Thomas Breuer and colleagues at GlaxoSmithKline respond to Peter Doshi

Summaries of the information relating to all pandemic vaccines used in Europe were made available to the public weekly on the European Medicines Agency website.2 The above disclosures were made in addition to the routine safety oversight processes established by the authorities for medicinal product...

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Veröffentlicht in:BMJ (Online) 2018-10, Vol.363, p.k4116-k4116
Hauptverfasser: Breuer, Thomas, Bauchau, Vincent, Poplazarova, Tatjana, Stegmann, Jens-Ulrich
Format: Artikel
Sprache:eng
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Zusammenfassung:Summaries of the information relating to all pandemic vaccines used in Europe were made available to the public weekly on the European Medicines Agency website.2 The above disclosures were made in addition to the routine safety oversight processes established by the authorities for medicinal products, which include the independent assessment of available safety data by experts in regulatory authorities and public health institutes. Furthermore, the analysis in The BMJ itself shows that the disparity in adverse event reporting rates between the two vaccines was very similar across several types of adverse events, which is a further indication that the reporting rates do not reflect differences between the two vaccines but rather different reporting intensities in the various countries and regions. Pandemic influenza pharmacovigilance updates. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000246.jsp&mid=WC0b01ac058004bf57 3 US Food and Drug Administration.
ISSN:0959-8138
1756-1833
DOI:10.1136/bmj.k4116