The Food and Drug Administration (FDA) this week approved the use of Novartis’ Flucelvax vaccine in adults, becoming the first cell-culture-derived influenza vaccine to receive approval in the United States.
Traditional vaccine production methods have relied on egg-based production, requiring a large number of fertilized chicken eggs to grow strains and often needing several months for organization of egg supplies, virus incubation and actual production before a vaccine is delivered to physicians or pharmacies.
Cell-culture technology utilizes a well-characterized mammalian cell line to grow virus strains, providing an avenue to more easily meet surge capacity needs in response to an epidemic. Cells can be frozen and stored in advance of an epidemic, or developed rapidly in response to an urgent public health need.
Cell-culture technology is successfully used to manufacture other vaccines, including those distributed during the H1N1 pandemic, as well as vaccines for polio, rubella and hepatitis A.
“Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way,” said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics.
The US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA) has provided partial funding to Novartis for the development of the cell-culture manufacturing technology, as well as for construction of a state-of-the-art production facility in Holly Springs, N.C. The Novartis facility enhances domestic pandemic preparedness capabilities and is the first of its kind in the US.
