What types of evidence will Health Canada use to assess and determine whether a pandemic H1N1 flu vaccine can be authorized?
Health Canada collaborated internationally with the WHO and other national regulatory authorities, such as the U.S. FDA and the European Medicines Agency to establish data requirements to licence a vaccine. In Canada, data required to support approval of the pandemic vaccine will include at a minimum: updated quality (chemistry and manufacturing) data on the vaccine manufacturing process to support the strain change from H5 to H1, clinical data in humans from a small safety and immunogenicity study to indicate that the H1N1 flu vaccine is safe and that the selected dose and schedule is appropriate to produce an immune response, and safety and other data from the review of the prototype H5N1 vaccine. Data from clinical trials that become available globally during the authorization process using similar or related pandemic vaccines will also be considered. Clinical studies and surveillance for any rare adverse events will continue after the vaccine is authorized.
