During a safety review of Bexsero, a vaccine used to protect against Neisseria meningitides serogroup B, Health Canada found more reports of serious adverse reactions with Bexsero in patients with complement mediated diseases (such as paroxysmal nocturnal hemoglobinuria [PNH] and atypical haemolytic uremic syndrome [atypical HUS]) who were being treated with SOLIRIS (a complement inhibitor), than in other patients vaccinated with Bexsero. Bexsero was marketed in Canada in 2014, which is 5 years after SOLIRIS (marketed since 2009). A further review of the reports with Bexsero in patients already being treated with SOLIRIS concluded that there was an increased risk of low hemoglobin, including anemia, or hemolysis. The risk was highest in patients receiving Bexsero vaccine when their predicted systemic SOLIRIS concentrations were relatively low.
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