BIOL 459 Final Exam V2 Canada’s Vaccine
Safety system (Latest 2026/ 2027 Update)
Actual Questions & Answers | 100% Verified |
Grade A | Complete Solutions
How does formaldehyde work?
modifies protein and disrupts the viral RNA (because it is shorter) so the inactivated virus binds
less
what was the the cutter labs case
they produced a defective salk polio vaccine that incompletely inactivated the virus with
formaldehyde causing several incidences of vaccine induced polio
how many children infected, developed muscle weakness, became paralyzed, died, and were
indirectly infected as a result of the cutter labs incompletely inactivated polio vaccine
220 000 infected, 70 000 muscle weakness, 164 paralyzed, 10 dies, 100 000 indirectly infected
4 results from congressional hearings about the cutter lab case
error and failure of oversight that guided the development of safety guidelines
cutter did not validate the salk process in their own facility
filtration, storage and inactivation were all inadequate
9/27 lots failed safety tests but were not reported to the regulator
what is the basis for product approval
clinical trials
, BIOL 459 Final Exam V2 Canada’s Vaccine
Safety system (Latest 2026/ 2027 Update)
Actual Questions & Answers | 100% Verified |
Grade A | Complete Solutions
what does the pre-clinical trial involve
development of vaccine in lab with animal models (deals with animal care committee)
what levels of clinical trials involve human subjects
1,2,3,4
what did the WHO advise in 2006
all clinical trials should be registered on the minimum data set that should be made publicly
available --> actually happened in 2007
phase 1 clinical trials involves how many people, tests what
less than 50, preliminary safety data and confirmation of desired immune response
Phase 2 clinical trials
few hundred participants, samples are randomized, optimal dose schedule, vaccine formulation
(eg. with or without an inhibitor)
Safety system (Latest 2026/ 2027 Update)
Actual Questions & Answers | 100% Verified |
Grade A | Complete Solutions
How does formaldehyde work?
modifies protein and disrupts the viral RNA (because it is shorter) so the inactivated virus binds
less
what was the the cutter labs case
they produced a defective salk polio vaccine that incompletely inactivated the virus with
formaldehyde causing several incidences of vaccine induced polio
how many children infected, developed muscle weakness, became paralyzed, died, and were
indirectly infected as a result of the cutter labs incompletely inactivated polio vaccine
220 000 infected, 70 000 muscle weakness, 164 paralyzed, 10 dies, 100 000 indirectly infected
4 results from congressional hearings about the cutter lab case
error and failure of oversight that guided the development of safety guidelines
cutter did not validate the salk process in their own facility
filtration, storage and inactivation were all inadequate
9/27 lots failed safety tests but were not reported to the regulator
what is the basis for product approval
clinical trials
, BIOL 459 Final Exam V2 Canada’s Vaccine
Safety system (Latest 2026/ 2027 Update)
Actual Questions & Answers | 100% Verified |
Grade A | Complete Solutions
what does the pre-clinical trial involve
development of vaccine in lab with animal models (deals with animal care committee)
what levels of clinical trials involve human subjects
1,2,3,4
what did the WHO advise in 2006
all clinical trials should be registered on the minimum data set that should be made publicly
available --> actually happened in 2007
phase 1 clinical trials involves how many people, tests what
less than 50, preliminary safety data and confirmation of desired immune response
Phase 2 clinical trials
few hundred participants, samples are randomized, optimal dose schedule, vaccine formulation
(eg. with or without an inhibitor)
