Cell-based Quadrivalent Inactivated Influenza Virus Vaccine (Flucelvax® Tetra/Flucelvax Quadrivalent®): A Review in the Prevention of Influenza
Compliance with Ethical Standards
Funding: The preparation of this review was not supported by any external funding.
Conflicts of interest: Yvette Lamb is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
Additional information about this Adis Drug Review can be found here
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.
© Springer Nature Switzerland AG 2019