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Strategies of Vaccinations -

Strength in Diversity

Roman Prymula

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Background I.

Vaccines have a major impact on society. Indeed, vaccination is one of the greatest public health achievements, and vaccines play a pivotal role in the sustainability of Health Care systems.

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Background II. Increase in the number of available

vaccines x increase in the number of injections.

The Children’s Vaccine Initiative of 1990 - provide a single vaccine to protect against all diseases

- unrealistic. Combination vaccines allow the number

of injections to be reduced. (In Germany, where the hexavalent

DTP/polio/hepatitis B/Hib vaccine and MMR vaccines are used, considerably fewer injections are required than in the US, where more monovalent vaccines are used).

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Background III. The countries have slightly different

schedules; however, all provide vaccines against diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, and hepatitis B. (EPI + Hib + Hep B)

More vaccines that are licensed or at various stages of clinical development.

Funding – governmental x privat The natural history of vaccination

programmes emphases the point that the very success of vaccinations leads to concerns that they are no longer necessary (and people have forgotten the seriousness of some diseases such as poliomyelitis).

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Current European situation

Different European national strategies could reduce the effectiveness of programmes for prevention. Harmonization of immunization policies and of recommendations for vaccine administration is advisable.

The mass vaccination of all young children combined with systematic revaccination is probably the most effective approach for elimination of infectious diseases in Europe.

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Summary

Wide variety of different vaccination strategies in Europe

Obstacles to harmonization– organizational– political– economical

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Components of vaccination programmes

Adverse events

surveillance

Surveillance of population susceptibility

Vaccine delivery - supply, clinics

Vaccine development

Advisory Board, Ministry

Surveillance of coverage

Predicting the future -

modelling

Monitoring attitudes to vaccination

Surveillance of diseases

Communication

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Principles

To avoid overlapping with ongoing activities– ECDC, WHO– Programmes– Projects– Existing networks

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Possible strategies for Europe

Evaluate and assess burden of (paediatric) infectious diseases and recommend optimal control measures

Discuss and agree to possible evolutions in (paediatric) vaccination calendars

Identify needs/issues around introduction of new vaccines (including funding, private/public, health and social security systems) and actions to address them

Provide recommendations and guidance for country implementation of newer vaccines/vaccination calendars

Prepare economic analyses on the cost effectiveness of introducing certain vaccines. Analyses should be based on each country’s economic data.

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Recommendations for introduction of new vaccines and implementation of sustainable financing strategies:

– Establish immunisation priorities framework – Evaluation processes to be clarified.– Increase transparency of evaluation processes – Increase transparency of approval processes – Specify timelines for price negotiations – Transparency in value for acceptable cost-

effectiveness – Assess therapeutic vaccines as per drugs– Partial government funding should be

available for vaccines; – In addition to which govt to encourage private

health insurers to offer coverage for non-government funded portion of vaccines costs

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Strenght in Diversity

EU countries: natural lab– Similar principles– Different schedules, various

approaches– Implementation of new vaccines

(HPV, Rota, Pneumo, ChickenPox)

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Strategies of vaccination – Objectives

1.1 To generate recommendations on guidelines for optimum vaccination schedules, based on current knowledge; to assess longer-term options for harmonising vaccination policy across the EU and for devising explicit criteria for selecting vaccination schedules.

1.2 To review the information available on immigrant infectious disease (e.g. HIV/AIDS, TB) and vaccination status and the current monitoring mechanisms, in order to elucidate the options for improving access of migrants to health services and to provide early alerts on unexpected transmissible disease.

1.3 To improve the efficiency of public health policies by integrating knowledge (e.g. regarding surveillance and regulation) from human and animal vaccination strategies.

1.4 To assess the current status of meta-analysis in systematic literature review and other methodologies in determining the safety and effectiveness of vaccines; to improve the use of this evidence base as a resource in answering policy questions.

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Strategies of vaccination – methodology

1.1 Case study analysis, monitoring, comparing and evaluating current principles and practices in Member States for vaccine schedules, selected to illustrate and clarify the wide range of immunisation strategies according to pathogen characterisation, e.g. tetanus, BCG, measles, hepatitis A and B, pertussis and mumps. Review and synthesis of evidence to be accompanied by survey of current criteria (explicit and implicit) used by Member States in prioritising schedule (according to safety, efficacy and cost-effectiveness considerations).

1.2 Collection and evaluation of surveillance data available (on infectious disease and vaccination status) from centres dealing with immigrants.

1.3 Collection and evaluation of EU and national information on extent of integration of human and animal vaccination strategies to identify gaps, develop models.

1.4 Generation and testing of database resource of vaccine safety and efficacy information derived by meta-analysis (and other clinical research methods) in order to assess quality of analysis (e.g. potential for bias) and gaps in knowledge.

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Strategies of vaccination – Expected results

(i) Project report on EU-Member State vaccination strategy analysis and conclusions.

(ii) Recommendations on guidelines for vaccination schedules and on other policy development options, including those options for (a) data collection for migrants, coupled with mechanism for real-time notification of unexpected transmissible disease (e.g. web-based models for creating standardised and networked data collection and surveillance procedures); (b) integration of human and animal vaccination strategies; (c) longer-term harmonisation of policy, that may require new EU instruments.

(iii) Development of systematic review (meta-analysis) as a new resource for policy makers and analysis of quality of methodological approaches to determining vaccine safety and efficacy, with initiation of new meta-analysis in order to inform policy development.

(iv) Synthesis of results from (i)-(iii) to frame new policy questions that can now be tackled by analysing the evidence base.

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N.B. Unless otherwise stated in the footnotes below, each coloured box represents one dose of pertussis vaccine.

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DTPa-Hib-IPV-HepB

                                                                                                                                                                                   

N.B. Unless otherwise stated in the footnotes below, each coloured box represents one dose of pertussis vaccine.

EU– Austria, Belgium, Czech Republic,

Germany, Luxemburg, Slovak Republic– Schedules

• 2,3,4 • 3,4,5• 2,4,6• 3,5,11 (12)

                                                                                                                                                                                   

N.B. Unless otherwise stated in the footnotes below, each coloured box represents one dose of pneumococcal vaccine.

                                                                                                                                                                                   

N.B. Unless otherwise stated in the footnotes below, each coloured box represents one dose of pneumococcal vaccine.

                                                                                                                                                                                   

N.B. Unless otherwise stated in the footnotes below, each coloured box represents one dose of pneumococcal vaccine.

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Age In months 1. a 2. d

Country N SC% (95%CI)

GMCg/ml (95%CI)

2,3 France 83 84.3 (74.7,91.4)

181.8 (126.4,261.6)

2,3 Germany 156 82.1 (75.1,87.7)

166.0 (126.0,218.9)

2,4 Spain 193 85.5 (79.6,90.2)

156.3 (123.4,198.0)

3,4 Czech Republic

182 84.6 (78.5,89.5)

152.5 (118.9,195.4)

3,5 Italy 13 92.3 (64.0,99.8)

205.1 (80.5,522.7)

3,5 Finland 167 94.6 (90.0,97.5)

412.2 (325.9,521.2)

total 794 86.5 (83.9,88.8)

197.2 (175.2,222.0)

Seroconversion rate and GMC after Rota vaccine

T. Vesikari, A. Karvonen, R. Prymula, …., ESPID 2006T. Vesikari, A. Karvonen, R. Prymula, …., ESPID 2006

PNC7 – European Strategy

universal (11)

no (10)

source: Modified Eurosurveillance Data

risk groups only (8)

PNC7 – universal programmes

3 + 1 (5)

2 + 1 (6)

source: Modified Eurosurveillance Data

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Pneumococcal conjugate vaccine – EU strategy

Schedule 3 + 1 x 2 + 1E. MILLER, ESPID 2007

* Randomized study (+ MCC), 2006* 390 babies, into 6 groups* 2/3 or 2/4 schedule

Results: Superior 2/4 schedule,Limited antibody response: 6B, 23F

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Conclusions

Harmonized European schedule difficult to establish

Recommended strategies based on specific epidemiological situation

Use of the best practises (implementation of the nationally verified schedules)

Step by step approach– Set targets in each infectious disease– To issue recommended schedule– Harmonization

To avoid commercial and national interests – independent body of experts needed to issue recommendations (FEAM)