Moderna Doses First Participants In Phase 2 Study Of Coronavirus Vaccine

Moderna Inc 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.

Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.

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. 

Related Links: 

Fauci Calls Moderna's Coronavirus Vaccine Candidate 'Quite Promising'

Moderna Expands Deal With CDMO To Source Raw Material For Coronavirus Vaccine