Moderna Inc. shares /zigman2/quotes/205619834/composite MRNA +4.33% soared 16% in premarket trade Monday, after the biotech said its COVID-19 vaccine candidate met its primary endpoint in a Phase 3 trial, demonstrating 94.5% efficacy. The news was shared in a news release and has not yet been published as a preprint or in a peer-reviewed medical journal. The company said it plans to submit an Emergency Use Authorization with the U.S. Food and Drug Administration in the coming weeks and expects it to be based on the final analysis of 151 cases and a median follow-up for more than two months. The Phase 3 trial enrolled more than 30,000 participants in the U.S. and is being conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna said the primary endpoint of the Phase 3 trial is based on the analysis of COVID-19 cases starting two weeks after the second dose of vaccine. The first analysis was based on 95 cases with 90 cases in the placebo group and 5 in the mRNA-1273 group. The 95 cases were in older adults, aged 65 years old and up, and 20 participants identifying as coming from diverse communities, with 12 Hispanic or LatinX, 4 Black or African-American, and 3 Asian Americans and 1 multi-racial person. The trial did not report any significant safety concerns. Last week, Pfizer INnc. /zigman2/quotes/202877789/composite PFE -0.98% and partner BioNTech SE /zigman2/quotes/214419716/composite BNTX -2.94% said their vaccine candidate had achieved 90% efficacy in a Phase 3 trial, a far higher benchmark than originally expected. Shares have gained 357% in the year to date, while the S&P 500 /zigman2/quotes/210599714/realtime SPX -0.48% has gained 11%.