The Strange Case of Bexsero®

From Section 4 of the Report on the Canada Vigilance Database
Bexsero® was approved for use in Canada in January of 2014 and first sold in Canada in February that year according to Health Canada’s Summary Basis of Decision (SBD) to Accept Bexsero. In the SBD Health Canada informs us, “Protection by the vaccine was inferred from immune responses against the four antigens of the vaccine.” This statement means efficacy for this vaccine has not been proven.
Furthermore, a Canadian study Epidemiology of serogroup B invasive meningococcal disease in Ontario, Canada, published in 2012 concerning the incidence of the meningitis B strain cases in Ontario calls it a rare disease — 256 cases in Ontario in 10 years.
To read the full document, please click here (pdf format).

Related VCC Pages

Vaccine Safety Report Released

An analysis of data & databases available to the Canadian Public The Vaccine Safety Report is the third VCC report concerned with our Canadian surveillance systems for tracking suspected vaccine […]

Meningococcal Diseases and Vaccine

Updated March, 2011 Meningococcal Diseases are associated with the bacterium, Neisseria meningitidis, also referred to as meningococcus, and include the invasive diseases, meningitis and blood poisoning, both of which can […]

Meningococcal Disease Outbreaks in Canada 2000-2001

During outbreaks of meningococcal disease in various regions of Canada, we were flooded with requests for information about the disease, the vaccines used in Canada and concerns about adverse reactions. […]

Related pAGES

×