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Austrian Immunization Program in 2000 compared to the European and WHO recommendations
W. Sedlak
(člen pracovní skupiny pro vakcinaci při Rakouské pediatrické společnosti)

More than 200 years ago Dr.Edward Jenner started the most revolutionary and exciting fight against infectious diseases. In May 1796 he gave the first cow-pox vaccine and started successfully an eradication program against smallpox.

The European office of the WHO has an overarching interest in developing an immunization policy suitable for implementation in all 51 European states. That was the reason, that we started a couple of years ago with a special program (Harmonization on Immunization in the European Union (Childhood immunisation in the European Union) –published in Eur J. Pediatr, 1998, 157). Despite many immunization programs in Europe with very different immunization schedules, some generalizations can be made. Nearly all countries have included diphtheria, tetanus, pertussis, polio, measles, mumps, rubella and Haemophilus influenza type b vaccinations in their childhood immunization program. nevertheless there are great differences in the schedules, the type of vaccines used and public health provisions. For example most countries of the European Union, like Austria, Belgium, Finland, France, Germany, Greece, Italy, Luxemburg, Netherlands, Portugal, Spain, Switzerland have a similar DTP-Immunisation schedule ( 3.,4., 5.month and a booster dosis between 13. – 18, month). Other countries, like UK, Ireland have DTP – vaccination at 2., 4.,6. and 2.,3., 4. month resp. and the booster dosis only given at the age of 4 to 5 years. From the Scandinavian countries we know that they have a 3., 5. and 12. month schedule. Vaccinations against Hepatitis B in childhood have been introduced routinely only in countries with increased risk of hepatitis B infection, especially in the south and central Europe, like Italy, Greece, France. Further this vaccine has been implemented routinely in such countries, which already started the WHO-eradication program, like Austria, Belgium, Germany, Luxemburg; wheras the Scandinavien countries and the UK, use it only for groups of population at risk. On behalf of the Expanded Programme on Immunization ( EPI ) of the World Health Organization ( WHO ) to eliminate or to eradicate diseases like poliomyelitis, measles, rubella and neonatal tetanus the Confederation of European Specialists in Paediatrics (CESP) has adapted a general recommendation and strategy of immunization in the countries of the European Union. The vaccination programs in the European countries should be coordinated internationally by the global Expanded Programme on Immunization, which has been established in 1974. The aim was to provide immunization available to every child worldwide by the year 1990. The vaccines recommended by the EPI to be included in routine schedule were BCG, OPV, DTP, hepatitis B and measles vaccines.

Current goals of the global EPI are that by the year 2000 at least 90% of children younger than 1 year should be immunized against diphteria, pertussis, tetanus, measles, poliomyelitis and tubureculosis. The aim is also, poliomyelitis and neonatal tetanus as well should be eradicated, by this time, especially in the developing countries (adapted from the Ninth General Programme of Work, 1996 -2001, WHO). Measles mortality and morbidity should be reduced by 95% and 90 % from the preimmunizastion era. the incidence of new carriers of hepatitis B virus (measured by the prevalence of hepatitis B surface antigen HBsAg prevalence) should be reduced by at least 80% (adapted from ninth General Programme of Work, 1996 – 2001, World Health Organization, Geneva).
Policies and strategies for vaccines included in the EPI are to administer vaccines before the age at which children are at the risk for the appropriate disease.

Therefore the vaccination should be provided in children in the youngest age group, which can develope an adequate immune response to vaccination with minimal adverse effects. In addition to the need to protect infants prior they encounter the wild disease-causing agents, administering vaccines early in life makes it easier to achieve high immunization coverage. To reduce the number of contacts with child´s family required to complete the immunization schedule, as many antigens as possible are given at a single visit (shot). All the EPI antigens are safe and effective when they are administered simultaneously.
However, the EPI does not recommend mixing different vaccines in one syringe before injection or using a fluid vaccine for reconstitution of a freeze-dried vaccine. Such practice may lead to lower the potency of both vaccines. If vaccines are not given on the same day, the main potential problem is the interference between two live vaccines, which should then be spaced at least 4 weeks apart booster dosis. Current WHO recommendations stresses the importance of the booster doses to maintain immunity (for instance against pertussis and diphtheria) and contribute to the long-term strategy for neonatal tetanus control. There should be given a booster dosis at primary school and a school-leaving booster of tetanus and diphteria (with a reduced diphtheria antigens) at the age of 13 - 15 years.
The priority of immunization programs is to ensure that infants are completely immunized against target diseases at the youngest age possible. The importance drawed to booster doses increased in recent years due to reoccurrence of diphtheria in some Eastern European countries. Altough a single dose may reduce mortality significantly, for eradication of pertussis and measles as well the booster dosis is required. This booster dose also protects children who failed to respond to the first dose and to provides another opportunity to reach children who did not receive the first dose of vaccine.

For BCG there is much controversy over the effectiveness of repeated dosis of the vaccine. Therefore the WHO does not recommend repeated vaccination. I need not to mention the technical problems and technical advices for the global eradication program such as the cold chain of the vaccines, monitoting of the immunization-dates, evaluation of immunization programs, the surveillance of diseases based on routine reports from health facilities, monitoring of adverse events. during the last 20 years, the EPI has helped to create a global consensus on disease prevention and immunization. To support these global strategies for disease control and eradication. the Confederation of European Specialists in Paediatrics (CESP) has prepared a new and completely update version focuses on the various immunisation practice and schedules of the European countries and gives criteria for minimal agreement of immunisation schedules in 15 member countries. Especially catch-up vaccinations and false contraindications are stressed, which will be discussed later on. To underline the problems on the harmonization of immunization programs for the European countries I like to mention, that schedules and vaccines in the northern and western countries are likely to reflect higher public health importance in vaccines against meningitis, whereas southern countries have higher priority for hepatitis B and hepatitis A vaccine combinations, . false contraindications or the fear of adverse reactions are one of the major reasons for decreased coverage. They should not lead to limitations or refuse of vaccination. Common false contraindications are listed in table.

Austria – immunisation programme 2000: After the shift from whole-cell to acellular pertussis vaccine in 1997, the Austrian immunization schedule has been modified and is now similar to the European one, as well as to the WHO recommendations for the general vaccinations in childhood and adolescents.
Because the prevention of chronic HBV infection has become a worldwide high priority, the Global Advisory Group to the WHO recommended in 1992 that all countries should intergrate Hepatitis B vaccine into their national immunization programs by 1997. Numerous studies have shown that routine infant immunization coupled with catch-up vaccination of older children can virtually eliminate HBV- transmission in a community. As you can see we start with the HB. vaccination at the age of 3 months in the new vaccine- combination with Hib, routinely. Infants born to HBsAg-positiv mothers still receive hepatitis B immune globulin within 12 houres after the delivery and simultanously hepatitis B vaccine. Because of growing concerns regarding the potential risks of using different adjuvants, stabilizers, antibiotics and preservations in the vaccines like Thiomersal (a mercury compound, which may causes allergic reactions ), the European adviser group, the American Academy of Pediatrics and the Public Health Service demanded in July 1999 to remove thiomersal from all vaccines for infants. That was the reason we changed now to vaccines without thiomersal (mercury) and human albumin. Today we use the combination of DTPIPV and HBV, Hib. So, wild poliovirus disappears from more and more countries. Switch from OPV to IPV should avoid the most severe complication of OPV- , the so called vaccine-associated paralytic poliomyelitis (VAPP ). We now switched to a sequential IPV/OPV schedule, like other countries, booster doses of OPV are only given after the primary vaccination with IPV. For HIB the number of dosis are today 2 to 3, it depends on type of vaccine, the booster is given about the age of 15- 18 months. The limited immunogenicity of the plain polysaccharide vaccine in infants and young children led to the development of the Hib protein conjugate vaccines, a vaccine with a safe carrier protein, tetanus or diphtheria toxins (which may increase the immune response that is characterized by helper T cell activation). The immune response induced by T-dependent antigens is different from the response induced by T-independent antigens. Since this conjugated Hib-vaccine is used, we can see a dramatic decrease in the incidence of wild diseases as shown in Switzerland earlier. For MMR, the first dosis is given at 14 - 18 monthes and the second dose at the age of 6 years with enrolement of children to primary school. 

Chronic hepatitis B - a worldwide problem: Chronic hepatitis B occurs when the infected patient fails to clear infected hepatocytes. Diagnosis is confirmed by failure to produce antibodies to HBsAg and the persistence of HBsAg in blood. The risk of progression to chronic HBV infection is associated with the age at infection. Around 10% of HBV-infected immunocompetent adults will become chronic carriers, while up to 90% of HBV-infected infants, pre- or perinatal progress to chronic infection. The mortality rate from HBV-related liver disease approaches 25% if the person was infected during childhood and 15% if infection occurred as an adult. There are ca 350 million carriers of HBV worldwide and, every year more than 1 million deaths result from HBV infection. Hepatitis A and B are not only travel-related risk factor, are not only infections in so called risk groups, but have become a general problem. That was the reason for the WHO to start worldwide with general vaccination strategy. Firstly this vaccination should be provided for groups at risk and then generally as a routine. There are figures demonstrating the predicted reduction in the numbers of HBV carriers - resulting from the different vaccination strategies: The strategy to vaccinate only the high-risk has only a little impact on the numbers of carriers within the populations. (e.g. healthcare workers,hospital staff like nurses, MD's, etc.) Travellers, especially sex-travellers, homosexuals, heterosexuals with multiple partners, intravenous drug users and those with occupational risk, like the Northern European countries or the UK. It is possible to get better results if you start with routine immunization of the infants, you will improve your targets when you vaccinate also the adolescents, an age where the teenagers start with sexual contacts. But all strategies incorporating routine vaccination together will have the best effect: with the infant/children, adolescents and high risk groups combination predicted to cause the highest reduction in HBV carrier numbers. We still have a simultaneous administration of a active and passive immunization particularly for thoses newborn babies, whose mothers are HbsAg positive during pregnancy.

Besides the general immunization recommended to infants, children and adolescents there are programs for vaccinations on indications: Nowdays, BCG is only recommended for populations at risk, influenza and pneumococcal vaccines are recommended for elder persons as well as to high risk persons with chronic diseases. Hepatitis A vaccination is recommended also for health care workers, workers in allied professions and for high risk groups, using a combined hepatitis A and B vaccine, which offers advantage to recipients: like fewer injections and less associated pains, fewer visits are required, that means also increased compliance and much more acceptable. FSME (tickborn encephalitis ), TicoVac, is also recommended for population in high risk areas. Since we started with routinely FSME - vaccination in Austria in 1979 we have noted a dramatic reduction of severe FSME-cases and deaths due this disease. Tickborn encephalitis is not only an Austrian speciality, but has become on European problem and could be solved by higher vaccination coverage. FSME is also a major problem in Slovenia with a remarkable mortality rate. I would think that the new decade will bring a number of new vaccines, a number of new vaccine-combinations, which will be save and with a minimum of risk. E. Jenner started the first single vaccine against the smallpox and now we face the time of combined vaccines with 6-7 different antigens. The "composition" will change, but will remain a masterpiece.