Moderna Inc. is moving closer to having its COVID-19 vaccine candidate available for distribution, as the biotechnology company said Monday it plans to request an emergency-use authorization “today” from the U.S. Food and Drug Administration.
The announcement comes as Moderna unveiled that a primary analysis of the Phase 3 study of mRNA-1273 demonstrated a 94.1% efficacy rate. That is in line with the “high efficacy” of 94.5% announced two weeks ago from the first interim analysis.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Moderna Chief Executive Stephane Bancel. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death.”
Shares of Moderna /zigman2/quotes/205619834/composite MRNA +2.48% shot higher by 13.1% toward record territory in premarket trading. The stock closed Friday at a record $127.03, following a two-day surge of 28.9%. It had soared 88.3% this month through Friday, while the S&P 500 index /zigman2/quotes/210599714/realtime SPX -2.45% has gained 11.3%.
Moderna said mRNA-1273 continues to be generally well-tolerated, with no new serious safety concerns identified. The most common adverse reactions from mRNA-1273 have included pain at the injection site, fatigue, headache, muscle pain, joint pain and redness at the injection site. The adverse reactions increased in frequency and severity after the second dose.
The primary efficacy analysis announced Monday was conducted on 196 cases, compared with 95 cases in the first interim analysis. Of the 196 cases, 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group.
A secondary endpoint of the Phase 3 trial included 30 severe cases of COVID-19, all of which occurred in the placebo group. The company said there has been one COVID-19–related death in the study.
Moderna said it would submit for an emergency-use authorization, or EUA, with the FDA and an application for conditional marketing authorization with the European Medicines Agency. The company said it is working with the U.S. Centers for Disease Control and Prevention, the executive-branch “Operation Warp Speed” and McKesson Corp. /zigman2/quotes/206975466/composite MCK -3.96% to prepare for distribution of mRNA-1273 if the EUA request is OK’d. It expects to have about 20 million doses available in the U.S. by the end of the year, and it remains on track to make 500 million to 1 billion doses globally in 2021, it said.
Moderna said the COVE Phase 3 study of mRNA-1273 has enrolled more than 30,000 participants, and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.