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Moderna to Initiate P-II Study of mRNA-1273 Against Novel COVID-19

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Moderna to Initiate P-II Study of mRNA-1273 Against Novel COVID-19

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  • 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


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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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