Vaccine Safety

vaccine-safety

Canada’s eight-step vaccine safety program*

  1. Prelicensure review and approval
. The government regulator conducts a thorough review of all the scientific product data for each vaccine before it can be sold
  2. Current good manufacturing practices
. Manufacturers must follow strict, globally recognized manufacturing procedures that include regular and random onsite checks of the manufacturing plants by government inspectors
  3. Lot assessment before release. 
Manufacturers test every lot (small quantities, all made at the same time) of vaccine potency, safety and purity before release. Government inspectors may test lots when conducting inspection
  4. Independent expert review of national vaccine recommendations
. A committee of independent experts reviews all safety and efficacy data on vaccines and recommendations for use are published
  5. Postmarketing surveillance for adverse events
. Reporting adverse events is mandatory for health care providers and vaccine manufacturers
- These reports are analyzed by independent experts
- Active search is also performed in 12 Canadian children’s hospitals for adverse events following immunization, vaccine failures and admissions due to vaccine-preventable infectious diseases
- Analysis of the data is published
  6. Rapid response to vaccine performance concerns. 
Detection of any concern about the safety of a vaccine triggers an immediate recall of a vaccine and/or nondistribution of a suspected lot of vaccine
  7. Expert causality assessment of serious adverse events following immunization
. Serious adverse events following immunization, such as deaths or hospitalizations, undergo rigorous scrutiny by a group of independent experts to determine the cause. Reports from this expert group are published
  8. International collaboration
. Data on adverse events following immunization, and detection of any concerns in the vaccine system, are sent to the World Health Organization where it is shared with all countries

* Excerpt from Canadian Paediatric Society Position Statement Nov 09
N MacDonald, L. Pickering; Canadian Paediatric Society, Infectious Diseases and Immunization Committee

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