Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season

Author:

Machado Marina Amaral de Avila1,Gandhi-Banga Sonja1,Gallo Sophie2,Cousseau Tathyana Giannotti3,Byrareddy Reddappa Maniganahally4,Nissilä Markku5,Schelling Jörg6,Monfredo Celine7

Affiliation:

1. Epidemiology & Benefit-Risk, Sanofi, Toronto, Canada

2. Medical Operations, Sanofi, Lyon, France

3. Patient Safety and Pharmacovigilance, Sanofi, Sao Paulo, Brazil

4. Patient Safety and Pharmacovigilance, Sanofi, Bangalore, India

5. Terveystalo Biobank and Clinical Research, Turku, Finland

6. Department of Medicine IV, LMU University Hospital, Munich, Germany

7. Biostatistical Sciences, Sanofi, Marcy l’Etoile, France

Funder

Sanofi

Publisher

Informa UK Limited

Reference22 articles.

1. Pharmacovigilance risk assessment committee (PRAC) EMA. Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU; 2014 [accessed 2014 Apr 10]. https://www.ema.europa.eu/en/interim-guidance-enhanced-safety-surveillance-seasonal-influenza-vaccines-eu-scientific-guideline.

2. Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety

3. Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16

4. Enhanced passive safety surveillance of the quadrivalent inactivated split-virion influenza vaccine (IIV4) in Finland during the 2019/20 influenza season

5. Surveillance of adverse events following immunisation: the model of SAEFVIC, Victoria;Clothier HJ;Commun Dis Intell Q Rep,2011

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