Moderna begins Phase 1 study dosing for new, refrigerator stable COVID-19 mRNA vaccine

The first candidates were dosed this week as part of a phase one study of mRNA-1283, a new mRNA COVID-19 vaccine from Moderna, Inc.

Unlike its predecessor, which has proved highly effective against the original strain of the virus, this new vaccine candidate is meant to solve a major hiccup to transportation and storage: temperature stability. Moderna’s currently authorized vaccine requires deep-freeze storage, as does another mRNA vaccine from Pfizer Inc. However, Moderna hopes to make mRNA-1283 refrigerator stable to make it easier for distribution and administration by healthcare providers.

“We are pleased to begin this Phase 1 study of our next generation COVID-19 vaccine candidate, mRNA-1283,” Moderna CEO Stéphane Bancel said. “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 potentially for developing countries. We remain committed to helping address this ongoing public health emergency.”

In its current study, mRNA-1283 will be evaluated across three dose levels: 10 µg, 30 µg, and 100 µg. All but the 100 µg regimen will be given in two doses, 28 days apart, to healthy adults. The 100 µg regimen will be given as a single dose. This will pit them against the current mRNA-1273, which is distributed as a 2-dose series of 100 µg under Food and Drug Administration (FDA) authorization.

If successful, mRNA-1283 could be utilized as a booster dose for the previously vaccinated, in addition to its use as a primary injection for those in need.

The phase one study will focus on the assessment of safety and immunogenicity. The candidate works by neutralizing portions of the SARS-CoV-2 spike protein, encoding the Receptor Binding Domain and N-terminal Domain.