Question

1) One question discussed there: can we just give vaccines that show promise in animal studies/preclinical data given this urgent need?
2) there is the interesting scientific data on the population response to the virus (children vs. adult vs. elderly) - how would a clinical trial be affected if enrolling adults vs. elderly? and how the generalizability of the findings be applicable?

Answer 1

1: No, we cannot give vaccines to human eventhough they have shown promise in animal studies as the preclinical data would suggest. The vaccine has to be tested in humans for its safety, immunogenicity, effectiveness, dosage and side effects in the various phases of clinical trials involving human subjects. The immunogenicity data of preclinical studies are used to optimise vaccine regimes in clinical trials on human. Preclinical study conducted on animal models along with study of safety and immunogenicity in phase I and IIa clinical trials on human are the the main criteria which is used to decide which vaccines will progress to human efficacy testing. Other criteria which has to be taken into account are vaccine candidate feasibility, it's its effect on target, its characterization and standardisation, it's manufacturing costs, the cost of final product, it's impact on health system, regulatory affairs and business strategies.