Cell-Based Quadrivalent Inactivated Influenza Virus Vaccine (Flucelvax® Tetra/Flucelvax Quadrivalent®): A Review in the Prevention of Influenza.

Abstract

Manufacturing influenza virus vaccines using a mammalian cell line rather than embryonated chicken eggs may carry certain advantages. A quadrivalent inactivated influenza virus vaccine produced using the Madin Darby canine kidney cell line has been approved in the EU (Flucelvax® Tetra) and USA (Flucelvax Quadrivalent®; QIVc hereafter) for the prevention of influenza in adults and children. The clinical development of QIVc has built upon that of a cell-based trivalent influenza virus vaccine (TIVc) manufactured using the same processes; the additional influenza B strain contained in QIVc reduces the risk of the strain in the vaccine not matching that in circulation. Pivotal phase III clinical trials in adult and paediatric participants have demonstrated the immunogenicity of QIVc to be noninferior to that of TIVc formulations against shared strains and superior against the influenza B strain absent from each TIVc formulation. Protective efficacy data for TIVc is considered foundational for QIVc and, in a phase III clinical trial, TIVc was effective in protecting adults against antigenically matched influenza strains. Large real-world studies from the 2017/2018 US influenza season further support the prophylactic effectiveness of QIVc, with possible benefits over egg-based vaccines. QIVc was generally well tolerated in clinical trials. In adult and paediatric QIVc recipients, the most common solicited adverse reactions were injection site pain and headache. Reactogenicity was comparable to that of TIVc; no safety signals unique to QIVc emerged. Through circumventing concerns around egg adaptation, QIVc has the potential to be more effective than currently available egg-based quadrivalent vaccines.Electronic supplementary materialThe online version of this article (10.1007/s40265-019-01176-z) contains supplementary material, which is available to authorized users.