Moderna asks FDA for emergency approval of COVID-19 vaccine, second company to pass milestone
Thomas Catenacci, DCNF
Pharmaceutical company Moderna announced Monday that it will submit its coronavirus vaccine to the federal government for emergency use authorization approval.
Moderna said it would ask the Food and Drug Administration (FDA) for approval after its large-scale human trial concluded and showed the company’s vaccine to have an overall efficacy of 94.1%, according to NBC News. The vaccine was found to be 100% effective in preventing severe cases of coronavirus, according to Moderna.
“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,” Moderna Chief Executive Officer Stéphane Bancel said, according to a Monday press release.
Moderna is the second company to seek emergency approval for a coronavirus vaccine after Pfizer requested FDA approval Nov. 20, the company announced. Following the announcement Monday, President Donald Trump tweeted that the FDA “must act quickly.”
Moderna now applying for Emergency Vaccine Approval.. @US_FDA MUST ACT QUICKLY!!! “Operation Warp Speed has been a great modern day miracle.”
— Donald J. Trump (@realDonaldTrump) November 30, 2020
Trump celebrated the progress of Operation Warp Speed, the federal government’s multiagency effort to produce a coronavirus vaccine quickly, during a news conference on Nov. 13. Moderna received $2.48 billion in research and supply funding related to its coronavirus vaccine development from the Trump Administration, according to Fierce Pharma.
Average coronavirus cases and deaths per million have been increasing rapidly nationwide for several weeks, according to The COVID Tracking Project. On Sunday, the U.S. reported 801 new coronavirus-related deaths and 134,184 new cases while 93,219 Americans remained hospitalized from the virus.
National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci warned on Sunday that the U.S. is approaching another significant coronavirus surge after millions of Americans traveled and attended gatherings for Thanksgiving.