Moderna intends to apply today to the FDA for authorization of its COVID vaccine asking it to review an expanded data set showing the vaccine is 94.1% effective.
The company says the vaccine is 100% effective at preventing severe cases of the disease. Dr. Paul Offit, a member of the FDA‘s vaccine advisory committee says,
“This is striking. These are amazing data.”
Moderna’s chief medical officer, Dr. Tal Zaks said he became emotional when he saw the data Saturday night,
“It was the first time I allowed myself to cry. We have a full expectation to change the course of this pandemic.”
Moderna President Dr. Stephen Hoge told Time magazine,
“I personally feel this is an incredible milestone.
But the goal is to stop the pandemic, and we need to deliver 100 million doses, then the second 100 million doses after that. There is a sense we are still fighting the war”
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.
According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the first vaccinations in the U.S. are expected to take place
“towards the latter part of December.”
The FDA is scheduled to meet with its Vaccines and Related Biological Products Advisory Committee on December 10 to review Pfizer’s application and on December 17 to review Moderna’s application.