Flucelvax utilizes full-scale cell-culture manufacturing technology, an alternative production method to traditional egg-based production. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.
The production occurs in a closed, sterile, controlled environment, which significantly reduces the risk of potential impurities. Flucelvax does not contain any preservatives, such as thimerosal, or antibiotics.
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 fertilized chicken eggs to grow virus strains and requires many months for organization of egg supplies, virus incubation and actual production before the vaccine is delivered to physicians or pharmacies. 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.”