Seqirus' Flucelvax nears Europe's first approval for cell-based flu vaccine

Seqirus Holly Springs manufacturing
Seqirus makes its cell-based flu vaccines at a former Novartis plant in Holly Springs, North Carolina. (Seqirus)

Seqirus has some big plans for its cell-based flu vaccine in the U.S. this year, but that doesn't mean its ambitions for Flucelvax stop at the U.S. borders. And with a new vote in the EU, those ambitions are scaling up further.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Seqirus’ four-strain, cell-based flu vaccine for approval, setting up an expected nod by the end of the year. If approved, the company would market the shot as Flucelvax Tetra in Europe starting in the 2019-2020 flu season.

The CHMP’s recommendation comes as Seqirus is working to boost its U.S. Flucelvax production to distribute 20 million doses this year. Known as Flucelvax Quadrivalent in the U.S., the vaccine won FDA approval in 2016.

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When CSL purchased Novartis' vaccines outfit and formed Seqirus back in 2015, its Holly Springs, North Carolina, plant was making just 3 million doses of cell-based vaccine per year. Now, it's set for that 20 million goal in the U.S., and it has the capacity to produce more for European markets, the company says. In all, Seqirus plans to distribute 40 million cell-based flu vaccine doses next year.

RELATED: Cell-derived flu vaccine strains a better match than eggs, Seqirus analysis finds

Cell-based vaccines like Flucelvax have garnered increasing interest as traditional egg-based flu shots face efficacy questions. Some recent studies have shown that cell-based alternatives provide better protection. This month, Seqirus presented an analysis of data from 12 flu seasons showing that H3N2 flu vaccine strains derived from cells better matched circulating strains than the vaccine strains made in eggs did.

At the time, Seqirus president Gordon Naylor said egg-based vaccines remain the “backbone of the industry,” but he envisions newer alternatives gaining steam and potentially taking over the market. That kind of growth would of course depend on a steady stream of positive efficacy data, increased manufacturing scale and support from the medical community, Naylor said.