Positive interim Phase 1 data from Moderna's SARS-CoV-2 vaccine, the first to be tested in the U.S., showed that it produced protective antibodies in a group of eight healthy volunteers.
The trial of 45 volunteers is being led by the National Institute of Allergy and Infectious Diseases. Today, Moderna announced that neutralizing antibody data are available for the first four participants in each of the 25 µg and 100 µg dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization assays against live SARS-CoV-2.
Additionally, mRNA-1273 was generally safe and well tolerated — no grade 4 adverse events or serious adverse events have been reported.
Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies. The NIAID-led Phase 1 study is being amended to include a 50 µg dose level cohort across each of the three age groups.
Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects to start Phase 3 trials in July.
Read the press release
Read more about vaccine production progress in our cover story, The billion dose dash.
