Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against COVID-19 Spike Protein; Phase 2 Trial in Preparation Now & Pivotal Phase 3 Trial Anticipated for July 2020

On May 18, 2020, Moderna, Inc., (Nasdaq: MRNA) ( a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Immunogenicity data are currently available for the 25-µg and 100-µg dose level (ages 18-55) after two doses (day 43) and at the 250-µg level (ages 18-55) after one dose (day 29). Dose-dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25-µg and 100-µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels sero-converted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25-µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100-µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants. At this time, neutralizing antibody data are available only 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 (PRNT) assays against live SARS-CoV-2.
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