Doc. 7681
7 October 1996

REPORT1 on vaccination in Europe

(Rapporteur: Mr CHRISTODOULIDES, Cyprus, Group of the Unified European Left)

Summary

       Infectious and epidemic diseases are reappearing in Europe. The report advocates a number of measures to improve the unsatisfactory level of immunisation in European populations.

I. Draft recommendation

1.       The Assembly observes that the political transformations which brought down the communist regimes in some countries of central and eastern Europe also swept away the existing state structures, including health systems, which disappeared or were completely reorganised. Public health services often have deteriorated and health budgets have been greatly reduced.

2.       In some countries, the economic difficulties arising from the transition have led to drastic employment and income reductions which, accompanied by unsatisfactory dietary standards, high consumption of alcohol and tobacco, adverse environmental conditions and stress, has affected public health in these regions. This deterioration, aggravated by shortage of vaccines and improper management of vaccinations, is responsible for higher incidence of infectious diseases.

3.       The recent diphtheria epidemic in the countries of the former Soviet Union is an example of the risks confronting us. Tens of thousands of cases have been reported since the outbreak of the epidemic in 1990, and thousands have died of a disease generally believed to have been wiped out. Other pockets of infection may attain epidemic proportions at any time: poliomyelitis, tuberculosis, tuberculous meningitis, pertussis, etc.

4.       The diphtheria epidemic very clearly demonstrated that health risks could not be contained locally. With millions of people now free to travel from one country to another, it has not been possible to halt such epidemics. The eruption of ethnic conflicts producing mass movements of refugees has created new problems in this respect, and the austerity imposed by economic reforms has worsened the situation.

5.       The Assembly considers that efforts to improve the immunisation level should not be concentrated solely on the plight of the countries undergoing transition. The immunisation level of populations in western Europe has been steadily declining in recent years. The low percentage of fully vaccinated people, coupled with outbreaks of infectious diseases in the same geographic area, raises fears of major epidemics in western Europe too.

6.       The Assembly therefore recommends that the Committee of Ministers invite member states:

i.       to devise or reactivate comprehensive public vaccination programmes as the most effective and economical means of preventing infectious diseases, and to arrange for efficient epidemiological surveillance;

ii.       to grant increased assistance as a matter of urgency, internationally co-ordinated through the World Health Organisation (WHO) and Unicef in particular, to the countries of the former Soviet Union suffering from the diphtheria epidemic, in order to supply adequate quantities of vaccines and medicines and train a medical staff qualified to handle and administer the vaccine with the following aims:

      a.       to achieve a high immunisation level among the population;

      b.       to allow rapid identification of contact cases and their standardised treatment;

      c.       to ensure early diagnosis and immediate hospital treatment of diphtheria cases;

iii.       to be unsparing in their financial assistance to the various vaccination campaigns conducted jointly by WHO, Unicef and other bodies to prevent resurgence and eradicate diseases such as poliomyelitis, tuberculosis, tuberculous meningitis and pertussis;

iv.       to increase the R&D funds devoted to perfecting prophylactic and therapeutic vaccines against such diseases as HIV, malaria, herpes and cancer.

7.       The Assembly furthermore invites the Committee of Ministers:

i.       to define a concerted pan-European policy on immunisation of the populations, in association with all partners concerned, for example, WHO, Unicef and the European Union, aimed at the formulation and observance of common quality standards for vaccines, and to ensure adequate supply of vaccines at a reasonable cost;

ii.       to call upon member states to ratify the European Social Charter of the Council of Europe, in particular Article 11 securing "The right to protection of health", and to instruct the Charter's supervisory bodies to pay due attention to the fulfilment of this undertaking.

II. Explanatory memorandum

by Mr CHRISTODOULIDES

Introduction

      The political changes which brought down the communist regimes in the countries of central and eastern Europe and the former Soviet Union wiped away the existing state structures, including health systems, which disappeared or were radically changed. The economic hardship resulting from radical reforms dictated by transition affected general health condition of the population in the region. The Assembly warned against such developments in its Resolution 1056 (1995). The esolution pointed out the unprecedented scale of changes in the countries of central and eastern Europe and demanded that all economic policies be backed by social measures.

      Deteriorated health conditions lead to higher incidence of infectious diseases. With the millions of people free to travel across the borders, the outbreaks of such diseases could not be contained locally. Eruptions of ethnical conflicts, producing mass movements of refugees created new problems in this regard. The austerity imposed by economic reforms made it very difficult to improve the situation.

      The motion for a recommendation on vaccination in Europe, on which this report is based, was an expression of concern regarding these developments. A call has to be made to the responsible authorities to undertake urgent measures to improve the situation and prevent outbreaks and spread of infectious diseases through effective immunisation programmes.

      The Social, Health and Family Affairs Committee organised a hearing on vaccination in Europe, which took place in Paris on 8 January 1996, with the participation of representatives of Unicef, the International Children's Centre, the World Bank European Office and the European Federation of Pharmaceutical Industries Associations. The discussions during that hearing served as a basis for the present report.

      The report first briefly examines the state of public health systems in central and eastern Europe. Its dramatic deterioration not only multiplied the risk of major epidemics, but also made any effective policies to combat the outbreak of infectious diseases virtually impossible.

      The recent outbreak of diphtheria in the countries of the former Soviet Union is given as an example of the risks we are facing. Tens of thousands of cases were reported since the outbreak in 1990 and thousands of people died from a disease that everybody thought had been wiped out.

      The efforts to improve immunisation levels should not exclusively focus on the situation in the countries in transition. The immunity levels of populations in Western Europe and neighbouring countries where adults are most often not protected, have been steadily declining over the last few years. A low percentage of fully vaccinated people, coupled with outbreaks of infectious diseases in the geographic neighbourhood, give ground to fears of major epidemics in western Europe.

      The situation is not likely to improve without regular and sufficient supply of vaccines and proper management of vaccination procedures, including cold storage and availability of trained medical staff. Nevertheless, Unicef together with the United States and Japan have supplied modern and complete refrigerator equipment to Tadjikistan, the three Caucasus countries and Moldova, as well as, partially, Ukraine, Kirgistan, Kazakstan and Turkmenistan.

      For fourteen of the fifteen republics of the former Soviet Union, Unicef and the WHO in June 1995 launched an urgent appeal to collect USD 31 million within a year. The Russian Federation was not included since it is able to cover its own needs. Apart from the USD 2,1 million not yet found for Kazakstan, Uzbekistan and Kirgistan, an additional USD 5 million will be needed in 1996 and 1997 to consolidate the checking of diphteria in the remaining 11 republics, which have been able to carry out large vaccination campaigns thanks to financial support from the European Union.

      Some estimations are predicting that the countries of the former Soviet Union need more than USD 50 million in two years to cover the costs for diphtheria vaccination alone. The cost and availability of vaccines is an issue of extreme importance, which demands a mixture of approaches, from donorship to closer co-operation with vaccine manufacturers and self-sufficiency of countries currently facing shortages.

Public health in central and eastern Europe

      Economic hardship and deterioration of social conditions took a particularly severe toll in Russia and Ukraine, as well as in some other former Soviet republics. The situation in central and eastern Europe was less dramatic, although a decline in overall health conditions did occur.

Causes of health deterioration

      The economic hardship of the transition that followed the political changes from 1989 onwards brought about drastic decreases in employment and income, accompanied by unsatisfactory dietary standards, high consumption of alcohol and tobacco, adverse environmental conditions and stress. All these factors contributed to sharp increases in conditions of heart and circulatory diseases.

      Infectious and parasitic diseases have taken a rapidly increasing toll.

      The public health care services, that had never been fully satisfactory, had deteriorated. Health budgets were drastically reduced, resulting in old buildings and equipment which was old, inadequate and not properly maintained, shortage of essential medicines, that are only available on the open market, lack of competent medical staff, etc.

      Adverse environmental conditions played their role in causing certain types of diseases or lowering resistance to others.

      The level of environmental degradation varies significantly and it had most serious consequences in some parts of the former Soviet Union.

      Deterioration of the water and sewerage systems have resulted in outbreaks of water-induced diarrhoeal diseases.

      Air pollution in many areas increased the risk of respiratory conditions.

      The accident at the Chernobyl nuclear power plant ten years ago provoked catastrophic consequences not only in Ukraine but in the neighbouring countries as well. More than 150 000 people, 60 000 children included, got an overdose of irradiation of the thyroid. The Dnieper river, source of water for more than 35 million people, was seriously contaminated. The prevalence of endocrinal conditions multiplied by three to six times, pregnancy pathologies by up to three times.

      As a result of poor water management, the infant mortality rate in parts of the Aral Sea area is about five times the average rate of the republics of the former USSR. The effect on children of environmental neglect is especially significant in Azerbaijan.

Child health

      Children are less or less directly exposed to a number of factors — such as stress, tobacco and alcohol consumption — that contributed to a dramatic rise in adult mortality in the region over the past few years. The rise in child and infant mortality was thus less significant than that of adults, but nevertheless, a number of countries in the region experienced steady increases in child and infant mortality since 1989.

      Deteriorated health and social conditions of adult populations including pregnant women results in low birth weight which reduces the child's chance of surviving the first year of life. Poor nutrition for newborns and an extremely low percentage of breast-feeding mothers further aggravate the situation.

Decline in life expectancy

      Deteriorated health conditions caused a dramatic rise in adult mortality and in particular among men of working age. The rise of mortality was more than dramatic, with the life expectancy of Russian men declined from 64,2 years in 1989 to 59 in 1993 and even to 57,3 in 1994 according to some reports.

      The extent of morbidity may be even more serious, as a number of sick persons no longer attend public health institutions.

High risks of epidemic outbreaks

      Given the absence of resistance as a result of bad diet, stress and abuse of alcohol and tobacco, an adverse physical environment and the lack of effective health care, aggravated by a lack of vaccines and improper management of vaccinations, infectious diseases such as diphtheria and tuberculosis take their toll.

      Another aggravating factor is an anti-vaccination propaganda that had been conducted since the beginning of the 1980s by the media as well as by some medical staff, and which had been based on exaggerated and wrongly interpreted facts. This had resulted in a large number of children who had not been vaccinated.

      Children are particularly vulnerable and in many countries the principal single cause of morbidity among children under 15 years has been infection of the respiratory tract. The majority of cases treated at the Central Tuberculosis Institute in Tbilisi are children aged zero to three years.

Diphtheria outbreak in the newly independent states

      The example here is of an outbreak of diphtheria that started in Russia and Ukraine in 1990 and swiftly spread to all the other Newly Independent States. In 1995 "only" 52 000 cases of diphtheria were registered due to a 10% decline in the incidence rate in Russia, where 70% of the adult population and 98% of children and young persons were vaccinated during the years 1993-95. The situation seems to be under control in six countries only (the Baltic states, Moldova, Azerbaijan and Tajikistan.

      The situation is far from being under control (for example in Ukraine and central Asia) and the estimations predicted up to 150 000 or even 200 000 cases. Final numbers are not yet known.

      The outbreak has also begun to leak cases to a few western countries — including the United States — via infected travellers, and populations in several countries may be vulnerable because levels of immunity in adults have declined in recent decades. It represents a serious threat for public health worldwide and not only in the region of the former Soviet Union.

Reasons for the outbreak of epidemic diphtheria

      The resurgence of the disease that had been thought wiped out can be explained by the reintroduction of toxigenic strains into populations with a high proportion of susceptible adults and children.

      The toxic strains had apparently been reintroduced by the arrival in Moscow in 1990 of a few infected military recruits from southern Russia, where the micro-organism C.diphtheriae, responsible for diphtheria is commonplace, but only causes a mild skin disease.

      The susceptibility of adults and children resulted from gaps in immunity in non-immunised adults and low immunisation coverage of children. The widespread vaccination of children in the 1970s in most countries had virtually wiped out C.diphtheriae and twenty years later there was not enough of it around to boost natural immunity.

      The erosion of public health systems in all countries concerned helped to create ideal conditions for rapid spread of the disease. Large movements of population that followed the dissolution of the Soviet Union further facilitated the spread.

      Late and inadequate response in the early phases of the epidemics, in particular the absence of appropriate control measures, especially mass immunisation, allowed the situation to escape control.

WHO/Unicef Strategy for diphtheria control in the Newly Independent States

      The extreme seriousness of epidemics makes a co-ordinated international support for the diphtheria-epidemic countries an urgent priority. The rapidly expanding epidemic is an international health emergency.

      The World Health Organisation, together with Unicef, reacted in early 1995 by proposing a strategy for controlling the epidemics, which was developed in close co-operation with the United States Agency for International Development (USAID), the Center for Disease Control and Prevention from the United States, the Robert Koch Institute from Germany and the International Federation of Red Cross and Red Crescent Societies.

      The strategy to control the disease emphasises the crucial importance of mass vaccination of the population. It recommends three measures:

      —pr       imary prevention by ensuring high population immunity through immunisation as the most effective measure to control epidemic diphtheria;—

      —se       condary prevention of contact cases of diphtheria by the rapid investigation of close contacts and their standardised treatment;—

      —te       rtiary prevention and prevention of complications and death from diphtheria by early diagnosis and immediate treatment and hospitalisation of diphtheria cases.Th

      The vaccine is far from being easily available and most of the countries in the region, with the exception of Russia, encountered difficulties in procuring sufficient quantities.

      The antitoxins, which are used in treatment of diphtheria cases are even less available as their total world production is relatively limited. They are relatively expensive, and the estimated average need per case of diphtheria, which is 100 000 international units (IU), costs about USD 160.

      The WHO/Unicef Strategy recommends routine immunisations of children, which should cover at least 95% of children, and immunisation campaigns, including children and adolescents as well as people in risk groups such as health workers, the armed forces, refugees, teachers, homeless people, alcoholics and drug users. Immunisation campaigns for children and adults should also be carried out in high risk areas where diphtheria outbreaks occurred.

What can be learned from the outbreak of diphtheria in the NIS

      The outbreak of diphtheria in the NIS provides a warning of what may happen if appropriate measures are not taken immediately, not only with regard to the NIS but also to the situation in western Europe and the rest of the world.

The risks caused by the deterioration of the public health systems

      The collapsing public health systems in the NIS represent an enormous risk for the spread of infectious diseases. The public health system, suffering from economic hardship of transition, is unable to ensure effective immunisation levels. Even when vaccine is available, there are problems in management, due to the lack of resources and qualified medical staff, that affect the quality of vaccine, reduce vaccination coverage of the population, etc.

      When the disease broke out, the system of epidemiological surveillance failed, and prevented an immediate action that could have limited the epidemic. Incidentally, epidemiological surveillance was a part of the public health system that had worked very well in the past.

      There were enormous problems concerning the secondary prevention of contact cases through their rapid investigation and their treatment.

More international aid is needed

       More international assistance is needed urgently not only to provide sufficient quantities of vaccine and medicaments for the treatment of infectious diseases, but also to train medical staff how to handle and administer the vaccine.

      Since 1992, Unicef, the European Union and the Governments of the United States, Canada and Japan have given important financial assistance to provide adequate facilities for the cold storage of vaccines. Unfortunately, all countries are still not appropriately equipped and even where they are, there are occasional problems of electricity supply, etc.

The availability and the economic aspects of vaccine

      Only Russia was producing diphtheria vaccines and had sufficient capacities for the entire region. The vaccines, however, were not exported to other NIS, because of the lack of hard currency and because of a decree that had forbidden exportations of the diphtheria vaccine.

      In addition, the Russian laboratories had never asked for authorisation from WHO, which was required in order to sell the vaccine on the world market.

      Three central Asian republics that had concluded an agreement with Japan had enough vaccine for initial vaccination of children under one year of age, but not for necessary re-vaccinations.

      Other countries of the former Soviet Union had no means to undertake effective immunisation campaigns — Ukraine and Moldova, together with Romania, were using World Bank loans to cover their immediate needs.

      Unicef had until today succeeded in providing vaccines to the countries where it had its representation offices, but without being able to guarantee multi-annual vaccination campaigns.

      Ukraine planned to begin its production in 1996 to become self-sufficient in two years' time, but the size of the market did not allow for an efficient scale of production.

      Until the economic situation in the countries in question improved, the provision of the necessary vaccines would depend on the good will of the international donors.

      Economic realities of vaccine production certainly have to be taken into account. Vaccine manufacturing needs large economy of scale in order to be cost efficient. There are very few countries in the world with populations big enough to support full range vaccine production.

      Recommended vaccine requirement per 1 million newborns, covering DTP (Diphtheria, Pertussis, tetanus), BCG, measles, polio and hepatitis B, is 1,8 million vials per year, which a small plant might produce in less than forty working days.

      Costs of vaccine production are often underestimated. A polyvalent, self-contained vaccine filling facility cost up to USD 30 million.

      The majority of manufacturers in eastern Europe, the NIS, Russia and the developing nations did not meet the minimum quality specifications that had been laid down by WHO, nor did they have means to correct the situation or to verify the quality of their own.

      In spite of these considerations and the difficulties that some countries encounter in procuring the vaccine through domestic production, the solution for sufficient vaccine availability in all the countries concerned will have to be a mixture of donorship, in order to resolve the short term needs and through importation but also through domestic production in order to ensure availability of the vaccine in the long term.

      The importance of the latter should not be underestimated. With absolute dependence on imports, there are greater risks of delays in obtaining the vaccine, large distances between the vaccine manufacturing plants and countries where they are used increase the risks of mishandling the vaccine, there is a positive spill-over from research involved in the vaccine production, etc.

      The outbreak of diphtheria also showed that some countries consider vaccine a strategic product and that they are reluctant to share it with other countries that may be in greater need.

Health risks cannot be contained locally

      The outbreak of diphtheria clearly showed that risks cannot be contained locally. The disease had rapidly spread from Moscow and St Petersburg, where it had originally broken out, to virtually all the Newly Independent States.

      Large migration movements not only within the territory of the former Soviet Union, but also between the NIS and the rest of the world resulted in the first cases being reported in Germany, Italy and the United States.

      It should also be borne in mind that if the efforts to control diphtheria bear fruit, there are other diseases that may break out in epidemic proportions at any moment.

      Poliomyelitis, for example, had practically disappeared from western Europe since 1980 and there were no cases reported except in Turkey and the Netherlands.

      In the NIS, 179 cases had been reported between January and September 1995. They had all been attributed to the same virus.

      In 1995, WHO and Unicef, in co-operation with the Rotary International, had launched mass poliomyelitis vaccination campaigns in eighteen countries of the Middle East and central and eastern Europe. Sixty-three million children under 5 years of age had received two vaccinations during this campaign and the number of cases dropped significantly.

      The April-May campaign was successful; but a last campaign would be necessary between October 1996 (Romania, Ukraine, the Federal Republic of Yugoslavia) and May 1997 (central Asia, Caucasus) to eliminate the disease in Europe. USD 4 million are still needed for that purpose.

      Tuberculosis and tubercular meningitis among children, that had been almost wiped out in the region, were in constant rise in recent years in all the NIS, proving that existing BCG vaccination had not been sufficient.

      An epidemic of whooping cough could break out at any moment, as no vaccination against it had been carried out in the past fifteen years.

Low immunisation levels in western Europe

      The experts warn that in many countries of the European region of the World Health Organisation, including western Europe, the immunisation levels of the adult population are dangerously low and might become so also for children.

      Paradoxically, to some extent we are victims of the success that mass vaccination policies had in the past. Because of the results obtained, the implementation of vaccination policies were neglected.

      In some cases, for example in the case of the outbreak of diphtheria, the mass vaccination in the early 1970s was so successful that it reduced the quantities of bacteria below the levels needed to boost natural immunity.

      The fact that there were autochthonous cases of diphtheria reported in the United Kingdom, Turkey and Finland shows that risks are not coming only from outside. Some estimations indicate that up to 50% of the population in western Europe may not be protected against diphtheria.

      The objectives for elimination of certain diseases, such as congenital german measles and mumps, set by WHO, seem to have been set too high and will have to be readjusted. There were no set dates for the control of some other diseases, such as hepatitis B and the haemophile influenza.

Conclusions

      It is without any doubt clear that vaccination is not only the most effective but also the cheapest way of combating infectious diseases.

      Recent outbreaks of infectious diseases in the NIS occurred as a result of too low immunisation levels in all segments of the population, resulting from the absence of efficient vaccination policies and from the fact that deteriorated health conditions made many people more vulnerable to the diseases.

      The public health systems in the countries concerned are suffering from drastic lack of funds, are understaffed and inadequately equipped and are not in a position to carry out measures of effective prevention and treatment of infectious diseases.

      International assistance is at the moment insufficient to cover the immediate needs for vaccine. In the long term, solutions to provide sufficient quantities of vaccine will have to be found through an increased domestic production and importation.

      Migratory movements within the region of the former Soviet Union and between that region and the rest of the world make it impossible to contain the risk of outbreaks of infectious diseases locally, although more stringent control, in particular with regard to people coming from high risk areas, could diminish the possibility of further spread of diseases.

      Although a majority of cases of diphtheria recently discovered in western Europe were linked to the outbreaks in the region of CIS, there were cases of autochthonous diphtheria in two west European countries.

      Immunisation levels in the western part of Europe are equally low and vaccination policies have to be revised and implemented adequately to reduce the chance of an epidemic.

      Reporting committee: Social, Health and Family Affairs Committee.

      Budgetary implications for the Assembly: none.

      Reference to committee: Doc. 6391 and Reference No. 1722 of 11 March 1991.

      Draft resolution adopted by the committee on 23 September 1996 (1 abstention).

      Members of the committee: Mr Gusenbauer (Chairman), Mr Rathbone (Vice-Chairman) (Alternate: Lord Dundee), Mr About, Mrs Albrink, Mrs Andnor, Mr Arnau, Mrs Aytaman, Mr Banks, Mrs Belohorská, Sir Andrew Bowden, MM. Bugli, Buzatu, Carvalho Martins, Christodoulides, Chyzh (Alternate: Stepanov), Dees, Deguara (Alternate: Farrugia), Dinçer, Dionisi, Djerov, Mrs Fleetwood, Mrs Gatterer, Mr Geoffroy, Mrs Golemi, MM. Gross, Haack, Hegyi, Mrs Høegh, MM. Horn, Jacquat, Jonsson, Keller, Kollwelter, Kotlar, Koucký, Mrs Kušnere, Mr Leitner, Mrs Luhtanen, MM. Maginas, Małachowski, Marmazov, Mrs Maximus, MM. Mazzone, Melnikov, Mozetič, Nestor, Mrs Van Nieuwenhoven, MM. Niza, Pattison, Paunescu, Mrs Poptodorova, Mrs Pulgar, MM. Raška, Raškinis, Scaglioso, Sharapov, Valkeniers (Alternate: Weyts) (Vice-Chairman), Mrs Vermot-Mangold, Mr Volodin (Alternate: Mrs Oleinik), MM. Vrettos, Wielowieyski.

      N.B.       The names of those members present at the meeting are printed in italics.

      Secretaries to the committee: Ms Coin et Ms Meunier.

1 ¹By the Social, Health and Family Affairs Committee.