Moderna to apply today for FDA authorization for its Covid-19 vaccine
Pharmaceutical company Moderna intends to apply Monday to the US Food and Drug Administration for authorization of its Covid-19 vaccine.
The company will ask the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19
and 100% effective at preventing severe cases of the disease
"This is striking," said Dr. Paul Offit, a member of the FDA's vaccine advisory committee. "These are amazing data."
Moderna's chief medical officer said he became emotional when he saw the data Saturday night.
"It was the first time I allowed myself to cry," Dr. Tal Zaks said. "We have a full expectation to change the course of this pandemic."
Moderna will become the second company to apply to the FDA for emergency use authorization for a coronavirus vaccine. Pfizer applied on November 20 with data showing similarly high efficacy.
The FDA will meet with its advisory committee in December to review Pfizer's and Moderna's applications.
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.