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

• Cell-culture technology is a modern alternative to manufacture influenza vaccines without chicken eggs, with potential to rapidly respond to a pandemic¹
• Flucelvax^®, an FDA-approved antibiotic- and preservative-free seasonal flu vaccine, will be manufactured at this site for the US market²
• Licensure marks milestone in Novartis’ public-private partnership to improve US capabilities to respond to seasonal epidemics and emerging public health threats

Novartis today announced that the US Food and Drug Administration (FDA) licensed its manufacturing facility in Holly Springs, N.C. 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 utilizes cell-culture technology to produce Flucelvax® (Influenza Virus Vaccine), which was the first FDA-approved seasonal influenza vaccine not manufactured with chicken eggs³. Flucelvax, approved for individuals 18 years of age and older, does not contain any antibiotics or preservatives². 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, state-of-the-art 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 pandemic¹. Novartis recently utilized 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). The two parties are committed to investing in innovation to better protect the public in the event of a pandemic or other health security threats. This facility was the overall winner of the ISPE Facility of the Year Award in 2013⁴.

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contracts HHSO100200600012C, HHSO100200700030C and HHSO100200900101C.