Moderna’s Second Generation COVID-19 Vaccine Candidate Launches Study
Massachusetts-based Moderna, Inc. announced participants had been dosed in a news Phase 1 study of mRNA-1283, the Company’s next-generation COVID-19 vaccine candidate.
The mRNA-1283 vaccine candidate encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain (RBD) and N-terminal Domain.
The encoded mRNA-1283 antigen is being developed as a potentially refrigerator-stable mRNA vaccine that will facilitate distribution and administration by healthcare providers.
This Phase 1 study will evaluate three dose levels, 10 µg, 30 µg, and 100 µg, of the mRNA-1283 vaccine candidate given to healthy adults as a 2-dose series, 28 days apart, and one dose level, 100 µg, of mRNA-1283 given to healthy adults in a single dose. These will be compared with a 2-dose series of 100 µg of mRNA-1273, the currently authorized dose level. mRNA-1283 is intended to be evaluated in futures studies for use as a booster dose for previously vaccinated or seropositive and in a primary series for seronegative individuals.
Stéphane Bancel, Chief Executive Officer of Moderna, stated in a press release issued on March 15, 2021, “Our investments in our mRNA platform have enabled us to develop this next generation vaccine candidate, which is a potential refrigerator-stable vaccine that could facilitate easier distribution and administration in a wider range of settings, including potential for developing countries."
The Moderna COVID-19 Vaccine is currently authorized for use under a U.S. FDA Emergency Use Authorization for active immunization to prevent COVID-19 in individuals 18 years of age and older. Moderna COVID-19 Vaccine is investigational and has not been approved by FDA.