FDA licenses Novartis facility to produce cell-culture influenza vaccines

The US Food and Drug Administration has licensed Swiss pharma major Novartis’ (NOVN: VX) manufacturing facility in Holly Springs, North Carolina, for the production of cell-culture influenza vaccines.

This is the first US facility of its kind and is now approved for commercial production, the company stated. The site will produce seasonal and pre-pandemic influenza vaccines, and has the capacity to significantly ramp up production in the event of a pandemic.

Novartis utilizes cell-culture technology to produce Flucelvax (influenza virus vaccine), which was the  first FDA-approved seasonal influenza vaccine not manufactured with chicken eggs. Flucelvax, approved for individuals 18 years of age and older, does not contain any antibiotics or preservatives. With the licensure of the Holly Springs facility, Flucelvax will be produced in the US for the first time.