For the first time, Food and Drug Administration has officially authorized a facility in North Carolina to begin producing a new, antibiotic-free influenza vaccine within the United States.
The announcement was made by Swiss pharmaceutical company Novartis, which will be operating the plant in Holly Springs, North Carolina. As noted in a press release, the operation will be the first of its kind in the US. Now that it’s been cleared by the FDA, the facility will be able to move forward with plans to manufacture seasonal cell-culture influenza vaccines.
Additionally, the plant will also have the capability of quickly ramping up vaccine production in the event of a pandemic.
Cited as a significant breakthrough for immunization efforts, cell-culture technology allows scientists to develop vaccines by growing them inside mammalian cells. Traditionally, flu vaccines have been grown inside chicken eggs.
"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 of Novartis Vaccines in a press release.
"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."
Since the production of cell-based vaccines is also more flexible than the typical flu shot, the Novartis facility should also be able to quickly adapt in case of a pandemic. The facility can reportedly develop 150 million doses of a vaccine within six months of a pandemic.
Specifically, the North Carolina-based plant will be manufacturing the cell-based Flucelvax vaccine, which contains zero antibiotics and zero preservatives. Although cell-culture technology has been used to create other vaccines in the past – polio and rubella shots, for example – Flucelvas was the first kind approved by the FDA to combat the flu
According to the University of Minnesota’s Center for Infectious Disease Research and Policy, Flucelvas made its US debut during the 2013-2014 flu season, but was manufactured in Germany due to lack of FDA approval. The vaccine has been in development since 2006, and the construction of the Holly Springs plant is the result of collaboration between the Department of Health and Human Services, which invested almost $500 million, and Novartis.