First cell-culture-based flu vaccine, Flucelvax, is approved for distribution

A $1-billion private/public partnership reaches fruition - with implications for vaccine supply chains

After decades of dependence on growing flu virus strains in eggs, and then refining the material to produce vaccines, the first cell-culture-based vaccine is now on the market: Flucelvax, from Novartis, just as this year’s flu season begins to take off. Novartis partnered with the US Dept. of Health and Human Services, to the tune of over $1 billion, to validate the production process and build a facility, in Holly Springs, NC. Per the product’s label, it is packaged as a prefilled syringe requiring 2-8C refrigeration and, like most vaccines, cannot be frozen.

Cell-culturing employs mammalian cells, bathed in nutrient solutions, to produce medically important vaccines, proteins and similar biological products. The production route makes use of preservatives and antibiotics unnecessary; moreover, the process can be scaled up or down more readily than the egg-based route (which requires specially prepared eggs as a pre-production step, and months of incubation in the eggs), which makes it suited to pandemic preparedness.

Traditionally health authorities in the Northern Hemisphere meet early each year to determine the flu strains likely to turn up in the following flu season, which usually begins around October. There follows a scramble to secure the eggs, begin the incubation, and estimate the breadth and severity of the flu season (which radically swings product demand). A similar cell-culturing process is also being used for vaccines for polio, rubella and hepatitis.