Enhanced passive safety surveillance of a quadrivalent inactivated split virion influenza vaccine in Finland during the influenza season 2020/21.

ABSTRACT:

Background

The European Medicines Agency (EMA) requires enhanced safety surveillance to be conducted for annual seasonal influenza vaccines with the aim of rapidly detecting any potential new safety concerns before the peak immunisation period of the vaccine in any given year. The aim of this study was to detect any clinically significant change in the frequency or severity of expected reactogenicity of the quadrivalent inactivated split-virion influenza vaccine (IIV4) during routine immunisation in Finland for the 2020/21 season. The primary objective was to investigate the frequency of suspected adverse drug reactions (ADRs) occurring within 7 days following vaccination.

Methods

Enhanced passive safety surveillance of individuals vaccinated with IIV4 was conducted from Oct

SUBMITTER: Syrkina O 

PROVIDER: S-EPMC9358077 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature