Search

Introduction: Influenza causes significant morbidity and mortality, but influenza vaccine uptake remains below most countries' targets. Vaccine policy recommendations vary, as do procedures for reviewing and appraising the evidence., Areas Covered: During a series of roundtable discussions, we reviewed procedures and methodologies used by health ministries in four European countries to inform vaccine recommendations. We review the type of evidence currently recommended by each health ministry and the range of approaches toward considering randomized controlled trials (RCTs) and real-world evidence (RWE) studies when setting influenza vaccine recommendations., Expert Opinion: Influenza vaccine recommendations should be based on data from both RCTs and RWE studies of efficacy, effectiveness, and safety. Such data should be considered alongside health-economic, cost-effectiveness, and budgetary factors. Although RCT data are more robust and less prone to bias, well-designed RWE studies permit timely evaluation of vaccine benefits, effectiveness comparisons over multiple seasons in large populations, and detection of rare adverse events, under real-world conditions. Given the variability of vaccine effectiveness due to influenza virus mutations and increasing diversification of influenza vaccines, we argue that consideration of both RWE and RCT evidence is the best approach to more nuanced and timely updates of influenza vaccine recommendations.

During COVID-19 vaccination campaign, possible ChAdOx1-S-associated risks of thrombosis with thrombocytopenia syndrome led to implement ChAdOx1-S/BNT162b2 heterologous vaccination, despite the limited information on its reactogenicity and safety. We conducted a prospective observational post-marketing surveillance study to assess the safety of this heterologous schedule. A casually selected sample of recipients (n: 85; age: 18-60 years) of ChAdOx1-S/BNT162b2 at the vaccination hub of the Foggia Hospital, Italy, was matched with an equal sample of recipients of homologous BNT162b2. Safety was evaluated 7 days, 1 month and 14 weeks after the primary vaccination series using an adapted version of the "V-safe active surveillance for COVID-19 vaccine safety" CDC standardized questionnaire. After 7 days, local reactions were highly frequent (>80%) in both groups, and systemic reactions were less common (<70%). Moderate or severe pain at the injection site (OR = 3.62; 95%CI, 1.45-9.33), moderate/severe fatigue (OR = 3.40; 95%CI, 1.22-9.49), moderate/severe headache (OR = 4.72; 95%CI, 1.37-16.23), intake of antipyretics (OR = 3.05; 95 CI%, 1.35-6.88), inability to perform daily activities and work (OR = 2.64; 95%CI, 1.24-5.62) were significantly more common with heterologous than homologous vaccination. No significant difference in self-reported health status was recorded 1 month or 14 weeks after the second dose with BNT162b2 or ChAdOx1-S/BNT162b2. Our study confirms the safety of both heterologous and homologous vaccination, with a slight increase in some short-term adverse events for the heterologous regimen. Therefore, administering a second dose of a mRNA vaccine to the recipients of a previous dose of viral vector vaccine may have represented an advantageous strategy to improve flexibility and to accelerate the vaccination campaign.

The decline in children's vaccination coverage and the resurgence of preventable infectious diseases draw attention to parents' vaccine hesitancy. Our study introduces two validated tools to independently assess vaccine hesitancy and health literacy among parents with school-age children. We developed a Vaccine Confidence Index (VCI) from 10 Likert items, exploring their relationships through exploratory and confirmatory factor analyses. We modified the IMETER (Italian medical term recognition test) to measure health literacy. We assessed the internal consistency of the modified IMETER and the 10 Likert items using Cronbach's alpha test (α) and McDonald's omega total coefficient (ω) with good results (ω = 0.92, α = 0.90; ω = 0.87, α = 0.82 respectively). We used these tools within a questionnaire conducted on 743 parents recruited from pediatric clinic waiting rooms in Italy, collecting demographic data, information sources on vaccines and vaccine-preventable diseases knowledge. The VCI resulting from factor analyses consisted of six items on a ten-point Likert scale, reflecting the ratio of positive to negative items. The survey revealed significant variations in the VCI according to individual features such as education, use of social networks, or Health institutions as sources of information. Multivariate logistic regression identified an association between vaccine intention and the VCI. Health literacy was functional for 91.2% of participants, but knowledge about vaccine-preventable diseases was generally low. The VCI showed no significant association with health literacy and vaccine-preventable diseases knowledge. The VCI and the modified IMETER effectively assess vaccination attitude and health literacy, offering valuable public health tools for tailoring vaccination campaigns to hesitant population subgroups.

Introduction: The DTaP5-IPV-Hib-HepB vaccine is the most recently approved combination hexavalent vaccine. In Europe, it is licensed since 2016 for primary and booster vaccination in infants and toddlers above the age of 6 weeks to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis, invasive diseases caused by Haemophilus influenzae type b and hepatitis B. In the US, DTaP5-IPV-Hib-HepB is approved since 2018 in children 6 weeks through 4 years of age. Its safety profile has been extensively documented in infants and children born at term, and also data in preterm infants are made available., Areas Covered: In this article, we conducted a safety evaluation of the DTaP5-IPV-Hib-HepB vaccine in infants and toddlers considering evidence from clinical trials and post-marketing use, also with regard to data on special populations e.g. preterm infants., Expert Opinion: Based on the available data, the DTaP5-IPV-Hib-HepB vaccine has demonstrated a good safety profile, similar to that of other approved penta- and hexavalent vaccines. Rather, post-marketing data are limited and are frequently reported in combination with other hexavalent vaccines or are not adjusted for shares of vaccines use. Neither relevant interferences with other co-administered pediatric vaccines nor safety issues in premature infants have been shown.

Infants are at risk of developing serious diseases as a consequence of pertussis infection. Thus, to protect newborns, many countries, including Italy, have introduced pertussis maternal immunization. However, despite the compelling evidence supporting Tdap vaccinations, the rates of coverage among Italian pregnant women have remained consistently very low. Numerous studies have shown that healthcare providers' recommendations are critical for achieving high maternal vaccination coverages. This study explores Italian gynecologists' knowledge, attitude and practices concerning pertussis maternal immunization. Between July 2018 and September 2018, we performed a national cross-sectional survey administered by e-mail using the mailing list of the Association of Italian Hospital Obstetricians and Gynecologists (AOGOI): the mailing list included more than 3500 members. A total of 451 respondents distributed throughout Italy completed the online survey. Overall, 275 (60.97%) respondents did not routinely recommend pertussis vaccination to pregnant women, mainly for suboptimal knowledge of the maternal pertussis vaccine, protocols, and guidelines: furthermore, 15.44% (69/447) of gynecologists were not aware of the pertussis vaccination program for pregnant women. Gynecologists working in the South or in the Islands of Italy were less aware about the need of administering Tdap in expectant mothers, suggesting that there is a potential risk of health inequalities based on differing levels of vaccine knowledge and recommendations across Italy. In order to enable healthcare professionals to provide accurate and timely information on pertussis immunization to pregnant women, targeted educational programs to improve gynecologists' knowledge on pertussis vaccination are needed.

Background : There is a need to better understand HPV vaccination (HPVv) implementation in WHO Europe Region (WHO/ER), including recommendations, funding, and vaccination coverage rates (VCR). Methods : A targeted literature review (up to 31 January 2020) was conducted using national health ministry websites, WHO database, and published studies from WHO/ER countries (n = 53). HPVv recommendations and funding data (target age, gender, schedule, setting, target and monitored VCR) for primary and catch-up cohorts were collected. Results : National recommendations for HPVv exist in 46/53 (87%) countries, of which 38 (83%), 2 (4%), and 6 (13%) countries provided full, partial, or no funding, respectively, for the primary cohort. Fully or partially funded HPVv was provided for girls only in 25/53 (47%) countries and for both boys and girls in 15/53 (28%) countries. HPVv catch-up was fully or partially funded in 14/53 (26%) countries. Among 40 countries with a national immunization program (NIP), monitored VCRs ranged from 4.3% to 99% (n = 30). Of the 10 countries reporting VCR targets, only Portugal exceeded its target. Conclusion : Of the 53 WHO/ER countries, 40 have funded HPVv NIPs, among which 30 report VCRs. Additional efforts are required to ensure HPVv NIPs are fully funded and high VCRs maintained.

Social media have become a common way for people to express their personal viewpoints, including sentiments about health topics. We present the results of an opinion mining analysis on vaccination performed on Twitter from September 2016 to August 2017 in Italy. Vaccine-related tweets were automatically classified as against, in favor or neutral in respect of the vaccination topic by means of supervised machine-learning techniques. During this period, we found an increasing trend in the number of tweets on this topic. According to the overall analysis by category, 60% of tweets were classified as neutral, 23% against vaccination, and 17% in favor of vaccination. Vaccine-related events appeared able to influence the number and the opinion polarity of tweets. In particular, the approval of the decree introducing mandatory immunization for selected childhood diseases produced a prominent effect in the social discussion in terms of number of tweets. Opinion mining analysis based on Twitter showed to be a potentially useful and timely sentinel system to assess the orientation of public opinion toward vaccination and, in future, it may effectively contribute to the development of appropriate communication and information strategies.

Background: Invasive meningococcal disease (IMD) in high-income countries usually occurs sporadically with low incidence and occasionally as small clusters or outbreaks. The WHO guidelines (GLs) for IMD outbreak applies only to African countries with high endemic incidence. Several high-income countries developed their own GLs on IMD outbreak, and we compare their terminology, classification, definitions, and public health interventions., Methods: National IMD outbreak GLs of the European Union and the Organisation for Economic Co-operation and Development member states were compared. Due to linguistic barriers, 17 out of forty-one countries were selected, and the GLs on the websites of the national health authorities were independently screened by two researchers., Results: National GLs on IMD outbreak were available for 12 countries. All GLs classify IMD outbreak into organization and community based using different terminology (cluster, epidemic, etc.). Two GLs introduce also a third condition of hyperendemic. Definitions, thresholds, and countermeasures vary among countries., Conclusions: Different definitions of organization and community-based outbreaks and countermeasures are expected because of uncertainties about their effectiveness, and differences between countries in health-care systems and public health policy approaches. Nevertheless, variations in terminology, definitions and countermeasures are confusing and reflect the need for an international standardization.

Immunization is one of the most important public health interventions to contrast infectious disease; however, many people nowadays refuse vaccination. Vaccine hesitancy (VH) is due to several factors that influence the complex decision-making process. Information technology tools might play an important role in vaccination programs. In particular, immunization information systems (IISs) have the potential to improve performance of vaccination programs and to increase vaccine uptake. This review aimed to present IIS functionalities in order to counter VH. In detail, we analyzed the automatic reminder/recall system, the interoperability of the system, the decision support system, the web page interface and the possibility to record adverse events following immunization. IIS could concretely represent a valid instrument to increase vaccine confidence, especially trust in both health-care workers and decision makers. There are not enough trials aimed to evaluate the efficacy of IIS to counter VH. Further researches might focalize on this aspect.

Introduction : The aim of this study was to investigate knowledge and practices about influenza among patients on dialysis services of Italian hospitals at risk of severe influenza infection and vaccine and to identify predictive factors to vaccination adherence. Methods : A cross-sectional observational study was carried out from January 2017 to July 2017 after the 2016/2017 influenza vaccination campaign. The questionnaire was administered to all patients treated in seven large Italian dialysis services. It consisted of influenza vaccination coverage, knowledge about influenza and its vaccination, perceived risk of influenza complications, recommendations on influenza uptake received by general practitioner (GP) and nephrologist. Results : Response rate was 90% (703/781). Patients' knowledge about influenza infection and vaccine were detected by nine closed questions: 35.6% of responders answered correctly to ≥ 6 sentences, 47.5% of them reported that "influenza vaccine can cause influenza" and 45.7% believed that "antibiotics are a correct strategy to treat influenza". Levels of perceived risks of hospitalisation and death were low in 39.3% and 16.5% of patients respectively. The adherence to the last seasonal influenza vaccination was 57.5%. The multivariate predictors of influenza vaccination uptake resulted: age ≥65, male, consulting TV/radio, asking information to GP and/or nephrologist. Conclusions : The study reveals the low adherence to influenza vaccination and the subotpimal level of knowledge in dialysis patients. Different strategies, including a greater alliance among nephrologists and GPs to prevent influenza should be encouraged to improve the adherence to influenza vaccination in this at risk group.

Introduction: Extending the benefits of vaccination against infectious diseases from childhood throughout the entire life-span is becoming an increasingly urgent priority in view of the world's aging population, emergence and reemergence of infectious diseases, and the necessity to invest more on prevention versus cure in global healthcare. Areas covered: This perspective discusses how life-course immunization could benefit human health at all stages of life. To achieve this, the current vaccination paradigm should be changed and all stakeholders have a role to play. Expert commentary: To enhance immunization confidence in the population, it is essential that stakeholders eliminate complacency toward infectious diseases, improve vaccination convenience, remove barriers among different healthcare specialties, and address prevention as a single entity. They must also consider societal and cultural mindsets by understanding and including public viewpoints. A new "4Cs' model encompassing convenience, confidence, complacency, and cultural acceptance is proposed to convert 'vaccine availability' to 'vaccination acceptance' throughout life. Life-course vaccination should become the new social norm of a healthy life-style, along with a healthy diet, adequate physical exercise, and not smoking. We are 'all in' to make life-course immunization a gateway for all people to lead longer, healthier lives.

Rapid population aging has become a major challenge in the industrialized world and progressive aging is a key reason for making improvement in vaccination a cornerstone of public health strategy. An increase in age-related disorders and conditions is likely to be seen in the near future, and these are risk factors for the occurrence of a number of vaccine-preventable diseases. An improvement in infectious diseases prevention specifically aimed at adults and the elderly can therefore also decrease the burden of these chronic conditions by reducing morbidity, disability, hospital admissions, health costs, mortality rates and, perhaps most importantly, by improving the quality of life. Among adults, it is necessary to identify groups at increased risk of vaccine-preventable diseases and highlight the epidemiological impact and benefits of vaccinations using an evidence-based approach. This document provides clinical practice guidance on immunization for adults in order to provide recommendations for decision makers and healthcare workers in Europe. Although immunization is considered one of the most impactful and cost-effective public health measures that can be undertaken, vaccination coverage rates among adults are largely lower than the stated goal of ≥ 95% among adults, and stronger efforts are needed to increase coverage in this population. Active surveillance of adult vaccine-preventable diseases, determining the effectiveness of the vaccines approved for marketing in the last 5 y, the efficacy and safety of vaccines in immunocompromised patients, as well as in pregnant women, represent the priorities for future research.

Introduction: Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere., Areas Covered: Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed., Expert Opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.

The WHO European Region has been declared polio-free since 2002. By 2010, inactivated polio vaccine (IPV) was the only polio vaccine in use in the EU/EEA for the primary vaccination of children. A systematic review of the literature on polio seroprevalence studies, complemented by the analysis of available vaccine coverage data, has been carried out with the aim of assessing the level of protection against polio in the European population. A total of 52 studies, with data from 14 out of the 31 EU/EEA countries, were included in the analysis. This systematic review shows that, overall, seroprevalence for PV1 and PV3 is high in most countries, although seroimmunity gaps have been detected in several birth cohorts. In particular, relatively low immunity status was found in some countries for individuals born in the 60's and 70's. Discrepancies between reported vaccination coverage and immunity levels have been also highlighted. Countries should make sure that their population is being vaccinated for polio to reduce the risk of local poliovirus transmission in case of importation. Moreover, assessing immunity status should be priority for those traveling to areas where wild polioviruses are still circulating.

Mandatory policies have occasionally been implemented, targeting optimal vaccination uptake among healthcare workers (HCWs). Herein, we analyze the existing recommendations in European countries and discuss the feasibility of implementing mandatory vaccination for HCWs. As reflected by a survey among vaccine experts from 29 European countries, guidelines on HCW vaccination were issued in all countries, though with substantial differences in targeted diseases, HCW groups and type of recommendation. Mandatory policies were only exceptionally implemented. Results from a second survey suggested that such policies would not become easily adopted, and recommendations might work better if focusing on specific HCW groups and appropriate diseases such as hepatitis B, influenza and measles. In conclusion, guidelines for HCW vaccination, but not mandatory policies, are widely adopted in Europe. Recommendations targeting specific HCW groups and diseases might be better accepted and facilitate higher vaccine uptake than policies vaguely targeting all HCW groups.

Annual epidemics of seasonal (inter-pandemic) influenza represent a significant burden on society in terms of morbidity, mortality, hospitalizations and lost working time. The impact of influenza depends on a mix of direct and indirect effects and is not easy to assess. Nevertheless there is a consensus in considering influenza prevention and mitigation high priorities for public health. We review the available evidence to assess the impact of influenza prevention focusing especially on vaccines and immunization strategies.

Assessing vaccination coverage is of paramount importance for improving quality and effectiveness of vaccination programs. In this article, some of the different systems that are used for assessing vaccination coverage within and outside the EU are reviewed in order to explore the need for improving vaccination coverage data quality. All countries in the EU have implemented vaccination programs for children, which include vaccinations to protect against between nine and 14 infectious diseases. Collecting and assessing vaccination coverage regularly is part of such programs, but the methods used vary widely. Some quality issues are evident when data reported through administrative methods are compared with seroprevalence studies or other surveys. More thorough assessment of vaccination coverage and more effective information sharing are needed in the EU. A homogeneous system for assessing vaccination coverage would facilitate comparability across countries and might increase the level of the quality of both the national and local systems. Cooperative and coordinated responses to vaccine-preventable disease threats might be improved by better information sharing.

The success of vaccination programs is an uncontroversial reality--in Europe as well as worldwide. On the other hand, the perceived risk of adverse events in the general public is the most important threat for implementing successful vaccination programs in Europe. For this reason, monitoring and assessing vaccine safety is a priority for public health. Vaccine safety is assessed both before and after vaccine authorization. In postmarketing settings, different activities related to vaccine safety usually involve several different stakeholders. In 2005, a new EU agency, the European Centre for Disease Prevention and Control, was established with the aim to strengthen Europe's defences against infectious diseases. Implementing stable links between different stakeholders and defining clear roles in the EU is paramount in order to provide optimal and transparent information on adverse reactions following immunization, with the final goal of increasing compliance to safe and effective vaccination programs.