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.

Immunization technologies: Time to consider new preventative solutions for respiratory syncytial virus infections.

New technologies for the prevention of infectious diseases are emerging to address unmet medical needs, in particular, the use of long-acting monoclonal antibodies (mAb) to prevent Respiratory Syncytial Virus (RSV) lower respiratory tract disease in infants during their first RSV season. The lack of precedent for mAbs for broad population protection creates challenges in the assessment of upcoming prophylactic long-acting mAbs for RSV, with associated consequences in legislative and registration categorization, as well as in recommendation, funding, and implementation pathways. We suggest that the legislative and regulatory categorization of preventative solutions should be decided by the effect of the product in terms of its impact on the population and health-care systems rather than by the technology used or its mechanism of action. Immunization can be passive and active, both having the same objective of prevention of infectious diseases. Long-acting prophylactic mAbs work as passive immunization, as such, their recommendations for use should fall under the remit of National Immunization Technical Advisory Groups or other relevant recommending bodies for inclusion into National Immunization Programs. Current regulations, policy, and legislative frameworks need to evolve to embrace such innovative preventative technologies and acknowledge them as one of key immunization and public health tools.

[Analysis of vaccination strategy against COVID-19 in Spain. The scientific basics (may 2022).] / Análisis de las estrategias de vacunación frente a la COVID-19 en España y las bases científicas sobre las que se han sustentado (mayo 2022).

After about a year and a half (at the moment these lines are being written) since the start of the massive vaccination campaign in which, thanks to the high coverage achieved in all groups eligible for vaccination, it has been possible to significantly reduce the morbidity and mortality due to COVID-19, it is important to review the scientific basics that have supported the recommendations implemented to date and those that could be adopted in the near future taking into consideration the epidemiological situation. The objective of this article is, therefore, to address the foundations of some of the technical decisions proposed by the Committee on Programme and Registry of Vaccinations (National Immunization Technical Advisory Group in Spain) and the Technical Working Group on Vaccination against COVID-19. Throughout the eleven updates of the Vaccination Strategy against COVID-19 in Spain, several issues pose intense debate as the vaccination intervals between doses, the convenience of using different types of vaccines, the use of heterologous schemes of vaccination, the benefits of hybrid immunity and the use of a fourth dose (second booster dose) for selected populations. All this without forgetting essential aspects of safety of vaccines. This article is divided into the following sections: Vaccination intervals; Heterologous or mixed scheme; Hybrid immunity (vaccination after infection and infection after vaccination [breakthrough]); Second booster dose.

Una vez transcurrido alrededor de un año y medio (en el momento de escribir estas líneas) desde el inicio de la campaña masiva de vacunación en la que, gracias a las altas coberturas alcanzadas en todos los grupos diana para vacunación, se ha conseguido reducir de manera muy significativa la morbimortalidad por la COVID-19, es importante revisar las bases científicas que han sustentado las recomendaciones implantadas hasta la fecha y aquellas que podrían adoptarse en un futuro próximo según la situación epidemiológica. El objetivo del presente artículo fue, por tanto, abordar los fundamentos de algunas de las decisiones técnicas propuestas desde la Ponencia de Programa y Registro de Vacunaciones y el Grupo de Trabajo Técnico de Vacunación frente a la COVID-19. A lo largo de once actualizaciones de la Estrategia de Vacunación frente a la COVID-19 en España, han sido objeto de intenso debate varias cuestiones relativas a los intervalos de vacunación entre dosis, la conveniencia del uso de diferentes tipos de vacunas, las combinaciones de las mismas, los beneficios de la inmunidad híbrida y el uso de una cuarta dosis (segunda dosis de recuerdo) para poblaciones seleccionadas. Todo ello sin olvidar aspectos esenciales de su seguridad. Este artículo se divide en los siguientes apartados: Intervalos de vacunación; Pauta heteróloga o mixta; Inmunidad híbrida (vacunación tras la infección e infección tras vacunación [breakthrough]); Segunda dosis de recuerdo.

RSV: perspectives to strengthen the need for protection in all infants.

Respiratory syncytial virus (RSV)-the most common viral cause of bronchiolitis-is a significant cause of serious illness among young children between the ages of 0-5 years and is especially concerning in the first year of life. Globally, RSV is a common cause of childhood acute lower respiratory illness (ALRI) and a major cause of hospital admissions in young children and infants and represents a substantial burden for health-care systems. This burden is strongly felt as there are currently no effective preventative options that are available for all infants. However, a renaissance in RSV prevention strategies is unfolding, with several new prophylactic options such as monoclonal antibodies and maternal vaccinations that are soon to be available. A key concern is that health decision makers and systems may not be ready to take full advantage of forthcoming technological innovations. A multi-stakeholder approach is necessary to bridge data gaps to fully utilise upcoming options. Knowledge must be made available at multiple levels to ensure that parents and doctors are aware of preventative options, but also to ensure that stakeholders and policymakers are given the necessary information to best advise implementation strategies.

Vaccination campaign at a temporary camp for victims of the earthquake in Lorca (Spain).

Outbreaks in temporary camps are an important risk for the health of the displaced population. The town of Lorca (Murcia, Spain) suffered 2 earthquakes on May 2011 that required the re-housing of 1,424 victims in a temporary camp. Following 4 cases of chickenpox control measures were adopted among the displaced population. These measures included vaccination against chickenpox; due to the existence of cases of measles in adjacent regions, it was decided to offer measles, mumps and rubella (MMR) vaccination as well. The immunization campaign was performed during 2 d (3 to 4 d after the first case). The immunity status of 1,041 (73,1%) of the residents was reviewed. Being vaccinated 523 (67%) against chickenpox and MMR, 133 (17%) against only MMR and 124 (16%) against only chickenpox. We consider the action taken was a success, as only 4 additional cases of chickenpox were subsequently recorded in the campsite, being avoidable only one of them. There is a major risk of outbreaks in a disaster situation. Because of this, conducting preventive actions are indicated to avoid doing worse this critical.

[Toward a New Immunization Schedule in Spain, 2016 (Part 1)]. / Nuevo calendario de vacunación para España, 2016 (Parte 1).

The immunization Schedule is a dynamic public health tool that has incorporated different changes over the years influenced by the epidemiologic situation and the scientific evidence. The Immunization Advisory Committee [Ponencia de Programa y Registro de Vacunaciones], as the Interterritorial Council scientific and technical advisory body, carries out assessments of different programmes and vaccines and proposes changes that after approval will be introduced in the Regions schedule. This article is divided into two parts presenting the rationale followed to propose a new schedule for the immunization against diphtheria, tetanus, pertussis, hepatitis B and invasive disease by Haemophilus influenzae type b. This first part is focused in the reasoning to undertake the assessment, the review of the immunization policy and the impact of immunization in Spain, as well as a review of the immunization schedules in similar countries.

OBJETIVO: El calendario de vacunación en España es una herramienta dinámica de salud pública que ha ido incorporando cambios en función de la situación epidemiológica y la evidencia científica. La Ponencia del Programa y Registro de Vacunaciones, órgano científico-técnico del Consejo Interterritorial del Sistema Nacional de Salud, realiza evaluaciones y propone modificaciones que se incorporan en el calendario de vacunación de las comunidades autónomas. Este artículo está dividido en dos partes y presenta la evaluación realizada para proponer un nuevo esquema de vacunación frente a difteria, tétanos, tosferina, poliomielitis, hepatitis B y enfermedad invasora por Haemophilus influenzae tipo b, centrándose esta primera parte en la exposición de motivos, el repaso a la política de vacunación en España y su impacto así como en la revisión de los calendarios de vacunación en países de nuestro entorno.

[Toward a New Immunization Schedule in Spain, 2016 (Part 2)]. / Nuevo calendario de vacunación para España, 2016 (Parte 2).

Immunization schedules are intrinsically dynamic in order to embed the immunologic and epidemiologic changes in any specific geographic Region. According to this, the current study addresses a proposal to modify the Childhood Immunization Schedule in Spain. In order to move from a three plus one schema to a two plus one, we undertake a review of the available literature to explore the immunological and clinical rationale behind this change, including an overview of the potential impact on this schedule of premature infants. Additionally, some recommendations are made regarding those Spanish regions which start hepatitis B vaccination at the newborn period.

OBJETIVO: En este documento se justifican los fundamentos inmunológicos y clínicos para abordar una modificación del Calendario de Vacunación Infantil de España para el año 2016. Se revisa la inmunogenicidad y la experiencia clínica con esquemas de vacunación de dos dosis como primovacunación en el primer año de vida y una dosis de recuerdo precoz, para los antígenos de difteria, tétanos, tosferina, Haemophilus influenzae tipo b, poliomielitis y hepatitis B. Por sus peculiaridades también se considera el impacto clínico que esta pauta de vacunación podría tener en el lactante prematuro. Debido a que varias comunidades autónomas administran la primera dosis de vacuna de hepatitis B al nacimiento, se exponen las condiciones que se deberían cumplir para iniciar la vacunación a los dos meses de vida. Se emiten las recomendaciones de calendario que incluyen como principales cambios la administración de las vacunas hexavalentes a los 2, 4 y 11 meses, añadiendo la recomendación del uso de vacuna DTPa-VPI a los seis años de edad.

A public-professional web-bridge for vaccines and vaccination: user concerns about vaccine safety.

Vacunas.org (http://www.vacunas.org), a website founded by the Spanish Association of Vaccinology offers a personalized service called Ask the Expert, which answers any questions posed by the public or health professionals about vaccines and vaccination. The aim of this study was to analyze the factors associated with questions on vaccination safety and determine the characteristics of questioners and the type of question asked during the period 2008-2010. A total of 1341 questions were finally included in the analysis. Of those, 30% were related to vaccine safety. Questions about pregnant women had 5.01 higher odds of asking about safety (95% CI 2.82-8.93) than people not belonging to any risk group. Older questioners (>50 years) were less likely to ask about vaccine safety compared to younger questioners (OR: 0.44, 95% CI 0.25-0.76). Questions made after vaccination or related to influenza (including H1N1) or travel vaccines were also associated with a higher likelihood of asking about vaccine safety. These results identify risk groups (pregnant women), population groups (older people) and some vaccines (travel and influenza vaccines, including H1N1) where greater efforts to provide improved, more-tailored vaccine information in general and on the Internet are required.

Effectiveness of the 7-valent pneumococcal conjugate vaccine: a population-based case-control study.

BACKGROUND: The 7-valent pneumococcal conjugate vaccine (PCV7) has shown high efficacy in preventing invasive pneumococcal disease (IPD) caused by vaccine serotypes. We aimed to assess the overall effectiveness of PCV7 against IPD in Navarra, Spain. METHODS: All children aged <5 years who were diagnosed with IPD during the period 2001-2005 (n=85) and 5 control subjects per case patient (n=425), individually matched by birth date and birth hospital, were analyzed. Vaccination records were obtained from the regional immunization registry. Conditional logistic regression was used to estimate odds ratios. RESULTS: Eighteen case patients (21%) and 114 control subjects (27%) had received >or=1 dose of PCV7. PCV7 serotypes were responsible for 34 (51%) of the cases in unvaccinated children. The overall effectiveness for case prevention was 31% (odds ratio, 0.69; 95% confidence interval, 0.37-1.27). In a separate analysis, vaccination with PCV7 was 88% effective in preventing IPD due to vaccine serotypes (odds ratio, 0.12; 95% confidence interval, 0.02-0.91) and was associated with a higher risk of IPD due to nonvaccine serogroups (odds ratio, 6.16; 95% confidence interval, 1.63-23.3). CONCLUSIONS: These data reveal a higher risk of IPD caused by non-PCV7 serogroups among vaccinated children. Consequently, the overall effectiveness of PCV7 for IPD prevention may be greatly reduced.

[Active immunization against serogroup B Neisseria meningitidis]. / La inmunización activa frente a Neisseria meningitidis serogrupo B.

Serogroup B Neisseria meningitidis causes high morbidity and mortality rates over the world. This article reviews the current vaccination strategies against this microorganism, including vaccines already tested on a large scale, particularly those based on class 1 outer membrane proteins, and vaccines in different stages of development. The latter involve several approaches, such as modification of the polysaccharide capsule composition or conjugation with proteins, and the use of recombinant DNA techniques to obtain vaccines that express the prevalent sero-subtypes in a particular geographical area. The challenges that have emerged with the sequencing of the meningococcus B genome are also addressed.