Moderna will apply Monday to Food and Drug Administration for emergency authorization for its coronavirus vaccine, the Cambridge, Mass.-based biotechnology giant announced.
Moderna will ask the FDA to review an expanded data set showing the vaccine 94.1% effective at stopping the coronavirus and 100% effective at preventing severe instances of the virus.
Moderna is expected to have about 20 million doses of its vaccine in the U.S. by the end of the year and is set to create 500 million to one billion doses worldwide in 2021, the drugmaker said in a release Monday.
Earlier this month, Pfizer became the first company to apply to the FDA for approval of a coronavirus vaccine, touting the 95% effectiveness of its candidate, which it developed with German partner BioNTech.
The FDA is expected to review Moderna and Pfizer’s applications in December, CNN reported.
As of Monday, the U.S. has approximately 13.4 million coronavirus cases and 267,000 related deaths — both tops globally — according to a Johns Hopkins University tracker.