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Moderna Shares Surge After Seeking FDA Approval for COVID Vaccine

Moderna said its coronavirus vaccine showed a 100% effectiveness rate against severe forms of COVID 19 in late-stage trials with no serious side-effects.

Moderna Inc.  (MRNA) - Get Moderna Inc. 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 Pfizer Inc. Report and its German partner BioNTech  (BNTX) - Get BioNTech SE 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."

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"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.