Module 3 - Vaccine Development & Evaluation

Question 1

What does the BGTD do?

Answer 1

Biologics and Genetic Therapies Directorate

• once the vaccine manufacturers has completed all the clinical trials necessary, they submit their data to the BGTD
• BGTD is the federal authority that regulates biological drugs for human use

Question 2

What are the key roles of BGTD?

Answer 2

• approving vaccine and monograph and issuing a vaccine DIN
• evaluating the production process and inspecting the production facilities to determine if they are suitable
• testing each batch of vaccine to ensure it meets safety and potency standards
• monitoring safety after release with Public Health Agency of Canada and the manufacturers

Question 3

Do BGTD make recommendations on the use of individual vaccines?

Answer 3

No - that is done by the National Advisory Committee on Immunization (NACI)

Question 4

What is NACI composed of?

Answer 4

12 voting members who are knowledgeable in the field of immunization practices, have multidisciplinary expertise in public health and in the use of vaccines and prophylaxis agents for the prevention of vaccine-preventable diseases

Question 5

What are some of NACI’s responsibilities?

Answer 5

• review of the product monograph
• thorough review of the scientific literature on the burden of disease, vaccine characteristics, and additional various factors
• review of the recommendations of other groups
• grading and reporting the level of evidence associated with its recommendations

Question 6

After the manufacturer researches the vaccine and conducts preclinical trials and safety testing, the _____ receives the clinical information from the manufacturer and reviews the info, inspects the manufacturing facilities and if satisfactory, approves the vaccine and it’s monograph

Answer 6

BGTD (biologics and genetic therapies directorate)

Question 7

After that, _____ is a group of clinical experts that advises the Public Health Agency of Canada on appropriate use of the vaccine based on their extensive literature search and analysis

Answer 7

NACI (national advisory committee on immunization)

Question 8

After that, the _____ is a national body that provides leadership and gives advice and recommendations on the implementation of the national immunization strategy and vaccine programs

Answer 8

CIC (canadian immunization committee)

Question 9

After that, _____ immunization committees are responsible for determining how a vaccine should be used in a province or territory and if the vaccine will be publicly funded.

Answer 9

provincial

Question 10

Describe passive surveillance

Answer 10

spontaneous reporting of adverse events by providers or recipients

Question 11

Describe active surveillance

Answer 11

ongoing watch and reporting of severe adverse events following childhood immunization

Question 12

CAEFISS is an important and ____ surveillance system

Answer 12

passive

*i.e. places the responsibility of reporting on immunizers, patients and parents/gaurdians

Question 13

What is IMPACT?

Answer 13

an active surveillance program (Immunization Monitoring Program ACTive)

• in teaching hospitals, a nurse actively reviews all admissions to the hospital for certain serious illnesses such as seizures, encephalitis, encephalopathy and acute paralysis
• they obtain immunization records to see if any of these events could be linked to vaccinations