Moderna Gets FDA Fast-Track Nod for Coronavirus Vaccine Phase 2 Trial

Moderna receives fast-track consent from the U.S. Food and Drug Administration to proceed with a phase 2 trial of its coronavirus vaccine candidate.
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Biopharmaceutical giant Moderna  (MRNA) - Get Report on Tuesday announced that it has received fast-track approval from the Food and Drug Administration to proceed with a phase 2 trial of its coronavirus vaccine candidate.

The vaccine candidate, named mRNA-1273, has so far shown promising signs in initial phase 1 tests, and will now proceed to a phase 2 trial involving 600 healthy patients, 300 between the ages of 18 and 55 and another 300 aged 55 years and up, the company said in a statement.

The Phase 2 study will evaluate the “safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart,” the company said, noting participants will be assigned both a placebo and different doses of the vaccine. Participants will be followed through 12 months after the second vaccination.

“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,” said Tal Zaks, Moderna’s chief medical officer.

Moderna also is finalizing a Phase 3 study, expected to begin in the early summer. The company initially announced its expectations on receiving fast-track approval on both phases in its quarterly earnings released last week.

Moderna is already known for its work in vaccines that treat and prevent other types of infectious diseases, including the flu, but also more-malignant diseases such as malaria and the ziki virus.

Part of its current efforts also include vaccines for pediatric respiratory syncytial virus (RSV), an Epstein-Barr virus (EBV) vaccine and an antibody against the chikungunya virus.

Shares of Moderna were down 2.75% at $65.06 in trading on Tuesday.