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FDA licenses Novartis facility to produce cell-based influenza vaccines
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Novartis recently announced that the FDA licensed its manufacturing facility in Holly Springs, N.C., for the production of cell-based influenza vaccines, according to a press release.
The facility will produce seasonal and pre-pandemic vaccines, and it has the ability to accelerate vaccine production in the event of an influenza pandemic.
“Cell-culture technology is the first major advancement in influenza vaccine production in the US in more than 40 years,” Andrin Oswald, MD, division head of Novartis Vaccines and Diagnostics Inc., said in the release. “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.”
The facility is the result of a public-private partnership between the Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services and Novartis, and is the first US facility to use cultured mammalian cells instead of hens’ eggs for the production of its vaccines. The process used to develop cell-based vaccines is faster compared with egg-based vaccines, which potentially allows the facility to rapidly produce larger quantities of vaccine in the event of a pandemic. The technology also avoids problems associated with egg allergies.
In November 2012, the FDA approved Novartis’ cell-based vaccine (Flucelvax) for adults aged at least 18 years. With the licensure of the Holly Springs facility, the vaccine will be produced in the United States for the first time, according to the company.
Novartis also has used cell-based technology to develop an influenza A(H7N9) vaccine candidate. H7N9 was first detected in China in March 2013, and the Holly Springs facility supplied the US government with a stockpile of H7N9 vaccines before the second wave of the outbreak in January.
“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,” Oswald said.