Index Entries

Lindsey R. Baden, Hana M. El Sahly, Brandon Essink, Karen Kotloff, Sharon Frey, Rick Novak, David Diemert, Stephen A. Spector, Nadine Rouphael, C. Buddy Creech, John McGettigan, Shishir Khetan, Nathan Segall, Joel Solis, Adam Brosz, Carlos Fierro, Howard Schwartz, Kathleen Neuzil, Lawrence Corey, Peter Gilbert, Holly Janes, Dean Follmann, Mary Marovich, John Mascola, Laura Polakowski, Julie Ledgerwood, Barney S. Graham, Hamilton Bennett, Rolando Pajon, Conor Knightly, Brett Leav, Weiping Deng, Honghong Zhou, Shu Han, Melanie Ivarsson, Jacqueline Miller, and Tal Zaks
December 30, 2020
New England Journal of Medicine (NEJM)
Moderna, Inc.

“The primary end point was the efficacy of the mRNA-1273 vaccine in preventing a first occurrence of symptomatic Covid-19 with onset at least 14?days after the second injection in the per-protocol population, among participants who were seronegative at baseline…

A secondary end point was the efficacy of mRNA-1273 in the prevention of severe Covid-19… Additional secondary end points included the efficacy of the vaccine at preventing Covid-19 after a single dose or at preventing Covid-19 according to a secondary (CDC), less restrictive case definition…”

Note: Efficacy against SARS-CoV-2 transmission/infection and COVID-19 mortality were not endpoints (i.e., tested outcomes).

document
COVID-19,FDA approvals,manufacturers,clinical trial endpoints,clinical trials,vaccines,mRNA