Document is current
Any future updates will be listed below
-
Authors
Syrkina, Olga
Inamdar, Ajinkya
Wague, Sophie
Monfredo, Céline
Nissilä, Markku
Chabanon, Anne-Laure
Serradell, Laurence
- License Information
-
More Information
Article History
Received: 25 June 2021
Accepted: 25 July 2022
First Online: 8 August 2022
Declarations
:
: As a passive surveillance system, the EPSS requires no informed consent. No sensitive data were collected about the vaccinees, and no ethics committee submission was required in Finland for the EPSS. Patient level data were anonymised and study documents redacted to protect the privacy of our trial participants. This surveillance was conducted in accordance with the EMA/PRAC/222346/2014 interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU [CitationRef removed]. No administrative permission was required to access the raw data used in this study.
: Not applicable
: LS, SW,ALC,CM, AI and OS are employees of Sanofi Pasteur and may hold shares and/or stock options in the company. MN is an employee of Suomen Terveystalo which received funding from Sanofi Pasteur for the study. AI was an employee of Sanofi Pasteur at the time the study was conducted and is currently an employee of Janssen Pharmaceutical Companies of Johnson & Johnson.
