First Seasonal Influenza Vaccine Produced in Cell Culture Approved in US

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture. The vaccine, Flucelvax, is approved for use in individuals 18 years of age or older.  According to the company press release, cell-culture technology has been successfully used to manufacture other vaccines, including those distributed during the H1N1 pandemic, as well as vaccines for polio, rubella, and hepatitis, but Flucelvax is the first seasonal vaccine produced by this method to be approved in the US. The virus for the vaccine is produced under closed, sterile conditions in a well-characterized mammalian cell line, rather than in chicken eggs.

Novartis partnered with the US Department of Health and Human Services and the Biomedical Advanced Research and Development Authority to develop the cell-culture manufacturing technology, as well as to construct a manufacturing facility in Holly Springs, NC. Total public/private investment in the technology development and facility is more than $1 billion. Flucelvax will be produced in Holly Springs once the facility is ready for full-scale commercial production.

In the release, Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics, said, "Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way."