SATURDAY, OCTOBER 1, 2016

Novartis receives FDA licensing for cell-culture influenza vaccine production in U.S.

Novartis announced on Monday that it received licensing from the U.S. Food and Drug Administration to produce cell-culture influenza vaccines at its manufacturing facility in Holly Springs, N.C.

The Novartis vaccine Flucelvax, which was the first FDA-approved seasonal influenza vaccine not made from chicken eggs, will be produced at the site, making it the first time the vaccine will be produced in the U.S.

"Cell-culture technology is the first major advancement in influenza vaccine production in the U.S. in more than 40 years," Andrin Oswald, the division head of Novartis Vaccines, said. "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. With this award-winning, state-of-the-art facility, we will be able to not only offer U.S. consumers an antibiotic- and preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future pandemic threats."

The North Carolina facility is the result of a joint partnership between Novartis, the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority.

Cell-culture vaccines differ from traditional influenza treatments because they can be produced more easily in the event of a pandemic. Novartis used cell-culture technology in response to the avian flu virus, which was first reported in China in 2013.