Premature vaccination. Official recommendations in Spain

Limia Sánchez, A.; Navarro Alonso, J.A.; Urbiztondo Perdices, L.C.; Moreno Pérez, D.; Taboada Rodríguez, J.A.; Arteagoitia Axpe, J.M.; Galmés Truyols, A.

doi:10.1016/j.vacune.2020.05.004

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Official recommendations in Spain" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "1" "paginaFinal" => "3" ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "A. Limia Sánchez, J.A. Navarro Alonso, L.C. Urbiztondo Perdices, D. Moreno Pérez, J.A. Taboada Rodríguez, J.M. Arteagoitia Axpe, A. Galmés Truyols" "autores" => array:8 [ 0 => array:2 [ "nombre" => "A." "apellidos" => "Limia Sánchez" ] 1 => array:2 [ "nombre" => "J.A." "apellidos" => "Navarro Alonso" ] 2 => array:2 [ "nombre" => "L.C." "apellidos" => "Urbiztondo Perdices" ] 3 => array:2 [ "nombre" => "D." "apellidos" => "Moreno Pérez" ] 4 => array:2 [ "nombre" => "J.A." "apellidos" => "Taboada Rodríguez" ] 5 => array:2 [ "nombre" => "J.M." "apellidos" => "Arteagoitia Axpe" ] 6 => array:2 [ "nombre" => "A." "apellidos" => "Galmés Truyols" ] 7 => array:1 [ "colaborador" => "Grupo de trabajo de Vacunación en prematuros de la Ponencia de Programa y Registro de Vacunaciones. Comisión de Salud Pública del Consejo Interterritorial del Sistema Nacional de Salud, España" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Vacunación en prematuros. Recomendaciones oficiales en España" ] ] "textoCompleto" => "On 4 December the Inter-territorial Council of the National Health System passed the document “Vacunación en prematuros”<a class="elsevierStyleCrossRef" href="#bib0005">1</a>(“Preterm Infant Vaccination”) prepared by the Vaccination Program and Registry Committee, and this was published on the same date in the web page of the Ministry of Health, Consumption and Social Wellbeing. The aim of this document was to review and present, in monographic form for the first time, the specific vaccination recommendations for this population group.After the transfer of authority in public health matters, the Autonomous Communities are in charge of establishing the indications for vaccination within their territory. Nevertheless, after 1988 clear differences emerged between the vaccination programs of the different autonomous communities, basically in terms of age and the moment individuals were included in the recommendations. With the aim of coordinating and harmonising vaccination strategies to guarantee equality and consistency in access to medical services, in December 1991 the Consejo Interterritorial del Sistema Nacional de Salud (CISNS) (Inter-territorial Council of the National Health System) agreed to create the Vaccination Program and Registry Committee, hereinunder the Vaccination Committee, a technical Public Health Commission Body, both of which are under the CISNS, to propose recommendations for the whole country at the request of the said Commission on vaccination programs, based on scientific evidence and the epidemiology of diseases that could be prevented by immunisation. Specific workgroups were formed for specific evaluations, with experts from the Committee itself and other external experts, when this was considered advisable. The work was reviewed and approved by the plenary Committee before the proposal was presented to the Public Health Commission. Recommendations made by the Vaccination Committee, as is the case for other CISNS bodies, are passed by consensus.<a class="elsevierStyleCrossRef" href="#bib0010">2</a>To date in our country recommendations for the vaccination of preterm infants were dispersed in multiple documents which included specific recommendations against certain diseases and the vaccination of groups at risk, etc. The 2016 Vaccination Committee document, “Review of the Vaccination Calendar”<a class="elsevierStyleCrossRef" href="#bib0015">3</a> recommended the vaccination of preterm newly born infants depending on their chronological age, in the same way as those born full-term. Nevertheless, in recent years some autonomous communities and certain scientific associations set different guidelines for certain vaccines, as well as including vaccination against rotavirus.Taking into account the concern about vaccination felt by medical personnel in the management of preterm infants, the Public Health Commission asked the Committee to prepare the document we present in this publication, reviewing the evidence on vaccination strategies and guides, paying special attention to the prevention of whooping cough, hepatitis B, invasive disease caused by type b Haemophilus influenzae, meningococcus and pneumococcus, rotavirus and influenza, due to the higher morbimortality of these diseases and worse immune response to some vaccines. It also contains a section on vaccine safety in this population group.Preterm newly born babies (PNB) covers those born before 37 weeks of gestational age (GA), which are estimated in Spain to comprise about 7% of newly born infants, approximately 28,000 per year, with a 36% increase since 1996. The highest morbimortality in PNB is observed in those born with a GA of from 28 to 32 weeks (very preterm) and, above all, those with less than 28 weeks (extreme preterm), which comprise as a whole 1% of all births (approximately 4,300 per year), as well as the PNB with very low weight (less than 1500 g). Currently in our environment 95% of PNB with  > 28 weeks GA survive, while 73% of those who are extremely preterm and weigh  < 1500 g do so.Their especial vulnerability to infections increases in PNB with a shorter GA and lower weight, and this includes several immuno-preventable diseases such as whooping cough, influenza and invasive pneumococcal disease (IPD), and this vulnerability seems to persist during the first years of life. The reasons that may explain this susceptibility to infections include the immaturity of cutaneous-mucosa barriers, the immaturity of the immune system (with less response to capsular polysaccharide antigens), reduced transfer of maternal antibodies (which starts at around week 17 of gestation, with concentrations in the mother and foetus equalling between weeks 32 and 36), the reduced rate of breastfeeding and the pathologies and treatments that are associated with preterm infants (malnutrition, pneumopathy, prolonged treatment with steroids and prolonged hospitalisation, etc.). Other contributing factors may be the presence of very young siblings in the home and a low socio-economic level.The immune response of PNB to vaccines may be weaker than those of infants born full-term, above all in those born before 28 weeks or with a weight lower than 1500 g, probably due to a reduced Th1 lymphocyte response and Th1/Th2 imbalance. However, in general protective concentrations are attained of antibodies to all of the vaccine antigens after the first vaccinations. Although the majority of studies published are with 3 + 1 vaccinations, countries that use 2 + 1 vaccinations have not reported any differences in the efficacy of vaccination depending on GA. The immune response in PNB is similar to that obtained in full-term infants for DTP, DTPa, poliovirus 1 and 2, pneumococcus and meningococcus, although it is less for hepatitis B, Hib and poliovirus 3. Its real clinical impact is currently unknown, above all for PNB when GA < 32 weeks and, even more so, when GA  < 28 weeks or  weight < 1500 g. There is little information on the long-term protection provided by these vaccines, although the available data suggest that after the second year of life these infants acquire sufficient immunological memory and will achieve suitable protection, similar to that which is observed in those born at full-term.All of the above reasons make it a priority to vaccinate this population in an optimum manner. When there are no contraindications, the recommendation is to start vaccinating PNB at the corresponding chronological age, i.e., at 2 months, regardless of their GA or weight. Nevertheless, the vaccination of PNB is often delayed, above all during the first 6 months of life. This occurs due to a range of reasons, including the incidence of simultaneous pathologies that temporarily contraindicate vaccination, and fear or lack of knowledge about the safety and reactogenicity of vaccines in this population.Recommendations<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0010">•Infant vaccination in those born preterm (before week 37) will take place according to chronological age, starting vaccination at the age of 2 months (postnatal), regardless of their gestational age or weight at birth.</li><li class="elsevierStyleListItem" id="lsti0015">•After reviewing the risk of whooping cough, hepatitis B and invasive disease by type b H. influenzae and pneumococcus in preterm infants, as well as the response of this population to vaccination, it does not seem necessary to modify the current 2 + 1 vaccination guideline used for full-term infants. The 1 + 1 guideline will also be kept for meningococcus, at 4 and 12 months of age. The community protected generated by the high coverage of infant vaccination support this recommendation.</li></ul></li><li class="elsevierStyleListItem" id="lsti0020">oIt is of capital importance to vaccinate “at the right time”, at the moment an infant reaches the established age (starting on the day they reach two months of life) or as soon as possible after this moment.</li><li class="elsevierStyleListItem" id="lsti0025">oTo prevent whooping cough in preterm infants during the first 2-3 months of life, vaccination of the pregnant mother is recommendable with dTpa after week 27, although preferentially in week 27 or 28, and increasing current coverage as far as possible.</li></ul>In pregnant women who are clinically stable and at high risk of preterm birth vaccination after week 20 of gestation may be considered.<ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0030"><ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0035">•To prevent perinatal infection by hepatitis B virus in the newborn infants of mothers who carry the virus or who have not been screened for it prenatally, it is recommended that single component hepatitis B vaccine and hyperimmune anti-hepatitis B immunoglobulin be administered in the first 12 hours of life, in preterm as well as in full-term infants. The guideline with hexavalent vaccine will continue to the followed as in the rest of the infant population, without it being necessary to consider weight at birth.</li><li class="elsevierStyleListItem" id="lsti0040">•Vaccination against rotavirus is recommended after 6 weeks of life in infants born from week 25-27 (depending on the vaccine used) and week 32 of gestation, in mothers who are clinically stable and without contraindications. Vaccination will take place according to chronological age and following the authorised guidelines for each vaccine. In preterm situations other than those described above, vaccination is to be evaluated on an individual basis.</li></ul></li><li class="elsevierStyleListItem" id="lsti0045">oAfter vaccination the standard primary preventive measures will be applied against the transmission of the vaccine virus, above all in the first 2 weeks. These measures will be applied with maximum rigour in the case of vaccine administration against rotavirus within a hospital environment.</li><li class="elsevierStyleListItem" id="lsti0050">oGiven the exceptional nature of severe or very severe disease in our environment, vaccination against rotavirus is not generally recommended in preterm infants whose mothers are receiving monoclonal antibodies and drugs such as etanercept with immunosuppressor effect during pregnancy. Vaccination may be considered depending on the therapeutic agent used and the time elapsed since the end of treatment, based on the scientific evidence that is available in each case.</li><li class="elsevierStyleListItem" id="lsti0055">•Preterm infants with less than 32 weeks gestation are considered to be at high risk for complications of influenza, and it is recommended that inactivated anti-influenza vaccine be administered to them from 6 to 24 months of age. If any risk factor is present annual vaccination will continue after the age of 24 months.</li><li class="elsevierStyleListItem" id="lsti0060">oThe first time they are vaccinated, 2 0.5 ml doses of anti-influenza vaccine are to be administered, separated by an interval of at least 4 weeks between doses. 1 dose is to be administered in subsequent vaccinations.</li><li class="elsevierStyleListItem" id="lsti0065">oThis preterm infant vaccination strategy is complemented by the current recommendations for the vaccination of pregnant women with a dose of inactivated vaccine at any time during gestation.</li><li class="elsevierStyleListItem" id="lsti0070">oThose who live with children with a history of preterm birth, whatever their age and until the said children reach the age of 24 months, must be vaccinated annually against influenza.</li><li class="elsevierStyleListItem" id="lsti0075">•Please remember that medical personnel who are in contact with preterm infants must be suitably vaccinated according to the current recommendations.45</li></ul>Vaccines have a safety profile similar to the one observed in full-term infants. Nevertheless, and as a precaution, in very early preterm births (GA < 32 weeks) monitoring is recommended after vaccination and, when vaccines have to be administered during hospitalisation, cardiorespiratory monitoring is recommended during 72 hours after vaccination, above all in those with a history of apnoea or cardiovascular instability, those who weigh less than 2000 grams at the time and those born earlier than 28 weeks gestation." "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Recommendations" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Moraga-Llop FA. Vacunación en prematuros. Recomendaciones oficiales en España. Vacunas. 2020;21:1–3." ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:3 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Vacunación en prematuros. Comisión de Salud Pública del Consejo Interterritorial del Sistema Nacional de Salud. Ministerio de Sanidad, Consumo y Bienestar Social, noviembre" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "Grupo de trabajo vacunación en prematuros de la Ponencia de Programa y Registro de Vacunaciones" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "2019" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "de la Ponencia de Programa y Registro de Vacunaciones. Criterios de Evaluación para Fundamentar Modificaciones en el Programa de Vacunación en España. Comisión de Salud Pública del Consejo Interterritorial del Sistema Nacional de Salud. Ministerio De Sanidad, Política Social e Igualdad, Septiembre 2011" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "Grupo de Trabajo Criterios" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "2011" ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Revisión del Calendario de Vacunación. Comisión de Salud Pública del Consejo Interterritorial del Sistema Nacional de Salud. Ministerio de Sanidad, Servicios Sociales e Igualdad, marzo" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "Grupo de trabajo de la Ponencia de Programa y Registro de Vacunaciones" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "2016" ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/24451460/0000002100000001/v4_202105130819/S2445146020300091/v4_202105130819/en/main.assets" "Apartado" => array:4 [ "identificador" => "66706" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Editorial" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/24451460/0000002100000001/v4_202105130819/S2445146020300091/v4_202105130819/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2445146020300091?idApp=UINPBA00004N"]

ISSN: 2445-1460

Official journal of the Asociación Española de Vacunología (AEV) Vacunas is a peer-reviewed journal supported by an advisory board of experts in the field of vaccinology. The aim of the journal is to contribute to the dissemination of the scientific advances made in the area of basic and applied research in the field of vaccine-preventable diseases in humans. It places special emphasis on aspects associated with planning and evaluation (epidemiology of vaccine-preventable diseases, development of vaccination programs, evaluation of the efficacy, effectiveness and efficiency of vaccinations). Vacunas publishes, in Spanish and in English, Editorials, Original Articles, Special Articles, Reviews, Strategies and Vaccination Programs. There are also sections on Literature Reviews, News and on Congresses associated with vaccinations. The peer review process is done anonymously by reviewers with expertise in the area of knowledge of each manuscript as well as experts in methodology or statistics, as determined by the Editorial board, which works towards maintaining an efficient editorial process in order for the manuscripts to be published as soon as possible.

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Vol. 21. Issue 1.