Novartis facility first US pandemic-ready site licensed by the FDA to produce cell-culture influenza vaccines

Novartis has announced that the US Food and Drug Administration (FDA) has licensed its manufacturing facility in Holly Springs 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 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 utilises 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.  

"Cell-culture technology is the first major advancement in influenza vaccine production in the US in more than 40 years. We are proud to be at the forefront of this innovation, which will allow us to deliver on our public health and health security commitments," said Andrin Oswald, division head, Novartis Vaccines. "With this award-winning facility, we will be able to not only offer US consumers an antibiotic- and preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future pandemic threats."

Cell-culture technology offers several potential benefits over traditional influenza vaccine production, which occurs in chicken eggs. The manufacturing process can be controlled more easily and is more flexible, enabling the potential to scale up production quickly to develop large quantities of vaccines in the event of a pandemic. Novartis recently utilised the technology to rapidly develop a vaccine candidate for the H7N9 avian influenza virus, which was first reported in China in March 2013. This facility supplied a stockpile of H7N9 vaccine to the US government prior to the second wave of the outbreak in January 2014.

The Holly Springs facility is a result of a joint partnership between Novartis and the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA).