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. If the phase 2 and other preparations go as planned, Moderna could get the pivotal clinical trial underway early in the summer, setting it up to gather the data it needs to potentially win full FDA approval for the vaccine next year.
