In what will be of little surprise to anyone, the FDA has hitched its fast-track tag to Moderna’s speedy attempt at an mRNA COVID-19 vaccine.
The label, which aims to help speed up the time a new drug or vaccine takes to hurdle the normal regulatory barriers, is specifically for mRNA-1273, which is hoping for a phase 3 summer trial to assess whether it can protect people from COVID-19.
“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “As we await the full set of clinical data from the NIAID-led phase 1 study, we are actively preparing for our phase 2 and phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”
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 among the first 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.”
It is in competition with two German rival biotechs: CureVac and Pfizer-partnered BioNTech, which are also both using mRNA tech for their COVID-19 vaccines, though Moderna is further down the development line.