Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine.

ABSTRACT: The objective of this paper is to summarize annual enhanced safety surveillance activity across three seasons (2019/20-2021/22) for cell culture-based quadrivalent influenza vaccine (QIVc; Flucelvax® Tetra) in all age groups. This activity was conducted in primary care setting in Genoa (Italy) during the seasons 2019/20, 2020/21 and 2021/22. All adverse events registered within the first seven days following immunization were analyzed by season, type, age group and seriousness. Over three seasons, 3,603 QIVc exposures were recorded within the enhanced passive safety surveillance activity. No safety signals were identified. The overall reporting rates of individual case safety reports for the seasons 2019/20, 2020/21 and 2021/22 were 1.75%, 0.48% and 0.40%, respectively. The average number

SUBMITTER: Domnich A 

PROVIDER: S-EPMC10549188 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature