What evidence was used to support the authorization of Arepanrix™ H1N1?
A prototype or “mock” vaccine was developed in the pre-pandemic period using another strain of influenza virus, the H5N1 strain. During this period Health Canada inspected the vaccine manufacturing facilities, validated the vaccine production process, and reviewed results from both animal and human studies with the mock vaccine. In addition, the safety and effectiveness of the adjuvant to be used with the vaccine was assessed by Health Canada. Once the H1N1 virus emerged as the pandemic virus, the manufacturer initiated vaccine production using the strain recommended by the WHO. The following data was used to support approval of Arepanrix™ H1N1: • Quality (chemistry and manufacturing) data on the vaccine manufacturing process to support the strain change from H5 to H1, • Information from non-clinical (animal studies) and clinical studies in humans conducted with Arepanrix™ and Pandemrix™, a similar H1N1 pandemic vaccine manufactured by GSK in Germany, and • Safety and other data from t
