Novel Coronavirus Vaccine: Moderna Prepares for Phase 2 Study

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Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

600 participant Phase 2 study to begin upon IND acceptance and safety data from ongoingĀ NIH-led Phase 1 study

Moderna Press Release

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr. 27, 2020–Ā Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has submitted an Investigational New Drug (IND) application to theĀ U.S. Food and Drug AdministrationĀ (FDA) for the companyā€™s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2) to evaluate mRNA-1273 in Phase 2 and late-stage studies if supported by safety data from the Phase 1 study led by theĀ National Institute of Allergy and Infectious DiseasesĀ (NIAID), part of theĀ National Institutes of Health.



ModernaĀ has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020. This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each subject will be assigned to receive placebo, a 50 Ī¼g or a 250 Ī¼g dose at both vaccinations. The company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Participants will be followed through 12 months after the second vaccination.

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