Flucelvax (subunit cell-based quadrivalent influenza vaccine; CSL) is an inactivated subunit cell-based quadrivalent influenza vaccine that contains antigens from two A strains and two B strains specified by the World Health Organization seasonally for influenza vaccination. The vaccine was originally developed by Novartis, which divested its influenza vaccines unit to CSL in August 2015. Flucelvax QIV was approved for use in people aged four years and older in the US in May 2016, and was the first vaccine created using cell-grown candidate virus. CSL plans to launch Flucelvax QIV in the EU in the 2019/20 season.
Flucelvax QIV (subunit cell-based quadrivalent influenza vaccine; CSL) was the first vaccine approved by the US Food and Drug Administration (FDA) with a manufacturing process that only relies on the use of cell-grown candidate virus. Although the speed of the process, which no longer relies on egg-based manufacturing, is not a strong competitive advantage in the seasonal influenza market, the FDA has highlighted that additional time before choosing the viral strains required for each influenza season could lead to better matches to the predominant circulating strains.
4 Drug Overview
5 Product Profiles
5 Flucelvax QIV : Seasonal influenza vaccines
LIST OF TABLES
6 Table 1: Flucelvax QIV drug profile
6 Table 2: Approval history of Flucelvax for seasonal influenza vaccination
8 Table 3: Late-phase trials of Flucelvax QIV for seasonal influenza vaccination
9 Table 4: Flucelvax QIV for seasonal influenza – SWOT analysis
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