Safety and immunogenicity of Sinovac’s prototype pandemic influenza H5N1 vaccines: a review on clinical trials

Abstract Sinovac Biotech started to develop prototype pandemic influenza H5N1 vaccines in March 2004. On 2 April 2008, Sinovac’s inactivated, aluminium‐adjuvanted, whole‐virion prototype pandemic influenza A (H5N1) vaccine (PanFlu™) was granted production licensure by the China regulatory authority State Food and Drug Administration. The whole‐virion H5N1 vaccine was manufactured in embryonated hens’ eggs using the reassortant strain NIBRG‐14 (A/Vietnam/1194/2004‐A/PR/8/34) as vaccine virus. It showed good safety, immunogenicity and cross‐reactivity in immunologically naïve adults. In primed adults, the vaccine induced a strong booster response. Plasma from a vaccinated individual showed a beneficial effect following passive immunotherapy of an H5N1 human infection case. This article reviews the process, status and results of clinical evaluation of Sinovac’s whole‐ and split‐virion H5N1 vaccines by focusing on the whole‐virion vaccine.