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Background paper to the recommendation for the preferential use of live-attenuated influenza vaccine in children aged 2–6 years in Germany

  • G. Falkenhorst
  • T. Harder
  • C. Remschmidt
  • M. Terhardt
  • F. Zepp
  • T. Ledig
  • S. Wicker
  • B. Keller-Stanislawski
  • T. Mertens
Tätigkeitsberichte

Abstract

The German Standing Committee on Vaccination (STIKO) recommends seasonal influenza vaccination for children and adolescents with chronic medical conditions that put them at risk for severe influenza illness. In addition to trivalent inactivated influenza vaccines (TIV), a trivalent live-attenuated influenza vaccine (LAIV) was licensed for children and adolescents aged 2–17 years in the European Union in 2011. Employing the methodology of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group, we examined the evidence for efficacy and safety of LAIV relative to TIV to guide STIKO’s decision on whether LAIV should be preferentially recommended for at-risk children. In our meta-analysis of data from two randomized trials directly comparing LAIV and TIV in children aged ≤ 6 years, the protective efficacy of LAIV against laboratory-confirmed influenza was 53 % [95 % confidence interval (CI): 45–61 %] higher than that of TIV. A similar study in individuals aged 6–17 years showed a 32 % (95 % CI: 3–52 %) higher efficacy of LAIV. The quality of the evidence for a superior protective efficacy of LAIV against all relevant clinical outcomes was rated ‘moderate’ for children aged 2–6 years and ‘low’ for the age group 7–17 years. Regarding safety outcomes, the available data suggest no significant differences between LAIV and TIV. Based on these results, STIKO recommends that LAIV should be used preferentially for influenza vaccination of at-risk children aged 2–6 years. In children and adolescents aged 7–17 years, either LAIV or TIV may be used without specific preference. Possible contraindications and the vaccinee’s and his/her guardians’ preferences should be taken into account.

Keywords

Influenza Vaccination Children Standing committee on vaccination (STIKO) Germany 

Hintergrundpapier zur Empfehlung einer bevorzugten Anwendung von attenuiertem Influenza-Lebendimpfstoff bei 2- bis 6-jährigen Kindern in Deutschland

Zusammenfassung

Die Ständige Impfkommission (STIKO) empfiehlt die saisonale Influenza-Impfung für Kinder und Jugendliche mit chronischen Krankheiten, die ein erhöhtes Risiko für eine schwere Erkrankung an Influenza mit sich bringen. Neben den trivalenten Influenza-Totimpfstoffen (TIV) wurde 2011 für 2- bis 17-Jährige ein trivalenter attenuierter Influenza-Lebendimpfstoff (LAIV) in der Europäischen Union zugelassen. Anhand der Methodik der Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group haben wir die Evidenz für die Effektivität und Sicherheit von LAIV im Vergleich zu TIV untersucht, als Entscheidungsgrundlage für eine mögliche präferenzielle Empfehlung von LAIV durch die STIKO. In unserer Metaanalyse der Daten aus 2 randomisierten Vergleichsstudien von LAIV und TIV bei Kindern ≤ 6 Jahren war die Schutzwirkung von LAIV gegen laborbestätigte Influenza um 53 % [95 %-Konfidenzintervall (KI): 45–61 %] höher als die von TIV. Eine ähnliche Studie mit 6- bis 17-Jährigen zeigte eine um 32 % (95 %-KI: 3–52 %) höhere Effektivität von LAIV. Die Qualität der Evidenz für eine bessere Effektivität von LAIV gegen alle klinisch relevanten Endpunkte wurde für 2- bis 6-Jährige als „moderat“ eingestuft, für 7- bis 17-Jährige als „niedrig“. Signifikante Sicherheitsunterschiede zwischen LAIV und TIV fanden sich nicht. Aufgrund dieser Ergebnisse empfiehlt die STIKO, Kinder im Alter von 2–6 Jahren mit einer Indikation für die Influenza-Impfung bevorzugt mit LAIV zu impfen. Bei 7- bis 17-Jährigen können LAIV und TIV gleichwertig verwendet werden, wobei mögliche Kontraindikationen und die Wünsche des Impflings bzw. der Eltern zu berücksichtigen sind.

Schlüsselwörter

Influenza Impfung Kinder Ständige Impfkommission (STIKO) Deutschland 

Notes

Conflict of interest

The corresponding author states the following: M. Terhardt has given non-product-related talks on influenza vaccination that were sponsored by AstraZeneca. S. Wicker has received honoraria for non-product-related talks on influenza vaccination from GlaxoSmithKline, Sanofi Pasteur, AstraZeneca and Novartis and has participated in workshops about health care workers and vaccination sponsored by Abbot. F. Zepp has participated in a collaborative research project on pandemic influenza vaccines (GlaxoSmithKline, GSK) and has participated as a member/expert in advisory boards on pandemic and seasonal influenza for Chiron, Novartis and GSK. He has given non-product-related talks and was moderator or (co-)chairperson in symposia on influenza vaccination sponsored by GSK, InfectoPharm and Novartis. The associated travel expenses have been financed or refinanced by these companies. All other authors declare that they have no conflicts of interest.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • G. Falkenhorst
    • 1
  • T. Harder
    • 1
  • C. Remschmidt
    • 1
  • M. Terhardt
    • 2
  • F. Zepp
    • 3
  • T. Ledig
    • 4
  • S. Wicker
    • 5
  • B. Keller-Stanislawski
    • 6
  • T. Mertens
    • 7
  1. 1.Immunization Unit, Department for Infectious Disease EpidemiologyRobert Koch InstituteBerlinGermany
  2. 2.Medical PracticeRatingenGermany
  3. 3.Department of Paediatrics and Adolescent Medicine, University Medical CentreJohannes Gutenberg UniversityMainzGermany
  4. 4.Medical PracticeDitzingenGermany
  5. 5.Occupational Health ServiceUniversity HospitalFrankfurt/MainGermany
  6. 6.Paul Ehrlich InstituteLangenGermany
  7. 7.Institute of VirologyUlm University Medical CentreUlmGermany

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