Novartis’ big investment in a $1 billion million vaccine production plant in Holly Springs appears to be paying a new dividend,
The U.S. Food and Drug Administration on Tuesday gave approval for a seasonal influenza vaccine produced at Novartis’ 430,000 square foot facility that cost some $600 million to build.
The FDA OK’d Flucevax to protect against seasonal influenza.
It’s the first time the FDA has approved an influenza vaccine produced through a cell-culture process, Novartis noted.
The Holly Springs plant was built to support that process as an alternative to traditional egg-based vaccine production.
Novartis calls the new technology as “the most significant advancement in influenza vaccine manufacturing in more than 40 years.”
The treatment is for people age 18 and older.
“The approval of Flucelvax is an important milestone for our influenza franchise and brings an innovative vaccine to the US,” said Andrin Oswald, the division head for 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 says the production process is “a closed, sterile, controlled environment” that helps cut down on potential impurities. The vaccine also does not contain preservatives.
Novartis partnered with the U.S. government in building the plant, which opened in 2009, with the new process aimed at being able to produce vaccine rapidly in the event of a pandemic.
“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,” Novartis noted. “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 A5,”