Shots:

• Moderna has submitted the IND to the US FDA to evaluate its mRNA vaccine candidate (mRNA-1273) in a P-II and late-stage studies upon IND acceptance and safety data from the P-I study led by NIH. Moderna has received FDA’s initial feedback on the design of planned P-II study with its anticipated initiation in Q2’20.
• The study will evaluate the safety- reactogenicity and immunogenicity of two vaccinations of mRNA-1273 (50/250 μg) given 28days apart vs PBO in ~600 healthy people across two cohorts of adults aged 18-55 yrs. and adults aged≥ 55yrs. Participants will be followed through 12mos. after the second vaccination
• Following the data from P-I & P-II study- the company anticipates the initiation of P-III study in the fall of 2020. BARDA has funded these studies and will support the late-stage clinical development programs as well as the scale-up of mRNA-1273 manufacturing

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Moderna

Related News: BARDA Grants ~ $483M to Moderna for Accelerating the Development of mRNA-1273 Against COVID-19