How should vaccination services be planned, organized, and managed? Results from a survey on the Italian vaccination services.

BACKGROUND: Quality improvement is an increasingly recognized approach to maximize service effectiveness and minimize costs in public health. However, the Italian law never provided for the institutional accreditation of vaccination services. Furthermore, a recently approved law added six more compulsory vaccinations to the original four, which has led to a considerable increase in vaccination efforts, without any previous resources evaluation. The aim of the study was to investigate structural, organizational and managerial characteristics of the Italian vaccination services, in order to suggest the adoption of adequate quality standards. STUDY DESIGN: A survey involving the representatives of the Italian Regions and Autonomous Provinces was performed between September 2017 and September 2018. METHODS: An online questionnaire, including 26 items, designed to evaluate the structural, organizational and managerial characteristics of vaccination services was administered. The correlation between the number of vaccination centres and the coverage for each region was used to evaluate the performance of the vaccination services. RESULTS: Respondents from seven Regions, totaling >15,000,000 inhabitants, answered the questionnaire. Overall, each vaccination service was potentially accessed by an average of 519 children aged zero to 24 months, with a ß-coefficient of -0.87 (p = 0.01) for infant vaccination coverage in 2016. Eighty-five percent of vaccination services were provided with architectural features to accommodate the disabled but only 49% provided reserved parking lots. An average of 0.4 physicians and 0.6 other healthcare workers per 10,000 inhabitants were employed in vaccination services, with complete computerization in 74% of them. CONCLUSION: The inverse relation between vaccination services' spatial accessibility and vaccination coverage suggests that distance and accessibility of vaccination services should be considered in planning. This survey constitutes a baseline data for Italian vaccination services that could be useful for decision makers in establishing minimum requirements to provide high-quality preventive healthcare service.

Quadrivalent influenza vaccine: a new opportunity to reduce the influenza burden.

Influenza illness is caused by influenza A and influenza B strains. Although influenza A viruses are perceived to carry greater risk because they account for the majority of influenza cases in most seasons and have been responsible for influenza pandemics, influenza B viruses also impose a substantial public health burden, particularly among children and at-risk subjects. Furthermore, since the 2001-2002 influenza season, both influenza B lineages, B/Victoria-like viruses and B/Yamagata-like viruses have co-circulated in Europe. The conventional trivalent influenza vaccines have shown a limited ability to induce effective protection when major or minor mismatches between the influenza B vaccine component and circulating strains occur. For this reason, the inclusion of a second B strain in influenza vaccines may help to overcome the well-known difficulties of predicting the circulating B lineage and choosing the influenza B vaccine component. Two quadrivalent influenza vaccines, a live-attenuated quadrivalent influenza vaccine (Q/LAIV) and a split inactivated quadrivalent influenza vaccine (I/QIV), were first licensed in the US in 2012. Since their introduction, models simulating the inclusion of QIV in influenza immunization programs have demonstrated the substantial health benefits, in terms of reducing the number of influenza cases, their complications and mortality. In the near future, evaluations from simulation models should be confirmed by effectiveness studies in the field, and more costeffectiveness analyses should be conducted in order to verify the expected benefits.

Methodological criticisms in the evaluation of Pneumococcal Conjugate Vaccine effectiveness.

Globally, lower respiratory tract infections (LRTIs), including community-acquired pneumonia (CAP), cause considerable of morbidity and mortality in adults, especially in the elderly. In addition to age, underlying medical conditions are associated with an increased risk of CAP. From an aetiological point of view, Streptococcus pneumoniae is the leading cause of adult CAP throughout the world. Two types of vaccine are available for the prevention of pneumococcal diseases: the pneumococcal polysaccharide vaccine (PPV23) and the pneumococcal conjugate vaccine (PCV7, PCV10 and PCV13). An accurate understanding of the LRTIs burden and the types of subjects at risk of CAP, allow to find an appropriately targeted immunization strategy and provide baseline data to evaluate pneumococcal vaccine effectiveness. Given the high variability in available estimates of LRTIs burden and associated risk factors, the objective of the study was to discuss the methodological criticism in its evaluation, in the light of the gradual introduction of PCV13 immunization strategy targeted to elderly and risk groups in middle-high income countries.

Herpes Zoster: the rationale for the introduction of vaccination in Italy.

Herpes Zoster (HZ) and its main complication, post-herpetic neuralgia (PHN), represent an important public health issue because of their relevant burden within older adult population and the actual suboptimal therapeutic management of the diseases. Incidences of HZ and PHN are comparable all over the world and are closely related with the population age. Epidemiological data collected in Italy about HZ and its complications confirmed the trend registered in North America and Europe. Moreover HZ related burden is exacerbated by a significant economic impact related to both direct and indirect costs. Since 2006 a live, attenuated varicella zoster virus vaccine, that contains VZV Oka strain [Zostavax, Merck & Co., Inc.], was licensed for the prevention of HZ and PHN in adults aged ≥ 60 years. Since 2011, the licensure has been extended to adults between 50 and 59 years. The vaccine has demonstrated a good immunogenicity, efficacy and safety profiles in two pivotal phase III clinical trials and the effectiveness was further confirmed after vaccine licensure. Pharmaco-economic studies concluded that HZ vaccine is cost-effective in most European countries and generally supported the economic value of this vaccination. The vaccine is actually recommended in USA, Canada and several European countries. The opportunity to reduce the burden of these diseases by the recommendation of HZ vaccination have been evaluated and suggested also in our Country and some Regions have been recently introduced the vaccine in their immunization plan. If the good results, already obtained with HZ vaccine in other countries, will be confirmed by these Italian pilot experiences, vaccination programs should be made uniform in all Country in order to ensure an equitable offer of this important preventive tool.

Influenza vaccination in the elderly: why are the overall benefits still hotly debated?

The exact magnitude of the benefit of influenza vaccine among elderly individuals is subject of considerable debated. Existing vaccine effectiveness estimates come mostly from observational studies, which may be biased because of difficulties in identifying and adjusting for confounders. In this paper, we examine the potential sources of bias in observational studies of influenza vaccine effectiveness in the elderly and we discuss available evidence regarding the efficacy and effectiveness of licensed influenza vaccines. Although several methodological criticisms among the available analyses on seasonal vaccines for elderly were identified, overall seasonal influenza vaccines showed relevant efficacy/effectiveness in reducing the risk of influenza and its complications in the elderly, considering different measure of outcome.

Decennial diphtheria-tetanus adult boosters: are they really necessary?

Available epidemiological data shows that an average number of 59 cases of tetanus per year are still reported in Italy. Most of cases (80.2%) occur in subjects > 64 years-old. Furthermore, the proportion of females among subjects ≥ 65 years-old is significantly higher than males (87.7% vs. 64.4%, p < 0.0001). Seroprevalence data show that the percentage of subjects with protective tetanus antibody levels (> 0.1 IU/ml) decreases with increasing age. Most people aged ≥ 65 years are unprotected. The antibody levels are higher in males than females (p < 0.001) in subjects > 25 years-old. Conversely, extensive childhood immunization and adequate boosting vaccination of adults led to the near-elimination of diphtheria in Western countries. The current Italian National Immunization Prevention Plan 2012- 2014 recommends the administration of a primary vaccine course in the first year of life and booster at the preschool age, in adolescents and in adults every 10 years. Nevertheless, the need for decennial booster doses is debated by some experts, who state that the best time to offer a single dose of vaccine against tetanus and diphtheria is the age of 50, since low levels of antibody titers are observed. Considering the availability of combined vaccines against diphtheria, tetanus and pertussis (DTaP or dTaP), and the increasing incidence of pertussis in infants, who are at highest risk of serious complications, in adolescents and in adults, some countries have introduced decennial dTaP in the adults immunization schedule. It is desirable that this recommendation is also introduced in the future Italian Immunization Prevention Plan. The present review overviews the epidemiological data and the immunization strategies against tetanus, diphtheria and pertussis in Italy, discussing the rationale not only of decennial dT booster but also of the dTaP booster.

Invasive bacterial diseases: national surveillance in Italy and vaccination coverage in the Local Health Agency 4 "Chiavarese", Liguria region (Italy).

INTRODUCTION: In 2007 in Italy, the National Institute of Health published a new protocol for the National Surveillance of Invasive Bacterial Diseases, in order to enhance the notification system of these diseases and to improve immunization strategies. Available vaccines to prevent these diseases were introduced for the first time into the 1999-2000 National Immunization Plan (NIP) (vaccination against Haemophilus influenzae type b) and the 2005-2007 NIP (vaccination against Streptococcus pneumoniae and Neisseria meningitidis serogroup C). We evaluated the frequency of invasive diseases, on the basis of the number of notifications, the different immunization strategies in the Italian Regions and the vaccination coverage in Local Health Agency 4 "Chiavarese" (LHA) in the Liguria Region (Italy). MATERIALS AND METHODS: We evaluated the number of notifications of invasive diseases collected by the national databank coordinated by the ISS (Informative System of Infectious Diseases, SIMI) from 1994 to 2011. We also examined regional regulations concerning immunization policies. Immunization coverage was calculated by means of the "OASIS" software (version 9.0.0) used in our LHA. RESULTS AND DISCUSSION: Available data indicate that the large-scale vaccination policy begun in 1999 in Italy has led to a great reduction in Haemophilus influenzae-related diseases in the pediatric age. Meningococcal diseases have declined to a lesser degree; this is due to the more recent introduction of vaccination against serogroup C (in 2005), the variability of the immunization strategies adopted in the different Italian Regions and the availability of the vaccination against serogroup C only in the pediatric age. The diseases caused by Streptococcus pneumoniae seem to have increased since 2007 because of the implementation of the Surveillance of Invasive Diseases Program and the subsequent notification of all invasive diseases (not only meningitis). Furthermore, the various Italian Regions have adopted different immunization strategies against this disease, too. We evaluated vaccination coverage in LHA 4 from 2003 to 2008. VC levels against Haemophilus influenzae are excellent; the objective indicated in the 2005-2007 NIP (> or = 95%) has therefore been reached. Vaccination coverage levels against Streptococcus pneumoniae and Neisseria meningitidis serogroup C at the 24th month of age are also good. However, we need to implement specific immunization strategies for adolescents, since the vaccination coverage levels are not completely satisfactory. CONCLUSIONS: The improvement of the national invasive disease surveillance system has provided better knowledge of the size of the problem and the impact of immunization strategies on the incidence of invasive bacterial diseases. Furthermore, immunization policies in Italy display territorial heterogeneity. Vaccination coverage levels against Haemophilus influenzae, Streptococcus pneumoniae and Neisseria meningitidis at the 24th month in LHA 4 are very high. In adolescents (15 year-olds) the immunization coverage are good but needs to be improved through specific strategies, such as raising the awareness of healthcare workers, involving general practitioners and educating the target population.

Prevention of invasive diseases: strategies to increase vaccination coverage in children and adolescents.

INTRODUCTION: Vaccines able to prevent invasive bacterial diseases have been introduced into national and/or regional immunization plans through different strategies. We evaluated Haemophilus influenzae type b, Pneumococcus and Meningococcus C vaccination coverage in the 5 Ligurian Local Health Agencies, in the Liguria Region, and in Italy in order to assess the efficacy of current immunisation policies concerning children at the 24th month and adolescents. Furthermore, we considered new strategies for increasing vaccination coverage. MATERIALS AND METHODS: We estimated the vaccination coverage of Local Health Agency 4 by means of the "OASIS" software. The regional mean vaccination coverage was calculated from the data provided by the other four Local Health Agencies in Liguria. National data were obtained from the database of the Ministry of Health and from the last report of the ICONA Working Group. We used a questionnaire to evaluate the knowledge of Meningococcus C vaccination among the pediatricians and general practitioners operating in our Local Health Agency. RESULTS: The regional vaccination coverage at the 24th month proved to be: > 95% for Haemophilus influenzae type b, 93% for Pneumococcus and 87% for Meningococcus C. The national mean is: > 95% for Haemophilus influenza type b, 55% for Pneumococcus and 37% for Meningococcus C. Meningococcus C vaccination coverage among adolescents is 49% in Liguria, while the national mean is 16%. The questionnaire administered to the physicians was composed of 5 questions, which were answered by 81% of pediatricians and only 22% of general practitioners. Reducing the incidence of invasive meningococcal diseases through large-scale vaccination was deemed very important by 92% of pediatricians and 81% of general practitioners. About 92% of pediatricians and 85% of general practitioners considered the vaccine safe and effective. All (100%) physicians expressed their agreement with the Ligurian immunization strategy. However, while all the pediatricians reported recommending this vaccination, only 76% of general practitioners did so. Finally, all the physicians interviewed stated their willingness to collaborate with the Department of Prevention to increase vaccination coverage. DISCUSSION: VC against Hib at the 24th month, in both Liguria and Italy, proved excellent. Compliance with vaccination against Pneumococcus has been very high since its introduction in 2003 in Liguria, while the national mean is suboptimal. The regional vaccination coverage against Meningococcus C at the 24th month is good; the national value, however, is low because some Italian Regions have not yet introduced this vaccination into their immunization plans. Vaccination coverage in adolescents varies widely among the Ligurian Local Health Agencies and needs to be increased; the national figure is very low because few Regions have introduced this vaccination. However, achieving compliance with vaccinations in adolescents is difficult. The questionnaire indicated that general practitioners place less emphasis on vaccinations than pediatricians. Nevertheless, both general practitioners and pediatricians expressed their willingness to collaborate with the Department of Prevention of Local Health Agency 4 in improving the immunization strategies aimed at adolescents. CONCLUSIONS: In conclusion, we consider it very important to create a network involving the Department of Prevention, pediatricians and general practitioners, in order to share the best immunization strategies.

Investigation on seasonal influenza vaccination among children with high-risk medical conditions who live in the area of Local Health Agency 4 "Chiavarese".

INTRODUCTION: The Italian Ministry of Health recommends influenza vaccination in patients with chronic diseases associated with an increased risk of influenza complications. We estimated the number of patients aged from 6 months to 14 years with chronic diseases living in the area of Local Health Agency 4 "Chiavarese". MATERIALS AND METHODS: In order to estimate the number of children with chronic diseases, we evaluated data from three sources: the Health Charge Exemption Records Office; the "Nocchiero Project", implemented by the Regional Health Agency in 2009, and independent pediatricians. RESULTS: The pediatric population in the district of Local Health Agency 4 "Chiavarese" consists of 16,118 subjects. The percentage of children with high-risk medical conditions is 4.14% of the pediatric population according to records of health-charge exemption, 6.36% according to the "Nocchiero Project" data and 3.38% according to the data provided by pediatricians. In the 2010-2011 influenza vaccination campaign, 415 children were vaccinated at Local Health Agency 4 "Chiavarese"; 335 of these had chronic diseases. Vaccination coverage was estimated as 50.07% on the basis of the list of patients exempt from health care charges, as 65.68% by the independent pediatricians and as 31.45% according to the "Nocchiero Project" data. DISCUSSION: Our investigation underlines the difficulty of dividing subjects into different risk categories. The data provided by independent pediatricians yielded higher estimates of vaccination coverage in pediatric patients than the data from the other two sources. CONCLUSIONS: Estimates of vaccination coverage vary according to the source of data. However, pediatricians seem to be the most reliable source, as they know their patients better. Collaboration between health authorities and independent pediatricians should therefore be improved in order to obtain the best results in terms of influenza prevention in high-risk groups.