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After the beginning of the influenza A (H1N1 pdm09) pandemic in 2009, several monovalent pandemic H1N1 vaccines were licensed using fast track procedures, with limited safety data in children and adolescents.1 Nonadjuvant monovalent vaccines were used in the United States and Australia, and on a limited scale, in Europe (France, Spain) and other countries. Within the European Union (EU), 2 different vaccines with adjuvant were licensed, both containing a new generation of squalene-based adjuvant: Focetria (Novartis, Philadelphia, PA), with the MF59 adjuvant, and Pandemrix (GSK, Philadelphia, PA), containing AS03 (squalene and α-tocopherol). Arepanrix, similar to Pandemrix, was used in Canada and Brazil. The vaccine program started in the EU by September 2009; concurrently, the European Center for Disease Prevention & Control (ECDC), Vaccine Adverse Event Surveillance and Communication, and other agencies initiated an active surveillance program to monitor safety and adverse events associated with this vaccine.
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- © 2013 American Academy of Neurology
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