Trivalent seasonal influenza vaccine derived from Vero cell culture technology.
On December 9 2014, Baxter International Inc. announced that it entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. The acquisition closed in August 2015.
The Vero cell technology is a serum and protein-free mammalian cell culture platform technology that is used in the production and development of a number of influenza vaccines currently approved in Europe and Japan, including PREFLUCEL®, a trivalent seasonal influenza vaccine. In clinical studies, PREFLUCEL® demonstrated similar vaccine efficacy against matching strains and superior cross-protection against all strains compared to egg-based vaccines. The Biological License Application (BLA) for PREFLUCEL® was filed in the United States in 2013 and is currently pending in the United States. CELVAPAN®, an H1N1 pre-pandemic vaccine, and VEPACEL®, which includes both an H5N1 mock-up and H5N1 pre-pandemic vaccine, were approved in Europe in 2009. The Vero cell culture technology is also used in additional infectious disease preclinical and clinical-stage programs, including vaccines for severe acute respiratory syndrome coronavirus, or SARS-CoV, Middle East respiratory syndrome coronavirus, or MERS-CoV, rotavirus, and strains of the Ross River, West Nile and Chikungunya viruses.
PREFLUCEL®, a trivalent seasonal influenza vaccine, is produced using the Vero cell culture technology. Vero cell and other cell-based manufacturing methods represent a unique opportunity for governments attempting to stabilize their influenza vaccine supply from season to season or to accelerate production in the event of a pandemic. PREFLUCEL® has been approved in 15 European countries and Brazil since 2010.
To date, PREFLUCEL® has been proved to be well tolerated and highly immunogenic. There have been eight clinical studies of PREFLUCEL® over seven influenza seasons from 2006 to 2013. Vaccine efficacy and safety for culture-confirmed influenza in the 2008/2009 influenza season met primary efficacy endpoints. Overall vaccine efficacy for PREFLUCEL® was 78.5% against matching strains and 71.5% against all strains. In addition, PREFLUCEL® has demonstrated a safety profile similar to licensed egg-derived vaccines.