Approval of the Pfizer and Moderna COVID mRNA vaccines by th…
Approval of the Pfizer and Moderna COVID mRNA vaccines by the FDA required they be tested in formal clinical trials. Using the randomized controlled trials of the COVID mRNA vaccines as a case study example… Indicate the various phases of a clinical trial, and for each phase- describe the broader goal or objective of the phase, the approximate number of subjects expected to be enrolled, whether there is a placebo control, what a logical primary outcome would be, what a secondary outcome(s) might be, and how what gets measured in the subjects as outcomes would be expected to change/evolve through the phases. Assume the goal is to achieve FDA-approval for use in humans, and there was no prior experience with mRNA-based vaccines in this context.
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