Moderna applied to US FDA for an emergency use authorization of its COVID-19 vaccine.
Moderna on Monday applied to the Food and Drug Administration in the United States (US FDA) for emergency use authorization (EUA) of its COVID-19 vaccine.
This, as Moderna asked the US FDA to review an expanded data set showing that the COVID-19 vaccine was 94.1% effective at preventing coronavirus disease and 100% effective at avoiding severe cases of the disease.
Moderna on Monday officially released an updated efficacy data for its Phase 3 clinical trials wherein it showed that its COVID-19 vaccine at preventing COVID-19.
With this, the chief medical officer of Moderna said that he became emotional when he saw the vaccine data on Saturday night.
According to Dr. Tal Zaks, it was the first time he allowed himself to cry as they had a “full expectation to change the course” of the coronavirus pandemic.
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Moderna was the second company to apply to the Food and Drug Administration for emergency use authorization for a COVID-19 vaccine.
To recall, Pfizer applied last November 20 with vaccine data showing similarly high efficacy.
The Food and Drug Administration would meet with its advisory committee in December in order to review Pfizer’s application on December 10 and to review Moderna’s application on December 17.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the first vaccinations in the United States were expected to take place “towards the latter part of December”.
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