Varicella epidemiology and varicella vaccination strategies in Italy Rome, March 18, 2005 Luigi D. Notarangelo Department of Pediatrics University of Brescia – Italy

Dicembre 2002 Tot. Pazienti: 117 Italy Population:57,321,070 inhabitants Northern Italy:25,782,796 Central Italy:10,980,912 Southern Italy:20,557,362 Newborns:544,063 Northern Italy:236,498 Central Italy: 99,501 Southern Italy: 208,064 ISTAT, December 2003

Thousands inhabitants Italy: Demographic data

Monthly incidence of diseases under active surveillance SPES, years 2000  2003 Mumps Pertussis Measles Rubella Number of cases per 100,000 inhabitants

NotificationSPES PopulationAll ages Entire country Up to 14 years Population sample (4%) Period Regularly, since 1934 Regularly, since 2000 Case definition clinic only Data flow From doctor to ASL From ASL to Region From Region to Ministery, ISS, ISTAT Data reported by SIMI From pediatrician to ISS

Notification (SIMI) vs sentinel-pediatricians surveillance (SPES) varicella in Italy – year 2000 SPES: 20,513 cases reported 4.4% of individuals <14 years (470 primary-care pediatricians, 370,000 citizens) SIMI: 90,540 cases notified 4,820/100,000 1,252/100,000 Ciofi degli Atti, Ann Ig 2002; ;14 (S6):11. SPES

Age group Under-reporting rate 0-4 years years years 6.5 Total 3.8 Under-reporting rate of varicella infection by age-group Children 014 years; Italy 2000 Ciofi degli Atti, Ann Ig 2002;14(S6):11.

Incidence of varicella in Italy among infants and children SPES (sentinel pediatricians) – years 2002 and 2003 Incidence (per 100,000) year 2002 year 2003

VZV seroprevalence by age-group and geographic area in Italy, 1996  1997 Reproduced from Gabutti, et al.Epidemiol Infect.2001;126:433-40, with permission from Cambridge University Press ( 17.9%

Anti-VZV antibodies GMT by age-group in the Italian population, mUI/ml Age-groups (years) months 7-11 months > 40 Gabutti, et al. Epidemiol Infect. 2001;126:

1992   seropos. dim increase serorev (1) seroconv. seroneg. 22.8% 11.1% booster first infection Changes of seroprevalence between 12 and 18 years 561 children born in 1981, first studied in 1992, and then again in 2000 Romanò, Ann Ig 2002;14(S6):7

The burden of varicella in Italia Fornaro, et al. Pediatr Infect Dis J 1999;18: Giaquinto, et al. Ann Igiene 2002;14(S6): complications reported in 3.5 – 4.8% of infected children - hospitalization required in 0.18 – 0.34% of infected children skin infections pneumonia neurological complications

Year Nr. hospitalizations Incidence of varicella-related hospitalizations (per 100,000) by age group – year < > 75 Incidence ( per 100,000 ) Varicella-related hospitalizations in Italy – Ministry of Health Age (years) The burden of varicella in Italia

< > 70 Deaths due to varicella, by age-group. Italy,  ISTAT Age (years) 96 deaths in 20 years (4.8 deaths/year)

Deaths due to/with herpes zoster, by age-group. Italy,  ISTAT > 69 N. cases Age (years) 550 deaths in 20 years (27.5 deaths/year) due to zoster or with zoster?

The economic burden of varicella in Italy For the family OTC medications Loss of work Private lessons Home-care Other costs (telephone, transportation) For the NHS Consultations Medications Hospitalization Lab testing For the society Work-loss

The economic burden of varicella in Italy For each pediatric patient Fornaro et al. Coudeville et al. <1 year1  6 ys7  17y - prescriptions10.90 €10.90 €10.90 € - OTC medications 3.98 € 3.98 € 3.98 € - hospitalizations 9.06 €43.20 € 4.70 € 4.70 € - consultations €37.80 €37.80 €35.60 € - complications 0.78 € - additional examinations 0.71 € 0.71 € 0.71 € - work losses €84.50 €84.50 €84.50 € - school losses € Total € € € € Fornaro, et al. Pediatr Infect Dis J 1999;18: Coudeville, et al., Pharmacoeconomics 2004; 22: €

Zotti Coudeville - prescriptions € - OTC medications 3.98 € - hospitalizations € € - consultations € € - additional examinations 1.55 € - work losses € € Total € € Zotti, et al. Ann Igiene 2002;14: Coudeville, et al. Pharmacoeconomics 2004;22: The economic burden of varicella in Italy For each adult patient €

w=0, anni dalla vaccinazione numero di nuovi casi reduction rate: 26% years from vaccination number of new cases Vaccination at 12 years, 80% coverage w=0, anni dalla vaccinazione numero di nuovi casi Vaccination at 1 year, 80% coverage and at 12 years, 50% coverage reduction rate: 94% years from vaccination w=0, anni dalla vaccinazione numero di nuovi casi Vaccination at 1 year, 80% coverage reduction rate: 82% years from vaccination number of new cases w=0, anni dalla vaccinazione numero di nuovi casi Vaccination at 1 year, 20% coverage reduction rate: 18% years from vaccination number of new cases 0-4 years 5-18 years years >24 years Modelling of varicella vaccination in Italy (Salmaso) Salmaso, et al. Epidemiol Prev 2003;27:154–60. Reproduced with permission.

< 50% 50-75% >75% MMR vaccine coverage in Italy ICONA, years 1998 and 2003

Universal varicella vaccination in Sicily - identified as a priority by the Regional Health Authority ( ) - approved with a law by Regione Sicilia, aims: - immunize at least 80% of infants at 15 months - immunize at least 50% of susceptible individuals at 12 years - monitor vaccination coverage - monitor adverse events (including identification of strain) - monitor epidemiology of varicella in Sicily - officially started in March 2003

- universal varicella vaccination (1  2 years) recommended for those Regions able to reach >80% coverage - varicella vaccination recommended for susceptible adolescents State-Regions Conference March 2005