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Hepatitis B immunisation programmes in European Union, Norway and Iceland: Where we were in 2009?
Vaccine 28 (2010) 4470–4477
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Hepatitis B immunisation programmes in European Union, Norway and Iceland: Where we were in 2009? Jolita Mereckiene a,b,∗,1 , Suzanne Cotter a,b,1 , Pierluigi Lopalco c,1 , Fortunato D’Ancona b,e,1 , Daniel Levy-Bruhl b,d,1 , Cristina Giambi b,e,1 , Kari Johansen c,1 , Luca Dematte b,g,1 , Stefania Salmaso b,e,1 , Pawel Stefanoff b,f,1 , Darina O’Flanagan a,b,1 a
Health Protection Surveillance Centre, Dublin, Ireland Vaccine European New Integrated Collaboration Effort (VENICE) Project, Italy c European Centre for Disease Prevention and Control, Stockholm, Sweden d Institut de Veille Sanitare, Saint-Maurice, France e Istituto Superiore di Sanita’, Rome, Italy f National Institute of Public Health - National Institute of Hygiene, Warsaw, Poland g CINECA Consortium of University, Bologna, Italy b
a r t i c l e
i n f o
Article history: Received 4 November 2009 Received in revised form 9 April 2010 Accepted 15 April 2010 Available online 6 May 2010 Keywords: Immunisation Vaccine Hepatitis B The VENICE project Universal vaccination Selective vaccination
a b s t r a c t In January 2009 25 European Union (EU) Member States (MSs), Norway and Iceland, participated in a survey seeking information on national hepatitis B vaccination programmes. Details of vaccination policy, schedule, population groups targeted for vaccination, programme funding, vaccine coverage and methods of monitoring of vaccine coverage were obtained. Twenty (74%) countries reported that they have a universal hepatitis B vaccination programme, in addition to immunisation of at risk groups; seven (26%) countries recommend HBV for high risk groups only (with some inter-country variation on groups considered at high risk). Among countries without universal hepatitis B vaccination programmes, the major factor for non-introduction is low disease endemicity. © 2010 Elsevier Ltd. All rights reserved.
1. Introduction The main objective of routine hepatitis B vaccination is to reduce susceptibility among the future age cohorts, control spread of the infection and reduce acute and chronic hepatitis B infection and its serious consequences, including hospitalisations, liver cirrhosis, hepatocellular cancer and deaths [1,2]. In 1992, the World Health Assembly recommended the integration of cost effective
∗ Corresponding author at: Health Protection Surveillance Centre, Vaccine Preventable Disease, 25-27 Middle Gardiner Street, Dublin, Ireland. Tel.: +353 1 8765355; fax: +353 1 8561299. E-mail addresses: [email protected] (J. Mereckiene), [email protected] (S. Cotter), [email protected] (P. Lopalco), [email protected] (F. D’Ancona), [email protected] (D. Levy-Bruhl), [email protected] (C. Giambi), [email protected] (K. Johansen), [email protected] (L. Dematte), [email protected] (S. Salmaso), [email protected] (P. Stefanoff), darina.ofl[email protected] (D. O’Flanagan). 1 On behalf of the VENICE project gatekeepers group (list of gatekeepers is available on VENICE website: http://venice.cineca.org). 0264-410X/$ – see front matter © 2010 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2010.04.037
new vaccines, such as hepatitis B vaccine, into national immunisation programmes where it was feasible. In that same year, World Health Organization (WHO) set a goal for all countries to integrate hepatitis B vaccination into their national immunisation schedules by 1997. The WHO set a goal to achieve immunisation coverage at 90% nationally, with at least 80% coverage in every district by 2010 or sooner [3]. Since then substantial progress has been made worldwide to introduce the vaccine into national programmes but the goal has not been fully met. By 2007, 22 countries worldwide (11.5%) had still not introduced an infant hepatitis B vaccine into their universal vaccination programme [4]. Internationally, the impact of the introduction of the hepatitis B vaccine into national immunisation programmes has been dramatic. The disease burden is currently much lower in Europe, compared to many other parts of the world. In Europe the incidence of acute hepatitis B has decreased markedly, from 6.7/100,000 in 1995 to 1.5/100,000 in 2005. The recent prevalence data (2008) indicate wide variation within Europe, with rates of chronic infection (HBsAg) ranging from 8% to 0.5% [5].
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By 2008 a number of northern European countries had still not introduced the vaccine into the routine programme. These countries do, however, offer vaccine to individuals considered to be at increased risk of infection or the complications of infection (subsequently referred to as “at risk”). Some countries with selective programmes have been influenced by national epidemiological and cost effectiveness studies indicating that introduction of a universal vaccination programme would not be cost effective for their country [6–8]. Our study was a part of a European Union (EU) funded endeavour, the Vaccine European New Integrated Collaboration Effort (VENICE) project. This European project involves all 27 EU Member States (MS) and two European Economic Area (EEA) countries (Iceland and Norway). It aims to promote and share knowledge and best practices in vaccination among European Member States immunisation experts. Each country nominates one national gatekeeper who, either directly or through liaison with national experts, participates in the VENICE surveys. The network has already produced valuable information on vaccination policy, coverage and immunisation programme issues in the EU/EEA countries. Rapid reporting and dissemination of results has been achieved in Eurosurveillance and at European meetings [9]. We conducted this study to assess hepatitis B vaccination policies and immunisation programmes in order to identify specific recommendations for targeted age and risk groups and to obtain the most recent vaccine coverage data among countries in EU/EEA MS.
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Fig. 1. Hepatitis B immunisation programmes in EU/EEA countries. Hepatitis B : selective immunisation; : routine survey in Europe, January 2009 (n = 29). : schoolchildren programme; : newborns/infants immunisation programme; did not take part in the survey.
2. Materials and methods VENICE invited gatekeepers of all 27 EU MSs, and Norway and Iceland, to participate in a cross-sectional web based survey in January 2009. A standard questionnaire was developed, piloted by project leading partners and then placed on a secure website platform for gatekeepers to enter data directly on-line. The survey questionnaire sought information using close-ended questions predominantly. Information was sought on population groups recommended hepatitis B vaccination (age, occupation, or individuals at increased risk of infection by their lifestyle); methods of monitoring vaccine coverage; recent vaccination coverage results by population group; payment and administration costs for vaccine; and anticipated vaccination policy changes over the next couple of years. The questionnaire was placed on the VENICE website in December 2008 and MSs were asked to complete the on-line questionnaire in January 2009. The survey data was collated into one database managed by CINECA (a consortium of Italian universities) providing technological support to VENICE project [10]. The data was extracted and subsequent analysis was done using STATA [11]. A preliminary report was prepared and subsequently validated by the national gatekeepers. A final report, completed in March 2009 and put on the VENICE website for Members area, is the basis for this paper (http://venice.cineca.org). 3. Results 3.1. Response rate The response rate among all EU/EEA MSs was 93% (27/29). Neither Austria nor Greece responded to the survey. This report therefore focuses on the responses from participating EU/EEA countries only (n = 27).
3.2. Universal hepatitis B vaccination Hepatitis B vaccination is included in the routine childhood vaccination in 20 (74%) of 27 countries targeting infants or older children; seven countries (26%) do not vaccinate children routinely but have selective immunisation programmes for those at risk (Denmark, Finland, Iceland, Netherlands, Norway, Sweden, United Kingdom) (Fig. 1). Of the 20 countries with universal childhood vaccination, 18 (90%) countries have implemented hepatitis B vaccination programmes for infants. The remaining two countries (Hungary, Slovenia) provide vaccination at school age. Vaccination schedules and number of administered doses differ between countries. Most countries recommend a three dose schedule (n = 15; 75%), one country recommends two doses (Hungary) and four countries with accelerated schedules in infancy (Belgium, Czech Republic, Luxembourg and Germany) recommend four doses, with the fourth dose after 12 months of age. In Germany four doses are recommended for the six valent vaccine, for the monovalent vaccine three doses are used. Routine hepatitis B vaccination of infants and older children or teenagers was introduced in most of these countries in the 1990s. The first country to implement this programme was Cyprus (1989) and the most recent Ireland (September 2008). Thirteen (65%) of 20 countries that introduced universal infant hepatitis B vaccine also organised catch-up programmes or vaccination of older children or teenagers and one country (Bulgaria) has recommended hepatitis B vaccine to all persons born before 1991, the year it introduced a universal infant programme. Two countries (Estonia, France) introduced a universal teenage programme before adopting a universal infant programme. Seven countries (35%) did not implement a catch-up programme. Details of hepatitis B vaccination programmes by country are presented in Table 1. In this table the last two columns refer to the age groups which, at the year of the survey (2009), were covered by the routine hepatitis B vaccination.
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Table 1 Universal and selective vaccination programmes against hepatitis B in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 27). : adolescents; : before school and first year of elementary school; : newborns and adults of 18 years. newborns or infants;
: selective immunisation;
: newborns or infants and adolescents;
:
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*Year of birth for newborns and infants vaccination programme also when vaccination of adolescents or adults started. † Vaccination of children aged 13 years was introduced in 1999. From 2008 recommended age of hepatitis B vaccination changed from 13 to 12 years. ‡ Catch-up not fixed for adolescents and adults.
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Table 2 Hepatitis B vaccination of individuals who are at increased risk by their lifestyle, occupation and other factors in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 27). Countries with routine immunisation programmes (n = 20)
Lifestyle Injecting drug users (IDUs) Those who are likely to ‘progress’ to injecting Non-injecting users who are living with current injectors Sexual partners of injecting users Children of injectors Individuals who change sexual partners frequentlya Men who have sex with men (MSM) Female commercial sex workers Close family contacts of a case or individual with chronic hepatitis B infection Inmates of custodial institutions (correctional facilities) Persons tattooing and body piercing Occupation Healthcare workers (including students and trainees) Laboratory staff Staff of residential and other accommodation for those with learning difficulties (developmentally disabled persons) Police Fire and rescue services Other reasons Babies born to mothers who are chronically infected with HBV or to mothers who have had acute hepatitis B during pregnancy People travelling to or going to reside in areas of high or intermediate prevalence Patients with chronic renal failure (persons with or likely to progress to end-stage renal disease) Patients with chronic liver disease Patients with immunosupression Families adopting children from countries with intermediate or high hepatitis B prevalence (HBsAg prevalence higher than 2%) Foster carers (short and/or permanent) Individuals receiving regular blood or blood products Carers of individuals receiving regular blood or blood products Individuals in residential accommodation for those with learning difficulties (developmentally disabled persons) a
Countries with selective immunisation programmes (n = 7)
Recommended No. (%)
Not recommended No. (%)
Unknown/not answered No. (%)
Recommended No. (%)
Not recommended No. (%)
16 (80) 9 (45) 8 (40)
3 (15) 10 (50) 11 (55)
1 (5) 1 (5) 1 (5)
7 (100) 4 (57) 6 (86)
0 3 (43) 1 (14)
8 (40) 8 (40) 12 (60)
11 (55) 11 (55) 7 (35)
1 (5) 1 (5) 1 (5)
6 (86) 5 (71) 1 (14)
1 (14) 2 (29) 6 (86)
12 (60) 12 (60) 18 (90)
7 (35) 6 (30) 2 (10)
1 (5) 2 (10) 0
6 (86) 4 (57) 7 (100)
1 (14) 3 (43) 0
9 (45)
9 (45)
2 (10)
3 (43)
4 (57)
8 (40)
11 (55)
1 (5)
1 (14)
6 (86)
20 (100)
0
0
7 (100)
0
19 (95) 13 (65)
1 (5) 6 (30)
0 1 (5)
7 (100) 3 (43)
0 4 (57)
16 (80) 17 (85)
3 (15) 3 (15)
1 (5) 0
6 (86) 5 (71)
1 (14) 2 (29)
19 (95)
1 (5)
0
6 (86)
1 (14)
15 (75)
4 (20)
1 (5)
6 (86)
1 (14)
19 (95)
1 (5)
0
4 (57)
3 (43)
14 (70) 11 (55) 5 (25)
6 (30) 9 (45) 14 (70)
0 0 1 (5)
4 (57) 1 (14) 3 (43)
3 (43) 6 (86) 4 (57)
4 (20) 13 (65)
15 (75) 6 (30)
1 (5) 1 (5)
1 (14) 5 (71)
6 (86) 2 (29)
4 (20)
15 (75)
1 (5)
1 (14)
6 (86)
11 (55)
8 (40)
1 (5)
5 (71)
2 (29)
Persons with more than one sex partner during the previous 6 months.
3.3. Hepatitis B vaccination of risk groups 3.3.1. Vaccination of individuals who are at increased risk by their lifestyle In the 20 countries with a universal vaccination programme, hepatitis B vaccine is recommended for close family contacts of an acute or chronic case in 18 (90%); injecting drug users (IDUs) in 16 (80%); and for men who have sex with men (MSM), female sex workers and individuals who change sexual partners frequently in 12 (60%); for individuals considered likely to ‘progress’ to IDU or inmates of custodial institutions in nine (45%); for close contacts of IDUs (individuals living with, sexual partners or children of) and for persons tattooing or body piercing in eight (40%). In countries with selective immunisation programmes only (n = 7) vaccination is recommended for close family contacts of indi-
viduals with chronic infection and injecting drug users in all seven (100%) countries; six countries (86%) recommend vaccine for close contacts (household or sexual) of IDUs and MSM. Vaccine is also recommended for children of IDUs and female sex workers, inmates of custodial institutions in five (71%), four (57%) and three (42%) countries respectively (Table 2). 3.3.2. Vaccination of individuals who are at increased risk by their occupation All countries recommend hepatitis B vaccination of individuals who are at increased occupational risk, although professional groups may vary between countries. Vaccination of at least some health care workers (HCWs) is recommended in all countries (100%); laboratory staff in 26 (96%); police, emergency and rescue services in 22 (81%); staff of residential and other accommoda-
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Table 3 Monitoring and methods used for vaccine coverage assessment in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 27). Vaccine uptake
Hepatitis B vaccine uptake Monitor Interval at which hepatitis B vaccine uptake is collected Annually Every 3–5 years Monthly Quarterly Every 6 months Administrative methods No. of subjects vaccinated No. of doses administered No. of doses distributed School records Immunisation register Survey methods Face to face School survey Household survey Telephone survey Mail survey Focus groups Survey methods, not specified type a
Countriesa With routine immunisation programmes (n = 20) No. (%)
With selective immunisation programmes (n = 7) No. (%)
20 (100)
3 (43)
14 (70) 3 (15) 1 (5) 1 (5) 1 (5)
3 (43) 0 0 0 0
15 (75) 4 (20) 0 1 (5) 0
2 (29) 0 0 0 1 (14)
2 (10) 1 (5) 2 (10) 1 (5) 1 (5) 0 0
0 0 0 0 0 0 1 (14)
Some countries use several methods to monitor vaccine coverage.
tion for individuals with learning difficulties in 16 countries (59%) (Table 2). 3.3.3. Vaccination of individuals who are at increased risk for other reasons Hepatitis B vaccine is recommended for babies born to mothers who had acute infection during pregnancy or with chronic infection in 25 (93%) countries; people travelling to, or going to reside in, areas of high or intermediate prevalence in 21 (78%); patients with chronic renal failure in 23 (85%); individuals with chronic liver disease or receiving regular blood or blood products in 18 (67%); individuals in residential accommodation for those with learning difficulties in 16 (59%) countries. Eight countries recommend vaccination for families adopting children from countries with intermediate or high hepatitis B prevalence (30%) and five countries (19%) recommend vaccination for carers of individuals receiving regular blood or blood products (Table 2). 3.4. Screening for hepatitis B Most countries recommend hepatitis B screening for pregnant women (n = 23; 85%). Screening of all foreign born persons (immigrants, refugees, asylum seekers, internationally adopted children) born in regions with high endemicity of hepatitis B infection is not common, with only seven countries recommending this. 3.5. Monitoring and methods used for vaccine coverage assessment Twenty-three countries (85%) monitor hepatitis B vaccine coverage, most of them annually (n = 17; 63%). The four countries that do not monitor are those without universal routine immunisation programmes. Countries monitoring coverage use a variety of methodologies, either administrative or survey. The administrative method most frequently used estimates coverage based on the number of subjects vaccinated (n = 17; 74%). Other countries estimate coverage based on number of doses administered or distributed only. Eight countries use survey methods to monitor coverage, either for the universal programme or for risk
groups. Four countries use both administrative methods and surveys to monitor coverage (France, Italy, Luxembourg and Sweden) (Table 3). Countries with universal programmes most commonly monitor coverage at 1 and 2 years of age. Two countries (Hungary and Slovenia) monitor coverage at 6 and 14 years respectively following vaccination at school age. A number of countries with catchup campaigns also monitor vaccine coverage for older children (range 5–18 years). Some countries with selective immunisation programmes monitor vaccine coverage for specific risk groups: children in families from high prevalence countries (Sweden); infants born to parents from endemic hepatitis B countries (Netherlands); infants born to hepatitis B surface antigen (HBsAg) positive mothers (Netherlands). United Kingdom conducts surveys among babies born to HBsAg positive mothers, IDUs, MSM and prisoners. 3.6. Vaccination coverage results The most recent vaccine coverage (at 1 and 2 years of age) obtained from each country is presented in Fig. 2. Country data were available for different years (2004–2007). Most countries reported vaccine coverage higher than 80%. In the countries that collected vaccine coverage at 1 year of age, the median vaccine coverage at 1 year of age was 96% (range 58.3–99.3%) and in the countries that collected at 2 years it was 94.5% (range 29–99.9%). Vaccine coverage among older children varied from 31.7% (Estonia) to 99.5% (Hungary) (median 85%). 3.7. Payment and administration for hepatitis B vaccine Vaccine and administration is free for all children (babies and/or infants), without regard to other risk indication in 20 countries (80%); for catch-up programmes in 10 of 12 (84%) countries with catch-up programmes; babies born to mothers with chronic infection or to mothers with acute infection during pregnancy in 26 (100%). Full vaccine and administration cost paid by all recipients is recommended for travellers going to high or intermediate prevalence countries in 20 (74%) countries (Table 4).
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Fig. 2. Hepatitis B vaccination coverage among children by age monitored in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 21). (Not all countries monitor vaccination coverage; Denmark, Finland, Iceland and Norway do not monitor vaccination coverage in risk groups; UK monitor vaccination coverage among those at risk, but did not provide data; data for Ireland on vaccine coverage expected in quarter 3 2009 for first cohort of vaccinated children as immunisation was introduced in September 2008. Netherlands and Sweden countries have selective immunisation programmes; the remaining countries have universal immunisation programmes.) *Percentage refers to the weighted average for Belgium based on surveys conducted in Flanders, Brussels and Wallonia, 2006–2008 for the 3rd dose. † Coverage of children included in the survey of 2006 among children 17–24 months. ‡ Result of the German Health Interview and Examination Survey for Children and Adolescents 2003–2006 (n = 16,460). § Coverage refers only to infants born to parents from endemic countries. Other infants do not get HBV vaccination. ± Coverage refers to children aged of 2 years in families from high prevalence countries. The exact denominator is not known but this likely to be between 80% and 90% of all children considered being at risk. Table 4 Payment for hepatitis B vaccine in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 27). Countries with routine immunisation programmes (n = 20)
All children Catch-up programme HCWs Emergency workers Travellers Increased risk by lifestyle Babies born to mothers HBsAg+ Chronically medical condition a
Countries with selective immunisation programmes (n = 7)
Denominatora Free to all (%)
Free to some (%)
Partial subsidy to all (%)
No subsidy Denominatora Free to all (%) (%)
Free to some (%)
Partial subsidy to all (%)
No subsidy (%)
20 12 20 18 20 17 19 19
1 (5) 1 (8) 1 (5) 1 (6) 4 (20) 5 (29) 0 2 (11)
0 0 0 1 (6) 0 1 (6) 0 2 (11)
0 1 (8) 1 (5) 2 (11) 14 (70) 5 (29) 0 3 (15)
4 (80) 0 1 (14) 3 (50) 0 2 (28) 0 0
0 0 0 0 0 0 0 0
0 0 1 (14) 1 (17) 6 (86) 1 (14) 0 3 (43)
19 (95) 10 (84) 18 (90) 14 (77) 2 (10) 6 (36) 19 (100) 12 (63)
5 0 7 6 7 7 7 7
1 (20) 0 5 (72) 2 (33) 1 (14) 4 (58) 7 (100) 4 (57)
Denominator differs as for some countries question is not applicable or not answered.
3.8. Policy changes Three of the seven countries with selective immunisation programmes (Netherlands, Norway and Sweden) reported that they were reviewing their vaccination policy at the time of the survey. In Netherlands hepatitis B vaccination was recommended but not implemented yet. 4. Discussion To our knowledge this is the most comprehensive hepatitis B vaccination programme survey among of EU and EEA MSs. A previous survey (2003) reviewed hepatitis B surveillance and prevention programmes among a smaller subset of 20 European countries [12,13]. Our survey obtained more detailed information on national hepatitis B vaccination policy among 27 EU/EEA countries. Our survey found that at the beginning of 2009 most EU/EEA countries had included hepatitis B vaccination in their routine childhood vaccination programme and more than half had implemented catch-up programmes for older children and teenagers in order to protect more quickly high risk individuals. Most countries introduced universal hepatitis B vaccination in the mid-1990s, soon after the WHO recommendation. In those countries which have had a long period
of universal vaccination and catch-up programmes a substantial proportion of the population is now protected against hepatitis B infection. For example the impact of the vaccination programme is well documented in Italy, which moved from being a country with intermediate to low incidence of HBV infection. A 24–50-fold decline in acute hepatitis B infection is evident since 1991 among children and young adults targeted by the vaccination programme [14–16]. Information on vaccine coverage provides valuable information on the progress of immunisation programmes and is used to measure programme performance [17]. In our study, inter-country variation in coverage levels for children by the age of 2 years ranged from 29% to 99.9%, with most countries (except France, Germany and Malta) achieving a WHO coverage >90%. The median coverage among catch-up programmes was 85% (range 31.7–99.4%) for older children and teenagers. Seroepidemiological surveys have been conducted across EU MSs in recent years and can provide additional information on the performance of vaccination programmes. The European seroepidemiological study carried out in 10 EU countries (ESEN 2 study 2003–2004) revealed that the reported vaccine coverage level in some participating countries was higher or lower than indicated by serosurvey and can be overestimated as well as underestimated [18]. Outside Europe, the experience of Australia
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has demonstrated how implementation of a universal programme even in countries with low prevalence rates still has a substantial impact [19]. All countries in our survey which reported selective immunisation programmes are considered to be low prevalence countries for HBsAg (prevalence among general population of HBsAg is less than 2%). In these countries the focus is on recommending vaccination for those at risk of hepatitis B infection or associated complications. As the risk of chronic infection is greatest for infants it is reassuring that most countries recommend vaccination of babies born to the HBsAg positive mothers. Regardless of whether a country has a universal programme or not there is a continued need for selective programmes for high risk groups in all countries [15]. Persons belonging to high risk groups, in particular risk groups associated with lifestyle risk factors, are often hard to identify and to reach. Hence universal immunisation in early childhood offers the best hope to protect them later in life [20,21]. Ensuring completed vaccination of at risk groups is challenging due to high mobility and often limited access to medical care. To minimise the risk of infection these individuals need protection before they commence risk behaviour. It is encouraging that most countries fund the childhood vaccination programmes, catch-up campaigns, vaccination of babies born to mothers HBsAg positive, health care and emergency workers. The provision of free vaccine and the absence of administration costs have been demonstrated to contribute substantially to the achievement of high immunisation coverage generally [22]. However, our survey identified some countries where despite the availability of free vaccine for all or some recipients low or suboptimal vaccine coverage was reported. Factors associated with low coverage were not explored in this survey but some of these countries may have been affected by negative publicity in relation to hepatitis B vaccination [23]. Funding of the hepatitis B programme for individuals who are at increased risk by their lifestyle or high risk social circumstances (i.e. IDUs, MSM, individuals who change sexual partners frequently, female commercial sex workers, inmates of correctional facilities) varies among countries. Only one country (Iceland) with just selective immunisation does not subsidise these risk groups for hepatitis B vaccination. Even in countries with a free universal vaccination programme, five countries do not fund the programme for these risk groups, and another five countries partially fund the programme. The impact of such funding policies cannot be determined from our survey. Only one country (Finland) was able to provide national data on coverage among IDUs (45%) and no data were available on coverage among MSM, commercial sex workers or inmates of prisons. It is possible that within countries local or regional data may be available, but the lack of such data at a national level highlights the challenges in monitoring the coverage in such groups and ensuring that individuals at risk are protected – further highlighting the importance of vaccinating children before they enter a high risk group. Most countries do not fund vaccination of travellers to high or intermediate hepatitis B prevalence countries, although most countries recommend vaccination. No national data was available on coverage among this group. However, studies undertaken in a number of European countries in recent years have found that hepatitis B vaccination coverage among travellers is generally very low, even amongst those at particular risk during travel [24,25]. The study has some limitations with regard to comparison of vaccination coverage. Countries measure vaccine coverage using different methods. Some countries used administrative data while others used survey methods. Comparison of vaccine coverage may be misleading when different numerators and denominators are used between countries. Additionally, we collected vaccine coverage data for just 1 year and trends cannot be assessed. The pos-
sibility of intra-country regional variation was also not explored. Not all countries were able to provide vaccination coverage for the same point in time. As some countries were only able to provide data relating to previous years it is possible that some countries may have higher coverage now than they did for the year reported. This is the first European Union-wide survey on national hepatitis B immunisation policies. The collected data provided baseline and the latest information which was available among EU/EEA countries on current policy and demonstrates that two different strategies among EU/EEA countries are used influenced strongly by national hepatitis B epidemiology. Most countries have now adopted a universal childhood vaccination but some countries continue with selective immunisation only for those at risk. The data provided by this study can assist EU MSs to assess and compare their hepatitis B vaccination programmes with those of other countries. Hopefully it will also inform the decision in those countries that are discussing changes in the vaccination policies. To our knowledge one country, the Netherlands, decided to implement universal hepatitis B vaccine into routine immunisation programme. This survey also demonstrates widespread consensus on the groups considered most at risk and for whom vaccination should be provided. In general, coverage rates achieved in countries implementing the universal programme meet WHO targets. However, gaps in vaccination coverage information still exist and there is limited data available on coverage amongst those at greatest risk of infection. Acknowledgments We would like to acknowledge to all VENICE gatekeepers who conducted study in each country: Belgium – Pierre Van Damme, Martine Sabbe; Bulgaria – Mira Kojouharova; Cyprus – Chryso Gregoriadou, Chrystalla Hadjianastassiou; Czech Republic – Bohumir Kriz; Denmark – Steffen Glismann; Estonia – Natalia Kerbo; Finland – Tuija Leino; Germany – Sabine Reiter; Hungary – Zsuzsanna Molnàr; Iceland – Thorulfur Gudnason; Latvia – Jurijs Perevoscikovs; Lithuania – Egle Valikoniene; Luxembourg – Danielle HansenKoenig, Malta Tanya Melillo; the Netherlands – Hester de Melker; Norway – Berit Feiring; Poland – Pawel Grzesiowski; Portugal – Teresa Fernandes, Paula Valente; Romania – Adriana Pistol, Mircea Ioan Popa; Slovakia – Jarmila Lancova, Helena Hudecova; Slovenia – Marta Grgic Vitek; Spain – Isabel Pachon del Amo; Sweden – Anders Tegnell; United Kingdom – Koye Balogun, Richard Pebody. We would like also to thank Eva Appelgren for her contribution conducting this survey. References [1] Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat 2004;11(March (2)):97–107. [2] Lavanchy D. Worldwide epidemiology of HBV infection, disease burden, and vaccine prevention. J Clin Virol 2005;34(December (Suppl. 1)):S1–3. [3] World Health Organization. Global situation; 2008. Available online: http://www.who.int/nuvi/hepb/en/. [4] World Health Organization. Progress towards global immunisation goals – 2007. Summary presentation of key indicators; 2008. Available online: http:// www.who.int/immunization monitoring/data/SlidesGlobalImmunization.pdf. [5] World Health Organization. Hepatitis B fact sheet; 2009. Available online: http://www.who.int/mediacentre/factsheets/fs204/en/index.html. [6] Van Damme P, Van Herck K, Leuridan E, Vorsters A. Introducing universal hepatitis B vaccination in Europe: differences still remain between countries. Euro Surveill 2004;8(47). [7] Van Vliet JA. Cost-effectiveness of national hepatitis B vaccination in the Netherlands. Euro Surveill 2000;4(29). [8] Tilson L, Thornton L, O’Flanagan D, Johnson H, Barry M. Cost effectiveness of hepatitis B vaccination strategies in Ireland: an economic evaluation. Eur J Public Health 2008;18(June (3)):275–82. [9] Mereckiene J, Cotter S, Weber JT, Nicoll A, Levy-Bruhl D, Ferro A, et al. Low coverage of seasonal influenza vaccination in the elderly in many European countries. Euro Surveill 2008;13(October (41)).
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[19] Gidding HF, Warlow M, MacIntyre CR, Backhouse J, Gilbert GL, Quinn HE, et al. The impact of a new universal infant and school-based adolescent hepatitis B vaccination program in Australia. Vaccine 2007;25(December (51)):8637– 41. [20] Franc¸ois G, Hallauer J, Van Damme P. Hepatitis B vaccination: how to reach risk groups. Vaccine 2002;21(1–4). [21] Zuckerman J, Van Hattum J, Cafferkey M, Gjorup I, Hoel T, Rummukainen ML, et al. Should hepatitis B vaccination be introduced into childhood immunisation programmes in northern Europe? Lancet Infect Dis 2007;7(June (6)): 410–9. [22] Kroneman M, Paget WJ, Van Essen GA. Influenza vaccination in Europe: an inventory of strategies to reach target populations and optimise vaccination uptake. Euro Surveill 2003;8(June (6)):130–8. [23] Zanetti AR, Van Damme P, Shouval D. The global impact of vaccination against hepatitis B: a historical overview. Vaccine 2008;26(November (49)):6266– 73. [24] Sonder GJ. Hepatitis B vaccination in travelers. Expert Rev Vaccines 2008;7(July (5)):673–7. [25] Zuckerman JN, Hoet B. Hepatitis B immunisation in travellers: poor risk perception and inadequate protection. Travel Med Infect Dis 2008;6(September (5)):315–20.
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Hepatitis B immunisation programmes in European Union, Norway and Iceland: Where we were in 2009? Jolita Mereckiene a,b,∗,1 , Suzanne Cotter a,b,1 , Pierluigi Lopalco c,1 , Fortunato D’Ancona b,e,1 , Daniel Levy-Bruhl b,d,1 , Cristina Giambi b,e,1 , Kari Johansen c,1 , Luca Dematte b,g,1 , Stefania Salmaso b,e,1 , Pawel Stefanoff b,f,1 , Darina O’Flanagan a,b,1 a
Health Protection Surveillance Centre, Dublin, Ireland Vaccine European New Integrated Collaboration Effort (VENICE) Project, Italy c European Centre for Disease Prevention and Control, Stockholm, Sweden d Institut de Veille Sanitare, Saint-Maurice, France e Istituto Superiore di Sanita’, Rome, Italy f National Institute of Public Health - National Institute of Hygiene, Warsaw, Poland g CINECA Consortium of University, Bologna, Italy b
a r t i c l e
i n f o
Article history: Received 4 November 2009 Received in revised form 9 April 2010 Accepted 15 April 2010 Available online 6 May 2010 Keywords: Immunisation Vaccine Hepatitis B The VENICE project Universal vaccination Selective vaccination
a b s t r a c t In January 2009 25 European Union (EU) Member States (MSs), Norway and Iceland, participated in a survey seeking information on national hepatitis B vaccination programmes. Details of vaccination policy, schedule, population groups targeted for vaccination, programme funding, vaccine coverage and methods of monitoring of vaccine coverage were obtained. Twenty (74%) countries reported that they have a universal hepatitis B vaccination programme, in addition to immunisation of at risk groups; seven (26%) countries recommend HBV for high risk groups only (with some inter-country variation on groups considered at high risk). Among countries without universal hepatitis B vaccination programmes, the major factor for non-introduction is low disease endemicity. © 2010 Elsevier Ltd. All rights reserved.
1. Introduction The main objective of routine hepatitis B vaccination is to reduce susceptibility among the future age cohorts, control spread of the infection and reduce acute and chronic hepatitis B infection and its serious consequences, including hospitalisations, liver cirrhosis, hepatocellular cancer and deaths [1,2]. In 1992, the World Health Assembly recommended the integration of cost effective
∗ Corresponding author at: Health Protection Surveillance Centre, Vaccine Preventable Disease, 25-27 Middle Gardiner Street, Dublin, Ireland. Tel.: +353 1 8765355; fax: +353 1 8561299. E-mail addresses: [email protected] (J. Mereckiene), [email protected] (S. Cotter), [email protected] (P. Lopalco), [email protected] (F. D’Ancona), [email protected] (D. Levy-Bruhl), [email protected] (C. Giambi), [email protected] (K. Johansen), [email protected] (L. Dematte), [email protected] (S. Salmaso), [email protected] (P. Stefanoff), darina.ofl[email protected] (D. O’Flanagan). 1 On behalf of the VENICE project gatekeepers group (list of gatekeepers is available on VENICE website: http://venice.cineca.org). 0264-410X/$ – see front matter © 2010 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2010.04.037
new vaccines, such as hepatitis B vaccine, into national immunisation programmes where it was feasible. In that same year, World Health Organization (WHO) set a goal for all countries to integrate hepatitis B vaccination into their national immunisation schedules by 1997. The WHO set a goal to achieve immunisation coverage at 90% nationally, with at least 80% coverage in every district by 2010 or sooner [3]. Since then substantial progress has been made worldwide to introduce the vaccine into national programmes but the goal has not been fully met. By 2007, 22 countries worldwide (11.5%) had still not introduced an infant hepatitis B vaccine into their universal vaccination programme [4]. Internationally, the impact of the introduction of the hepatitis B vaccine into national immunisation programmes has been dramatic. The disease burden is currently much lower in Europe, compared to many other parts of the world. In Europe the incidence of acute hepatitis B has decreased markedly, from 6.7/100,000 in 1995 to 1.5/100,000 in 2005. The recent prevalence data (2008) indicate wide variation within Europe, with rates of chronic infection (HBsAg) ranging from 8% to 0.5% [5].
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By 2008 a number of northern European countries had still not introduced the vaccine into the routine programme. These countries do, however, offer vaccine to individuals considered to be at increased risk of infection or the complications of infection (subsequently referred to as “at risk”). Some countries with selective programmes have been influenced by national epidemiological and cost effectiveness studies indicating that introduction of a universal vaccination programme would not be cost effective for their country [6–8]. Our study was a part of a European Union (EU) funded endeavour, the Vaccine European New Integrated Collaboration Effort (VENICE) project. This European project involves all 27 EU Member States (MS) and two European Economic Area (EEA) countries (Iceland and Norway). It aims to promote and share knowledge and best practices in vaccination among European Member States immunisation experts. Each country nominates one national gatekeeper who, either directly or through liaison with national experts, participates in the VENICE surveys. The network has already produced valuable information on vaccination policy, coverage and immunisation programme issues in the EU/EEA countries. Rapid reporting and dissemination of results has been achieved in Eurosurveillance and at European meetings [9]. We conducted this study to assess hepatitis B vaccination policies and immunisation programmes in order to identify specific recommendations for targeted age and risk groups and to obtain the most recent vaccine coverage data among countries in EU/EEA MS.
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Fig. 1. Hepatitis B immunisation programmes in EU/EEA countries. Hepatitis B : selective immunisation; : routine survey in Europe, January 2009 (n = 29). : schoolchildren programme; : newborns/infants immunisation programme; did not take part in the survey.
2. Materials and methods VENICE invited gatekeepers of all 27 EU MSs, and Norway and Iceland, to participate in a cross-sectional web based survey in January 2009. A standard questionnaire was developed, piloted by project leading partners and then placed on a secure website platform for gatekeepers to enter data directly on-line. The survey questionnaire sought information using close-ended questions predominantly. Information was sought on population groups recommended hepatitis B vaccination (age, occupation, or individuals at increased risk of infection by their lifestyle); methods of monitoring vaccine coverage; recent vaccination coverage results by population group; payment and administration costs for vaccine; and anticipated vaccination policy changes over the next couple of years. The questionnaire was placed on the VENICE website in December 2008 and MSs were asked to complete the on-line questionnaire in January 2009. The survey data was collated into one database managed by CINECA (a consortium of Italian universities) providing technological support to VENICE project [10]. The data was extracted and subsequent analysis was done using STATA [11]. A preliminary report was prepared and subsequently validated by the national gatekeepers. A final report, completed in March 2009 and put on the VENICE website for Members area, is the basis for this paper (http://venice.cineca.org). 3. Results 3.1. Response rate The response rate among all EU/EEA MSs was 93% (27/29). Neither Austria nor Greece responded to the survey. This report therefore focuses on the responses from participating EU/EEA countries only (n = 27).
3.2. Universal hepatitis B vaccination Hepatitis B vaccination is included in the routine childhood vaccination in 20 (74%) of 27 countries targeting infants or older children; seven countries (26%) do not vaccinate children routinely but have selective immunisation programmes for those at risk (Denmark, Finland, Iceland, Netherlands, Norway, Sweden, United Kingdom) (Fig. 1). Of the 20 countries with universal childhood vaccination, 18 (90%) countries have implemented hepatitis B vaccination programmes for infants. The remaining two countries (Hungary, Slovenia) provide vaccination at school age. Vaccination schedules and number of administered doses differ between countries. Most countries recommend a three dose schedule (n = 15; 75%), one country recommends two doses (Hungary) and four countries with accelerated schedules in infancy (Belgium, Czech Republic, Luxembourg and Germany) recommend four doses, with the fourth dose after 12 months of age. In Germany four doses are recommended for the six valent vaccine, for the monovalent vaccine three doses are used. Routine hepatitis B vaccination of infants and older children or teenagers was introduced in most of these countries in the 1990s. The first country to implement this programme was Cyprus (1989) and the most recent Ireland (September 2008). Thirteen (65%) of 20 countries that introduced universal infant hepatitis B vaccine also organised catch-up programmes or vaccination of older children or teenagers and one country (Bulgaria) has recommended hepatitis B vaccine to all persons born before 1991, the year it introduced a universal infant programme. Two countries (Estonia, France) introduced a universal teenage programme before adopting a universal infant programme. Seven countries (35%) did not implement a catch-up programme. Details of hepatitis B vaccination programmes by country are presented in Table 1. In this table the last two columns refer to the age groups which, at the year of the survey (2009), were covered by the routine hepatitis B vaccination.
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Table 1 Universal and selective vaccination programmes against hepatitis B in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 27). : adolescents; : before school and first year of elementary school; : newborns and adults of 18 years. newborns or infants;
: selective immunisation;
: newborns or infants and adolescents;
:
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*Year of birth for newborns and infants vaccination programme also when vaccination of adolescents or adults started. † Vaccination of children aged 13 years was introduced in 1999. From 2008 recommended age of hepatitis B vaccination changed from 13 to 12 years. ‡ Catch-up not fixed for adolescents and adults.
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Table 2 Hepatitis B vaccination of individuals who are at increased risk by their lifestyle, occupation and other factors in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 27). Countries with routine immunisation programmes (n = 20)
Lifestyle Injecting drug users (IDUs) Those who are likely to ‘progress’ to injecting Non-injecting users who are living with current injectors Sexual partners of injecting users Children of injectors Individuals who change sexual partners frequentlya Men who have sex with men (MSM) Female commercial sex workers Close family contacts of a case or individual with chronic hepatitis B infection Inmates of custodial institutions (correctional facilities) Persons tattooing and body piercing Occupation Healthcare workers (including students and trainees) Laboratory staff Staff of residential and other accommodation for those with learning difficulties (developmentally disabled persons) Police Fire and rescue services Other reasons Babies born to mothers who are chronically infected with HBV or to mothers who have had acute hepatitis B during pregnancy People travelling to or going to reside in areas of high or intermediate prevalence Patients with chronic renal failure (persons with or likely to progress to end-stage renal disease) Patients with chronic liver disease Patients with immunosupression Families adopting children from countries with intermediate or high hepatitis B prevalence (HBsAg prevalence higher than 2%) Foster carers (short and/or permanent) Individuals receiving regular blood or blood products Carers of individuals receiving regular blood or blood products Individuals in residential accommodation for those with learning difficulties (developmentally disabled persons) a
Countries with selective immunisation programmes (n = 7)
Recommended No. (%)
Not recommended No. (%)
Unknown/not answered No. (%)
Recommended No. (%)
Not recommended No. (%)
16 (80) 9 (45) 8 (40)
3 (15) 10 (50) 11 (55)
1 (5) 1 (5) 1 (5)
7 (100) 4 (57) 6 (86)
0 3 (43) 1 (14)
8 (40) 8 (40) 12 (60)
11 (55) 11 (55) 7 (35)
1 (5) 1 (5) 1 (5)
6 (86) 5 (71) 1 (14)
1 (14) 2 (29) 6 (86)
12 (60) 12 (60) 18 (90)
7 (35) 6 (30) 2 (10)
1 (5) 2 (10) 0
6 (86) 4 (57) 7 (100)
1 (14) 3 (43) 0
9 (45)
9 (45)
2 (10)
3 (43)
4 (57)
8 (40)
11 (55)
1 (5)
1 (14)
6 (86)
20 (100)
0
0
7 (100)
0
19 (95) 13 (65)
1 (5) 6 (30)
0 1 (5)
7 (100) 3 (43)
0 4 (57)
16 (80) 17 (85)
3 (15) 3 (15)
1 (5) 0
6 (86) 5 (71)
1 (14) 2 (29)
19 (95)
1 (5)
0
6 (86)
1 (14)
15 (75)
4 (20)
1 (5)
6 (86)
1 (14)
19 (95)
1 (5)
0
4 (57)
3 (43)
14 (70) 11 (55) 5 (25)
6 (30) 9 (45) 14 (70)
0 0 1 (5)
4 (57) 1 (14) 3 (43)
3 (43) 6 (86) 4 (57)
4 (20) 13 (65)
15 (75) 6 (30)
1 (5) 1 (5)
1 (14) 5 (71)
6 (86) 2 (29)
4 (20)
15 (75)
1 (5)
1 (14)
6 (86)
11 (55)
8 (40)
1 (5)
5 (71)
2 (29)
Persons with more than one sex partner during the previous 6 months.
3.3. Hepatitis B vaccination of risk groups 3.3.1. Vaccination of individuals who are at increased risk by their lifestyle In the 20 countries with a universal vaccination programme, hepatitis B vaccine is recommended for close family contacts of an acute or chronic case in 18 (90%); injecting drug users (IDUs) in 16 (80%); and for men who have sex with men (MSM), female sex workers and individuals who change sexual partners frequently in 12 (60%); for individuals considered likely to ‘progress’ to IDU or inmates of custodial institutions in nine (45%); for close contacts of IDUs (individuals living with, sexual partners or children of) and for persons tattooing or body piercing in eight (40%). In countries with selective immunisation programmes only (n = 7) vaccination is recommended for close family contacts of indi-
viduals with chronic infection and injecting drug users in all seven (100%) countries; six countries (86%) recommend vaccine for close contacts (household or sexual) of IDUs and MSM. Vaccine is also recommended for children of IDUs and female sex workers, inmates of custodial institutions in five (71%), four (57%) and three (42%) countries respectively (Table 2). 3.3.2. Vaccination of individuals who are at increased risk by their occupation All countries recommend hepatitis B vaccination of individuals who are at increased occupational risk, although professional groups may vary between countries. Vaccination of at least some health care workers (HCWs) is recommended in all countries (100%); laboratory staff in 26 (96%); police, emergency and rescue services in 22 (81%); staff of residential and other accommoda-
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Table 3 Monitoring and methods used for vaccine coverage assessment in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 27). Vaccine uptake
Hepatitis B vaccine uptake Monitor Interval at which hepatitis B vaccine uptake is collected Annually Every 3–5 years Monthly Quarterly Every 6 months Administrative methods No. of subjects vaccinated No. of doses administered No. of doses distributed School records Immunisation register Survey methods Face to face School survey Household survey Telephone survey Mail survey Focus groups Survey methods, not specified type a
Countriesa With routine immunisation programmes (n = 20) No. (%)
With selective immunisation programmes (n = 7) No. (%)
20 (100)
3 (43)
14 (70) 3 (15) 1 (5) 1 (5) 1 (5)
3 (43) 0 0 0 0
15 (75) 4 (20) 0 1 (5) 0
2 (29) 0 0 0 1 (14)
2 (10) 1 (5) 2 (10) 1 (5) 1 (5) 0 0
0 0 0 0 0 0 1 (14)
Some countries use several methods to monitor vaccine coverage.
tion for individuals with learning difficulties in 16 countries (59%) (Table 2). 3.3.3. Vaccination of individuals who are at increased risk for other reasons Hepatitis B vaccine is recommended for babies born to mothers who had acute infection during pregnancy or with chronic infection in 25 (93%) countries; people travelling to, or going to reside in, areas of high or intermediate prevalence in 21 (78%); patients with chronic renal failure in 23 (85%); individuals with chronic liver disease or receiving regular blood or blood products in 18 (67%); individuals in residential accommodation for those with learning difficulties in 16 (59%) countries. Eight countries recommend vaccination for families adopting children from countries with intermediate or high hepatitis B prevalence (30%) and five countries (19%) recommend vaccination for carers of individuals receiving regular blood or blood products (Table 2). 3.4. Screening for hepatitis B Most countries recommend hepatitis B screening for pregnant women (n = 23; 85%). Screening of all foreign born persons (immigrants, refugees, asylum seekers, internationally adopted children) born in regions with high endemicity of hepatitis B infection is not common, with only seven countries recommending this. 3.5. Monitoring and methods used for vaccine coverage assessment Twenty-three countries (85%) monitor hepatitis B vaccine coverage, most of them annually (n = 17; 63%). The four countries that do not monitor are those without universal routine immunisation programmes. Countries monitoring coverage use a variety of methodologies, either administrative or survey. The administrative method most frequently used estimates coverage based on the number of subjects vaccinated (n = 17; 74%). Other countries estimate coverage based on number of doses administered or distributed only. Eight countries use survey methods to monitor coverage, either for the universal programme or for risk
groups. Four countries use both administrative methods and surveys to monitor coverage (France, Italy, Luxembourg and Sweden) (Table 3). Countries with universal programmes most commonly monitor coverage at 1 and 2 years of age. Two countries (Hungary and Slovenia) monitor coverage at 6 and 14 years respectively following vaccination at school age. A number of countries with catchup campaigns also monitor vaccine coverage for older children (range 5–18 years). Some countries with selective immunisation programmes monitor vaccine coverage for specific risk groups: children in families from high prevalence countries (Sweden); infants born to parents from endemic hepatitis B countries (Netherlands); infants born to hepatitis B surface antigen (HBsAg) positive mothers (Netherlands). United Kingdom conducts surveys among babies born to HBsAg positive mothers, IDUs, MSM and prisoners. 3.6. Vaccination coverage results The most recent vaccine coverage (at 1 and 2 years of age) obtained from each country is presented in Fig. 2. Country data were available for different years (2004–2007). Most countries reported vaccine coverage higher than 80%. In the countries that collected vaccine coverage at 1 year of age, the median vaccine coverage at 1 year of age was 96% (range 58.3–99.3%) and in the countries that collected at 2 years it was 94.5% (range 29–99.9%). Vaccine coverage among older children varied from 31.7% (Estonia) to 99.5% (Hungary) (median 85%). 3.7. Payment and administration for hepatitis B vaccine Vaccine and administration is free for all children (babies and/or infants), without regard to other risk indication in 20 countries (80%); for catch-up programmes in 10 of 12 (84%) countries with catch-up programmes; babies born to mothers with chronic infection or to mothers with acute infection during pregnancy in 26 (100%). Full vaccine and administration cost paid by all recipients is recommended for travellers going to high or intermediate prevalence countries in 20 (74%) countries (Table 4).
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Fig. 2. Hepatitis B vaccination coverage among children by age monitored in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 21). (Not all countries monitor vaccination coverage; Denmark, Finland, Iceland and Norway do not monitor vaccination coverage in risk groups; UK monitor vaccination coverage among those at risk, but did not provide data; data for Ireland on vaccine coverage expected in quarter 3 2009 for first cohort of vaccinated children as immunisation was introduced in September 2008. Netherlands and Sweden countries have selective immunisation programmes; the remaining countries have universal immunisation programmes.) *Percentage refers to the weighted average for Belgium based on surveys conducted in Flanders, Brussels and Wallonia, 2006–2008 for the 3rd dose. † Coverage of children included in the survey of 2006 among children 17–24 months. ‡ Result of the German Health Interview and Examination Survey for Children and Adolescents 2003–2006 (n = 16,460). § Coverage refers only to infants born to parents from endemic countries. Other infants do not get HBV vaccination. ± Coverage refers to children aged of 2 years in families from high prevalence countries. The exact denominator is not known but this likely to be between 80% and 90% of all children considered being at risk. Table 4 Payment for hepatitis B vaccine in EU/EEA countries. Hepatitis B survey in Europe, January 2009 (n = 27). Countries with routine immunisation programmes (n = 20)
All children Catch-up programme HCWs Emergency workers Travellers Increased risk by lifestyle Babies born to mothers HBsAg+ Chronically medical condition a
Countries with selective immunisation programmes (n = 7)
Denominatora Free to all (%)
Free to some (%)
Partial subsidy to all (%)
No subsidy Denominatora Free to all (%) (%)
Free to some (%)
Partial subsidy to all (%)
No subsidy (%)
20 12 20 18 20 17 19 19
1 (5) 1 (8) 1 (5) 1 (6) 4 (20) 5 (29) 0 2 (11)
0 0 0 1 (6) 0 1 (6) 0 2 (11)
0 1 (8) 1 (5) 2 (11) 14 (70) 5 (29) 0 3 (15)
4 (80) 0 1 (14) 3 (50) 0 2 (28) 0 0
0 0 0 0 0 0 0 0
0 0 1 (14) 1 (17) 6 (86) 1 (14) 0 3 (43)
19 (95) 10 (84) 18 (90) 14 (77) 2 (10) 6 (36) 19 (100) 12 (63)
5 0 7 6 7 7 7 7
1 (20) 0 5 (72) 2 (33) 1 (14) 4 (58) 7 (100) 4 (57)
Denominator differs as for some countries question is not applicable or not answered.
3.8. Policy changes Three of the seven countries with selective immunisation programmes (Netherlands, Norway and Sweden) reported that they were reviewing their vaccination policy at the time of the survey. In Netherlands hepatitis B vaccination was recommended but not implemented yet. 4. Discussion To our knowledge this is the most comprehensive hepatitis B vaccination programme survey among of EU and EEA MSs. A previous survey (2003) reviewed hepatitis B surveillance and prevention programmes among a smaller subset of 20 European countries [12,13]. Our survey obtained more detailed information on national hepatitis B vaccination policy among 27 EU/EEA countries. Our survey found that at the beginning of 2009 most EU/EEA countries had included hepatitis B vaccination in their routine childhood vaccination programme and more than half had implemented catch-up programmes for older children and teenagers in order to protect more quickly high risk individuals. Most countries introduced universal hepatitis B vaccination in the mid-1990s, soon after the WHO recommendation. In those countries which have had a long period
of universal vaccination and catch-up programmes a substantial proportion of the population is now protected against hepatitis B infection. For example the impact of the vaccination programme is well documented in Italy, which moved from being a country with intermediate to low incidence of HBV infection. A 24–50-fold decline in acute hepatitis B infection is evident since 1991 among children and young adults targeted by the vaccination programme [14–16]. Information on vaccine coverage provides valuable information on the progress of immunisation programmes and is used to measure programme performance [17]. In our study, inter-country variation in coverage levels for children by the age of 2 years ranged from 29% to 99.9%, with most countries (except France, Germany and Malta) achieving a WHO coverage >90%. The median coverage among catch-up programmes was 85% (range 31.7–99.4%) for older children and teenagers. Seroepidemiological surveys have been conducted across EU MSs in recent years and can provide additional information on the performance of vaccination programmes. The European seroepidemiological study carried out in 10 EU countries (ESEN 2 study 2003–2004) revealed that the reported vaccine coverage level in some participating countries was higher or lower than indicated by serosurvey and can be overestimated as well as underestimated [18]. Outside Europe, the experience of Australia
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has demonstrated how implementation of a universal programme even in countries with low prevalence rates still has a substantial impact [19]. All countries in our survey which reported selective immunisation programmes are considered to be low prevalence countries for HBsAg (prevalence among general population of HBsAg is less than 2%). In these countries the focus is on recommending vaccination for those at risk of hepatitis B infection or associated complications. As the risk of chronic infection is greatest for infants it is reassuring that most countries recommend vaccination of babies born to the HBsAg positive mothers. Regardless of whether a country has a universal programme or not there is a continued need for selective programmes for high risk groups in all countries [15]. Persons belonging to high risk groups, in particular risk groups associated with lifestyle risk factors, are often hard to identify and to reach. Hence universal immunisation in early childhood offers the best hope to protect them later in life [20,21]. Ensuring completed vaccination of at risk groups is challenging due to high mobility and often limited access to medical care. To minimise the risk of infection these individuals need protection before they commence risk behaviour. It is encouraging that most countries fund the childhood vaccination programmes, catch-up campaigns, vaccination of babies born to mothers HBsAg positive, health care and emergency workers. The provision of free vaccine and the absence of administration costs have been demonstrated to contribute substantially to the achievement of high immunisation coverage generally [22]. However, our survey identified some countries where despite the availability of free vaccine for all or some recipients low or suboptimal vaccine coverage was reported. Factors associated with low coverage were not explored in this survey but some of these countries may have been affected by negative publicity in relation to hepatitis B vaccination [23]. Funding of the hepatitis B programme for individuals who are at increased risk by their lifestyle or high risk social circumstances (i.e. IDUs, MSM, individuals who change sexual partners frequently, female commercial sex workers, inmates of correctional facilities) varies among countries. Only one country (Iceland) with just selective immunisation does not subsidise these risk groups for hepatitis B vaccination. Even in countries with a free universal vaccination programme, five countries do not fund the programme for these risk groups, and another five countries partially fund the programme. The impact of such funding policies cannot be determined from our survey. Only one country (Finland) was able to provide national data on coverage among IDUs (45%) and no data were available on coverage among MSM, commercial sex workers or inmates of prisons. It is possible that within countries local or regional data may be available, but the lack of such data at a national level highlights the challenges in monitoring the coverage in such groups and ensuring that individuals at risk are protected – further highlighting the importance of vaccinating children before they enter a high risk group. Most countries do not fund vaccination of travellers to high or intermediate hepatitis B prevalence countries, although most countries recommend vaccination. No national data was available on coverage among this group. However, studies undertaken in a number of European countries in recent years have found that hepatitis B vaccination coverage among travellers is generally very low, even amongst those at particular risk during travel [24,25]. The study has some limitations with regard to comparison of vaccination coverage. Countries measure vaccine coverage using different methods. Some countries used administrative data while others used survey methods. Comparison of vaccine coverage may be misleading when different numerators and denominators are used between countries. Additionally, we collected vaccine coverage data for just 1 year and trends cannot be assessed. The pos-
sibility of intra-country regional variation was also not explored. Not all countries were able to provide vaccination coverage for the same point in time. As some countries were only able to provide data relating to previous years it is possible that some countries may have higher coverage now than they did for the year reported. This is the first European Union-wide survey on national hepatitis B immunisation policies. The collected data provided baseline and the latest information which was available among EU/EEA countries on current policy and demonstrates that two different strategies among EU/EEA countries are used influenced strongly by national hepatitis B epidemiology. Most countries have now adopted a universal childhood vaccination but some countries continue with selective immunisation only for those at risk. The data provided by this study can assist EU MSs to assess and compare their hepatitis B vaccination programmes with those of other countries. Hopefully it will also inform the decision in those countries that are discussing changes in the vaccination policies. To our knowledge one country, the Netherlands, decided to implement universal hepatitis B vaccine into routine immunisation programme. This survey also demonstrates widespread consensus on the groups considered most at risk and for whom vaccination should be provided. In general, coverage rates achieved in countries implementing the universal programme meet WHO targets. However, gaps in vaccination coverage information still exist and there is limited data available on coverage amongst those at greatest risk of infection. Acknowledgments We would like to acknowledge to all VENICE gatekeepers who conducted study in each country: Belgium – Pierre Van Damme, Martine Sabbe; Bulgaria – Mira Kojouharova; Cyprus – Chryso Gregoriadou, Chrystalla Hadjianastassiou; Czech Republic – Bohumir Kriz; Denmark – Steffen Glismann; Estonia – Natalia Kerbo; Finland – Tuija Leino; Germany – Sabine Reiter; Hungary – Zsuzsanna Molnàr; Iceland – Thorulfur Gudnason; Latvia – Jurijs Perevoscikovs; Lithuania – Egle Valikoniene; Luxembourg – Danielle HansenKoenig, Malta Tanya Melillo; the Netherlands – Hester de Melker; Norway – Berit Feiring; Poland – Pawel Grzesiowski; Portugal – Teresa Fernandes, Paula Valente; Romania – Adriana Pistol, Mircea Ioan Popa; Slovakia – Jarmila Lancova, Helena Hudecova; Slovenia – Marta Grgic Vitek; Spain – Isabel Pachon del Amo; Sweden – Anders Tegnell; United Kingdom – Koye Balogun, Richard Pebody. We would like also to thank Eva Appelgren for her contribution conducting this survey. References [1] Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat 2004;11(March (2)):97–107. [2] Lavanchy D. Worldwide epidemiology of HBV infection, disease burden, and vaccine prevention. J Clin Virol 2005;34(December (Suppl. 1)):S1–3. [3] World Health Organization. Global situation; 2008. Available online: http://www.who.int/nuvi/hepb/en/. [4] World Health Organization. Progress towards global immunisation goals – 2007. Summary presentation of key indicators; 2008. Available online: http:// www.who.int/immunization monitoring/data/SlidesGlobalImmunization.pdf. [5] World Health Organization. Hepatitis B fact sheet; 2009. Available online: http://www.who.int/mediacentre/factsheets/fs204/en/index.html. [6] Van Damme P, Van Herck K, Leuridan E, Vorsters A. Introducing universal hepatitis B vaccination in Europe: differences still remain between countries. Euro Surveill 2004;8(47). [7] Van Vliet JA. Cost-effectiveness of national hepatitis B vaccination in the Netherlands. Euro Surveill 2000;4(29). [8] Tilson L, Thornton L, O’Flanagan D, Johnson H, Barry M. Cost effectiveness of hepatitis B vaccination strategies in Ireland: an economic evaluation. Eur J Public Health 2008;18(June (3)):275–82. [9] Mereckiene J, Cotter S, Weber JT, Nicoll A, Levy-Bruhl D, Ferro A, et al. Low coverage of seasonal influenza vaccination in the elderly in many European countries. Euro Surveill 2008;13(October (41)).
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