The Cambridge, Mass., drugmaker already had begun the review process with the ministry and was awaiting review for emergency-use authorization in the U.S.
On Monday, Moderna said that its late-stage, or Phase 3, trial of its vaccine in 196 cases confirmed a 94.1% efficacy rate, nearing the 95% threshold reported by Pfizer (PFE) - Get Report for its vaccine. The Phase 3 trial involves more than 30,000 participants.
The company also noted that its product can last as long as six months when stored at standard freezer temperatures of minus-4 degrees Fahrenheit, compared with the minus-94 degree temperature the Pfizer vaccine requires.
Moderna also said that it was working to increase manufacturing to deliver around 500 million doses of its vaccine a year, and perhaps up to 1 billion doses a year, starting in 2021.
Moderna shares had surged to a record on Tuesday after the biotech filed for marketing approval from European health authorities for its coronavirus vaccine
The company, which on Monday reported a 100% efficacy rate against severe forms of covid-19 from late-stage trials of its mRNA-based vaccine, will likely get a decision from the European Medicines Agency on Jan. 12, officials indicated.
Moderna on Monday filed its application for emergency use with the U.S. Food and Drug Administration, with an assessment scheduled for Dec. 17.