Novartis’ Flucelvax cell-culture influenza virus vaccine has received FDA approval for use in adults aged 18 or older.
Flucelvax is an influenza vaccine based on cell-culture technology, the first vaccine of its type to be approved in the US, and does not contain any preservatives or antibiotics.
The cell-culture manufacturing technology requires well-characterised mammalian cells for the growth of virus strains instead of chicken eggs used in the traditional egg-based production method.
Novartis vaccines and diagnostics division head Andrin Oswald said the approval of Flucelvax brings an innovative vaccine to the US.
"Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way," Oswald said.
As the full-scale technology occurs in a closed, sterile, controlled environment, the risk of potential impurities can be minimised in this method.
Once the Holly Springs facility gets set for full-scale commercial production, it will start the production of Flucelvax.
Vanderbilt University, Nashville, Tennessee, professor of medicine and preventive medicine chairman Dr William Schaffner said the availability of a cell-culture vaccine will ensure company’s readiness for seasonal influenza, as well as a potential pandemic.
"Annual influenza vaccination is an important public health measure that helps protect thousands of people from illness and death each year," Schaffner said.
Image: Novartis Flucelvax is the only influenza vaccine of its kind in the US. Photo: Courtesy of Andrew Hecht.