Moderna is finalizing the protocol for a phase 3 trial of its COVID-19 vaccine with a view to starting the study early in the summer. The establishment of the timeline, which follows FDA clearance to run a phase 2 trial, puts Moderna on track to win approval for its mRNA vaccine mRNA-1273 next year.
Having been the first group to start testing a vaccine against SARS-CoV-2, Moderna is now on the cusp of phase 2. With the FDA having completed its review of the IND, Moderna expects to start the 600-subject phase 2 “shortly.”
The phase 3 is following closely behind. Moderna is currently finalizing the protocol for the pivotal trial.