Novartis receives FDA approval to make first cell-culture vaccine in US for seasonal influenza
21 Nov 2012
Basel-based drug giant Novartis today said that the US Food and Drug Administration (FDA) has approved the use of Flucelvax (influenza virus vaccine), the first cell-culture-derived vaccine, for adults.
Flucelvax utilises full-scale cell-culture manufacturing technology, an alternative production method to traditional egg-based production. Cell-culture technology utilises a well-characterised mammalian cell line rather than chicken eggs to grow virus strains.
The production takes placed in a closed, sterile, controlled environment, which significantly reduces the risk of potential impurities, Novartis said in a statement. Flucelvax does not contain any preservatives, such as thimerosal, or antibiotics, it added.
"Cell-culture technology enables rapid response to urgent public health needs such as a pandemic within weeks. Traditional influenza vaccine production depends on a large number of fertilised chicken eggs to grow virus strains and requires many months for organisation of egg supplies, virus incubation and actual production before the vaccine is delivered to physicians or pharmacies," The company said.
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.
"The approval of Flucelvax is an important milestone for our influenza franchise and brings an innovative vaccine to the US," said Andrin Oswald, division head, Novartis Vaccines and Diagnostics. "Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way."
Novartis said it has worked with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority, for the development of the cell-culture manufacturing technology, as well as for construction of the state-of-the-art facility in Holly Springs, North Carolina.
Total public / private investment in the technology development and facility is over $1 billion. Flucelvax will be produced in Holly Springs once the facility is ready for full-scale commercial production. The facility is the first of its kind in the US and also allows for enhanced domestic pandemic preparedness.
