Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance

Xavier KurzAna Hidalgo-Simon


The 14,543 spontaneous reports of suspected adverse reactions received in EudraVigilance from 1 November 2009 to 30 April 2010 for three centrally authorized Influenza A/H1N1 vaccines marketed in the European Economic Area (Celvapan, Focetria and Pandemrix) were extracted to evaluate the effectiveness of recommendations to strengthen pharmacovigilance systems during the pandemic and illustrate methods of signal detection used by the European Medicines Agency in this context. The number of vaccinees on 30 April 2010 was estimated to be at least 37,166,000 with a reporting rate of 391 per million vaccinees. 81.4% of reports were received in a period of 2 months ending 31 December 2009. Reports for A/H1N1 vaccines had fewer missing values for date of birth, age, case narrative, vaccination date and reaction onset date than reports involving human papilloma virus vaccines in a pre-pandemic period but more missing batch numbers (46.6%), with earlier notification by health care professionals to national authorities (median of 7 days since reaction onset date) and by national authorities to EudraVigilance (4 days). The network of European pharmacovigilance centers and the Agency was effective for monitoring the safety of A/H1N1 vaccin...Continue Reading


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Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.