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.

Recombinant HA-based vaccine outperforms split and subunit vaccines in elicitation of influenza-specific CD4 T cells and CD4 T cell-dependent antibody responses in humans

“…In three successive seasons (2015–2016, 2016–2017 and 2017–2018), subjects were enrolled in a vaccination study to evaluate both their CD4 T-cell and B-cell responses to influenza vaccination. An independent group of subjects in each year was randomized and divided into three cohorts that received one of the three distinct formulations of licensed vaccines, Fluzone 14 , Flucelvax 11 , 21 Flublok 22 . The characteristics of the cohorts in each year with regard to age, sex and self-reported vaccine history are shown in Supplementary Table 1.…”

Broadly Protective Strategies Against Influenza Viruses: Universal Vaccines and Therapeutics

“…In contrast to embryonated egg-based vaccines, manufacturing of Flublok ® takes approximately 2 months and can be administered in individuals with egg allergies, providing an advantage over traditional seasonal egg-based vaccines (Cox and Hollister, 2009). In regard to cell-based vaccines, Flucelvax ® is a licensed quadrivalent inactivated vaccine that is grown in a mammalian cell line and can avoid any potential egg-based mutations (Lamb, 2019). As with Flublok ® , Flucelvax ® can be administered to individuals with egg allergies and requires a shorter production time than egg-grown vaccines.…”

Influenza – Krankheitslast und Impfprävention bei Kindern und Jugendlichen

“…Während der besonders heftigen Grippesaison 2017-2018, die in den USA und Australien A(H3N2) dominiert war, lag die errech nete insgesamte Impfstoffwirksamkeit der WHOempfohlenen In fluenzaVakzine für A(H3N2) bei historisch niedrigen 33 % [16]. Ein auf caninen (Hunde) Nierenzellen bebrüteter tetravalenter Grip peimpfstoff (EU: Flucelvax ® Tetra; USA: Flucelvax Quadrivalent ®) zeigte in den USA in dieser Saison auch bei Kindern und Jugendli chen gute Wirksamkeit bei guter Verträglichkeit [14]. Auch in Süd korea konnte schon in der Grippesaison 2014/15 in einer großen randomisierten doppelblinden kontrollierten Studie (454 Impflin ge, Alter 6 Monate bis 18 Jahre) für den zellkulturbasierten tetra valenten Grippeimpfstoff NBP607QIV gute Immunogenität und Verträglichkeit gezeigt werden [15].…”