Moderna’s COVID-19 Vaccine Grabs Fast-Track Designation From FDA

The FDA has granted Moderna’s COVID-19 vaccine candidate a fast-track designation, making it the first potential vaccine to receive the agency’s expedited review status.

The company is finalizing the protocol for a phase 3 study of the vaccine, mRNA-1273. The phase 3 trial is expected to begin in early summer.

The FDA has approved a phase 2 trial of the COVID-19 vaccine candidate in approximately 600 participants. Moderna is currently awaiting the full results from a phase 1 study being led by the NIH’s National Institute of Allergy and Infectious Diseases.

Moderna previously received fast-track designations for three other messenger RNA vaccine programs, including its investigational Zika vaccine. It hopes to have the COVID-19 vaccine approved in early 2021 (DID, May 8).

Other frontrunners in the race to develop a COVID-19 vaccine include Pfizer and BioNTech. The two companies recently launched a phase 1/2 study to assess four vaccine hopefuls in a single, continuous trial (DID, May 6). — James Miessler