se mantienen las mismas recomendaciones que el año anterior en cuanto a las vacunas hexavalentes y a la vacuna neumocócica conjugada de 13 serotipos, al refuerzo con tétanos, difteria, tosferina y poliomielitis inactivada (Tdpa-VPI) a los seis años y con tétanos, difteria y tosferina (Tdpa) a los 12-14 años y a las embarazadas a partir de la semana 27 (desde la semana 20 si hay alto riesgo de parto pretérmino). Lo mismo sucede con las vacunas del rotavirus, del meningococo B tetraantigénica (2 + 1), de la vacuna meningocócica tetravalente (MenACWY), de la triple vírica, de la varicela y de la vacuna del virus del papiloma humano (VPH), en ambos géneros.Como novedades este año el CAV-AEP recomienda: La vacunación antigripal de seis a 59 meses de edad siempre que sea factible y no perjudique al programa vacunal dirigido a las personas de mayor riesgo. En consonancia con las recomendaciones oficiales nacionales, el CAV-AEP recomienda el uso sistemático a partir de los 5 años de las vacunas para la COVID-19 de ARNm. (AU)

After reviewing the best available scientific information, CAV-AEP publishes their new recommendations to protect pregnant women, children and adolescents living in Spain through vaccination. The same recommendations as the previous year regarding hexavalent vaccines, pneumococcal conjugate vaccine of 13 serotypes, booster with tetanus, diphtheria, pertussis and inactivated poliomyelitis (Tdpa-IPV) at 6 years and with tetanus, diphtheria and pertussis (Tdpa) at 12–14 years and pregnant women from week 27 (from week 20 if there is a high risk of preterm delivery). Also with rotavirus, tetraantigenic meningococcal B (2+1), meningococcal quadrivalent (MenACWY), MMR, varicella and human papillomavirus (HPV) vaccines, for both genders. As novelties this year the CAV-AEP recommends: Influenza vaccination from 6 to 59 months of age whenever feasible and does not harm the vaccination program aimed at people at higher risk. According to official national recommendations, the CAV-AEP recommends the systematic use of COVID mRNA vaccines since 5 years old. (AU)

Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season.

BACKGROUND: Traditional clinical trials are conducted at investigator sites. Participants must visit healthcare facilities several times for the trial procedures. Decentralized clinical trials offer an interesting alternative. They use telemedicine and other technological solutions (apps, monitoring devices or web platforms) to decrease the number of visits to study sites, minimise the impact on daily routine, and decrease geographical barriers for participants. Not much information is available on the use of decentralization in randomized clinical trials with vaccines. METHODS: A hybrid clinical trial may be assisted by parental recording of symptoms using electronic log diaries in combination with home collected nasal swabs. During two influenza seasons, children aged 12 to 35 months with a history of recurrent acute respiratory infections were recruited in 12 primary health centers of the Valencia Region in Spain. Parents completed a symptom diary through an ad hoc mobile app that subsequently assessed whether it was an acute respiratory infection and requested collection of a nasal swab. Feasibility was measured using the percentage of returned electronic diaries and the validity of nasal swabs collected during the influenza season. Respiratory viruses were detected by real-time PCR. RESULTS: Ninety-nine toddlers were enrolled. Parents completed 10,476 electronic diaries out of the 10,804 requested (97%). The mobile app detected 188 potential acute respiratory infections (ARIs) and requested a nasal swab. In 173 (92%) ARI episodes a swab was taken. 165 (95.4%) of these swabs were collected at home and 144 (87.3%) of them were considered valid for laboratory testing. Overall, 152 (81%) of the ARIs detected in the study had its corresponding valid sample collected. CONCLUSIONS: Hybrid procedures used in this clinical trial with the influenza vaccine in toddlers were considered adequate, as we diagnosed most of the ARI cases on time, and had a valid swab in 81% of the cases. Hybrid clinical trials improve participant adherence to the study procedures and could improve recruitment and quality of life of the participants and the research team by decreasing the number of visits to the investigator site. This report emphasises that the conduct of hybrid CTs is a valid alternative to traditional CTs with vaccines. This hybrid CT achieved high adherence of participant to the study procedures. TRIAL REGISTRATION: 2019-001186-33 (EudraCT).