Moderna Inc (NASDAQ: MRNA) announced late Friday it has dosed the first participants in a Phase 2 trial of its mRNA vaccine, codenamed mRNA-1273, against SARS-CoV-2, the virus that causes COVID-19.
Moderna's Vaccine Update
Cambridge, Massachusetts-based Moderna said first participants in the two cohorts — adults ages 18-55 and older adults ages 55 years and above — have been dosed.
The Phase 2 study sponsored by the company will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart, with each participant receiving placebo, a 50-microgram dose or a 100-microgram dose at both vaccinations.
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The company said the participants will be followed through 12 months after the second vaccination.
In mid-May, Moderna announced positive interim Phase 1 data from a NIAID-sponsored Phase 1 trial, showing dose-dependent increases in immunogenicity across three dose levels and between prime and boost within the 25-microgram and 100-microgram dose levels.
Citing the data, Moderna said in Friday's release that it decided not to pursue the 250-microgram dose level in the Phase 2 study.
The vaccine candidate has a Fast Track designation from the FDA. The company has received $483 million in funding from the BARDA for its coronavirus vaccine program. The company has also finalized an collaboration agreement with Swiss CDMO Lonza to enable manufacturing up to 1 billion doses of the vaccine per year.
What's Next For Moderna
Moderna said the NIH will submit the Phase 1 data to a peer-to-peer reviewed clinical publication.
The company now plans to start the Phase 3 study in collaboration with the NIH in July, subject to finalization of the clinical protocol.
MRNA Price Action
Moderna shares were trading 1.64% higher at $62.51 at the time of publication Monday.
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