Moderna has announced that they are finally ready to request emergency clearance from the Food and Drug Administration (FDA) as they are confident in their 94 percent effective rate in preventing COVID-19 safely. This will make Moderna the second drugmaker to seek emergency use from the FDA, 10 days after Pfizer.
The company is set to ask the FDA no later than Monday, November 30, to review an expanded data set showing the vaccine is 94.1 percent effective at preventing COVID-19 and 100 percent effective at preventing severe cases of the disease.
Moderna’s chief medical officer, Dr. Tal Zaks, said that he became emotional when he saw the data the night of Saturday, November 28. “It was the first time I allowed myself to cry,” Zaks said. “We have a full expectation to change the course of this pandemic.”
“This is striking,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory committee. “These are amazing data.”
Possible side effects
Moderna said that its vaccine trials covered a wide-span of Americans including 33 of the 196 confirmed cases were over the age of 65 and 42 were from Black, Latino, and other diverse ethnicities.
The vaccine was also well tolerated with the most common side effects being fatigue, muscle pain, headache, and pain at the injection site, the company said.
The first vaccinations in the United States are expected to take place “towards the latter part of December,” according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
Moderna said it also plans to apply for authorization from the European Medicines Agency on Monday.