Would vaccine be available sooner if Health Canada treated it as a variant to the seasonal flu vaccine?
Due to the extensive evaluation of the mock (H5N1) vaccine during the pre-pandemic period, a lot of the work to support approval of the pandemic vaccine has already been completed. The remaining data requirements necessary for authorization of the H1N1 flu vaccine are similar to what is required each year to support the seasonal flu vaccine in Canada. In Canada, the file is a “rolling submission”, which means that Health Canada experts have been reviewing data as it becomes available. The evaluation process will continue concurrent with production of the vaccine. Health Canada is working closely with GSK to review production timelines and will be in a position to make a decision on the authorization of a vaccine as soon as one becomes available, depending on the results of the Health Canada’s review. Canadians can be confident that there will be no delay in getting vaccine to Canadians due to regulatory requirements.
