For those interested, this article see attached just appeared in N Engl J Med This article describes the Phase 1, dose-escalation, open-label trial — including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273in a dose of 25 μg, 100 μg, or 250 μg. Adverse reactions were reported.
There were 15 participants in each dose group. I’m not an expert on Phase 1 trials, but these findings apparently rendered the vaccine sufficiently safe to proceed with the much large Phase 2 clinical trials. 😊
An mRNA Vaccine against SARS-CoV-2 — Preliminary ReportL.A. Jackson, E.J. Anderson, N.G. Rouphael, P.C. Roberts, M. Makhene, R.N. Coler, M.P. McCullough, J.D. Chappell, M.R. Denison, L.J. Stevens, A.J. Pruijssers, A. McDermott, B. Flach, N.A. Doria-Rose, K.S. Corbett, K.M. Morabito, S. O’Dell, S.D. Schmidt, P.A. Swanson II, M. Padilla, J.R. Mascola, K.M. Neuzil, H. Bennett, W. Sun, E. Peters, M. Makowski, J. Albert, K. Cross, W. Buchanan, R. Pikaart-Tautges, J.E. Ledgerwood, B.S. Graham, and J.H. Beigel, for the mRNA-1273 Study Group*