Immunization in Europe

POLICY-MAKING PROCESSES IN EUROPEAN COUNTRIES

As of December 2019, 50 of the 53 Member States in the Region had established NITAGs or an equivalent advisory expert committee. According to data available within the WHO European Region, the three countries that do not have a functional NITAG or equivalent committee include Cyprus, Hungary, and Romania. Further, in 2021, Italy and Liechtenstein reported no functioning advisory committees, however, although not all countries have advisory expert committees’ public health vaccine policy officers from all 30 EU/EEA Member States attend the meetings of the newly established EU/EEA NITAG Collaboration where immunization and vaccine program information is shared. The aim of the EU/EEA NITAG Collaboration is to exchange existing scientific evidence on available vaccines and jointly generate new scientific evidence, if possible, in systematic literature reviews using evidence-based methodology assessing public health outcomes of EU authorized vaccines and their use to be shared transparently within the EU and beyond. Information obtained in these meetings is being used by the national decision-making bodies since health is the competence of each EU Member State. The WHO European regional office also convenes public health vaccine policy officers in regular meetings (face-to-face or online) to inform all countries of the European Region in a timely manner on available vaccines, their effectiveness and safety, and related issues. In addition, Liechtenstein attends the Swiss NITAG meetings and adopts the Swiss vaccine recommendations for use in their own country.

The majority of the existing committees in the WHO EURO region do have a legislative basis for making vaccine recommendations to the Ministries of Health and the government. The effect of the recommendations made varies according to how immunization programs are organized (centralized or decentralized) and the balance between public and private sector provision of immunization services. The following examples demonstrate how immunization policy is made and implemented in selected countries with markedly different systems.

France has a national-level immunization technical advisory committee, Comité technique des vaccinations (CTV), set up by decree ( https://www.hcsp.fr/explore.cgi/groupe?clef=64 ). This committee proposes the immunization schedule annually to the Directorate-General for Health at the Ministry of Social Affairs, Health and Women’s Rights that is, responsible for the management of the committee and implementation of its recommendations. Some vaccinations are mandatory (polio, diphtheria, tetanus, measles, mumps, and rubella). Around 85% of childhood vaccinations are performed by private sector pediatricians with the remainder provided by public maternal and child health clinics where most vaccinations are free. Parents claim reimbursement for paid-for vaccinations in the private sector either through their voluntary complementary health insurance or through the national Social Security Scheme. MMR and influenza vaccinations for those in recommended groups are also free, irrespective of where they are provided. Physicians in the private sector choose which vaccine products to offer to patients.

Similarly, in Germany and Spain, the federal states (Germany) (n = 16) or the autonomous communities (Spain) (n = 17) are responsible for public health. Although these countries have strong NITAGs that use evidence-based methodology, their recommendations can still be modified at the regional level and the vaccines actually provided depend to a large extent on the choice of private practitioners and the reimbursement arrangements with governments and/or insurance companies.

In Germany, recommendations on vaccine use are made by the Standing Committee on Vaccination (STIKO) ( https://www.rki.de/DE/Content/Kommissionen/STIKO/stiko_node.html ) which reports to the Ministry of Health through the Robert Koch Institute, a federal public health agency that oversees national surveillance and prevention activities for communicable diseases. However, STIKO recommendations need to be approved by each federal state (n = 16) before being implemented. Decisions regarding reimbursement for vaccination in Germany are made by each of the more than 400 insurance plans, almost all of which are statutory and predominantly financed through payroll taxes. Physicians bill the patient’s insurance plan for services provided. Only 10% of vaccines are paid for by the federal states through special programs. The other 90% are primarily covered by statutory insurance plans. The federal government sets requirements for which health services are mandatory, but vaccinations are not currently among these mandatory services.

The Autonomous Communities in Spain are responsible for managing the immunization program, from establishing their respective immunization programs to the procurement, distribution, and administration of vaccines. Following the creation of the Spanish Committee for Immunization ( https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/home.htm ) the following five criteria are considered in an orderly and evidence-based manner before changes in the nationally recommended immunization schedule or introduction of a new vaccine: (1) disease burden, (2) effectiveness and safety of the vaccine. (3) impact of the possible introduction, (4) ethical considerations, and (5) an economic evaluation. ^, The Committee for Immunization also discusses and agrees on other issues related to the functioning of immunization programs, including possible joint procurement of vaccines, actions to address problems in the supply and availability of vaccines, and recording of immunizations in immunization registries, and the creation of immunization information systems. In 2010, a common national vaccination schedule was adopted to promote quality, equity, and sustainability of the immunization program. The Committee for Immunization also reviews vaccination in risky working environments, during pregnancy and in the postpartum period, in immigrants, and in premature infants.

The NITAG of the Republic of Moldova was established by ministerial decree in 2013 to provide independent advice on immunization policy and practice. The NITAG consists of 14 core members who represent a wide diversity of medical disciplines. There are also 17 noncore members, including representatives of the Ministry of Health, immunization program, and medical societies. The Moldovian NITAG is generally believed to be fully functioning with a legal basis and terms of reference, links to the Ministry of Health, a core membership drawn from an appropriate range of disciplines, and secretarial support provided through the National Centre of Public Health. The NITAG developed recommendations on removing BCG booster doses from the national immunization schedule, introducing one dose of IPV, switching from tOPV to bOPV, vaccinating of risk groups against hepatitis A, seasonal influenza vaccination, and introduction of HPV vaccine. All NITAG recommendations were accepted and fully implemented by the Ministry of Health. The Moldovian NITAG faces similar challenges as other NITAGs in middle-income countries, including difficulties in generating evidence-based recommendations because of limited capacity to conduct a systematic literature review and lack of funding that leaves the NITAG with very limited technical support from the Secretariat. In order to overcome these challenges, the NITAG makes use of available information, such as WHO position papers, and documents of the Strategic Advisory Group of Experts (SAGE) on Immunization together with detailed local data, to make evidence-based recommendations. WHO and international partners support in establishment and building capacity of the Moldavian NITAG was essential. It included the participation of NITAG members in regional meetings and trainings, a visit to the well-functioning French NITAG, and a formal NITAG evaluation.

In Sweden, the national immunization schedule is recommended centrally to all children, adolescents and adults by the national government following advice from the Public Health Agency of Sweden and its reference committee ( https://www.folkhalsomyndigheten.se/smittskydd-beredskap/vaccinationer/vaccinationsprogram/referensgrupp-for-nationella-vaccinationsprogram/ ) but regional health authorities (n = 21) have the freedom to select among and procure vaccine products having valid market authorization and may also introduce vaccines before national recommendations are adopted. The cost of immunization services and vaccines are covered by regional public funds. Vaccines are offered through public well-baby clinics up to the age of 6 years, and thereafter through school-based preventive clinics covering children and adolescents up to the age of 18 years. For adults, general practitioners in primary care settings take on the main responsibility for vaccinations.

The United Kingdom has a centralized health system in which the UK National Health Service (NHS) provides universal comprehensive health services, including immunization. The Chief Medical Officers within the health departments of England, Wales, Scotland, and Northern Ireland are responsible for coordinating and providing health-related advice to the government. Routine immunization services are provided by general practitioners in primary care or by nurses in school settings. In the United Kingdom, the Joint Committee on Vaccination and Immunization (JCVI) ( https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation ), a statutory committee independent of the Department of Health, makes recommendations to the Secretary of State for Health for England and to the devolved administrations in Wales, Scotland, and Northern Ireland; thus immunization policy is implemented similarly in each of these four countries. There is a joint procurement process so that the same vaccine products are provided in all of the United Kingdom. JCVI recommendations must have the approval of the Chief Medical Officers before they are submitted to the respective health minister and/or secretary of state for approval for implementation. In England, under the provisions of the Health Protection (Vaccination) Regulations 2009, which implements the NHS Constitution in England, following a request for advice by the Secretary of State, the JCVI must make recommendations relating to new provisions for vaccination (other than relating to travel or occupational health) under a national program. It also makes recommendations to change existing provisions under such a program, based on an assessment that demonstrates cost-effectiveness. The Secretary of State for Health is obliged to fund such recommendations. Once national funding has been agreed upon, implementation arrangements are taken forward, with all four countries implementing the new policy in the same way and almost always at the same time. Efforts are made to ensure that all localities make changes to their immunization programs simultaneously, facilitated by the existence of national conformity of immunization computing arrangements that call up children for their immunizations, chase defaulters, pay providers, and measure coverage. Local providers have very little discretion in whether to accept or modify national recommendations. Before implementation, consultation takes place with the representatives of the primary care providers because changes in policy can have consequences for the remuneration of physicians.

For many years, some vaccinations under national immunization schedules were considered mandatory in the WHO European Region under respective infection control legislations. In 2020, 12 EU/EEA countries mandated one or several vaccines in the routine immunization programs for children ( https://vaccine-schedule.ecdc.europa.eu ), with hepatitis B, diphtheria, polio, pertussis, and tetanus vaccinations most commonly mandated. Some Member States consider mandatory vaccination to be a way of improving compliance with vaccination programs. However, compliance with recommendations is high in many programs in Europe without being mandatory. There is little evidence of any punitive action being taken against those who choose not to accept vaccination although the law may allow for it. However, to curb the recent measles outbreaks observed in Europe in the last 10–15 years the possibility to fine families is available in France and Italy and orders to unvaccinated not to attend school during outbreaks are being tested in for example, in Germany to contain spread of vaccine-preventable diseases, a strategy that has proven effective to increase uptake in some communities refraining from vaccination. A few countries in the European Region have already made COVID-19 vaccination mandatory for some occupational groups (e.g., healthcare workers and other frontline workers in France, Italy, and Russia) and unvaccinated may either be moved to a different type of work, be forced to unpaid leave or lose their job. An alternative in Italy to vaccination is providing regular negative rapid swab tests or proof of recent recovery from Covid-19 through an antibody test.

As part of the COVID-19 pandemic control measures and holding to the free movement principle, since July 2021, EU has introduced the use of an EU Digital COVID-19 vaccine passport/certificate. An EU digital COVID-19 certificate is a digital proof that a person has either been vaccinated against COVID-19, received a negative test result for COVID-19 or recovered from COVID-19. The aim of these certificates are that those holding such a document will be able to travel throughout the EU without the need to quarantine or test for COVID-19, although the Member States may impose additional restrictions for particular countries with a higher COVID-19 rate, which has happened already. Through quarantine and testing traveling between countries in the EU/EEA and the rest of the world is currently mostly possible. With the arrival of the omicron variants many EU/EEA countries have opened up and waived the certificates due to lack of protection by the vaccines against transmission of the omicron sublineages. It still varies by airline in August 2022 if a negative PCR-test is requested and the situation will be monitored closely.

There are fewer variations in the immunization policymaking processes in the non-EU/EEA countries of the region. Most countries have centralized policy-making processes, public sector programs, and state procurement. In Albania and Armenia, for example, the national immunization schedule is recommended centrally by the Ministry of Health and the government, based on the recommendation of the NITAG and implemented through the immunization system managed by the government. In Georgia, the immunization policy is also set by the government, but the services are delivered through privatized health insurance schemes.

The WHO Regional Office for Europe is working with its Member States to strengthen the decision-making process thereby enhancing the work of the national immunization technical advisory groups (NITAGs).

In addition, the European Region is experiencing an increasing involvement of the private sector in pediatric and adult immunization programs, for example, in Georgia, Greece, Spain, and Turkey. The same is true for most European countries with regard to travel vaccines.

ORGANIZATIONS WORKING IN IMMUNIZATION IN THE EUROPEAN REGION

Organizations and institutions working on immunization in the European Region are shown in Box 75.1 .

EUROPEAN-FUNDED HEALTH RESEARCH IS COORDINATED BY THE DIRECTORATE GENERAL RESEARCH AND INNOVATION (DG RTD)

The Directorate-General is responsible for the development and implementation of EU research and innovation policies. It manages the European Framework Programs that support research and innovation. The main tasks are: to develop European Union policy in the field of research and technological innovation, with special emphasis on improving the competitiveness of European businesses, to coordinate the European research activities in the Member States, manage the EU’s research programs, promote a better understanding of the role of science in modern society and to stimulate public debate on a European level about matters related to research.

The funding under DG RTD is currently named Horizon Europe Budget with nearly €95.5 billion available over the coming 7 years (2021 to 2027) that aims to support European research institutions in reaching scientific breakthroughs, remove barriers to innovation and make it easier for the public and private sectors to work together in delivering innovation. Research collaborations on new vaccines with or without adjuvants, universal influenza vaccines, Ebola vaccines, COVID-19 vaccines, and a clinical trials network for COVID-19 vaccines have been funded under this stream.

The Horizon 2020 further contributes funding to the formerly called Innovative Medicine Initiative (IMI) and since 2021 Innovative Health Initiative Joint Undertaking (IHI JU) established in 2021, research program, a public and private partnership (Joint Undertaking) equally cofunded by the European Commission and the member vaccine manufacturers of the European Federation of Pharmaceutical Industries and Associations (EFPIA) https://european-union.europa.eu/institutions-law-budget/institutions-and-bodies/institutions-and-bodies-profiles/innovative-health-initiative-joint-undertaking-ihi-ju_en ). The main priority of this research agenda is to tackle the major challenges in drug development— including vaccines—with a specific focus on evaluating vaccine safety and efficacy. Eight large vaccine-related projects have been funded in the last 12 years; PROTECT (Pharmacoepidemiological research on outcomes of therapeutics) funded in 2009 ( https://www.imi.europa.eu/sites/default/files/uploads/documents/projects/PROTECT_summary_final_report.pdf ), ADVANCE (vaccine benefit-risk assessments) funded in 2013 ( https://www.imi.europa.eu/projects-results/project-factsheets/advance ), Correlates of Protection for influenza FLUCOP funded in 2014 ( https://www.imi.europa.eu/projects-results/project-factsheets/flucop ), support to Ebola vaccine development funded in 2014 ( https://www.imi.europa.eu/projects-results/project-factsheets/ebola ), PERISCOPE set up to understand how the currently available pertussis vaccines work, and to aid the development and licensing of the next generation of improved pertussis vaccines funded in 2015 ( https://www.imi.europa.eu/projects-results/project-factsheets/periscope ), DRIVE which has the aim to bringing together all stakeholders to set up a platform, to study brand-specific influenza vaccine effectiveness in the EU over a five-year period funded in 2017 ( https://www.imi.europa.eu/projects-results/project-factsheets/drive ), RESCEU developing evidence on RSV disease burden and economic impact in the EU and providing infrastructure to perform future pivotal trials for RSV vaccines and therapeutics funded in 2017 ( https://www.imi.europa.eu/projects-results/project-factsheets/resceu ), followed by PROMISE which will continue developing methodology for RSV vaccine R&D, newly founded in 2021 ( https://www.imi.europa.eu/projects-results/project-factsheets/promise ).

A very recent development in 2021 in the EU is the new authority HERA, the European Health Emergency Preparedness and Response Authority ( https://ec.europa.eu/commission/presscorner/detail/en/ip_21_1522 ). The COVID-19 pandemic demonstrated the need for coordinated EU-level action to respond to health emergencies. It revealed gaps in foresight, including demand/supply dimensions, preparedness, and response tools. A European HERA is seen as a central element for strengthening the European Health Union with better EU preparedness and response to serious cross-border health threats, by enabling rapid availability, access, and distribution of needed countermeasures. How exactly vaccine R&D, regulation, joint procurement, policy formation, and surveillance which now is the responsibility of several independent organizations will be better coordinated at the EU level, remains to be seen. As a first step, the EU is setting up a European bio-defense preparedness plan “the HERA Incubator” against COVID-19 variants to bring together researchers, biotech companies, manufacturers, regulators, and public authorities to monitor variants, exchange data, and cooperate on adapting vaccines. The plan will focus on detecting, analyzing, and adapting to SARS-CoV-2 virus variants; speeding up regulatory approval of vaccines, providing guidance on data requirements, and facilitating the certification of new or repurposed manufacturing infrastructures; and supporting the speedy mass production of adapted or novel COVID-19 vaccines. A clinical trials network VACCELERATE initiated in February 2021 is part of this plan ( https://cordis.europa.eu/project/id/101037867 ). More recently Joint Procurement for monkeypox vaccines have been accomplished with >300,000 to be donated to the EU/EEA Member States.

PROCUREMENT

Procurement of vaccines in EU/EEA countries may be undertaken by governments as public sector provision of vaccines that are usually free to recipients or through private sector arrangements where there may be full or partial reimbursements of costs or through a mix of these arrangements. In non-EU countries, nearly all procurement of vaccines in national immunization schedules for the different age groups, children, adolescents, and adults, is through government or public sector central arrangements. The role of the private sector in supporting immunization services is reportedly increasing in areas such as logistics and service delivery as countries move to decentralize public administration and health services and phase out immunization as vertical standalone programs, anchoring it within the general medical practice. The vaccine supply systems vary from very centralized public procurement and distribution systems to completely decentralized systems where each immunization site contracts with a private supplier for vaccines. The Provision of paid private immunization services has significantly increased in central and eastern Europe and in the newly independent states since the turn of the present century, picking up an increasing role in meeting the demands of specific population groups.

However, budget lines for routine immunization vaccine procurement exist in all of the European Region countries, particularly covering full costs of the vaccines in their routine pediatric immunization schedule. Member States reporting less than 100% government funding for vaccine procurement reflect either financial or in-kind contributions of Gavi or funding through insurance schemes or at the subnational budget and financial mechanisms. Immunization as per the national schedule for children and adolescents is available free of charge or against reimbursement through health insurance in all Member States of the Region, with some optional vaccines provided against copayment or full reimbursement by health insurance. The latter may be true for the recommended adult vaccines.

UNICEF plays a critical role in vaccine procurement in almost all Gavi-supported and graduated countries as well as some other fifteen countries in the European Region with specific difficulties in procuring vaccines. Some national legislation on public procurement allows contracting for the current calendar year only, which in turn may lead to difficulties securing stable vaccine supplies. The vaccines procured by UNICEF are not necessarily produced and registered in Europe, but all have been prequalified by WHO.

There has been increasing conformity of the vaccines being used in European countries, diminishing the differences that used to occur between EU and non-EU countries. However, there are considerable differences in the prices that are paid. The EU countries tend to pay full industrialized country prices, subject to national procurement arrangements where centralized contracts might achieve better prices than private-sector purchasing. Countries with smaller to mid-range sizes of relevant vaccine cohorts frequently report problems negotiating prices, a lack of interest from suppliers to apply to vaccine procurement tenders, and hence often resulting in vaccine prices that exceed considerably the ones achieved by the EU Member States. Recently, the WHO Regional Office for Europe has been working closely with low and upper- middle-income countries to ensure equitable access to vaccines at affordable prices. There is an ongoing review of different schemes, including tiered pricing and pooled procurement.

The 2009 influenza pandemic highlighted the differences in procurement arrangements for vaccines in Europe. Based on assessments of risks of H5N1 influenza viruses being the likely cause of the next pandemic, approximately one-half of the EU countries had made arrangements with vaccine-producing companies for access to pandemic vaccines through Advance Purchase Agreements (APAs). When the 2009 H1N1 pandemic began, countries that did not have APAs were obliged either to wait for the second phase of pandemic vaccine production after the advance purchase agreements had been fulfilled or to apply to WHO for access to its influenza A (H1N1) pdm09 vaccine supplies. Azerbaijan, Georgia, the Republic of Moldova, and Tajikistan received vaccines through WHO donations.

Following the 2009 pandemic, EU Member States asked the European Commission to investigate mechanisms that would permit a more equitable sharing of access to vaccines in a future pandemic so that less-affluent countries did not have to be as disadvantaged as they had been in 2009. The Commission investigated the opportunities ranging from central procurement for EU countries to joint contracting arrangements by like-minded countries and production of purchasing guidelines to help countries do their own procurement. The European Commission issued an assessment report on EU-wide pandemic vaccine strategies in August 2010. The efforts have since continued and an EU/EEA-wide joint procurement mechanism for all countermeasures including pandemic vaccines is now in place supported by legislation in the event of serious cross-border threats. The joint procurement mechanism was put to test in early 2020 when the Commission entered into Advance Purchase Agreements for COVID-19 vaccines with individual vaccine producers on behalf of all EU Member States ( https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-health/eu-vaccines-strategy_en ). In return for the right to buy a specified number of vaccine doses in a given timeframe and at a given price, the Commission financed a part of the upfront costs faced by vaccine producers from the €2.7 billion Emergency Support Instrument. This funding was considered a down-payment on the vaccines that Member States would purchase. Additional support for vaccine producers was possible through loans from the European Investment Bank. This approach was meant to decrease risks for companies while speeding up manufacturing. The joint procurement has provided stronger negotiating power, lower costs, and equitable access within the EU, and also helped create a common understanding of liability issues. Other issues addressed include dealing with excess doses included in donations to third countries, economic sanctions for delayed delivery of vaccines, liability should a safety concern arise, and conditions under which a contract becomes void. As of June 2022, the Commission has made contracts with six vaccine manufacturers, an additional two are being negotiated, and the COVID-19 vaccine coverage of the EU is now in early autumn of 2021 among the highest in the world.

SURVEILLANCE OF VACCINE-PREVENTABLE DISEASES IN THE EUROPEAN REGION

The responsibility for surveillance of vaccine-preventable diseases lies with individual countries. Within the countries, some vaccine-preventable diseases are statutorily reportable (e.g., measles in all WHO EURO region countries), some are collected nationally on a voluntary basis (e.g., pneumococcal infection in the United Kingdom and the Netherlands), and others are kept under surveillance through sentinel systems (influenza in all EU/EEA countries, rotavirus in Ukraine, and invasive bacterial diseases in Azerbaijan and Uzbekistan).

In the EU/EEA the following vaccine-preventable communicable diseases included in vaccination programs are notifiable: COVID-19, diphtheria, hepatitis A, hepatitis B, Hemophilus influenza type b, influenza, meningococcal disease, pneumococcal disease, measles, mumps, pertussis, polio, rubella, tetanus, tick-born encephalitis (TBE) and tuberculosis. In addition, rabies, yellow fever, and malaria are notifiable.

The ECDC and the WHO Regional Office for Europe have undertaken a review of diseases under epidemiologic surveillance and the case definitions used. This has resulted in strengthened surveillance systems for vaccine-preventable diseases within the WHO European Region through the availability of information on a broader range of diseases, using mutually agreed upon case definitions, and reducing the duplication of reporting by the Member States.

For polio surveillance, 43 of 53 member states of the European Region, including 21 of 30 EU/EEA countries, conduct surveillance for acute flaccid paralysis (AFP) and report weekly to WHO/Europe. The number of countries abolishing traditional AFP surveillance is increasing in the era of widespread use of advanced imaging techniques and molecular biology technologies that help establish a diagnosis in much shorter timeframe than is required for virus isolation. Thirty-nine countries conduct enhanced enterovirus surveillance and 22 conduct environmental surveillance through sewage collection. A WHO polio laboratory network of 48 laboratories located in 37 countries undergoes annual accreditation. In addition, four regional reference laboratories (Berlin, Bilthoven, Paris, and Rome) and three of the global polio reference laboratories (Bilthoven, London, and Moscow) are located in the WHO European Region ( https://www.euro.who.int/en/health-topics/communicable-diseases/poliomyelitis/activities/polio-laboratory-network ).

Measles is notifiable in all 53 member states. Countries report clinically diagnosed measles cases to WHO annually through the WHO/UNICEF Joint Reporting Form. In accordance with regional surveillance guidelines, 38 countries report case-based information to WHO monthly. The Regional measles and rubella laboratory network was established in 2002 and consists of 72 laboratories: one global (London), three regional (Luxembourg, Berlin, and Moscow), and 48 national and 20 subnational laboratories.

Fifty-one of the 53 member states, including all EU/EEA countries, conduct measles surveillance. All data are stored and disseminated using the centralized information system for infectious diseases (CISID) ( http://data.euro.who.int/cisid/ ). National and regional reference laboratories provide a WHO measles and rubella regional laboratory network for genotyping identified measles and rubella viruses and sharing these data for identifying circulating viruses and monitoring progress toward elimination ( https://www.euro.who.int/en/health-topics/communicable-diseases/measles-and-rubella/activities/measles-and-rubella-laboratory-network ).

Reporting of rubella cases at the national level is mandatory in 43 of the 53 Member States. Of these, 34 have case-based surveillance at the national level, and the reporting scheme is similar to the one described for measles. Belgium, Denmark, and France do not have mandatory notification systems covering the total population for reporting rubella cases. Germany introduced a national rubella notification system in 2013. Intense efforts are underway to strengthen rubella surveillance in the region. Some countries face difficulties justifying the additional expense of comprehensive surveillance for measles, rubella, and congenital rubella syndrome given the current scarcity of funding for health and the nature of national health funding priorities. However, samples from suspect cases are sent to the European reference laboratories if the national laboratories do not provide timely diagnostics.

All EU/EEA Member States have surveillance for invasive bacterial diseases caused by N. meningitidis, S. pneumoniae, and H. influenzae type b. The WHO European Regional Office is working with Eastern European countries and newly independent states to establish and strengthen the invasive bacterial disease surveillance network, currently comprising laboratories in seven countries to monitor circulating serotypes.

The WHO European Regional Office has also established a rotavirus surveillance network for Eastern European countries with a regional reference laboratory based in Minsk, Belarus. Surveillance for rotavirus genotypes in the Western part of the European region already exists through a regulatory requirement on the two manufacturers (EuroRotaNet) with the last published report in 2020 ( https://www.eurorotanet.com/ ).

The European Member States had a target to eliminate indigenous diphtheria by the year 2000 (the absence of indigenous cases caused by toxigenic Corynebacterium diphtheriae strains). ECDC has since assumed diphtheria surveillance responsibility for the EU/EEA countries while all Eastern European countries report monthly to WHO/Europe.

Reporting of tuberculosis in the Member States, new and relapsing cases, are reported jointly to ECDC and the WHO European Regional Office and joint annual reports are compiled ( https://www.ecdc.europa.eu/sites/default/files/documents/TB-Surveillance-report_24March2020.pdf ). Also, multidrug resistance strains are reported while reporting of latent tuberculosis cases is not conducted but would be of interest.

COVID-19 was added to the list of notifiable diseases in 2020. Almost all countries report case-based data from the community, in hospitals, in intensive care, and in mortality, on a daily basis. Further, sequencing or full-genome sequencing capacity has been expanded through public health and private laboratories and in the EU with significant funding through the HERA agency.

In the EU/EEA no EU-level surveillance is conducted for the following vaccine-preventable communicable diseases: Varicella, herpes zoster, rotavirus (beyond the EMA regulatory requirement that is now stopping 15 years after the EU authorization), HPV, RSV (IMI project ongoing) and latent TB. However, efforts in individual countries are ongoing by either Public Health Institutes or academia. An example of such a national initiative is the surveillance of varicella in Germany.

VACCINES USED AND IMMUNIZATION COVERAGE IN THE EUROPEAN REGION

The vaccines and immunization schedules used in the 53 countries of the European Region are undergoing continuous change with the introduction of new antigens and the increasing use of combined-antigen vaccines. Annual information is collected from WHO Member States on immunization programs and vaccine-preventable diseases using the WHO/UNICEF Joint Reporting Form (JRF) as part of the global data collection jointly conducted with UNICEF. The information for a given year is collected during the spring of the following year and usually is available by the summer. The data referred to in this chapter are those available to the WHO European Regional office on immunization programs for 2020. Information on vaccines included in the national immunization schedules for any age group is listed in Table 75.1 but for the yearly updates moving forward the reader is encouraged to access the WHO website ( https://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5Bcountry%5D%5B%5D=ISL ). Other vaccines may be in selective use, either for specific risk groups, in selected geographical areas, by parental choice, for outbreak/pandemic management or in relation to travel. Vaccines that have obtained NITAG recommendation but are pending introduction are also not reflected in the overview.

The measurement of immunization coverage in the European Region is challenging because of the wide range of techniques employed for data collection in individual countries resulting in issues with data quality and comparability. The methods for assessing coverage include collecting data manually or electronically by the administrative method (doses reported administered divided by estimates of the target population), conducting surveys at regular time intervals of selected populations, or use of manual/electronic immunization registers preferably with a personal identifier that can be linked to other health registries. All three methods are used in the European region but the number of countries with electronic immunization registries has dramatically increased ahead of the large COVID-19 vaccination campaigns starting in late 2020 or early 2021 with the need for documentation of COVID-19 vaccine product, dose number, and batch number. The systems established can often, but not always, document all vaccines in all age groups. In the countries with established immunization registries, public health data are fully computerized and actively managed; thus, coverage is calculated by comparing the number of individuals who have completed immunization by a specified age with the number of individuals of the same age residing in the particular community: coverage by age cohort. These data are reported on a weekly basis at the EU level and in the UK, so close to real-time reporting. Also, breakthrough infections following vaccinations are monitored by linking the electronic immunization registries to disease surveillance databases.

Earlier in countries where the private-sector providers administer many immunizations, coverage is calculated by comparing the number of doses of vaccine imported or distributed with the estimated target population. In these countries, allowances for wastage and inaccuracies in the target population make these coverage estimates unreliable. However, many of these countries have also built systems for at least documenting the COVID-19 vaccines and hopefully, the lessons learned will spill over to all vaccines administered in any age- or target group.

In non-EU countries, administrative coverage is usually reported as the number of doses administered in each locality divided by the estimated target population. Inaccuracies can occur in the estimates of the numerators and denominators because of inaccurate census data and facilities incorrectly determining their catchment population. Many countries also routinely conduct household surveys, such as the Demographic Health Surveys or Multiple Indicator Cluster Surveys. These data are used in calculating the best estimate by WHO and UNICEF.

Traditionally, in most countries, coverage for the infant program has been measured at 2 years of age but for example, in Germany it has been measured at school entry, usually at 5 years of age, through data held by health insurance providers. Because countries use such different techniques for estimating coverage and with variable accuracy, comparisons among countries’ coverage reports should be made with caution.

There are three schedule patterns for primary pediatric immunizations in the European Region. The Netherlands and the United Kingdom use a 3-dose early-onset schedule with vaccination at 2, 3, and 4 months of age, as do Azerbaijan, Bulgaria, Georgia, and Kazakhstan. Belgium, Ireland, and Switzerland use a three-dose middle-onset schedule at 3, 4, and 5 months or 2, 4, and 6 months of age. Most of these three-dose priming schedules offer a booster dose during the second year of life. France and Slovakia use a three-dose early schedule at 2 and 4 months with a third booster dose administered at 10–11 months. Austria, Denmark, Finland, Norway, Sweden, Iceland, and Italy use a two-dose late schedule, whereby doses are recommended at 3 and 5 months, and a third booster dose is given around the first birthday. See Table 75.1 .