Moderna Inc. (MRNA) - Get Report said Monday it will ask the U.S. Food & Drug Administration for emergency approval of its coronavirus vaccine later today, adding that late-stage trial data showed a 100% effectiveness rate against severe forms of the respiratory virus.
Moderna said the FDA has set a meeting data of December 17 to consider its application, one week to the day after a similar date was set to assess the Emergency Use Authorization application filed last week by Pfizer Inc. (PFE) - Get Report and its German partner BioNTech (BNTX) - Get Report.
Vaccinations, Moderna said, could being 'within 24 hours' of FDA approval.
“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. 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,” said CEO Stéphane Bancel . “I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus."
"I would again like to thank our partners at NIH, NIAID, BARDA and Operation Warp Speed who have helped us advance the clinical development of mRNA-1273," he added. "Finally, I want to thank the Moderna team and our suppliers and partners for their tireless work on the research, development and manufacturing of our vaccine."
Moderna shares were marked 13.2% higher in early trading following new of the FDA application to change hands at $143.75 each.
Moderna, which is using so-called 'messenger RNA' techniques for its vaccine candidate, reiterated that it could have 20 million doses available for the U.S. market this year, as well as a total supply of between 500 million and 1 billion doses worldwide next year.