Real life hexavalent vaccination among children as a practical guide for public health professionals: Four years (from 2016 to 2019) of clinical practice in Sicily, Italy.

Hexavalent (HV) vaccination is a priority for newborn protection and in Italy is included in the National Immunization Plan with a three doses cycle at 61, 121 and 301 days of age. A retrospective clinical study has been conducted to evaluate real life clinical practice of HV vaccination in the fourth most populous Italian Region. Data on the completion of the HV cycle, on the interchangeability between the two HV adopted in 2016-2017 (DTaP3-IPV-HB/Hib) and 2018-2019 (DTaP5-IPV-HB-Hib) and on the use above the established age, were collected in five Sicilian Local Health Authorities. Data showed an average 91.5% completion of the vaccination cycle at 24 months of age. The average age of administration was significantly higher in children who switched between the two hexavalent vaccines compared to those who completed the vaccination cycle with the same product (p-value <.01). Interchangeability with one or two doses of HV was also documented in 17.8% (2018) and 16% (2019) of vaccinated infants. Co-administration with other vaccines included in the Sicilian Vaccination Schedule was 85% with anti-pneumococcal vaccination and 65% with anti-rotavirus vaccination. Children vaccinated above recommended age (from 15 to >36 months) significantly after the introduction of mandatory vaccination in Italy (p-value <.001). This retrospective analysis will contribute to manage potential disruptions due to missed routine immunization opportunities, as the pandemic has caused, with strategies such as catch up above recommended age as well as interchangeability. Data could also help to demonstrate the need to optimize vaccine sessions through co-administration, that strongly contribute to increase vaccination coverage rates and respect of timing of vaccination schedules.

Attitudes of Healthcare Personnel towards Vaccinations before and during the COVID-19 Pandemic.

Vaccines constitute highly effective tools for controlling and eliminating vaccine-preventable diseases (VPDs) and are assessed to avert between two to three million deaths per year globally. Healthcare personnel (HCP) constitute a priority group for several vaccinations. However, studies indicate significant rates of vaccine hesitancy among them and, therefore, of acceptance of vaccination recommendations. This cross-sectional study was conducted in a university hospital in Southern Italy to assess the knowledge and attitudes of HCP about VPDs before and during the COVID-19 pandemic, estimate their intention to get vaccinated against COVID-19, and search for determinants that may influence their choice. A self-administered questionnaire was used. HCP improved their knowledge about VPDs and were more favorable to vaccinations in September-December 2020 compared to January-December 2019. Overall, 75% of respondents would get a COVID-19 vaccine. Our findings indicate a potential role of the ongoing COVID-19 pandemic on Italian HCP's knowledge and attitudes towards vaccines.

Measles and Pregnancy: Immunity and Immunization-What Can Be Learned from Observing Complications during an Epidemic Year.

Measles is a highly contagious airborne disease. Unvaccinated pregnant women are not only at risk of infection but also at risk of severe pregnancy complications. As measles causes a dysregulation of the entire immune system, we describe immunological variations and how immune response mechanisms can lead to adverse pregnancy outcomes. We evaluated data during the measles outbreak reported in the province of Catania, Italy, from May 2017 to June 2018. We controlled hospital discharge records for patients admitted to hospital obstetric wards searching the measles diagnostic code. We have indicated the case as "confirmed" when the IgM was found to be positive with the ELISA method. We registered 843 cases of measles and 51% were females (430 cases). 24 patients between the ages of 17 and 40 had measles while they were pregnant. Adverse pregnancy outcomes included 2 spontaneous abortions, 1 therapeutic abortion, 1 foetal death, and 6 preterm deliveries. Respiratory complications were more prevalent in pregnant women (21%) than in nonpregnant women with measles (9%). 14 health care workers (1.7%) were infected with measles, and none of these had been previously vaccinated. Immune response mechanisms were associated with adverse pregnancy outcomes in women with measles. To reduce the rate of measles complications, gynaecologists should investigate vaccination history and antibody test results in all women of childbearing age. During a measles outbreak, gynaecologists and midwives should be active proponents of vaccination administration and counteract any vaccine hesitancy not only in patients but also among health care workers.

Case-control study on intestinal intussusception: implications for anti-rotavirus vaccination.

BACKGROUND: Intussusception represents the most common cause of abdominal emergency among young children but nearly 75% of cases are still considered idiopathic. RESEARCH DESIGN AND METHODS: A case-control study was conducted among Sicilian children aged 0-59 months with a hospital admission for intussusception between 2009 and 2015 to identify factors associated with intussusception onset. RESULTS: Overall, 125 cases and 190 controls were recruited for the study. Birth order (OR 1.49, 95%CI: 1.10, 2.02, P = 0.02) and having had gastroenteritis or having taken antibiotics during the 30 days prior to hospitalization (OR 11.55, 95%CI: 3.23, 41.23, P < 0.001; 3.09, 95%CI: 1.17, 8.12, P = 0.009, respectively) were significantly associated with intussusception. On the other hand, exclusive breastfeeding for at least two months was a protective factor (OR 0.48, 95%CI: 0.23, 0.99, P = 0.009). Anti-rotavirus vaccination did not correlate with risk of intussusception (OR 0.96, 95% CI: 0.41, 2.25, P = 0.92). CONCLUSIONS: These findings increase the awareness of intussusception among clinical and public health service providers to obtain a better susceptibility profile. Moreover, identifying children at higher risk of intussusception could be useful in vaccination counselling to intercept early symptoms and to reduce the number of serious cases.

[Breastfeeding in Sicily Region (Southern Italy): analysis of prevalence, of contextual inequalities, and of other associated risk factors]. / Allattamento al seno in Sicilia: analisi della prevalenza, delle disuguaglianze di contesto e di altri fattori di rischio associati.

OBJECTIVES: to describe the prevalence of breastfeeding in Sicily Region (Southern Italy) and to analyze the socioeconomic status and other major risk factors on the attitudes towards exclusive breastfeeding. DESIGN: information on the practice of breastfeeding in Sicily have been collected from a Regional survey on Sudden Infant Death Syndrome (SIDS). An index of socioeconomic position was created by using data from the 2011 Census of the Italian National Institute of Statistics. SETTING AND PARTICIPANTS: in May 2015, a questionnaire was distributed to all mothers accessing to immunization services in Sicily for the first vaccination of their children. Two hundred seventy-three (273) vaccination centres have been involved, and 2,692 questionnaires were administered. MAIN OUTCOME MEASURES: five socio-economic levels were identified and, for each of them, the prevalence of breastfeeding and the risk factors for nonadherence to exclusive breastfeeding were described. RESULTS: the prevalence of exclusive breastfeeding was 30.6%, unevenly distributed in the region, being the lowest in the Province of Messina (21.4%). Nonadherence to exclusive breastfeeding was associated with the disadvantage of the low context culture (χ2: 14.9), and was more common in the areas with higher socioeconomic deprivation index (odds ratio - OR: 1.81). Among other determinants investigated, being premature was a risk factor for not being breastfed (OR: 1.59). CONCLUSION: the study confirms a low prevalence of breastfeeding in Sicily and its association with the socioeconomic level, being lower among women living in higher disadvantage areas. Moreover, this study confirms the association with co-sleeping practices (rooming-in and bed-sharing) for preterm babies. However, mother-child bed-sharing is not a guarantee for a successful breastfeeding, indeed being associated with a higher risk of SIDS. Finally, the study suggests the need for appropriate interventions focusing on specific high-risk groups.

Persistence of immunity 18-19 years after vaccination against hepatitis B in 2 cohorts of vaccinees primed as infants or as adolescents in Italy.

This study was aimed at assessing the anti-HBs persistence and immune memory 18-19 y after vaccination against hepatitis B in healthy individuals primed as infants or adolescents. We enrolled 405 teenagers (Group A) vaccinated as infants, and 409 young adults (Group B) vaccinated as adolescents. All vaccinees were tested for anti-HBs and anti-HBc antibodies; those found anti-HBc positive were further tested for HBsAg and HBV DNA. Eight individuals belonging to Group B were positive for anti-HBc alone, and were excluded from analysis. Individuals with anti-HBs concentration ≥ 10 mIU/ml were considered protected while those with anti-HBs concentration <10 mIU/ml were offered a booster dose and re-tested 2 weeks later. Overall, 67.9% individuals showed anti-HBs concentrations ≥ 10 mIU/ml (48.9% in Group A vs 87.0% in Group B, p < 0.001). The antibody geometric mean concentration (GMC) was higher in Group B than in Group A (102.5 mIU/ml vs 6.9 mIU/ml; p < 0.001). When boosted, 94.2% of vaccinees with anti-HBs <10 mIU/ml belonging to Group A and 94.7% to Group B showed an anamnestic response. Post-booster GMCs were similar in both groups (477.9 mIU/ml for Group A vs 710.0 mIU/ml for Group B, p = n.s.). Strong immunological memory persists for at least 18-19 y after immunization of infants or adolescents with a primary course of vaccination. Thus, booster doses are not needed at this time, but additional follow up is required to assess the long-life longevity of protection.

The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy.

INTRODUCTION: Multiple vaccination visits and administrations can be stressful for infants, parents and healthcare providers. Multivalent combination vaccines can deliver the required number of antigens in fewer injections and clinic visits, while vaccine co-administration can also reduce the number of visits. This non-inferiority study was undertaken to evaluate the feasibility of co-administering a combined measles-mumps-rubella-varicella (MMRV) vaccine with conjugated meningococcal C (MenC) vaccine in a large cohort of healthy Italian toddlers. METHODS: Healthy subjects aged 13-15months were randomized (2:1:1) to receive single doses of either: co-administered MMRV+MenC at the same visit (MMRV+MenC group); or MMRV followed 42days later by MenC (MMRV group); or MenC followed 42days later by MMRV (MenC group). Blood samples were collected before and 43days after vaccination. Antibody titers against MMRV were measured using ELISA. Functional-anti-meningococcal-serogroup activity (rSBAMenC) was assessed using a serum bactericidal test. Solicited local and general reactions were recorded for up to 4 and 42days post-vaccination, respectively. Non-inferiority of MMRV+MenC to MMRV (post-dose-1 seroconversion rates) and MMRV+MenC to MenC (post-dose-1 seroprotection rates) was achieved if the lower limit (LL) of the 95% confidence interval (CI) for the group difference was ⩾-10% for each antigen. RESULTS: 716 subjects were enrolled in the study. At 42days post-vaccination, the MMRV seroconversion rates were 99.3% (measles), 94.5% (mumps), 100% (rubella) and 99.7% (varicella) in the MMRV+MenC group, and 99.4%, 93.2%, 100% and 100%, respectively, in the MMRV group. The seroprotection rates against rSBA-MenC were 98.3% in the MMRV+MenC group and 99.3% in the MenC group. Non-inferiority was reached for all the vaccine antigens. The safety profiles were as expected for these vaccines. CONCLUSION: The immune responses elicited by co-administered MMRV+MenC were non-inferior to those elicited by MMRV or MenC alone and support vaccination of children with both vaccines at a single visit. CLINICAL TRIALS REGISTRATION: NCT01506193.

Analysis of hospitalizations due to intussusception in Sicily in the pre-rotavirus vaccination era (2003-2012).

BACKGROUND: Intussusception is the most common cause of bowel obstruction in infants with an incidence ranging from 9-328 cases per 100,000 infants aged 0-11 months. Causes underlining this clinical manifestation are still unknown. Possible relationship with a withdrawn tetravalent rotavirus vaccine was not confirmed by post-licensure studies and actually no increased risk of intussusception was found between infants vaccinated with both the recently licensed rotavirus vaccines. Aim of this study is to analyze the intussusception hospitalizations in Sicily from 2003 to 2012 before the introduction of rotavirus universal vaccination and its possible relation with rotavirus gastroenteritis trend. METHODS: Were collected data from hospital discharge records occurred from 1(st) January 2003 to 31(st) December 2012 in Sicily. Intussusception cases were defined as all hospitalizations with an ICD-9-CM code of 560.0 on any discharge diagnoses. As a proxy for the severity of cases were considered ICD-9-CM procedure codes accounting for surgical or radiologic reduction. RESULTS: A total of 340 intussusception cases were hospitalized in Sicily from 2003 to 2012 in children aged 0-59 months. 46.8 % occurred in the age class 0-11 months. Hospitalization rate for intussusception was 11.4 cases per 100,000 per year (32.6 cases per 100,000 among 0-11 months children; 7.3 cases per 100,000 among 12-59 months children), with a M:F sex ratio of 1.8. During hospitalization only 25 % of intussusceptions had a spontaneous resolution, 56.5 % of cases required a surgical intervention. From 2003 to 2012 intussusception cases were equally distributed during the year without any seasonality, while gastroenteritis hospitalizations due to rotavirus infection have a typically late winter and spring distribution. CONCLUSIONS: In Sicily from 2003 to 2012 hospitalizations due to intestinal invagination were higher among children aged 0-11 months with observed rates similar to other European countries. Regional baseline data analysis of intussusception among 0-59 children is recognized as an evidence-based public health strategy by international health authorities. Indeed, this strategy is necessary to compare any post-licensure age or sex-related change in intussusception trend after universal rotavirus vaccination introduction.

A measles outbreak in Catania, Sicily: the importance of high vaccination coverage and early notification of cases for health and economic reasons.

Measles is a paediatric exanthematous disease. Even though vaccination has dramatically reduced measles morbidity and mortality, outbreaks still occur due to insufficient vaccination coverage and importation of the virus from endemic regions. Although child vaccination coverage in Italy has been broadened (from 74% in 2000 to 90.1% in 2011), outbreaks are still observed at a regional level. We describe epidemiological and clinical characteristics of cases reported from January 2009 to May 2010 to the Epidemiology Service of the Provincial Health Authority of Catania. We obtained demographic data and vaccination status from the database of the Epidemiology Service and clinical features and laboratory data from medical records. In all, 522 cases were notified: 286 males (54%), median age 12 years (interquartile range (IQR) 4-18); 401 cases (77%) were notified by the hospital, and 121 (23%) by general practitioners. Only one patient had been previously vaccinated. 52 cases were hospitalized, median age 18 years (IQR 17-23). We observed hypertransaminasaemia in 20 patients (38%), thrombocytopenia in 22 patients (42%) and a creatine phosphokinase increase in 16 (30%). Complications (pneumonia, haemorrhagic cystitis, acute hepatitis) occurred in 10 patients (19%), all older than 18. Recent outbreaks show that immunization practices are still insufficient. Most cases were recorded in adolescents and young adults; even if the vaccine has limited virus circulation in childhood, it did not prevent the infection of other age groups. The number of notifications also suggests that the phenomenon is underestimated. In order to monitor the disease we need early notification of cases and increased vaccination coverage.

Booster vaccination of pre-school children with reduced-antigen-content diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine co-administered with measles-mumps-rubella-varicella vaccine: a randomized, controlled trial in children primed according to a 2 + 1 schedule in infancy.

BACKGROUND: Pertussis occurs in older children, adolescents and adults due to waning immunity after primary vaccination. Booster vaccination for pre-school children has been recommended in Italy since 1999. In this study (NCT00871000), the immunogenicity, safety and reactogenicity of a booster dose of reduced-antigen content diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (dTpa-IPV; GSK Biologicals Boostrix™-Polio; 3-component pertussis) vs. full-strength DTPa-IPV vaccine (sanofi-pasteur--MSD Tetravac™; 2-component pertussis) was evaluated in pre-school Italian children. METHODS: Healthy children aged 5-6 y primed in a routine vaccination setting with three doses of DTPa-based vaccines were enrolled and randomized (1:1) in this phase IIIb, booster study to receive a single dose of dTpa-IPV or DTPa-IPV; the MMRV vaccine was co-administered. Antibody concentrations/titers against diphtheria, tetanus, pertussis and poliovirus 1-3 were measured before and one month post-booster. Reactogenicity and safety was assessed. RESULTS: 305 subjects were enrolled of whom 303 (dTpa-IPV = 151; DTPa-IPV = 152) received booster vaccination. One month post-booster, all subjects were seroprotected/seropositive for anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-poliovirus 1-3; 99.3% of dTpa-IPV and 60.4% of DTPa-IPV subjects were seropositive for anti-PRN; 98-100% of subjects were seropositive against MMRV antigens post-booster. Pain at the injection site (dTpa-IPV: 63.6%; DTPa-IPV: 63.2%) and fatigue (dTpa-IPV: 26.5%; DTPa-IPV: 23.7%) were the most commonly reported solicited local and general symptoms, during the 4-d follow-up period. No SAEs or fatalities were reported. CONCLUSIONS: The reduced-antigen-content dTpa-IPV vaccine was non-inferior to full-strength DTPa-IPV vaccine with respect to immunogenicity. The vaccine was well-tolerated and can be confidently used as a booster dose in pre-school children.

[Cutaneous leishmaniasis in Catania (Italy): persistently endemic and underestimated]. / Leishmaniosi cutanea: una endemia persistente e sottostimata.

Cases of cutaneous leishmaniasis diagnosed at the laboratory of Department of Hygiene of the University of Catania (Italy), from 1998-2007 were evaluated. Specifically, demographic and personal data, area of origin and temporal trend of the 97 cases confirmed by microscopy in this 10-year period were examined. The data collected shows that the disease is still widely present in this area ; on the other hand official data regarding this disease appears incomplete and shows various inconsistencies. This is due to underreporting but also to scarce knowledge of the disease by physicians. Elimination of cutaneous leishmaniasis can be achieved by controlling leishmaniasis in dogs and improving environmental conditions; this requires greater efforts not only by institutions but also by individuals.

Safety and immunogenicity of a measles-mumps-rubella-varicella vaccine given as a second dose in children up to six years of age.

Two doses of measles-mumps-rubella vaccine (MMR) are widely recommended and consideration is being given to a similar schedule for varicella vaccine. A combined measles-mumps-rubella-varicella vaccine (MMRV) could be considered for this second dose in children previously vaccinated separately with MMR and varicella vaccines. Healthy children (N=390) aged 15-75 months (median 54 months) previously immunized with MMR and varicella vaccines were randomly allocated to receive MMRV or separate injections of MMR and varicella vaccines. Before administration of study vaccines, seropositivity rates were 96.4% for measles, 94.3% for mumps, 99.5% for rubella, and 97.9% for varicella. Post-immunization, seropositivity rates were 99.5% for measles and mumps and 100% for rubella and varicella in the MMR+varicella group and 100% for all four antigens in the MMRV group; a 26.2- and 27.2-fold increase in varicella titer was observed in the MMR+varicella vaccine and MMRV groups, respectively. Except for more frequent pain in the MMRV group (33.3% vs. 23.7%, p=0.043), there were no differences in the incidence of local and solicited symptoms between groups. In children primed with MMR and varicella vaccine, MMRV had non-inferior immunogenicity and similar safety profiles as a second dose of licensed MMR and varicella vaccine administered concomitantly.

Molecular epidemiology of a hepatitis C virus outbreak in a hemodialysis unit in Italy.

Hemodialysis patients are at increased risk of hepatitis C virus (HCV) infection. The aim of this study was to investigate a HCV outbreak in a hemodialysis unit using epidemiological and molecular methods. Between April 2003 and October 2003, anti-HCV seronconversion was detected in four patients attending the unit. These cases were added to 10 patients already anti-HCV positive upon admission in the unit. All 14 anti-HCV patients were tested for HCV RNA and HCV genotype. NS5B and HVR1/ E2 genomic regions were amplified and sequenced in all HCV RNA positive patients and phylogenetic analysis was performed. Furthermore, clinical-epidemiological records obtained from all patients were examined. All four patients newly infected harbored genotype 2c. Genotype 2c was also detected in 2 of 10 patients already anti-HCV positive upon admission. Phylogenetic analysis showed that all newly HCV infected patients harbored very closely related viral isolates that clustered together with the 2c isolate found in one of the two 2c chronic infected patients. All HCV-2c infected patients had no other risk factors except hemodialysis. Three of four newly HCV-2c infected patients and the one HCV-2c chronically infected involved in the outbreak received dialysis on the same day and same shift but used different machines. The remaining HCV-2c newly infected patient and one of the above cited three received dialysis on the same day during different shifts but used the same machine. The outbreak was probably due to breaks of infection control procedures although a related-machine transmission cannot be excluded in one of the cases.

Molecular epidemiological and antibiotic susceptibility characterization of Brucella isolates from humans in Sicily, Italy.

Brucellosis is a serious problem in Sicily. Brucella melitensis was identified as the species most frequently isolated in humans in Italy. No data, however, are available about the molecular epidemiological characterization of Brucella isolates from humans. We have conducted this study to molecularly characterize clinical isolates of Brucella spp. and to evaluate their antimicrobial susceptibilities. Twenty Brucella isolates were studied. Differential growth characteristics and DNA polymorphisms such as the restriction patterns of the PCR-amplified omp2a and omp2b genes, rpoB nucleotide sequencing, and multiple-locus variable-number tandem repeat analysis of 16 loci (MLVA-16) were used to characterize the strains. In vitro antibiotic susceptibility was determined by the E-test method on two different agar media, and the results were compared. All isolates were identified as B. melitensis biovar 3. rpoB nucleotide sequence analysis allowed the identification of two different genotypes of B. melitensis biovar 3. On the other hand, the MLVA-16 typing assay recognized 17 distinct genotypes. All isolates were sensitive to all tested antibiotics (rifampin, doxycycline, ciprofloxacin, ceftriaxone, and trimethoprim-sulfamethoxazole), and the Mueller-Hinton agar plate is recommended for antibiotic susceptibility testing by the E-test method. Our findings identify B. melitensis biovar 3 as the etiological agent isolated in Sicily and encourage the use of both molecular methods, and in particular of the MLVA-16 assay, in epidemiological trace-back analysis. This study represents the first epidemiological data from molecular typing of Brucella strains circulating in Italy and, in particular, in eastern Sicily.

Long-term immunogenicity of hepatitis B vaccination and policy for booster: an Italian multicentre study.

BACKGROUND: Universal anti-hepatitis-B vaccination of infants and adolescents was implemented in Italy in 1991. We undertook a multicentre study in previously vaccinated individuals to assess the duration of immunity and need for booster, over 10 years after vaccination. METHODS: In 1212 children and 446 Italian Air Force recruits vaccinated as infants and adolescents, respectively, we measured the concentrations of antibodies to hepatitis-B surface antigen (anti-HBs) and the presence of antibodies to hepatitis-B core antigen (anti-HBc) at enrollment; postimmunisation values were not available. Individuals positive for anti-HBc were tested for hepatitis B surface antigen (HBsAg) and hepatitis B viral DNA. Individuals with anti-HBs concentrations at 10 IU/L or more were regarded as protected; those with antibody less than 10 IU/L were given a booster dose and retested 2 weeks later. Individuals showing postbooster anti-HBs concentrations of less than 10 IU/L were offered two additional vaccine doses and retested 1 month after the third dose. FINDINGS: Protective anti-HBs concentrations were retained in 779 (64%, 95% CI 61.6-67) children and 398 (89%, 86.4-92.1) recruits. We recorded antibody amounts of less than 10 IU/L in 433 children (36%, 33-38.4) and 48 (11%, 7.9-13.6) recruits. One child and four recruits were positive for anti-HBc, but negative for HBsAg and hepatitis B viral DNA. Antibody concentrations were higher in recruits than in children (geometric mean titre 234.8 IU/L vs 32.1 IU/L, p=0.0001). 332 (97%) of 342 children and 46 (96%) of 48 recruits who received a booster showed an anamnestic response, whereas ten (3%) children and two (4%) recruits remained negative for anti-HBs or had antibody concentrations of less than 10 IU/L. Prebooster and postbooster antibody titres were strongly correlated with each other in both groups. All individuals given two additional vaccine doses (eight children and two recruits) showed anti-HBs amounts of more than 10 IU/L at 1 month after vaccination. INTERPRETATION: Strong immunological memory persists more than 10 years after immunisation of infants and adolescents with a primary course of vaccination. Booster doses of vaccine do not seem necessary to ensure long-term protection.

[Health effects of environmental contamination due to volcanic ash of Mount Etna in autumn 2002]. / Effetti sulla salute della popolazione derivanti dalla contaminazione amibientale delle ceneri dell'Etna nell'autunno 2002.

OBJECTIVE: During autumn 2002 a large eruption of Mount Etna (Sicily, Italy) occurred. High levels (over 200 microg/m3) of total suspended particles (PM10) were recorded. The aim of the study was to evaluate the acute health effects on mortality and hospital admissions in the area around the volcano. DESIGN: Deaths and hospital admissions occurring during the eruption period were compared with the corresponding figures during the same periods of the previous year (same day of the week). Relative risks, RR, and their 95% confidence intervals, CI, were computed. Variations in daily hospital admissions for cardiovascular diseases associated with daily level of PM10 were estimated. RESULTS: No effects on overall and cause-specific mortality were observed during the eruption period. Increases were observed in hospital admissions for cardiovascular diseases (ischemic diseases: RR 1.31, 95% CI 1.10-1.56; myocardial infarction: RR 1.34, 95% CI 1.02-1.76) and for cerebrovascular diseases (RR 1.24, 95% CI 1.05-1.47). The excesses were stronger among the elderly. Daily admissions for cardiovascular diseases were not associated to PM10 levels. CONCLUSION: The effects of the eruption of Mount Etna were limited to a temporary increase of cardiovascular morbidity, especially among the elderly, possibly as a consequence of stress.