Questa è la relazione presentata dal Prof. Gaetano Maria Fara, Presidente del Comitato Nazionale
per la certificazione di eradicazione della poliomielite al Meeting organizzato dall’Ufficio Regionale
Europeo dell’OMS nel mese di maggio per la revisione della documentazione presentata da alcuni
Paesi dell’Europa meridionale e centrale
Italy
Country Report Summary
for the Certification
of the Eradication of Poliomyelitis
May, 1999
1. Structure/Responsibilities of National Polio Eradication Initiative
Policies and activities regarding polio immunization, as well as other immunizations, are set by
the Ministry of Health (MOH) which, according to the current Laws, has mainly functions of
legislative propulsion and of co-ordination of the regional Health Authorities.
As a matter of fact, a wide decentralization has been started since 1972, and the process of
transferring functions and competencies to the Regions, which have administrative and legislative
capacities, is now being completed.
In the Ministry of Health the responsibilities for immunization programmes and surveillance
of communicable diseases are allocated in the Communicable Diseases Unit of the Department of
Prevention .
Polio Laboratory activities are performed by the Istituto Superiore di Sanità (ISS) - Laboratory
of Virology, which participates in the Global Polio Laboratory Network and acts, besides as national
reference centre for Italy.
2. Polio Immunization Activities
Polio immunization is mandatory in Italy , on a full legal basis, since 1966 (Law 4
February 1966, n° 51).
Previously, the Law n° 695 of 30 July 1959 had given provisions for universal polio
vaccination, recommended by the Ministry of Health since March 1957.
Inactivated Polio Vaccine has been used in Italy from March-April 1957 until the end of
1963.
The Circular of the Ministry of Health n° 10 of 27 January 1964 gave formal
recommendations for the use of OPV in substitution of the inactivated one.
In 1983, in connection with the spreading of HIV-AIDS epidemic, IPV was partly
reintroduced, with formal recommendations for its use in immunocompromised persons and
other selected groups and for the immunization of adults.
Italy has switched to polio sequential schedule, based on the administration of two
doses of IPV, followed by two doses of OPV; the new schedule is being applied from April,
30, 1999.
Polio vaccination, like the other mandatory and recommended vaccinations, is entirely
free of charge in the structures of the National Health Service; in some Regions there are also
agreements with the General Practitioners and the Paediatricians operating for the NHS for the
administration of vaccines at the same conditions.
3. Routine Polio Immunization Coverage
The immunization coverage is very satisfactory, far exceeding 90% all over the Italian
territory; the vaccination coverage is assessed on the basis of the six-monthly recapitulations of
the vaccinations done sent by the Regions to the MOH.
Moreover, the ISS carries out periodical surveys to assess the vaccination coverage for
mandatory and recommended immunizations and possible delays in the completion of the
vaccination schedules.
The last of these surveys, called ICONA (Indagine COpertura vaccinale NAzionale) has
been carried out in 1998.
Moreover, recent seroepidemiological studies have allowed to assess that about 90%95% of 12-year-old subjects have antibodies at protective titers against the 3 types of poliovirus.
Nevertheless, some problems are related to delays in the administration of the primary
cycle of vaccination in some areas of Southern Italy and to the ideological refusal of
vaccination raising in some areas of Northern Italy.
4. History of poliomyelitis cases
Polio was an endemo-epidemic disease in Italy; since the late thirties, the morbidity for
poliomyelitis gradually increased passing from an average of 1000-1500 cases per year of the decade
1930-39, to an average of 2,000 case of the decade 1940-49 . In the period 1950-59, the average
morbidity per year was about 4,000 cases, to decrease in the following decade, after the introduction
of inactivated polio vaccine (IPV) , to 1,500 cases per year. The widest epidemics were registered in
1939 (6,007 cases), in 1953 (5,028 cases), in 1958 (8,394 cases of polio).
The introduction of oral polio vaccination (OPV), in 1964 as a monovalent vaccines, and in
1972 as a trivalent one (TOPV), marked a dramatic decrease of the incidence of poliomyelitis ( 71% in 1964 with respect to 1963, and - 69% in 1965 with respect to 1964), far greater than that
observed after the introduction of IPV (decrease of 45% in 1959 with respect to 1858, and of 21%
in 1960 with respect to 1959)
The last two indigenous cases of wild poliovirus poliomyelitis were recorded in 1982, in a small
outbreak occurred in Naples, (Campania).
In 1984 and in 1988 two imported cases of wild poliovirus poliomyelitis were registered.
Another imported case of wild poliovirus poliomyelitis had been registered in 1982.
5. Structure/responsibilities of Surveillance System
Poliomyelitis is a reportable diseases in Italy since 1940 . In 1975, poliomyelitis was included
among the diseases for which an immediate reporting was required even if only suspect, and this
provision was confirmed in the last revision of the National Reporting System for Communicable
Diseases (Ministerial Decree 15 December 1990 – Class I : Diseases for which the immediate reporting is
required, either because they are subject to the International Health Regulations or because they present a peculiar
epidemiological relevance).
At the beginning of 1995, after the alarm raised by the reporting of a suspected case of polio
in 17-month-old boy, belonging to a gypsy community living in a camp in the outskirts of Rome, a
Circular was issued by the Ministry of Health, requesting to the Regional Health Authorities the
report of acute flaccid paralysis, of any suspected aetiology.
In consideration of the low performance of the passive surveillance system, at the end of 1996
a “pilot study” of the Laboratory of Virology of ISS assessed the feasibility of an “active”
surveillance system , based on biweekly contacts with Paediatric, Neurology, Infectious Diseases
Wards of selected Hospitals.
University Institutes of Hygiene and Public Health located in four Regions (Piedmont, EmiliaRomagna, Umbria, Campania) were involved.
In 1997, the network of collaborating Institutes extended to cover the whole Italian territory .
The network is co-ordinated by the Ministry of Health and by the Istituto Superiore di Sanità
and consists of 20 Regional Reference Centres, located at the level of First Administrative Units
(Region); they on their side collect information from Hospitals scattered all over the regional
territory and located not only at the level of 2nd Administrative Units but sometimes also at the level
of Municipalities (3rd Level).
The Institutes participating in the network of active surveillance of this disease assure biweekly
reports from the facilities targeted for active surveillance; some of them have laboratory facilities
and expertise to perform virologic isolations and identifications of poliovirus and other Enterovirus.
In 1997 each laboratory of the network for the active surveillance of AFP has been submitted
by the ISS to a proficiency testing similar to that proposed by WHO for national reference centres.
If we take into account the data of AFP surveillance for he year 1997, we have to admit that
the rate of AFP has been lower than expected in some Italian Regions (Lombardy, Tuscany, Apulia,
Sicily).
The situation has changed for which concerns Sicily in 1998 (10 cases reported, rate 1.05),
thanks to the strong commitment of the Regional Health Authority in Sicily, a Region very close to
Northern Africa and target of a constant migratory flow from the Maghreb, but has remained
substantially unchanged in the other Regions because sometimes it is hard to convince Italian
physicians to report a very vague diagnosis like AFP. The complex of laboratory and
electrodiagnostic investigations usually carried out in the Italian Hospitals allows to make very
precise diagnosis and to rule out the possibility of polio.
Anyway, the rate of AFP in 1998 has been on the average of 0.72 cases per 100.000 people
under 15 years, with an increase of about 10% with respect to the previous year.
6. Additional Surveillance Activities for Certification
From 1989 until 1997, the Ministry of Health has financed some University Institutes of
Hygiene and Public Health for investigations regarding polio immunity coverage of the Italian
population and the circulation of poliovirus and other Enterovirus in sewage and surface water.
The surveys carried out by the Institutes of Hygiene of the Universities of Turin, Milan,
Parma, Sienna, Rome (University “La Sapienza” and University “Tor Vergata”), Naples, Bar i,
Palermo have allowed to collect data from Northern, Central and Southern Italy and have
excluded, till now, the circulation of wild poliovirus in Italy.
They have taken into account the following items:
 polio immunization coverage in children and adult population, as assessed through the
determination of antibody titers against the three types of poliovirus and the evaluation of
vaccination records.
 search for poliovirus and other Enterovirus in stool specimens taken from healthy children and
from people of all ages with neurological symptoms
 search for poliovirus and other Enterovirus in samples taken from environmental matrices
(surface waters, sewage).
On the whole, in the period 1989-1997, more than 16,700 persons belonging to various
age groups (range 1 year - more than 60 years) have been examined for the presence of
neutralizing antibodies against poliovirus.
Titers  1: 4 have been found in percentages ranging from 83% to 99% for poliovirus
type 1, from 79.5% to 99% for poliovirus type 2, and from 72.3% to 95.9% for poliovirus type 3.
About 5,000 stool samples have been taken, mostly form healthy children frequenting
kindergartens and primary schools. Besides non-polio Enterovirus (NPEV) and other faecally-
orally transmitted virus such as Rotavirus, Adenovirus, Cytomegalovirus, several strains of poliovirus
have been isolated, all characterized as Sabin-like.
No wild poliovirus has been isolated either from samples of surface waters (rivers, streams,
sea) and of sewage. Also in this case, several strains of NPEV and of other virus transmitted via
the oral-faecal route have been isolated through the years, including Sabin-like strains, but no
wild poliovirus. The Laboratory of Virology of ISS has carried out the characterization of the
isolates and is still carrying out the sequencing of the strains isolated during the last multi centric survey commissioned in 1997 by the Ministry of Health to the Institute of Hygiene of
the University “La Sapienza” of Rome, which has acted in collaboration with the Ins titutes of
Parma (Northern Italy) and Bari (Southern Italy).
7. Evidence of he absence of Poliovirus in Italy

Italy has been polio free for 10 years (the last indigenous cases occurred in 1982, and the last
imported one in 1988)

Italy has achieved since the late 60’ high immunization coverage in new-borns;

Italy has a long lasting system of reporting of communicable diseases, on a mandatory basis;

Italy has high quality polio reference laboratory (the Laboratory of Virology of the ISS and at
least 6 University Institute of Hygiene, all participating in the network for the active surveillance
of AFP and meeting the proficiency standards set by W.H.O.);

There is no evidence of wild poliovirus circulation in Italy;

No imported case has been confirmed since 1988, despite some reports of suspected cases in
migrant and nomad children;

Italy has a National Health System which warrants high quality primary and hospital health care;

Italy has high socio-economic standards of life and high level of sanitation.
On the basis of the above described situation, we can affirm that Italy has no longer
circulation of wild poliovirus, though the risk for importation of wild poliovirus from still
endemic areas can not be undervalued.
Indeed, the geographical position, very close to Northern Africa and to the Balkans
(only 30 marine miles divide Apulia from Albania) expose Italy to a continuous and very
difficult to control traffic of clandestine migrants.
The recent unrests in the former Yugoslavia and the troubles in Kossovo (an Albanian
enclave in the Republic of Serbia) have been causing an unceasing movement of refugees and
displaced persons from that region of the Balkans.
Moreover, the nearby Albania has also become the pivot for other migrants and
refugees to reach Italy (people from Kurdistan, another region affected from civil unrests, from
Bangladesh and from other countries of the far East) with a traffic fuelled by criminal
organizations.
However, the average high coverage for polio vaccination registered all over Italy makes
us reasonably confident that a potential importation of wild poliovirus cannot cause any spread
of it in the population.
The many children landing on Calabria and Apulia beaches in connection with this
persistent migratory flow are offered the same opportunities for immunizations than the Italian
children (whenever possible, the schedule started in the countries of origin is completed, but in
absence of a vaccination documentation, the Italian vaccination schedule is followed.
As for Italian children, the immunization for foreign children is absolutely free of any
charge in the clinics of the National Health System, according to the Immigration Act (Testo
Unico delle Leggi sull’Immigrazione ) D.P.R. 25 July 1998, n. 286, independently from their
condition of either regular or irregular migrants.
The epidemiological surveillance system carried out in the occasion of the two massive
migrations from Albania to Italy (March 1991, March-April 1997) has allowed to exclude that
any case of poliomyelitis occurred in the refugees; previously, in connection with the polio
epidemic occurred in Albania in 1996, provisions were given to the Region in order to actively
offer polio vaccines to Albanian and other nationality migrants with a very god result in term s
of acceptation of the vaccination. The Ministry of Health in that occasion purchased about
20,000 doses of IPV in addition to those usually purchased every year to meet the requirements
of the Regions for the immunization of high-risk persons, in order to have adult migrants, and
particularly those coming back and forth from Albania, vaccinated against polio.
8. Strategy for polio importation response
People travelling to polio epidemic and endemic areas are advised to be vaccinated against
polio.
In case a suspect case of polio should be reported to the Ministry of Health, a
supplementary dose of OPV would be offer to the children, independently
from their
vaccination status, aged 0-5 years, contacts of the case
The immunity status of children and adults belonging to the neighbourhood of the case
would be investigated, as provided for in several recommendations of the Ministry of Health,
the last being the Circular n° 4 of March 1998, and as done in the occasion of the last three
reports of suspected polio, all concerning gypsy children of Yugoslavian origin (Firenze, 1994;
Roma, 1994; Barcellona Pozzo di Gotto, Messina, 1995) and in which the subsequent laboratory
investigations definitely cleared the diagnosis, allowing to otherwise classify them (non polio
Enterovirus infection, EBV infection, Guillain Barrè Syndrome).