In response to the global outbreak of the H1N1 virus in April 2009, Sinovac commenced preparatory activities for the development of a vaccine. Sinovac began production of the vaccine in June 2009, after it received the virus strain necessary for production. The Company completed its clinical trials in August 2009 and received its production license from the SFDA in September 2009.
The seasonal influenza vaccine manufacturing process is adopted for the production of PANFLU.1. The virus strain utilized for the production of PANFLU.1 is X-179 (A/California/7/2009), which is manufactured by New York Medical College (NYMC) and recommended by WHO.
The major manufacturing process steps that include virus culture in chicken embryo, harvest, inactivation, ultra filtration, chromatography, disruption and formulation, were adopted for the production of PANFLU.1.
According to the accelerated stability study, the shelf life of this vaccine is defined as 12 months.