Cent Eur J Public Health 2015, 23(3):218-222 | DOI: 10.21101/cejph.a4170

How do we evaluate and manage many different vaccination schedules in the EU?

Vladimír Oleár1, Zuzana Krištúfková1, Mária Štefkovičová2
1 Department of Epidemiology, Faculty of Public Health Studies, Slovak Medical University, Bratislava, Slovak Republic
2 Faculty of Healthcare, Alexander Dubček University of Trenčín, Trenčín, Slovak Republic

Background: Vaccines are biologic medical products, the biological activity and characteristics of which are significantly different from common drugs and other medical products. The process of determining the dosing (vaccination) schedule for a particular vaccine is based on different principles and rules than other drugs. The dosing schedule for drugs is based on the essential pharmacological properties: pharmacokinetics and pharmacodynamics. When determining the schedule for vaccines, the pharmacokinetic and pharmacodynamic principles cannot be applied: sero-conversion and sero-protectivity of the biologically active component of the vaccine need to be applied. As opposed to drugs and medical products the dosing (vaccination) schedule in the Summary of Product Characteristics (SPC) is often provided in several versions, sometimes with a supplement referring to official (national) recommendations. In relation to the large variability vaccination schedules in the European Union (EU), it is not realistic to test each vaccination schedule in clinical studies. Requiring clinical trials for each vaccination schedule used only for the needs of regulators is more of an ethical issue than a scientific one. The European Centre for Disease Prevention and Control (ECDC), which is the Scientific Panel on Childhood Immunisation Schedule (SPACIS), accepts all the schedules used in EU countries as valid.

Methods and Results: A review of the literature on immunisation schedules for primary series and booster doses choosing the following key words: immunisation, vaccination schedule, primary, booster, timing, vaccination delay.

Keywords: immunisation, vaccination schedule, primary, booster, vaccination delay

Received: November 10, 2014; Revised: January 11, 2015; Accepted: January 11, 2015; Published: September 1, 2015  Show citation

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Oleár V, Krištúfková Z, Štefkovičová M. How do we evaluate and manage many different vaccination schedules in the EU? Cent Eur J Public Health. 2015;23(3):218-222. doi: 10.21101/cejph.a4170. PubMed PMID: 26615653.
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References

  1. WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment 2013. 16th ed. Oslo: Norwegian Institute of PublicHealth; 2012.
  2. Mehrotra DV. Vaccine clinical trials - a statistical primer. J Biopharm Stat. 2006;16(4):403-14. Go to original source... Go to PubMed...
  3. Larson HJ, Cooper LZ, Eskola J, Katz SL, Ratzan S. Addressing the vaccine confidence gap. Lancet. 2011 Aug 6;378(9790):526-35. Go to original source... Go to PubMed...
  4. KrogerAT,AtkinsonWL, Marcuse EK, Pickering LK, General immunization practices. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 6th ed. London: W.B. Saunders; 2013. p. 93-94.
  5. Theeten H1, Nohynek H, Coenen TM; European Science Advisory Network for Health (EuSANH). EuSANH workshop "Reasons behind the differences in national vaccination schedules for under-five", European Public Health pre-conference workshop, Malta, 8 November 2012. Vaccine. 2013 Oct 1;31(42):4694-6. Go to original source... Go to PubMed...
  6. European Centre for Disease Prevention and Control. Scientific panel on childhood immunisation schedule: Diphtheria-tetanus-pertussis (DTP) vaccination. Stockholm: ECDC; 2009.
  7. The childhood immunization schedule and safety: Stakeholder concerns, scientific evidence, and future studies. Washington, D.C.: The National Academies Press; 2013.
  8. Hambidge SJ, Newcomer SR, Narwaney KJ, Glanz JM, Daley MF, Xu S, et al. Timely versus delayed early childhood vaccination and seizures. Pediatrics. 2014 Jun;133(6):e1492-9. Go to original source... Go to PubMed...
  9. Guideline on Clinical evaluation of new vaccines. EMEA/CHMP/ VWP/164653/2005 [Internet]. London: EMEA; 2006 [cited 2014 May 22]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003870.pdf.
  10. Lopalco PL, de Carvalho HG, Kreidl P, Leitmeyer K, Giesecke J. Childhood vaccination schedules in Europe vary widely Is this a problem? Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2009 Nov;52(11):1095-8. Go to original source... Go to PubMed...
  11. Kulldorff M. Study designs for the safety evaluation of different childhood immunization schedules. In: The childhood immunization schedule and safety: Stakeholder concerns, scientific evidence, and future studies. Washington, D.C.: The National Academies Press; 2013. p. 161-90.
  12. D'Ancona F; Venice II Group. VENICE II: Go on combining our efforts towards a European common vaccination policy! Euro Surveill. 2009 Mar 26;14(12);pii:19161.
  13. Chlíbek R, Smetana J, Boštíková V, Špliňo M, Hanovcová I. Vaccination schedule in Czech versus EU. Vakcinologie. 2013,7(3):108-14. (In Czech.)
  14. National Center for Immunization and Respiratory Diseases. General recommendations on immunization - recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 28;60(2):1-64. Erratum in: MMWR Recomm Rep. 2011 Jul 29;60:993.
  15. Wiese-Posselt M, Reiter S, Gilsdorf A, Krause G. Needs and obstacles of uniform immunisation schedules in the European Union. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2009 Nov;52(11):1099-104. Go to original source... Go to PubMed...
  16. European MedicinesAgency [Internet]. London: EMA; 2014 [cited 2014 Jun 5]. European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA). Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000303.jsp.
  17. Fine PE. Herd immunity: history, theory, practice. Epidemiol Rev. 1993;15(2):265-302. Go to original source... Go to PubMed...
  18. Centers for Disease Control and Prevention [Internet].Atlanta: CDC; 2013 [cited 2014 May 22]. For parents: vaccines for your children. Available from: http://www.cdc.gov/vaccines/parents/sets-schedule.html.
  19. TheVaccine European New Integrated Collaboration Effort (VENICE) III project [Internet]. Rome: Istituto Superiore di Sanità; 2014 [cited 2014 Oct 22]. Available from: http://venice.cineca.org/the_project.html.