Vaccine Development + Evaluation Flashcards
What are the main two stages of development for vaccine
Preclinical research
Clinical trials
What are the 2 stages of pre-clinical research?
step 1: ID infectious agent: understand its epidemiology + patho of disease, its causes + conduct research on Ag etc
Step 2: Animal research: used to determine immunogenicity (what response you need to prevent disease) + safety
—— may include challenge studies when animals intentionally infected with target micro
What are the 3 stages of clinical trials ? How many people are in each
Phase 1: 10-100+ healthy volunteers
- done to help understand vaccine immunogenicity
Phase 2: 50-500 volunteers (normally healthy)
- done to help determine optimal dose + schedule in target pop
- safety monitoring
Phase 3: 300-30,000 volunteers: determine efficacy in target pop
Where do manufacturers need to submit their new drug submission once done research ?
BGTD
What info needs to be included in new drug submission
preclinical and clinical trials info
details of production methods
packaging + labelling details for proposed monograph
evidence regarding therapeutic claims + SEs
What does BGTD do once review NDS
on site evaluation of production facility + lab testing in 3-5 consecutive lots
—- determine if following FDA guidelines; if so = submit notice of compliance + get DIN
What activities are included in pharmacovigilance
activities that detect, assess, understand and communicate AEs following immunization (AEFI) + other vaccine related or immunization related issues + to prevent unwanted effects of vaccines + immunization
Benefits of pharmacovigilance
- can ID changes in freq or severity of previously seen vaccine related reactions
- ID rare reaction that are only detectable when used in large pop
- ID areas that require further investigation to determine if changes in vaccine use needed
What is the Lot Release program
part of vaccine pharmacovigilance
- BGTD testing of each lot of vaccine produced before it can be released for use
What are the main programs of vaccines pharmacovigilance
- lot release program
- inspections of manufacturing facilities
- expanded safety-related data collections
- AEFI surveillance systems
- post marketing studies
How often are inspections of the manufacturing facilities done
done every 2-3 yrs
What is the importance of expanding safety-related data collection for vaccines
may include scientific or epidemiological studies that examine the safety profile of the vaccine in pops not studied in trials OR look for interactions
What does the AEFI surveillance system do
- detect vaccine safety signals
- these signals are then investigated to determine root cause
Post marketing studies: what are they
pop based epidemiological studies, RCT, or investigation of individual case reports to ID rare AEFIs and determine whether or not they are due to vaccine
What are the 2 main AEFI surveillance programs for Canada
Canada Vigilance Program
CAEFISS: includes passive and active surveillance
