Canada's eight-component vaccine safety system: A primer for health care workers

Question 1

What are the eight components of Canada’s vaccine safety system?

Answer 1

1. Evidence-based pre-licensing review and approval
2. Good practice standards and regulations for manufacturers
3. Evidence based vaccine recommendations
4. Immunization competencies for health care providers
5. Pharmacovigilance for adverse events following immunization (AEFIs)
6. AEFIs: causality assessment
7. Vaccine safety and efficacy signal detection
8. Canadian Immunization Research Network special immunization clinics (SICs)

Question 2

What are the components of good practice standards and regulations for manufacturers?

Answer 2

1. good laboratory practices
2. good clinical practices
3. good manufacturing practices
4. vaccine lot assessment before release
5. review of vaccine safety data submitted by the market authorization holder

Question 3

Who is responsible for vaccine recommendations in Canada?

Answer 3

National Advisory Committee (NACI)

Question 4

What is the definition of a very rare side effect?

Answer 4

<1/10 000 exposures

Question 5

How do you detect a very rare side effect?

Answer 5

Pharmacovigilance for adverse events following immunizations

Question 6

What are the components of pharmacovigilance for adverse events following immunization?

Answer 6

1. requirements for post-market vaccine safety studies and surveillance
2. the Canadian adverse events following immunization surveillance system: passive, enhanced, and active (IMPACT)
3. International surveillance

Question 7

What are the objectives of the Canadian Adverse Events following Immunization Surveillance System (CAEFISS)?

Answer 7

1. To continuously monitor the safety of marketed vaccines in Canada
2. To identify increases in the frequency or severity of recognized AEFI
3. To identify previously unknown AEFIs that may possibly be related to vaccine
4. To identify areas that require further investigation and/or research
5. to provide timely information for analysts and policy makers on AEFI profiles for vaccines marketed in Canada

Question 8

What is the name of the active vaccine safety surveillance component?

Answer 8

Immunization Monitoring Program ACTive (IMPACT)

Question 9

Who does causality assessments for AEFIs in Canada?

Answer 9

The Public Health Agency of Canada