Panflu® is an inactivated H5N1 influenza (avian flu) vaccine that was approved by State Food and Drug Administration in April 2008. This product was co-developed by Sinovac Biotech Co., Ltd and the Chinese Center for Disease Control.
The vaccine is approved for supply within China to the Chinese national vaccine stockpiling program and may not be sold directly to the Chinese commercial market. Panflu is also registered for sale in the Hong Kong market.
The virus strain utilized for Panflu® is NIBRG-14 (A/VietNam/1194/2003(H5N1)RG). This virus stain is manufactured by the National Institute Biological Standards and Control (NIBSC) with Reverse Generic technology, which is recommended by WHO for vaccine production.
The major manufacturing process steps, including virus culture in chicken embryo, harvest, inactivation, ultra filtration, chromatography, adsorption by Aluminum and formulation, were adopted for the production of Panflu® .
A total of 508 adults were vaccinated with this vaccine with dosage of 1.25µg-15g in clinical studies. Through the clinical observation and evaluation on serology and biochemistry, after the vaccine schedule with 2 doses, the good safety has been approved; and the immunogenicity of vaccine with the dosage of 10µg or 15µg has been approved by the assay of antibody in serum of subjects. From the data of cross immunity test, this vaccine is capable to induce the cross immunity reaction against the other H5N1 virus stains, Hanhui strain and Indonesia strain.
Sinovac commenced the development of its pandemic influenza vaccine in 2004. In June 2006, the Phase I clinical trial results indicated good immunogenicity and safety. The results were published in September 2006 in "The Lancet," an independent medical journal.
Sinovac received approval from the China State Food and Drug Administration (SFDA) in April 2007 to conduct clinical trials for the H5N1 influenza vaccine. In December 2007, Sinovac reported positive top-line results from the completed Phase II clinical trial of Panflu® , its pandemic influenza (H5N1) whole viron inactivated vaccine. In April 2008, Panflu was granted a production license by the China State Food and Drug Administration (SFDA).
Through the stability studies that include an accelerated stability study and a long-term stability study, the shelf life of this product is defined as 24 months.