title: Safety of pandemic H1N1 vaccines in children and adolescents.
abstract: During the 2009 influenza A (H1N1) pandemic several pandemic H1N1 vaccines were licensed using fast track procedures, with relatively limited data on the safety in children and adolescents. Different extensive safety monitoring efforts were put in place to ensure timely detection of adverse events following immunization. These combined efforts have generated large amounts of data on the safety of the different pandemic H1N1 vaccines, also in children and adolescents. In this overview we shortly summarize the safety experience with seasonal influenza vaccines as a background and focus on the clinical and post marketing safety data of the pandemic H1N1 vaccines in children. We identified 25 different clinical studies including 10,505 children and adolescents, both healthy and with underlying medical conditions, between the ages of 6 months and 23 years. In addition, large monitoring efforts have resulted in large amounts of data, with almost 13,000 individual case reports in children and adolescents to the WHO. However, the diversity in methods and data presentation in clinical study publications and publications of spontaneous reports hampered the analysis of safety of the different vaccines. As a result, relatively little has been learned on the comparative safety of these pandemic H1N1 vaccines - particularly in children. It should be a collective effort to give added value to the enormous work going into the individual studies by adhering to available guidelines for the collection, analysis, and presentation of vaccine safety data in clinical studies and to guidance for the clinical investigation of medicinal products in the pediatric population. Importantly the pandemic has brought us the beginning of an infrastructure for collaborative vaccine safety studies in the EU, USA and globally.
authors.affiliation: Erasmus Medical Center, Rotterdam, The Netherlands. e.wijnans@erasmusmc.nl
authors.forename: Leonoor
authors.initials: L
authors.lastname: Wijnans
authors.forename: Sandra
authors.initials: S
authors.lastname: de Bie
authors.forename: Jeanne
authors.initials: J
authors.lastname: Dieleman
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
authors.forename: Miriam
authors.initials: M
authors.lastname: Sturkenboom
mesh_terms: D000276:Adjuvants, Immunologic; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology* / Q000517:prevention & control*; D058873:Pandemics; D014611:Vaccination / Q000009:adverse effects*; D014613:Vaccines, Attenuated; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated