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Introduction
In Italy, childhood vaccinations are usually administered by vaccination
clinics in Local Health Units, which are coordinated by the Health
Authorities of the 21 Italian regions (Regional Health Authorities,
RHAs). Since 2001, when the National Health System was decentralised,
vaccination strategies to be implemented throughout the whole country
should be agreed on by the Ministry of Health and the RHAs. Commissione
Nazionale Vaccini (The National Committee on Vaccinations), where representatives
of the RHAs, Ministry of Health, National Institute of Health (Istituto
Superiore di Sanità, ISS), and scientific societies took part,
proposes the national vaccination schedule and the national vaccination
plan, which are submitted for approval to a political body, Conferenza
Stato-Regioni (Government-Regions Committee). The current national
schedule calls for universal vaccination against nine diseases: diphtheria,
tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae b,
measles, mumps and pertussis. To guarantee the adherence of all 21
Italian regions to this schedule, and the availability of these vaccinations
for all children, irrespective of their socioeconomic status, these
nine vaccines are included in the list of essential health services
that all regions must offer free of charge.
Other vaccines which have been authorised for marketing are available
at full price in pharmacies, and RHAs can decide to offer them in Local
Health Units, free of charge or at a reduced cost compared to the pharmacy
price.
Vaccines for prevention of pneumococcal invasive diseases, meningococcal
C diseases and varicella recently became available on the European market,
initiating a debate concerning their introduction into routine immunisation
programs [1-3]. Pneumococcal and meningococcal C infections are characterised
by a low transmissibility, with a basic reproduction rate lower than
2 [4,5], yet they can cause severe illnesses, ranging from pneumonia
to meningitis and fulminant sepsis. In Europe, the estimated annual incidence
per 100 000 population ranges from 0.3 to 20.3 for invasive pneumococcal
disease and from 0.39 to 7.41 for meningococcal disease [6,7]. Incidence
also varies by age groups, with highest figures observed in children < 2
years of age [8,9].
Varicella, on the other hand, is highly infectious, with a lifetime incidence
of nearly 100%. In temperate climates and in the absence of vaccination,
80%-98% of individuals acquire the infection by 15 years of age [10,11].
Though the disease is usually mild, the risk of complications is higher
for children < 1 year of age and people aged over 15 years (the risk
increases with age) [12].
In Europe, nine countries have so far introduced the 7-valent anti-pneumococcal
conjugate vaccine (PCV) in their routine immunisation programs [13],
and six have introduced anti-meningococcal C-conjugate vaccine (MenC)
[7]. Universal varicella vaccination has been introduced in one only
country [14].
Universal immunisation has not yet been recommended in Italy for any
of these vaccines. In fact, the current national vaccination plan recommends
PCV, MenC and varicella vaccination for specific groups of population
[15], which are summarised in the table. Since RHAs can choose to offer
these vaccines to other target populations, we conducted a survey to
describe the current recommendations on giving PCV, MenC and varicella
vaccines in the 21 Italian regions.
Methods
In November 2005, we mailed to the 21 RHAs a questionnaire on PCV, MenC
and varicella vaccination strategies. The questionnaire included items
on the existence of regional recommendations on these vaccinations,
and their date of approval. If recommendations were in place, RHAs
were asked to describe the vaccination target population, and whether
vaccination of various target groups was performed free of charge,
or at a reduced cost.
For PCV, the target population was divided into the following three subgroups,
which are listed in National Vaccine Plan in order of priority:
a) specific groups, as listed in the table;
b) children < 3 years of age attending day-care facilities;
c) all infants in the first year of life.
For MenC, the following sub-groups were listed:
a) specific groups, as listed in the table;
b) all infants in the first year of life.
For varicella vaccine, the target population was also divided according
to the priority order given in the National Plan, that is:
a) specific groups [TABLE],
b) adolescents with no clinical history of varicella;
c) all children in the second year of life.
For each target group, the RHA was asked whether the vaccine was administered
free of charge, or at a reduced price compared to pharmacies.
In May 2006, we contacted all RHAs by telephone in order to verify the
information provided in the returned questionnaires, and to update the
responses if further recommendations had been issued since the questionnaire
had been returned. All data were analysed at the Istituto Superiore Sanità,
using Excel software.
Results
All 21 regions completed and returned the questionnaire and were contacted
for follow-up.
Recommendations about the offering of at least one of these three vaccines
existed in 20 out of 21 regions. Ten of these regions had approved their
recommendations prior to the publication of the 2005-2007 National Vaccine
Plan, while seven had approved or updated them in the period November
2005-May 2006.
All 20 regional recommendations included PCV, while MenC and varicella
vaccinations were considered in 17 and 19 regions, respectively. In all
these regions, it was recommended that vaccination of specific population
groups be given free of charge [FIGURES 1-3], while vaccination of other
individuals varied greatly, as reported below.
PCV vaccination
Fourteen of the 20 regions provided PCV free of charge to children < 3
years of age attending day-care facilities, and nine regions provided
PCV free of charge to all infants [FIGURE 1]. In addition, eight regions
made PCV available for infants at a reduced price.
MEN C vaccination
Of the 17 regions with MenC recommendations, nine included vaccination
free of charge for all infants [FIGURE 2]. Vaccine at a reduced cost
was available for infants in six additional regions.
Varicella vaccination
Vaccination free of charge for susceptible adolescents was recommended
in nine out of 19 regions [FIGURE 3]; three of these nine regions also
provided vaccine free of charge to children in the second year of life.
Varicella vaccine at a reduced cost was available for susceptible adolescents
in five of the remaining regions, and for children in the second year
of life in four.
Discussion
The harmonisation of vaccination policies in countries with decentralised
health systems presents a never-ending challenge, and this survey evaluated
the regional adherence to national recommendations on three vaccines
recently introduced onto the market. The Italian National Vaccination
Plan identifies as priority target groups for PCV, MenC and varicella
vaccination individuals with at high risk of acquiring the disease
or who are more likely to develop complications [15]. The results of
our survey show that the regional adherence to this recommendation
is still not complete, and varies by type of vaccine, being highest
for PCV (implemented in 20/21 regions), followed by varicella vaccine
(19 regions), and MenC (17 regions). Efforts are therefore needed in
order to guarantee proper protection of high risk population.
Universal PCV, MenC, and varicella vaccinations have not yet been introduced
in Italy. For the first two vaccines, this was mainly due to the available
data (although limited) showing a modest incidence of pneumococcal and
meningococcal invasive diseases. In fact, in the years 2003-2005, an
annual mean of 23 cases of pneumococcal meningitis was reported for children
under 2 years of age, accounting for an annual incidence of 2.1-5.7 per
100 000 population [16,17]. When pneumococcal sepsis is also taken into
account, annual incidence in children < 2 years of age increases to
5.9-11.3 per 100 000 population [17], which is lower than the weighted
mean incidence of invasive pneumococcal diseases reported for western
Europe (27.03 per 100 000 population) [18]. Italy has the lowest reported
incidence of invasive meningococcal disease in Europe [7]. For meningococcal
meningitis in particular, in the period 2003-2005, an annual mean of
50 cases was reported among children < 2 years of age (incidence of
4.6 per 100 000 population), and of these cases, a mean of 18 (54.7%
of the serotyped isolates) were caused by serotype C (incidence of 1.6
per 100 000 population) and could thus have been prevented by vaccination
[16].
Varicella vaccination has not been introduced nationally because of the
potential risk of suboptimal vaccination coverage. In fact, modelling
studies have shown that coverage rates lower than 80% in the second year
of life could increase the inter-epidemic interval, with an increase
in the number of individuals acquiring the infection at older ages, when
the risk of complications is higher [19;20]. It was thus stated that
universal vaccination should be introduced if vaccination coverage > 85%
could be achieved and maintained [15].
The measure of reducing out-of-pocket vaccination costs is strongly recommended
if vaccine acceptance is to be improved [21]. Results of this survey
show that free of charge PCV and MenC vaccinations targeting all infants
have been recommended in nine regions, and varicella vaccination targeting
all children in the second year of life in three. As has previously been
found for other vaccinations, such as mumps, measles and rubella (MMR)
[22], we are now observing heterogeneous regional immunisation strategies.
This can lead to marked variation in vaccination coverage rates observed
through the country, with a consequent different level of control of
vaccine-preventable diseases. For highly transmissible diseases, such
as varicella, this could also limit the herd immunity effect, making
it more difficult to effectively control infections at the national level
[23]. Moreover, the adoption of different strategies by region has ethical
implications, because individuals living in contiguous areas could have
a different availability of preventive measures. Furthermore, when vaccine
offering varies greatly, both health workers and the public could raise
doubts on the role of and the need for vaccinations. Information on regional
offering of vaccinations should also be regularly collected, since this
may evolve rapidly.
For all these reasons, it is now crucial to monitor vaccination coverage
rates properly for PCV, MenC and varicella, as these are not now routinely
collected at the national level. Analysis of these data, along with disease
incidence figures, will help to assess the effectiveness of various strategies
implemented at the regional level, in order to harmonise PCV, MenC and
varicella recommendations.
* Regional referents for infectious diseases and vaccinations
R Cassiani (Regione Abruzzo); G Cauzillo, F Locuratolo (Regione Basilicata);
G Morosetti (Provincia Autonoma Bolzano); R Curia, A Zaccone (Regione
Calabria); R Pizzuti (Regione Campania); AC Finarelli, B Borrini (Regione
Emilia-Romagna); G Rocco (Regione Friuli Venezia Giulia); F Curtale
(Regione Lazio); R Gasparini (Regione Liguria); M Gramegna, A Pavan,
L Macchi (Regione Lombardia); G Grilli (Regione Marche); R Patriarchi,
LA D’Alò (Regione Molise); A Barale (Regione Piemonte);
R Prato, C Germinario (Regione Puglia); G Rossi (Regione Sardegna);
S Ciriminna (Regione Sicilia); E Balocchini (Regione Toscana); V Carraro
(Provincia autonoma Trento); A Tosti, M Giaimo (Regione Umbria); L
Sudano (Regione Val d’Aosta); A Ferro, S. Milani (Regione Veneto).
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