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Control of viral hepatitis in Europe

In 1991 the Global Advisory Group of the Expanded Programme for Immunisation of the World Health Organisation called for all countries to add the hepatitis B vaccine to their national immunisation programmes by 1997. This recommendation was ratified by the World Health Assembly, the governing body of WHO, in 1992. As of mid 1995, 75 countries had an official policy of using this vaccine in their national immunisation programmes.

In Europe and North America, the primary areas of concern of the Viral Hepatitis Prevention Board (VHPB), Portugal, Spain, Italy, France, Germany, Poland, Albania, Bulgaria, and the United States and Canada have introduced this vaccine into routine infant and/or adolescent immunisation. Many other countries such as Greece, Turkey, Switzerland, Belgium, and the Netherlands are seriously considering the introduction of this vaccine.

In Western Europe, only the Scandinavian countries, Great Britain and Ireland have not yet begun to seriously consider use of this vaccine, since they are not yet convinced that the burden of disease in countries merits the expense and additional injections that adding HB vaccine in their immunisation programmes would entail. This was a common attitude in the US until the CDC (Centers for Disease Control) showed the lifetime burden of HBV infection was significantly greater in terms of morbidity and mortality than any of the other vaccine-preventable diseases (including Haemophilus influenza b) in that country before vaccines against those diseases were introduced. Cost-effectiveness and cost-benefit analyses in many low endemicity countries have now been published and confirm the cost-effectiveness of HB immunisation. These studies need to be done to convince these governments to begin HB immunisation. Another aspect of the problem is that patients dying of HBV-related liver disease are seen by gastroenterologists and hepatologists, not be paediatricians who have most influence over infant and adolescent immunisation programmes. Personally, I find it difficult to believe that in 10 years the only young people who will not be protected will be from this part of the world.

A much larger problem from the point of view of WHO is the financial constraints that are keeping children in Eastern and Central Europe and the Newly Independent States (NIS) from receiving HB vaccination. The burden of HBV-related disease in many of these countries is orders of magnitude greater than in Western Europe, and the need for the vaccine in these countries is not questioned. However, developing a sustainable supply of all vaccines and other drugs, is a very serious problem for those countries who now must pay hard currency to buy products which were formerly available.

International and bilateral aid agencies trying to help with this problem have taken the position that they do not want to discuss HB vaccine until sustainable supplies of the other vaccines are ensured. While there is some merit to this argument, a number of the countries themselves consider hepatitis B to be their most important communicable disease problem and do not see why others, with other agendas, should define priorities for them.

The VHPB has been a useful forum for a discussion of these issues, and plans to have a major meeting on Viral Hepatitis in Eastern and Central Europe and the NIS, co-sponsored by the European Regional Office of WHO, WHO Geneva, and the US CDC. The VHPB will also continue to support efforts in Western Europe to ensure that information on viral hepatitis and its control gets to public health officials, health care workers, opinion leaders, and the public.

Dr Mark Kane

Global Programme for Vaccines and Immunisation, WHO, Geneva

VHPB successful in promoting WHO vaccination target

The VHPB has made significant contributions in countering the threat of hepatitis B to community health in Europe, and has played a major role in persuading many countries to meet the WHO recommendations on HB vaccination. Universal vaccination programmes are now in place in Albania, Bulgaria, Italy, France, Germany, Portugal and Spain; and Greece, Turkey, Switzerland, Belgium and the Netherlands look increasingly likely to follow suit.

In a role sanctioned by the European WHO office, the VHPB can accept some credit for persuading countries to comply with the World Health Assembly's 1992 recommendation to integrate hepatitis B vaccination into immunisation programmes by 1997. 'The VHPB has had a major impact in encouraging many countries to adopt universal vaccination,' said Dr Mark Kane of the WHO Global Programme for Vaccines and Immunisation.

This is, however, no time for complacency. In Scandinavia and Great Britain health officials remain resistant to universal HBV vaccination policies, and the extremely high prevalence of HBV infection throughout the former Soviet Union and much of Eastern Europe is also cause for concern. Nevertheless, progress made over the past four years proves the influence of the VHPB on governmental health policy.

Battle on to control HBV in Eastern Europe

Eastern Europe poses the next major challenge in the fight against hepatitis B. A recent WHO survey on hepatitis B in Europe showed the estimated incidence of hepatitis B to amount to approximately 100 per 100,000 in Eastern Europe - as compared to 550 per 100,000 in Central Europe and 35 per 100,000 in Western Europe.

In presenting the study results, Ms Punam Mangtani of the London School of Hygiene and Tropical Medicine emphasised the lack of consistency in surveillance across Europe, conceding that this poses difficulties in drawing solid conclusions from the survey. Still, general trends indicate that the further east one looks the higher the incidence of HBV infection.

Dr Mark Kane of the WHO Global Programme for Vaccines and Immunisation also stressed the problem of HBV infection in Eastern Europe: 'There is an unbelievable problem of nosocomial transmission of hepatitis in Eastern Europe and this is where the VHPB should be involved.'

At an overall survey response rate of 82%, government officials responsible for surveillance and control of infectious disease in 50 European countries supplied information on surveillance systems, incidence of acute symptomatic infections, seroprevalence and vaccination policies. Results indicate that while hepatitis B vaccination policies vary considerably, those countries with the highest prevalence of HBV infection (with the exception of Uzbekistan and Bulgaria) have the least effective vaccination strategies.

HBV Vaccination cuts healthcare costs

Vaccination against hepatitis B is up to 300 times more cost effective than the haemophilus influenza B vaccine, according to a study carried out in Belgium. Using a mathematical model, researchers at the University of Antwerp Department of Epidemiology assessed the direct and indirect costs of infant and adolescent hepatitis B vaccination programmes, and compared these to the cost of allowing the HBV infection to go unchecked.

According to the study, infant vaccination systems would prevent 5,400 HBV infections per vaccinated cohort and adolescent policies would prevent 4,300. With lost productivity estimated at $125 US per day, the savings per life year gained was figured to be 21,260 BEF ($709 US) for infant vaccination and 17,628 BEF ($588 US) for adolescent vaccination.

The net direct medical costs per year of infant vaccination were 8.5 million BEF ($ 283,300 US); while the costs of adolescent vaccination were 5.72 million BEF ($190,667 US). Immunisation programme outlay was determined by estimating the price of vaccination per dose at $41 US if given by a GP; $15 US if administered through an existing childhood immunisation programme; and $17 US if given through the school medical system.

'It's important to consider the long term', said the study's health economist Philippe Beutels. 'During a lifetime approximately 89 per cent of the direct medical costs of infant vaccination can be recuperated.' Mr Beutels also pointed out that the estimated cost effectiveness of the Haemophilus influenza b vaccine is between $100,000 US and $200,000 US per life year gained. 'In other words, HBV vaccination is about 300 times more cost effective than HiB,' he said.

Government action dependent on accurate data

The key to convincing governments to implement hepatitis B vaccination policies is accurate data on prevalence, risk and cost-effectiveness, says US epidemiologist Dr Harold Margolis of the Centers for Disease Control.

Since 1991, the United States has had a policy of screening all pregnant women for the HBV surface antigen and administering HBV immunoglobulin and HBV vaccination to at-risk neonates; all infants and high-risk adolescents also receive vaccination. The policy was put in place on the recommendation of the Immunization Practices Advisory Committee and the Red Book Committee of the American Academy of Pediatrics after it was shown that hepatitis B was a significant health problem and that vaccination would save money as well as lives.

Using seroprevalence data from the National Health and Nutrition Examination Survey, US epidemiologists estimated the lifetime risk of contracting HBV to be five per cent. 'There are 22,000 new cases of antigen-positive women and 6,000 chronic HBV-infected children each year,' said Dr Margolis. 'The sequelae of HBV carry direct medical costs plus work-loss costs and welfare programme costs. In fact, HBV has more indirect costs than direct costs.'

To convince government officials of the financial viability of universal vaccination, an economic analysis comparing the cost-effectiveness of infant and adolescent vaccination programmes was carried out. Assuming a not overly ambitious coverage of 68 per cent, the research showed that vaccinating infants against HBV would result in a net savings of approximately $19.7 US million per year; targeting adolescents would save $3.5 US million per year.

'One of the things we had to deal with was people saying "in my area we don't have hepatitis B", said Dr Margolis. 'And of course as you go around the US you do see different risks. But even in areas of low risk there is a favourable cost-effectiveness ratio and that is very attractive to health economists.'

Germany and Switzerland move towards universal vaccination

Proving the persuasiveness of scientific argument on government legislation, representatives from Germany and Switzerland announced that universal hepatitis B vaccination programmes were likely to be implemented in a few months.

The German government committee for vaccination, STIKO, is expected to integrate hepatitis B vaccination into the schedule of infant vaccinations. The groundwork for this decision was laid at the October 1994 meeting of STIKO when, impressed by figures indicating a 70 to 80 per cent drop in the incidence of occupational hepatitis B in health care workers since the introduction of targeted vaccination, STIKO pledged its support for universal vaccination. At the group's May 1995 conference, insurance company representatives and vaccine manufacturers also agreed to an infant vaccination programme - noting the benefits of child doses and of combining HB vaccination with other vaccinations like DTP and Hib.

Similar progress has been made in Switzerland. As early as 1982, Swiss experts on viral hepatitis recommended vaccinating all high-risk individuals, a recommendation that was officially adopted by the federal public health office in 1987.

In 1994, a new set of recommendations called for the general vaccination of all new-borns and adolescents as well as the continued vaccination of high-risk individuals, HBsAg screening of pregnant women, anti-HBc screening of refugees and immigrants, and HBsAg (anti-HBc) screening of blood donors.

'At the moment, the health authorities and the insurance companies are saying we would like to take your advice. But they both want the other to pay. It's no longer a scientific problem, now it's a political problem,' said Professor Peter Grob, head of Immunology at the University Hospital of Zurich. Nevertheless, he expects the political problems will be ironed out and universal vaccination implemented in a matter of months.

Hepatitis B a community-wide risk

The lesson learned from the Viral Hepatitis Prevention Board (VHPB) meeting in Antwerp is that universal vaccination is necessary to control and possibly eliminate hepatitis B. The next step is finding strategies for meeting that goal in countries with different health care structures and financial resources.

Attempts to protect the whole community by vaccinating only high-risk individual have not been successful (1-2). It is not enough to produce safe, effective vaccines which can prevent disease or to know who is at risk. What is needed is public policy based on expert assessment of epidemiological data, and the translation of that policy into correct, effective vaccination.

WHO Europe, in close collaboration with the VHPB, initiated a study to estimate the scale of community-acquired hepatitis B in the 50 countries of the WHO European Region. This pan-European study, along with information on country specific epidemiology, the burden of disease and vaccination strategies was presented by VHPB advisers and experts.

Consideration of epidemiological and economic data presented shows that universal vaccination strategies are cost-effective even in countries with a low prevalence of hepatitis B (3,4,5). Hepatitis B prevention programmes incorporating universal immunisation of new-borns and/or adolescents have been highly successful in Spain and Italy, and their success offers an exemplary model for other countries.

The VHPB strive to increase awareness of the community health risk posed by the hepatitis B virus (HBV), and to develop a set of recommendations to bolster the commitment to vaccination. The impetus for establishing effective vaccination programmes already there, it is now time for the initiatives of the VHPB to be implemented at the national level.

WHO and World Health Assembly set guidelines for control of HB

In 1991, the WHO Global Advisory Group for the Expanded Programme for Immunisation (EPI) produced guidelines for vaccination (6), recommending that HBV vaccination be included in all national vaccination programmes by 1997; the World Health Assembly confirmed the recommendation the following year.

Though target groups and goals may vary, countries with a hepatitis B carrier prevalence of 2% or more were encouraged to integrate hepatitis B vaccination into routine infant immunisation schemes. Countries with a carrier prevalence less than 2% (North America and Europe) were advised to consider vaccinating adolescents as either an alternative to or in addition to infant vaccination.

During its 9^th assembly, (to be confirmed) WHO set the goal of reducing the incidence of HB in children by 80% by 2001 through universal hepatitis B vaccination (7). Universal infant and/or adolescent vaccination programmes have already been instituted in the Western Pacific and South East Asian Regions (China, Thailand, Indonesia, New Zealand); the Middle East countries; Europe (Albania, Bulgaria, France, Israel, Italy, Poland, Portugal and Spain); and North America (USA and Canada).

Most African countries, however, have not yet implemented vaccination programmes. Numerous obstacles stand in the way of realising universal vaccination programmes there: already poor immunisation coverage (50%) makes adding a new vaccine to the EPI unlikely; and financial constraints mean vaccines would need to be donated by organisations like UNICEF, for example.

Central and Eastern European countries also face a serious hepatitis B problem. Political and economical difficulties hinder implementation of universal vaccination programmes. In this region, education and information on disease control and the prevention of nosocomial infections through better hygiene are as important as universal vaccination.

Among Western European countries, Great Britain, Ireland, Austria and Scandinavia are reluctant to consider seriously universal vaccination strategies. Germany, Belgium, Luxembourg, Switzerland and the Netherlands, however, are likely to institute national vaccination policies soon. (Editor's note: Germany instituted a policy of universal vaccination at the end of 1995; and Luxembourg adopted universal vaccination January 1, 1996.)

Meeting the WHO goal of controlling hepatitis B as a community health risk world-wide is still a long way off. The VHPB are committed to pursuing this goal in both high-prevalence areas like Central and Eastern Europe and low-prevalence regions like Great Britain and Scandinavia.

VHPB objectives for the Antwerp meeting

1. Examine strategies for controlling hepatitis B in the community.

2. Review the progress made in implementing universal vaccination at the national level.

3. Assess the information and actions needed to support new or existing universal

vaccination policies.

4. Develop comprehensive summaries of national situations to support consensus recommendations strategies for controlling hepatitis B in the community.

Survey on HB epidemiology and vaccination strategies in Europe

In co-operation with WHO, the VHPB supported a study of the WHO European Region to assess the completeness and accuracy of surveillance data for acute hepatitis B, and to determine the HBV vaccination policies in Europe. Survey data will provide a baseline for gauging the necessity of further support in bringing hepatitis B infection under control in Europe.

Fifty government officials responsible for surveillance and control of infectious disease were surveyed on type of surveillance systems in place, incidence of acute infection and vaccination policies. The overall response rate was 82% (41/50), with an 86% response rate for both Western and Central Europe, and a 50% response from Eastern Europe.

Although surveillance systems vary in method and completeness, the pattern of disease is clear: North European countries report incidence rates of approximately 1/100,000 per year; southern countries 6/100,000; and markedly higher rates of 20 to 100/100,000 per year are found in Central and Eastern Europe, respectively. The surveillance of acute hepatitis B infections could not be compared across countries. Though, where an effective vaccination strategy is most needed, (Central and Eastern Europe, for instance) it is mostly lacking.

West European countries in transition from intermediate to low HBsAg prevalence (e.g. Italy), have implemented universal infant and/or adolescent vaccination. Despite good access to healthcare facilities, however, less than half of all West European countries have universal ante-natal testing, and selective vaccination of those at high risk.

In conclusion, the survey brought to light the incompleteness of surveillance systems and the under-reporting of infection, and proved the need for more systematic reporting. The comparison of seroprevalence information and vaccination policies revealed a piecemeal public health response to the threat of HBV infection. Universal vaccination must be combined with universal ante-natal testing and the vaccination of individuals most at risk.

The rationale behind infant vaccination

Extensive studies have been carried out in the United States to estimate the prevalence of hepatitis B infection (1,8,9). Data from the National Health and Nutrition Examination Survey (NHANES) surveillance and seroprevalence studies show the estimated annual number of infections to be approximately 40 per 100,000 - largely unchanged from 1980 to 1990.

Hepatitis B is primarily a disease of young adults; most patients are between 20 and 35 years old. Prevalence varies among racial and ethnic groups (1), and a number of risk factors are associated with acute HBV infection. Most infections are linked to sexual activity: 41% are attributed to heterosexual activity, and 14% to homosexual activity. Intravenous drug users represent 12% of cases, and about 26% of cases occur in people who do not report any risk factor. It is estimated that 300,000 HBV infections occur each year.

Although the US is considered a low-endemic country, the burden of morbidity and mortality is still enormous. Despite the licensing of HBV vaccines in 1982, the incidence of disease increased until 1986. Because most infections occurred in adults definable by lifestyle or occupation, vaccination of high-risk groups was initiated. The strategy of targeting high-risk groups, however, has had limited impact. Failure of high-risk group vaccination can be understood by examining the reported cases in the US, and realising the difficulty of reaching these groups and ensuring compliance.

Justifying routine infant immunisation in the United States

Chronic HBV infection is a major cause of cirrhosis and liver cancer in the United States, and the strategy of targeting high-risk groups is an admitted failure. Routine HBV vaccination is a cost-effective alternative to other medical interventions (5). Because of the structure of the health delivery system in the US, universal adolescent HBV vaccination is not feasible, making infant vaccination the only viable alternative.

There are two compelling arguments in favour of universal infant vaccination. First, those infected at an early age, from whatever source, are far more likely to become chronic carriers of the infection. Second, effective systems for administering vaccines to infants are well established. National immunisation programmes (EPI) are highly effective in delivering vaccines to infants, and integrating hepatitis B vaccination into the US EPI system is a cost-effective way of achieving universal vaccination.

Cost-benefit data were generated in the US to demonstrate the financial advantages of universal vaccination. The study considered the demographics of risk, estimating what age- and risk groups were likely to become infected. Taking into account direct medical costs, work loss and programme cost, the net benefits for HBV immunisation strategies are: $41.1 million US for peri-natal immunisation; $19.7 million US for infant immunisation; and $3.5 million US for adolescent immunisation. The outcome also showed infant vaccination to be the best strategy in terms of compliance as well as cost (5).

The best way to tackle hepatitis B in low-endemic countries is to focus on the prevention of both childhood and adult infection. The US has taken the following approach:

Phase 1 Introduction of universal HBsAg screening in pregnant women

In 1990, public health officials set the goal of preventing peri-natal transmission. A 1993 national survey of maternity hospitals found that 86% of women surveyed had an HBsAg test result available at the time of delivery. Because no federal law regulates screening, however, the success of the programme is difficult to measure and is dependent on individual hospital policy.

Phase 2 Introduction of universal infant immunisation

At present, approximately 50% of all infants are vaccinated. There is, however, a marked difference in vaccination rates when a paediatrician is the provider and when a GP is the provider: 66% versus 33%. This indicates that programme acceptance is not complete and that education remains an issue.

Phase 3 Catch-up immunisation of adolescents and selective immunisation of high-risk groups

In 1995, the Advising Committee on Immunization Practice (ACIP) recommended routine vaccination for a single-age cohort of adolescents between 11 and 12 years of age, and vaccination of all high-risk adolescents. Universal immunisation of adolescents could easily be organised at the start of middle school.

With regard adult vaccination, the ACIP recommended vaccinating health care workers and high-risk groups in 1982 and later - following the OSHA regulations in 1991 - advised vaccinating those with occupational exposure to blood or infectious body fluids. As a result, health care workers are now immunised at high rates and the OSHA regulations have led to the vaccination of all employees.

Progress made towards the adoption of universal vaccination

Those at risk for hepatitis B infection comprise many groups; similarly, many factors contribute to the failure of selective risk-group immunisation. The hepatitis B vaccine should be used to protect individuals and should have an impact on the prevalence of disease in the population as a whole. Practically and theoretically, the risk-group approach to vaccination is insufficient. Judging from the experiences of countries with regional or national universal vaccination programmes, universal vaccination appears to be the only valid alternative.

The status of hepatitis B prevention in selected countries within Europe is as follows:

Hepatitis B reporting is not compulsory. The reported incidence of acute HBV infection is 3/100,000; most cases occur in the 20-29 age group. The estimated prevalence of HBsAg is 3% within the general population.

• 1971 introduction of screening in blood banks
• 1991 vaccination mandatory for HCW and students
• 1992 systematic screening of pregnant women compulsory
• 1994 introduction of universal immunisation

• vaccination of all neonates within EPI at 2,3,4, and 16-18 months.
• passive-active immunisation of neonates of HBsAg-carrier mothers
• vaccination of 11 to 13-year-olds with 0,1,6 schedule
• vaccination of all infants
• catch-up vaccination of adolescents with 0,1,6, schedule

Infants under 15 years of age receive a 10 mg/dose; adults receives a 20 mg/dose and immunocompromised adults receive a 40 mg/dose of vaccine.

The vaccine for schoolchildren is paid for by the social security system and negotiations with vaccine producers have resulted in a significant drop in price. One adult dose now costs 35 USD. Sixty-five per cent of the cost of adult vaccination is reimbursed by social security, although this does not apply uniformly across France.

The vaccination coverage of general practitioners rose from just over 20% in 1989 to approximately 82% in 1994. There is no public information package on the need for vaccination, and according to a public opinion poll in 1995, 36% of infants were not immunised due to lack of parental information. The efficacy of prenatal screening is not monitored.

Hepatitis B reporting is compulsory. The reported incidence is 6.9/100,000, with approximately 5,500 acute hepatitis B cases occurring every year. The highest incidence occurs in the 16-24 age group. The estimated prevalence of HBsAg is 0.7% within the general population.

• 1982 vaccination of risk groups only
• 1994 mandatory screening of pregnant women
• 1995 universal vaccination

Universal vaccination has been in place since early 1996. The Immunisation Committee (STIKO) decided on universal vaccination in 1994, and in 1995 the manufacturers and health insurers also agreed to integrate HB vaccination into infant vaccinations.

Since there is no infrastructure for adolescent vaccination and the coverage of DTP-vaccination is around 90%, combining the HB vaccine with the EPI program is most feasible at 3,4,5 and 16 months of age.

One adult dose costs $50 US in the public sector and $80 US in the private sector. An infant doses costs $37.5 US and $80 US, respectively. The vaccine is almost always reimbursed by either the insurer or the employer.

At present only healthcare workers have been immunised to a certain degree (60-80%), resulting in a reduction of HBV infection in HCW between 1984 and 1993 of 70 to 80%, but with only a marginal effect on HBV incidence in the general population (<10%). The coverage of selective vaccination of risk groups remains a problem.

Compulsory notification of acute HBV infection shows an incidence of 20/100,000 (1982-84) and of 6/100,000 (1991-92); or approximately 600 new acute infections per year. The prevalence of HBsAg within the general population 0.7. The age-specific seroprevalence of HBV markers for the general population shows a marked increase at the cross-over between 20-24 and 25-29 age groups, suggesting that sexual transmission is the principle means of HBV transmission.

• 1982 vaccine recommended for healthcare workers and high-risk groups
• 1988 implementation of universal ante-natal screening

Though universal vaccination has been seriously considered, because of financial constraints it is not yet in place. The H. influenzae vaccination, however, is less cost-saving but was implemented without problems.

One adult dose of the HB vaccine costs $40 US. The vaccine is free of charge for healthcare workers and 75% of the cost is reimbursed for some risk groups (mostly high-risk patients). In 1995, the Ministry of Health recommended vaccinating household contacts of HBeAg carriers. Recent economic evaluation shows that universal HB vaccination performed in the mother and child health clinics would be cost saving at a vaccine price of $13 US. There is, however a slight preference from the health care payer for universal vaccination in adolescents over infants.

The vaccination coverage in HCW is around 90%. The coverage of screening for HBsAg is not known. Meanwhile, a better definition of groups at risk for hepatitis B infection is needed.

HBV reporting is obligatory. The estimated incidence is 30/100,000 or 3,000 cases per year. The highest incidence occurs in 25-44 year olds. Greece has the highest prevalence of HBV infection in Southern Europe, with 1-2% of the general population a HBsAg-carrier and 67% of adults showing markers of infection.

• 1982 selective vaccination of high-risk groups
• 1994 universal vaccination of infants and adolescents was recommended by a National Committee on Immunisation and various scientific associations.

• vaccination of neonates of HBsAg-positive mothers at 0,1,4,10-15 months
• vaccination of adolescents and high-risk groups

The infrastructure of the healthcare delivery system has been changed to include HBV vaccination in infancy and adolescence. The private sector, which performs more than 50% of all immunisations, has already implemented HB vaccination in about 18% of infants.

One adult dose of vaccine costs $27 US in the private sector and $10 US in the public sector. Most insurers are beginning to show support for free infant vaccination. The vaccine is provided free of charge for all high-risk groups except homosexuals and IVDU. Government and the private sector should join forces to achieve universal vaccination. For universal vaccination to be a success, a free or low-cost supply of vaccines is needed.

According to compulsory notification, the incidence of acute HBV infection is 1.45/100,000, or 300 cases per year. HBV infections occur mainly in the 15-44 age groups. The HBsAg prevalence is 0.45% among pregnant women.

• 1983 selective vaccination of high-risk groups
• 1989 universal screening of pregnant women

Universal vaccination is not yet in place. The National Health Board advised recently that preparations be made to investigate universal infant and/or adolescent immunisation. HB vaccination could easily be integrated in the EPI program; at present neonates of HBsAg carrier mothers already receive DTPP (DTP plus polio) and HB vaccination at 3, 4, 5, and 11 months of age.

The availability of a combined HB-DTPP vaccine is considered essential for universal HB vaccination. The cost of one adult dose of vaccine is $35 US; for several risk groups vaccination is reimbursed by most insurance companies except in the case of homosexuals, heterosexuals and IUVD. The vaccination coverage in neonates and high-risk patients is over 90%; coverage is low or unknown in other risk groups.

Notification of hepatitis B infection is obligatory. The incidence is 7-10/100,000 cases, or approximately 500 cases per year. Fifty-three per cent of acute cases occur among 20-29 year olds. The HBsAg prevalence is 0.2% in the general population.

• 1978 HBsAg screening of immigrants
• 1980 selective screening of pregnant women
• 1982-1984 selective vaccination of high-risk groups
• 1996 universal screening of pregnant women recommended

Universal vaccination is not yet in place. A group of experts (SEPHEP) recommended screening pregnant women and universal vaccination of new-borns and adolescents in 1994. In April 1995 it was decided by law that 'prophylactic measures are decided upon and refunded by health insurers'.

Universal hepatitis B vaccination is no longer a scientific problem but has become a political issue as insurance companies and government work out the issue of payment. A good school health system exists for implementing an adolescent HB vaccination program.

About 60-80% of immigrants are screened for antiHBc and 80% of pregnant women for HBsAg. Data on the vaccination coverage of high-risk groups are not available.

No reliable data or test methods for HBV markers exist. Several studies mention HBsAg prevalence rates between 4-10% and 25-60% markers of infection. In 1994, the reported morbidity rate due to hepatitis B was 5.02/100,000. Most infections occur in childhood or adolescence. In addition, health care workers belong to one the highest risk groups.

• vaccination of some high-risk groups

Universal vaccination is not yet in place. The need for HB vaccination is obvious but recommendations on hepatitis B prevention are desperately needed as well as funding. The government has reserved money for hepatitis B vaccination for 1996. Dependent on the price of the vaccine, universal vaccination of infants and high-risk group vaccination will be feasible. The coverage of the EPI programme is around 80% and universal HB vaccination could be given simultaneously at 0,2,9 or at 2,4,9 months. An adult dose of vaccine costs $15 US but is free for high-risk groups.

Notification of hepatitis B is obligatory. The reported incidence is 1-2/100,000 per year and the HBsAg prevalence in the general population is estimated at 0.03%.

• 1982 high-risk group vaccination
• 1988 risk assessment for biological agents
• 1995 compulsory screening and vaccination of HCW

Universal vaccination is not in place nor is it seriously under consideration. There are no general recommendations on hepatitis B prevention. Local clinics decide whether to screen and/or vaccinate certain groups at risk. The payment scheme for vaccination is also not clear. Unfortunately, no initiatives concerning universal hepatitis B vaccination are underway at present.

A hepatitis B advisory group must make recommendations for either infant or adolescent vaccination, after which the Department of Health will issue guidelines. It is then up to the various regions to implement the plan. Patients at high risk for HB infection, such as haemophiliacs, are vaccinated to a high degree.

Notification is mandatory and based on both clinical and laboratory data. The incidence of HB cases before the introduction of mass vaccination was 6.5/100,000 with a HBsAg prevalence of 3.1% in the general population.

• 1983 vaccination of high-risk groups
• 1984 voluntary HBsAg screening of pregnant women
• 1988 vaccination of high-risk groups free of charge
• 1991 compulsory vaccination of new-borns and adolescents

• vaccination of all neonates is integrated into EPI at 3,5,11 months of age
• vaccination of neonates of HBsAg-positive mothers
• vaccination of adolescents at 12 years of age

Neonatal hepatitis B vaccination through the national health system is free. Since 1994, the use of combined DTP-HB vaccine has been considered. Adolescent vaccination is performed by Public Health Services and the delivery system is well organised.

Hepatitis B vaccination is well received because high public awareness of the risks of infection. Media and medical services offered adequate information to the public before the introduction of universal vaccination. One adult dose of vaccine costs $11 US in the public sector and $14-22 US in the private sector. Vaccination coverage is over 90% in the north and 70% in other regions.

Despite an excellently organised hepatitis B prevention programme, vaccination surveillance still needs improvement. The growing number of immigrants with no access to any health care structure in Italy also poses a problem.

An obligatory notification system has been in place since 1982 but no differentiation is made between HAV, HBV and HCV. The estimated prevalence of HBsAg in the general population is 1.2%. Most HBV carriers are in the 25-44 year age group.

• 1982 vaccination of high-risk groups
• 1992 obligatory immunisation of adolescents
• 1995 obligatory immunisation of new-borns

• vaccination of new-borns occurs within the EPI at 0,2-3,6-7 months
• vaccination of adolescents of 13-14 years at 0,1,6 months

Universal adolescent immunisation was introduced in Catalonia because of a steep increase of hepatitis B infections in 13-14 year olds. Other autonomous regions followed suit and today only Madrid and Cantabria (making up 18% of the population) have not yet implemented the programme because of financial limitations. Adolescents receive half the adult dose of vaccine by mobile health teams or medical departments in the private sector.

Seven autonomous regions (including Madrid) have implemented vaccination for new-borns since 1994. The adult dose of vaccine costs $10 US and the infant dose $7 US.

From 1993 to 1994, between 77 and 97% of adolescents were immunised. The coverage of high-risk groups and neonates is unknown. The current cost of vaccine still impedes the spread of universal vaccination.

Notification of HBV infection has been obligatory since 1988. The incidence is estimated at 11/100,000 or 1,100 cases per year. The prevalence of HBsAg in the general population is 1.25%.

History of hepatitis B prevention:

• 1990 free vaccination for certain high-risk groups
• 1994 vaccination of adolescents

A national group of experts recommended vaccinating 11 to 13-year-old adolescents in 1993; the recommendation was included in the national vaccination programme in 1994. The cost of vaccination is reimbursed by the government if delivered by the public sector.

In 1995, the group recommended vaccinating household contacts of HBsAg carriers, medical teachers and students. Since the prevalence of HBsAg in infants is considered low, a recommendation for universal vaccination of new-borns will not be considered until a later phase. Vaccination coverage is not yet known.

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Pierre Van Damme