Moderna’s mRNA-1273 Receives the US FDA’s Fast Track Designation to Treat COVID-19

Shots:

• The US FDA has granted the FT designation to the Moderna’s mRNA vaccine (mRNA-1273) candidate against COVID-19. FT designation is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need
• On May 06, 2020, the FDA has completed its review of mRNA-1273’s IND, allowing to continue to a P-II study, which is expected to begin shortly while the company is finalizing the protocols for a P-III study, anticipated to be initiated in early summer of 2020
• The P-II study will evaluate two vaccinations of mRNA-1273 (50μg/250μg) vs PBO given 28days apart, followed through 12mos. after the second vaccination and is expected to enroll ~600 patients across two cohorts aged 18-55yrs. & 55+yrs.  The FT designation marks Moderna’s fourth FT designation following its mRNA-1893, mRNA-3704 and mRNA-3927) programs

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: CBS Boston

Related News: Moderna Anticipates the Initiation of P-III Study of mRNA-1273 for COVID-19 by Early Summer