US FDA's Spikevax Review By The Numbers
Executive Summary
A timeline of the development and approval of Moderna's mRNA vaccine, and a listing of FDA reviewers on the biologics license application.
Elsewhere in this Drug Review Profile, the Pink Sheet examines how the US Food and Drug Administration took the Omicron variant's predominance into account in its review and January approval of Moderna, Inc.'s COVID-19 vaccine Spikevax. (Also see "COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US" - Pink Sheet, 3 May, 2022.)
Below is the clinical development review timeline and a table of the agency reviewers involved.