Moderna, which reported a 100% efficacy rate against severe forms of COVID-19 from late-stage trials of its mRNA-based vaccine on Monday, will likely get a decision from the European Medicines Agency (EMA) on January 12, officials indicated. A similar application was made by Pfizer PFE and its German partner BioNTech BNTX earlier Tuesday, with the EMA indicating a final verdict on December 29.
Moderna filed its Emergency Use Authorization application with the U.S. Food & Drug Administration Monday, with an assessment scheduled for December 17.
Moderna shares were marked 13.5% higher in early trading Tuesday to change hands at $173.40 each, an all-time high that extends the stock's six-month gain to around 175% and takes it market value to just under $70 billion.
Moderna said its vaccine hit an overall efficacy rate of 94.1% efficacy rate, nearing the 95% threshold reported by Pfizer last week, and noted that it can last for up to six months when stored at standard freezer temperatures of -4 degrees Fahrenheit, compared to the -94 degree temperatures required for the Pfizer vaccine.
Contracts with the U.S. government, as part of Operation Warp Speed, as well as those signed with Britain and the European Union, provided an early revenue boost for the Cambridge, Massachusetts-based biotech, while extended orders into 2021 and beyond could boost its topline to around $4.5 billion, analysts have estimated.
Modena said 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.