Moderna just asked the FDA to authorize its coronavirus vaccine, a key step before it can be given to more people
Added 11-30-20 05:14:03pm EST - “If the Food and Drug Administration authorizes Moderna's vaccine for emergency use, people could start getting shots in December.” - Businessinsider.com
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Posted By TheNewsCommenter: From Businessinsider.com: “Moderna just asked the FDA to authorize its coronavirus vaccine, a key step before it can be given to more people”. Below is an excerpt from the article.
Moderna has asked US regulators to allow the emergency use of its coronavirus vaccine, starting a process that could allow the shot to be given more widely within weeks.
The biotech company filed for emergency-use authorization with the US Food and Drug Administration on Monday, it said in a statement, about a week after Pfizer and BioNTech asked the FDA to authorize their vaccine. The company is also seeking authorization from regulators in other countries.
Moderna said its vaccine was 94.1% effective at preventing COVID-19, the disease caused by the new coronavirus, in an analysis of 196 COVID-19 cases from a 30,000-person trial. The company said on November 16 that the vaccine was 94.5% effective, in an earlier analysis from that trial.
"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 CEO Stéphane Bancel said in the statement.
Vaccines developed by Moderna and by Pfizer are likely to be the first immunizations that can help the US stop the COVID-19 pandemic. Pfizer has said its shot was 95% effective at preventing COVID-19. The US surpassed records for coronavirus infections and COVID-19 hospitalizations in November. More than a quarter of a million Americans have died from COVID-19.
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